Part 1.
TEXAS DEPARTMENT OF HEALTH
Chapter 37.
MATERNAL AND INFANT HEALTH SERVICES
Subchapter D. NEWBORN SCREENING PROGRAM
25 TAC §37.52, §37.53
The Texas Department of Health (department) proposes amendments
to §§37.52 and 37.53, concerning the Newborn Screening Program.
Specifically, §37.52 concerns definitions, and §37.53 concerns conditions
for which newborn screening tests are required. Section 37.53(2) requires
that all newborns delivered in Texas shall be subjected to two screening tests
for galactosemia. The term "galactosemia" includes three different but related
conditions. Galactosemia caused by abnormal levels of the enzymes epimerase
and kinase may be associated with cataracts, but only classical galactosemia,
or galactose-1-phosphate uridyltransferase deficiency, is life-threatening.
The proposed amendments to §37.52 and §37.53 will enable the department
to discontinue testing for the other two forms of galactosemia and to screen
for only galactose-1-phosphate uridyltransferase deficiency.
Margaret Drummond-Borg, M.D., Director, Genetic Screening and Case Management
Division, has determined that for each year of the first five-year period
the sections are in effect, there will be no fiscal implications to the state
as a result of enforcing or administering the sections as proposed. Although
the proposed amendments will result in approximately $9,747 per year in savings
because one-time use of certain laboratory consumables necessary to test blood,
such as microtiter plates and pipette tips, will be discontinued, those savings
will be offset by increased mailing costs for returning specimens to the newborn
screening laboratory and higher costs for reagents. There will be no fiscal
implications to local governments because the department's laboratory performs
all testing for the newborn screening program.
Dr. Drummond-Borg has also determined that for each year of the first five
years the sections are in effect, the public benefit anticipated from amending
these sections will be less need for expensive confirmatory tests by metabolic
specialists, and fewer errors and/or unsatisfactory results from tests performed
by the department's laboratory. There will be no costs to small businesses
or micro-businesses, no costs to persons required to comply with these sections,
and no effect on local employment, because all newborn screening testing is
performed by the department's laboratory.
Comments on the proposal may be submitted to Margaret Drummond-Borg, M.D.,
Director, Genetic Screening and Case Management Division, Texas Department
of Health, 1100 West 49th Street, Austin, Texas, 78756, (512) 458-7443, fax
(512) 458-7350. Comments will be accepted for 30 days following publication
of this proposal in the
Texas Register
.
The amendments are proposed under the Health and Safety Code, §33.002,
which directs the Texas Board of Health (board) to adopt a rule specifying
diseases to be included in the newborn screening program in addition to phenylketonuria
and hypothyroidism; and the Health and Safety Code, §12.001, which provides
the board with the authority to adopt rules for the performance of every duty
imposed by law on the board, the department, and the commissioner of health.
The amendments affect the Health and Safety Code, Chapter 33.
§37.52.Definitions.
The following words and terms, when used in these sections, shall have
the following meanings, unless the context clearly indicates otherwise.
(1) - (5)
(No change.)
(6)
Galactose-1-phosphate uridyltransferase deficiency
[
(7) - (15)
(No change.)
§37.53.Conditions for Which Newborn Screening Tests Are Required.
Except as permitted in §37.54 of this title (relating to Exemption
from Screening), all newborns delivered in Texas shall receive two screening
tests for the following conditions:
(1)
(No change.)
(2)
galactose-1-phosphate uridyltransferase deficiency
[
(3) - (5)
(No change.)
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State on March 11, 2004.
TRD-200401856
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 458-7236
25 TAC §38.10
The Texas Department of Health (department) proposes an amendment
to §38.10, concerning the payment of services in the Children with Special
Health Care Needs Services (CSHCN) Program. The amendment changes correction
and resubmission deadlines for denied claims.
Because the claims payment contractor and many of the providers are the
same for Medicaid and for the CSHCN Program, and for simplification of procedures,
claims processing deadlines for the CSHCN Program have historically been the
same as those for the Medicaid program. The Medicaid program recently adopted
changes to its deadlines at 1 Texas Administrative Code, §354.1003(b)-(c),
and the amendment to §38.10 will make the CSHCN rule consistent with
those changes.
Specifically, §38.10(1)(B)(ii) is amended by changing the denied claim
correction and resubmission deadline from 95 to 120 days and by adding language
to clarify that the deadline is calculated from the date of the last denial
of or adjustment to the original claim. Paragraphs (3) and (5) are amended
by changing the language that specifies the type of deadline exception.
Lee Johnson, Director, Financial Management Division, has determined that
for each year of the first five years the section is in effect, there will
be no fiscal implications to state government as a result of enforcing or
administering the section as proposed, because the correction and resubmission
deadline component of the claims payment system functions neither to the advantage
nor to the disadvantage of the state in considering a claim. The correction
and resubmission deadline may apply more than once in the consideration of
a claim, and therefore changing the deadline from 95 to 120 days should have
no effect on the number of complete, correct claims ultimately paid. There
will be no fiscal implications to local governments, because there are no
local governments which are CSHCN program providers and subject to the revised
deadlines.
Sam B. Cooper III, MSW, LMSW, has determined that for each year of the
first five years the section is in effect, the public benefit anticipated
as a result of enforcing the section is simplification of CSHCN claims processing
procedures. The changes ensure that CSHCN filing and correction or resubmission
deadlines and procedures are consistent with recent Medicaid program changes.
There are no anticipated economic costs to micro-businesses or small businesses,
since those businesses should be able to meet the revised denied claim correction
and resubmission deadlines by applying proper business management practices.
There are no anticipated economic costs to persons who are required to comply
with the section as proposed, and no anticipated impact on local employment.
Comments on the proposal may be submitted by mail to Sam B. Cooper III,
MSW, LMSW, Director, Children with Special Health Care Needs Division, Texas
Department of Health, 1100 West 49th Street, Austin, Texas, 78756-3199, by
telephone to (800) 252-8023 or (512) 458-7111, extension 3110, or by fax to
"CSHCN Deadlines Rule Change" at (512) 458-7417. Comments will be accepted
for 30 days following the date of publication of this proposal in the
The amendment is proposed under the Health and Safety Code, §35.009,
which authorizes the Texas Board of Health (board) to adopt reasonable procedures
and standards for the determination of fees; and §12.001, which provides
the board with the authority to adopt rules for its procedures and for the
performance of each duty imposed by law on the board, the department, or the
commissioner of health.
The amendment affects the Health and Safety Code, Chapter 35.
§38.10.Payment of Services.
The CSHCN program reimburses participating providers for covered services
for CSHCN clients. Payment may be made only after the delivery of the service,
with the exception of meals, transportation, and lodging and insurance premium
payments. Excluding allowable insurance or health maintenance organization
co-payments, the client or client's family must not be billed for the service
or be required to make a preadmission or pretreatment payment or deposit.
Providers must agree to accept established fees as payment in full. The program
may negotiate reimbursement alternatives to reduce costs through requests
for proposals, contract purchases, and/or incentive programs.
(1)
Payment or denial of claims. All payments made on behalf
of a client will be for claims received by the CSHCN program or its payment
contractor within 95 days of the date of service, within 95 days from the
date of discharge from inpatient hospital and inpatient rehabilitation facilities,
within 95 days from the date the client's eligibility is added to program
automation systems, or within the submission deadlines listed in paragraphs
(1)(B)(ii) and (2) of this section, whichever is later. If the 95th day for
receipt of a claim falls on a weekend or holiday, the deadline shall be extended
to the next business day following the weekend or holiday. Claims will either
be paid or denied within 30 days. The CSHCN Division Director or his/her designee(s)
may waive the filing deadlines according to the conditions and circumstances
specified in paragraphs (3)-(5) of this section. A claim must be processed
and paid within 24 months of the date of service. Claims received by the CSHCN
program or its payment contractor after this time frame will not be considered
for payment by the CSHCN program.
(A)
(No change.)
(B)
Denied claims are claims which are incomplete, submitted
on the wrong form, lack necessary documentation, contain inaccurate information,
fail to meet the filing deadline, and/or are for ineligible recipients, services,
or providers.
(i)
(No change.)
(ii)
Denied claims may be corrected and resubmitted for reconsideration
if received within
120
[
(2)
(No change.)
(3)
Exceptions to the [
(A) - (D)
(No change.)
(4)
(No change.)
(5)
Other exceptions to claims receipt
or correction and
resubmission
deadlines. The CSHCN Division Director or his/her designee(s)
will consider a provider's request for an exception to claims receipt
or correction and resubmission
deadlines due to delays caused by entities
other than the provider and the program under the following circumstances:
(A) - (D)
(No change.)
(6) - (8)
(No change.)
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State on March 11, 2004.
TRD-200401857
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 458-7236
Subchapter A. KIDNEY HEALTH CARE PROGRAM
The Texas Department of Health (department) proposes amendments to §§61.1
- 61.4, 61.6 - 61.9 and 61.13 - 61.15, concerning Kidney Health Care (KHC)
benefits, and the repeal of §§61.5, 61.10 and 61.11, concerning,
respectively, the establishment of co-pay liability standards for all Kidney
Health Care recipients, the program's notice of intent to take action and
reconsideration, and the fair hearing process. These amendments are required
in order to effect changes in program benefits and program eligibility requirements,
and to provide clarity and consistency in existing language. The repeal of §61.5
is required as the program no longer establishes co-pay liability standards
for KHC recipients. The repeal of §§61.10 and 61.11 is required
as the language concerning the notice of intent to take action and the fair
hearing process have been provided elsewhere in 25 Texas Administrative Code
(TAC), §§1.51 - 1.55.
Specifically, an amendment to §61.2 denies program eligibility to
persons who are eligible for Medicaid drug, transportation and medical benefits.
A second amendment to §61.2 establishes gross income, instead of adjusted
gross income, as the means for determining a person's financial eligibility.
A third amendment to §61.2 requires recipients to reapply for Medicare
benefits if there is a change in their qualifying status. Amendments to §61.3
facilitate the application process by changing the number of required residency
documents. An amendment to §61.4 changes the effective date for program
benefits to the date the program receives the completed application. An amendment
to §61.6 denies immunosuppressive drug coverage to recipients who are
eligible for this coverage under Medicare. A second amendment to §61.6
denies medical benefits coverage to recipients with private group/health insurance
that covers the treatment of end stage renal disease. A third amendment to §61.6
allows for the establishment of a waiting list of applicants eligible for
program benefits if budgetary limitations exist. An amendment to §61.8
changes the filing deadline of resubmitted claims. An amendment to §61.9
requires all providers participating with Kidney Health Care to enter into
a contractual agreement with the program. Amendments made throughout the sections
provide for clarity and consistency of language and facilitate compliance
with the administration of the rules.
Government Code, §2001.039, requires that each state agency review
and consider for readoption each rule adopted by that agency pursuant to the
Government Code, Chapter 2001 (Administrative Procedure Act). Sections 61.1
- 61.15 have been reviewed and the department has determined that reasons
for adopting the sections continue to exist, because rules on this subject
are needed. Required revisions to the rules are outlined in this preamble.
The department published a Notice of Intent to Review for §§61.1
- 61.15 as required by Government Code, §2001.039, in the
Texas Register
on April 25, 2003 (28 TexReg 3531). No comments were
received due to publication of this notice.
Phillip W. Walker, Chief, Bureau of Kidney Health Care, has determined
that for the first five-year period the sections are in effect there will
be fiscal implications as a result of enforcing or administering the proposed
sections. For fiscal year 2004, the effect on state government will be an
estimated reduction in costs of approximately $963,000. This reduction in
costs includes approximately $900,000 for drug services as a result of discontinuing
the program's coverage of Medicaid eligible recipients and approximately $63,000
for dialysis services as a result of changing the KHC eligibility date for
newly approved recipients. For fiscal year 2005, the estimated reduction in
costs will be approximately $968,000, which includes $900,000 for drug services
and $68,000 for dialysis services. For fiscal years 2006 through 2008, the
reduction in costs will be minimal as any cost reductions from program changes
will have been realized. There is no anticipated economic effect on local
government.
Mr. Walker also has determined that for each year of the first five years
the proposed sections are in effect the public benefit anticipated as a result
of enforcing the sections will be to increase access for recipients by encouraging
the on-line submission of applications by the dialysis providers. There is
anticipated economic cost to persons who may be required to comply with the
sections as proposed. These costs are from a limitation of program coverage
of provided services. The amendment to discontinue program coverage of one
prescription per month for Medicaid eligible recipients may affect an estimated
6,030 persons. There is anticipated economic cost to dialysis facilities resulting
from changing the KHC eligibility date for newly approved recipients. However,
this cost should be minimal due to the increasing number of facilities submitting
applications on-line and the program's goal of attaining 90% participation
in the on-line application process. There will be no costs to small businesses
or micro-businesses resulting from compliance with these sections as proposed
because none of the entities or persons affected constitute micro-businesses
or small businesses. There is no anticipated effect on local employment.
Comments on the proposal may be submitted to Mr. Phillip W. Walker, Chief,
Bureau of Kidney Health Care, Texas Department of Health, 1100 West 49th Street,
Austin, Texas 78756, (512) 834 - 6770. Comments will be accepted for 30 days
following the date of publication of this proposal in the
Texas Register
.
25 TAC §§61.1 - 61.4, 61.6 - 61.9, 61.13 - 61.15
The amendments are proposed under the Health and Safety Code, §42.003,
which provides the Texas Department of Health with the authority to adopt
rules to provide adequate kidney care and treatment for the citizens of the
State of Texas and to carry out the purposes and intent of the Texas Kidney
Health Care Act; and §12.001, which provides the Texas Board of Health
(board) with the authority to adopt rules for the performance of every duty
imposed by law on the board, the department, and the commissioner of health.
The amendments affect Health and Safety Code, Chapter 42. The review of
the rules implements Government Code, §2001.039.
§61.1.General.
(a) - (b)
(No change.)
(c)
Definitions. The following words and terms when used in
this chapter shall have the following meanings, unless the context clearly
indicates otherwise.
(1) - (3)
(No change.)
(4)
Applicant--An individual whose application for KHC benefits
has been submitted
by
[
(5) - (6)
(No change.)
(7)
CMS--The Centers for Medicare
and Medicaid Services, formerly known as the Health Care Financing Administration.
(8)
[
(9)
[
(10)
[
(11)
[
(12)
[
(13)
[
(14)
[
(15)
[
(16)
[
(17)
[
(18)
[
(19)
[
(20)
[
(A)
outpatient dialysis facilities [
(B)
out-of-state outpatient dialysis facilities [
(C)
hospitals and ambulatory surgical
centers (ASCs) located and licensed in Texas;
(D)
out-of-state hospitals and
ASCs;
[
[
[
[
[
[
[
(E)
[
(F)
pharmacies approved as Texas
Medicaid Providers and licensed to operate within the United States and its
territories, including mail order pharmacies;
(G)
physicians and Certified Registered
Nurse Anesthetists (CRNAs) furnishing covered services to KHC recipients;
or
(H)
out-of-state physicians and
CRNAs furnishing covered services to KHC recipients.
[
[
(21)
[
[
(22)
[
(23)
[
(24)
[
§61.2.Recipient Requirements.
(a)
A person shall meet all of the following requirements to
be eligible for Kidney Health Care (KHC) benefits:
(1) - (3)
(No change.)
(4)
be a resident of Texas as determined in §61.3 of this
title (relating to Residency and Residency Documentation Requirements), and
not be:
(A)
(No change.)
(B)
a ward of the state;
or
(C)
eligible for drug, transportation,
and medical benefits under the Medicaid Program;
[
[
(5)
submit an application for benefits through a participating
outpatient dialysis
facility
or hospital
; and
(6)
have, or the person(s) who has a legal obligation to support
the applicant have,
a
[
(b)
A
recipient's eligibility for
[
(1)
(No change.)
(2)
failure to
maintain the income requirements for eligibility
or to
provide income data as requested by the department to determine
continued KHC eligibility [
(3) - (4)
(No change.)
[
[
[
[
[
[
[
(5)
[
(6)
[
(7)
recipient voluntarily stops
treatment for ESRD;
(8)
recipient becomes a ward of the state;
(9)
recipient becomes eligible
for drug, transportation, and medical benefits under the Medicaid Program;
(10)
[
(11)
[
(12)
[
(c)
A recipient may have their
KHC benefits modified or suspended for any of the following reasons:
(1)
failure to apply for Medicare hospitalization
and medical benefits under Title XVIII, Social Security Act (Medicare);
(2)
failure to reapply for Medicare hospitalization
and medical benefits as requested by KHC if there are changes in the recipient's
status that would make the recipient potentially eligible for Medicare benefits;
(3)
failure to continue premium payments on health
insurance plans under Medicare, individual or group health insurance plans
and prepaid medical plans, where eligibility was effective prior to KHC eligibility;
(4)
failure to provide authorization for Medicare
premium payments by KHC, as specified in §61.6 of this title (relating
to Limitations and Benefits Provided), if not eligible for Medicare premium-free
hospitalization; or
(5)
failure to notify/verify KHC of changes in the
following:
(A)
permanent home address;
(B)
treatment status;
(C)
insurance coverage; or
(D)
location of treatment.
(d)
[
[
[
[
[
[
[
(e)
In order to requalify for KHC, an applicant shall reapply
[
(f)
(No change.)
(g)
A recipient whose benefits are modified [
(1)
KHC may not terminate KHC participation until a final decision
is rendered under the department's [
(2)
KHC may withhold payments on claims pending final decision
under the department's [
(3)
(No change.)
§61.3.Residency and Residency Documentation Requirements.
(a) - (c)
(No change.)
[
[
(d)
[
(1)
[
(2)
[
(3)
[
(4)
[
(5)
[
(6)
[
(7)
[
(8)
[
(9)
[
(10)
[
(11)
[
(12)
[
(e) - (f)
(No change.)
§61.4.Applications.
Persons meeting the eligibility requirements set forth in §61.2(a)(1),
(2), (3), (4), and (6)[
(1)
Complete application. A complete application is required
before any eligibility determination will be made. A complete application
shall consist of all of the following:
(A) - (C)
(No change.)
(D)
a copy (front and back) of the applicant's social security
card issued by the Social Security Administration, or an allowable substitute,
as follows:
(i)
(No change.)
(ii)
a copy of a valid Medicare [
(E)
applicant financial data. Acceptable data to establish
the applicant's financial qualifications shall be submitted with the application.
[
(i) - (ii)
(No change.)
(2)
(No change.)
(3)
Eligibility date for KHC benefits. The KHC eligibility
date will be the
date KHC receives a complete application. If KHC benefits
are terminated, the eligibility date for any subsequent benefit period will
be the date on which KHC receives a subsequent completed application for KHC
benefits.
[
[
[
[
[
[
(4)
An applicant whose eligibility
for benefits is denied may appeal KHC's decision under the procedure contained
in §§1.51 - 1.55 of this title (relating to Fair Hearing Procedures).
[
§61.6.Limitations and Benefits Provided.
(a)
Benefits payable by Kidney Health Care (KHC) are as follows:
(1) - (2)
(No change.)
(3)
access surgery (
hospital charges, ambulatory surgical
center charges,
[
(4) - (5)
(No change.)
(6)
Medicare Part A and B premiums, if qualified. To qualify
for this benefit, recipients:
(A)
(No change.)
(B)
shall apply and be accepted for Medicare hospital and medical
insurance;
and
[
(C)
[
(b)
All KHC benefits are limited to services received in Texas
except for:
(1)
covered services received from a participating out-of-state
provider
[
(2)
(No change.)
(c)
Depending on the recipient's eligibility status, KHC will
pay for covered services up to a maximum allowable amount per recipient based
upon:
(1) - (2)
(No change.)
[
(3)
[
(4)
[
(5)
[
(6)
[
(d)
Recipients eligible for immunosuppressive
drug (ISD) coverage under Medicare are not eligible to receive KHC ISD coverage.
[
(e) - (g)
(No change.)
(h)
Limited medical benefits are available beyond the qualifying
period for [
(i)
Recipients eligible for hospital and medical benefits from
Medicare, [
(j)
Recipients eligible for hospital and medical benefits from
private/group health insurance
which covers the treatment of ESRD are
not
[
(k)
KHC is payor of last resort. All third parties must be
billed prior to KHC. The Commissioner of Health (Commissioner) may waive this
requirement in individually considered cases where its enforcement will deny
services to a class of
ESRD
[
(l)
If budgetary limitations exist,
the department may:
(1)
restrict or categorize covered services. Categories
will be prioritized based upon medical necessity, other third party eligibility
and projected third party payments for the different treatment modalities,
caseloads, and demands for services. Caseloads and demands for services may
be based on current and/or projected data. In the event covered services must
be reduced, they will be reduced in a manner that takes into consideration
medical necessity and other third party coverage. The department may change
covered services by adding or deleting specific services, entire categories
or by making changes proportionally across a category or categories, or by
a combination of these methods; and/or
(2)
establish a waiting list of eligible applicants.
Appropriate information will be collected from each applicant who is placed
on a waiting list. The information will be used to facilitate contacting the
applicant when benefits become available and to allow efficient enrollment
of the applicant for benefits.
[
§61.7.Claims Submission and Payment Rates.
(a)
Drug claims shall be submitted electronically to the Vendor
Drug Program (VDP) by the participating pharmacy [
(b)
Claims for medical benefits shall be submitted to Kidney
Health Care (KHC) by the
participating
provider who rendered the
service(s) to the KHC recipient.
(c)
Claims for transportation benefits administered by
the Texas Department of Transportation and contracted through the Health and
Human Services Commission shall be submitted to KHC by the recipient or the
participating provider performing outpatient dialysis services or any Texas
Department of Transportation approved transportation provider.
[
(d)
(No change.)
[
[
[
[
§61.8.Claim Filing Deadlines.
(a)
Claims shall be received by Kidney Health Care (KHC) within
the claim filing deadlines established in this section. Claims which are incomplete
or incorrect will not be
considered for payment
[
(b)
Claims
[
(1) - (2)
(No change.)
(3)
60 days from the date on the KHC notice of eligibility
for newly approved recipients
.
(c)
Claims for out-patient dialysis services from
participating
providers
[
(1) - (2)
(No change.)
(3)
60 days from the date on the KHC notice of eligibility
for newly approved recipients
; or
(4)
60 days from the date on the
contract/agreement
[
(d)
Claims for access surgery charges
shall be received by KHC the later of:
(1)
95 days from the last day of the month in which
services were provided;
(2)
60 days from the date on the third party EOB,
but not later than 180 days from the date of service; or
(3)
60 days from the date on the KHC notice of eligibility
for newly approved recipients.
[
[
[
[
(e)
Claims for travel reimbursement shall be received by KHC
the later of:
(1)
(No change.)
(2)
60 days from the date on the KHC notice of eligibility
for newly approved recipients
.
[
[
[
[
(f)
[
(g)
[
(1)
be resubmitted with a copy of the KHC return letter or
KHC EOB, if applicable;
(2)
be resubmitted on the original claim form, if applicable;
and
(3)
contain no new or additional charges for service.
§61.9.Participating [
(a)
The following criteria must be met for a facility, pharmacy,
or
other
provider to qualify for participation in Kidney Health
Care (KHC).
(1)
Outpatient dialysis facilities [
(A) - (D)
(No change.)
(E)
not currently be on suspension as a KHC participating
provider
[
(2)
KHC may
enter into a contract/agreement
[
(3)
Outpatient dialysis facilities
requesting enrollment as participating providers may be given interim approval
by KHC. Recipient applications for KHC benefits may be submitted by the facility
during the period of interim approval. Interim approval will last no longer
than six months from the date KHC mails the contract/agreement to the facility.
If interim approval lapses, the unexecuted contract/agreement will be nullified
and a new contract/ agreement with new term dates and period of interim approval
may be initiated by KHC. Claims for outpatient dialysis services will not
be considered for payment by KHC until KHC has fully executed a contract/agreement
with the facility. Claim filing deadlines will apply, as contained in §61.8
of this title (relating to Claim Filing Deadlines).
[
(4)
(No change.)
(5)
Physicians
and Certified Registered Nurse Anesthetists
(CRNAs)
providing
allowable KHC
services in the State of
Texas shall meet the following criteria to participate in, or enter into an
agreement to participate in, KHC:
(A)
if a physician,
be licensed to practice medicine
in the State of Texas
, or if a CRNA, be certified to practice within
the scope of their certification in the State of Texas
;
(B)
(No change.)
(C)
not currently be on suspension as a KHC participating provider,
as a physician licensed to practice medicine in the State of Texas,
as a CRNA certified to practice within the scope of their certification in
the State of Texas,
or as a Texas Medicaid provider; and
(D)
reimburse KHC for any overpayments made to the physician
or CRNA
by KHC upon request. KHC may withhold payment on claims submitted
by the physician
or CRNA
to recoup any overpayments.
(6)
Physicians
and CRNAs
providing
allowable
KHC
services outside the State of Texas shall meet the following criteria
to participate in, or enter into an agreement to participate in, KHC:
[
(A)
[
(B)
[
(C)
[
(D)
[
(7)
Hospitals
and ambulatory surgical centers (ASCs)
shall
meet the following criteria to participate in, or enter into an agreement
to participate in, KHC:
(A)
be
in compliance with all licensing requirements
[
(B) - (C)
(No change.)
(D)
not currently be on suspension as a KHC participating provider,
as a hospital licensed to provide hospital services in the State of Texas,
as an ASC licensed to provide ASC services in the State of Texas,
as
a Texas Medicaid provider, or as a Medicare certified hospital; and
(E)
reimburse KHC for any overpayments made to the hospital
or ASC
by KHC upon request. KHC may withhold payment on claims submitted
by the hospital
or ASC
to recoup any overpayments.
(8)
Out-of-state hospitals
and out-of-state ASCs
shall
meet the following criteria to participate in, or enter into an agreement
to participate in, KHC:
(A)
be licensed to provide hospital
or ASC
services
in the state in which services are to be provided;
(B) - (C)
(No change.)
(D)
not currently be on suspension as a KHC participating provider,
as a hospital licensed to provide hospital services in the state in which
services are [
(E)
reimburse KHC for any overpayments made to the hospital
or ASC
by KHC upon request. KHC may withhold payment on claims submitted
by the hospital
or ASC
to recoup any overpayments.
(b)
Effective dates for participation in KHC are as follows:
(1)
The effective date of all outpatient dialysis facility
contracts/agreements
[
(2)
(No change.)
(3)
The effective date of all other
provider contracts/agreements, listed in subsection (a)(5), (6), (7), and
(8) of this subsection, shall be the first day of the sixth month prior to
the KHC receipt of the completed and signed provider contract/agreement.
(c)
Reasons for suspension or termination from participation
in KHC are as follows.
(1)
Any participating [
(A) - (D)
(No change.)
(E)
filing false or fraudulent information or claims with KHC
or VDP; [
(F)
failure to submit a payable
claim to KHC during a minimum period of 12 consecutive months; or
(G)
[
(2)
A participating [
(A)
KHC may not terminate KHC participation until a final decision
is rendered under the department's [
(B)
KHC may withhold payments on claims pending final decision
under the department's [
(C)
KHC shall release any withheld payments and reinstate participation
in KHC if the final determination is in favor of the participating [
(D)
KHC shall not enter into, extend, or renew a contract or
agreement with a participating [
(E)
A participating [
§61.13.Forms.
Forms
approved
[
§61.14.Confidentiality of Information.
(a)
(No change.)
(b)
Information may be disclosed in summary, statistical, or
other forms which does not identify
specific
[
§61.15.Nondiscrimination Statement.
The Texas Department of Health (department) operates in compliance
with the Civil Rights Act of 1964, Title VI (Public Law 88-352)
,
[
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of
the Secretary of State on March 15, 2004.
TRD-200401951
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 458-7236
25 TAC §§61.5, 61.10, 61.11
(Editor's note: The text of the following sections proposed for
repeal will not be published. The sections may be examined in the offices
of the Texas Department of Health or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeals are proposed under the Health and Safety
Code, §42.003, which provides the Texas Department of Health with the
authority to adopt rules to provide adequate kidney care and treatment for
the citizens of the State of Texas and to carry out the purposes and intent
of the Texas Kidney Health Care Act; and §12.001, which provides the
Texas Board of Health (board) with the authority to adopt rules for the performance
of every duty imposed by law on the board, the department, and the commissioner
of health.
The repeals affect Health and Safety Code, Chapter 42. The review of the
rules implements Government Code, §2001.039.
§61.5.Recipient Co-pay Liability.
§61.10.Notice of Intent To Take Action and Reconsideration.
§61.11.Notice and Fair Hearing.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed
with the Office of the Secretary of State on March 15, 2004.
TRD-200401952
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 458-7236
25 TAC §§123.3, 123.4, 123.6, 123.7, 123.9, 123.10, 123.12, 123.16
The Texas Department of Health (department) proposes amendments
to §§123.3, 123.4, 123.6, 123.7, 123.9, 123.10, 123.12 and new 123.16,
concerning the Respiratory Care Practitioners Certification Program. Specifically,
the amendments concern respiratory care practitioner fees, application requirements
and procedures, certificate renewal, continuing education extensions, professional
and ethical standards and suspension of license for failure to pay child support.
The licensing fee amendments are required as a result of revisions to the
Health and Safety Code, Chapter 12, §§12.0111 and 12.0112, pursuant
to House Bill 2292, 78th Legislature, 2003. Senate Bill 1152, 78th Legislature,
Regular Session, directs all department administered licensing programs to
participate in Texas Online, an electronic fee payment system developed and
maintained by the Texas Online Authority. Wording is added that authorizes
the Committee to collect subscription and convenience fees, in amounts to
be determined by the Texas Online Authority, to recover costs associated with
application and renewal application processing.
The proposed amendments require impartiality and nondiscrimination regarding
a person's race, religion, color, gender, national origin, age, disability,
sexual orientation, genetic information, or family health history; add a reactivation
fee for reentering into active status and add a reinstatement fee for a license
that was suspended for failure to pay child support; amend requirements for
education records for applicants that are nationally certified; amend language
for reactivation of a certificate; require that a practitioner shall not employ
another person in the capacity of a respiratory care practitioner who does
not hold a certificate or permit to practice respiratory care; and add a new
section concerning suspension of license for failure to pay child support.
Jim Zukowski, Bureau Chief, Consumer Health Protection, has determined
that for each of the first five years the sections will be in effect there
will be a fiscal implications for state or local government as a result of
enforcing or administering the sections as proposed. The estimated increase
in general revenue cannot be established because the number of persons required
to comply with the proposed sections cannot be determined. For all applications
and renewal applications; the department is authorized to collect subscription
and convenience fees, in amounts determined by the Texas Online Authority,
to recover costs associated with application and renewal application processing
through Texas Online.
Mr. Zukowski, has also determined that for each of the first five years
the proposed sections are in effect, the public benefit anticipated as a result
of enforcing the sections as proposed will be to ensure the appropriate regulation
of respiratory therapists. There will be no impact on small businesses or
micro-businesses. The cost to persons required to comply with the sections
would be $50 for failure to pay child support. There is no anticipated impact
on local employment.
Comments on the proposal may be submitted to Pam K. Kaderka, Program Specialist,
Respiratory Care Practitioners Certification Program, 1100 West 49th Street,
Austin, Texas 78756-3183, (512) 834-6632. Comments will be accepted for 30
days following publication of the proposal in the
Texas Register
.
The amendments and new section are proposed under Texas Occupations
Code, §604.052, which requires the Respiratory Care Practitioners Certification
Program to adopt rules, with the approval of the Texas Board of Health; and
the Health and Safety Code, §12.001, that are reasonably necessary to
properly perform its duties under this Act.
The amendments and new section affect the Occupations Code, Chapter 604.
§123.3.Respiratory Care Practitioners Advisory Committee.
(a) - (p)
(No change.)
(q)
Impartiality and Nondiscrimination.
The committee shall make no decision in the discharge of its statutory authority
with regard to any person's race, religion, color, gender, national origin,
age, disability, sexual orientation, genetic information, or family health
history.
§123.4.Fees.
The following fees are prescribed by the board and are required to
be paid to the department before any certificate or permit is issued. All
fees shall be submitted in the form of a check or money order and are nonrefundable.
The department may direct examination applicants to submit examination fees
to the National Board for Respiratory Care, Inc. (NBRC).
(1)
Schedule of fees for certification as a respiratory care
practitioner:
(A)
application (includes initial certificate) fee--$60;
(B)
for a license issued for a one year term is $45;
[
(C)
for a license issued for a
two year term is $90;
(D)
[
(E)
[
(F)
[
(G)
[
(H)
[
[
(I)
annual inactive status fee--$25
;
[
(J)
reinstatement fee for a license
that was suspended for failure to pay child support--$50;
(K)
one to 90 days late renewal
fee--one and one half times the normally required renewal fee;
(L)
91days to one year late renewal
fee--two times the normally required renewal fee;
(M)
For all applications and renewal
applications, the department (or board) is authorized to collect subscription
and convenience fees, in amounts determined by the Texas Online Authority,
to recover costs associated with application and renewal application processing
through Texas Online; and
(N)
For all applications and renewal
applications, the department (or board) is authorized to collect fees to fund
the Office of Patient Protection, Health Professions Council, as mandated
by law.
(2)
(No change.)
(3)
Any certificate holder whose check to the department
is returned marked insufficient funds, account closed, or payment stopped
shall remit to the department a money order or check for guaranteed funds
in the amount of the check submitted to the department plus the returned check
fee within 30 days of the date of receipt of the department's notice. Failure
to comply with this requirement may be the grounds for disciplinary action,
up to and including denial of the certificate holder application or the revocation
of the certificate. If a certificate is issued or renewed or an application
processed upon the submission of a check to the department, and if such check
is later returned unpaid, the department may cancel the certificate or application
if the certificate holder or applicant does not redeem the check in compliance
with this section. The effect of such a cancellation shall be the same as
if the application for renewal or for licensure had not been submitted.
[
[
[
[
(4)
[
(5)
[
§123.6.Application Requirements and Procedures.
(a)
(No change.)
(b)
Required application materials.
(1)
Application form. The application form shall contain:
(A) - (J)
(No change.)
(2)
Educational
record for regular certification. The
department shall issue a regular certificate to an applicant who is currently
credentialed by the National Board for Respiratory Care (NBRC) and nationally
certified as a Certified Respiratory Practitioner (CRT), a Certified Respiratory
Therapy Technician (CRTT), or a Registered Respiratory Therapist (RRT), upon
payment of the application fee, submission of the application forms and approval
by the department, the department shall issue a regular certificate to a person
who is currently credentialed by the National Board for Respiratory Care (NBRC)
[
[
[
[
[
[
[
[
[
[
[
[
[
[
(3)
Education record for temporary
permit. Individuals applying for a temporary permit who do not meet the requirements
of subsection (b) of this section shall provide the following documents to
the department.
(A)
An expected graduation statement, including
the expected date of graduation, signed by the respiratory care program director
at the school.
(B)
Within thirty days following the expected date
of graduation, the applicant must provide to the department:
(i)
a copy of the certificate of completion; or
(ii)
a statement signed by the program director
indicating that the applicant officially completed the program but the certificate
is not available within 30 day of the completion date.
(4)
[
(A)
If the applicant is making application for a temporary
permit, an examination score release form shall be signed allowing the department
to obtain the applicant's examination results from the NBRC, or other agency
administering the examination prescribed by the board.
(B)
If an applicant for a regular certificate is:
(i)
recognized as certified respiratory therapist or registered
respiratory therapist by the NBRC at the time of application, a photocopy
of the certificate issued by NBRC shall be submitted in lieu of examination
results; or
(ii)
unable to show proof of successful completion or otherwise
provide documentation acceptable to the department of the applicant's examination
results, the application shall be disapproved.
(5)
[
(6)
[
(c) - (d)
(No change.)
(e)
Application approval.
(1)
The
department
[
(2)
The
department
[
(f)
Disapproved applications.
(1) - (2)
(No change.)
(3)
An applicant whose application has been disapproved under
paragraph (1)(E) and (F) of this subsection shall be permitted to reapply
after a period of not less than on year from the date of the disapproval and
shall submit with the reapplication proof satisfactory to the department of
compliance with all rules of the board and the provisions of the Act in effect
at the time of reapplication. The date of disapproval is the effective date
of a disapproval order signed by the commissioner of health
or the commissioner's
designee
.
§123.7.Types of Certificates and Temporary Permits and Applicant Eligibility.
(a)
(No change.)
(b)
Issuance of certificates and permits.
(1)
(No change.)
(2)
Certificates issued within
three
[
(c) - (d)
(No change.)
§123.9.Certificate Renewal.
(a)
General. Except as provided by subsection (b) of this section,
a practitioner shall renew the certificate
biennially on or before the
last day of the practitioner's birth month.
[
(1) - (4)
(No change.)
(b) - (h)
(No change.)
§123.10.Continuing Education Requirements.
(a) - (c)
(No change.)
(d)
Reporting of continuing education. Each practitioner shall
be responsible for reporting to the department the continuing education activities
completed.
(1)
A practitioner shall report the number of hours of continuing
education completed during the renewal period. If requested by the department,
each practitioner shall submit proof of completion of the required continuing
education activity to the department at the time of certificate renewal, or
at other times as directed by the department. [
(2)
(No change.)
(e)
Activities unacceptable as continuing education. The department
may not grant continuing education credit to any practitioner for:
(1) - (4)
(No change.)
[
(5)
[
(f)
Failure to complete required continuing education.
[
[
[
[
[
[
(g)
Other miscellaneous provisions.
(1) - (4)
(No change.)
(5)
No continuing education hours may be carried over from
one renewal period to another renewal period [
§123.12.Professional and Ethical Standards.
The purpose of this section shall be to establish the standards of
professional and ethical conduct required of a practitioner pursuant to the
Act, §604.201(b)(4).
(1)
Professional representation and responsibilities.
(A) - (P)
(No change.)
(Q)
A practitioner shall not employ
another person in the capacity of a respiratory care practitioner who does
not hold a certificate or permit to practice respiratory care.
(2) - (6)
(No change.)
§123.16.Suspension of License Relating to Child Support and Child Custody.
(a)
On receipt of a final court or attorney general's order
suspending a license due to failure to pay child support or for failure to
comply with the terms of a court order providing for the possession of or
access to a child, the department shall immediately determine if the Respiratory
Care Practitioner Certification has issued a certificate to the person named
in the order. If a license has been issued the department shall:
(1)
record the suspension of the license in the departments
records;
(2)
report the suspension as appropriate; and
(3)
demand surrender of the suspended license.
(b)
The department shall implement the terms of a final court
or attorney general's order suspending a license without additional review
or hearing. The department shall implement the terms of a final court or attorney
general's order suspending a license without additional review or hearing.
The department will provide notice as appropriate to the licensee or to others
concerned with the license.
(c)
The department may not modify, remand, reverse, vacate,
or stay a court or attorney general's order suspending a license issued under
the Texas Family Code, Chapter 232, and may not review, vacate, or reconsider
the terms of an order.
(d)
A licensee who is the subject of a final court or attorney
general's order suspending his or her license is not entitled to a refund
for any fee paid to the department.
(e)
If a suspension overlaps a license renewal period, an individual
with a license suspended under this section shall comply with the standard
renewal procedures in the Respiratory Care Practitioner Certification Act,
Texas Occupations Code, §604.153, and §604.157, of this title (relating
to Issuance of Renewal Certificate and Renewal of Temporary Permit). However,
the license will not be renewed until the requirements of subsections (g)
and (h) of this section are met.
(f)
An individual who continues to use the titles "respiratory
care," "respiratory therapist," "respiratory care practitioner," "certified
respiratory care practitioner," "respiratory therapy technician," or the letters
"RCP" or any other words, letters, abbreviations, or insignia indicating or
implying that the person is a respiratory care practitioner after the issuance
of a court or attorney general's order suspending the license is liable for
the same civil and criminal penalties provided for engaging in the prohibited
activity without a license or while a license is suspended as any other license
holder of the department.
(g)
On receipt of a court or attorney general's order vacating
or staying an order suspending a license, the department shall promptly issue
the affected license to the individual if the individual is otherwise qualified
for the license.
(h)
The individual must pay a reinstatement fee as referred
in §123.4 of this title (relating to Fees) prior to issuance of the license
under subsection (g) of this section.
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of
the Secretary of State on March 15, 2004.
TRD-200401934
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 458-7236
The Texas Department of Health (department) proposes the repeal of
existing §§125.1 - 125.9, and new §§125.1 - 125.3, 125.11
- 125.15, 125.31 - 125.35, 125.51, 125.61, 125.62, 125.71 - 125.73, 125.81
- 125.83, and 125.91 - 125.96, concerning the regulation of special care facilities.
These rules are proposed in accordance with Health and Safety Code (HSC),
Chapter 248, which charges the department with the responsibility to license
special care facilities. Government Code, §2001.039, requires that each
state agency review and consider for readoption each rule adopted by that
agency pursuant to the Government Code, Chapter 2001 (Administrative Procedures
Act). Sections 125.1 - 125.9 have been reviewed and the department has determined
that reasons for adopting the sections continue to exist in that rules on
this subject is needed; however, the rules need revision as described in this
preamble. The repeals and new sections are required as a result of the provisions
of Senate Bill (SB) 1152, which amended Government Code, Chapter 2054, regarding
the Texas Online Authority; the revisions to the Health and Safety Code (HSC),
Chapter 248, required by Senate Bill 162, adding probation as a new penalty
alternative; and House Bill 2292, 78th Legislature, 2003, which revised HSC, §12.0111
and §12.0112, regarding two-year terms for fees. The repeal of existing
rules and new sections allows the reorganization and renumbering of the sections
for clarification.
The sections proposed for repeal cover definitions, application and issuance
of a license, processing of applications and fees, operating standards, license
denial, suspension or revocation, criminal and administrative penalties. The
proposed new sections cover general provisions, facility licensing, operational
requirements, waivers, inspections and investigations, enforcement, safety
requirements and facility design and construction. The most notable differences
between the rules being repealed and the adopted new rules are summarized
as follows.
New §125.1 describes the purpose of the rules and the authority for
their promulgation. New §125.2 includes some definitions from the rules
being repealed, and eliminates certain definitions which are not included
in the proposed new sections, or which were obsolete. New §125.3 describes
the process for determining the occupancy classification of a facility, which
relates to fire safety and construction requirements.
New §§125.11 - 125.15 describes the processing of applications
and issuance of licenses, time periods for processing and issuing licenses,
and fees. The new sections include transition to a two-year license renewal
cycle, an increase in licensing fees, and for the recovery of costs associated
with application and renewal application processing through Texas Online.
Portions of the requirements in the new sections were previously located in §§125.2,
125.4, 125.5 and 125.8 of the rules proposed for repeal.
New §§125.31 - 125.35 contains provisions related to facility
administration and polices and procedures; resident care and services; resident
rights, including new requirements related to resident rights and abuse and
neglect; resident records and the requirements for a residential AIDS hospice
designation that were formerly addressed in §125.6 of the rules proposed
for repeal.
New §125.51 includes the process by which facilities may request a
waiver or modification for certain provisions in the rules.
New §125.61 and §125.62 describes inspection and investigation
procedures and protocols and the process for lodging a complaint regarding
a Texas Department of Health representative.
New §§125.71 - 125.73 includes the process for denying, suspending,
revoking or probating a license, and the imposition of civil, criminal penalties
and administrative penalties.
New §§125.81 - 125.83 provides requirements related to general
safety, emergency preparedness and fire safety.
New §§125.91 - 125.96 contains provisions for new and existing
facility construction, spatial requirements, elevators, the process for the
preparation, submittal, review and approval of construction plans, and requirements
related to architectural inspections and project approval.
The department published a Notice of Intention to Review for Title 25,
Texas Administrative Code, Part 1, Chapter 125, Special Care Facilities, §§125.1
- 125.8, as required by Government Code §2001.039, in the
Texas Register
(24 TexReg 1003) on February 12, 1999. There were no
comments received by the department on the sections following publication
of the notice.
Lisa Subia, Associateship for Consumer Health Protection, has determined
that for each year of the first five years the sections are in effect, there
will be fiscal implications as a result of administering the sections as proposed.
The effect on state government will be related to the proposed increase in
licensing fees to provide for cost recovery of expenses and the conversion
to the two-year renewal cycle. Assuming an effective date of June 1, 2004,
for the revised fee schedule, and considering the anticipated license renewal
dates for existing facilities, the initial fiscal impact will not occur until
Fiscal Year (FY) 2005, when there will be an increase in revenue of $3,855
related to the fee increase. Since FY 2005 will be the first year in a two-year
phase-in process for the two-year renewal cycle, there will be an additional
temporary increase in revenue of approximately $1,928, bringing the total
estimated increased revenue to $5,783. This estimate is based on the fact
that during FY 2005, one-half of the facilities will be renewing their licenses
to be effective for two years, and will pay a corresponding fee to cover the
two-year license period. The remainder of the facilities will be renewing
their licenses for a one-year period in FY 2005, which will result in the
temporary additional revenue. This second group of facilities will renew their
licenses for the two-year period in FY 2006, so the anticipated additional
revenue in Fiscal Years 2006 through 2009 will be approximately $3,855 per
year. There will be no effect on local government unless the local government
operates a special care facility. In that case, the local government would
be subject to the proposed new fees and other requirements.
Ms. Subia has also determined that for each year of the first five years
the sections are in effect, the public benefit anticipated as a result of
enforcing or administering the sections will be to insure compliance by special
care facilities with new legislative mandates. There will be economic costs
for micro-businesses, small businesses and persons who are required to comply
with the new sections. These costs are related to the increase in licensing
fees and conversion to two-year renewal cycles. All regulated facilities will
be subject to the fee increase, with the total increase ranging from $100
per year for the smallest facility to $1,500 per year for the largest facility.
Once conversion to the two-year renewal cycle begins, facilities will be required
to pay the fee for the two-year period. This increase for each facility will
range from $200 per one-year licensing period for the smallest facility to
$3,000 per two-year licensing period for the largest facility. Senate Bill
1152, 78th Legislature, Regular Session, 2003, directs all departments that
administer licensing programs to participate in Texas Online, an electronic
fee payment system developed and maintained by the Texas Online Authority.
Wording is added that authorizes the department to collect subscription and
convenience fees, in amounts to be determined by the Texas Online Authority,
to recover costs associated with application and renewal application processing.
There will be no anticipated impact on local employment.
Comments may be submitted to Cindy Bednar, Director of Hospital Programs,
Health Facility Licensing and Compliance Division, Texas Department of Health,
1100 West 49th Street, Austin, Texas 78756, (512) 834-6648. Comments will
be accepted for 30 days following publication of this proposal in the
25 TAC §§125.1 - 125.9
(Editor's note: The text of the following sections proposed for
repeal will not be published. The sections may be examined in the offices
of the Texas Department of Health or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeals are proposed under Health and Safety
Code, §248.026, concerning rules and minimum standards to protect and
promote the public health and welfare by providing for the issuance, renewal,
denial, suspension, and revocation of each level of license; and Health and
Safety Code, §12.001, which provides the Texas Board of Health (board)
with the authority to adopt rules for the performance of every duty imposed
by law on the board, the department, and commissioner of health.
The repeals affect the Health and Safety Code, Chapters 248 and 12. The
review of the rules implements Government Code, §2001.039.
§125.1.Definitions.
§125.2.Application and Issuance of License for First-Time Applicants.
§125.3.Inspections.
§125.4.Renewal of License.
§125.5.Licensing Application, Construction Plan Review, and Construction Inspection Fees.
§125.6.Standards.
§125.7.License Denial, Suspension, or Revocation and Criminal Penalties.
§125.8.Time Periods for Processing and Issuing a Special Care Facility License.
§125.9.Administrative Penalties.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State on March 15, 2004.
TRD-200401938
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 458-7236
Subchapter A. GENERAL PROVISIONS
25 TAC §§125.1 - 125.3
The new sections are proposed under Health and Safety Code, §248.026,
concerning rules and minimum standards to protect and promote the public health
and welfare by providing for the issuance, renewal, denial, suspension, and
revocation of each level of license; and Health and Safety Code, §12.001,
which provides the Texas Board of Health (board) with the authority to adopt
rules for the performance of every duty imposed by law on the board, the department,
and commissioner of health.
The new sections affect the Health and Safety Code, Chapters 248 and 12.
The review of the rules implements Government Code, §2001.039.
§125.1.Purpose.
The purpose of this chapter is to implement the Texas Special Care
Facility Licensing Act as authorized under the Health and Safety Code, Chapter
248, and provide minimum standards for the licensing of special care facilities.
§125.2.Definitions.
The following words and terms, when used in this chapter, shall have
the following meanings, unless the context clearly indicates otherwise.
(1)
Applicant--The person legally responsible for the operation
of the facility, whether by lease or ownership, who seeks a license from the
department.
(2)
Administration of medication--The direct application of
any medication by injection, inhalation, ingestion, or any other means to
the body of a patient. The preparation of medication is part of the administration
of medication and is the act or process of making ready a medication for administration,
including the calculation of a resident's medication dosage; altering the
form of the medication by crushing, dissolving, or any other method; pouring
a quantity of a liquid to be ingested; reconstitution of an injectable medication;
drawing an injectable medication into a syringe; preparing an intravenous
admixture; or any other act required to render the medication ready for administration.
(3)
AIDS--Acquired immune deficiency syndrome.
(4)
Assistance with medication or treatment regimen--Aid provided
to a resident who self-administers their own medication or treatment, such
as reminding a resident to take a medication at the prescribed time, opening
and closing a medication container, returning a medication to the proper storage
area, and assisting in reordering medications from a pharmacy. Such ancillary
aid shall not include administration of any medication.
(5)
Bereavement--The process by which a survivor of a deceased
person mourns and experiences grief.
(6)
Bereavement services--Support services offered to a family
during bereavement. Family includes a significant other(s).
(7)
Board--The Texas Board of Health.
(8)
Controlled substance--A drug, controlled substance, or
immediate precursor as defined in the Texas Controlled Substance Act, Health
and Safety Code, §481.002, or the Federal Controlled Substance Act of
1970, Public Law 91-513.
(9)
Dangerous drugs--Any dangerous drug as defined in the Texas
Dangerous Drug Act, Health and Safety Code, §483.001.
(10)
Department--The Texas Department of Health.
(11)
Dietitian--A person who is currently licensed by the Texas
State Board of Examiners of Dietitians.
(12)
Director--The director of the Health Facility Licensing
and Compliance Division of the Texas Department of Health or his or her designee.
(13)
Facility--A special care facility.
(14)
Fast-track project--A construction project in which it
is necessary to begin initial phases of construction before later phases of
the construction documents are fully completed in order to establish other
design conditions or because of time constraints such as mandated deadlines.
(15)
Hospice services--Services, including services provided
by unlicensed personnel under the delegation of a registered nurse or physical
therapist, provided to a resident or resident's family as part of a coordinated
program which includes palliative care for terminally ill residents and support
services for a resident and a resident's family that are available 24 hours
a day, seven days a week, during the last stages of illness, during death,
and during bereavement; and are provided by a medically directed interdisciplinary
team.
(16)
Incident--An unusual or abnormal event or occurrence in,
at, or affecting the facility or the residents of the facility.
(17)
Licensed vocational nurse--An individual who is currently
licensed as a licensed vocational nurse (LVN) by the Board of Vocational Nurse
Examiners in accordance with Texas Occupations Code, Chapter 302.
(18)
Local health authority--The physician having local jurisdiction
to administer state and local laws or ordinances relating to public health
as defined in the Health and Safety Code, Chapter 121, Subchapter B.
(19)
Medical care--Care that is:
(A)
required for improving life span and quality of life, for
comfort, for prevention and treatment of illness, and for maintenance of bodily
and mental function;
(B)
under the continued supervision of a physician; and
(C)
provided by a registered nurse or licensed vocational nurse
available to carry out a physician's plan of care for a resident.
(20)
Nursing care--Services provided by nursing personnel as
prescribed by a physician, including services to:
(A)
promote and maintain health;
(B)
prevent illness and disability;
(C)
manage health care during acute and chronic phases of illness,
including end of life care;
(D)
provide guidance and counseling of individuals and families;
and
(E)
provide referrals to physicians, other health care providers,
and community resources when appropriate.
(21)
Palliative care--Services that focus primarily on the
reduction or abatement of physical, psychosocial, and spiritual symptoms of
a terminal illness.
(22)
Pharmacist--A person who is licensed to practice pharmacy
by the Texas Board of Pharmacy in accordance with Texas Occupations Code,
Chapter 558.
(23)
Physician--An individual who is:
(A)
licensed as a physician by the Texas State Board of Medical
Examiners in accordance with Texas Occupations Code, Chapter 155; or
(B)
authorized to perform medical acts under an institutional
permit at a Texas postgraduate training program approved by the Accreditation
Council on Graduate Medical Education, the American Osteopathic Association,
or the Texas State Board of Medical Examiners.
(24)
Presurvey conference--A conference held with department
staff and the applicant and/or his or her representative to review licensure
standards, survey documents, and facility policies and procedures and provide
consultation prior to issuance of a license and the on-site licensure inspection.
(25)
Registered nurse (RN)--An individual who is licensed as
a registered nurse by the Board of Nurse Examiners in accordance with Texas
Occupations Code, Chapter 301.
(26)
Resident--An individual accepted for care in a special
care facility.
(27)
Residential AIDS hospice--A special care facility licensed
and designated as a residential AIDS hospice in accordance with §125.24
of this title (relating to Residential AIDS Hospice Designation).
(28)
Social worker--A person who is currently licensed as a
social worker in accordance with Texas Occupations Code, Chapter 505.
(29)
Special care facility--An institution or establishment
that provides a continuum of nursing or medical care or services primarily
to persons with acquired immune deficiency syndrome or other terminal illnesses.
The term includes a special residential care facility.
(30)
Violation--Failure to comply with the licensing statute,
a rule or standard, special license provision, or an order issued by the commissioner
of health or the commissioner's designee, adopted or enforced under the licensing
statute.
§125.3.Occupancy Classification.
(a)
The level of care that the resident requires determines
the facility's occupancy classification.
(b)
A new facility shall be classified into one of the following
two occupancy classifications:
(1)
Limited care facility (LCF). A LCF provides medical and
nursing care, treatment and other services to residents who require staff
attendance and supervision, including staff assistance to evacuate the facility.
These residents are not able to participate in fire drills because they are
either physically unable to respond to the fire alarm or they are incapable
of following directions under emergency conditions.
(2)
Residential board and care facility (RBCF). A RBCF provides
medical and nursing care, treatment and other services for residents who do
not require routine or continuous staff attendance and supervision, and are
physically and mentally able to evacuate the facility. These residents must
be able to participate in fire drills, be able to transfer and evacuate themselves
and be capable of following directions under emergency conditions. A RBCF
is further classified as either small or large.
(A)
A small RBCF provides sleeping accommodations for up to
16 residents.
(B)
A large RBCF provides sleeping accommodations for more
than 16 residents.
(c)
New applicants shall identify the classification of the
facility at the time the license application is submitted.
(d)
A licensed special care facility which was licensed prior
to the effective date of these rules is considered to be an existing facility
and is not required to identify or specify their occupancy classification.
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on March 15, 2004.
TRD-200401939
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 458-7236
25 TAC §§125.11 - 125.15
The new sections are proposed under Health and Safety Code, §248.026,
concerning rules and minimum standards to protect and promote the public health
and welfare by providing for the issuance, renewal, denial, suspension, and
revocation of each level of license; and Health and Safety Code, §12.001,
which provides the Texas Board of Health (board) with the authority to adopt
rules for the performance of every duty imposed by law on the board, the department,
and commissioner of health.
The new sections affect the Health and Safety Code, Chapters 248 and 12.
The review of the rules implements Government Code, §2001.039.
§125.11.General Licensing Requirements.
(a)
License required.
(1)
A facility shall obtain a license prior to admitting patients.
(2)
A facility shall only admit and provide services for the
number of residents which may be accommodated based on the approved number
of licensed beds.
(3)
All residents receiving services under the license must
be admitted for 24-hour residential care.
(b)
Display. A facility shall prominently and conspicuously
display the license in a public area of the licensed premises that is readily
visible to patients, employees, and visitors.
(c)
Alteration. A facility license shall not be altered.
(d)
Transfer or assignment prohibited. A facility license shall
not be transferred or assigned. The facility shall comply with the provisions
of §125.12(h) of this title (relating to Application and Issuance of
Initial License) in the event of a change in the ownership.
(e)
Changes which affect the license. A facility shall notify
the department in writing prior to the occurrence of any of the following:
(1)
any construction, renovation, or modification of the facility
buildings;
(2)
changes in designed bed capacity;
(3)
cessation of operation of the facility; and
(4)
change in facility name, telephone number or administrator.
§125.12.Application and Issuance of Initial License.
(a)
Application submittal. The applicant shall submit the following
documents to the department no earlier than 60 calendar days prior to the
projected opening date of the facility:
(1)
an accurate and complete application form;
(2)
evidence of project and occupancy approval under local
codes, if applicable, or in accordance with §125.95 of this title (relating
to Construction, Inspections, and Approval of Project).
(3)
the appropriate license fee as required in §125.15
of this title (relating to Fees).
(b)
Presurvey conference. The applicant or the applicant's
representative shall attend a presurvey conference at the office designated
by the department. The purpose of the presurvey conference, which is conducted
by department staff, is to review licensure rules, survey documents and facility
policies and procedures, and provide consultation prior to the on-site licensure
survey. The department staff conducting the presurvey conference is responsible
for making a recommendation regarding the issuance of the initial license.
The department may waive the presurvey conference requirement.
(c)
Residential AIDS hospice designation. The designation must
be requested at the time of license application. The facility shall provide
evidence of compliance with §125.35 of this title (relating to Residential
AIDS Hospice Designation) at the time of the presurvey conference.
(d)
Issuance of license. When it is determined that the facility
has complied with subsections (a) and (b) of this section and, if applicable,
subsection (c) of this section, the department shall issue the license to
the applicant.
(1)
Effective date. The license shall be effective on the date
the facility is determined to be in compliance with subsections (a) and (b)
of this section, and, if applicable subsection (c) of this section.
(2)
Expiration date.
(A)
For initial licenses issued prior to January 1, 2005.
(i)
If the effective date of the license is the first day of
a month, the license expires on the last day of the 11th month after issuance.
(ii)
If the effective date of the license is the second or
any subsequent day of a month, the license expires on the last day of the
12th month after issuance.
(B)
For initial licenses issued January 1, 2005, or after.
(i)
If the effective date of the license is the first day of
a month, the license expires on the last day of the 23rd month after issuance.
(ii)
If the effective date of the license is the second or
any subsequent day of a month, the license expires on the last day of the
24th month after issuance.
(e)
Withdrawal of application. If an applicant decides not
to continue the application process for a license or renewal of a license,
the application may be withdrawn. The department shall acknowledge receipt
of the request to withdraw.
(f)
Denial of a license. Denial of a license shall be governed
by §125.71 of this title (relating to License Denial, Suspension, Revocation
and Probation).
(g)
Survey. During the initial licensing period, the department
shall conduct a survey of the facility to ascertain compliance with the provisions
of the Health and Safety Code, Chapter 248, and this chapter.
(1)
A facility shall request an on-site survey to be conducted
after one inpatient has been admitted and provided services.
(2)
A facility shall be providing services to at least one
inpatient in the facility at the time of the survey.
(h)
Change of ownership. A change of ownership occurs when
there is a change in the person legally responsible for the operation of the
facility, whether by lease or by ownership. If a corporate licensee amends
its articles of incorporation to revise its name and the tax identification
number does not change, this subsection does not apply, except that the corporation
must notify the department within 10 calendar days after the effective date
of the name change. The sale of stock of a corporate licensee does not cause
this subsection to apply. A change of ownership requires submission of an
initial license application.
(1)
The new owner shall submit an application for an initial
license to the department prior to the date of the change of ownership or
not later than 10 calendar days following the date of a change of ownership.
The application shall be in accordance with subsection (a) of this section.
In addition to the documents required in subsection (a) of this section, the
applicant shall include the effective date of the change of ownership.
(2)
Surveys. The on-site construction and health surveys required
by subsection (g) of this section, and §125.61 of this title (relating
to Inspection and Investigation Procedures) may be waived by the department.
(3)
Issuance of license. When the new owner has complied with
the provisions of subsection (a) of this section, the department shall issue
a license which shall be effective the date of the change of ownership.
(4)
Expiration of license. The expiration date of the license
shall be in accordance with subsection (d)(2) of this section.
(5)
License void. The previous owner's license shall be void
on the effective date of the new owner's license.
§125.13.Application and Issuance of Renewal License.
(a)
Renewal notice. The department may send a renewal notice
to a facility up to 60 calendar days before the expiration date of a license.
(1)
If the facility has not received the renewal notice from
the department within 30 calendar days prior to the expiration date, it is
the duty of the facility to notify the department and request a renewal application
for a license.
(2)
If the facility fails to submit the application and fee
within 15 calendar days prior to the expiration date of the license, the department
shall send to the facility a letter advising that unless the license is renewed,
the facility must cease operations upon the expiration of the license.
(b)
Renewal license. The department shall issue a renewal license
to a facility that meets the minimum requirements for a license.
(1)
The facility shall submit the following to the department
prior to the expiration date of the license:
(A)
a complete and accurate application form;
(B)
a copy of a fire safety survey indicating approval by the
local fire authority in whose jurisdiction the facility is based that is dated
no earlier than one year prior to the application date;
(C)
the renewal license fee;
(2)
The department may conduct a survey prior to issuing a
renewal license in accordance with §125.61 of this title (relating to
Inspection and Investigation Procedures).
(3)
Renewal licenses issued prior to January 1, 2005, will
be valid for 12 months.
(4)
Renewal licenses issued January 1, 2005, through December
31, 2005, will be valid for either 12 or 24 months, to be determined by the
department prior to the time of license renewal.
(5)
Renewal licenses issued January 1, 2006, or after will
be valid for 24 months.
(c)
Notice to cease operation and return license. If a facility
fails to submit the application, documents, and fee by the expiration date
of the license, the department shall notify the facility by certified mail
that it must cease operation and immediately return the license by certified
mail to the department. If the facility wishes to provide services after the
expiration date of the license, it shall apply for a license under §125.12
of this title (relating to Application and Issuance of Initial License).
§125.14.Time Periods for Processing and Issuing Licenses.
(a)
General.
(1)
The receipt date for an application for an initial license
or a renewal license is the date the application is received by the division.
(2)
An application for an initial license is complete when
the division has received, reviewed, and found acceptable the information
described in §125.12(a) of this title (relating to Application and Issuance
of Initial License).
(3)
An application for a renewal license is complete when the
division has received, reviewed, and found acceptable the information described
in §125.13(b) of this title (relating to Application and Issuance of
Renewal License).
(b)
Time periods. An application for an initial license or
renewal license shall be processed in accordance with the following time periods.
(1)
The first time period begins on the date the division receives
the application and ends on the date the license is issued, or, if the application
is received incomplete, the period ends on the date the facility is issued
a written notice that the application is incomplete. The written notice shall
describe the specific information that is required before the application
is considered complete. The first time period is 20 working days.
(2)
The second time period begins on the date the division
receives the last item necessary to complete the application and ends on the
date the license is issued. The second time period is 20 working days.
(c)
Reimbursement of fees.
(1)
In the event the application is not processed in the time
periods as stated in subsection (b) of this section, the applicant has the
right to request the division to reimburse in full the fee paid in that particular
application process. If the division does not agree that the established periods
have been violated or finds that good cause existed for exceeding the established
periods, the request shall be denied.
(2)
Good cause for exceeding the period established is considered
to exist if:
(A)
the number of applications for licenses to be processed
exceeds by 15% or more the number processed in the same calendar quarter the
preceding year;
(B)
another public or private entity utilized in the application
process caused the delay; or
(C)
other conditions existed which gave good cause for exceeding
the established periods.
(d)
Appeal. If the request for full reimbursement authorized
by subsection (c) of this section is denied, the applicant may then appeal
to the commissioner of health (commissioner) for a resolution of the dispute.
The applicant shall give written notice to the commissioner requesting full
reimbursement of all filing fees paid because the application was not processed
within the adopted time period. The division shall submit a written report
of the facts related to the processing of the application and good cause for
exceeding the established time periods. The commissioner shall make the final
decision and provide written notification of the decision to the applicant
and the division.
(e)
Contested case hearings. The procedures set out in §1.21
of this title (relating to Formal Hearing Procedures) apply to all hearings
requested under this chapter.
§125.15.Fees.
(a)
General.
(1)
All fees paid to the department are nonrefundable with
the exception of fees for surveys that were not conducted.
(2)
All fees shall be paid to the department.
(b)
License fees. The fee for an initial license or a renewal
license is $35 per bed per 12 months based upon the designed bed capacity.
The total fee may not be less than $300 or more than $2,500.
(c)
Plan review fees. This subsection outlines the fees that
must accompany the application for plan review.
(1)
Construction plans will not be reviewed or approved until
the required fee and an application for plan review are received by the department.
(2)
Plan review fees are based upon the estimated construction
project costs which are the total expenditures required for a proposed project
from initiation to completion. The plan review schedule is as follows:
(A)
$150,000 or less--$200;
(B)
$150,001 to $600,000--$500;
(C)
$600,001 to $2,000,000--$850;
(D)
$2,000,001 to $5,000,000--$1,500;
(E)
$5,000,001 to $10,000,000--$2,000; and
(F)
$10,000,001 and over--$3,000.
(3)
If an estimated construction cost cannot be established,
the estimated cost shall be based on $105 per square foot. No construction
project shall be increased in size, scope, or cost unless the appropriate
fees are submitted with the proposed changes.
(d)
Construction survey fees. A fee of $500 and an Application
for Survey form for each survey shall be submitted to the department at least
three weeks prior to the anticipated survey date. Construction surveys will
not be conducted until all required fees are received by the department. If
additional construction surveys of the proposed project are requested, or
if follow-up construction surveys are required to verify plans of correction,
the appropriate additional fees shall be submitted to the department.
(e)
Other fees. For all applications and renewal applications,
the department is authorized to collect subscription and convenience fees,
in amounts determined by the Texas Online Authority, to recover costs associated
with application and renewal application processing through Texas Online,
in accordance with Texas Government Code, §2054.111.
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on March 15, 2004.
TRD-200401940
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 458-7236
25 TAC §§125.31 - 125.35
The new sections are proposed under Health and Safety Code, §248.026,
concerning rules and minimum standards to protect and promote the public health
and welfare by providing for the issuance, renewal, denial, suspension, and
revocation of each level of license; and Health and Safety Code, §12.001,
which provides the Texas Board of Health (board) with the authority to adopt
rules for the performance of every duty imposed by law on the board, the department,
and commissioner of health.
The new sections affect the Health and Safety Code, Chapters 248 and 12.
The review of the rules implements Government Code, §2001.039.
§125.31.General Functions.
(a)
Administration and staffing.
(1)
Legal responsibility. There shall be an individual or individuals
that assume(s) full legal responsibility for the overall conduct of the facility
and are responsible for compliance with all applicable laws and rules of the
department.
(2)
Facility director.
(A)
The facility director, who is to be accountable for the
overall management of the facility, shall be named in writing.
(B)
The director's responsibilities shall be defined in writing.
(C)
If the facility can be successfully managed with less than
the director's full-time management, the director may be less than full-time.
In such instances, the director shall assign another responsible individual
who can perform management tasks so that there is administrative management
essentially for the usual and customary 40-hours-per-week business operations.
(D)
There shall be a competent individual authorized to be
in charge of the facility when the director is absent.
(E)
The director shall be at least 18 years of age and shall
be qualified by education or training to perform the duties required to manage
the facility.
(F)
The director shall be responsible for coordinating the
provision of all services.
(3)
Personnel requirements.
(A)
The facility shall have written personnel policies and
procedures for paid staff and volunteer staff which include at a minimum:
(i)
written position descriptions that include responsibilities
for all positions in the facility;
(ii)
qualifications for employment for all positions in the
facility; and,
(iii)
the process for filling a position, evaluating performance
and termination.
(B)
The facility shall maintain personnel records which contain
sufficient information to support appropriate placement of an individual in
a position. The file shall include a copy of the individual's current license
or certification, if applicable, or other evidence that license or certification
status was verified.
(C)
The facility shall be staffed at all times with sufficient
qualified personnel to meet the needs of residents and maintain a clean and
safe environment. A minimum of one staff person shall be on duty at all times.
A qualified staff person will be designated as in charge on each shift.
(4)
Contracted services. If a facility does not employ a person
qualified to provide a required or needed service, it shall have a contract
with an outside resource to provide the service directly to residents or to
act as a consultant to the facility. The facility maintains responsibility
for ensuring that contract staff is qualified to perform the services to be
provided and that they are appropriately supervised.
(5)
Volunteer services. Volunteer staff may be placed in any
position for which they are qualified. Requirements in paragraph (6) of this
subsection shall apply to all volunteer staff.
(6)
Staff development and training.
(A)
All staff shall receive orientation training prior to being
allowed to work with residents. Orientation shall include information pertaining
to the facility's mission and philosophy, position specific responsibilities
and all operational policies and procedures.
(B)
All staff must participate in periodic staff development
training designed to update their knowledge and skills in providing care to
residents. Training will also include a review of operational policies and
procedures.
(C)
The facility shall maintain documentation which verifies
each staff person's participation in the orientation training program and
staff development training.
(b)
Policies and procedures. The facility shall adopt, implement
and enforce written policies and procedures detailing the operations of the
facility. The policies shall be reviewed and updated annually. In addition
to describing the operations of the facility and the manner in which care
and services will be provided, the policies and procedures shall include:
(1)
Resident admission.
(A)
Admission policies shall include qualifications and criteria
for admission based on the mission and philosophy of the facility.
(B)
Policies may include restriction of admission and retention
of individuals with regard to illegal drug use, alcohol abuse, or actions
that pose a threat to the health and safety of other residents or staff.
(C)
Policies shall require a written admission agreement between
the resident and the facility that addresses the care and services to be provided
and the method of payment for services.
(D)
The facility policy shall require that a chronological
register of all residents admitted to and discharged from the facility be
maintained. The register shall contain at least the name of the resident,
date of birth, date of admission, date of discharge or death, and disposition.
(2)
Infection control and universal precautions. There shall
be written policies and procedures providing for a safe and sanitary environment,
and the control of communicable diseases and infections in staff, residents,
and visitors. The policy shall also provide for monitoring compliance of the
facility and its staff with universal precautions in accordance with the Health
and Safety Code (HSC), Chapter 85, Subchapter I (relating to the Prevention
of Transmission of Human Immunodeficiency Virus and Hepatitis B Virus by Infected
Health Care Workers).
(3)
Determination of death. If applicable, there shall be a
written policy with protocols to be used in determining death that complies
with HSC, Title 8, Subtitle A, Chapter 671, Subchapter A (relating to Determination
of Death).
(4)
Special waste. The facility shall comply with the requirements
set forth by the department in §1.131 - 1.137 of this title (relating
to Definition, Treatment, and Disposition of Special Waste from Health Care
Related Facilities), and the Texas Commission on Environmental Quality requirements
in Title 30, Texas Administrative Code, Subchapter Y, §330.1004 (relating
to Generators of Medical Waste).
(5)
Confidentiality of records. There shall be a written policy
that addresses the confidentiality of resident information.
(6)
Advance directives. There shall be policies and procedures
regarding the use of advance directives in the facility. These policies and
procedures shall be in accordance with the Advance Directives Act, HSC, Chapter
166. Violations of §166.004 may result in the assessment of administrative
penalties, in accordance with HSC, §248.0545 (relating to Violation of
Law Relating to Advance Directives).
§125.32.Resident Care and Services.
(a)
Physician services.
(1)
Each resident shall have an attending physician who is
charge of the resident's medical care.
(2)
The facility shall make a reasonable effort to contact
the resident's physician within 72 hours after admission to obtain any information
relating to the care of the resident. Any relevant information obtained from
the physician will be recorded in the resident's care document.
(3)
In the event of an acute illness, condition, or accident
requiring medical and/or nursing care beyond the capabilities of the facility,
the resident shall be transferred, in a medically appropriate manner, to a
hospital or other health care facility as appropriate where needed services
and facilities are available.
(b)
Nursing services.
(1)
Licensed nurses shall function consistent with the nursing
practices recognized and authorized by Texas Board of Nurse Examiners.
(2)
When nursing services are provided, nursing personnel are
responsible for ensuring that residents receive treatments, medications, and
diets as prescribed; receive preventive care to prevent and minimize the incidence
of skin breakdown; are kept comfortable with personal hygiene needs met; are
protected from accident and injury through the initiation of appropriate safety
measures; and are treated with kindness and respect.
(3)
Nursing or attendant personnel on duty shall be responsible
for obtaining emergency medical care when a resident's condition so requires
and shall be responsible for notify the attending physician.
(c)
Medications.
(1)
Medications shall be provided as required for those residents
on a physician-ordered medication therapy regimen.
(2)
Upon admission, and as part of the plan of care, the admitting
physician shall determine whether a resident can self-administer his or her
medications or will require administration by qualified personnel in accordance
with paragraph (7) of this subsection.
(3)
Each resident's health status shall be reviewed at least
quarterly, or more often if indicated, to determine if any changes are necessary
in the medication administration procedures.
(A)
The appropriateness for a resident to self-administer medications
shall be reviewed by facility staff and the attending physician.
(B)
A resident's drug regimen review shall be incorporated
into the individual's plan of care.
(4)
Medications must be kept secured at all times. Only the
resident and authorized facility staff shall have access to the secured medications.
Residents self-administering their medications may:
(A)
keep medications in their possession at all times;
(B)
secure their medications within their locked room if the
room is not shared with others, or in a locked cabinet in their room; or
(C)
allow the facility to keep residents' medications in a
central medication storage area under control of facility staff.
(5)
The central medication storage shall be kept locked when
facility staff is not actually in or at the storage area.
(6)
Residents may be permitted entrance or access to the storage
area for the purpose of self-administering their medications or treatments
or receiving assistance with their medication or treatment regimen. A facility
staff member shall remain in or at the storage area the entire time any resident
is in the storage area.
(7)
Medications that are administered to a resident shall be
administered only by a registered professional nurse, licensed vocational
nurse, or an individual under direct delegation orders by a physician and
in conformance with all laws, rules, and recognized professional standards
of practice. A home health agency who is providing services within a special
care facility may use a home health medication aide in accordance with 40
Texas Administrative Code, §95.128 (relating to Home Health Medication
Aides).
(A)
The person administering medications shall properly record
the medications administered. This record will be retained in the resident
file.
(B)
Medications classified as dangerous drugs may not be taken
by or administered to residents unless the medication was obtained directly
from or under a valid prescription or order of a physician. If facility staff
administer the medications, they shall only be administered under written
orders, or verbal orders which are subsequently verified in writing by the
treating physician.
(C)
All injectable medication, intravenous solutions, or medications
administered by way of a tube inserted in a cavity of the body shall be administered
under physician's orders by a physician, registered professional nurse, licensed
vocational nurse, or other individual qualified under state law.
(D)
If administration of medications to residents is performed
by a registered professional nurse or licensed vocational nurse the following
shall apply.
(i)
There shall be a specific area designated for medication
that is:
(I)
sufficient in size and/or space for the storage of all
medications that are being administered to residents and for the preparation
of medications for administration to residents;
(II)
lockable and shall be maintained locked at all times when
not occupied;
(III)
accessible only to persons authorized to administer medications
to residents;
(IV)
equipped with a sink having hot and cold water available
at all times; and
(V)
adequately ventilated and temperature controlled.
(ii)
A medication storage cart may be used in addition to the
medication room for the storage of residents' medications. When not in use,
the medication storage cart must be kept locked in the locked medication room
or in the designated locked storage room that shall be used only for the storage
of the cart.
(8)
When a resident needs assistance with taking oral medication,
only those individuals approved in writing by the director of the facility
may provide that assistance.
(A)
A mechanism will be developed, implemented and monitored
by the facility director to insure that the resident is given only those medications
that have been prescribed by the resident's physician at the intervals detailed
on the resident's medication container.
(B)
When assistance with taking oral medication is provided,
the facility will maintain a medication record which documents the medication,
date, and time taken. The name of the individual who assisted the resident
taking the oral medication shall also be documented.
(C)
The facility director or designee will monitor the medication
records daily to insure accuracy.
(9)
Medication requiring refrigeration shall be stored in a
separate refrigerator designated for medications which is kept in the secured
medication storage area. Medications may be stored in an area within the common
refrigerator if they are stored in a manner that prevents contamination of
the medications, and allows for the security of the medication to be maintained.
(10)
Medication under storage control of the facility shall
be returned to the resident upon dismissal from the facility, or as directed
by the physician.
(11)
Medications of a resident shall not be used for another
resident. When a resident is dismissed from or otherwise leaves the facility
for a period of time greater than 48 hours, medications which had been under
the control of the resident and left in the facility shall be secured under
locked storage control of the facility until reclaimed by the resident and
no longer than 90 days. Medications of deceased residents shall not remain
in the facility for more than 7 days after the resident's death. Medications
of deceased residents and medications which have been left unclaimed in the
facility for more than 90 days shall be handled in one of the following manners.
(A)
Medications may be returned to any licensed pharmacy for
destruction in accordance with regulations of the Texas Board of Pharmacy
governing the destruction of dangerous drugs or controlled substances. A record
shall be maintained by the facility which itemizes the quantity and strength
of each medication returned to a pharmacy for destruction. Such record shall
be signed by the director of the facility and the pharmacist accepting the
drugs for destruction and shall be retained in the resident's file.
(B)
Medications may be destroyed beyond reclamation on site
by the facility director. Drugs should be destroyed by incineration, if possible.
Small amounts of drugs may be flushed into the sewer system unless prohibited
by local ordinance. Large quantities of drugs may be destroyed by removing
the drugs from the prescription containers, placing them in a strong plastic
container, and adulterating the drugs with water or bleach.
(i)
A record of the destruction shall be maintained by the
facility and include:
(I)
the name, strength, and quantity of the drug;
(II)
the method of destruction; and
(III)
the signature of the facility director who destroyed
the drugs and signatures of two other individuals who witnessed the destruction.
(ii)
This record shall be retained in the resident's file.
(12)
Controlled substances and drugs under storage control
of the facility shall be kept separately locked in a permanently affixed compartment
within the medicine room or medication storage cart.
(A)
A separate record must be maintained for each controlled
substance and drug.
(B)
The record shall include, but not be limited to, prescription
number, name and strength of drug, date received by the facility, date and
time each dose is provided, signature of person providing the dose, name of
resident, and the original amount received with the balance verifiable by
drug inventory at least daily.
(13)
All residents' medications shall be properly labeled in
accordance with applicable laws and regulations.
(d)
Dietary services.
(1)
A dining room, rooms, or space with appropriate furnishings
shall be provided. The dining space and furnishings should allow the residents
who can come to the dining room to dine at one sitting. Where alternate or
second meal services are employed, quantity and quality shall be maintained.
(2)
The facility shall have a kitchen or dietary area to meet
the food service needs of the residents. It shall include provisions for the
storage, refrigeration, preparation, and serving of food; for dish and utensil
cleaning; and for refuse storage and removal.
(3)
Meal service at intervals of at least three meals per day,
seven days per week, shall be provided or arranged to be commensurate with
the needs of the residents. Meals shall be palatable and meet the nutritional
needs of the residents.
(4)
Procedures to prevent cross contamination shall be observed
in the storage, preparation, and distribution of food; in the cleaning of
dishes, equipment, and work area; and in the storage and disposal of waste.
The facility shall provide storage of food for emergency use for a minimum
of four calendar days.
(5)
All dishes and utensils shall be washed in an automatic
dishwasher or by the use of manual dishwashing procedures.
(A)
A three-compartment sink shall be used if washing, rinsing
and sanitizing of utensils and equipment is done manually; or a two-compartment
sink may be utilized if single service tableware is provided, or when an approved
detergent sanitizer is used.
(B)
Cleaning and sanitizing may be done by spray-type or immersion
dishwashing machines or by any other type of machine or device if it is demonstrated
that it thoroughly cleans and sanitizes equipment and utensils either by chemical
or mechanical sanitization.
(6)
Sanitary hand washing and drying provisions shall be provided
in the kitchen area and shall include soap, water and individual disposable
towels.
(e)
Social services/pastoral care. Services to meet identified
social, spiritual, and emotional needs shall be offered to the resident. Services
may also be available to the resident's family, responsible party, and significant
other persons. Acceptance of these services will be at the option of the resident.
(f)
Personal care services.
(1)
The facility shall provide personal care services in accordance
with the individualized needs of each resident.
(2)
Personal care services shall include normal activities
of daily, and may include:
(A)
assistance with their medications;
(B)
assistance with hygiene;
(C)
assistance with dressing;
(D)
assistance with ambulation; and
(E)
emotional support.
(g)
Laboratory services.
(1)
A facility that provides laboratory services shall comply
with the Clinical Laboratory Improvement Amendments of 1988 (CLIA 1988), in
accordance with the requirements specified in 42 Code of Federal Regulations
(CFR), Chapter IV, Part 493, §§493.1 - 493.1780. CLIA 1988 applies
to all facilities with laboratories that examine human specimens for the diagnosis,
prevention, or treatment of any disease or impairment of, or the assessment
of the health of, human beings.
(2)
The facility shall ensure that all laboratory services
provided to its residents through a contractual agreement are performed in
a facility certified in the appropriate specialties and subspecialties of
service in accordance with the requirements specified in 42 CFR, Chapter IV,
Part 493 to comply with CLIA 1988.
§125.33.Resident Rights.
(a)
General. The facility shall promote and protect the rights
of all residents. Policies that ensure resident rights shall be adopted, implemented
and enforced. The policies shall include:
(1)
the right of the resident to considerate and respectful
care:
(A)
the care of the resident includes consideration of the
psychosocial, spiritual, and cultural variables that influence the perceptions
of illness; and
(B)
the care of the dying resident optimizes the comfort and
dignity of the patient;
(2)
the right of the patient, in collaboration with his or
her physician, to make decisions involving his or her health care;
(3)
the right of the resident to formulate advance directives
and to appoint a surrogate to make health care decisions on his or her behalf
to the extent permitted by law:
(A)
a facility shall have in place a mechanism to ascertain
the existence of, and, as appropriate, assist in the development of advance
directives at the time of the resident's admission;
(B)
the provision of care shall not be conditioned on the existence
of an advance directive; and
(C)
an advance directive(s) shall be in the resident's record
and shall be reviewed periodically with the patient or surrogate decision
maker if the patient has executed an advance directive;
(4)
the right of the resident, within the limits of law, to
personal privacy and confidentiality of information;
(5)
the right to receive care in a safe setting:
(A)
all accidents, whether or not they result in injury, and
any unusual incidents or abnormal events, including allegations of mistreatment
of residents by staff, personnel, or visitors, shall be investigated by the
facility; and
(B)
documentation shall be maintained in separate administrative
records, to be filed in the facility director's office.
(6)
the right to have unlimited freedom to move to and from
the facility;
(7)
the right to only be discharged from the facility for reasons
specified in the admission policies and to have due notification;
(8)
the right to keep and maintain his or her personal belongings
in his or her possession:
(A)
within 72 hours of admission, the facility must prepare
a written inventory of the personal property a resident brings to the facility
(inventory of the resident's clothing is not required);
(B)
if requested by the resident or responsible party, the
inventory shall be updated; and
(C)
the facility shall have a mechanism to protect resident
clothing.
(9)
the right to keep and maintain his or her own finances;
(10)
the right to participate in, or abstain from, religious
observances;
(11)
the right to receive and send mail unopened and without
undue delay; and
(12)
the right to receive visitors at reasonable hours, within
reasonable limitations, as may be required by the facility in its operation
policies.
(b)
Rights of the elderly. Rights of the elderly specified
in Human Resources Code, Title 6, Chapter 102, shall apply to residents 60
years of age or older.
(c)
Abuse, neglect and exploitation. The facility shall adopt,
implement and enforce policies which ensure that residents are protected from
abuse, neglect and exploitation.
(1)
Reporting requirements.
(A)
Abuse or neglect of a child, as defined in §1.204(a)
and (b) of this title (relating to Investigations of Abuse, Neglect, or Exploitation
of Children or Elderly or Disabled Persons), which occurs in a facility shall
be reported to the Texas Department of Health (department).
(B)
Abuse, neglect or exploitation of an elderly or disabled
person, as defined in §1.204(a) and (b) of this title, which occurs in
a facility shall be reported to the department.
(2)
Investigations.
(A)
Submission of complaints. A complaint alleging abuse, neglect
or exploitation may be submitted in writing or verbally to the Health Facility
Licensing and Compliance Division, Texas Department of Health, 1100 West 49th
Street, Austin, Texas 78756-3199, telephone, (888) 973-0022.
(B)
Investigations by the department. A complaint containing
allegations of abuse, neglect or exploitation as defined in §1.204(a)
and (b) of this title shall be investigated by the department.
(C)
Allegations of abuse, neglect or exploitation which are
not under the jurisdiction of the department will be referred to law enforcement
agencies or other agencies, as appropriate.
§125.34.Resident Records.
(a)
The facility shall maintain for each resident admitted,
a separate record with all entries kept current, dated and signed by the recorder.
The record shall be accurately written, promptly completed, properly stored
and filed, and accessible. At a minimum, the record shall include:
(1)
identification data. The facility shall secure at the time
of admission appropriate identifying information, including full name; sex;
date of birth; usual occupation; social security number; family/friend name,
address, and telephone number; and physician names and telephone numbers including
emergency numbers;
(2)
medical history and physical exam reports, if available;
(3)
any physician orders and progress notes, if available;
(4)
any documentation of the resident's change in health condition
requiring emergency procedures, and health services provided by facility personnel;
(5)
other documents or reports related to the care of the resident
as required by facility policy;
(6)
if appropriate, documentation of nursing services provided
and nursing staff observation as required by facility policy; and
(7)
a list of medications the resident is taking.
(b)
The facility director shall be responsible for the organization
and management of the resident file.
(c)
The facility will protect the resident file against loss,
damage, destruction, and unauthorized use by:
(1)
safeguarding the confidentiality of the resident file and
allowing access or release only as specifically allowed by federal or state
laws;
(2)
maintaining files in an organized manner and filing them
using an organized system;
(3)
recording entries in ink, computer, or typewritten format
and keeping original reports and records; and
(4)
storing files in a lockable area during non-use and after
resident's discharge.
(d)
Resident files must be retained for at least five years
after services end. In the case of a minor, the resident file must be retained
for at least three years after the minor reaches majority under state law.
(e)
The facility may not destroy resident files that relate
to any matter that is involved in litigation if the facility knows the litigation
has not been finally resolved.
§125.35.Residential AIDS Hospice Designation.
(a)
General. A special care facility designated as a residential
AIDS hospice shall meet the standards of this section. These standards are
in addition to the other standards described in this chapter that apply to
special care facilities.
(b)
Service requirements.
(1)
Palliative care. The facility shall provide palliative
care that is reasonable and necessary to meet the needs of a resident and
the management of the resident's terminal illness and related conditions.
(2)
Support services. Support services shall be available to
both the resident and the family. Support services shall:
(A)
include social, spiritual and emotional care provided to
a resident and the family; and
(B)
be under the supervision of a qualified individual who
may be a person with a master's degree in social work, an accredited or ordained
member of the clergy, or other individual with appropriate training and experience.
(3)
Counseling services. Counseling services shall be available
to the resident and the family. If provided, counseling services shall be
identified as a need in the resident's plan of care described in subsection
(c) of this section.
(4)
Bereavement services. Bereavement services shall be available
to the family. The provision of bereavement services shall be:
(A)
provided in an organized program under the supervision
of a qualified person who may be a person with a master's in social work,
an accredited or ordained member of the clergy, or other individual with appropriate
training and experience;
(B)
available to families for up to one year following the
death of the resident; and
(C)
identified as a need for the family in the resident's plan
of care described in subsection (c) of this section.
(c)
Plan of care.
(1)
An interdisciplinary team shall develop an individual plan
of care for each resident receiving hospice services.
(A)
The interdisciplinary team shall consist of the resident,
a physician, a registered nurse and other appropriate members who are involved
with the resident's care.
(B)
Members of the interdisciplinary team may also include
a volunteer, an employee of the facility, an individual under contract with
facility, or an employee or representative of a home and community support
services agency employed by the resident to provide services.
(C)
The interdisciplinary team shall review and revise the
resident's plan of care as needed based on changes in the resident's needs,
but not less than once a month.
(2)
The plan of care shall identify the need for counseling
and bereavement services, as appropriate.
(3)
A physician shall conduct a clinical and medical review
of the care and services provided to a resident receiving hospice services.
The physician conducting the review shall serve as a member of the interdisciplinary
team described in paragraph (1) of this subsection. The physician may be an
employee, a volunteer, or a contracted consultant to the facility.
(d)
Designation process. The department must approve a special
care facility's designation as a residential AIDS hospice prior to the facility's
implementation of hospice services.
(1)
A special care facility may request designation as a residential
AIDS hospice on the initial application form, or by submitting a written request
to the department at any time during the licensing period.
(2)
The department will evaluate the facility's compliance
with subsections (a) - (c) of this section prior to approving the residential
AIDS hospice designation. This evaluation may be accomplished through a presurvey
conference with review of required policies and documents or by means of an
onsite inspection.
(3)
The department will send a written notice to the facility
regarding the approval or denial of the residential AIDS hospice designation.
If denied, the written notice will state the deficient items that resulted
in the denial of the application. The facility may submit additional information
and request reconsideration of the application.
(4)
The facility may withdraw the residential AIDS hospice
designation by submitting a written request to the department. The request
shall include the effective date of withdrawal.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed
with the Office of the Secretary of State on March 15, 2004.
TRD-200401941
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 458-7236
25 TAC §125.51
The new section is proposed under Health and Safety Code, §248.026,
concerning rules and minimum standards to protect and promote the public health
and welfare by providing for the issuance, renewal, denial, suspension, and
revocation of each level of license; and Health and Safety Code, §12.001,
which provides the Texas Board of Health (board) with the authority to adopt
rules for the performance of every duty imposed by law on the board, the department,
and commissioner of health.
The new section affects the Health and Safety Code, Chapters 248 and 12.
The review of the rules implements Government Code, §2001.039.
§125.51.Waivers, Modifications, and Variations to Provisions.
(a)
Physical plant waiver. On the request of the facility,
the department may grant a waiver or modification for certain provisions of
the physical plant and environment that, in the opinion of the department,
would be impractical for the facility to meet. Waivers will not be granted
for fire safety requirements required by the National Fire Protection Association
(NFPA). The facility's written request must specify the specific provision
for which waiver is requested.
(b)
Facility operation waiver. On the request of the facility,
the department may grant a waiver or approve a variation for certain provisions
of facility operation that, in the opinion of the department, would be impractical
or inappropriate for the facility to meet. The facility's written request
must specify the specific provision for which waiver is requested.
(c)
Consideration. In considering the waiver or modification
request, the department shall consider information submitted by the facility
and whether the waiver or modification:
(1)
will adversely affect the health and safety of the facility
patients, employees, or the general public;
(2)
if not granted, would impose an unreasonable hardship on
the facility in providing adequate care for patients;
(3)
will facilitate the creation or operation of the facility;
and
(4)
is appropriate when balanced against the best interests
of the individuals served or to be served by the facility.
(d)
Supporting documentation. The department may request written
documentation from the facility to support the waiver or modification including,
but not limited to:
(1)
a statement addressing each of the criteria in subsection
(c) of this section;
(2)
evidence of approval by the local building and fire authorities;
(3)
evidence of provisions in the Act or this chapter which
will mitigate any adverse effect of the waiver or modification; and
(4)
evidence of any mitigating act in excess of the Act or
this chapter which will be used by the hospital to offset any adverse effect
of the waiver or modification.
(e)
Written recommendation. The director shall submit a written
recommendation for granting or denying the waiver to the commissioner of health
(commissioner).
(f)
Granting order. If the director recommends that the waiver
or modification be granted, the commissioner may issue a written order granting
the waiver or modification.
(g)
Denial of order. If the director recommends that the waiver
or modification be denied, the commissioner may issue a written order denying
the waiver or modification.
(h)
File documentation. The licensing file for the facility
maintained by the Texas Department of Health shall contain a copy of the request,
the written recommendation of the director, and the order of the commissioner.
The facility shall also maintain a copy of the order.
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on March 15, 2004.
TRD-200401942
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 458-7236
25 TAC §125.61, §125.62
The new sections are proposed under Health and Safety Code, §248.026,
concerning rules and minimum standards to protect and promote the public health
and welfare by providing for the issuance, renewal, denial, suspension, and
revocation of each level of license; and Health and Safety Code, §12.001,
which provides the Texas Board of Health (board) with the authority to adopt
rules for the performance of every duty imposed by law on the board, the department,
and commissioner of health.
The new sections affect the Health and Safety Code, Chapters 248 and 12.
The review of the rules implements Government Code, §2001.039.
§125.61.Inspection and Investigation Procedures.
(a)
Routine inspections. The department may conduct an inspection
of a facility prior to the issuance or renewal of a license.
(b)
Complaint investigations.
(1)
Complaint investigations are unannounced and are conducted
to ensure compliance of the facility with the provisions of Health and Safety
Code (HSC), Chapter 248, this chapter, special license conditions, or orders
of the commissioner of health (commissioner).
(2)
Complaints received by the department concerning abuse,
neglect, or exploitation will be investigated in accordance with §125.33(c)(2)
of this title (relating to Resident Rights).
(3)
If an individual wishes to report an alleged violation
of the Act or this chapter, the individual shall notify the department in
persons, by telephone at (888) 973-0022, by facsimile or by writing the department
at Health Facility Licensing and Certification Division, 1100 West 49th Street,
Austin, Texas 78756-3199, or electronic medium.
(c)
General.
(1)
The department may make any survey, inspection or investigation
that it considers necessary. A department representative(s) may enter the
premises of a facility at any reasonable time to make an inspection or an
investigation to ensure compliance with or prevent a violation of HSC, Chapter
248, this chapter, an order or special order of the commissioner, a special
license provision, a court order granting injunctive relief, or other enforcement
procedures. Ensuring compliance includes permitting photocopying of any records
or other information by or on behalf of the department as necessary to determine
or verify compliance with the statute or rules adopted under the statute.
(2)
The department representative(s) is entitled to access
to all books, records, or other documents maintained by or on behalf of the
facility to the extent necessary to enforce HSC, Chapter 248, this chapter,
an order or special order of the commissioner, a special license provision,
a court order granting injunctive relief, or other enforcement procedures.
The department shall maintain the confidentiality of facility records under
federal or state law.
(3)
By applying for or holding a facility license, the facility
consents to entry and inspection or investigation of the facility by the department
in accordance with HSC, Chapter 248, and this chapter.
(d)
Inspection and investigation protocol.
(1)
The department representative(s) shall hold a conference
with the facility director or designee before beginning the on-site inspection
or investigation to explain the nature, scope, and estimated time schedule
of the inspection or investigation.
(2)
The department representative(s) may conduct interviews
with any person with knowledge of the facts.
(3)
The department representative(s) shall inform the facility
director or designee of the preliminary findings of the inspection or investigation
and shall give the person a reasonable opportunity to submit additional facts
or other information to the department representative in response to those
findings.
(4)
Following an inspection or investigation of a facility
by the department, the department representative(s) shall hold an exit conference
with the facility director or designee and other invited staff and provide
the following information:
(A)
the nature of the inspection or investigation;
(B)
an overview of the findings regarding alleged violations
or deficiencies identified by the department representative(s);
(C)
identity of any records that were duplicated; and
(D)
if there are no deficiencies found, a verbal statement
indicating this fact.
(5)
If deficiencies are cited, the facility shall provide a
plan of correction (POC) to the department either at the time of the exit
conference or within 10 calendar days following the facility's receipt of
a statement of deficiencies (SOD).
(A)
The POC shall include the facility's planned action to
correct the deficiency and the expected completion date. The POC shall be
specific and realistic, stating exactly how the deficiency was or will be
corrected. The director or their designee must sign the POC.
(B)
A facility may refute the accuracy of a cited deficiency
or survey finding.
(i)
Objections may be recorded on the SOD form, however, a
POC is still required to be submitted; or
(ii)
A facility may record an objection on the SOD form and
not submit a POC, however, the facility must submit a convincing argument
and documented evidence that the cited deficiency or survey finding is invalid.
(iii)
Should the department agree with the supporting documentation,
the cited deficiency or survey finding shall be deleted from the SOD form.
(iv)
Should the department sustain the cited deficiency, the
department will inform the facility in writing that a POC is required. The
facility shall submit a POC to the department within 10 calendar days of the
facility's receipt of the department's decision.
(6)
The department representative(s) shall inform the director
or their designee of the facility's right to an informal administrative review
when there is disagreement with the representative's findings and recommendations
or when additional information bearing on the findings is available.
(7)
If the department determines that the POC is not acceptable,
the department shall notify the facility in writing that it is responsible
to provide the department an acceptable POC. The facility shall submit the
new POC within 10 calendar days of the facility's receipt of the department's
written notice.
(8)
The facility shall come into compliance by the completion
date provided on the POC.
(9)
The department may verify the correction of deficiencies
either in writing or by an on-site survey or investigation.
§125.62.Complaint Against a Texas Department of Health Representative.
(a)
A facility may register a complaint against a department
representative who conducts a survey or investigation in accordance with this
section The complaint must be registered within 10 working days of the facility's
receipt of the statement of deficiencies (SOD).
(b)
A complaint against a department representative shall be
registered with the Health Facility Licensing and Compliance Division, Texas
Department of Health, 1100 West 49th Street, Austin, Texas 78756-3199, telephone
(512) 834-6650 or (888) 973-0022.
(1)
A complaint against a department representative which is
received by telephone will be referred within two working days to the appropriate
supervisor. The caller will be requested to submit the complaint in writing.
(2)
When a complaint is received in writing, it will be forwarded
to the appropriate supervisor within two working days. Within 10 calendar
days of receipt of the complaint, the Health Facility Licensing and Compliance
Division will inform the complainant in writing that the complaint has been
forwarded to the appropriate supervisor.
(3)
Within 10 calendar days of the supervisor's receipt of
the complaint, the supervisor will notify the complainant in writing that
an investigation will be done.
(4)
The supervisor will review the documentation in the survey
packet and interview the department representative identified in the complaint
to obtain facts and assess the objectivity of the department representative
in the department representative's application of this chapter during the
inspection or investigation.
(5)
The supervisor shall offer to meet with the complainant
to resolve the issue. The department representative identified in the complaint
will participate in the discussion. The resolution meeting may be conducted
at the division's office or during an on-site follow-up visit to the facility.
(6)
Changes and deletions will be made to the SOD, if necessary.
(7)
The supervisor will notify the complainant in writing of
the status of the investigation within 30 calendar days of the date the supervisor
received the complaint.
(8)
The supervisor will forward all final documentation to
the director of the Health Facility Licensing and Compliance Division and
notify the complainant of the results.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed
with the Office of the Secretary of State on March 15, 2004.
TRD-200401943
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 458-7236
25 TAC §§125.71 - 125.73
The new sections are proposed under Health and Safety Code, §248.026,
concerning rules and minimum standards to protect and promote the public health
and welfare by providing for the issuance, renewal, denial, suspension, and
revocation of each level of license; and Health and Safety Code, §12.001,
which provides the Texas Board of Health (board) with the authority to adopt
rules for the performance of every duty imposed by law on the board, the department,
and commissioner of health.
The new sections affect the Health and Safety Code, Chapters 248 and 12.
The review of the rules implements Government Code, §2001.039.
§125.71.License Denial, Suspension, Revocation and Probation.
(a)
The department may deny, suspend, suspend on an emergency
basis, or revoke a license if the applicant or facility fails to comply with
any provision of the Act or this chapter.
(b)
The department may take action under subsection (a) of
this section for fraud, misrepresentation, or concealment of a material fact
on any documents required to be submitted to the department or required to
be maintained by the facility pursuant to the provisions of this chapter.
(c)
The department may suspend or revoke an existing valid
license, or disqualify a person from receiving a license because of a person's
conviction of a felony or misdemeanor if the crime directly relates to the
duties and responsibilities of the ownership or operation of a facility.
(1)
In determining whether a criminal conviction directly relates,
the department shall consider:
(A)
the nature and seriousness of the crime;
(B)
the relationship of the crime to the purposes for requiring
a license to engage in the occupation;
(C)
the extent to which a license might offer an opportunity
to engage in further criminal activity of the same type as that in which the
person previously had been involved; and
(D)
the relationship of the crime to the ability, capacity,
or fitness required to perform the duties and discharge the responsibilities
of the licensed occupation.
(2)
In addition to the factors that may be considered under
paragraph (1) of this subsection, the department, in determining the present
fitness of a person who has been convicted of a crime, shall consider the
provisions of Texas Occupations Code, §53.022 and §53.023 (relating
to Ineligibility for License).
(3)
The following felonies and misdemeanors directly relate
because these criminal offenses indicate an ability or a tendency for the
person to be unable to own or operate a facility:
(A)
a violation of the Act;
(B)
an offense involving moral turpitude;
(C)
an offense relating to deceptive business practice;
(D)
an offense of practicing any health-related profession
without a required license;
(E)
an offense under any federal or state law relating to drugs,
dangerous drugs, or controlled substances;
(F)
an offense under Title 5 of the Texas Penal Code involving
a patient or client of a health care facility or agency; or
(G)
an offense under various titles of the Texas Penal Code:
(i)
Title 5 concerning offenses against the person;
(ii)
Title 7 concerning offenses against property;
(iii)
Title 9 concerning offenses against public order and
decency;
(iv)
Title 10 concerning offenses against public health, safety,
and morals;
(v)
Title 4 concerning offenses of attempting or conspiring
to commit any of the offenses in this subsection; or
(H)
other misdemeanors or felonies which indicate an inability
or tendency for the person to be unable to own or operate a facility if action
by the department will promote the intent of the Act, this chapter or Texas
Occupations Code, §53.022 and §53.023.
(d)
Upon a licensee's felony conviction, felony probation revocation,
revocation of parole, or revocation of mandatory supervision, his license
shall be revoked.
(e)
If the department proposes to deny, suspend, or revoke
a license, the director shall notify the applicant or the facility by mail
of the reasons for the proposed action and offer the applicant or facility
an opportunity for a hearing. The applicant or facility must request a hearing
within 30 calendar days of receipt of the notice. The request must be in writing
and submitted to the Health Facility Licensing and Compliance Division, Texas
Department of Health, 1100 West 49th Street, Austin, Texas 78756. A hearing
shall be conducted pursuant to the Administrative Procedure Act, Government
Code, Chapter 2001, and the department's formal hearing procedures in Chapter
1 of this title (relating to Texas Board of Health). If the applicant or facility
does not request a hearing, in writing, within 30 calendar days of receipt
of the notice or does not appear at a scheduled hearing, the applicant or
facility is deemed to have waived the opportunity for a hearing and the proposed
action shall be taken. Receipt of the notice is presumed to occur on the tenth
calendar day after the notice is mailed to the last address known to the department
unless another date is reflected on a United States Postal Service return
receipt.
(f)
The department may suspend or revoke a license to be effective
immediately when the department has reasonable cause to believe the health
and safety of persons are threatened. The department shall notify the facility
of the emergency action by mail or personal delivery of the notice. If requested
by the license holder, the department shall conduct a hearing, which shall
be not earlier than ten calendar days from the effective date of the suspension
or revocation. The effective date of the emergency action shall be stated
in the notice. The hearing shall be conducted pursuant to the Administrative
Procedure Act, Government Code, Chapter 2001, and the department's formal
hearing procedures in Chapter 1 of this title (relating to the Texas Board
of Health).
(g)
If a person violates a requirement of the Act or this chapter,
the department may petition the district court to restrain the person from
continuing the violation.
(h)
In lieu of suspending or revoking the license, the department
may schedule the facility for a probation period of not less than 30 days
if the facility is found in repeated non-compliance and the facility's noncompliance
does not endanger the health and safety of the public.
§125.72.Civil and Criminal Penalties.
(a)
A license holder or person who violates the Act or any
rule adopted by the board under the Act is liable for a civil penalty, to
be imposed by a district court, of not more than $1,000 for each day of violation.
(b)
A person who knowingly establishes or operates a special
care facility without a license issued under this Act commits an offense.
An offense under this section is a Class B misdemeanor. Each day of a continuing
violation constitutes a separate offense.
§125.73.Administrative Penalties.
(a)
Imposition of penalty. The department may impose an administrative
penalty on a person licensed under this chapter who violates the Act, this
chapter, or order adopted under this chapter.
(b)
Deposit of penalty. A penalty collected under this section
shall be deposited in the state treasury in the general revenue fund.
(c)
Contested case. A proceeding to impose the penalty is considered
to be a contested case under Government Code, Chapter 2001.
(d)
Amount of penalty.
(1)
The amount of the penalty may not exceed $1,000 for each
violation, except for violations of §125.31(b)(6) of this title (relating
to General Functions), which are limited to $500. Each day a violation continues
or occurs is a separate violation for purposes of imposing a penalty. The
total amount of the penalty assessed for a violation continuing or occurring
on separate days under this paragraph may not exceed $5,000.
(2)
In determining the amount of an administrative penalty
assessed under this section, the department shall consider:
(A)
the seriousness of the violation, including the nature,
circumstances, extent, and gravity of the violation;
(B)
the threat to health or safety caused by the violation;
(C)
the history of previous violations;
(D)
the amount necessary to deter a future violation;
(E)
whether the violator demonstrated good faith, including
when applicable whether the violator made good faith efforts to correct the
violation; and
(F)
any other matter that justice may require.
(e)
Report and notice of violation and penalty.
(1)
If the department initially determines that a violation
occurred, the department will give written notice of the report by mail to
the person alleged to have committed the violation.
(2)
The notice must include:
(A)
a brief summary of the alleged violation;
(B)
a statement of the amount of the recommended penalty based
on the factors listed in subsection (d)(2) of this section; and
(C)
a statement of the person's right to a hearing on the occurrence
of the violation, the amount of the penalty, or both.
(f)
Penalty to be paid or hearing requested.
(1)
Within 20 days after the date the person receives the notice
sent under subsection (e) of this section, the person in writing may:
(A)
accept the determination and recommended penalty of the
department; or
(B)
make a request for a hearing on the occurrence of the violation,
the amount of the penalty, or both.
(2)
If the person accepts the determination and recommended
penalty or if the person fails to respond to the notice, the commissioner
of public health (commissioner) or the commissioner's designee by order shall
approve the determination and impose the recommended penalty.
(g)
Hearing.
(1)
If the person requests a hearing, the commissioner or the
commissioner's designee shall refer the matter to the State Office of Administrative
Hearings (SOAH).
(2)
As mandated by Health and Safety Code, §248.105(a),
the SOAH shall promptly set a hearing date and give written notice of the
time and place of the hearing to the person.
(A)
An administrative law judge of the SOAH shall conduct the
hearing.
(B)
The administrative law judge shall make findings of fact
and conclusions of law and promptly issue to the commissioner a proposal for
a decision about the occurrence of the violation and the amount of a proposed
penalty.
(h)
Decision by commissioner.
(1)
Based on the findings of fact, conclusions of law, and
proposal for a decision made by the administrative law judge under subsection
(g)(2) of this section, the commissioner or the commissioner's designee by
order may find that a violation has occurred and may impose a penalty or may
find that no violation has occurred.
(2)
The commissioner or the commissioner's designee shall give
notice of the commissioner's order under paragraph (1) of this subsection
to the person alleged to have committed the violation in accordance with Government
Code, Chapter 2001. The notice must include:
(A)
a statement of the right of the person to judicial review
of the order;
(B)
separate statements of the findings of fact and conclusions
of law; and
(C)
the amount of any penalty assessed.
(i)
Options following decision. Within 30 days after the date
the order of the commissioner under subsection (h) of this section that imposes
an administrative penalty becomes final, the person shall:
(1)
pay the penalty; or
(2)
appeal the penalty by filing a petition for judicial review
of the commissioner's order contesting the occurrence of the violation, the
amount of the penalty, or both.
(j)
Stay of enforcement of penalty.
(1)
Within the 30-day period prescribed by subsection (i) of
this section, a person who files a petition for judicial review in accordance
with subsection (i)(2) of this section may:
(A)
stay enforcement of the penalty by:
(i)
paying the penalty to the court for placement in an escrow
account; or
(ii)
giving to the court a supersedeas bond that is approved
by the court for the amount of the penalty and that is effective until all
judicial review of the commissioner's order is final; or
(B)
request the court to stay enforcement of the penalty by:
(i)
filing with the court a sworn affidavit of the person stating
that the person is financially unable to pay the penalty and is financially
unable to give the supersedeas bond; and
(ii)
sending a copy of the affidavit to the commissioner by
mail.
(2)
If the commissioner receives a copy of an affidavit under
paragraph (1)(B) of this subsection, the commissioner may file with the court,
within five days after the date the copy is received, a contest to the affidavit.
In accordance with Health and Safety Code (HSC), §248.108(b), the court
shall hold a hearing on the facts alleged in the affidavit as soon as practicable
and shall stay the enforcement of the penalty on finding that the alleged
facts are true. The person who files an affidavit has the burden of proving
that the person is financially unable to pay the penalty or to give a supersedeas
bond.
(k)
Collection of penalty.
(1)
If the person does not pay the penalty and the enforcement
of the penalty is not stayed, the department may refer the matter to the attorney
general for collection of the penalty.
(2)
As provided by HSC, §248.109(b), the attorney general
may sue to collect the penalty.
(l)
Decision by court. A decision by the court is governed
by HSC, §248.110, and provides the following.
(1)
If the court sustains the finding that a violation occurred,
the court may uphold or reduce the amount of the penalty and order the person
to pay the full or reduced amount of the penalty.
(2)
If the court does not sustain the finding that a violation
occurred, the court shall order that no penalty is owed.
(m)
Remittance of penalty and interest and release of supersedeas
bond. The remittance of penalty and interest is governed by HSC, §248.111,
and provides the following.
(1)
If the person paid the penalty and if the amount of the
penalty is reduced or the penalty is not upheld by the court, the court shall
order, when the court's judgment becomes final, that the appropriate amount
plus accrued interest be remitted to the person within 30 days after the date
that the judgment of the court becomes final.
(2)
The interest accrues at the rate charged on loans to depository
institutions by the New York Federal Reserve Bank.
(3)
The interest shall be paid for the period beginning on
the date the penalty is paid and ending on the date the penalty is remitted.
(n)
Release of bond. The release of supersedeas bond is governed
by HSC, §248.112, and provides the following.
(1)
If the person gave a supersedeas bond and the penalty is
not upheld by the court, the court shall order, when the court's judgment
becomes final, the release of the bond.
(2)
If the person gave a supersedeas bond and the amount of
the penalty is reduced, the court shall order the release of the bond after
the person pays the reduced amount.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed
with the Office of the Secretary of State on March 15, 2004.
TRD-200401944
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 458-7236
25 TAC §§125.81 - 125.83
The new sections are proposed under Health and Safety Code, §248.026,
concerning rules and minimum standards to protect and promote the public health
and welfare by providing for the issuance, renewal, denial, suspension, and
revocation of each level of license; and Health and Safety Code, §12.001,
which provides the Texas Board of Health (board) with the authority to adopt
rules for the performance of every duty imposed by law on the board, the department,
and commissioner of health.
The new sections affect the Health and Safety Code, Chapters 248 and 12.
The review of the rules implements Government Code, §2001.039.
§125.81.General Safety.
(a)
The building must be kept in good repair. Electrical, heating
and cooling must be maintained in a safe manner. The department may require
the licensee to submit evidence to this effect, consisting of a report from
the fire marshal, city or county building official having jurisdiction, licensed
electrician, or a registered professional engineer.
(b)
Use of electrical appliances, devices, and lamps, must
be such as not to overload circuits or cause excessive lengths of extension
cords.
(c)
In facilities of 16 beds or less, all draperies and other
window coverings in public or common areas, and in bedrooms and living units
shall be flame resistant. In facilities of 17 beds or more, draperies shall
be flame resistant, where smoking is permitted.
(d)
In facilities of 17 beds or more, all floor carpet installed
in public or common spaces shall be Class I or II based on the "Critical Radiant
Flux" ratings. Proper documentation must be provided.
(e)
Open flame heating devices are prohibited. All fuel burning
heating devices must be vented. Working fireplaces are accepted if of safe
design and construction and if screened or otherwise enclosed.
(f)
There must be a least one telephone in the facility available
to both staff and residents for use in case of an emergency. Emergency telephone
numbers, including at least fire, police, ambulances, EMS, and poison control
center, must be posted conspicuously at or near the telephone.
(g)
An initial pressure test of facility gas lines from the
meter must be provided. Additional pressure tests will be required when the
facility has major renovations or additions where the gas service is interrupted.
All gas heating systems must be checked prior to the heating season for proper
operation and safety by persons who are licensed or approved by the State
of Texas to inspect such equipment. A record of this service must be maintained
by the facility. Any unsatisfactory conditions must be corrected promptly.
(h)
Exterior and interior stairs must have handrails that are
firmly secured to prevent falls.
(i)
Cooling and heating must be provided for occupant comfort.
Conditioning systems must be capable of maintaining the comfort ranges of
68 degrees Fahrenheit to 82 degrees Fahrenheit in resident-use areas. Heating,
ventilating, and air conditioning (HVAC) equipment must comply with the provisions
of National Fire Protection Association (NFPA) 90A, Standard for the Installation
of Air Conditioning and Ventilating Systems, 1999 edition, or NFPA 90B, Standard
for the Installation of Warm Air Heating and Air Conditioning Systems, 1999,
as applicable. NFPA 90A requires automatic shut down upon activation of the
fire alarm in HVAC systems of over 2,000 cubic feet per minute (CFM) capacity.
All documents published by NFPA as referenced in these rules may be obtained
by writing or calling the NFPA at the following address or telephone number:
National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02169-7471
or (800) 344-3555.
(j)
For existing facilities which were licensed prior to the
effective date of these rules, illumination shall be provided to meet the
needs of the residents and staff without eye strain or glare. Each resident
bedroom shall have sufficient illumination for reading and general use. For
new facilities, minimum illumination must be 10 foot-candles in resident rooms
during the day and 20 foot-candles in corridors, staff stations, dining rooms,
lobbies, toilets, bathing facilities, laundries, stairways and elevators during
the day. Illumination requirements for these areas apply to lighting throughout
the space and should be measured at approximately 30 inches above the floor
anywhere in the room. Minimum illumination for medication preparation or storage
areas, kitchen, and staff station desks must be 50 foot-candles during the
day. Illumination requirements for these areas apply to the task performed
and should be measured on the tasks.
(k)
All buildings three floors or higher and in facilities
that provide services, treatment, or social activities of floors above or
below the level of discharge shall have a passenger elevator. The lowest level
of discharge will be the first floor for determining floor level.
(l)
Floor, ceiling, and wall finish materials must be complete
and in place to provide a sanitary and structurally safe environment.
(m)
All equipment requiring periodic maintenance, testing,
and servicing must be reasonably accessible. Necessary equipment to conduct
these services, such as ladders, specific tools, and keys, must be readily
available on site. Access panels (20 inches x 20 inches minimum) must be provided
for building maintenance and must be located for reasonable access to equipment
or barriers installed in the attic or other concealed spaces.
(n)
The facility shall implement procedures, in accordance
with the standards and recommendations of Compressed Gas Association in its
publication, Safe Handling of Compressed Gases in Containers, 1991 edition,
that assure safe and sanitary use and storage of oxygen. Liquid oxygen containers
must be certified by Underwriters Laboratory (UL) or other approved testing
laboratory for compliance with NFPA 50, Standard for Bulk Oxygen Systems of
Consumer Sites, 1996 edition. The facility is responsible for defining all
potential hazards both graphically and verbally to all persons involved in
the use of liquid oxygen and ensuring the liquid oxygen provider does also.
§125.82.Emergency Preparedness.
(a)
Disaster management. Each SCF shall develop written plans
for effective preparedness, mitigation, response, and recovery from disasters.
(b)
The administration must have in effect and available to
all personnel written copies of a plan for the protection of all persons in
the event of fire and for their remaining in place, for their evacuation to
areas of refuge, and from the building when necessary. The plan must include
special staff actions including fire protection procedure needed to ensure
the safety of any resident and must be amended or revised when needed. All
employees must be periodically instructed and kept informed with respect to
their duties and responsibilities under the plan. A copy of the plan must
be readily available at all times within the facility. This written plan must
reflect the current evacuation capabilities of the resident or patient.
(c)
The SCF must have written preparedness and response plan.
Procedures to be followed in an internal or external disaster should be attached
to the plan. The plan must address, at a minimum, the eight core functions
of emergency management, which are: direction and control; warning (how the
facility will be notified of emergencies and who they will notify); communication
(with whom and by what mechanism); sheltering arrangements; evacuation (destinations,
routes); transportation; health and medical needs; and resource management
(supplies, staffing, emergency equipment, records). A copy of the plan must
be provided to the local emergency management coordinator and should address
those emergencies that could affect the facility. Information about the local
emergency management coordinator may be obtained from the office of the local
mayor or county judge.
§125.83.Fire Safety Requirements.
(a)
Fire evacuation classification rating and National Fire
Protection Association (NFPA) compliance. All documents published by NFPA
as referenced in these rules may be obtained by writing or calling the NFPA,
1 Batterymarch Park, Quincy, MA 02169-7471 or (800) 344-3555. NFPA Life Safety
Code.
(1)
An existing special care facility, which was licensed prior
to the effective date of the rules, shall:
(A)
comply, at a minimum, with the edition of the National
Fire Protection Association 101, Code for Safety to Life from Fire in Buildings
and Structures, 2000 edition (NFPA 101), under which it was initially licensed;
or
(B)
if classified as a health care occupancy, with NFPA 101,
Chapter 19, 2000 edition; or
(C)
if classified as an occupancy other than a health care
occupancy, NFPA 101, Chapter 33; or
(D)
if classified as an occupancy other than a health care
occupancy, the applicable code as determined by the local fire authority.
(2)
A new special care facility shall be classified as a Limited
Care Facility (LCF) or a Residential Board and Care Facility (RBCF).
(A)
A LCF, as the term is defined in §125.3(b)(1) of this
title (relating to Occupancy Classification), shall be classified as a health
care occupancy and shall comply with NFPA 101, Chapter 18.
(B)
For an RBCF, the fire evacuation classification rating,
as the term is defined in §125.3(b)(2) of this title, shall be determined
based on the evacuation capability of the residents. A RBCF shall be designated
as having an evacuation capability of prompt or impractical.
(i)
To be designated as prompt, all residents must be able
to travel from their living unit to a central location, such as a lobby, living
room or dining room area, on the level of the building where the fire exit
to the outside of the facility is located, within a 13 minute period without
continuous staff assistance. Elevators cannot be used as an evacuation route.
(ii)
A RBCF that is not able to meet all criteria specified
in clause (i) of this subparagraph will be designated as impractical.
(C)
A RBCF with an evacuation capability of prompt shall be
classified as a residential board and care occupancy, and must comply with
NFPA 101, Chapter 32.
(D)
A RBCF with an evacuation capability rating of impractical
shall be classified as a health care occupancy and must comply with subparagraph
(A) of this paragraph.
(b)
Fire protection. Fire protection shall be provided in accordance
with the requirements of NFPA 101, §12-7, and §125.91 of this title
(relating to Construction Requirements). When required or installed, sprinkler
systems for exterior fire exposures shall comply with NFPA 80A, Recommended
Practice for Protection of Buildings from Exterior Fire Exposures, 1996 edition.
(c)
Fire inspections.
(1)
Annual inspection. Approval of the fire protection of a
SCF by the local fire department shall be a prerequisite for licensure.
(2)
Purpose of inspection. The purpose of these inspections
shall be to ascertain and to cause to be corrected any conditions liable to
cause fire or violations of any of the provisions or intent of these rules,
or of any other applicable ordinances, which affect fire safety in any way.
(3)
Hazardous or dangerous conditions or materials. Whenever
any of the officers, members, or inspectors of the fire department or bureau
of fire prevention find in any building or upon any premises dangerous or
hazardous conditions or materials, removal or remedy of dangerous conditions
or materials shall be carried out in a manner specified by the head of the
local fire department.
(4)
Access for inspection. At all reasonable hours, the chief
of the fire department, the chief of the bureau of fire prevention, or any
of the fire inspectors may enter any building or premises for the purpose
of making an inspection or investigation which may be deemed necessary under
the provisions of these rules.
(d)
Fire reporting. All occurrences of fire shall be reported
to the local fire authority and shall be reported in writing to the director
as soon as possible but not later than 10 calendar days following the occurrence.
Any fire causing injury or death to a resident shall be reported within 24
hours of incident.
(e)
Smoking rules. Each SCF shall adopt, implement and enforce
a smoking policy. The policy shall include the minimal provisions of NFPA
101, §18.7.4, or §32.7.4.
(f)
Fire extinguishing systems. Inspection, testing, and maintenance
of fire-fighting equipment shall be conducted by each SCF.
(1)
Water-based fire protection systems. All fire sprinkler
systems, fire pumps, fire standpipe and hose systems, water storage tanks,
and valves and fire department connections shall be inspected, tested and
maintained in accordance with NFPA 25, Standard for the Inspection, Testing
and Maintenance of Water-Based Fire Protection Systems, 1998 edition.
(2)
Range hood extinguishers. Fire extinguishing systems for
commercial cooking equipment, such as at range hoods, shall be inspected and
maintained in accordance with NFPA 96, Standard for Ventilation Control and
Fire Protection of Cooking Operations, 1998 edition.
(3)
Portable fire extinguishers. Every portable fire extinguisher
located in a SCF or upon SCF property shall be installed, tagged, and maintained
in accordance with NFPA 10, Standard for Portable Fire Extinguishers, 1998
edition.
(A)
Extinguishers in resident corridors must be spaced so that
travel distance is not more than 75 feet. The minimum size of extinguishers
must be either 2 1/2 gallon for water type of five pounds for ABC type. In
large facilities, at least one portable Underwriters Laboratory or Factory
Mutual-approved five-pound Class B:C dry chemical fire extinguisher, rechargeable
type, is required in each laundry, kitchen and walk-in mechanical room.
(B)
Extinguishers must be surface wall-mounted or recessed
in an approved cabinet where they are not subject to physical damage or dislodgement.
(g)
Fire protection and evacuation plan. A plan for the protection
of patients in the event of fire and their evacuation from the building when
necessary shall be formulated according to NFPA 101, §18.7, or §32.7.
Copies of the plan shall be available to all staff.
(1)
Posting requirements. An evacuation floor plan shall be
prominently and conspicuously posted for display throughout the SCF in public
areas that are readily visible to patients, residents, employees, and visitors.
(2)
Annual training. Each SCF shall conduct an annual training
program for instruction of all personnel in the location and use of fire-fighting
equipment. All employees shall be instructed regarding their duties under
the fire protection and evacuation plan.
(h)
Fire drills. The SCF shall conduct fire drills on a regular
basis.
(1)
For existing facilities which were licensed prior to the
effective date of these rules, fire drills shall be conducted at least quarterly.
(2)
New facilities shall conduct fire drills as follows:
(A)
A LCF shall conduct fire drills quarterly for each shift.
(B)
A RBCF shall conduct fire drills quarterly with not less
than two drills conducted during the night when residents are sleeping.
(i)
The drills may be announced in advance to the residents.
(ii)
The drills shall involve the residents, family, and staff
in accordance with the emergency plan.
(iii)
Residents shall be informed of evacuation procedures
and locations of exits.
(3)
All fire drills shall be documented on a form. There shall
be an evaluation of each drill with respect to the fire plan.
(4)
The fire drill for a new facility classified as a LCF or
a RBCF shall include communication of alarms, and use of fire-fighting equipments.
The LCF drill may include simulation of evacuation of patients.
(5)
When drills are conducted between 9:00 p.m. and 6:00 a.m.,
a coded announcement may be used instead of audible alarms in a LCF.
(i)
Fire alarm system.
(1)
For existing facilities which were licensed prior to the
effective date of these rules, a fire alarm system must be provided only if
required by local code, or under the applicable NFPA 101 occupancy category
under which the facility was initially licensed.
(2)
For new facilities, all buildings used for resident care
shall have an approved fire alarm system. Each fire alarm system shall be
installed and tested in accordance with NFPA 101, §9.6, 1999 edition.
(j)
System for communicating an alarm of fire. A reliable communication
system shall be provided as a means of reporting a fire to the fire department.
This is in addition to the automatic alarm transmission to the fire department,
required by NFPA 101, §§18.3.4.3, 32.2.3.4, or 32.3.3.4.
(k)
Fire department access. As an aid to fire department services,
every SCF shall provide the following.
(1)
Driveways. The SCF shall maintain driveways, free from
all obstructions, to main buildings for fire department apparatus use.
(2)
Submission of plans. Upon request, the SCF shall submit
a copy of the floor plans of the building to the local fire department officials.
(3)
Outside identification. The SCF shall place proper identification
on the outside of the main building showing the locations of siamese connections
and standpipes as required by the local fire department services.
(l)
Fire department protection. When a SCF is located outside
of the service area or range of the public fire protection, arrangements shall
be made to have the nearest fire department respond in case of a fire.
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on March 15, 2004.
TRD-200401945
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 458-7236
25 TAC §§125.91 - 125.96
The new sections are proposed under Health and Safety Code, §248.026,
concerning rules and minimum standards to protect and promote the public health
and welfare by providing for the issuance, renewal, denial, suspension, and
revocation of each level of license; and Health and Safety Code, §12.001,
which provides the Texas Board of Health (board) with the authority to adopt
rules for the performance of every duty imposed by law on the board, the department,
and commissioner of health.
The new sections affect the Health and Safety Code, Chapters 248 and 12.
The review of the rules implements Government Code, §2001.039.
§125.91.Construction Requirements.
(a)
General. When local regulations are in effect and enforced
governing the construction of a SCF, the SCF shall be constructed in accordance
with the local regulations. An existing SCF may voluntarily comply with any
of the following requirements.
(b)
Existing special care facilities. In the absence of local
regulations, an existing SCF shall comply with the following sections.
(1)
Compliance.
(A)
A licensed SCF which is licensed prior to the effective
date of these rules is considered to be an existing licensed SCF and shall
continue, at a minimum, to meet the licensing requirements under which it
was originally licensed.
(B)
In lieu of meeting the requirements in subparagraph (A)
of this paragraph, an existing licensed SCF may, instead, comply with National
Fire Protection Association 101, Code for Safety to Life from Fire in Buildings
and Structures, 2000 edition (NFPA 101), Chapter 33, Existing Residential
Board and Care Facilities, or Chapter 19, Existing Health Care Occupancies.
All documents published by NFPA as referenced in these rules may be obtained
by writing or calling the NFPA, 1 Batterymarch Park, Quincy, MA 02169-7471,
or (800) 344-3555.
(2)
Remodeling and additions. All remodeling, renovations,
additions and alterations to or relocation of an existing SCF shall be done
in accordance with the requirements for new construction in subsection (c)
of this section. When existing conditions make such changes impractical, the
department may grant a conditional approval of minor deviations from the requirements
of subsection (c) of this section, if the intent of the requirements is met
and if the care, safety and welfare of residents will not be jeopardized.
The operation of the SCF, accessibility of individuals with disabilities,
and safety of the residents shall not be compromised by a condition(s) that
is not in compliance with this chapter.
(A)
Building equipment alterations or installations. Any alteration
or any installation of new building equipment, such as mechanical, electrical,
plumbing, fire protection, or piped medical gas system shall comply with the
requirements for new construction and may not be replaced, materially altered,
or extended in an existing SCF until complete plans and specifications have
been submitted to the department, and the department has reviewed and approved
the plans and specifications in accordance with §125.94 of this title
(relating to Preparation, Submittal, Review and Approval of Plans).
(B)
Minor remodeling or alterations. Minor remodeling or alterations
within an existing SCF which do not involve alterations to load bearing members
and partitions, change functional operation, affect fire safety, add or subtract
services, or involve any of the major changes listed in subparagraph of this
paragraph are considered to be minor projects and require evaluation and approval
by the department. An SCF shall submit a written request for evaluation, a
brief description of the proposed changes, and sketches of the area being
remodeled or altered. Based on such submittal, the department will evaluate
and determine whether any additional submittals or inspections are required.
The department will notify the SCF of its decision.
(C)
Major remodeling or alterations. All remodeling or alterations
which involve alterations to load bearing members or partitions, change functional
operation, affect fire safety, or add or delete services, are considered major
projects. A SCF shall comply with this subparagraph prior to beginning construction
of major projects.
(i)
Submittal of plans. Plans shall be submitted in accordance
with §125.94 of this title for all major remodeling or alterations.
(ii)
Phasing of construction in existing facilities. Projects
involving alterations of or additions to existing buildings shall be programmed
and phased so that on-site construction will minimize disruptions of existing
functions.
(I)
Access, exit access, fire protection and all necessary
functions shall be maintained so that the safety of the occupants will not
be jeopardized during construction.
(II)
Construction, dust, objectionable fumes and vapor barriers
shall be provided to separate areas undergoing demolition and construction
from occupied areas.
(III)
Temporary sound barriers shall be provided where intense,
prolonged construction noises will disturb patients, residents or staff in
the occupied portions of the building.
(3)
Previously licensed SCF. A previously licensed SCF that
has been vacated for 12 months or longer or used for other purposes shall
comply with all the requirements for new construction contained in subsection
(c) of this section in order to be licensed.
(c)
Construction requirements for new SCFs.
(1)
SCF location. A SCF may be a distinct separate part of
an existing hospital. It may occupy an entire separate independent structure,
or it may be located within another building such as an office building or
commercial building.
(A)
Accessibility to facility. The location of a proposed new
SCF shall be easily accessible to service vehicles and fire protection apparatus.
(B)
Means of egress. A SCF shall have at least two exits remotely
located in accordance with NFPA 101, §§18.2.4.1, 32.2.2.1, and 32.3.2.4.
When a required means of egress from the SCF is through another portion of
the building, that means of egress shall comply with the requirements of NFPA
101 which are applicable to the occupancy of the other building. Such means
of egress shall be open, available, unlocked, unrestricted, and lighted at
all times during the SCF hours of operation.
(C)
Hazardous locations.
(i)
Underground and above ground hazards. A new SCF or an addition(s)
to an existing SCF shall not be constructed within 125 feet of a hazardous
location or easement. Hazardous locations include underground liquid butane
or propane, liquid petroleum or natural gas transmission lines, high-pressure
lines, or under high voltage electrical lines.
(ii)
Fire hazards. A new SCF shall not be built within 300
feet of above ground or underground storage tanks containing liquid petroleum
or other flammable liquids used in connection with a bulk plant, marine terminal,
aircraft refueling, bottling plant of a liquefied petroleum gas installation,
or near other hazardous or hazard producing areas.
(iii)
Health and safety hazards. A new SCF shall not be located
in a building which, because of its location, physical condition, state of
repair, or arrangement of facilities, would be determined hazardous to the
health or safety of the resident.
(D)
Undesirable locations.
(i)
Nuisance producing sites. A new SCF shall not be located
near nuisance producing sites such as industrial sites, feed lots, sanitary
landfills, or manufacturing plants which produce excessive noise or air pollution.
(ii)
Flood plains. Construction of a new SCF shall be avoided
in designated flood plains. Where such is unavoidable, access and required
SCF components shall be constructed at least one foot above the designated
flood plain. This requirement also applies to new additions to an existing
SCF or a portion of facility which has been licensed previously as a SCF,
but which has been vacated or used for other purposes. This requirement does
not apply to remodeling of an existing licensed SCF.
(iii)
Cemeteries. A new SCF shall not be located near a cemetery
in a manner that allows direct views of the cemetery from resident rooms,
dining area, living areas or front entry of the facility.
(2)
SCF site. The SCF site shall include paved roads, walkways,
and parking in accordance with the requirements set out in this paragraph.
(A)
Paved roads and walkways.
(i)
Paved roads shall be provided within lot lines for access
from public roads to the main entrance and to service entrances. Gravel-based
roads are permitted in rural areas.
(ii)
Finished surface walkways shall be provided for pedestrians.
When public transportation or walkways serve the site, finished surface walkways
or paved roads shall extend from the public conveyance to the building entrance.
(B)
Parking.
(i)
Off street parking shall be provided at the minimum ratio
of one space for each four resident beds, one space for each daytime staff
member, and one visitor space for every four resident beds, or per local code,
whichever is more stringent.
(ii)
Handicapped parking. Parking spaces for handicapped persons
shall be provided in accordance with the Americans with Disabilities Act (ADA)
of 1990, Public Law 101-336, 42 United States Code, Chapter 126, and Title
36 Code of Federal Regulations, Part 1191, Appendix A, Accessibility Guidelines
for Buildings and Facilities.
(3)
Building design and construction requirements. Every building
and every portion thereof shall be designed and constructed to sustain all
dead and live loads in accordance with accepted engineering practices and
standards and local governing building codes. Where there is no local governing
building code, the International Building Code (IBC), 2000 edition, or the
International Residential Code (IRC) shall govern: The IBC and IRC are published
by the International Code Council, 5203 Leesburg Pike, Suite 600, Falls Church,
VA 22041, telephone (703) 931-4533.
(A)
General architectural requirements. All new construction,
including conversion of an existing building to a SCF or establishing a separately
licensed SCF within another existing building, shall comply with NFPA 101,
Chapter 32, New Residential Board and Care Occupancies, or Chapter 18, New
Health Care Occupancies, and this subchapter.
(i)
Construction types for multiple building occupancy.
(I)
Mixed occupancies. When a SCF is part of another occupancy,
the SCF shall be separated from the other occupancy with a minimum of 2-hour
fire rated construction, in accordance with NFPA 101, §18.1.2.3, and §32.1.2.
(II)
Small facility. When a SCF is classified as a small facility
for residential board and care occupancy, the SCF shall comply with NFPA 101, §32.2.1.3,
Minimum Construction Requirements.
(III)
Large facility. When a SCF is classified as a large facility
for residential board and care occupancy, the SCF shall comply with NFPA 101, §32.3.1.3,
Minimum Construction Requirements.
(IV)
Multistory buildings. When a SCF is located in a multistory
building of two or more stories, the entire building shall meet the construction
requirements of NFPA 101, §32.3.1.3, or §18.1.6.2. A SCF shall not
be located in a multistory building that does not comply with the minimum
construction requirements of NFPA 101, §18.1.6.2. or §32.3.1.3.
(V)
Single story buildings. When a SCF is part of a one-story
building that does not comply with the construction requirements of NFPA 101, §§18.1.6.1,
32.2.1.3, or 32.3.1.3. The SCF must be separated from the remainder of the
building with a 2-hour fire rated construction. The designated SCF portion
shall have the construction type upgraded to comply with NFPA 101, §§18.1.6.1,
32.2.1.3, or 32.3.3.1.3, as applicable.
(ii)
Special design provisions. Special provisions shall be
made in the design of a facility if located in a region where local experience
shows loss of life or extensive damage to buildings resulting from hurricanes,
tornadoes, or floods.
(iii)
Foundations. Foundations shall rest on natural solid
bearing if satisfactory bearing is available. Proper soil-bearing values shall
be established in accordance with nationally recognized requirements. If solid
bearing is not encountered at practical depths, the structure shall be supported
on driven piles or drilled piers designed to support the intended load without
detrimental settlement, except that one-story buildings may rest on a fill
designed by a soils engineer. When engineered fill is used, site preparation
and placement of fill shall be done under the direct full-time supervision
of the soils engineer. The soils engineer shall issue a final report on the
compacted fill operation and certification of compliance with the job specifications.
(iv)
Physical environment. A physical environment that protects
the health and safety of resident, personnel, and the public shall be provided
in each facility. The physical premises of the facility and those areas of
the facility's physical structure that are used by the residents (including
all stairwells, corridors, and passageways) shall meet the local building
and fire safety codes and the requirements of this chapter.
(v)
Handicapped requirements. Special considerations that benefit
handicapped residents, staff, and visitors shall be provided. Each SCF shall
comply with the Americans with Disabilities Act (ADA) of 1990, Public Law
101-336, 42 United States Code, Chapter 126, and Title 36, Code of Federal
Regulations, Chapter XI, Part 1191, Appendix A, Accessibility Guidelines for
Buildings and Facilities.
(vi)
Other regulations. Certain projects may be subject to
other regulations, including those of federal, state, and local authorities.
The more stringent standard or requirement shall apply when a difference in
requirements exists.
(vii)
Exceeding minimum requirements. Nothing in these sections
shall be construed to prohibit a better type of building construction or otherwise
safer conditions than the minimum requirements specified in these sections.
(viii)
Equivalency. Nothing in these sections is intended to
prevent the use of systems, methods, or devices of equivalent or superior
quality, strength, fire resistance, effectiveness, durability, performance
and safety to those prescribed by these sections, provided technical documentation
which demonstrates equivalency is submitted to the department for approval.
(ix)
Separate freestanding buildings (not for resident use).
Separate freestanding buildings for non-patient use which are located at least
20 feet from the SCF building such as the heating plant, boiler plant, repair
workshops, or general storage may be designed and constructed in accordance
with other applicable occupancy classification requirements listed in NFPA
101.
(B)
General detail requirements.
(i)
Corridors. The minimum clear and unobstructed width of
a public corridor shall be at least four feet in a RBCF. In a LCF, the minimum
clear and unobstructed width of public corridor shall be at least eight feet.
(ii)
Doors and windows.
(I)
Door types. Doors at all openings between corridors and
rooms or spaces subject to occupancy shall be swing type. Elevator doors are
excluded from this requirement.
(II)
Door swing. Doors, except doors to spaces such as small
closets that are not subject to occupancy, shall not swing into corridors
in a manner that might obstruct traffic flow or reduce the required corridor
width. Large walk-in type closets are considered as occupied spaces.
(III)
Labeled doors. Labeled fire doors shall be listed by
an independent testing laboratory and shall meet the construction requirement
for fire doors in NFPA 80, Standard for Fire Doors and Fire Windows, 1999
edition. Reference to a labeled door shall be construed to include labeled
frame and hardware.
(IV)
Glazing. Glass doors, sidelights, borrowed lights, and
windows located within 12 inches of a door jamb or with a bottom-frame height
of less than 18 inches above the finished floor shall be glazed with safety
glass or plastic glazing material that will resist breaking and will not create
dangerous cutting edges when broken. Similar materials shall be used for wall
openings unless otherwise required for fire safety. Safety glass, tempered
glass, or plastic glazing materials shall be used for shower doors, bath enclosures,
interior windows, and doors (which have glazing).
(V)
Operable windows. All operable windows shall be insect
screened.
(iii)
Ceiling heights. The minimum ceiling height shall be
eight feet with the following exceptions. Ceilings in storage rooms, toilet
rooms, and other minor rooms not meant for resident of public use shall be
not less than seven feet six inches.
(iv)
Toilet room accessories. Grab bars shall be provided at
resident showers and tubs. The bars shall be one and one-half inches in diameter,
shall have one and one-half inches clearance to walls, and shall have sufficient
strength and anchorage to sustain a concentrated vertical or horizontal load
of 250 pounds. Grab bars intended for use by the disabled shall also comply
with ADA requirements.
(v)
Hand drying. Provisions for hand drying shall be included
at all hand washing facilities. Hot air dryers or individual paper units shall
be provided and must be enclosed in such a way as to provide protection against
dust or soil.
(vi)
Rooms with heat producing equipment. Rooms containing
heat producing equipment such as mechanical and electrical equipment and laundry
rooms shall be insulated and ventilated to prevent floors of any occupied
room located above it from exceeding a temperature differential of 10 degrees
Fahrenheit above the ambient room temperature.
(C)
General finish requirements.
(i)
Floor finishes.
(I)
General. Floor materials shall be easily cleanable, wear
resistant, and appropriate for the location involved. In areas subject to
frequent wet cleaning methods, floor materials shall not be physically affected
by germicidal and cleaning solutions. Floors that are subject to traffic while
wet, such as shower areas, shall have non-slip surfaces.
(II)
Threshold and expansion joint covers. Thresholds at doorways
may not exceed 3/4 inch in height for exterior sliding doors or 1/2 inch for
other type doors. Raised thresholds and floor level changes at accessible
doorways shall be beveled with a slope no greater than 1:2. Expansion joint
covers may not exceed 1/2 inch in height and shall have beveled edges with
a slope no greater than 1:2.
(ii)
Wall finishes. Wall finishes shall be smooth, washable,
moisture resistant, and cleanable by standard housekeeping practices. Wall
finishes shall be in compliance with the requirements of NFPA 101, §18.3.3,
and §32.3.3.3, relating to flame spread.
(I)
Finishes at plumbing fixtures. Wall finishes shall be water
resistant in the immediate area of plumbing fixtures.
(II)
Wet cleaning methods. Wall finishes in areas subject to
frequent wet cleaning methods shall be impervious to water, tightly sealed;
and without voids.
(iii)
Ceiling finishes.
(I)
General. All occupied rooms and spaces shall be provided
with finished ceilings, unless otherwise noted. Ceilings that are a part of
a rated roof and ceiling assembly or a floor-ceiling assembly shall be constructed
of listed components (by a nationally recognized testing laboratory) and installed
in accordance with the listing.
(II)
Special requirements. Finished ceilings may be omitted
in mechanical and equipment spaces, shops, and similar spaces unless required
for fire-resistive purposes.
(iv)
Floor, wall, and ceiling penetrations. Floor, wall, and
ceiling penetrations by pipes, ducts, and conduits shall be tightly sealed
to minimize entry of dirt particles, rodents, and insects. Joints of structural
elements shall be similarly sealed.
(v)
Cubicle curtains, draperies, and other hanging fabrics.
Cubicle curtains, draperies, and other hanging fabrics shall be noncombustible
or flame retardant and shall pass both the small scale and large scale test
of NFPA 701, Standard Methods of Fire Tests for Flame-Resistant Textiles and
Films, 1996 edition. Copies of laboratory test reports for installed materials
shall be submitted to the department at the time of the final construction
inspection.
(D)
General mechanical requirements. This subparagraph contains
requirements for mechanical systems; air-conditioning, heating and ventilating
systems; steam and hot and cold water systems; plumbing fixtures; piping systems;
and thermal and acoustical insulation.
(i)
Cost. All mechanical systems shall be designed for overall
efficiency and life cycle costing, including operational costs. Recognized
engineering practices shall be followed to achieve the most economical and
effective results except that in no case shall patient care or safety be sacrificed
for conservation.
(ii)
Equipment location. Mechanical equipment may be located
indoors or outdoors (when in a weatherproof enclosure), or in a separate building(s).
(iii)
Vibration isolation. Mechanical equipment shall be mounted
on vibration isolators as required to prevent unacceptable structure-borne
vibration. Ducts, pipes, etc., connected to mechanical equipment which is
a source of vibration shall be isolated from the equipment with vibration
isolators.
(iv)
Performance and acceptance. Prior to completion and acceptance
of the facility, all mechanical systems shall be tested, balanced, and operated
to demonstrate to the design engineer or his representative that the installation
and performance of these systems conform to the requirements of the plans
and specifications.
(I)
Material lists. Upon completion of the contract, the owner
shall obtain from the construction contractor parts lists and procurement
information with numbers and description for each piece of equipment.
(II)
Instructions. Upon completion of the contract, the owner
shall obtain from the construction contractor instructions in the operational
use and maintenance of systems and equipment as required.
(v)
Heating, ventilating, and air conditioning (HVAC) systems.
(I)
Code requirements. All central HVAC systems shall comply
with and shall be installed in accordance with the requirements of NFPA 90A,
Standard for the Installation of Air Conditioning and Ventilating Systems,
1999 edition, or NFPA 90B, Standard for the Installation of Warm Air Heating
and Air-Conditioning Systems, 1999 edition, as applicable and the requirements
contained in this clause. Air handling units serving two or more rooms are
considered to be central units.
(-a-)
Temperature and humidity. The indoor design temperature
shall be 75 degrees Fahrenheit with relative humidity of not less than 30
percent.
(-b-)
Thermostat gauges. Thermostats shall be provided for
all heating and cooling systems with an on and off switch.
(-c-)
Air handling duct requirements. Fully ducted supply,
return and exhaust air systems shall be provided for all resident care areas.
Combination systems, utilizing both ducts and plenums for movement of air
in these areas shall not be permitted.
(-1-)
Protection of ducts penetrating fire and smoke partitions.
Combination fire and smoke leakage limiting dampers (Class II) shall be installed
in accordance with manufacturer's instructions for all ducts penetrating 1
and 2-hour rated fire and smoke partitions required by NFPA 101, §12-6.3.7,
Subdivision of Building Space (not required in SCFs meeting the provisions
of NFPA 101, §12-6.3.7.3, Exception).
(-2-)
Fail-safe installation. Combination smoke and fire dampers
shall close on activation of the fire alarm system by smoke detectors installed
and located as required by NFPA 72, Chapter 5, National Fire Alarm Code, 1996
edition; NFPA 90A, Chapter 4; and NFPA 101, §12-6.3.7; by activation
of the fire sprinkler system; and upon loss of electrical power. Smoke dampers
shall not close by fan shut-down alone. This requirement applies to all existing
and new installations.
(-3-)
Interconnection of air handling fans and smoke dampers.
Air handling fans and smoke damper controls shall be interlocked so that closing
of smoke dampers will not damage the ducts.
(-4-)
Frangible devices. The use of frangible (non-resetting)
devices for shutting smoke dampers shall not be permitted.
(-d-)
Outside air intake locations. Outside air intakes shall
be located at least 10 feet from exhaust outlets of ventilating systems, combustion
equipment stacks, plumbing vents, or areas which may collect vehicular exhaust
or other noxious fumes. (Prevailing winds and proximity to other structures
may require other arrangements.)
(-e-)
Pressure relationship. Ventilation systems for a LCF
shall be designed and balanced to provide pressure relationships contained
in Table 1 of this title. For reductions and shut down of ventilation systems
when a room is unoccupied, the provisions in Note 4 of Table 1 of this title
shall be followed.
(-f-)
Duct linings. Friable internal linings shall not be used
in ducts, air terminal units, or other air system components. This requirement
shall not apply to air terminal units and sound attenuators that have approved
nonfriable coverings, e.g., foil facing, over such linings.
(II)
Thermal and acoustical insulation for air handling systems.
Asbestos containing insulation materials shall not be used.
(-a-)
Thermal duct insulation. Air ducts and casings with outside
surface temperature below the ambient dew point or temperature above 80 degrees
Fahrenheit shall be provided with thermal insulation.
(-b-)
Insulation in air plenums and ducts. When installed,
linings in air ducts and equipment shall meet the Erosion Test Method described
in Underwriters' Laboratories, Inc., Standard 181, Factory-Made Duct Materials
and Air Duct Connectors. This document may be obtained from the Underwriters'
Laboratories, Inc., 333 Pfingsten Road, Northbrook, IL 60062-2096.
(-c-)
Insulation flame spread and smoke developed ratings.
Interior and exterior insulation, including finishes and adhesives on the
exterior surfaces of ducts and equipment, shall have a flame spread rating
of 25 or less and a smoke developed rating of 50 or less as required by NFPA
90A, Chapters 2 and 3 and as determined by an independent testing laboratory
in accordance with NFPA 255, A Standard Method of Test of Surface Burning
Characteristics of Building Materials, 1999 edition.
(-d-)
Friable insulation. Insulation of soft and spray-on types
shall not be used where it is subject to air currents or mechanical erosion
or where loose particles may create a maintenance problem or occupant discomfort.
(vi)
Piping systems and plumbing fixture requirements. All
piping systems and plumbing fixtures shall be designed and installed in accordance
with the requirements of the International Plumbing Code (IPC), 2000 edition.
The IPC is published by the International Code Council, 5203 Leesburg Pike,
Suite 600, Falls Church, VA 22041, telephone (703) 931-4533.
(I)
Water supply piping systems. Water supply piping systems
shall be designed to supply water at sufficient pressure to operate all fixtures
and equipment during maximum demand.
(-a-)
Valves. Each water service main, branch main, riser,
and branch to a group of fixtures shall be valved. Stop valves shall be provided
at each fixture.
(-b-)
Backflow preventers. Backflow preventers (vacuum breakers)
shall be installed on hose bibs, laboratory sinks, janitor sinks, bedpan-flushing
attachments, and on all other fixtures to which hoses or tubing can be attached.
Connections to high hazard sources, e.g., x-ray film processors, shall be
from a cold-water hose bibb through a reduced pressure principle type backflow
preventer (RPBFP).
(-c-)
Flushing valves. Flush valves installed on plumbing fixtures
shall be of a quiet operating type, equipped with silencers.
(-d-)
Water storage tanks. Water storage tanks shall be fabricated
of corrosion-resistant metal or lined with noncorrosive material.
(II)
Fire sprinkler systems. When provided, fire sprinkler
systems shall comply with the requirements of NFPA 101, §7-7, Automatic
Sprinklers and Other Extinguishing Equipment, and the requirements of this
subclause. All fire sprinkler systems shall be designed, installed, and maintained
in accordance with the requirements of NFPA 13, Standard for the Installation
of Sprinkler Systems, 1999 edition, and shall be certified as required by §125.84
of this title (relating to Preparation, Submittal, Review, and Approval of
Plans).
(vii)
Steam and hot water systems.
(I)
Boilers. When provided, boilers shall have the capacity,
based upon the net ratings published by the Hydronics Institute or another
acceptable national standard, to supply the normal heating, hot water, and
steam requirements of all systems and equipment.
(-a-)
Valves. Supply and return mains and risers of cooling,
heating, and process steam systems shall be valved to isolate the various
sections of each system. Each piece of equipment shall be valved at the supply
and return ends except that vacuum condensate returns need not be valved at
each piece of equipment.
(-b-)
Boiler certification. When required, the SCF shall ensure
compliance with Texas Department of Licensing and Regulation, Boiler Section,
Texas Boiler Law, 1995 (Health and Safety Code, Chapter 755, Boilers), which
requires certification documentation for boilers to be posted on site at each
boiler installation.
(II)
Domestic hot water system. Hot water distribution system
serving all resident care areas shall be under constant recirculation to provide
continuous hot water at each hot water outlet.
(-a-)
Capacity of water heating equipment. Water heating equipment
shall have sufficient capacity to supply water for all residents' needs based
on accepted engineering practices using actual number and type of fixtures
and for heating, when applicable.
(-b-)
Water temperature measurements. Water temperatures shall
be measured at hot water point of use or at the inlet to processing equipment.
Hot water temperature at point of use for residents, staff and visitors shall
not exceed 110 degrees Fahrenheit.
(viii)
Drainage systems. Building sewers shall discharge into
a community sewage system. Where such a system is not available, a facility
providing sewage treatment must conform to applicable local and state regulations.
(I)
Above ground piping. Soil stacks and roof drains installed
above ground within buildings shall be drain-waste-vent (DWV) weight or heavier
and shall be: copper pipe, copper tube, cast iron pipe, or Schedule 40 polyvinyl
chloride (PVC) pipe. In LCF schedule 40 polyvinylchloride (PVC) pipe is not
permitted.
(II)
Underground piping. All underground building drains shall
be cast iron soil pipe, hard temper copper tube (DWV or heavier), acrylonitrile-butodiene-styrene
(ABS) plastic pipe (DWV Schedule 40 or heavier), or PVC pipe (DWV Schedule
40 or heavier. Underground piping shall have at least 12 inches of earth cover
or comply with local codes.
(ix)
Thermal insulation for piping systems and equipment. Asbestos
containing insulation materials shall not be used.
(I)
Insulation. Insulation shall be provided for the following:
(-a-)
boilers, smoke breeching, and stacks;
(-b-)
steam supply and condensate return piping;
(-c-)
hot water piping and all hot water heaters, generators,
converters, and storage tanks;
(-d-)
chilled water, refrigerant, other process piping, equipment
operating with fluid temperatures below ambient dew point, and water supply
and drainage piping on which condensation may occur. Insulation on cold surfaces
shall include an exterior vapor barrier; and
(-e-)
other piping, ducts, and equipment as necessary to maintain
the efficiency of the system.
(II)
Flame spread. Flame spread shall not exceed 25 and smoke
development rating shall not exceed 50 for pipe insulation as determined by
an independent testing laboratory in accordance with NFPA 255, Standard Method
of Test of Surface Burning Characteristics of Building Materials, 1996 edition.
(x)
Plumbing fixtures. Plumbing fixtures shall be made of nonabsorptive,
acid resistant materials and shall comply with the requirements of the International
Plumbing Code, 2000 edition, and this clause.
(I)
Sink and lavatory controls. All lavatories used by residents
and staff shall be trimmed with valves or electronic controls.
(II)
Back flow or siphoning. All plumbing fixtures and equipment
shall be designed and installed to prevent the back-flow or back-siphonage
of any material into the water supply. The over-the-rim type water inlet shall
be used wherever possible. Vacuum-breaking devices shall be properly installed
when an over-the-rim type water inlet cannot be utilized.
(III)
Floor drains or floor sinks. Where floor drains or floor
sinks are installed, they shall be of a type that can be easily cleaned by
removal of the cover. Removable stainless steel mesh shall be provided in
addition to a grilled drain cover to prevent entry of large particles of waste
which might cause stoppages.
(IV)
Under counter piping. Under counter piping and above floor
drains shall be arranged (raised) so as not to interfere with cleaning of
the floor below the equipment.
(E)
General electrical requirements. All electrical material
and equipment, including conductors, controls, and signaling devices, shall
be installed in compliance with applicable sections of the NFPA 70, National
Electrical Code, 1999 edition, NFPA 99, 1999 edition, the requirements of
this subparagraph; and as necessary to provide a complete electrical system.
Electrical systems and components shall be listed by nationally recognized
listing agencies as complying with available standards and shall be installed
in accordance with the listings and manufacturer's instructions.
(i)
All fixtures, switches, sockets, and other pieces of apparatus
shall be maintained in a safe and working condition.
(ii)
Extension cords and cables shall not be used for permanent
wiring.
(iii)
All electrical heating devices shall be equipped with
a pilot light to indicate when the device is in service, unless equipped with
a temperature limiting device integral with the heater.
(iv)
All equipment, fixtures, and appliances shall be properly
grounded in accordance with NFPA 70.
(v)
Under-counter electrical installations shall be arranged
(raised) to not interfere with cleaning of the floor below the equipment.
(vi)
Installation testing and certification. The electrical
installations, including grounding continuity, fire alarm, and communication
systems, shall be tested to demonstrate that equipment installation and operation
is appropriate and functional. A written record of performance tests on special
electrical systems and equipment must show compliance with applicable codes
and standards and shall be available to the department upon request.
(vii)
Electrical safeguards. Shielded isolation transformers,
voltage regulators, filters, surge suppressors, and other safeguards shall
be provided as required where power line disturbances are likely to affect
fire alarm components, data processing, equipment used for treatment, and
automated laboratory diagnostic equipment.
(viii)
Services and switchboards. Main switchboards shall be
located in an area separate from plumbing and mechanical equipment and shall
be accessible to authorized persons only. Switchboards shall be convenient
for use, readily accessible for maintenance, away from traffic lanes, and
located in dry, ventilated spaces free of corrosive or explosive fumes, gases,
or any flammable material. Overload protective devices must operate properly
in ambient temperatures.
(ix)
Panelboard. Distribution panels containing circuit breakers
that control lighting and power to essential and normal electrical circuits
shall be located within the SCF.
(x)
Wiring. When a SCF provides an essential electrical system
all conductors for controls, equipment, lighting and power operating at 100
volts or higher shall be installed in metal or metallic raceways in accordance
with the requirements of NFPA 70, Article 517. All surface mounted wiring
operating at less than 100 volts shall be protected from mechanical injury
with metal raceways to a height of seven feet above the floor. Conduits and
cables shall be supported in accordance with NFPA 70, Article 300.
(xi)
Lighting.
(I)
In LCF lighting intensity for staff and patient needs shall
comply with guidelines for health care facilities set forth in the Illuminating
Engineering Society of North America (IES) Handbook published by the Illuminating
Engineering Society of North America, 120 Wall Street, New York, NY 10025-4001.
(-a-)
Consideration should be given to controlling light intensity
and wavelength to prevent harm to the patient's eyes.
(-b-)
Approaches to buildings and parking lots, and all spaces
within buildings shall have fixtures that can be illuminated as necessary.
All rooms including storerooms, electrical and mechanical equipment rooms,
and all attics shall have sufficient artificial lighting so that all spaces
shall be clearly visible.
(II)
Means of egress and exit sign lighting intensity shall
comply with NFPA 101, §§5-8, 5-9 and 5-10.
(III)
Electric lamps which may be subject to breakage or which
are installed in fixtures in confined locations when near woodwork, paper,
clothing, or other combustible materials, shall be protected by wire guards,
or plastic shields.
(xii)
Receptacles.
(I)
Appliances shall be grounded in accordance with NFPA 99,
Chapter 9.
(II)
A minimum of one duplex receptacle in each wall shall
be installed in each work area or room other than storage or lockers. Each
examination and work table shall have access to a minimum of two duplex receptacles.
(xiii)
Grounding requirements. Fixed electrical equipment shall
be grounded in accordance with the requirements of NFPA 99, §3-3.1.2,
and NFPA 70, Article 517-13.
(xiv)
Nurses calling systems.
(I)
An audible voice two way communication nurse call system
shall be provided in a SCF when it is classified as a LCF. The audible signal
shall sound at a nurse station or similar control station.
(II)
Distinct visible and audible signals shall be activated
in the nurse's duty station, lounge, and workroom, soiled workroom and clean
workroom.
(xv)
Essential electrical system (EES). When SCF provides or
requires an essential electrical system, the EES system shall comply with
the requirements of NFPA 99, §3-5. A Type I EES shall be provided for
LCF when patients require the use of life-support systems.
(xvi)
Fire alarm system. A fire alarm system which complies
with the requirements of NFPA 101, §§12-6.3.4, 32.2.3.4.1, 32.3.3.4.1,
NFPA 70, Article 760; and NFPA 72, Chapter 3, shall be provided in each facility.
(I)
Fire alarm system shall be installed by or under direct
supervision of a fire alarm installer licensed by the State Fire Marshal.
(II)
The SCF shall submit a copy of the Fire Alarm Installation
Certificate (State Fire Marshal's form FML 009 040392) to the department for
all new installations and for any material changes to the existing systems.
§125.92.Minimum Spatial Requirements for New Facilities.
(a)
Administration and public suite.
(1)
Entrance. Entrances shall be located at grade level, be
accessible to individuals with disabilities, and protected against inclement
weather. When an SCF is located on a floor above grade level, elevators shall
be accessible and shall meet the requirements of §125.93 of this title
(relating to Elevators).
(2)
Waiting area. A waiting area or foyer shall be provided
which includes having access to the following rooms and items:
(A)
public toilet facilities; and
(B)
telephone(s) for public use.
(3)
General or individual office(s). An office(s) shall be
provided for business transactions, records, and administrative and professional
staff.
(4)
Resident records area. Resident record storage space shall
be located within a secure designated area under direct visual supervision
of administrative staff.
(b)
Dietary suite. In addition to the requirements of §125.32(d)
of this title (relating to Resident Care and Services), the facility shall
provide the following.
(1)
Dining area for ambulatory patients, staff, and visitors.
A dining area for ambulatory patients, staff, and visitors with a minimum
floor space of 15 square feet per person to be seated shall be provided. The
footage requirement does not include serving area. The dining area and service
areas shall be separate from the food preparation and distribution area.
(2)
Food service for a 50-bed residence or more. The food service
for a 50-bed residence or more shall be provided by an on-site food preparation
system or an off-site food service system or a combination of the two. The
following minimum functional elements shall be provided on-site regardless
of the type of dietary services.
(A)
Receiving area. A receiving area shall be provided and
shall have direct access to the outside for incoming dietary supplies or off-site
food preparation service and shall be separate from the general receiving
area. The receiving area shall contain a control station and an area for breakout
for loading, unloading, uncrating, and weighing supplies. The entrance area
to the receiving area shall be covered from the weather.
(B)
Storage spaces. Storage spaces shall be convenient to receiving
area and food preparation area and shall be located to exclude traffic through
the food preparation area. Regardless of the type of food services provided,
the facility shall provide storage of food for emergency use for a minimum
of four calendar days.
(i)
Storage space(s) shall be provided for bulk, refrigerated,
and frozen foods.
(ii)
A cleaning supply storage room or closet shall be provided
to store non-food items that might contaminate edibles. This storage area
may be combined with the housekeeping room.
(C)
Counter space. Counter space shall be provided for food
prep work, equipment, and an area to assemble trays for distribution for patient
meals.
(D)
Hand washing fixtures. Hand washing fixtures with hands-free
operable controls shall be conveniently located at all food preparation area
and serving areas.
(E)
Cart distribution system. When a cart distribution system
is provided, space shall be provided for storage, loading, distribution, receiving,
and sanitizing of the food service carts. The cart traffic shall be designed
to eliminate any danger of cross-circulation between outgoing food carts and
incoming soiled carts, and the cleaning and sanitizing process. Cart circulation
shall not be through food processing areas.
(F)
Ware washing room. A ware washing room equipped with commercial
type dishwasher equipment shall be located separate from the food preparation
and serving areas. Space shall be provided for receiving, scraping, sorting,
and stacking soiled tableware and for transferring clean tableware to the
using areas. Hand washing facilities with hands-free operable controls shall
be located within the soiled dish wash area. A physical separation to prevent
cross traffic between "dirty side and "clean side" of the dish wash areas
shall be provided.
(G)
Three-compartmented sink. A three-compartmented sink of
adequate size for pot washing shall be provided convenient to the food preparation
area. It shall have direct access to the SCF waste collection and disposal
facilities.
(H)
Food waste storage room. A food waste storage room shall
be conveniently located to the food preparation and ware washing areas but
not within the food preparation area. It shall have direct access to the SCF
waste collection and disposal facilities.
(I)
Storage areas and sanitizing facilities. Storage areas
and sanitizing facilities for garbage or refuse cans, carts, and mobile tray
conveyors shall be provided. All containers for trash storage shall have tight-fitting
lids.
(J)
Housekeeping room. A housekeeping room shall be provided
for the exclusive use of the dietary department. Where hot water or steam
is used for general cleaning, additional space within the room shall be provided
for the storage of hoses and nozzles.
(K)
Dietary office. An office shall be provided for the use
of the food service manager or the dietary service manager. In smaller facilities,
a designated alcove may be located in an area that is part of the food preparation
area.
(L)
Toilet room. A toilet room shall be provided for the exclusive
use of the dietary staff. Toilets shall not open directly into the food preparation
areas, but must be in a close proximity to them. For larger facilities, a
locker room or space for lockers shall be provided for staff belongings.
(M)
Additional service areas, rooms and facilities. When an
on-site food preparation system is used, in addition to the items required
in subparagraphs (A) - (L) of this paragraph, the following service areas,
rooms, and facilities shall be provided.
(i)
When food preparation systems are provided, there shall
be space and equipment for preparing, cooking, and baking.
(ii)
A patient tray assembly and distribution area shall be
located within close proximity to the food preparation and distribution areas.
(iii)
When food is prepared on-site, the storage room shall
be adequate to accommodate food for a seven-calendar day menu cycle.
(iv)
An additional room(s) shall be provided for the storage
of clean cooking wares, extra trays, flatware, plastic and paper products,
and portable equipment.
(v)
Provisions shall be made for drying and storage of pots
and pans from the pot washing room or area.
(N)
Details.
(i)
Food storage shelves shall not be less than four inches
above the finished floor and the space below the bottom shelf shall be closed
in and sealed tight for ease of cleaning.
(ii)
Operable windows and doors not equipped with automatic
closing devices shall be equipped with insect screens.
(iii)
Food processing areas in the central dietary kitchen
shall have ceilings height not less than nine feet. In a facility classified
as a RBCF, ceiling height shall not be less then eight feet. Ceiling mounted
equipment shall be supported from rigid structures located above the finished
ceilings.
(iv)
Mirrors shall not be installed at hand washing fixtures
in the food preparation areas.
(O)
Finishes.
(i)
Floors in areas used for food preparations, food assembly,
and soiled and clean ware cleaning shall be water-resistance and greaseproof.
Floor surfaces, including tile joints, shall be resistant to food acids.
(ii)
Wall bases in food preparation, food assembly, soiled
and clean ware cleaning and other areas which are frequently subject to wet
cleaning methods shall be made integral and coved with the floor, tightly
sealed to the wall, constructed without voids that can harbor insects, retain
dirt particles, and be impervious to water.
(iii)
In the dietary and food preparation areas, the wall construction,
finishes, and trims, including the joints between the wall and the floor,
shall be free of voids, cracks, and crevices.
(iv)
The ceiling in food preparation and food assembly areas
shall be washable. Smooth moisture impervious materials such as painted lay-in
gypsum wallboard or vinyl faced acoustic tile in a metal grid.
(v)
The ceiling in the soiled and clean ware cleaning area
shall be monolithic from wall to wall (painted solid gypsum wallboard), smooth
and without fissures, open joints, or crevices and with a washable and moisture
impervious finish.
(c)
Laboratory suite. When a laboratory is located on-site
the following minimum items shall be provided:
(1)
a room with work counter, utility sink, and storage cabinets
or closet(s); and
(2)
specimen collection facilities. For dip stick urinalysis,
urine collection rooms shall be equipped with water closet and lavatory. Blood
collection facilities shall have space for a chair, work counter and hand
washing facilities.
(d)
Laundry and linen storage and processing suite. Clean linen
shall be available in a quantity sufficient to meet the needs of the residents.
Clean linens shall be stored in clean linen storage areas.
(1)
The SCF shall provide an area or room with a washer and
dryer for resident use.
(2)
In a facility classified as a large RBCF or a LCF, soiled
and clean processing operations shall be separated and arranged to provide
a one-way traffic pattern from soiled to clean areas. The following rooms
and items shall be provided:
(A)
a soiled linen processing room which includes areas for
receiving, holding, sorting, and washing;
(B)
a clean linen processing room which includes areas for
drying, sorting, folding, and holding prior to distribution;
(C)
supply storage cabinets in the soiled and clean linen processing
rooms;
(D)
hand washing facilities within the soiled linen processing
room; and
(e)
Medication room. The medication room shall be in compliance
with the spatial and security requirements under §125.32(c)(7)(D) of
this title.
(f)
Resident bedroom suite.
(1)
Bedrooms shall be arranged and equipped for adequate delivery
of services and for comfort and privacy.
(2)
Useable bedroom clear floor space shall be not less than
80 square feet for a one-bed room and not less than 60 square feet (40 square
feet where bassinets or cribs are used) per bed for a multiple-bed room. Larger
rooms are recommended for those residents needing nursing care. A bedroom
shall be not less than eight feet in the smallest dimension.
(3)
No more than four beds shall be in any bedroom.
(4)
In the bedrooms and for each resident there shall be a
bed, chair, table, dresser, and closet space or wardrobe providing security
and privacy for clothing and personal belongings.
(5)
Each resident bedroom shall have at least one operable
outside window that can be readily opened from the inside without the use
of tools. The height of the windowsill shall not exceed 36 inches from the
floor. Operable window sections may be restricted for security or safety reasons,
but the required one operable section shall not be restricted to less than
six inches. Each window shall be provided with a flame-retardant shade, curtain,
or blind.
(6)
All resident rooms shall open upon an egress corridor leading
to an exterior exit either by stairway or a door opening to the exterior.
(7)
All resident rooms shall be arranged for convenient and
sheltered resident access to living or public areas, restrooms, and dining
facilities.
(g)
Resident toilet and bathing facilities.
(1)
All bedrooms shall be served males and females by separate
private, connecting, or general toilet rooms for each males and females (if
the facility houses both sexes). The general toilet room or bathing room shall
be accessible from a corridor or public space. A lavatory shall be readily
accessible to each water closet. The facility shall provide at least one full
bath on each resident sleeping floor.
(2)
One water closet and one lavatory shall be provided for
each four residents or fraction thereof. One tub or one shower shall be provided
for each six residents or fraction thereof.
(3)
Privacy partitions and shields shall be provided at water
closets and bathing units in rooms for multi-resident use.
(4)
A public or staff toilet, commode and lavatory, complying
with accessibility standards, is required for every facility up to and including
50 beds. Facilities over 50 beds must have separate public toilets and staff
toilets (this is in addition to the staff toilet(s) required for the dietary
staff).
(5)
All bathrooms, toilet rooms, and other odor-producing rooms
shall be ventilated with operable windows or powered exhaust to the exterior
for order control.
(6)
Soap and towel dispensers shall be provided at all hand
washing facilities.
(h)
Recreation, living, or day room.
(1)
Recreation, living, or day room space and furniture shall
be provided to allow seating of residents. Each facility shall have at least
one space of not less than 144 square feet. A facility with a capacity of
nine or more residents shall provide a space of 10 square feet more per resident
in addition to the 144 square feet minimum.
(2)
At least one of the recreation, living, or day room areas
shall have exterior windows providing a view to the outside.
(i)
Additional service areas.
(1)
Janitor's closet. A sufficient number of janitor closets
shall be provided throughout the facility to maintain a clean and sanitary
environment. The closet shall contain a floor receptor or service sink and
storage space for housekeeping supplies and equipment.
(2)
Storage room. A resident storage room shall be a minimum
of 50 square feet per six resident beds or fraction thereof.
(3)
Medical gas storage room. When provided or required by
National Fire Protection Association 101, (NFPA 101), Code for Safety to Life
from Fire in Buildings and Structures, 2000 edition, a medical gas storage
room shall comply with the requirements of NFPA 99, Chapter 4-4, Gas and Vacuum
Systems. All documents published by the ASME/ANSI as referenced in this section
may be obtained by writing the ANSI, 25 West 43rd Street, New York, N.Y. 10036.
All documents published by NFPA as referenced in these rules may be obtained
by writing or calling the NFPA, 1 Batterymarch Park, Quincy, MA 02169-7471,
or (800) 344-3555.
(4)
Area for emergency crash cart, if provided. An area or
alcove located out of traffic and conveniently located near medication room
or similar staff control room shall be provided for an emergency crash cart.
(5)
Medical waste processing. Space and facilities shall be
provided for the safe storage and disposal of waste as appropriate for the
material being handled and in compliance with all applicable rules and regulations.
§125.93.Elevators.
(a)
General. All buildings that have resident services located
on other than the main entrance floor shall have electric or electro hydraulic
elevators. The elevators shall be installed in sufficient quantity, capacity,
and speed to ensure that the average interval of dispatch time will not exceed
one minute, and average peak loading can be accommodated.
(b)
Requirements for new elevators. New elevators shall be
installed in accordance with the requirements of Health and Safety Code (HSC),
Chapter 754, Elevators, Escalators, and Related Equipment, and ASME/ANSI A17.1,
Safety Code for Elevators and Escalators, 1996 edition, published by the American
Society of Mechanical Engineers and the American National Standards Institute.
All new elevators shall conform to the Fire Fighters' Service Requirements
of ASME/ANSI A17.1, in accordance with National Fire Protection Association
101, (NFPA 101), Code for Safety to Life from Fire in Buildings and Structures,
2000 edition, §7-4.4. All documents published by the ASME/ANSI as referenced
in this section may be obtained by writing the ANSI, 25 West 43rd Street,
New York, N.Y. 10036. All documents published by NFPA as referenced in these
rules may be obtained by writing or calling the NFPA, 1 Batterymarch Park,
Quincy, MA 02169-7471, or (800) 344-3555.
(c)
Requirements for existing elevators. Existing elevators
shall comply with the ASME/ANSI A17.1, Part XII, Alterations, Repair, Replacements,
and Maintenance, and ASME/ANSI A17.3, Safety Code for Existing Elevators and
Escalators, current edition. All existing elevators having a travel distance
of 25 feet or more above or below the level that best serves the needs of
emergency personnel for fire fighting or rescue purposes shall conform to
Fire Fighters' Service Requirements of ASME/ANSI A17.3, as required by NFPA
101, §7-4.5.
(d)
Elevator machine rooms. Elevator machine rooms that contain
solid-state equipment for elevators having a travel distance of more than
50 feet above the level of exit discharge or more than 30 feet below the level
of exit discharge shall be provided with independent ventilation or air-conditioning
systems with the capability to maintain an operating temperature during fire
fighter service operations. The operating temperature shall be established
by the elevator equipment manufacturer's specifications and shall be posted
in each such elevator machine room. When standby power is connected to the
elevator, the machine room ventilation or air conditioning shall also be connected
to standby power. These requirements are not applicable to existing elevators.
(e)
Elevator car size. Minimum elevator car size shall be five
feet wide and five feet deep. A minimum LCF elevator car size shall be five
feet wide and eight feet deep.
(f)
Elevator and elevator shaft doors. When light beams are
used for operating door-opening devices, the beams shall be used in combination
with door edge devices and shall be interconnected with a system of smoke
detectors. The light control feature shall be disengaged when smoke is detected
in any elevator lobby.
(1)
The smallest elevator car door opening shall be at least
three feet wide and seven feet high.
(2)
The elevator car door opening for a LCF elevator shall
be at least 48 inches wide and seven feet high.
(3)
The elevator cars for LCF shall be at least five feet by
eight inches wide by eight feet six inches deep.
(g)
Type of controls and alarms. Elevator call buttons, controls,
and door safety stops shall be of a type that will not be activated by heat
or smoke.
(h)
Leveling. All elevators shall be equipped with an automatic
leveling device of the two-way automatic maintaining type with an accuracy
of one-half inch.
(i)
Operation. All elevators, except freight elevators, shall
be equipped with a two-way key operated service switch permitting cars to
bypass all landing button calls and be dispatched directly to any floor.
(j)
Accessibility of controls and alarms. Elevator controls,
alarm buttons, and telephones shall be accessible to wheelchair occupants
in accordance with the Americans with Disabilities Act.
(k)
Location. Elevators shall not open to an exit.
(l)
Testing. An SCF shall have all elevators and escalators
routinely and periodically inspected and tested in accordance with ASME/ANSI
A17.1. All elevators equipped with fire fighter service shall be subject to
a monthly operation with a written record of the findings made and kept on
the premises as required by NFPA 101, §7-4.8, Elevator Testing.
(m)
Certification. An SCF shall obtain a certificate of inspection
evidencing that the elevators and related equipment were inspected in accordance
with the requirements in HSC, Chapter 754, Subchapter B, and determined to
be in compliance with the safety standards adopted under HSC, §754.014,
administered by the Texas Department of Licensing and Regulation. The certificate
of inspection shall be on record in each center.
§125.94.Preparation, Submittal, Review and Approval of Plans.
(a)
Compliance.
(1)
When local regulations are in effect and enforced governing
the construction of a new SCF or the renovation or modification of an existing
SCF, the SCF shall be constructed in accordance with the local regulations
and submission of construction documents to the department is not required.
An SCF may voluntarily submit construction documents to the department.
(2)
In the absence of local regulations, a new or existing
SCF shall comply with the following subparagraphs (A) - (E) of this paragraph,
and subsections (b) - (e) of this section.
(A)
Facility owners or operators may not begin construction
of a new building or additions to or renovations or conversions of existing
buildings until final construction documents are reviewed and approved by
the department.
(B)
Plans and specifications describing the construction of
new buildings and additions to or renovations and conversions of existing
buildings shall be prepared by registered architects and/or licensed professional
engineers.
(C)
A program narrative shall prepared in accordance with subsection
(b) of this section and submitted to the department at the time of the submission
of the Application for Plan Review.
(D)
Preliminary plans shall be prepared and submitted in accordance
with subsection (c) of this section.
(E)
Final plans and specifications shall be prepared and submitted
in accordance with subsection (d) of this section.
(b)
Functional program narrative. The facility shall provide
a functional program narrative presented on facility letterhead and signed
by facility administration. The narrative shall include the functional description
of each space and the following:
(1)
departmental relationships, number of patient beds in each
category, and other basic information relating to the fulfillment of the facility's
objectives;
(2)
a description of each function to be performed, approximate
space needed for these functions, occupants of the various spaces, types of
equipment required, interrelationship of various functions and spaces;
(3)
energy conservation measures, included in building, mechanical
and electrical designs; and
(4)
the type of construction (existing or proposed) as stated
in §18-1.6.2, or §32.1.1.3, National Fire Protection Association
101, Code for Safety to Life from Fire in Buildings and Structures, 2000 edition
(NFPA 101), published by the National Fire Protection Association. All documents
published by the NFPA as referenced in this section may be obtained by writing
or calling the NFPA at the following address and telephone number: Post Office
Box 9101, 1 Batterymarch Park, Quincy, Massachusetts 02169-7471, (800) 344-3555.
(c)
Preliminary documents. Preliminary documents shall consist
of a functional program narrative, preliminary plans, and outline specifications.
These documents shall contain sufficient information to establish the project
scope, description of functions to be performed, project location, required
fire safety and exiting requirements, building construction type, compartmentation
showing fire and smoke barriers, bed count and services, and the usage of
all spaces, areas, and rooms on every floor level.
(1)
Preparation of preliminary plans. Preliminary plans shall
be of a sufficiently large scale to clearly illustrate the proposed design
but not less than one-eighth inch equals one foot. Preliminary plans shall
provide the following information.
(A)
Floor area and bed distribution. The total floor area on
each level involved in construction, together with the proposed bed distribution,
shall be shown on the drawings.
(B)
Floor plan. Each floor plan shall indicate and identify
all individual spaces, doors, windows and means of egress.
(C)
Existing floor plan. An overall floor plan showing existing
spaces, smoke partitions, smoke compartments, and exits and their relationship
to the new construction shall be submitted on all renovations or additions
to an existing facility. Plans for remodeling of spaces above or below the
level of discharge shall include the level of discharge floor plan, showing
all exits at that level. When there are two different levels of discharge,
plans for both levels shall be submitted.
(D)
Construction type and fire rating. Building sections shall
be provided to illustrate construction type and fire protection rating. Section(s)
shall be drawn at a scale sufficiently large to clearly present the proposed
construction system.
(E)
Area map. A map of the area within a two mile radius of
the facility site shall be provided and any hazardous and undesirable location
noted in §125.91(c) of this title (relating to Construction Requirements)
shall be identified.
(F)
Site plan. A site plan shall be submitted and shall indicate
the location of the proposed building(s) in relation to property lines, existing
buildings or structures, access and approach roads, and parking areas and
drives. Any overhead or underground utilities or service lines shall also
be indicated.
(G)
Outline specifications. Outline specifications shall provide
a general description of the construction, materials, and finishes that are
not shown on the drawings.
(2)
Submission of preliminary plans. One set of preliminary
plans, outline specifications covering the construction of new buildings or
alterations, additions, conversions, modernizations, or renovations to existing
buildings, a functional program narrative, a completed and signed Application
for Plan Review, and the applicable plan review fee in accordance with §125.15
of this title (relating to Fees) shall be submitted to the Texas Department
of Health, 1100 West 49th Street, Austin, Texas 78756, for review and approval.
For convenience, preliminary plans may be reduced for preliminary submittal.
The cost of submitting plans and specifications shall be borne by the sender.
(3)
Preliminary plan review. All deficiencies noted in the
preliminary plan review shall be satisfactorily resolved.
(d)
Construction documents. Construction documents or final
plans and specifications shall be submitted to the department for review and
approval prior to start of construction. All final plans and specifications
shall be appropriately sealed and signed by a registered architect and a professional
engineer licensed by the State of Texas.
(1)
Preparation of construction documents. Construction documents
shall be well prepared so that clear and distinct prints may be obtained,
shall be accurately and adequately dimensioned, and shall include all necessary
explanatory notes, schedules, and legends and shall be adequate for contract
purposes. Compliance with model building codes and this chapter shall be indicated.
The type of construction, as classified by National Fire Protection Association
220, Standard on Types of Building Construction, 1999 edition, shall be provided
for existing and new facilities. Final plans shall be drawn to a sufficiently
large scale to clearly illustrate the proposed design but not less than one-eighth
inch equals one foot. All rooms shall be identified by usage on all plans
(architectural, fire safety, mechanical, electrical, etc.) submitted. Separate
drawings shall be prepared for each of the following branches of work.
(A)
Architectural plans. Architectural drawings shall include
the following:
(i)
site plan showing all new topography, newly established
levels and grades, existing structures on the site (if any), new buildings
and structures, roadways, walks, and the extent of the areas to be landscaped.
All structures which are to be removed under the construction contract and
improvements shall be shown. A general description of the immediate area surrounding
the site shall be provided;
(ii)
plan of each floor and roof to include fire and smoke
separation, means of egress, and identification of all spaces;
(iii)
schedules of doors, windows, and finishes;
(iv)
elevations of each facade;
(v)
sections through building; and
(vi)
scaled details as necessary.
(B)
Fire safety plans. These drawings shall be provided for
all newly constructed buildings, conversions of existing buildings for facilities,
additions to existing licensed facilities, and remodeled portions of existing
buildings containing licensed facilities. Fire safety plans shall be of a
sufficiently large scale to clearly illustrate the proposed design but not
less than one-sixteenth inch equals one foot and shall include the following
information:
(i)
separate fire safety plans (preferably one floor plan per
sheet) shall indicate location of fire protection rated walls and partitions,
location and fire resistance rating of each fire damper, and the required
means of egress (corridors, stairs, exits, exit passageways):
(I)
when a new building is to contain a proposed facility,
when an existing building is converted to a facility, or when an addition
is made to an existing facility building, plans of each floor and roof shall
be provided;
(II)
when a portion of a building is remodeled or when a new
service is added, only the plan of the floor where the remodeling will take
place or new service will be introduced and the plan of the floor of discharge
shall be provided;
(ii)
designated smoke compartments with floor areas of each
compartment, location and fire resistance rating (one or two hour) of each
smoke partition, location, type and fire resistance rating of each smoke damper;
(iii)
location of all required fire alarm devices, including
all fire alarm control panels, manual pull stations, audible and visual fire
alarm signaling devices, smoke detectors (ceiling and duct mounted), fire
alarm annunciators, fire alarm transmission devices, fire sprinkler flow switches
and control valve supervisory switches on each of the floor plans; and
(iv)
areas protected with fire sprinkler systems (pendant,
sidewall or upright, normal or quick response, and temperature rating shall
be indicated), stand pipe system risers and sizes with valves and inside and
outside fire department connections, fire sprinkler risers and sizes, location
and type of portable fire extinguishers.
(C)
Equipment drawings. Equipment drawings shall include the
following:
(i)
all equipment necessary for the operation of the facility
as planned. The design shall indicate provisions for the installation of large
and special items of equipment and for service accessibility;
(ii)
fixed equipment (equipment which is permanently affixed
to the building or which must be permanently connected to a service distribution
system designed and installed during construction for the specific use of
the equipment). The term "fixed equipment" includes items such as laundry
extractors, walk-in refrigerators, communication systems, and built-in casework
(cabinets);
(iii)
movable equipment (equipment not described in clause
(ii) of this subparagraph as fixed). The term "moveable equipment" includes
wheeled equipment, plug-in type monitoring equipment, and relocatable items;
and
(iv)
equipment which is not included in the construction contract
but which requires mechanical or electrical service connections or construction
modifications. The equipment described in this clause shall be identified
on the drawings to ensure its coordination with the architectural, mechanical,
and electrical phases of construction.
(D)
Structural drawings. Structural drawings shall include:
(i)
plans for foundations, floors, roofs, and all intermediate
levels;
(ii)
a complete design with sizes, sections, and the relative
location of the various members;
(iii)
a schedule of beams, girders, and columns;
(iv)
dimensioned floor levels, column centers, and offsets;
(v)
details of all special connections, assemblies, and expansion
joints; and
(vi)
special openings and pipe sleeves dimensioned or otherwise
noted for easy reference.
(E)
Mechanical drawings. Documentation for selection of the
type of heating and cooling system based on requirements contained in §125.91(c)(3)(D)
of this title shall be included with the mechanical plans. Mechanical drawings
shall include:
(i)
complete ventilation systems (supply, return, exhaust),
all fire and smoke partitions, locations of all dampers, registers, and grilles,
air volume flow at each device, and identification of all spaces (e.g. corridor,
patient room, operating room);
(ii)
boilers, chillers, heating and cooling piping systems
(steam piping, hot water, chilled water), and associated pumps;
(iii)
cold and warm water supply systems, water heaters, storage
tanks, circulating pumps, plumbing fixtures, emergency water storage tank(s)
(if provided), and special piping systems such as for deionized water;
(iv)
drain piping systems (waste and soiled piping systems,
roof drain systems);
(v)
fire protection piping systems (sprinkler piping systems,
fire standpipe systems, water or chemical extinguisher piping system for cooking
equipment); and
(vi)
piping riser diagrams, equipment schedules, control diagrams
or narrative description of controls, filters, and location of all duct mounted
smoke detectors.
(F)
Electrical drawings. Electrical drawings shall include:
(i)
electrical service entrance with service switches, service
feeders to the public service feeders, and characteristics of the light and
power current including transformers and their connections;
(ii)
location of all normal electrical system and essential
electrical system conduits, wiring, receptacles, light fixtures, switches
and equipment which require permanent electrical connections, on plans of
each building level;
(iii)
telephone and communication, fixed computers, terminals,
connections, outlets, and equipment;
(iv)
nurses calling system showing all stations, signals, and
annunciators on the plans;
(v)
in addition to electrical plans, single line diagrams prepared
for:
(I)
complete electrical system consisting of the normal electrical
system transformers, conduit, wire sizes, main switchboard, power panels,
light panels, and equipment for additions to existing buildings, proposed
new facilities, and remodeled portions of existing facilities. Feeder and
conduit sizes shall be shown with schedule of feeder breakers or switches;
(II)
a single line diagram of the complete fire alarm system
showing all control panels, signaling and detection devices and the room number
where each device is located; and
(vi)
schedules of all panels indicating connected load at each
panel.
(2)
Final plan review. All deficiencies noted in the final
plan review shall be satisfactorily resolved before approval of project for
construction will be granted.
(3)
Construction approval. Construction shall not begin until
written approval by the department is received by the owner of the facility.
(4)
Construction document changes. Any changes to construction
documents which affect or change the function, design, or designated use of
an area shall be submitted to the department for approval prior to authorization
of the modifications.
(e)
Special submittals.
(1)
Designer certified construction documents. In an effort
to shorten the plan review and approval process, design professionals may
submit, at the discretion of the department, a set of final construction documents,
the department's completed checklist of licensing requirements and a certification
letter which states that the plans and specifications, based on the department's
checklist comply with the requirements of this chapter. Project certification
forms shall be signed by the licensee or applicant and the architect(s) and
engineer(s) of record.
(2)
Fast-track projects. Submittal of fast-track projects shall
be at the discretion of the department and shall be submitted in not more
than three separate packages.
(A)
First package. The first package shall include:
(i)
a map showing the location of the proposed facility site
and adjacent surrounding area at least two miles in radius identifying any
hazardous and undesirable location noted in §125.91(c) of this title;
(ii)
preliminary architectural plans and a detailed building
site plan showing all adjacent streets, site work, underslab mechanical, electrical,
and plumbing work, and related specifications; and
(iii)
foundation and structural plans.
(B)
Second package. The second package shall include complete
architectural plans and details with specifications and fire safety plans
as described in subsection (c) of this section.
(C)
Third package. The third package shall include complete
mechanical, electrical, equipment and furnishings, and plumbing plans and
specifications, as described in subsection (c) of this section.
(3)
Fire sprinkler systems. Fire sprinkler systems shall comply
with the requirements of National Fire Protection Association 13, Standard
for the Installation of Sprinkler systems, 1999 edition. Fire sprinkler systems
shall be designed or reviewed by an engineer who is registered by the Texas
State Board of Registration for Professional Engineers in fire protection
specialty or is experienced in hydraulic design and fire sprinkler system
installation. A short resume shall be submitted if registration is not in
fire protection specialty.
(A)
Fire sprinkler working plans, complete hydraulic calculations
and water supply information shall be prepared in accordance with NFPA 13, §§8-1,
8-2 and 8-3, for new fire sprinkler systems, alterations of and additions
to existing ones.
(B)
Certification of changes in an existing system is not required
when relocation of not more than twenty sprinkler heads is involved.
(C)
One set of fire sprinkler working plans (sealed by the
engineer), calculations and water supply information shall be forwarded to
the department together with the engineer's certification letter stating that
the sprinkler system design complies with the requirements of NFPA 13. Certification
of the fire sprinkler system shall be submitted prior to system installation.
(D)
Upon completion of the fire sprinkler system installation
and any required corrections, written certification by the engineer, stating
that the fire sprinkler system is installed in accordance with NFPA 13 requirements,
shall be submitted prior to or with the written request for the final construction
inspection of the project.
(f)
Resubmittal of construction documents. When construction
is delayed for longer than one year from the plan approval date, construction
documents shall be resubmitted to the department for review and approval.
The plans shall be accompanied by a new Application for Plan Review and a
plan review fee.
(g)
Project delay or cancellation. The licensee or owner shall
provide written notification to the department when a project has been placed
on hold, canceled or abandoned.
(h)
On-hold projects. The department may close a project file
after one year of its receipt of an Application for Plan Review for projects
that have been placed on hold.
§125.95.Construction, Inspections, and Approval of Projects for New or Existing Facilities in the Absence of Local Codes and Regulations.
(a)
Construction.
(1)
Major construction. Construction, of other than minor alterations,
shall not commence until the final plan review deficiencies have been satisfactorily
resolved, the appropriate plan review fee, according to the plan review schedule
in §125.15 of this title (relating to Fees), has been paid, and the department
has issued a letter granting approval to begin construction. Such authorization
does not constitute release from the requirements contained in this chapter.
If the construction takes place in or near occupied areas, adequate provision
shall be made for the safety and comfort of occupants.
(2)
Construction commencement notification. The architect of
record or the licensee or applicant shall provide written notification to
the department when construction will commence. The department shall be notified
in writing of any change in the completion schedules.
(3)
Completion. Construction shall be completed in compliance
with the construction documents including all addenda or modifications approved
for the project.
(b)
Construction inspections. All facilities including those
which maintain certification under Title XVIII of the Social Security Act
(42 United States Code, §1395 et seq.), are subject to construction surveys.
(1)
Number of construction inspections. A minimum of two construction
inspections of the project is generally required for the purpose of verifying
compliance with subchapters G and H of this chapter and the approved plans
and specifications. The final plan approval letter will inform the architect
of record and the owner as to the minimum number of inspection required for
the project.
(2)
Requesting an inspection. The architect of record or the
licensee shall request a inspection by submitting an Application for Inspection
and the construction inspection fee in accordance with §125.15(d) of
this title for each intermediate inspection, final inspection, and reinspection
requested. Inspection requests by contractors will not be honored.
(A)
The architect of record or the licensee shall request an
intermediate construction inspection to occur at approximately 80% completion.
All major work above the ceiling shall be completed at the time of the intermediate
inspection, however ceilings should not be installed.
(B)
The architect of record or the licensee shall request a
final construction inspection at 100% completion. One-hundred percent completion
means that the project is completed to the extent that all equipment is operating
in accordance with specifications, all necessary furnishings are in place,
and patients could be admitted and treated in all areas of the project.
(3)
Reinspection. Depending upon the number and nature of the
deficiencies cited during the final inspection, the surveyor may require that
a inspection be conducted to confirm correction of all deficiencies cited.
The request for re-inspection shall be submitted in accordance with paragraph
(2) of this subsection.
(c)
Approval of project. Patients shall not occupy a new structure
or remodeled or renovated space until approval has been received from the
local building and fire authorities or the department.
(1)
Documentation requirements. The licensee shall submit the
following documents to the department before the project will be approved:
(A)
written approval of the project by the fire authority;
(B)
a certificate of occupancy for the project issued by the
local building authority;
(C)
written certification by the engineer, stating that the
fire sprinkler system is installed in accordance with the requirements of
NFPA 13, Standard for the Installation of Sprinkler Systems, 1999 edition,
if applicable;
(D)
fire alarm system certification (form FML-009 040392 of
the Office of the State Fire Marshal), if applicable;
(E)
a written plan of correction signed by the licensee for
any deficiencies noted during the final inspection;
(F)
a copy of documentation indicating the flame spread rating
and the smoke development rating of any wall covering installed in this project.
Provide a signed letter or statement corroborating the installation of the
product in the project;
(G)
a copy of documentation indicating that draperies, curtains,
and other similar loosely hanging furnishings and decorations are flame resistant
as demonstrated by passing both the small and large-scale tests of National
Fire Protection Association (NFPA) 701, Standard Methods of Fire Tests for
Flame-Resistant Textiles and Films, 1999 edition, as required by NFPA 101,
Code for Safety to Life from Fire in Buildings and Structures, §18-7.5,
and provide a signed letter or statement corroborating the installation of
the product in the project. All documents published by NFPA as referenced
in these rules may be obtained by writing or calling the NFPA, 1 Batterymarch
Park, Quincy, MA 02169-7471, or (800) 344-3555.
(H)
a Final Construction Approval form signed by the licensee;
and
(I)
any other documentation or information required due to
the type of the project.
(2)
Verbal occupancy approval.
(A)
If, during the final inspection, the surveyor finds only
a few minor deficiencies that do not jeopardize resident health, safety and
welfare, the surveyor may grant verbal approval for occupancy contingent upon
the documents listed in paragraph (1)(A) - (E) of this subsection being provided
to and approved by the surveyor at the time of the final inspection.
(B)
Verbal occupancy approval allows the licensee to occupy
the project. However, the licensee must submit the documents required in paragraph
(1)(F) -(I) of this subsection before the project receives final approval.
(3)
Final approval. Upon its receipt and acceptance of the
documents required in paragraph (1) of this subsection, the department will
issue final approval of the project.
§125.96.Tables.
Table 1. Ventilation Requirements for LCF Facilities.
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on March 15, 2004.
TRD-200401946
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 458-7236
Subchapter A. RABIES CONTROL AND ERADICATION
25 TAC §169.26
The Texas Department of Health (department) proposes an amendment
to §169.26, concerning facilities for the quarantining or impounding
of animals. The amendment clarifies existing language so personnel working
in animal quarantine and impoundment facilities have a clearer understanding
of the required minimum standards for storage of nonperishable foods, primary
enclosures, and outdoor facilities.
Jane C. Mahlow, DVM, MS, Director of the Zoonosis Control Division, has
determined that for each year of the first five years that the amendment is
in effect there will be no fiscal implications to state or local government
as a result of enforcing or administering the amendment as proposed.
Dr. Mahlow has also determined that for each year of the first five years
the amendment is in effect the public benefit anticipated as a result of this
will be that all facilities for impounding animals must meet the minimum standards
required for storage of nonperishable foods and outdoor facilities. The proposed
changes do not involve adaptation from current practice; therefore, there
is no anticipated additional cost to persons who are required to comply with
the amendment as proposed. Because animal quarantine and impoundment facilities
are operated exclusively by governmental and non-profit entities, there is
no anticipated additional cost to small businesses or micro-businesses. There
is no anticipated effect on local employment.
Comments on the proposal may be submitted to Jane C. Mahlow, DVM, MS, Texas
Department of Health, Zoonosis Control Division, 1100 West 49th Street, Austin,
Texas 78756, (512) 458-7255, jane.mahlow@tdh.state.tx.us. Comments will be
accepted for 30 days after publication in the
Texas
Register
.
The amendment is proposed under Texas Health and Safety Code,
Chapter 826, "Rabies," §826.011, which requires the Texas Board of Health
(board) to administer the rabies control program and adopt rules necessary
to effectively administer this program; §826.051, which requires the
department to adopt rules governing the types of facilities that may be used
to quarantine or impound animals; and §12.001, which provides the board
with the authority to adopt rules for the performance of every duty imposed
by law on the board, the department, and the commissioner of health.
The amendment affects Texas Health and Safety Code, Chapter 826.
§169.26.Facilities for the Quarantining or Impounding of Animals.
(a)
Generally.
(1) - (2)
(No change.)
(3)
Storage. Supplies of food and bedding shall be stored in
facilities which adequately protect such supplies against infestation or contamination
by vermin. Refrigeration shall be provided for supplies of perishable food.
Non-perishable foods, such as dry food, do not require refrigeration. For
example, open bags of non-perishable dry food may be stored in sealed cans,
and unopened bags may be stacked on pallets or shelves with at least 12 inches
of clearance between the floor and the first level.
(4) - (11)
(No change.)
(12)
Primary enclosures. Primary enclosures shall:
(A) - (C)
(No change.)
(D)
be constructed and maintained so that
the surfaces
[
(E) - (F)
(No change.)
(b) - (e)
(No change.)
(f)
Outdoor facilities are acceptable under
this section provided those facilities meet all the requirements of this section.
(g)
[
(h)
[
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of
the Secretary of State on March 11, 2004.
TRD-200401853
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 458-7236
The Texas Department of Health (department) proposes amendments to §§181.1-
181.2, 181.5 - 181.8, 181.10, 181.13 - 181.14, 181.22 - 181.24, 181.26, 181.28
- 181.32, 181.44 - 181.45, and new 181.33 and 181.34, concerning administrative
procedures, issuance of vital records events and statistical information,
and the Central Adoption Registry of the Bureau of Vital Statistics.
Specifically, the amendments cover the following: Subchapter A clarifies
key vital statistics words and terms; provides instructions and requirements
for the preservation, transportation, and final disposition of dead bodies;
set requirements regarding access, confidentiality and filing of supplemental
birth certificates, fetal death certificates; and defines the form and content
of birth, death, and fetal death certificates. Subchapter B provides instructions,
sets requirements, and fees for issuance of certified copies, and registration
of birth and death records; defines how abused, misused or flagged records
are handled; provides instructions and requirements for filing of amendment
to medical certification of the certificate of death; sets minimum requirements
for adoption reporting and index access; and establishes notification, maintenance,
and preservation requirements for out-of-business child-placing agencies'
records. Subchapter C establishes rules for notifying adoptive parents about
the Central/Voluntary Adoption Registry; defines the duties, responsibilities
and fees associated with the voluntary adoption registries; and provides guidelines
pertaining to the confidentiality, notification and the release of information.
The new sections provide instructions and requirements for registering a certificate
of death by catastrophe and instructions; and requirements for reporting assisted
reproduction procedures performed by a health care facility under a gestational
agreement.
Debra F. Owens, Chief and State Registrar, Bureau of Vital Statistics,
has determined that for each year of the first five years, there will be no
fiscal implications to state or local government as a result of administering
the sections as proposed.
Ms. Owens has also determined that for each year of the first five years
the sections are in effect, the public benefit anticipated as a result of
administering the sections as proposed will be an increased protection of
vital records events and statistical information. There will no adverse economic
effect on micro-businesses, small businesses or to persons who are required
to comply the sections as proposed. This was determined by interpretation
of the rules, which address only access of individual persons rather than
micro-businesses or small businesses to vital records, and which afford applicants
for hearings the practical options of obtaining less costly legal services
than might be required in a contested case hearing before the State Office
of Administrative Hearings, or electing to proceed without counsel. Furthermore,
the proposed sections require no actions for compliance by micro-businesses
or small businesses. There will be no impact on local employment as a result
of administering the sections as proposed.
Comments on the proposed rules may be submitted to Debra F. Owens, Chief
and State Registrar, Bureau of Vital Statistics, Texas Department of Health,
1100 West 49th Street, Austin, Texas 78756-3191, (512) 458-7366. Public comments
will be accepted for 60 days after publication in the
Texas Register
.
Subchapter A. MISCELLANEOUS PROVISIONS
25 TAC §§181.1, 181.2, 181.5 - 181.8, 181.10, 181.13, 181.14
The amendments are proposed under authority of the Health
and Safety Code, §191.003, which provides the Board of Health with authority
to adopt necessary rules for collecting, recording, transcribing, compiling,
and preserving vital statistics; and §12.001 which provides the board
with the authority to adopt rules for the performance of every duty imposed
by law on the board, department, and the Commissioner of Health.
The amendments affect Health and Safety Code, §191.003.
§181.1.Definitions.
The following words and terms, when used in this chapter, shall have
the following meanings, unless the context clearly indicates otherwise.
(1)-(13)
(No change.)
(14)
Immediate family member--The registrant, [
(15)-(23)
(No change.)
(24)
Registrar--The State Registrar
or a local registrar as recognized by the Texas Department of Health, Bureau
of Vital Statistics.
(25)
[
(26)
[
(27)
[
(28)
[
(29)
[
(30)
[
(31)
[
(32)
[
(33)
[
(34)
[
(35)
[
(36)
[
§181.2.Assuming Custody of Body.
(a)
The funeral director, or person acting as such, who [
(b)
If a dead body or fetus is to be removed from this state,
transported by common carrier within this state, or cremated, the funeral
director, or person acting as such, shall obtain a burial-transit permit from
the local registrar [
(c)
(No change.)
§181.5.Embalming and Standards of the Funeral Industry.
(a)
The department adopts by reference the rules of the Texas
Funeral Service Commission in 22 TAC
§203.16
[
(b)
(No change.)
§181.6.Disinterment.
(a) - (b)
(No change.)
(c)
The state registrar shall issue a disinterment permit [
(d)
(No change.)
(e)
A disinterment permit shall not be required to remove
cremains.
[
(f)
Cremation is considered to be a final disposition
of remains.
[
(g)
A disinterred body must be
transported in a container which insures against the seepage of fluid or the
escape of offensive odors. When shipped by common carrier, a disinterred body
must be enclosed in an airtight metal casket encased in a strong outside shipping
case, or in a sound casket encased in an airtight metal or metal-lined shipping
case. This requirement shall not apply if the disinterred remains involve
no soft parts.
[
(h)
The disinterment permit issued
by the state registrar shall serve as the authority to disinter, transport
by means other than a common carrier, and re-inter a body within this state.
(See §181.2 of this title (relating to Assuming Custody of Body).
[
(i)
A body kept in a receiving
vault shall not be regarded as a disinterred body until after the expiration
of 30 days.
[
(j)
All disinterred remains kept
in receiving vaults shall be thoroughly embalmed in a manner approved by the
Texas Funeral Service Commission and shall be enclosed in a permanently sealed
casket.
[
(k)
The licensed funeral director
or embalmer requesting a disinterment permit shall be responsible for obtaining
a written consent of the cemetery, the owner of the plot, and the decedent's
next-of-kin.
(l)
The licensed funeral director
or embalmer requesting a disinterment permit shall be responsible for obtaining
a written consent order from the county judge to disinter a body from a grave
when the cemetery, plot owner, and the decedent's next-of-kin are unknown.
§181.7.Fetal Death (Stillbirth).
(a)
A certificate of fetal death shall be filed for any
fetus weighing 350 grams or more, or if the weight is unknown, a fetus aged
20 weeks or more
[
(b)
(No change.)
§181.8.Supplemental Birth Certificates.
(a)-(c)
(No change.)
(d)
Where application is made for the filing of a supplemental
certificate based on paternity, the applicant shall submit to the bureau an
Application for
New
[
(1)-(2)
(No change.)
(3)
a certified copy of the court decree establishing paternity
if the information concerning the court decree is not already in the bureau
files. If a court decree is in the bureau files, the Application for
New
[
(4)
a certified copy of the court
decree establishing a gestational agreement. The Application for New Birth
Certificate Based on Parentage must be signed by at least one parent in the
presence of a Notary Public.
(e)
(No change.)
§181.10.Availability of Birth Records to Ensure Confidentiality of Adoption Placement.
(a)
(No change.)
(b)
Availability of birth records generally.
(1)
Copies of birth records are available to the public for
searching or inspection on or after the
75th
[
(2)
(No change.)
§181.13.Birth Certificate Format [
(a)
The State Registrar shall determine the items of information
to be contained on certificates of birth. The format of the items will be
designated on department forms [
(b)
The State Registrar shall prescribe a User Agreement
for the orderly implementation of electronic birth registration.
[
(c)
Hospitals, licensed birthing centers, midwives, and
local registration officials must comply with the User Agreement in order
to participate in electronic birth registration.
[
[
[
[
(d)
The bureau may discontinue
any institution or individual's
participation in electronic birth registration for failure to comply with
the User Agreement.
[
§181.14.Death and Fetal Death Certificate Format [
(a)
The State Registrar shall determine the items of information
to be contained on certificates of death and fetal death. The format of the
items will be designated in forms [
(b)
Funeral directors or
other
persons in charge
of
disposition
[
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of
the Secretary of State on March 15, 2004.
TRD-200401935
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 458-7236
25 TAC §§181.22 - 181.24, 181.26, 181.28 - 181.32, 181.33, 181.34
The amendments and new rules are proposed under authority
of the Health and Safety Code, §191.003, which provides the Board of
Health with authority to adopt necessary rules for collecting, recording,
transcribing, compiling, and preserving vital statistics; and §12.001
which provides the board with the authority to adopt rules for the performance
of every duty imposed by law on the board, department, and the Commissioner
of Health.
The amendments and new rules affect Health and Safety Code, §191.003.
§181.22.Fees Charged for Vital Records Services.
(a) - (j)
(No change.)
(k)
The fee for a new birth record based upon adoption, or
parentage
[
(l) - (q)
(No change.)
§181.23.Indexes for Vital Records.
(a)
(No change.)
(b)
Birth indexes.
(1)
(No change.)
(2)
A general birth index is public information and available
to the public to the extent the index relates to a birth record that is public
on or after the
75th
[
(3)
(No change.)
(c) - (e)
(No change.)
§181.24.Abused, Misused, or Flagged Records.
(a)
Abused birth record.
(1)
(No change.)
(2)
Local registrars shall notify the
Bureau
[
(3)
(No change.)
(b) - (d)
(No change.)
§181.26.Filing of Birth Certificates for Infants Born Outside of a Licensed Institution.
(a)
(No change.)
(b)
A
[
(c)
The essential elements to register a noninstitutional birth
are:
(1)
proof of pregnancy
;
[
[
[
(2)
proof that there was an infant born alive;
(3)
proof
that the birth occurred in the registration
district; and
[
[
[
[
[
[
(4)
proof that
the infant's birth occurred on the
date stated.
(d) - (j)
(No change.)
§181.28.Instructions and Requirements for Issuance of Certified Copies of Vital Records by the State Registrar, Local Registrar, or County Clerk.
(a)
Birth certificates.
(1)
The state registrar, local registrar, or county clerk shall
issue only two types of certified copies:
(A)
(No change.)
(B)
an abstract of birth facts, taken from the original record.
Probate records and delayed records [
(i) - (iv)
(No change.)
(2) - (3)
(No change.)
(b)
(No change.)
(c)
Security features. No certified copy or abstract shall
be issued unless the issuing office provides security features in the paper
used for issuance. Each sheet or document shall be made on paper which contains
as a minimum the following features:
(1)
consecutive numbers
- document that contain sequential
numbers for control purposes
;
(2)
background security features
- a repetitious design
consisting of a pattern that hinders counterfeiting efforts
;
(3)
a copy void pantograph
- the word void appears when
the document is photocopied
;
(4)
an engraved border
- a border that is produced from
engraved artwork containing images from fine lines to very complex patterns
;
(5)
microline printing or security thread
- a line of
small alpha characters in capitol letters that requires a magnifying glass
to read
;
(6)
sensitized security paper
- paper that is reactive
to chemicals commonly used to alter documents
;
(7)
prismatic printing
- a rainbow printing that is used
as a deterrent to color copying
;
(8)
erasable fluorescent printing
- fluoresces under ultraviolet
light and reacts to any attempt to erase in such a manner as to be immediately
detectable
;
(9)
non-optical brighteners
- paper without added optical
paper brighteners that will not fluoresce under ultraviolet light
; [
(10)
complex colors
- colors that are developed by using
a mixture of two or more of the primary colors (red, yellow and blue) and
black is required
;
(11)
intaglio printing - the printing
process in which the paper is firmly pressed into the inked engraved plate.
Once the paper is removed, the ink sticks to the top of the paper, creating
a texture that can be felt with your fingers;
(12)
latent image - designs in
the engraved border that contains hidden images that appear only when viewed
from a prescribed angle to a light source. The intaglio process can print
these images;
(13)
watermark - a three-dimensional
graphic element molded into the paper in a continuous pattern during the paper
manufacturing process.
(d)
Other permitted security features. Other security features
such as, but not limited to the following, may also be incorporated in the
paper used:
(1)
security laminate - a plastic laminate is placed over
printed information as to reveal any attempts to alter the printed material;
or
[
(2)
security
thread - micro printed polyester thread that
is introduced into the paper during the forming process so that the thread
is embedded and is an integral part of the paper.
[
[
[
[
(e)
(No change.)
§181.29.Foreign Adoptions.
(a)
(No change.)
(b)
A certified copy of the decree
of adoption granted in a foreign country and information with translation
into the English language relating to the adoptive parent(s) and adoptee should
be submitted to a court of competent jurisdiction of this state for validation.
It is the responsibility of the applicant(s) to have all required documents
translated into the English language. An official certificate of adoption
must be prepared and submitted to the Bureau by the clerk of the court validating
the foreign adoption.
(c)
[
(1)
a request by the resident adoptive parent(s) to file a
new certificate of birth in the adoptive parent(s') names;
(2)
an official certificate of adoption prepared and filed
in accordance with the laws of this state by the court which
registered
[
[
(3)
[
(d)
[
(1)
The state registrar shall not alter or change the place
of birth or the date of birth from the information contained in the documentation
presented.
(2)
The new certificate shall be prepared on the current certificate
form in the same manner as an in-state adoption is prepared and shall bear
the title "Certificate of Foreign Birth."
(3)
As prescribed in the Health and Safety Code, §192.008,
all documentation used to prepare the new certificate of birth shall be placed
in a sealed file and accessed by an applicant only upon presentation of a
certified copy of an order from a court of competent jurisdiction.
(4)
Once a file is sealed, a standard fee shall be charged
for a search for the file and any copies of records.
(e)
[
§181.30.Instructions and Requirements for Filing of Amendments to Medical Certification of Certificate of Death with a Local Registrar.
(a)
An amending certificate (medical amendment) may be filed
with the appropriate local registrar
or state registrar electronically
through a Bureau of Vital Statistics electronic death registration system
to complete or correct medical certification information on a certificate
of death that is incomplete or inaccurate. The medical amendment must be
in a format
[
(b)
A certificate described in subsection (a) of this section
shall only be filed upon completion by the individual responsible for the
certification of the original death certificate. If the original was
certified
[
(c)
The [
(d)
If the medical amendment is incomplete or unsatisfactory,
the [
(e)
The [
(f)
The [
(g)
The [
§181.31.Minimum Requirements for Adoption Reporting.
(a)
The court that renders a decree of adoption shall send
to the
Bureau
[
(b)
When the Bureau determines
that a certificate of adoption filed with the state registrar requires correction,
the Bureau shall mail the certificate directly to the attorney of record for
correction. Upon correction, the attorney shall return the corrected certificate
to the Bureau. If there is no attorney of record, the Bureau shall mail the
certificate to the clerk of the court for correction.
(c)
[
§181.32.Maintenance of Out-of-Business Child-Placing Agency Records and Health, Social, Educational and Genetic History Reports.
(a)
(No change.)
(b)
The
Bureau
[
(c)
If a child-placing agency designates the
Bureau
[
(1)
(No change.)
(2)
The agency must provide two index cards for each adoption
file, one that cross-references the birth mother's name with the adoptive
parents' and adoptee's name, and one cross-referencing the adoptive parents'
names with the birth mother's and adoptee's name. Each card must include the
date of birth of each child and the child's adoptive name. The information
may also be provided electronically in a format compatible or acceptable to
the
Bureau's
[
(d)
If the child-placing agency designates the
Bureau
[
(e)
If a birth relative provides post-adoption medical or social
information to the
Bureau
[
(1)
The
Bureau
[
(2)
(No change.)
(f)
If a child is biologically unrelated to the prospective
adoptive parents and placed outside of a licensed child-placing agency, the
adopting attorney shall provide to the
Bureau
[
(g)
International adoptions. If a child born in a foreign country
is placed with prospective adoptive parent(s) who reside in this state
and the child is being adopted in this state
, the adopting attorney
shall file a HSEGH with the
Bureau
[
(h)
(No change.)
§181.33.Instructions and Requirements for Registering a Certificate of Death by Catastrophe.
(a)
Catastrophe is defined in the Health and Safety Code, §193.010.
(b)
When catastrophe is deemed the cause of death, the local
registrar shall prepare and file the certificate of death.
(c)
The local registrar shall only prepare and file a certificate
of death caused by catastrophe if:
(1)
the body has not been found; and;
(2)
an affidavit has been submitted to the local registrar
according to the guidelines set forth in the Health and Safety Code, §193.010(b),
and the affiant has followed the specific criteria laid out in Health and
Safety Code, §193.010(b).
(d)
The Bureau may prepare and file a certificate of death
by catastrophe for a minor or a person for whom a guardian has been appointed
who is the subject of a custody or guardianship dispute only if all parties
to the dispute submit an affidavit under the Health and Safety Code, §193.010(b).
(e)
A registrar completing a certificate of death that is a
death by catastrophe shall complete the cause of death information as follows.
(1)
Type the words, "Death by Catastrophe" in item number 35,
Part 1a.
(2)
Do not complete the rest of item 35.
(3)
Complete items 36 through 40 if known.
(4)
Items 41a through 41f must be completed on all certificates
of death by catastrophe.
§181.34.Instructions and Requirements for Reporting Assisted Reproduction Procedures Performed by a Health Care Facility Under a Gestational Agreement.
(a)
Healthcare facilities in this state at which assisted reproduction
procedures are performed under gestational agreements must report reproduction
procedures under gestational agreements and the current status of embryos
created for said procedures on the Report of Assisted Reproduction Procedures
Under Gestational Agreements.
(b)
The Bureau in accordance with the guidelines of Texas Family
Code, §160.763 shall prescribe the form and content of the reporting
form.
(c)
Reporting healthcare facilities must submit this report
to the Bureau on a yearly basis.
(d)
The reporting form must be submitted no later than January
31st for the previous calendar year.
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on March 15, 2004.
TRD-200401936
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 458-7236
25 TAC §181.44, §181.45
The amendments are proposed under authority of the Health
and Safety Code, §191.003, which provides the Board of Health with authority
to adopt necessary rules for collecting, recording, transcribing, compiling,
and preserving vital statistics; and §12.001 which provides the board
with the authority to adopt rules for the performance of every duty imposed
by law on the board, department, and the Commissioner of Health.
The amendments affect Health and Safety Code, §191.003.
§181.44.Inquiry through the Central Index.
(a)
The
Bureau
[
(b)
Each applicant must provide proof
[
(c)
The
CAR
[
§181.45.Registration in the Voluntary Adoption Registry System.
(a)
To register with the Central Adoption Registry (CAR) or
any other authorized registry as defined in Texas Family Code, §162.403(b),
a person must comply with the following requirements:
(1)
(No change.)
(2)
provide proof of
age and
identity, [
(3)
(No change.)
(b) - (c)
(No change.)
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on March 15, 2004.
TRD-200401937
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 458-7236
Subchapter F. LICENSE REGULATIONS
The Texas Department of Health (department) proposes a repeal of §289.254
and new §289.254, concerning licensing of radioactive waste processing
and storage facilities.
Government Code, §2001.039, requires that each state agency review
and consider for readoption each rule adopted by that agency pursuant to the
Government Code, Chapter 2001 (Administrative Procedure Act). Section 289.254
has been reviewed and the department has determined that the reasons for adopting
the section continue to exist; however, revisions to the rule are necessary
as outlined in this preamble.
The department published a Notice of Intention to Review for §289.254
regarding Government Code, §2001.039, in the
Texas Register
(29 TexReg 1231) on February 6, 2004. No comments were
received by the department on this section following publication of the notice.
The new section is a reorganized and reformatted version of the repealed
section to provide for a more efficient rule. The new rule omits requirements
for: filing application for a specific license; issuance of licenses; specific
terms and conditions of licenses; financial assurance and record keeping for
decommissioning; emergency plan for responding to a release; technical renewal
of licenses; expiration and termination of licenses, decommissioning of sites
and separate buildings or outdoor areas; agency action on application to renew
or amend; and modification and revocation of licenses. These requirements
are currently addressed in §289.252 of this title (relating to Licensing
of Radioactive Material). All applicants for radioactive material licenses
and radioactive material licensees are required to comply with §289.252
of this title, as stated in this section and other sections of this title,
as applicable. The new section references new requirements regarding administrative
and technical renewals of licenses that have been added to §289.252 of
this title to implement legislation passed by House Bill 2292, 78th Legislature,
Regular Session, 2003, which added Health and Safety Code, §12.0112,
that requires two-year terms for radioactive material licenses.
This repeal and new section are part of the department's continuing effort
to update, clarify, and simplify its rules regarding the control of radiation
based upon technological advances, public concerns, legislative directives,
or other factors.
Ruth E. McBurney, C.H.P., Director, Division of Licensing, Registration
and Standards, Bureau of Radiation Control, has determined that for each year
of the first five years the sections are in effect, there will be no fiscal
implications for state government as a result of enforcing or administering
the sections as proposed. There will be no fiscal implications for local government
as a result of enforcing or administering the sections as proposed.
Mrs. McBurney has also determined that for each year of the first five
years the proposed sections are in effect, the public benefit anticipated
as a result of enforcing the sections will be to ensure continued protection
of the public, workers, and the environment from unnecessary exposure to radiation
by ensuring that rules are clear and specific. There will be no fiscal impact
on applicants/licensees that are small businesses, micro-businesses or other
persons required to comply with the rules. No additional costs will be incurred
because the additional referenced requirements are relatively minor changes
to the process for renewing licenses. The revisions correct reference citations
and clarify the intent. There is no anticipated impact on local employment.
Comments on the proposal may be submitted to Ruth E. McBurney, C.H.P.,
Director, Division of Licensing, Registration and Standards, Bureau of Radiation
Control, Texas Department of Health, 1100 West 49th Street, Austin, Texas
78756-3189, Telephone (512) 834-6688 or electronic mail at Ruth.McBurney@tdh.state.tx.us.
Public comments will be accepted for 30 days following publication of this
proposal in the
Texas Register
. In addition,
a public meeting to accept oral comments will be held at 1:30 p.m., Wednesday,
April 14, 2004, in Conference Room N-218, Texas Department of Health, Bureau
of Radiation Control, located at the Exchange Building, 8407 Wall Street,
Austin, Texas.
25 TAC §289.254
(Editor's note: The text of the following section proposed for
repeal will not be published. The section may be examined in the offices of
the Texas Department of Health or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeal is proposed under the Health and Safety
Code, §401.051, which provides the Texas Board of Health (board) with
authority to adopt rules and guidelines relating to the control of radiation;
and §12.001, which provides the board with the authority to adopt rules
for its procedure and for the performance of each duty imposed by law on the
board, the department, or the commissioner of health.
The repeal affects Health and Safety Code, Chapters 12 and 401. The review
of the rule implements Government Code, §2001.039.
§289.254.Licensing of Radioactive Waste Processing and Storage Facilities.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State on March 15, 2004.
TRD-200401947
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 458-7236
25 TAC §289.254
The new section is proposed under the Health and Safety Code, §401.051,
which provides the Texas Board of Health (board) with authority to adopt rules
and guidelines relating to the control of radiation; and §12.001, which
provides the board with the authority to adopt rules for its procedure and
for the performance of each duty imposed by law on the board, the department,
or the commissioner of health.
The new section affects Health and Safety Code, Chapters 12 and 401. The
review of the rule implements Government Code, §2001.039.
§289.254.Licensing of Radioactive Waste Processing and Storage Facilities.
(a)
Purpose and scope.
(1)
This section establishes the requirements for management
of commercial radioactive waste processing and storage facilities, the procedures
and criteria for the issuance of licenses to receive, possess, transport,
store, and process radioactive waste from other persons, and the terms and
conditions upon which the agency will issue such licenses.
(2)
Except as otherwise provided, this section applies to all
persons who transport, receive, possess, store, or process radioactive waste
from other persons. In addition to the requirements of this section, all licensees,
unless otherwise specified, are subject to the requirements of §289.201
of this title (relating to General Provisions for Radioactive Material), §289.202
of this title (relating to Standards for Protection Against Radiation from
Radioactive Materials), §289.203 of this title (relating to Notices,
Instructions, and Reports to Workers; Inspections), §289.204 of this
title (relating to Fees for Certificates of Registration, Radioactive Material
Licenses, Emergency Planning and Implementation, and Other Regulatory Services), §289.205
of this title (relating to Hearing and Enforcement Procedures), §289.252
of this title (relating to Licensing of Radioactive Material), and §289.257
of this title (relating to Packaging and Transportation of Radioactive Material).
(b)
Definitions. The following words and terms, when used in
this section, shall have the following meanings, unless the context clearly
indicates otherwise.
(1)
Commencement of major construction--Any major structural
erection or major alterations to existing structures, or other substantial
action that would change the facility design or site for the purpose of establishing
a radioactive waste processing or storage facility. The term does not mean
the acquisition of existing structures or minor changes thereto.
(2)
Decommissioning--The final activities carried out at a
radioactive waste processing or storage site after completion of processing
operations to remove safely from service and reduce residual radioactivity
to a level that permits release of the property for unrestricted use and/or
termination of the license. Such activities shall include:
(A)
disposing of all radioactive waste at a licensed radioactive
waste disposal site;
(B)
dismantling or decontaminating site structures;
(C)
decontaminating site surfaces and remaining equipment;
and
(D)
conducting final closure surveys, decontamination, and
reclamation of the site.
(3)
Disposal--Isolation or removal of radioactive wastes from
mankind and his environment. The term does not include emissions and discharges
under rules of the agency.
(4)
Engineered barriers--Man-made devices to contain or limit
the potential movement of radioactive material, which might result from spills
or other accidents.
(5)
Floodplain--The lowland and relatively flat areas adjoining
inland and coastal waters, including flood prone areas of off-shore islands.
(6)
Local government--A county, an incorporated city or town,
a special district, or other political subdivision of the state.
(7)
Major aquifer--An aquifer that yields large quantities
of water in a comparatively large area of the state. Major aquifers are located
in the following formations: Ogallala, Alluvium and Bolsom Deposits, Edwards-Trinity
(Plateau), Edwards (Balcones Fault Zone - San Antonio Region), Edwards (Balcones
Fault Zone - Austin Region), Trinity Group, Carrizo-Wilcox, and Gulf Coast.
(8)
Natural barriers--The natural characteristics of a site
or surface and subsurface composition that serves to impede the movement of
radioactive material. Natural barriers may include, for example, the location
of a facility remote from an aquifer, or the sorptive capability of the soil
surrounding a facility.
(9)
Processing--The storage, extraction of materials, transfer,
volume reduction, compaction, incineration, solidification, or other separation
and preparation of radioactive waste from other persons for reuse or disposal,
including any treatment or activity that renders the waste less hazardous,
safer for transport, or amenable to recovery, storage, or disposal.
(10)
Radioactive waste processing facility--A facility where
radioactive waste received from other persons is processed and/or repackaged
according to United States Department of Transportation (DOT) regulations.
(11)
Radioactive waste storage facility--A facility where radioactive
waste received from other persons is stored while awaiting shipment to a licensed
radioactive waste processing or disposal facility.
(12)
Reconnaissance level information--Any information or analysis
that can be retrieved or generated without the performance of new comprehensive
site-specific investigations. Reconnaissance level information includes, but
is not limited to, relevant published scientific literature; drilling records
required by state agencies, such as the Railroad Commission of Texas, the
Texas Environmental Quality Commission (Commission), and the Texas Natural
Resources Information System; and reports of governmental agencies.
(13)
Site--The real property, including the buffer zone, on
which a radioactive waste processing or storage facility may be located.
(14)
Site monitoring--The procedures for the monitoring of
the site and environment to assess quality of site operations and performance
and to detect and quantify levels and types of radioactivity and chemicals
in the environment. It includes preoperational, operational, and license termination
phases.
(15)
Site operations--The routine day-to-day activities carried
out at the site for the receipt, processing, and storage of radioactive waste.
(16)
Site suitability--The capability of the various characteristics
of a processing or storage facility or site to safely contain the radioactive
waste expected to be present at the site.
(17)
Sole source aquifer--The aquifer that is the sole or principal
source of drinking water for an area designated under the Safe Drinking Water
Act of 1974, 42 United States Codes Annotated 300f, et seq.
(18)
Waste processing and storage categories--Radionuclides
classified as follows:
(A)
any one of seven groups into which radionuclides in normal
form are classified, according to their toxicity and their relative potential
hazard in transport, as specified in subsection (p) of this section; and
(B)
any radionuclide not specifically listed in one of the
categories in subsection (p) of this section shall be assigned to one of the
categories in accordance with subsection (p)(2) of this section.
(19)
Wetlands--Areas that are inundated or saturated by surface
or groundwater at a frequency and duration sufficient to support and that,
under normal circumstances, do support a prevalence of vegetation typically
adapted for life in saturated soil conditions. Wetlands generally include
playa lakes, swamps, marshes, bogs, and similar areas.
(c)
Activities requiring license. Except for persons exempted
by this section, no person shall receive, possess, and store or process radioactive
waste from another person except as authorized in a specific license issued
in accordance with this section.
(d)
Radioactive waste processing and storage facility classification.
(1)
Classification of radioactive waste processing and storage
facilities. Radioactive waste processing and storage facilities are classified
according to the radionuclides, other than sealed sources, received, possessed,
or processed in each of the waste processing and storage categories, as defined
in subsection (b) of this section with all applicable provisions, except that,
for the purposes of this section which apply to processing and storage of
radioactive waste, Category IV shall include waste processing and storage
categories IV-VII. The total possession limit of each category of unsealed
(dispersible) radionuclides for each class of facility is as follows:
(2)
Class III storage facilities are those in which the applicable
possession limit of radioactive waste exceeds any limit of Class II storage
facilities.
(3)
Class III processing facilities are those in which the
applicable possession limit of radioactive waste exceeds any limit of Class
II processing facilities.
(e)
Exemptions.
(1)
Sealed sources. Persons who receive, possess, or process
sealed sources of radioactive material as radioactive waste from other persons
are exempt from this section, provided that:
(A)
encapsulated sources are tested upon receipt and determined
to have less than 0.005 microcurie of removable contamination; and
(B)
sealed sources of radioactive material remain in sealed
form after receipt.
(2)
Unsealed sources.
(A)
Persons who receive, possess, or process sources of radioactive
material in unsealed form as radioactive waste from other persons are exempt
from this section provided that:
(i)
the total radioactivity of all radioactive waste possessed
at any one time does not exceed the applicable limits for Class I processing
or storage facilities as described in subsection (d) of this section; and
(ii)
the total volume of radioactive waste processed in any
one year does not exceed 50 cubic feet.
(B)
Persons who receive, possess, and store radioactive material
in unsealed form as radioactive waste from other persons are exempt from this
section provided that:
(i)
the radioactive waste consists only of radiopharmaceutical
residues resulting from radiopharmaceuticals manufactured, compounded, and
supplied by those persons receiving the radiopharmaceutical residues as radioactive
waste;
(ii)
the radioactive waste is held in storage for decay to
background radiation levels; and
(iii)
the radioactive waste is not shipped to a radioactive
waste processing or disposal facility.
(3)
Radioactive material. A person who receives, possesses,
and stores radioactive material as radioactive waste from sites owned and
controlled by that same person is not considered to have received waste from
other persons.
(f)
Filing application for a specific license. Unless otherwise
specified, an applicant for a license to receive, possess, or process radioactive
waste from other persons is subject to the requirements in §289.252(d)
of this title. The applicant shall also comply with the following additional
filing requirements.
(1)
The applicant for a license to receive, possess, or process
radioactive waste from other persons shall submit seven copies of each license
application or application for amendment and any supporting documents in a
manner specified by the agency. Applications for issuance of licenses shall
include all general and specific technical requirements, financial information,
and environmental requirements, if applicable, described in this section.
(2)
Each application shall clearly demonstrate how the requirements
of this subsection and subsections (g), (h), and (i) of this section have
been addressed.
(3)
Applications for licenses shall be processed in accordance
with the following time periods.
(A)
The first period is the time from receipt of an application
by the Division of Licensing, Registration and Standards to the date of issuance
or denial of the license or a written notice outlining why the application
is incomplete or unacceptable. This time period is 90 days.
(B)
The second period is the time from receipt of the last
item necessary to complete the application to the date of issuance or denial
of the license. This time period is 90 days.
(C)
These time periods are exclusive of any time period incident
to hearings and post-hearing activities required by Government Code, Chapters
2001 and 2002.
(4)
Notwithstanding the provisions of §289.204(d)(1) of
this title, reimbursement of application fees may be granted in the following
manner.
(A)
In the event the application is not processed in the time
periods as stated in paragraph (3) of this subsection, the applicant has the
right to request of the director of the Radiation Control Program full reimbursement
of all application fees paid in that particular application process. If the
director does not agree that the established periods have been violated or
finds that good cause existed for exceeding the established periods, the request
will be denied.
(B)
Good cause for exceeding the period established is considered
to exist if:
(i)
the number of applications for licenses to be processed
exceeds by 15% or more the number processed in the same calendar quarter the
preceding year;
(ii)
another public or private entity utilized in the application
process caused the delay; or
(iii)
other conditions existed giving good cause for exceeding
the established periods.
(C)
If the request for full reimbursement authorized by subparagraph
(A) of this paragraph is denied, the applicant may then request a hearing
by appeal to the Commissioner of Health for a resolution of the dispute. The
appeal will be processed in accordance with Title 1, Texas Administrative
Code, Chapter 155 (relating to Rules of Procedure) and the Formal Hearing
Procedures, §§1.21, 1.23, 1.25, and 1.27 of this title (relating
to the Texas Board of Health).
(5)
An applicant for a license under this section shall include
the following additional information in the application to the agency:
(A)
identity of the applicant including the full name, address,
telephone number, and description of the business(es) or occupation(s) of
the applicant;
(B)
the organizational structure of the applicant, both off-site
and on-site, including a description of lines of authority and assignments
of responsibilities, whether in the form of administrative directives, contract
provisions, or otherwise;
(C)
a description of past operations that the applicant has
been involved in including any license limitations, suspensions or revocations
of such licenses, and any other information that will allow the agency to
assess the applicant's past operating history;
(D)
the technical qualifications, including training and experience,
of the applicant and members of the applicant's staff to engage in the proposed
activities; and minimum training and experience requirements for personnel;
(E)
a description of the personnel training and retraining
program;
(F)
a statement of need and a description of the proposed activities
identifying:
(i)
the location of the proposed site;
(ii)
the character of the proposed activities;
(iii)
the types, chemical and/or physical forms and quantities
of radioactive waste to be received, possessed, and processed; and
(iv)
the plans for use of the facility for purposes other than
processing of radioactive waste;
(G)
proposed time schedules for construction and receipt and
processing of radioactive waste at the proposed facility;
(H)
description of the site and accurate drawings of the facility
including, but not limited to:
(i)
construction;
(ii)
foundation details;
(iii)
ventilation;
(iv)
plumbing and fire suppression systems;
(v)
physical security system;
(vi)
storage areas;
(vii)
radioactive waste handling or processing areas;
(viii)
proximity to creeks or culverts; and
(ix)
soil types under the facility with respect to compatibility
with foundation and structural design;
(I)
a description that demonstrates that the site suitability
characteristics will meet the following requirements:
(i)
the overall hydrogeologic environment of the site, in combination
with engineering design, shall act to minimize and control potential radioactive
waste migration into surface water and groundwaters;
(ii)
no new site shall be located in a 100-year floodplain,
as designated by the Commission, or a wetland; and
(iii)
no new site shall be located in the recharge area of
a sole source aquifer or a major aquifer unless it can be demonstrated with
reasonable assurance that the new site will be designed, constructed, operated,
and closed without an unreasonable risk to the aquifer.
(J)
minimum criteria for facility design and operation to include:
(i)
the building used for processing radioactive wastes shall
have a minimum classification of Type II (111) in accordance with National
Fire Protection Association 220 titled, "Standard Types of Building Construction";
(I)
buildings used for processing or storage of radioactive
wastes shall have ventilation and fire protection systems to minimize the
release of radioactive materials into the soils, waters, and the atmosphere;
and
(II)
facilities and equipment for repackaging leaking and/or
damaged containers shall be provided.
(ii)
the design and operation of the radioactive waste processing
or storage facility shall be such that:
(I)
releases of non-radiological noxious materials from the
facility are minimized; and
(II)
radiation levels, concentrations, and potential exposures
off-site due to airborne releases during operations are within the limits
established in §289.202 of this title and are maintained as low as reasonably
achievable.
(iii)
the design and operation of the radioactive waste processing
or storage facility shall be compatible with the objectives of the site closure
and decommissioning plan;
(iv)
the facility shall be designed to confine spills. Independent
and diverse engineered barriers shall be provided, as necessary, to complement
natural barriers in minimizing potential releases from the facility and in
complying with this section;
(v)
the location and construction of any new radioactive waste
processing facility shall have a buffer zone adequate to permit emergency
measures to be implemented following accidents and to address airborne plume
dispersions and, as a minimum, shall be such that:
(I)
the active components of a Class II facility are located
at least 30 meters from the nearest residence as of the date of the license
application; and
(II)
the active components of a Class III facility are located
at least 30 meters from the nearest property not owned or occupied by the
licensee.
(K)
a flow diagram of radioactive waste processing operations;
(L)
a description and accurate drawings of processing equipment
and any required special handling techniques to be employed;
(M)
a description of personnel monitoring methods, training,
and procedures to be followed to keep employees from ingesting and inhaling
radioactive materials, including a description of methods to keep the radiation
exposure to levels as low as reasonably achievable;
(N)
a description of the site monitoring program to include
prelicense data and proposed operational monitoring programs for direct gamma
radiation measurements and radioactive and chemical characteristics of the
soils, groundwater, surface waters, and vegetation, as applicable;
(i)
for radioactive waste storage facilities, the applicant
shall address on-site air quality; and
(ii)
for radioactive waste processing facilities, the applicant
shall address on-site and off-site air quality;
(O)
spill detection and cleanup plans for the licensed site
and for associated transportation of radioactive material;
(P)
an operating, safety, and emergency procedures manual that
shall provide detailed procedures for receiving, handling, storing, processing,
and shipping radioactive waste;
(Q)
for radioactive waste processing facilities, a description
of the equipment to be installed to maintain control over maximum concentrations
of radioactive materials in gaseous and liquid effluents produced during normal
operations and the means to be employed for keeping levels of radioactive
material in effluents to unrestricted areas as low as reasonably achievable
and within the limits listed in §289.202 of this title;
(R)
methods of ultimate disposal and decommissioning; and
(S)
the system for maintaining inventory of receipt, storage,
and transfer of radioactive waste.
(g)
Additional environmental requirements for Class III facilities.
An application for a license for a class III processing or storage facility
shall include environmental information that may be based on reconnaissance
level information when appropriate and addresses the following:
(1)
description of present land uses and population distribution
in the vicinity of the site:
(A)
for radioactive waste storage facilities, the description
shall address properties adjacent to the site; and
(B)
for radioactive waste processing facilities, the description
shall address properties adjacent to the site and shall include population
distribution within a one-mile radius of the site;
(2)
area/site suitability including geology, hydrology, and
natural hazards. For radioactive waste processing facilities, area meteorology
also shall be addressed;
(3)
site and project alternatives including alternative siting
analysis;
(4)
socioeconomic effects on surrounding communities of operation
of the licensed activity and of associated transportation of radioactive material;
and
(5)
environmental effects of postulated accidents.
(h)
Issuance of licenses.
(1)
A license for a radioactive waste processing or storage
facility will be issued if the agency finds reasonable assurance that:
(A)
an application meets the requirements of the Act and the
rules of the agency;
(B)
the proposed radioactive waste facility will be sited,
designed, operated, decommissioned, and closed in accordance with this section;
(C)
the issuance of the license will not be inimical to the
health and safety of the public or the environment; and
(D)
there is no reason to deny the license as specified in §289.252(d)(10)
of this title.
(2)
The agency may request, and the licensee shall provide,
additional information after the license has been issued to enable the agency
to determine whether the license should be modified in accordance with §289.202(dd)
of this title.
(i)
Commencement of major construction. Commencement of major
construction is prohibited until 30 days after the agency has given notice
that a license is proposed to be granted, and the environmental analysis is
available. If a hearing is requested, the commencement of major construction
is prohibited until notice of the contested case hearing is noticed in accordance
with the Act. Commencement of major construction subsequent to issuance of
the notices is at the economic risk of the applicant.
(j)
Commencement of operations. No licensee issued a license
under this section may commence operations until the licensee has obtained
licenses or permits from other agencies as required by law.
(k)
Specific terms and conditions of licenses. Unless otherwise
specified, each license issued in accordance with this section is subject
to the requirements in §289.252(x) of this title. A license issued under
this section shall include license conditions derived from the evaluations
of the application and analyses performed by the agency, including amendments
and changes made before a license is issued. License conditions may include,
but are not limited to, the following:
(1)
restrictions as to the total radioactive inventory of radioactive
waste to be received;
(2)
restrictions as to size, shape, and materials and methods
of construction of radioactive waste packaging and maximum number of package
units stored, at any one time;
(3)
restrictions as to the physical and chemical form and radioisotopic
content and concentration of radioactive waste;
(4)
controls to be applied to restrict access to the site;
(5)
controls to be applied to maintain and protect the health
and safety of the public and site employees and the environment;
(6)
administrative controls, which are the provisions relating
to organization, management, and operating procedures; record-keeping, review
and audit; and reporting necessary to assure that activities at the facility
are conducted in a safe manner and in conformity with agency rules and license
conditions; and
(7)
maximum retention time for radioactive waste received at
the facility.
(l)
Technical renewal of licenses.
(1)
Technical renewal of licenses shall be filed in accordance
with §289.252(z) of this title.
(2)
The licensee is responsible for decommissioning the facility
and continued safe storage of any radioactive waste whether an application
for continued receipt of wastes is filed or not.
(m)
Amendment of license at request of licensee. Applications
for amendment of a license shall be filed in accordance with subsection (f)
of this section and §289.252(d)(1) and (3) of this title. Such applications
shall be signed by the RSO and specify how the licensee desires his license
to be amended and the basis for such amendment.
(n)
Waste processing and packaging requirements. All processed
radioactive waste offered for transport or disposal shall meet:
(1)
all applicable transportation requirements of the agency,
the United States Nuclear Regulatory Commission, and of the DOT; and
(2)
all applicable disposal facility license conditions.
(o)
Environmental assessment. A written analysis of the impact
on the human environment will be prepared or secured by the agency for any
license for a class III processing or storage facility and shall be available
to the public for written comment at least 30 days prior to the beginning
of a hearing, if any, on the issuance or renewal of the license.
(p)
Waste processing and storage categories of radionuclides.
(1)
The following table contains waste processing and storage
categories of radionuclides.
(2)
Any radionuclide not specifically listed in paragraph (1)
of this section shall be assigned to one of the categories in accordance with
the following table.
(3)
For mixtures of radionuclides, the following shall apply.
(A)
If the identity and respective activity of each radionuclide
are known, the permissible activity of each radionuclide shall be such that
the sum, for all categories present, of the ratio between the total activity
for each category to the permissible activity for each category will not be
greater than unity.
(B)
If the categories of the radionuclides are known but the
amount in each category cannot be reasonably determined, the mixture shall
be assigned to the most restrictive category present.
(C)
If the identity of all or some of the radionuclides cannot
be reasonably determined, each of those unidentified radionuclides shall be
considered as belonging to the most restrictive category that cannot be positively
excluded.
(D)
Mixtures consisting of a single radioactive decay chain
where the radionuclides are in the naturally occurring proportions shall be
considered as consisting of a single radionuclide. The category and activity
shall be that of the first member present in the chain, except that if radionuclide
"X" has a half-life longer than that of that first member and an activity
greater than that of any other member, including the first, at any time during
processing, the waste processing and storage category shall be that of nuclide
"X" and the activity of the mixture shall be the maximum activity of nuclide
"X" during processing.
This agency hereby certifies that the proposal
has been reviewed by legal counsel and found to be within the agency's legal
authority to adopt.
Filed
with the Office of the Secretary of State on March 15, 2004.
TRD-200401948
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 458-7236
The Texas Department of Health (department) proposes the repeal of §289.301
and new §289.301, concerning registration and radiation safety requirements
for lasers and intense-pulsed light devices.
Government Code, §2001.039, requires that each state agency review
and consider for readoption each rule adopted by that agency pursuant to the
Government Code, Chapter 2001 (Administrative Procedure Act). Section 289.301
has been reviewed and the department has determined that the reasons for adopting
the section continue to exist in that a rule on this subject is needed; however,
the rule needs revisions as described in this preamble.
The department published a Notice of Intention to Review for §289.301
regarding Government Code, §2001.039, in the
Texas Register
(26 TexReg 6737) on August 31, 2001. No comments were
received by the department on this section following publication of this notice.
The new section incorporates legislation passed by the 78th Legislature,
Regular Session, 2003. House Bill (HB) 2292, 78th Legislature, Regular Session,
2003, which added Health and Safety Code, §12.012, requires two-year
terms for certificates of laser registration. The department has historically
required renewal of certificates of laser registration that includes submission
to the department of updated technical information regarding the lasers possessed
by the registrant, operating and safety procedures, and personnel responsible
for the security and safe use of the machines. In order to incorporate the
provisions of HB 2292 concerning two-year terms and to continue requiring
a renewal that includes pertinent technical information, the department is
implementing an administrative renewal and a technical renewal. The registrant
will be required to renew the certificate of laser registration every two
years by paying the required fee and having a satisfactory compliance history.
This administrative renewal will not involve review of technical information
regarding the certificate of laser registration. At a longer interval, the
registrant will be required to submit certain technical information for review.
This technical renewal date will be specified in the certificate of laser
registration and will be for an interval of an even number of years in order
to eventually coincide with the administrative renewal. Maintaining the more
resource-intensive technical renewal allows the department to ensure continued
security and safe use of lasers.
House Bill 253, 78th Legislature, Regular Session, 2003, which amended
Health and Safety Code, §401.110, requires the department to deny a certificate
of laser registration application, amendment or renewal if the applicant's
compliance history reveals a recurring pattern of conduct that demonstrates
a consistent disregard for the regulatory process through significant violations
of the Radiation Control Act or the department's radiation control rules.
The department has defined "a recurring pattern of conduct that demonstrates
a consistent disregard for the regulatory process through significant violations..."
by adding a requirement that states the department will deny an application
if at least three department actions are issued within the previous six years,
that assess administrative or civil penalties against the registrant or if
an order is issued to revoke or suspend the certificate of laser registration.
The definition of radiation in Health and Safety Code, §401.003(17)
includes both laser radiation and radiation from intense-pulsed light devices.
Therefore, requirements for protection against radiation from intense-pulsed
light (IPL) devices are added throughout the section; however, these devices
are not required to be registered. In addition, clarifying language is added
to indicate that only Class 3b and Class 4 lasers are required to be registered.
Definitions for healing arts, intense-pulsed light devices, invisible radiation,
and mobile service operation are added to define language used within the
rule. The definitions for the different classes of lasers are revised to reflect
the current numbering system utilized by the International Electrotechnical
Commission and the American National Standards Institute (ANSI) as well as
references to the applicable, accessible emission limits in ANSI Z136.1-2000,
Safe Use of Lasers. Definitions for beam, collateral radiation, divergence,
infrared radiation, irradiance, practitioner of the healing arts, provider
of lasers, and visible radiation were revised to state more clearly the intent
of the rule. Multiple definitions are deleted, as they are not used in the
text of the rule. Throughout the section, outdated tables and graphics have
been deleted and references to the outdated material are changed. New references
to ANSI Z136.1-2000, Safe Use of Lasers and to Title 21, Code of Federal Regulations
(CFR), Part 1040.10 are inserted. A requirement exempting persons who perform
laser services only for the registrant by whom they are employed is added.
Requirements are revised to clarify that persons providing alignment, calibration,
and/or repair of Class 3b or 4 lasers or other lasers that allow access to
Class 3b or 4 lasers shall be registered. A requirement is added to allow
the agency to request and require the registrant to provide additional information
after the certificate of laser registration has been issued in order to be
consistent with other permitting sections of this title. A requirement for
registrants to annually inventory their lasers is added. An inventory requirement
is added to ensure registrants, especially those with multiple lasers, are
aware of the location of lasers and how many lasers the registrant possesses.
Receipt, transfer, and disposal requirements for lasers are moved to this
section from another section of this title in order to more logically place
it with inventory requirements. In addition, revisions are made to the requirements
for expiration of certificates of laser registration to correspond with the
requirements for administrative and technical renewals. Language is also added
to the expiration and termination subsections to clarify requirements for
the disposition or transfer of lasers if a registrant terminates a certificate
of laser registration or it expires. Modification, suspension, and revocation
of certificates of laser registration language is moved to this section from
another section of this title to be consistent with other permitting sections
of this title. The requirements for notification of bankruptcy have been revised
to be consistent with language in other sections of this title. Requirements
for providing written instructions for personnel operating lasers are added
to ensure personnel are aware of laser radiation hazards and the procedures
for safely operating the lasers. Language on viewing ports, viewing optics,
collecting optics, and display screens is revised to include requirements
for maintaining laser radiation at or below the permissible limits. A requirement
for a key-actuated or computer-actuated password master control is added to
ensure the laser or IPL device is not activated when unattended. Language
regarding labeling and posting of laser facilities is revised to be consistent
with Title 21, CFR, Part 1040.10. Requirements for reporting stolen, lost,
or missing lasers or IPL devices are added to ensure that registrants are
aware of their responsibilities if these events occur. The timeline for keeping
records/documents subsection was revised to reflect changes in the section.
The section was reformatted for better flow of language and easier readability.
Other minor grammatical changes are made and reference citations are corrected
for clarification.
This repeal and new section are part of the department's continuing effort
to update, clarify, and simplify its rules regarding the control of radiation
based upon technological advances, public concerns, legislative directives,
or other factors.
Ruth E. McBurney, C.H.P., Director, Division of Licensing, Registration
and Standards, Bureau of Radiation Control, has determined that for each year
of the first five years the sections are in effect, there will be no fiscal
implications for state or local government as a result of enforcing or administering
the section as proposed.
Mrs. McBurney has also determined that for each year of the first five
years the proposed sections are in effect, the public benefit anticipated
as a result of enforcing the section will be to ensure the continued protection
of the public, workers, and the environment from unnecessary exposure to radiation
by ensuring that rules are clear and specific, that those persons regulated
are informed of the appropriate registration procedures, that registrants
are aware of the number and location of lasers for purposes of safety and
security, and that users of IPL devices are aware of necessary safety precautions.
There will be a slight increase in a registrant's time required to perform
an annual inventory. Depending on the number and location of machines and
locations of sub-sites, a facility could spend from 10 minutes to over eight
hours in this endeavor. There will be no significant fiscal impact on applicants/registrants
that are small businesses, micro-businesses or other persons required to comply
with the rule because there are no requirements being added that would require
expenditures on equipment, protective devices, training, or regulatory fees.
There is no anticipated impact on local employment.
Comments on the proposal may be submitted to Ruth E. McBurney, C.H.P.,
Director, Division of Licensing, Registration and Standards, Bureau of Radiation
Control, Texas Department of Health, 1100 West 49th Street, Austin, Texas
78756-3189, Telephone (512) 834-6688 or electronic mail at Ruth.McBurney@tdh.state.tx.us.
Public comments will be accepted for 30 days following publication of this
proposal in the
Texas Register
. In addition,
a public meeting to accept oral comments will be held at 9:00 a.m., Wednesday,
April 14, 2004, in Conference Room N-218, Texas Department of Health, Bureau
of Radiation Control, located at the Exchange Building, 8407 Wall Street,
Austin, Texas.
25 TAC §289.301
(Editor's note: The text of the following section proposed for
repeal will not be published. The section may be examined in the offices of
the Texas Department of Health or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeal is proposed under the Health and Safety
Code, Chapter 401, which provides the Texas Board of Health (board) with the
authority to adopt rules and guidelines relating to the control of radiation;
and §12.001, which provides the board with the authority to adopt rules
for the performance of each duty imposed by law on the board, the department,
or the commissioner of health.
The repeal affects Health and Safety Code, Chapters 12 and 401. The review
of the rule implements Government Code, §2001.039.
§289.301.Registration and Radiation Safety Requirements for Lasers.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State on March 15, 2004.
TRD-200401949
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 458-7236
25 TAC §289.301
The new section is proposed under the Health and Safety Code,
Chapter 401, which provides the Texas Board of Health (board) with the authority
to adopt rules and guidelines relating to the control of radiation; and §12.001,
which provides the board with the authority to adopt rules for the performance
of each duty imposed by law on the board, the department, or the commissioner
of health.
The new section affects Health and Safety Code, Chapters 12 and 401. The
review of the rule implements Government Code, §2001.039.
§289.301.Registration and Radiation Safety Requirements for Lasers and Intense-Pulsed Light Devices.
(a)
Purpose.
(1)
This section establishes requirements for protection against
all classes of laser radiation and intense-pulsed light (IPL) device hazards.
This section includes responsibilities of the registrant and the laser safety
officer (LSO), laser and IPL device hazard control methods, training requirements,
and notification of injuries.
(2)
This section establishes requirements for the registration
of persons who receive, possess, acquire, transfer, or use Class 3b and Class
4 lasers in the healing arts, veterinary medicine, industry, academic, research
and development institutions, and of persons who are in the business of providing
laser services. No person shall use Class 3b or 4 lasers or perform laser
services except as authorized in a certificate of laser registration issued
by the agency in accordance with the requirements of this section. Class 1,
2, and 3a lasers and IPL devices are not required to be registered. However,
use of Class 1, 2, and 3a lasers and IPL devices are subject to other applicable
requirements in this section.
(b)
Scope.
(1)
Except as otherwise specifically provided, this section
applies to all persons who receive, possess, acquire, transfer, or use lasers
that emit or may emit laser radiation. Individuals shall not use lasers or
IPL devices on humans unless under the supervision of a licensed practitioner
of the healing arts and unless the use of lasers or IPL devices is within
the scope of practice of their professional license. Nothing in this section
shall be interpreted as limiting the intentional exposure of patients to laser
or IPL device radiation for the purpose of diagnosis, therapy, or treatment
by a licensed practitioner of the healing arts within the scope of practice
of their professional license. This section does not apply to the manufacture
of lasers or IPL devices.
(2)
This section applies to lasers that operate at wavelengths
between 180 nanometers (nm) and 1 millimeter (mm).
(3)
This section applies to IPL devices. These devices shall
be Class 2 or Class 3 surgical devices certified as complying with the design,
labeling, and manufacturing standards of the United States Food and Drug Administration
(FDA).
(4)
In addition to the requirements of this section, all registrants
are subject to the applicable requirements of §289.203 of this title
(relating to Notices, Instructions, and Reports to Workers; Inspections); §289.204
of this title (relating to Fees for Certificates of Registration, Radioactive
Material Licenses, Emergency Planning and Implementation, and Other Regulatory
Services); §289.205 of this title (relating to Hearing and Enforcement
Procedures); and the applicable non-ionizing requirements of §289.231
of this title (relating to General Provisions and Standards for Protection
Against Machine-Produced Radiation).
(c)
Prohibitions.
(1)
The agency may prohibit the use of lasers and IPL devices
that pose significant threat or endanger occupational or public health and
safety, in accordance with §289.205 of this title and §289.231 of
this title.
(2)
Individuals shall not be intentionally exposed to laser
and IPL radiation above the maximum permissible exposure (MPE) unless such
exposure has been authorized by a licensed practitioner of the healing arts.
This provision specifically prohibits intentional exposure for the following
purposes:
(A)
exposure of an individual for training, demonstration,
or other non-healing arts purposes;
(B)
exposure of an individual for the purpose of healing arts
screening, except as specifically authorized by the agency; and
(C)
exposure of an individual for the purpose of research,
except as authorized in research studies. Any research using radiation-producing
devices on humans must be approved by an institutional review board (IRB)
as required by Title 45, Code of Federal Regulations (CFR), Part 46 and Title
21, CFR, Part 56. The IRB must include at least one practitioner of the healing
arts to direct use of laser and IPL device radiation in accordance with subsection
(b)(1) of this section.
(d)
Definitions. The following words and terms, when used in
this section, shall have the following meanings, unless the context clearly
indicates otherwise.
(1)
Accessible emission limit (AEL)--The maximum accessible
emission level permitted within a particular class.
(2)
Aperture--An opening through which radiation can pass.
(3)
Apparent visual angle--The angular subtense of the source
as calculated from source size and distance from the eye. It is not the beam
divergence of the source.
(4)
Beam--A collection of rays characterized by direction,
diameter (or dimensions), and divergence (or convergence).
(5)
Class 1 (I) laser, International Electrotechnical Commission
(IEC) Class 1M--Any laser that does not permit access during the operation
to levels of laser radiation in excess of the applicable, accessible emission
limits contained in American National Standards Institute (ANSI) Z136.1-2000,
Safe Use of Lasers.
(6)
Class 2 (II) laser, IEC Class 2M--Any laser that permits
human access during operation to levels of visible laser radiation in excess
of the applicable, accessible emission limits contained in ANSI Z136.1-2000,
Safe Use of Lasers, but does not permit human access during operation to levels
of laser radiation in excess of the applicable, accessible emission limits
contained in ANSI Z136.1-2000, Safe Use of Lasers.
(7)
Class 3a (IIIa) laser, IEC Class 3M--Any laser that permits
human access during operation to levels of visible laser radiation in excess
of the applicable, accessible emission limits contained in ANSI Z136.1-2000,
Safe Use of Lasers, but does not permit human access during operation to levels
of laser radiation in excess of the applicable, accessible emission limits
contained in ANSI Z136.1-2000, Safe Use of Lasers.
(8)
Class 3b (IIIb) laser--Any laser that permits human access
during operation to levels of laser radiation in excess of the applicable,
accessible emission limits in ANSI Z136.1-2000, Safe Use of Lasers but does
not permit human access during operation to levels of laser radiation in excess
of the applicable, accessible emission limits contained in ANSI Z136.1-2000,
Safe Use of Lasers.
(9)
Class 4 (IV) laser--Any laser that permits human access
during operation to levels of laser radiation in excess of the applicable,
accessible emission limits contained in the most recent edition of ANSI Z136.1-2000,
Safe Use of Lasers.
(10)
Coherent--A light beam is said to be coherent when the
electric vector at any point in it is related to that at any other point by
a definite, continuous function.
(11)
Collateral radiation--Any electromagnetic radiation, except
laser radiation, emitted by a laser that is physically necessary for its operation.
The applicable, accessible emission limits for collateral radiation may be
found in Title 21, CFR, Part 1040.10.
(12)
Continuous wave--The output of a laser that is operated
in a continuous rather than a pulsed mode. In this section, a laser operating
with a continuous output for a period of ?0.25 seconds is regarded as a continuous
wave laser.
(13)
Controlled area--An area where the occupancy and activity
of those within is subject to control and supervision by the registrant for
the purpose of protection from radiation hazards.
(14)
Divergence--For the purposes of this section, divergence
is taken as the plane angle projection of the cone that includes 1 - 1/e (for
example 63.2%) of the total radiant energy or power. The value of the divergence
is expressed in radians or milliradians.
(15)
Electromagnetic radiation--The flow of energy consisting
of orthogonally vibrating electric and magnetic fields lying transverse to
the direction of propagation. X-ray, ultraviolet, visible, infrared, and radio
waves occupy various portions of the electromagnetic spectrum and differ only
in frequency, wavelength, or photon energy.
(16)
Electronic product--Any product or article defined as
follows:
(A)
any manufactured or assembled product that, when in operation:
(i)
contains or acts as part of an electronic circuit; and
(ii)
emits, or in the absence of effective shielding or other
controls would emit, electronic product radiation; or
(B)
any manufactured or assembled article that is intended
for use as a component, part, or accessory of a product described in subparagraph
(A) of this paragraph and that when in operation emits, or in the absence
of effective shielding or other controls would emit, such radiation.
(17)
Energy--The capacity for doing work. Energy content is
commonly used to characterize the output from pulsed lasers, and is generally
expressed in joules (J).
(18)
Healing arts--Any system, treatment, operation, diagnosis,
prescription, or practice for the ascertainment, cure, relief, palliation,
adjustment, or correction of any human disease, ailment, deformity, injury,
or unhealthy or abnormal physical or mental condition.
(19)
Intense-pulsed light (IPL) device--A device that emits
radiation to energy density levels that could reasonably cause bodily harm
and that is used for photothermolysis. This device is a Class 2 or Class 3
surgical device certified as complying with the design, labeling, and manufacturing
standards of the United States Food and Drug Administration (FDA).
(20)
Infrared radiation--The region of the electromagnetic
spectrum between the long-wavelength extreme of the visible spectrum (about
0.7 µm) and the shortest microwaves (about 1 mm).
(21)
Institutional Review Board (IRB)--Any board, committee,
or other group formally designated by an institution to review, approve the
initiation of, and conduct periodic review of biomedical research involving
human subjects.
(22)
Invisible radiation--Laser or collateral radiation having
wavelengths of equal to or greater than 180 nm but less than or equal to 400
nm or greater than 710 nm but less than or equal to 1.0 x 10
6
nm (1 millimeter).
(23)
Irradiance--Radiant power incident per unit area upon
a surface, expressed in watts-per-square-centimeter (W-cm
-2
).
(24)
Joule--A unit of energy. One joule is equal to one watt •
second.
(25)
Laser--An electronic device that emits stimulated radiation
to energy density levels that could reasonably cause bodily harm. A laser
may also produce an intense, coherent, directional beam of light by stimulating
electronic or molecular transitions to lower energy levels. The term "laser"
also includes the assembly of electrical, mechanical, and optical components
associated with the laser. A laser can be a component of a product or system.
(26)
Laser product--Any manufactured product or assemblage
of components that constitutes, incorporates, or is intended to incorporate
a laser and is classified as a Class 1, 2, 3a, 3b, or 4 laser product according
to the performance standards set by the United States Food and Drug Administration
(FDA). A laser that is intended for use as a component of an electronic product
shall itself be considered a laser product. A laser product can contain an
enclosed laser with an assigned class number higher than the inherent capability
of the laser product in which it is incorporated and where the product's lower
classification is appropriate due to the engineering features limiting accessible
emission.
(27)
Laser safety officer (LSO)--An individual who has a knowledge
of and the authority and responsibility to apply appropriate laser radiation
protection rules, standards, and practices, and who must be specifically authorized
on a certificate of laser registration.
(28)
Maximum permissible exposure (MPE)--The level of laser
radiation to which a person may be exposed without hazardous effect or adverse
biological changes in the eye or skin. For the purposes of this section, maximum
permissible exposures for laser radiation may be found in ANSI Z136.1-2000,
Safe Use of Lasers.
(29)
Medical event--Any adverse patient health effect that
is a result of failure or misuse of laser safety equipment.
(30)
Mobile service operation--The provision of lasers and
personnel at temporary sites for limited time periods. The lasers may be fixed
inside a motorized vehicle or may be a portable laser that may be removed
from the vehicle and taken into a facility for use.
(31)
Nominal hazard zone (NHZ)--The space within which the
level of direct, reflected, or scattered radiation during operation exceeds
the applicable MPE. Exposure levels beyond the boundary of the NHZ are below
the applicable MPE level.
(32)
Optical density (D
λ
)--The
logarithm to the base ten of the reciprocal of the transmittance. D
λ
=
-log10 &tgr;λ
, where
(33)
Practitioner of the healing arts (practitioner)--For the
purposes of this section, a person licensed to practice the healing arts by
either the Texas State Board of Medical Examiners as a physician; the Texas
State Board of Dental Examiners; the Texas Board of Chiropractic Examiners;
or the Texas State Board of Podiatry Examiners. A practitioner's use of a
laser is limited to his/her scope of professional practice as determined by
the appropriate licensing agency.
(34)
Protective housing--An enclosure surrounding the laser
that prevents access to laser radiation above the applicable MPE level. The
aperture through which the useful beam is emitted is not part of the protective
housing. The protective housing may enclose associated optics and a work station
and shall limit access to other associated radiant energy emissions and to
electrical hazards associated with components and terminals.
(35)
Provider of lasers--Provision of lasers on a routine basis
to a facility for limited time periods.
(36)
Pulse duration--The duration of a laser pulse. This is
usually measured as the time interval between the half-power points on the
leading and trailing edges of the laser pulse.
(37)
Pulsed laser--A laser that delivers its energy in the
form of a single pulse or a train of pulses. In this section, the duration
of a pulse is <0.25 seconds.
(38)
Reflection--The deviation of radiation following incidence
on a surface.
(39)
Source--A laser or a laser-illuminated reflecting surface.
(40)
Transmission--Passage of radiation through a medium.
(41)
Ultraviolet radiation--Electromagnetic radiation with
wavelengths shorter than those of visible radiation; for the purposes of this
section 0.18 to 0.4 µm.
(42)
Visible radiation (light)--In this section, the term is
used to describe electromagnetic radiation that can be detected by the human
eye. This term is commonly used to describe wavelengths that lie in the range
of 0.4 to 0.7 µm.
(43)
Watt--The unit of power or radiant flux. 1 watt equals
1 joule per second.
(44)
Wavelength (λ)--The distance between two successive
points on a periodic wave that have the same phase.
(e)
Exemptions.
(1)
Lasers in transit or in storage incident to transit are
exempt from the requirements of this section. This exemption does not apply
to the providers of lasers.
(2)
Inoperable lasers are exempt from the requirements of this
section.
(3)
Class 1, Class 2, and Class 3a lasers or products and IPL
devices are exempt from the registration requirements of subsections (f) and
(g) of this section.
(4)
Facilities, including academic institutions and research
or development facilities, registered for the use of lasers are exempt from
the registration requirements of subsections (f) of this section, regarding
laser services, and the applicable paragraphs of subsection (g) of this section,
to the extent that their personnel perform laser services only for the registrant
by whom they are employed.
(f)
Registration of use of Class 3b and 4 lasers and laser
services.
(1)
For purposes of this section, use of Class 3b or 4 lasers
and laser services shall include, but may not be limited to:
(A)
possession and use of lasers in the healing arts, veterinary
medicine, industry, academic, and research and development institutions;
(B)
demonstration and sales of lasers that require the individual
to operate or cause a laser to be operated in order to demonstrate or sell;
(C)
provision of lasers on a routine basis to a facility for
limited time periods by a provider of lasers. For healing arts facilities,
the use of lasers shall be directed by a practitioner employed by the contracting
facility;
(D)
alignment, calibration, and/or repair; or
(E)
laser light shows.
(2)
A person who has made application for registration in accordance
with this section and is using a Class 3b or 4 laser prior to receiving a
certificate of laser registration is subject to the requirements of this chapter.
(g)
Application requirements.
(1)
General application requirements.
(A)
Application for certificate of laser registration shall
be completed on forms prescribed by the agency and shall contain all the information
required by the form and accompanying instructions.
(B)
An LSO shall be designated on each application form. The
qualifications of that individual shall be submitted to the agency with the
application. The LSO shall meet the applicable requirements of subsection
(p) of this section and carry out the responsibilities of subsection (q) of
this section.
(C)
Each application shall be accompanied by a completed BRC
Form 226-1 (Business Information Form).
(D)
Each application for a certificate of laser registration
shall be accompanied by the appropriate fee prescribed in §289.204 of
this title.
(E)
An application for a certificate of laser registration
may include a request for authorization of one or more activities.
(F)
The agency may, at any time after filing of the original
application, require further statements in order to enable the agency to determine
whether the certificate of laser registration should be granted or denied.
(G)
Applications and documents submitted to the agency may
be made available for public inspection except that the agency may withhold
any document or part thereof from public inspection in accordance with §289.231(aa)
of this title.
(2)
Application for use of Class 3b or 4 lasers on humans or
animals.
(A)
In addition to the requirements of subsection (g)(1) of
this section, each person having a Class 3b or 4 laser for use in the healing
arts, or for use on animals, shall submit an application to the agency within
30 days after beginning operation of the laser.
(B)
An application for healing arts shall be signed by a licensed
practitioner of the healing arts. An application for veterinary medicine shall
be signed by a licensed veterinarian. The signature of the administrator,
president, or chief executive officer will be accepted in lieu of a licensed
practitioner's signature if the facility is a licensed hospital or a medical
facility. A signature by the administrator, president, or chief executive
officer does not relieve the practitioner user or veterinarian user from complying
with the requirements of this section.
(C)
If a person is furnished a Class 3b or 4 laser by a provider
of lasers, that person is responsible for ensuring that a licensed practitioner
of the healing arts authorizes intentional exposure of laser radiation to
humans.
(3)
Application for use of Class 3b or 4 lasers in industrial,
academic, and research and development institutions. In addition to the requirements
of subsection (g)(1) of this section, each applicant having a laser(s) for
use in industrial, academic, and research and development institutions shall
submit an application to the agency within 30 days after beginning operation
of the laser.
(4)
Application for demonstration for the purpose of sales
of Class 3b or 4 lasers. Each applicant shall apply for and receive a certificate
of laser registration before the demonstration for purpose of selling laser(s)
in accordance with paragraph (1) of this subsection.
(5)
Application for providers Class 3b or 4 lasers.
(A)
Each applicant shall apply for and receive a certificate
of laser registration before providing Class 3b or 4 lasers.
(B)
In addition to the requirements of subsection (g)(1) of
this section, the applicant shall submit the address of the established main
location where the laser and records will be maintained for inspection. This
shall be a physical street address, not a post office box number.
(6)
Application for alignment, calibration, and/or repair of
Class 3b or 4 lasers. In addition to the requirements of subsection (g)(1)
of this section, each applicant shall apply for and receive a certificate
of laser radiation for alignment, calibration, and/or repair before providing
alignment, calibration, and/or repair of Class 3b or 4 lasers or other lasers
that allow access, through alignment, calibration, and/or repair, to Class
3b or 4 lasers.
(7)
Application for laser light show.
(A)
Each applicant shall apply for and receive a certificate
of laser registration for a laser light show before beginning any show.
(B)
In accordance with subparagraph (A) of this paragraph and
in addition to the requirements of subsection (g)(1) of this section, each
applicant shall submit the following:
(i)
a valid variance issued from the FDA for the laser intended
to be used with all applicable documents required by the variance; and
(ii)
a written notice of the laser light show to be performed
in Texas. The information contained in BRC Form 301-3 shall be provided at
least seven days prior to each show. If, in a specific case, the seven-day
period would impose an undue hardship on the applicant, the applicant may,
upon written request to the agency, obtain permission to proceed sooner.
(8)
Application for mobile service operation for Class 3b or
4 lasers used in the healing arts and veterinary arts.
(A)
Each applicant shall apply for and receive a certificate
of laser registration for mobile service operation involving Class 3b or 4
lasers before beginning mobile service operation.
(B)
In addition to the requirements of subsection (g)(1) of
this section, each applicant shall submit the address of the established main
location where the laser, records, etc. will be maintained for inspection.
This shall be a physical street address, not a post office box number.
(C)
An application for mobile service operation for the healing
arts shall be signed by a licensed practitioner of the healing arts and an
application for mobile services for veterinary medicine shall be signed by
a licensed veterinarian.
(h)
Issuance of certificate of laser registration.
(1)
Upon determination that an application meets the requirements
of the Texas Radiation Control Act (Act) and the rules of the agency, the
agency may issue a certificate of laser registration authorizing the proposed
activity in such form and containing such conditions and limitations as the
agency deems appropriate or necessary.
(2)
The agency may incorporate in the certificate of laser
registration at the time of issuance, or thereafter by amendment, additional
requirements and conditions with respect to the registrant's receipt, possession,
use, and transfer of lasers subject to this section as it deems appropriate
or necessary in order to:
(A)
minimize danger to occupational and public health and safety;
(B)
require additional reports and the keeping of additional
records as may be appropriate or necessary; and
(C)
prevent loss or theft of lasers subject to this section.
(3)
The agency may request, and the registrant shall provide,
additional information after the certificate of laser registration has been
issued to enable the agency to determine whether the certificate of laser
registration should be modified in accordance with subsection (n) of this
section.
(i)
Specific terms and conditions of certificates of laser
registration.
(1)
Each certificate of laser registration issued in accordance
with this section shall be subject to the applicable provisions of the Act,
now or hereafter in effect, and to the applicable rules in this chapter and
orders issued by the agency.
(2)
Each person registered by the agency for laser use in accordance
with this section shall confine use and possession of the laser registered
to the locations and purposes authorized in the certificate.
(3)
No certificate of laser registration issued or granted
under this section shall be transferred, assigned, or in any manner disposed
of, either voluntarily or involuntarily, to any person unless the agency authorizes
the transfer in writing.
(4)
In making a determination whether to grant, deny, amend,
renew, revoke, suspend, or restrict a certificate of laser registration, the
agency may consider the technical competence and compliance history of an
applicant or holder of a certificate of laser registration. After an opportunity
for a hearing, the agency shall deny an application for a certificate of laser
registration, an amendment to a certificate of laser registration, or renewal
of a certificate of laser registration if the applicant's compliance history
reveals that at least three agency actions have been issued against the applicant,
within the previous six years, that assess administrative or civil penalties
against the applicant, or that revoke or suspend the certificate of laser
registration.
(j)
Responsibilities of registrant.
(1)
The registrant shall notify the agency in writing within
30 days of a change in any of the following:
(A)
business name and mailing address;
(B)
street address where laser(s) will be used;
(C)
laser safety officer (LSO); or
(D)
name of facility contracted for "provider of services",
if applicable.
(2)
No person shall make, sell, lease, transfer, or lend lasers
unless such machines and equipment, when properly placed in operation and
used, meet the applicable requirements of this section.
(3)
Each registrant shall inventory all lasers in their possession
at an interval not to exceed one year. The inventory record shall be maintained
for inspection by the agency in accordance with subsection (ee) of this section
and shall include:
(A)
manufacturer's name;
(B)
model and serial number of the laser(s);
(C)
description of the laser(s) (for example, yag, silicon,
CO
2
, neon);
(D)
location of laser(s) (for example, room number); and
(E)
if using a provider of lasers in accordance with subsection
(d)(35) of this section, a statement with the inventory that the registrant
is using lasers provided by a provider of lasers.
(4)
Notification to the agency concerning laser inventory is
required within 30 days of the following:
(A)
any increase in the number of lasers authorized by the
certificate of laser registration; or
(B)
if the registrant begins or terminates the use of a provider
of lasers in accordance with subsection (d)(35) of this section.
(5)
No registrant shall engage any person for services described
in subsection (g)(6) of this section until such person provides to the registrant
evidence of registration with the agency.
(6)
The registrant is responsible for complying with this section
and the conditions of the certificate of laser registration.
(7)
Registrants with certificates of laser registration in
accordance with subsection (g)(7) of this section shall have the following
documents on site at each laser light show:
(A)
certificate of laser registration;
(B)
FDA variance with all applicable documents required by
the variance; and
(C)
instructions for the safe use of lasers in accordance with
subsection (r)(2) of this section.
(8)
Each registrant shall maintain records of receipt, transfer,
and disposal of lasers for inspection by the agency. The records shall include
the following information and shall be kept until disposal is authorized by
the agency:
(A)
manufacturer's name;
(B)
model and serial number from the laser;
(C)
date of the receipt, transfer, and disposal;
(D)
name and address of person laser(s) received from, transferred
to, or disposed of; and
(E)
name of the individual recording the information.
(k)
Expiration of certificates of laser registration and administrative
renewal.
(1)
Effective September 1, 2004, the term of the certificate
of registration is two years. Except as provided by subsection (m) of this
section, each certificate of laser registration expires at the end of the
day, in the month and year stated in the certificate of laser registration.
Upon payment of the fee required by §289.204 of this title and if the
agency does not deny the renewal in accordance with subsection (i)(4) of this
section, the certificate of registration will be administratively renewed.
(2)
If the fee is not paid and the certificate of laser registration
is not renewed in accordance with paragraph (1) of this subsection, the certificate
of laser registration expires, and the registrant is in violation of the requirements
of this chapter and is subject to administrative penalties in accordance with §289.205
of this title.
(A)
If the registrant pays the fee required by §289.204
of this title within 30 days after expiration of the certificate of laser
registration, the certificate of laser registration will be reinstated and
the registrant will not be required to file an application in accordance with
subsection (g) of this section.
(B)
If the registrant fails to pay the fee within 30 days after
expiration of the certificate of laser registration, the registrant shall
file an application in accordance with subsection (g) of this section.
(3)
If a registrant fails to pay the fee required by §289.204
of this title and the certificate of laser registration is not renewed, the
registrant shall:
(A)
terminate use of all lasers and/or terminate laser servicing
or laser services;
(B)
submit to the agency a record of the disposition of the
lasers, if applicable, and if, to whom it was transferred within 30 days following
the expiration date.
(4)
Expiration of the certificate of laser registration does
not relieve the registrant of the requirements of this chapter.
(l)
Termination of certificates of laser registration. When
a registrant decides to terminate all activities involving laser or laser
services authorized under the certificate of laser registration, the registrant
shall immediately do the following:
(1)
request termination of the certificate of laser registration
in writing;
(2)
submit to the agency a record of the disposition of the
radiation machines, if applicable; and if transferred, to whom it was transferred;
and
(3)
pay any outstanding fees in accordance with §289.204
of this title.
(m)
Technical renewal of certificate of laser registration.
(1)
If required by the certificate of laser registration, an
application for technical renewal of a certificate of laser registration shall
be filed in accordance with subsection (g)(1)(A)-(B), and (E)-(G) of this
section and applicable paragraphs of subsections (g)(2), (4), and (7) of this
section. Application for a technical renewal of a certificate of laser registration
shall be submitted to the agency by the date specified in the existing certificate
of laser registration. If the registrant fails to apply, or the agency does
not approve the application in accordance with subsection (h)(1) of this section,
the certificate of laser registration expires and the registrant is in violation
of the requirements of this chapter and is subject to administrative penalties
in accordance with §289.205 of this title. The registrant shall comply
with the requirements of subsection (k)(3) of this section.
(2)
Expiration of the certificate of registration does not
relieve the registrant of the requirements of this chapter.
(3)
If a registrant files an application for a technical renewal
in proper form before the existing certificate of laser registration expires,
such existing certificate of laser registration shall not expire until the
application status has been determined by the agency.
(n)
Modification, suspension, and revocation of certificates
of laser registration.
(1)
The terms and conditions of all certificates of laser registration
shall be subject to revision or modification.
(2)
Any certificate of laser registration may be revoked, suspended,
or modified, in whole or in part, for any of the following:
(A)
any material false statement in the application or any
statement of fact required under the provisions of the Act;
(B)
conditions revealed by such application or statement of
fact, or any report, record, or inspection, or other means that would warrant
the agency to refuse to grant a certificate of laser registration on an original
application;
(C)
violation of, or failure to observe any of the terms and
conditions of the Act, this chapter, or of the certificate of laser registration,
or order of the agency; or
(D)
existing conditions that constitute a substantial threat
to the public health or safety or the environment.
(3)
Each certificate of laser registration revoked by the agency
ends at the end of the day on the date of the agency's final determination
to revoke the certificate of laser registration, or on the revocation date
stated in the determination, or as otherwise provided by the agency order.
(4)
Except in cases in which the occupational and public health
or safety requires otherwise, no certificate of laser registration shall be
suspended, or revoked unless, prior to the institution of proceedings therefore,
facts or conduct that may warrant such action shall have been called to the
attention of the registrant in writing and the registrant shall have been
afforded an opportunity to demonstrate compliance with all lawful requirements.
(o)
Notifications. The following applies to voluntary or involuntary
petitions for bankruptcy.
(1)
Each registrant shall notify the agency, in writing, immediately
following the filing of a voluntary or involuntary petition for bankruptcy
by the registrant or its parent company. This notification shall include:
(A)
the bankruptcy court in which the petition for bankruptcy
was filed; and
(B)
the date of the filing of the petition.
(2)
A copy of the "petition for bankruptcy" shall be submitted
to the agency along with the written notification.
(p)
LSO qualifications. LSO qualifications shall be submitted
to the agency and shall include the following:
(1)
educational courses related to laser radiation safety or
a laser safety officer course; or
(2)
experience in the use and familiarity of the type of equipment
or services registered for; and
(3)
knowledge of potential laser radiation hazards and laser
emergency situations.
(q)
LSO duties. Specific duties of the LSO shall include, but
not be limited to the following:
(1)
ensuring that users of lasers are trained in laser safety,
as applicable for the class and type of lasers the individual uses;
(2)
assuming control and having the authority to institute
corrective actions including shutdown of operations when necessary in emergency
situations or unsafe conditions; and
(3)
specifying whether any changes in control measures are
required following:
(A)
any service and maintenance of lasers that may affect the
output power or operating characteristics; or
(B)
whenever deliberate modifications are made that could change
the laser class and affect the output power or operating characteristics.
(4)
ensuring maintenance and other practices required for safe
operation of the laser(s) are performed;
(5)
ensuring the proper use of protective eyewear and other
safety measures; and
(6)
ensuring compliance with the requirements in this section
and with any engineering or operational controls specified by the registrant.
(r)
Requirements for protection against laser and IPL device
radiation. These requirements are for lasers and IPL devices in their intended
mode of operation and include special requirements for service, testing, maintenance,
and modification. During some operations, certain engineering controls may
be inappropriate. In situations where an engineering control may be inappropriate,
for example, during medical procedures or surgery, the LSO shall specify alternate
controls to obtain equivalent safety protection.
(1)
MPE. Each registrant or user of any laser shall not permit
any individual to be exposed to levels of laser or collateral radiation higher
than are specified in ANSI Z136.1-2000, Safe Use of Lasers and Title 21, CFR,
Part 1040.10 respectively.
(2)
Personnel operating each laser shall be provided with written
instructions for safe use, including clear warnings and precautions to avoid
possible exposure to laser and collateral radiation in excess of the MPE,
as delineated in ANSI Z136.1-2000, Safe Use of Lasers and the collateral limits
listed in Title 21, CFR, Part 1040.10.
(3)
Engineering controls.
(A)
Protective housing.
(i)
Each laser shall have a protective housing that prevents
human access during the operation to laser and to collateral radiation that
exceeds the limits of Class 1 lasers as delineated in ANSI Z136.1-2000, Safe
Use of Lasers and Title 21, CFR, Part 1040.10, respectively, wherever and
whenever such human access is not necessary in order for the laser to perform
its intended function.
(ii)
Wherever and whenever human access to laser radiation
levels that exceed the limits of Class 1 is necessary, these levels shall
not exceed the limits of the lowest laser class necessary to perform the intended
function(s).
(B)
Safety interlocks.
(i)
A safety interlock, that shall ensure that radiation is
not accessible above MPE limits as delineated in ANSI Z136.1-2000, Safe Use
of Lasers, shall be provided for any portion of the protective housing that
by design can be removed or displaced without the use of tools during normal
operation or maintenance, and thereby allows access to radiation above the
MPE limits.
(ii)
Adjustment during operation, service, testing, or maintenance
of a laser containing interlocks shall not cause the interlocks to become
inoperative or the radiation to exceed MPE limits outside protective housing
except where a laser controlled area as specified in subparagraph (E) of this
paragraph is established.
(iii)
For pulsed lasers, interlocks shall be designed so as
to prevent firing of the laser; for example, by dumping the stored energy
into a dummy load.
(iv)
For continuous wave lasers, the interlocks shall turn
off the power supply or interrupt the beam; for example, by means of shutters.
(v)
An interlock shall not allow automatic accessibility of
radiation emission above MPE limits when the interlock is closed.
(vi)
Either multiple safety interlocks or a means to preclude
removal or displacement of the interlocked portion of the protective housing
upon interlock failure shall be provided, if failure of a single interlock
would allow the following:
(I)
human access to levels of laser radiation in excess of
the accessible emission limit of Class 3a laser radiation; or
(II)
laser radiation in excess of the accessible emission limits
of Class 2 to be emitted directly through the opening created by removal or
displacement of that portion of the protective housing.
(C)
Viewing optics and windows.
(i)
All viewing ports, viewing optics, or display screens included
as an integral part of an enclosed laser or laser product shall incorporate
suitable means, (such as interlocks, filters, or attenuators, to maintain
the laser radiation at the viewing position at or below the applicable MPE
as delineated in ANSI Z136.1-2000, Safe Use of Lasers and the collateral limits
listed in Title 21, CFR, Part 1040.10, under any conditions of operation of
the laser.
(ii)
All collecting optics, such as lenses, telescopes, microscopes,
endoscopes, etc., intended for viewing use with a laser shall incorporate
suitable means, such as interlocks, filters, or attenuators, to maintain the
laser radiation transmitted through the collecting optics to levels at or
below the appropriate MPE, as delineated in ANSI Z136.1-2000, Safe Use of
Lasers. Normal or prescription eyewear is not considered collecting optics.
(D)
Warning systems. Each Class 3b or 4 laser or laser product
shall provide visual or audible indication during the emission of accessible
laser radiation. In the case of Class 3b lasers, except those that allow access
only to less than 5 milliwatt (mW) peak visible laser radiation, and Class
4 lasers, this indication shall be sufficient prior to emission of such radiation
to allow appropriate action to avoid exposure. Any visual indicator shall
be clearly visible through protective eyewear designed specifically for the
wavelength(s) of the emitted laser radiation. If the laser and laser energy
source are housed separately and can be operated at a separation distance
of greater than two meters, both laser and laser energy source shall incorporate
visual or audible indicators. The visual indicators shall be positioned so
that viewing does not require human access to laser radiation in excess of
the MPE, as delineated in ANSI Z136.1-2000, Safe Use of Lasers.
(E)
Controlled area. With a Class 3b laser, except those that
allow access only to less than 5 mW visible peak power, or Class 4 laser,
a controlled area shall be established when exposure to the laser radiation
in excess of the MPE, as delineated in ANSI Z136.1-2000, Safe Use of Lasers
or the collateral limits listed in Title 21, CFR, Part 1040.10 is possible.
The controlled area shall meet the following requirements, as applicable.
(i)
The area shall be posted as required by subsection (v)
of this section.
(ii)
Access to the controlled area shall be restricted.
(iii)
For Class 4 indoor controlled areas, latches, interlocks,
or other appropriate means shall be used to prevent unauthorized entry into
controlled areas.
(I)
Such measures shall be designed to allow rapid egress by
the laser personnel at all times and admittance to the controlled area in
an emergency condition. For such emergency conditions, a control-disconnect
switch or equivalent device (panic button) shall be available for deactivating
the laser.
(II)
Where safety latches or interlocks are not feasible or
are inappropriate, for example during medical procedures, such as surgery,
the following shall apply.
(-a-)
All authorized personnel shall be trained in laser safety
and appropriate personal protective equipment shall be provided upon entry.
(-b-)
A door, blocking barrier, screen, or curtains shall be
used to block, screen, or attenuate the laser radiation at the entryway. The
level at the exterior of these devices shall not exceed the applicable MPE,
as delineated in ANSI Z136.1-2000, Safe Use of Lasers, nor shall personnel
experience any exposure above the MPE immediately upon entry.
(-c-)
At the entryway there shall be a visible or audible signal
indicating that the laser is energized and operating at Class 4 levels. A
lighted laser warning sign, flashing light (visible through laser protective
eyewear), and other appropriate signage are some of the methods to accomplish
this requirement. Alternatively, an entryway warning light assembly may be
interfaced to the laser in such a manner that one light will indicate when
the laser is not operational (high voltage off) and by an additional light
when the laser is powered up (high voltage applied, but no laser emission)
and by an additional (flashing optional) light that activates when the laser
is operating.
(iv)
For Class 4 indoor controlled areas, during tests requiring
continuous operation, the individual in charge of the controlled area shall
be permitted to momentarily override the safety interlocks to allow access
to other authorized personnel if it is clearly evident that there is no optical
radiation hazard at the point of entry, and if the necessary protective devices
are being worn by the entering personnel.
(v)
For Class 4 indoor controlled areas, optical paths (for
example, windows) from an indoor facility shall be controlled in such a manner
as to reduce the transmitted values of the laser radiation to levels at or
below the appropriate ocular MPE, as delineated in ANSI Z136.1-2000, Safe
Use of Lasers and the collateral limits listed in Title 21, CFR, Part 1040.10.
(When the laser beam must exit the indoor controlled area (as in the case
of exterior atmospheric beam paths), the operator shall be responsible for
ensuring that air traffic is protected from any laser projecting into navigable
air space (contact Federal Aviation Administration (FAA) or other appropriate
agencies, as necessary) or controlled ground space when the beam irradiance
or radiant exposure is above the appropriate MPE, as delineated in ANSI Z136.1-2000,
Safe Use of Lasers.
(vi)
When the removal of panels or protective covers and/or
overriding of interlocks becomes necessary, such as for servicing, testing,
or maintenance, and accessible laser radiation exceeds the MPE, as delineated
in ANSI Z136.1-2000, Safe Use of Lasers and the collateral limits listed in
Title 21, CFR, Part 1040.10, a temporary controlled area shall be established
and posted.
(4)
Key control. Each laser and IPL device shall incorporate
a key-actuated or computer-actuated password master control. The key shall
be removable and the laser or IPL device shall not be operable when the key
is removed. When not being prepared for operation or is unattended, the key
will be removed from the device and stored in a location away from the machine.
(s)
Additional requirements for special lasers and applications.
(1)
Infrared laser. The beam from a laser shall be terminated
in fire-resistant material where necessary. Inspection intervals of absorbent
material and actions to be taken in the event or evidence of degradation shall
be specified in the operating and safety procedures.
(2)
Laser optical fiber transmission system.
(A)
Laser transmission systems that employ optical cables shall
be considered enclosed systems with the optical cable forming part of the
protective housing.
(B)
Disconnection of a connector resulting in access to radiation
in excess of the applicable MPE limits, as delineated in ANSI Z136.1-2000,
Safe Use of Lasers and the collateral limits listed in Title 21, CFR, Part
1040.10, shall take place in a controlled area. Except for medical lasers
whose manufacture has been approved by the FDA, the use of a tool shall be
required for the disconnection of a connector for service and maintenance
purposes when the connector is not within a secured enclosure. All connectors
shall bear the appropriate label or tag specified in subsection (v)(3) of
this section.
(t)
Additional requirements for safe operation.
(1)
Eye protection. Protective eyewear shall be worn by all
individuals with access to Class 3b and/or Class 4 levels of laser radiation.
Protective eyewear devices shall meet the following requirements:
(A)
provide a comfortable and appropriate fit all around the
area of the eye;
(B)
be in proper condition to ensure the optical filter(s)
and holder provide the required optical density or greater at the desired
wavelengths, and retain all protective properties during its use;
(C)
be suitable for the specific wavelength of the laser and
be of optical density adequate for the energy involved;
(D)
have the optical density or densities and associated wavelength(s)
permanently labeled on the filters or eyewear; and
(E)
be examined, at intervals not to exceed six months, to
ensure the reliability of the protective filters and integrity of the protective
filter frames. Unreliable eyewear shall be discarded.
(2)
Skin protection. When there is a possibility of exposure
to laser radiation that exceeds the MPE limits for skin as specified in ANSI
Z136.1-2000 Safe Use of Lasers, the registrant shall require the appropriate
use of protective gloves, clothing, or shields.
(u)
NHZ. Where applicable, in the presence of unenclosed Class
3b and Class 4 laser beam paths, an NHZ shall be established. If the beam
of an unenclosed Class 3b and Class 4 laser is contained within a region by
adequate control measures to protect personnel from exposure to levels of
radiation above the appropriate MPE, as delineated in ANSI Z136.1-2000, Safe
Use of Lasers, that region may be considered to be the NHZ. The NHZ may be
determined by information supplied by the laser manufacturer, by measurement,
or by using the appropriate laser range equation or other equivalent assessment.
(v)
Caution signs, labels, and posting for lasers and IPL devices.
(1)
General requirements. Except as otherwise authorized by
the agency, signs, symbols, and labels prescribed by this section shall use
the design and colors specified in subsection (dd) of this section.
(2)
Posting. The laser controlled area shall be conspicuously
posted with a sign or signs as specified in paragraph (3) of this subsection
and subsection (dd) of this section.
(3)
Labeling lasers and posting laser facilities. All signs
and labels associated with Class 2, 3a, 3b, and 4 lasers shall contain the
following wording.
(A)
The signal word "CAUTION" shall be used with all signs
and labels associated with all Class 2 lasers and all Class 3a lasers that
do not exceed the appropriate MPE, as designated in ANSI Z136.1-2000, Safe
Use of Lasers. This signal word is used in accordance with the sign in subsection
(dd)(1) of this section.
(B)
The signal word "DANGER" shall be used with all Class 3a
lasers that exceed the appropriate MPE, as designated in ANSI Z136.1-2000,
Safe Use of Lasers, and all Class 3b and 4 lasers. This signal word is used
in accordance with the sign in subsection (dd)(2) of this section.
(C)
Position 1 in the signs in subsection (dd)(1) and (dd)(2)
of this section shall contain the following information, as applicable:
(i)
for all Class 2 lasers, the words "LASER RADIATION - DO
NOT STARE INTO BEAM";
(ii)
for Class 3a lasers that do not exceed the appropriate
MPE, as designated in ANSI Z136.1-2000, Safe Use of Lasers, the words "LASER
RADIATION - DO NOT STARE INTO BEAM OR VIEW DIRECTLY WITH OPTICAL INSTRUMENTS";
(iii)
for all other Class 3a lasers, the words "LASER RADIATION
- AVOID DIRECT EYE EXPOSURE";
(iv)
for all Class 3b lasers, the words "LASER RADIATION -
AVOID DIRECT EYE EXPOSURE"; or
(v)
for Class 4 lasers, the words "LASER RADIATION - AVOID
EYE or SKIN EXPOSURE to DIRECT or SCATTERED RADIATION".
(D)
Positions 2 and 3 in the signs in subsections (dd)(1) and
(2) of this section shall contain the following information, as applicable.
(i)
Position 2 shall contain the type of laser or the emitted
wavelength, pulse duration (if appropriate), or maximum output.
(ii)
Position 3 shall contain the class of laser.
(E)
Lasers, except lasers used in the practice of medicine,
shall have a label(s) in close proximity to each aperture through which is
emitted accessible laser or collateral radiation in excess of the limits specified
in ANSI Z136.1-2000, Safe Use of Lasers and the collateral limits listed in
Title 21, CFR, Part 1040.10, with the following wording as applicable.
(i)
"AVOID EXPOSURE - Laser radiation is emitted from this
aperture," if the radiation emitted through such aperture is laser radiation.
(ii)
"AVOID EXPOSURE - Hazardous electromagnetic radiation
is emitted from this aperture," if the radiation emitted through such aperture
is collateral radiation.
(iii)
"AVOID EXPOSURE - Hazardous x-rays are emitted from this
aperture," if the radiation emitted through such aperture is collateral x-ray
radiation.
(F)
Each noninterlocked or defeatably interlocked portion of
the protective housing or enclosure that is designed to be displaced or removed
during normal operation or servicing, and that would permit human access to
laser or collateral radiation, shall have labels as follows:
(i)
for Class 3b accessible laser radiation the wording, "DANGER
- LASER RADIATION WHEN OPEN. AVOID DIRECT EXPOSURE TO BEAM";
(ii)
for Class 4 accessible laser radiation the wording, "DANGER
- LASER RADIATION WHEN OPEN. AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED
RADIATION"; or
(iii)
for collateral radiation in excess of the emission limits
as described in Title 21, CFR, Part 1040.10, "CAUTION - HAZARDOUS ELECTROMAGNETIC
RADIATION WHEN OPEN" and "CAUTION - HAZARDOUS X-RAY RADIATION" as applicable.
(G)
For protective housing or enclosures that provide a defeatable
interlock, the words "and interlock defeated" shall be included in the labels
specified in subparagraph (F)(i) and (ii) of this paragraph.
(H)
Other required information.
(i)
The word "invisible" shall immediately precede the word
"radiation" on labels and signs required by this subparagraph for wavelengths
of laser and collateral radiation that are outside of the range of 400 to
700 nm.
(ii)
The words "visible and invisible" shall immediately precede
the word "radiation" on labels and signs required by this subparagraph for
wavelengths of laser and collateral radiation that are both within and outside
the range of 400 to 700 nm.
(I)
Labels required by this subparagraph shall be clearly visible,
legible, and permanently attached to the laser or facility. Signs required
by this subparagraph shall be clearly visible, legible, and securely attached
to the facility.
(w)
Surveys. Each registrant shall make or cause to be made
such surveys as may be necessary to comply with this section. Surveys shall
be performed at intervals not to exceed 12 months, to include but not be limited
to the following:
(1)
a determination that all laser and IPL protective devices
are labeled correctly, functioning within the design specifications, and properly
chosen for lasers and IPL devices in use;
(2)
a determination that all warning devices are functioning
within their design specifications;
(3)
a determination that the controlled area is properly controlled
and posted with accurate warning signs in accordance with subsection (v) of
this section;
(4)
a re-evaluation of potential hazards from surfaces that
may be associated with beam paths; and
(5)
additional surveys that may be required to evaluate the
primary and collateral radiation hazard incident to the use of lasers and
IPL devices.
(x)
Records/documents. Each registrant shall maintain current
records/documents in accordance with subsection (ee) of this section.
(y)
Measurements and instrumentation. Each determination requiring
a measurement for compliance with this section shall use instrumentation that
is calibrated and designed for use with the laser or IPL device that is to
be tested.
(z)
Notification of injury other than a medical event.
(1)
Each registrant or user of an IPL device shall immediately
seek appropriate medical attention for the individual and notify the agency
by telephone of any injury involving a laser possessed by the registrant or
an IPL device, other than intentional exposure of patients for medical purposes,
that has or may have caused:
(A)
an injury to an individual that involves the partial or
total loss of sight in either eye; or
(B)
an injury to an individual that involves intentional perforation
of the skin or other serious injury exclusive of eye injury.
(2)
Each registrant or user of an IPL device shall, within
24 hours of discovery of an injury, report to the agency each injury involving
any laser possessed by the registrant or IPL device possessed by a user, as
applicable, other than intentional exposure of patients for medical purposes,
that may have caused, or threatens to cause, an exposure to an individual
with second or third-degree burns to the skin or potential injury and partial
loss of sight.
(aa)
Reports of injuries.
(1)
Each registrant or user of an IPL device shall make a report
in writing, or by electronic transmittal, within 30 days to the agency of
any injury required to be reported in accordance with subsection (z) of this
section.
(2)
Each report shall describe the following:
(A)
the extent of injury to individuals from radiation from
lasers or IPL devices;
(B)
power output of laser or IPL device involved;
(C)
the cause of the injury; and
(D)
corrective steps taken or planned to be taken to prevent
a recurrence.
(3)
Any report filed with the agency in accordance with this
subsection shall include the full name of each individual injured and a description
of the injury. The report shall be prepared so that this information is stated
in a separate part of the report.
(4)
When a registrant or user of an IPL device is required
in accordance with paragraphs (1)-(3) of this subsection to report to the
agency any injury of an individual from radiation from lasers or IPL devices,
the registrant or user of an IPL device shall also notify the individual.
Such notice shall be transmitted to the individual at a time not later than
the transmittal to the agency.
(bb)
Medical event.
(1)
The registrant or user of an IPL device shall notify the
agency, by telephone or electronic transmittal, within 24 hours of any injury
to or death of a patient. Within 30 days after a 24 hour notification is made,
the registrant or user of an IPL device shall submit a written report to the
agency of the event.
(2)
The written report shall include the following:
(A)
the registrant's or user's name;
(B)
a brief description of the event;
(C)
the effect on the patient;
(D)
the action taken to prevent recurrence; and
(E)
whether the registrant or user informed the patient or
the patient's responsible relative or guardian.
(3)
When a medical event occurs, the registrant or user shall
promptly investigate its cause, make a record for agency review, and retain
the records as stated in subsection (ee) of this section.
(cc)
Reports of stolen, lost, or missing lasers and IPL devices.
(1)
Each person shall report to the agency by telephone a stolen,
lost, or missing laser or IPL device within 24 hours after its occurrence
becomes known to the registrant or IPL device user.
(2)
Each person required to make a report in accordance with
paragraph (1) of this subsection shall, within 30 days after making the telephone
report, make a written report to the agency that includes the following information:
(A)
a description of the laser or IPL device involved, including
the manufacturer, model, serial number, and class;
(B)
a description of the circumstances under which the loss
or theft occurred;
(C)
a statement of disposition, or probable disposition, of
the laser or IPL device involved;
(D)
actions that have been taken, or will be taken, to recover
the laser or IPL device; and
(E)
procedures or measures that have been taken to prevent
a recurrence of the loss or theft of lasers or IPL devices.
(dd)
Caution and danger signs. The following contains signs
required in accordance with subsection (v)(3) of this section.
(1)
This sign shall be used with all Class 2 lasers and Class
3a lasers that do not exceed the appropriate MPE, as designated in ANSI Z.136-2000,
Safe Use of Lasers.
Figure: 25 TAC §289.301(dd)(1)
(2)
This sign shall be used with all Class 3a lasers that exceed
the appropriate MPE, as designated in ANSI Z.136-2000, Safe Use of Lasers,
and all Class 3b and Class 4 lasers.
Figure: 25 TAC §289.301(dd)(2)
(ee)
Keeping records/documents. The following chart contains
time requirements for keeping records/documents:
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on March 15, 2004.
TRD-200401950
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 458-7236
Galactosemia
]--An inherited condition, which if not treated,
may cause fatal infection or mental retardation.
galactosemia
];
Chapter 38.
CHILDREN WITH SPECIAL HEALTH CARE NEEDS SERVICES PROGRAM
95
] days of
the last
denial
of and/or adjustment to the original claim
. If the results of the reconsideration
process are unsatisfactory, denied claims may be appealed according to §38.13
of this title (relating to Right of Appeal).
95-day
] claim receipt
or correction and resubmission
deadlines. The CSHCN Division Director
or his/her designee(s) will consider a provider's request for an exception
to the [
95-day
] claim receipt
or correction and resubmission
deadlines provided in paragraphs (1) and (2) of this section, if the
delay in claim receipt
or correction and resubmission
is due to
one of the following reasons:
Chapter 61.
CHRONIC DISEASES
through
] a participating
outpatient dialysis facility or hospital
[
facility
] and has
not received a final determination of eligibility. This includes an individual
whose application is submitted by a representative or person with legal authority
to act for the individual.
(7)
] Commissioner--The commissioner
of the Texas Department of Health.
(8)
] Co-pay [
liability
]--The
portion of the allowable amount for which a KHC recipient is responsible.
(9)
] Covered services--Drugs, transportation,
pharmaceutical products, medical care, treatment, services or equipment which
have been approved by KHC for payment.
(10)
] Department--The Texas Department
of Health.
(11)
] End-Stage Renal Disease (ESRD)--The
final stage of renal impairment which is
usually
irreversible and
permanent and requires dialysis and/or kidney transplant to reduce uremic
symptoms and/or prevent the death of the patient.
(12)
] EOB--A form, in paper or
electronic format, which provides an explanation of benefits. It is used to
explain a payment or denial of a claim.
(13)
] Fair hearing--The informal
hearing process the department follows under
§§1.51 - 1.55
[
§61.11
] of this title (relating to [
Notice and
] Fair Hearing
Procedures
).
(14)
] Final decision--A decision
that is
made
[
reached
] by a decision maker after conducting
a fair hearing under
§§1.51 - 1.55 of
this title
(relating to Fair Hearing Procedures)
.
(15)
] HCFA--
The
[
Stands for the
] Health Care Financing Administration
, now known
as the Centers for Medicare and Medicaid Services
.
(16)
] Interim approval--The
status
[
approval
] given by KHC to
an outpatient dialysis
facility, free standing or hospital based,
[
a facility
] which
has applied for participation as a KHC
provider
[
facility
] but has not executed a
contract/agreement
[
contract
] with KHC.
(17)
] KHC--
The
[
Stands for the
] Kidney Health Care program.
(18)
] Medical benefits--Any
inpatient or outpatient
medical treatment or procedure approved by KHC
as a covered service.
(19)
] Participating
provider
[
facility
]--Any
individual or entity with KHC approval
to furnish covered services to KHC recipients
[
KHC approved or
interim approved facility
] including:
with whom KHC has
contracted
];
with
whom KHC has contracted
];
(C)
home health agencies with
whom KHC has contracted;]
(D)
hospitals located and licensed
in Texas that are:]
(i)
approved by Medicare; and]
(ii)
an approved Texas Medicaid provider;]
(E)
out-of-state hospitals that are:
]
(i)
approved by Medicare; and
]
(ii)
an approved Texas Medicaid provider;
]
(F)
] military or Veterans Administration
hospitals located in Texas which have a renal unit approved by the Joint Commission
on Accreditation of Healthcare Organizations (JCAHO) or the American Osteopathic
Association (AOA)
;
[
.
]
(20)
Participating pharmacy--Any
KHC and Texas Medicaid Vendor Drug Program approved pharmacy licensed to operate
within the United States and its territories, including mail order pharmacies.]
(21)
Provider--Any individual
or entity with KHC approval to furnish covered services to KHC recipients.]
(22)
] Recipient--An individual
who is eligible to receive KHC benefits.
(23)
Reconsideration--The administrative
review process KHC follows under this chapter.]
(24)
] Suspended benefits--Eligibility
for benefits or claims which are denied and/or held pending satisfaction of
a KHC request or requirement.
(25)
] TDCI--
The
[
Stands for the
] Texas Drug Code Index. This [
microfiche
]
list of drugs by National Drug Code includes drugs and drug products approved
by the department for payment as a benefit of KHC. Not all drugs listed on
the TDCI are covered by KHC; however, all drugs covered by KHC are included
on the TDCI.
(26)
] VDP--
The
[
Stands for the
] Texas Medicaid Vendor Drug Program.
(C)
a Medicaid-eligible nursing
home recipient; or]
(D)
a Medicaid recipient under
the age of 21;]
an adjusted
] gross income [
(AGI)
] of less than $60,000. Income reported as "joint income" is considered
as one income [
and may not be divided in computing the recipient's co-pay
liability
]. The person or persons who have a legal obligation to support
the recipient will be determined by the applicable state law.
recipient
may have all
] KHC benefits
may be
[
modified, suspended
or
] terminated for any of the following reasons:
and co-pay liability
];
(5)
failure to inform KHC within
30 days of changes in the following:]
(A)
permanent home address;]
(B)
treatment status;]
(C)
insurance coverage;]
(D)
location of treatment;]
(E)
the round trip mileage from the recipient's
permanent home address to the location of treatment; or]
(F)
changes in income or financial qualifications
which would affect either the recipient's eligibility or co-pay liability;]
(6)
] recipient is incarcerated in
a city, county, state, or federal jail, or prison;
(7)
] recipient regains kidney function
;
[
or voluntarily stops treatment for ESRD;
]
(9)
] KHC determines that the recipient
has made a material misstatement or misrepresentation on their application
or any document required to support their application;
(10)
] KHC determines that the recipient
has submitted false claim(s); or
(11)
] KHC has not paid a claim
for benefits on behalf of the recipient
for a minimum
[
during
any
] period of 12 consecutive months.
(c)
] Any action taken under subsection
(b)
or (c)
of this section does not release the recipient, or the
person(s) with legal obligation to support the recipient, of any financial
obligation owed to KHC.
(d)
A recipient may have a portion
of their KHC benefits modified, suspended or terminated, or claim(s) denied
for any of the following reasons:]
(1)
failure to receive services through participating
facilities, pharmacies, and providers;]
(2)
failure to submit claims for reimbursement
within filing deadlines, as specified in §61.8 of this title (relating
to Claim Filing Deadlines);]
(3)
failure to apply for benefits under Title XVIII,
Social Security Act (Medicare);]
(4)
failure to continue premium payments on health
insurance plans under Medicare, individual or group health insurance plans
and prepaid medical plans, where eligibility was effective prior to KHC eligibility;
or]
(5)
failure to provide authorization for Medicare
premium payments by KHC as specified in §61.6 of this title (relating
to Limitations and Benefits Provided); if not eligible for Medicare premium-free
hospitalization.]
and requalify
] for KHC benefits when eligibility for KHC benefits
is terminated.
,
]
or
suspended
,
or
whose eligibility is
terminated,
[
or whose claim(s) are denied,
] may appeal KHC's decision under
the procedure contained in
§§1.51 - 1.55
[
§61.10
] of this title relating to
Fair Hearing Procedures).
[
Notice of Intent to Take Action and Reconsideration) and §61.11 of this
title (relating to Notice and Fair Hearing).
]
reconsideration and
] fair hearings
process, if a [
reconsideration or
] hearing is requested by the
recipient.
reconsideration and
] fair hearings process.
(d)
All documents submitted to establish the
residency of an applicant shall be in English or, if required by KHC, accompanied
by an accurate English translation.
]
(1)
An applicant who is currently a Texas
resident and has been currently approved to receive Texas Medicaid benefits
is not required to provide additional residency verification.
]
(2)
] An applicant, or person establishing
residency for the applicant under subsections (b) and (c) of this section,
may submit
a copy
[
copies
] of any
one
[
two
] of the following documents as evidence of residency. All documents
shall be in the applicant's name, or in the name of the person establishing
residency for the applicant, [
and
] provide some verification of
a Texas address or domicile
,
[
.
]
and be in English
or, if required by KHC, accompanied by an accurate English translation.
[
Each of the following documents listed may only be counted once:
]
(A)
] a valid Texas driver's license,
or an identification card issued by the Texas Department of Public Safety;
(B)
] a valid Texas voter's registration
card, or a copy of a validated (at the county clerk's office) application
for a voter's registration card;
(C)
] a current Texas motor vehicle
registration or automobile license plate registration renewal form;
(D)
] a mortgage payment receipt
from any of the three months immediately preceding the date of the application;
(E)
] a rent payment receipt from
any of the three months immediately preceding the date of the application;
(F)
] a
written
[
notarized
] statement reflecting that the applicant is currently receiving
rent-free housing. The statement must be
from any of the three months
immediately preceding the date of the application, must be
signed by
the individual providing the rent-free housing and must include the address
and phone number of the individual providing the rent-free housing;
(G)
] a utility
bill or
payment
receipt from any of the three months immediately preceding the date of the
application;
(H)
] a Texas property tax receipt
for the most recently completed tax year;
(I)
] a payroll or retirement check
dated within the three months immediately preceding the date of the application;
(J)
] employment/unemployment records
prepared within the three months immediately preceding the date of the application;
(K)
] a statement from a financial
institution issued within the three months immediately preceding the date
of the application; or
(L)
] social security supplemental
income or disability income records or social security retirement benefit
records issued within the three months immediately preceding the date of application.
,
] of this title (relating to Recipient
Requirements) must make an application for benefits through a Kidney Health
Care (KHC) participating
outpatient dialysis
facility
or hospital
.
or Medicaid
] card,
if the Medicare account was established in the applicant's own social security
number and the social security number is printed on the Medicare [
or
Medicaid
] card.
An adult applicant who is currently a Texas Medicaid recipient is not
required to provide financial data.
] Changes in income or financial
qualifications which would affect the applicant's eligibility shall be reported
to KHC. The applicant may attach any of the following documents to verify
income:
later of:
]
(A)
30 days prior to the date
KHC receives a complete application;]
(B)
the date the applicant is
no longer considered a ward of the state;]
(C)
the date the applicant is
no longer incarcerated in a city, county, state, or federal jail, or prison;]
(D)
the date the applicant received
the first chronic dialysis treatment or hospitalization for transplant surgery
as reflected on the HCFA 2728; or]
(E)
the date the applicant established
Texas residency.]
(4)
Eligibility date for reinstatement
of KHC benefits. If KHC benefits are terminated, the eligibility date for
any subsequent benefit period will be the date on which KHC receives a subsequent
completed application for KHC benefits.]
hospitalization,
] surgeon's fees, assistant
surgeon's fees,
anesthesiologist's
[
anesthesiologist'
]
fees, Certified Registered Nurse
Anesthetist's
[
Anesthetist
] fees);
(C)
shall sign a Medicare agreement
which allows KHC to make Medicare premium payments in their behalf; and]
(D)
] shall promptly submit all Medicare
premium due notice statements to KHC for payment.
facility
]; and
(3)
any contract between the department
and the recipient's participating facility;]
(4)
] a
contract/agreement
[
contract
] between the department and the recipient's participating provider;
(5)
] the reimbursement rates established
by the department;
(6)
] any co-pay
KHC may apply
to client service benefits;
[
liability rates as established by
the department;
] and
(7)
] any third-party liability.
(d)
Recipients who are eligible
for transportation benefits under the Medicaid Transportation Program (MTP),
including those on suspended status under MTP, are not eligible to receive
KHC transportation benefits.]
non-Medicaid
] eligible recipients who have applied
for and have been denied Medicare coverage based on
end-stage renal disease
(ESRD)
[
ESRD
]. Recipients shall submit a copy of an official
Social Security Administration Medicare denial notification (based on chronic
renal disease) to the department. Transplant patients who have been successfully
transplanted for three years or more are not eligible for limited medical
benefits.
Medicaid,
] the Veterans Administration, the military,
or other government programs
which cover the treatment of ESRD
are
not eligible to receive KHC medical benefits.
may be
] eligible for KHC medical benefits. [
If
the recipient's third party coverage has a liability equal to or greater than
the KHC allowable rates, KHC will not be liable for payment.
]
end-stage renal disease (ESRD)
] patients because of conflicting state or federal laws or regulations,
under the Texas Health and Safety Code, Chapter 42, §42.009.
(l)
The department may restrict
or categorize covered services to meet budgetary limitations. Categories will
be prioritized based upon medical necessity, other third party eligibility
and projected third party payments for the different treatment modalities,
caseloads, and demands for services. Caseloads and demands for services may
be based on current and/or projected data. In the event covered services must
be reduced, they will be reduced in a manner that takes into consideration
medical necessity and other third party coverage. The department may change
covered services by adding or deleting specific services, entire categories
or by making changes proportionally across a category or categories, or by
a combination of these methods.]
through the VDP electronic
claims management system
], except when VDP allows or requires paper
submissions.
Recipients who are not eligible for transportation benefits under the Medicaid
Medical Transportation Program (MTP) shall submit claims to KHC for transportation
reimbursement.
]
(e)
Claims for medical benefits
which are submitted for third party payment and the third party payor has
denied the claim without written explanation shall be submitted to KHC with
the following information:]
(1)
written explanation by the provider or recipient
of the reason for the denial;]
(2)
coverage termination dates, if applicable;
and]
(3)
the name and phone number of the third party
payor's representative providing the information.]
paid
]
until they are completed or corrected. Claims which are not received by KHC
within the deadlines established in this section
will be denied
[
shall not be considered for
] payment.
Hospital claims
] for in-patient
hospital
services, other than access surgery, shall be received by KHC
the later of:
contracted facilities
] shall be received by KHC
the later of:
contract
] approval letter for newly
approved participating providers
[
contracted facilities
], but not later than 180 days from
the date of service.
(d)
Claims for physician services,
other than access surgery, shall be received by KHC the later of:]
(1)
95 days from the last day of the month in which
services were provided;]
(2)
60 days from the date on the third party EOB,
but not later than 180 days from the date of service; or]
(3)
60 days from the date on the KHC notice of
eligibility.]
(f)
Claims for access surgery
charges shall be received by KHC the later of:]
(1)
95 days from the last day of the month in which
services were provided;]
(2)
60 days from the date on the third party EOB,
but not later than 180 days from the recipient's KHC eligibility effective
date; or]
(3)
60 days from the date on the KHC notice of
eligibility.]
(g)
] Claims for drug charges shall
be submitted to the Vendor Drug Program (VDP) in accordance with VDP drug
claim filing deadlines.
(h)
] Resubmitted claims, other than
drug claims, shall be received by KHC within the deadlines established under
subsections (b), (c), (d),
and
(e) [
, and (f)
] of this
section, or within
30
[
180
] days from the date of the
KHC return letter or KHC EOB, whichever is later. Resubmitted claims shall:
Facilities, Participating Pharmacies, and ] Providers.
and licensed Class
B home health agencies
] shall execute a
contract/agreement
[
contract
] with KHC, and shall meet the following criteria:
facility
], as a Texas Medicaid provider, as a Medicare
certified ESRD facility, or as a licensed Texas ESRD facility.
contract
] with an outpatient dialysis facility located in another state
if the out-of-state facility meets all the requirements of paragraph (1)(A),
(B), and (D) of this subsection, and is licensed by their respective state,
if applicable. Outpatient dialysis facilities located in another state may
not currently be on suspension as a KHC participating facility, as a Medicaid
provider in Texas or their respective state, as a Medicare certified ESRD
facility, or by the ESRD licensing authority of their applicable state.
(3)
Outpatient dialysis facilities
or home health agencies with interim approval for Medicare participation will
qualify for interim approval by KHC. Facility claims will not be paid by KHC
until the facility receives final Medicare certification and a KHC contract
is executed. Recipient applications for KHC eligibility may be submitted by
the facility during the period of interim approval. Interim approval will
last no longer than six months from the date of the initial KHC contact. If
interim approval lapses before a KHC contract is executed, the interim approval
will be terminated and claims submitted will not be paid.]
(A)
be associated with a contracted
out-of-state facility;]
(B)
]
if a physician,
be
licensed to practice medicine in the state in which services are [
to
be
] provided
, or if a CRNA, be certified to practice within the
scope of their certification in the state in which services are provided
;
(C)
] be a current Texas Medicaid
provider;
(D)
] not currently be on suspension
as a KHC participating provider, as a physician licensed to practice medicine
in the state in which services are to be provided,
as a CRNA certified
to practice within the scope of their certification in the state in which
services are provided,
or as a Medicaid provider in Texas or their respective
state; and
(E)
] reimburse KHC for any overpayments
made to the physician
or CRNA
by KHC upon request. KHC may withhold
payment on claims submitted by the physician
or CRNA
to recoup
any overpayments.
licensed
] to provide hospital
or ASC
services in the State
of Texas;
to be
] provided,
as an ASC licensed to provide
ASC services in the state in which services are to be provided,
as a
Medicaid provider in Texas or their respective state, or as a Medicare certified
hospital; and
or home health care agency contracts
]
shall be on or after the Medicare ESRD certification date.
facility, participating pharmacy,
or
] provider may be terminated or suspended for:
or
]
(F)
] failure to maintain the participation
criteria contained in subsection (a) of this section.
facility, participating pharmacy,
or
] provider may appeal a termination or suspension through the department's
[
reconsideration and
] fair hearings process, as contained in
§§1.51 - 1.55 of this title (relating to Fair Hearing Procedures).
[
§61.10 of this title (relating to Notice of Intent to Take
Action and Reconsideration) and §61.11 of this title (relating to Notice
and Fair Hearing).
]
reconsideration and
] fair hearings
process.
reconsideration and
] fair hearings process.
facility, participating pharmacy, or
] provider.
facility, participating pharmacy, or
] provider until a final decision is rendered under the department's
[
reconsideration and
] fair hearings process.
facility, participating pharmacy,
or
] provider may not appeal a termination of a
contract/agreement
[
contract
] which results from limitations in appropriations
or funding for covered services or benefits or which terminates under its
own terms.
which have been developed
] by
the Texas Department of Health (department) for use in the Bureau of Kidney
Health Care (KHC) will be provided to applicants [
, participating facilities,
] and
participating
providers, as necessary.
particular
]
individuals.
;
]
and
45 Code of Federal Regulations Part 80
,
so
that no person will be excluded for participation in, be denied benefits,
or otherwise subjected to discrimination on the grounds of race, color, [
or
] national origin, sex, creed, handicap or age.
Chapter 123.
RESPIRATORY CARE PRACTITIONER CERTIFICATION
renewal fee--$45;
]
(C)
] certificate and/or identification
card replacement fee--$20;
(D)
] NBRC examination fee--the fee
designated by the NBRC at the time of examination or reexamination;
(E)
] certificate fee for upgrade
of temporary permit--$30;
(F)
] written verification of certification
status--$10;
(G)
] returned check fee--$50;
(H)
continuing education extension
fee--$30.; and]
.
]
An applicant whose check for the application fee is returned due to insufficient
funds, account closed, or payment stopped shall be allowed to reinstate the
application by remitting to the department a money order or check for guaranteed
funds in the amount of the application fee plus the returned check fee within
30 days of the date of receipt of the department's notice. An application
will be considered incomplete until the fee has been received and cleared
through the appropriate financial institution.
]
(4)
An approved applicant whose
check for the temporary permit or certificate fee is returned marked insufficient
funds, account closed, or payment stopped shall remit to the department a
money order or check for guaranteed funds in the amount of the temporary permit
or certificate fee plus the returned check fee within 30 days of the date
of receipt of the department's notice. Otherwise, the application and the
approval shall be invalid.]
(5)
A temporary permit holder
whose check for the temporary permit extension fee is returned due to insufficient
funds, account closed or payment stopped shall remit to the department a money
order or check for guaranteed funds in the amount of the temporary permit
extension fee plus the returned check fee within 30 days of the date of the
department's notice. Otherwise, the temporary permit shall not be extended,
or if already extended shall be invalid.]
(6)
A certificate holder whose
check for the renewal fee is returned due to insufficient funds, account closed
or payment stopped shall remit to the department a money order or check for
guaranteed funds in the amount of the renewal fee plus the returned check
fee within 30 days of the date of receipt of the department's notice. Otherwise,
the certificate shall not be renewed. If a renewal certificate has already
been issued, it shall be invalid.]
(7)
] If the department's notice,
as set out in
paragraph (3)
[
paragraphs (3) - (6)
] of
this section, is returned unclaimed, the department shall mail the notice
to the applicant or certificate holder by first class mail. If a money order
or check for guaranteed funds is not received by the department's cashier
within 30 days of the postmarked date on the second mailing, the approval
or certificate issued shall be invalid. The department shall notify the applicant's
or certificate holder's employer that the person has failed to comply with
this section.
(8)
] The administrator, on behalf
of the board, shall make periodic reviews of the fee schedule and recommend
any adjustments necessary to provide sufficient funds to meet the expenses
of the respiratory care practitioner certification program without creating
an unnecessary surplus. Such adjustments shall be made through rule amendments
approved by the board.
records
]. [
Applicants for a certificate, who were
not certified or registered in respiratory care by the NBRC on or before September
1, 1985, or a temporary permit must submit:
]
(A)
a photocopy which is a true
and exact copy of un unaltered:]
(i)
an official diploma or official transcript
indicating graduation from high school;]
(ii)
certificate of high school equivalency issued
by the appropriate educational agency; or]
(iii)
official transcript from an accredited college
or university indicating that the applicant received a high school diploma
or equivalency or was awarded an associate, baccalaureate, or post-baccalaureate
degree; and]
(B)
a photocopy which is a true
and exact copy of an unaltered certificate of completion from a respiratory
care education program. The certificate must contain:]
(i)
name and number of the program (exactly as
listed with the educational accrediting body);]
(ii)
name of the graduate;]
(iii)
exact day and month individual is recognized
as a program graduate;]
(iv)
accreditation statement; and]
(v)
signatures of the medical director, program
director and administrative official; or]
(C)
an expected graduation statement
signed by the program director. Within 30 days of the completion date noted
in the statement, the department must receive either:]
(i)
a copy of the certificate of completion, as
set out in subparagraph (B) of this paragraph; or]
(ii)
a statement signed by the program director
indicating that the applicant officially completed the program but the certificate
is not available within 30 day of the completion date.]
(3)
] Examination results.
(4)
] Employment/experience documentation
report form. Persons applying for any certificate or permit who are not recognized
as a certified respiratory therapist or registered respiratory therapist by
the NBRC and who are licensed, registered, or otherwise regulated in another
state, territory, or country at the time of application must submit with their
applications a properly completed employment/experience documentation report
form signed by their medical director as defined in §123.2 of this title
(relating to Definitions), attesting that the applicant is currently practicing,
or has practiced respiratory care within the 12-month period immediately preceding
application to the department.
(5)
] Medical direction requirement.
If the applicant is practicing respiratory care in Texas at the time of application
to the department, the applicant shall provide on the application form the
signature and license number of the qualified medical director as defined
in §123.2 of this title (relating to Definitions) or other Texas licensed
physician directing the provision of respiratory care services.
administrator
] shall
be responsible for reviewing all applications.
administrator
] shall
approve all applications which are in compliance with subsections (a) - (c)
of this section and which properly document applicant eligibility, unless
the application is disapproved under the provisions of subsection (f) of this
section.
six
]
months of the practitioner's birth month shall be issued for
the next
full renewal period
[
that period of time plus the next full year
]. Certificates shall expire on the last day of the practitioner's birth
month.
annually. A practitioner
shall renew the certificate annually.
]
However, if an extension
has been granted in accordance with subsection (f) of this section, the practitioner
shall file the continuing education hours immediately following completion
of the activity.
]
(5)
any continuing education activity
completed before or after the renewal year for which the continuing education
credit is submitted except as allowed under subsection (f)(1) of this section;]
(6)
] activities which have been
completed more than once during the continuing education period.
(1)
A practitioner who has failed
to complete the requirements for continuing education as specified in subsection
(a) of this section may be granted up to a 90-day extension to a reporting
period if the renewal fee and continuing education extension fee is paid on
or prior to the expiration date. The 90-day extension is the maximum that
may be granted and there will be no exceptions.]
(A)
Following the receipt of the current renewal
form, renewal fee and continuing education extension fee, the department shall
issue identification cards valid for a 90-day period beginning with the day
following the expiration date of the practitioner's annual certificate and
a written notice that the continuing education period has been extended.]
(B)
If the deficiency is made up prior to the end
of the extension, the department will notify the practitioner that the next
reporting period commences on the day following the completion of the credits
to correct the deficiency. The new reporting period shall end on the next
renewal date. In other words, whenever an extension is granted, the time is
borrowed from the next reporting period.]
(C)
If an excess number of credits were earned
during an extension, the excess will be credited toward the new reporting
period.]
(D)
A practitioner may not receive another extension
at the end of the 90-day extension.]
(2)
]
A practitioner who has failed to complete
the requirements for continuing education as specified in subsection (a) of
this section [
and who has not completed the continuing education requirement
during the 90-day extension
] shall return the certificate and identification
cards to the department and shall not advertise or represent himself or herself
as a respiratory care practitioner in any manner. The person may renew the
certificate or reapply for a new certificate in accordance with §123.9(d)
of this title (relating to Certificate Renewal).
unless the hours were earned
during a continuing education extension as set out in subsection (f) of this
section
].
Chapter 125.
SPECIAL CARE FACILITIES
Chapter 125.
SPECIAL CARE FACILITIES
Subchapter B. FACILITY LICENSING
Subchapter C. GENERAL FUNCTIONS
Subchapter D. WAIVERS
Subchapter E. INSPECTIONS AND INVESTIGATIONS
Subchapter F. ENFORCEMENT
Subchapter G. SAFETY REQUIREMENTS AND FIRE PROTECTION
Subchapter H. PHYSICAL PLANT AND CONSTRUCTION REQUIREMENTS
Chapter 169.
ZOONOSIS CONTROL
they
] are impervious to moisture and may be readily sanitized;
(f)
] This section applies to all
animal shelters located in counties with a population of 75,000 or greater
as required by Health and Safety Code, Chapter 823 and to all quarantine or
impoundment facilities regardless of county population.
(g)
] Impoundment facilities in counties
with a population less than 75,000 have until January 16, 2005, to be in compliance
with the minimum standards set forth in this section.
Chapter 181.
VITAL STATISTICS
a member
of his or her immediate family either by blood, marriage or adoption,
]
his or her guardian,
or the children, spouses, parents, siblings, or
grandparents of the registrant.
[
or his or her legal agent or representative.
]
(24)
] Research copy--A plain paper
noncertified reproduction of the complete original document or a portion of
the original document.
(25)
] Search--The act of examining
the files and/or indexes maintained by the Bureau of Vital Statistics for
a specific record or information.
(26)
] Signature--The name of a
person written with his or her own hand; or by an electronic process approved
by the State Registrar.
(27)
] State Registrar--The Chief,
Bureau of Vital Statistics, Texas Department of Health.
(28)
] Supplemental Birth Certificate--A
new birth certificate prepared and filed by the Bureau, which is based upon
a paternity determination, or adoption. This new birth certificate replaces
the original certificate of birth.
(29)
] Birth Verification--A noncertified
statement only of the registrant's name, date of birth, and place of birth
as it appears on the birth index filed with the Bureau of Vital Statistics.
(30)
] Death Verification--A noncertified
statement only of the registrant's name, date of death, and place of death
as it appears on the death index filed with the Bureau of Vital Statistics.
(31)
] Fetal Death Verification--A
noncertified statement only of the registrant's name, date of delivery, and
place of delivery as it appears on the fetal death index filed with the Bureau
of Vital Statistics.
(32)
] Marriage Verification--A
noncertified statement only of the registrant's name, date of marriage, and
place of marriage as it appears on the application for marriage license index
filed with the Bureau of Vital Statistics.
(33)
] Report of Divorce or Annulment
of Marriage Verification--A noncertified statement only of the registrant's
name, date of divorce, and place of divorce as it appears on the report of
divorce or annulment of marriage index as it appears on the birth index filed
with the Bureau of Vital Statistics.
(34)
] Vital statistics--The registration,
preparation, transcription, collection, compilation, distribution and preservation
of data pertaining to births, adoptions, paternity determinations, deaths,
fetal deaths, suits affecting parent child relationship, court of continuing
jurisdiction, marital status, and such other data as deemed necessary by the
department.
(35)
] Vital Statistics Act--The
Health and Safety Code, Title 3.
first
] assumes custody of a dead body or fetus shall
obtain an
electronically filed report of death through a Bureau of Vital Statistics
system or complete a report of death before transporting the body. The report
of death shall
within 24 hours [
either mail or otherwise transmit
a report of death
]
be mailed or otherwise transmitted
to
the local registrar of the district in which the death occurred or in which
the body was found. [
The report of death form shall be prescribed and
furnished by the Department and a copy of such report
]
A copy of
the completed or electronically filed report of death as prescribed by the
Bureau of Vital Statistics
shall serve as authority to transport or
bury the body or fetus within this state.
of the district in which the death occurred or in
which the body was found.
]
where the death certificate is or will
be filed, or from the state registrar electronically through a Bureau of Vital
Statistics electronic death registration system.
The [
local
]
registrar shall not issue a burial-transit permit until a certificate of death,
completed in so far as possible, has been presented (See §181.6 of this
title (relating to Disinterment)).
§203.13
], covering minimum standards for embalming.
in four parts. One
]
so as to provide
copy [
shall be
retained by
]
for
the state registrar, [
one
]
a
copy retained by the funeral director to whom issued, [
one
]
a
copy filed with the sexton or person in charge of the cemetery in
which the disinterment is to be made, and [
one
]
a
copy
[
sent to
]
for
the local registrar of the district in
which the death occurred. The state
registrar
[
registrar's
copy
] and the local
registrar
[
registrar's copy
]
shall [
be attached as an amendment to
]
amend
the certificate
of death filed in their respective offices.
A disinterred body must be transported in a container
which insures against the seepage of fluid or the escape of offensive odors.
When shipped by common carrier, a disinterred body must be enclosed in an
airtight metal casket encased in a strong outside shipping case, or in a sound
casket encased in an airtight metal or metal-lined shipping case. This requirement
shall not apply if the disinterred remains involve no soft parts.
]
The disinterment permit issued by the state registrar
shall serve as the authority to disinter, transport by means other than a
common carrier, and reenter a body within this state. (See §181.2 of
this title (relating to Assuming Custody of Body).
]
(g)
A body kept in a receiving
vault shall not be regarded as a disinterred body until after the expiration
of 30 days.]
(h)
All disinterred remains kept
in receiving vaults shall be thoroughly embalmed in a manner approved by the
Texas Funeral Service Commission and shall be enclosed in a permanently sealed
casket.]
(i)
The licensed funeral director
or embalmer requesting a disinterment permit shall be responsible for obtaining
the written consent of the cemetery, the owner of the plot, and the decedent's
next-of-kin.]
(j)
The licensed funeral director
or embalmer requesting a disinterment permit shall be responsible for obtaining
a written consent order from the county judge to disinter a body from a grave
when the cemetery, plot owner, and the decedent's next-of-kin are unknown.]
fetal death if the period of gestation is 20
completed weeks or more
]
as calculated from the start date of the
last normal menstrual period to the date of delivery
.
Amended
] Birth Certificate Based
on
Parentage
[
Paternity
] (VS-166) signed by both parents
in the presence of a Notary Public, and:
Amended
] Birth Certificate Based on
Parentage
[
Paternity
] only has to be signed by one of the parents in the presence
of a Notary Public.
50th
]
anniversary of the date of birth as shown on the record filed with the bureau
or the local registration official. Original birth records shall not be made
available to the public in the interest of preservation of the records.
Form ] and Content.
,VS-111 and VS-111.1 entitled "Certificate
of Birth"
].
The department shall prescribe two versions of the Certificate of Birth. One
version (VS-111) shall contain all information required to be collected as
determined by the State Registrar. The alternate form (VS-111.1) shall not
include the section titled "For Medical and Health Use Only" and shall contain
only the demographic information relating to the birth, the mother's marital
status, the immunization registry consent question, the child's social security
number request question, the social security numbers of the parents, and the
signature of a parent.
]
Only hospitals
or licensed birthing centers may prepare and file certificates of birth on
the alternate form (VS-111.1) if:
]
(1)
the facility is using the
birth certificate software (Certificate Manager), provided by the department;]
(2)
the facility obtains all the
information required on VS-111; and]
(3)
the complete information is
electronically transmitted to the department no later than the seventh calendar
day after the date of birth.]
the hospital's or licensed birthing center's
authorization to use the alternate form (VS-111.1) for failure to transmit
information within the time limit as described in paragraph (c)(3) of this
subsection.
]
Form ] and Content.
VS-112
] entitled "Certificate
of Death" and [
VS-113 entitled
] "Certificate of Fetal Death".
interment
] or in charge of removal of
a body from a registration district for disposition may prepare and file the
Certificate of Death [
form (VS-112)
] and the Certificate of Fetal
Death [
form (VS-113)
].
Subchapter B. VITAL RECORDS
paternity
] determination shall be $25.
50th
] anniversary of the date
of birth as shown on the record unless the fact of an adoption or paternity
determination can be revealed or broken or if the index contains specific
identifying information relating to the parents of the child who is the subject
of an adoption placement. The bureau of vital statistics and local registration
officials shall expunge or delete any state or local file numbers included
in any general birth index made available to the public because such file
numbers may be used to discover information concerning specific adoptions,
paternity determinations, or the identity of the parents of children who are
the subjects of adoption placements.
bureau's Anti-Fraud Prevention Program
] of any abused record. Requests
for additional certifications shall be made to the bureau.
The signature on the certificate of
the
] registered, certified, or documented health care
provider's
signature on the birth certificate, or participation in electronic birth registration
[
provider
] shall serve as prima facie evidence of the essential
elements of proof required in subsection (c) of this section. The local registrar
may accept certificates by mail when the signature of the registered, certified,
or documented health care provider is on file with that registrar's office.
in the following order
of preference:
]
(A)
an affidavit from a licensed,
registered, or certified health care provider who is qualified to determine
pregnancy as part of the scope of his/her license or registration, or certification;
or]
(B)
an affidavit from one person,
other than the parents, having knowledge of the pregnancy/birth.]
of the mother's presence in the registration district
on the date of the birth if the birth occurred outside the locale of the mother's
primary place of residence. Such proof shall consist of an affidavit from
a person having knowledge of the mother's presence in the registration district
in which the birth occurred on the date of the birth. If the birth occurred
in the mother's primary place of residence, proof shall be presented in the
following order of preference:
]
(A)
a utility, telephone, or other
bill which includes the mother's name and address;]
(B)
a rent receipt or agreement
which includes the mother's name and address, and the printed name, address,
and signature of the mother's landlord;]
(C)
a driver's license, or state
issued identification card, which includes the mother's current residence
on the face of the license/card;]
(D)
an envelope addressed to the
mother at her place of residence, and postmarked prior to the date of the
birth; or]
(E)
an affidavit attesting to
the mother's place of residence from a person, other than the father, who
was either living with the mother at the time of the alleged birth, or has
other knowledge of the mother's residency; and]
which
] may not be abstracted.
An abstract shall be issued in one of four styles:
and
]
intaglio printing;
]
laminate;
]
(3)
latent image;]
(4)
security thread; or]
(5)
watermark.]
(b)
] Certificate of birth. The state
registrar shall prepare a new certificate of birth for a person born in a
foreign country, and adopted under the laws of a foreign country or under
the laws of this state, when the state registrar receives the following from
a resident of this state:
grants
] or
validated
[
validates
]
the adoption;
and
(3)
A certified copy of the decree
of adoption granted in a foreign country and information with translation
into the English language relating to the adoptive parent(s) and adoptee should
be submitted to a court of competent jurisdiction of this state for validation.
It is the responsibility of the applicant(s) to have all required documents
translated into the English language. An official certificate of adoption
must be prepared and submitted to the Bureau by the clerk of the court validating
the foreign adoption;]
(4)
] payment of all applicable fees.
(c)
] Guidelines. The state registrar
shall use the following guidelines when preparing a new certificate of birth.
(d)
] Exceptions. The guidelines,
as stated in subsection
(d)
[
(c)
] of this section, do
not apply if a child was born in a foreign country and was a citizen of the
United States at the time of birth. This record may only be processed by the
United States Department of State.
on Form VS-174
] as prescribed by the department.
signed
] by a physician, and a justice of the peace
(JP) or medical examiner's office (ME) has subsequently conducted an inquest
as authorized by the Code of Criminal Procedure, Chapter 49, the medical amendment
may be filed by the JP or ME that conducted the inquest.
local
] registrar shall carefully examine
each medical amendment when presented for registration to determine if it
is complete as required by the state registrar's instructions.
local
] registrar shall call attention to the error and/or
omission in the return.
local
] registrar shall number the medical
amendment with the same file number assigned to the original death certificate.
The local registrar shall sign each medical amendment to attest to the date
the amendment is filed in the local registrar's office. The signature may
be either
electronic,
handwritten or a facsimile stamp, [
and must be written or stamped with permanent black or blue ink
]. The
medical amendment shall be attached to and become a part of the legal record
of the death if the amendment is accepted for filing.
local
] registrar shall
duplicate
[
make a photographic duplication of
] the medical amendment as authorized
by the Local Government Code, Chapters 201 or 204. The
duplicate
[
copy
] shall be permanently preserved in the local registrar's office
as the local record, in the manner directed by the state registrar.
local
] registrar shall forward
all
[
the
] original
non-electronic,
[
properly
filed
] medical
amendments
[
amendment
] to the state
registrar within 10 days of filing.
Texas Department of Health, Bureau of Vital
Statistics
] a certificate of adoption on Form VS-160. The clerk of the
court shall send the form not later than the 10th day of the first month after
the month in which the court renders the adoption decree. The certificate
shall include, the information as prescribed in Texas Family Code, §108.003.
(b)
] When the clerk of the court
collects the $15 fee required by the Texas Family Code, §108.006(b),
for each adoption petition filed,
the clerk shall
attach the fee
to the certificate of adoption(s), and forward to the Bureau, as provided
in subsection (a) to
[
send the fee by check or money order to the
Texas Department of Health-
] Bureau of Vital Statistics, P.O. Box 12040,
Austin, Texas 78711-2040.
bureau
] maintains many
records of closed adoption agencies and is one entity a child-placing agency
may designate to preserve its adoption records. An agency may also designate
another Texas licensed child-placing agency to preserve its records.
bureau
] to house its records, the agency shall assume the responsibility
of shipping the records to a designation specified by the
Bureau
[
bureau
]. The agency must ensure that the records are free from insects
and rodents, and mildew-free and dry. The records shall be shipped in sturdy
cardboard boxes (no larger than 12 inches x 15 inches) via an insured carrier.
bureau's
] standards.
bureau
] to maintain and preserve its records, a redacted
or de-identified copy of the birth and/or adoption record shall be prepared
by the
Bureau
[
bureau
] for a qualified requestor under
the Texas Family Code, §162.018, Access to Information. Charges for copies
shall be as allowed by the Open Records Act, Government Code, Chapter 552.
bureau
] and the
Bureau
[
bureau
] houses the records of the closed child-placing
agency, the
Bureau
[
bureau
] may place the information
with the original child-placing agency's file. If a birth relative provides
post-adoption medical or social information to the
Bureau
[
bureau
], the adoption occurred outside of a licensed child-placing agency,
and the
Bureau
[
bureau
] readily identifies the sealed
adoption file, the
Bureau
[
bureau
] shall place the updated
information in the Health, Social, Education and Genetic History record series
in the date received and cross-referenced in the
Bureau's
[
bureau's
] database.
bureau
] shall make a
diligent effort to locate the last known address of the adoptive parents and
attempt to inform them of their right to examine the redacted or de-identified
portion of the record.
bureau
]
a copy of the Health, Social, Education and Genetic History report (HSEGH)
as prescribed by the Family Code. Within a reasonable amount to time, the
Bureau
[
bureau
] shall provide a certificate to the adopting
attorney acknowledging receipt of the report.
bureau
] along with
all foreign documents relating to the child's history prior to being placed
for adoption, along with each document's English translation. If no information
is available about the child prior to placement with its prospective adoptive
parent(s), the adopting parents may state that no other information except
for the aforementioned documents is available concerning the child's background.
Subchapter C. CENTRAL ADOPTION REGISTRY
bureau
] charges a fee
of $5.00 to determine if a child-placing agency that operates its own registry
was involved in a specified adoption.
An eligible applicant
[
The person
] may send the inquiry, along with the appropriate fee and
proof of age and identity to the Central Adoption Registry (CAR), P.O. Box
140123, Austin, Texas 78714-0123 or may inquire in person at the Bureau of
Vital Statistics, 1100 West 49th Street, Austin, Texas.
Proof
] of age and identity
, in the form of a
[
is a copy of
the requestor's driver's license or other
] photo
ID
[
identification
] and
,
[
a copy of the birth certificate,
] if the
applicant's
[
requestor's
] name has changed
due to marriage
, a copy of his or her birth certificate or marriage certificate
. If the
applicant is a birth sibling, a copy of his/her birth
certificate must be included. If his or her
name has been legally changed
,
[
through a court order,
] a certified copy of the
court
order
verifying the name change
shall accompany the
request.
department
] shall provide
the child-placing agency's name, address, telephone number, and E-mail address,
if appropriate, if that agency operates its own registry to which a person
may apply. If the CAR finds inconclusive information to determine which agency
handled the adoption, the person is entitled to apply only to the CAR.
such
as a copy
]
in the form
of [
his or her driver's license
or other
]
a
[
governmental
]
government-issued
photo
ID
[
identification
] and, if the
applicant's
[
requestor's
] name has changed due to marriage, a copy of
his or her birth certificate or marriage certificate.
If the applicant
is a birth sibling, a copy of his/her birth certificate shall be included.
If his or her name has been legally changed, a certified copy of the
court order shall accompany the registration form; and
Chapter 289.
RADIATION CONTROL
Subchapter G. REGISTRATION REGULATIONS