Part 1.
TEXAS DEPARTMENT OF HEALTH
Chapter 61.
CHRONIC DISEASES
Subchapter A. KIDNEY HEALTH CARE PROGRAM
The Texas Department of Health (department) adopts amendments to §§61.1
- 61.4, 61.6 - 61.9 and 61.13 - 61.15, relating to Kidney Health Care (KHC)
benefits, and the repeal of §§61.5, 61.10 and 61.11 relating to,
respectively, the establishment of co-pay liability standards for all KHC
recipients, the program's notice of intent to take action and reconsideration,
and the fair hearing process. Sections 61.1 - 61.2, 61.4, and 61.6 - 61.9
are adopted with changes to the proposed text as published in the March 26,
2004, issue of the
Texas Register
(29 TexReg
3098). The repealed §§61.5, 61.10 and 61.11 and the amended §§61.3
and 61.13 - 61.15 are adopted without changes and, therefore, these sections
will not be republished.
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 has been provided elsewhere in 25 Texas
Administrative Code (TAC), §§1.51 - 1.55.
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. An amendment to §61.3
reduces 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 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; however, revisions were needed to provide
for clarity and consistency of language and facilitate compliance with the
administration of the rules.
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.
Comments were received on the proposed amendments from one organization
during the comment period. In addition, the department is making minor changes
due to staff comments to further clarify the intent and improve the accuracy
of the sections.
Comment: Concerning §§61.2(a)(4)(C), (b)(9), and (c), the commenter
recommended that no benefits be denied to end-stage renal disease patients
until it is known if a patient is receiving other benefits.
Response: The department wishes to clarify that the proposed rules do not
change how KHC currently handles a patient's third party coverage. The program
does not take action to deny, modify, or suspend a patient's eligibility for
Kidney Health Care (KHC) benefits until the program has received verification
of a patient's eligibility for Medicaid or private/group health insurance.
No change was made as a result of this comment.
Comment: Concerning §61.6(l)(2), the commenter was opposed to waiting
lists and recommended that the program make all new end-stage renal disease
patient's dialysis treatments a top priority.
Response: The department wishes to clarify that the waiting list is to
provide the program with an option when projections have exceeded the available
appropriation for client services and it is no longer feasible to further
modify benefits. A waiting list would only be used to maintain current services
for the current caseload, or pre-determined threshold, in order to remain
within the current appropriation, and when further modifications to the current
level of benefits would result in an extremely inadequate level of benefits.
No change was made as a result of this comment.
Comment: Concerning the Fiscal Implications paragraph of the preamble,
the commenter asked for an explanation of the projected $968,000 cost savings.
Response: The department responds that the estimated $968,000 reduction
in costs for Fiscal Year (FY) 2005 ($963,000 for FY2004) was based on reductions
in cost that will be realized as a result of discontinuing KHC coverage of
Medicaid eligible recipients and changing the eligibility date for newly approved
recipients. KHC estimates that approximately 300 dialysis claims in FY2004
and 320 in FY2005 may be affected by changing an applicant's KHC eligibility
date to the date a completed application is received by KHC. Based on KHC's
current reimbursement rate per dialysis treatment, KHC estimates a reduction
in dialysis costs of approximately $63,000 in FY2004 and $68,000 in FY2005.
With over 70% of the applications and dialysis claims being submitted on line,
KHC believes the fiscal impact will be minimal to the dialysis facilities,
so the estimates may actually be lower with the expected increased use of
on-line submissions.
In addition, KHC paid $850,398 in FY2003 for drug benefits for 5,854 Medicaid
eligible recipients. The average cost was $145.26 per recipient per year for
one drug per month. For FY2004, KHC estimates the number of Medicaid recipients
will be 6,030, at an average cost of $149.24 per recipient per year, or a
total estimated reduction in drug costs of approximately $900,000. We used
the same estimated savings for FY2005. No change was made as a result of this
comment.
Comment: Concerning the Public Benefit paragraph of the preamble, the commenter
expressed concern about the impact of the proposed rules on persons eligible
for Medicaid.
Response: The department responds that, initially, some Medicaid patients
may be adversely affected by the discontinuance of one drug per month coverage
by the program. However, we expect that within the following months these
patients will be able to extend their Medicaid monthly drug utilization because
of the Medicaid 90 days supply limit for covered drugs, limiting the impact
to the patients. No change was made as a result of this comment.
Change: Concerning §61.1(c)(4), the words "whose" and "has been submitted
by" were deleted and the words "who has submitted an" was added after the
word "individual" and "through" was added after the word "benefits" to clarify
the intent of the sentence.
Change: Concerning §61.1(c)(4), the sentence "This includes an individual
whose application is submitted by a representative or person with legal authority
to act for the individual" was deleted because the reference was unnecessary
in the context of the definition.
Change: Concerning §61.1(c)(5), (8) and (11), the words "or his successor"
and the words "or its successor" was added after the word "Health" because
the agency name will change and the Board of Health will be dissolved on September
1, 2004.
Change: Concerning §61.1(c)(17), the term "a contract/agreement" was
deleted and the term "an agreement" was added in its place because the reference
to both "contract" and "agreement" is redundant. This change was also made
in §§61.6(c)(3), 61.8(c)(4), 61.9(a)(1), 61.9(a)(2), 61.9(a)(3),
61.9(b)(1), 61.9(b)(3), and 61.9(c)(2)(E).
Change: Concerning §61.1(c)(20)(C), the words "and licensed in Texas"
were deleted and the words "in Texas and operating in compliance with applicable
law" were added after the word "located" to clarify the intent of the definition.
Change: Concerning §61.1(c)(20)(F), the word "Providers" following
"Texas Medicaid" was changed to "providers" to correct a capitalization error.
Change: Concerning §61.1(c)(20)(G)-(H) the phrase "furnishing covered
services to KHC recipients" was deleted because the words "to furnish covered
services to KHC recipients" appear earlier in §61.1(c)(20).
Change: Concerning §61.1(c)(24), the definition "VDP - The Texas Medicaid
Vendor Drug Program" was deleted because it was unnecessary.
Change: Concerning §61.2(b)(2), the word "maintain" was deleted and
the words "continue to meet" were added after the words "failure to", in order
to clarify the intent of this requirement.
Change: Concerning §61.2(g), the open parenthesis was added before
the words "relating to Fair Hearing Procedures" since it was omitted in the
proposed rule.
Change: Concerning §61.4(1)(E), the sentence "Changes in income or
financial qualifications which would affect the applicant's eligibility shall
be reported to KHC" was deleted because the language is previously cited in §61.2(b)(2).
Change: Concerning §61.4(3), the last sentence "Exception: The eligibility
date for in-center dialysis patients for transportation services will be the
first day of the month following the KHC eligibility effective date" was added
for clarification.
Change: Concerning §61.6(b)(1), the words "a participating" were deleted
and the article "an" was added before the words "out-of-state" and the word
"participating" was added after the words "out-of-state" for clarity of language.
Change: Concerning §61.6(k), the words "of Health (Commissioner)"
following the word "Commissioner" were deleted because they were unnecessary
since the term "Commissioner" was previously defined in §61.1(c)(8).
Change: Concerning §61.7(a), the words "Vendor Drug Program (VDP)"
and "VDP allows or requires" were deleted from the sentence and the words
"designated claims processor for Kidney Health Care (KHC)" were added after
the words "submitted electronically to the" and the words " are allowed or
required" were added after the word "submissions" because the intent of the
rule requires more general language.
Change: Concerning §61.7(c), the words "administered by the Texas
Department of Transportation and contracted through the Health and Human Services
Commission" and "or any Texas Department of Transportation approved transportation
provider" were deleted from the original proposed sentence and a second sentence
"Claims shall be submitted electronically through the KHC Automated System
for Kidney Information Tracking (ASKIT), or any other designated claims payment
system, except when KHC allows or requires paper submissions" was added in
order to more clearly identify the responsible entities and the required method
of claim submission.
Change: Concerning §61.8(f), the words "Vendor Drug Program (VDP)"
and "VDP drug" were deleted from the sentence and the words "designated claims
processor for KHC" were added after the word "the" because the intent of the
rule requires more general language. Also, the words "contained in 1 Texas
Administrative Code, §354.1901, (relating to Pharmacy Claims)" were added
after the word "deadlines" in order to provide a point of reference for the
claim filing deadlines requirements.
Change: Concerning §61.9(a)(3), the word "a" was added after the word
"has" to correct a grammatical error in the fourth sentence.
Change: Concerning §61.9(a)(4), the words "Vendor Drug Program (VDP)"
were deleted and the words "Health and Human Services Commission Pharmacy
Contracts unit or designated contractor" were added in order to reflect the
current organizational structure. This subdivision, which was previously designated
in the proposal as "(No Change)", required changes in order to correct inconsistencies
in language that occurred as a result of additional changes being made in
the open subdivisions.
Change: Concerning §61.9(a)(5)(D), the words "KHC may withhold" were
deleted and the words "and allow KHC to apply" were added after the word "request"
in order to clarify the intent of the requirement. This change was also made
in §§61.9(a)(6)(D), 61.9(a)(7)(E), and 61.9(a)(8)(E).
Change: Concerning §61.9(a)(7)(A), the words "licensing requirements"
were deleted and the words "applicable laws" were added after the word "all"
to clarify the intent of the requirement.
Change: Concerning §61.9(a)(7)(D), the word "licensed" was deleted
and the words "authorized under applicable law" was added after the first
occurrence of the word "hospital" to clarify the intent of the requirement.
The words "or ASC" were added after the word "hospital" in the last line because
they were omitted in the original submission.
Change: Concerning §61.9(a)(8)(D), the words "or ASC" were added after
the words "certified hospital" because they were omitted in the original submission.
Change: Concerning §61.9(b)(2), the term "VDP" was deleted and the
words "the Health and Human Services Commission Pharmacy Contracts unit or
designated contractor" were added in order to reflect the current organizational
structure. This subdivision, which was previously designated in the proposal
as "(No change.)", required changes in order to correct inconsistencies in
language that occurred as a result of additional changes being made in the
open subdivisions.
Change: Concerning §61.9(c)(1)(E), the words "with KHC or VDP" were
deleted and the words "for KHC benefits" were added in order to clarify the
intent of the rule.
Change: Concerning §61.9(c)(2)(D), the words "a contract or" were
deleted and the article "an" was added after the word "renew" because the
reference to both "contract" and "agreement" is redundant.
The commenter was the Texas Renal Coalition. The commenter was generally
not in favor of some of the amendments and expressed concern, asked questions,
and made recommendations.
25 TAC §§61.1 - 61.4, 61.6 - 61.9, 61.13 - 61.15
The amendments are adopted under the Health and Safety Code, §42.003,
which provides the Texas Board of Health (board) 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 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.
§61.1.General.
(a)
Purpose. The purpose of this Chapter is to establish rules
for Kidney Health Care (KHC). The authority for these rules is granted in
the Texas Health and Safety Code, Chapter 42.
(b)
Delegation of Authority. Under the Texas Health and Safety
Code, Chapter 11, §11.013, the Board of Health (board) delegates to the
Commissioner of Health (commissioner), or to the person acting as commissioner
in the commissioner's absence, the authority to administer KHC, exclusive
of rulemaking authority.
(c)
Definitions. The following words and terms when used in
this chapter shall have the following meanings, unless the context clearly
indicates otherwise.
(1)
Access surgery--The surgical procedure which creates or
maintains the access site necessary to perform dialysis.
(2)
Action--A denial, termination, suspension or reduction
of KHC-covered services or eligibility.
(3)
Allowable amount--The maximum amount that KHC will pay
or reimburse for a covered benefit or service.
(4)
Applicant--An individual who has submitted an application
for KHC benefits through a participating outpatient dialysis facility or hospital
and has not received a final determination of eligibility.
(5)
Board--The Texas Board of Health or its successor.
(6)
Claim--A request for payment or reimbursement of services.
(7)
CMS--The Centers for Medicare and Medicaid Services, formerly
known as the Health Care Financing Administration.
(8)
Commissioner--The commissioner of the Texas Department
of Health, or his successor.
(9)
Co-pay--The portion of the allowable amount for which a
KHC recipient is responsible.
(10)
Covered services--Drugs, transportation, pharmaceutical
products, medical care, treatment, services or equipment which have been approved
by KHC for payment.
(11)
Department--The Texas Department of Health, or its successor.
(12)
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.
(13)
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.
(14)
Fair hearing--The informal hearing process the department
follows under §§1.51 - 1.55 of this title (relating to Fair Hearing
Procedures).
(15)
Final decision--A decision that is made by a decision
maker after conducting a fair hearing under §§1.51 - 1.55 of this
title (relating to Fair Hearing Procedures).
(16)
HCFA--The Health Care Financing Administration, now known
as the Centers for Medicare and Medicaid Services.
(17)
Interim approval--The status given by KHC to an outpatient
dialysis facility, free standing or hospital based, which has applied for
participation as a KHC provider but has not executed an agreement with KHC.
(18)
KHC--The Kidney Health Care program.
(19)
Medical benefits--Any inpatient or outpatient medical
treatment or procedure approved by KHC as a covered service.
(20)
Participating provider--Any individual or entity with
KHC approval to furnish covered services to KHC recipients including:
(A)
outpatient dialysis facilities;
(B)
out-of-state outpatient dialysis facilities;
(C)
hospitals and ambulatory surgical centers (ASCs) located
in Texas and operating in compliance with applicable law;
(D)
out-of-state hospitals and ASCs;
(E)
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);
(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); or
(H)
out-of-state physicians and CRNAs.
(21)
Recipient--An individual who is eligible to receive KHC
benefits.
(22)
Suspended benefits--Eligibility for benefits or claims
which are denied and/or held pending satisfaction of a KHC request or requirement.
(23)
TDCI--The Texas Drug Code Index. This 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.
§61.2.Recipient Requirements.
(a)
A person shall meet all of the following requirements to
be eligible for Kidney Health Care (KHC) benefits:
(1)
have a diagnosis of end-stage renal disease (ESRD) certified
by a licensed physician who is board eligible or board certified in internal
medicine, nephrology, or pediatric nephrology;
(2)
meet the Medicare criteria for ESRD;
(3)
be receiving a regular course of chronic renal dialysis
treatments or have received a kidney transplant;
(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)
incarcerated in a city, county, state, or federal jail,
or prison;
(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 gross income of less than $60,000. Income reported as
"joint income" is considered as one income. The person or persons who have
a legal obligation to support the recipient will be determined by the applicable
state law.
(b)
A recipient's eligibility for KHC benefits may be terminated
for any of the following reasons:
(1)
failure to maintain Texas residency or, upon demand, furnish
evidence of such using the criteria in §61.3 of this title (relating
to Residency and Residency Documentation Requirements);
(2)
failure to continue to meet the income requirements for
eligibility or to provide income data as requested by the department to determine
continued KHC eligibility;
(3)
failure to reimburse the department as requested for overpayments
made to the recipient;
(4)
failure to apply for medical, drug, and transportation
benefits under Title XIX, Social Security Act (Medicaid), if the applicant
meets income and other eligibility requirements for Medicaid;
(5)
recipient is incarcerated in a city, county, state, or
federal jail, or prison;
(6)
recipient regains kidney function;
(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)
KHC determines that the recipient has made a material
misstatement or misrepresentation on their application or any document required
to support their application;
(11)
KHC determines that the recipient has submitted false
claim(s); or
(12)
KHC has not paid a claim for benefits on behalf of the
recipient for a minimum period of 12 consecutive months.
(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)
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.
(e)
In order to requalify for KHC, an applicant shall reapply
for KHC benefits when eligibility for KHC benefits is terminated.
(f)
A recipient who loses eligibility will not be reinstated
until all outstanding debts owed to KHC by the recipient are paid or arrangements
acceptable to KHC are made for payment.
(g)
A recipient whose benefits are modified or suspended, or
whose eligibility is terminated, may appeal KHC's decision under the procedure
contained in §§1.51 - 1.55 of this title (relating to Fair Hearing
Procedures).
(1)
KHC may not terminate KHC participation until a final decision
is rendered under the department's fair hearings process, if a hearing is
requested by the recipient.
(2)
KHC may withhold payments on claims pending final decision
under the department's fair hearings process.
(3)
KHC shall release withheld payments and reinstate participation
in KHC if the final determination is in the recipient's favor.
§61.4.Applications.
Persons meeting the eligibility requirements set forth in §61.2(a)(1),
(2), (3), (4), and (6) 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.
(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)
a complete and notarized Application for Benefits, with
the applicant's, or the applicant's representative's, original signature or
"mark";
(B)
a copy of the completed, signed and dated (MM/DD/YY) Health
Care Financing Administration (HCFA) End-Stage Renal Disease Medical Evidence
Report;
(C)
documentation of Texas residency as required by §61.3
of this title (relating to Residency and Residency Documentation Requirements);
(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)
a copy of a Social Security Administration document which
verifies the social security number; or
(ii)
a copy of a valid Medicare 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 card.
(E)
applicant financial data. Acceptable data to establish
the applicant's financial qualifications shall be submitted with the application.
The applicant may attach any of the following documents to verify income:
(i)
A copy of the first page of either the applicant's, or
the person(s) legally obligated to support the applicant's, IRS individual
income tax return form for the most recently completed tax year or an estimated
or declared income for the current tax year on the Application for Benefits.
(ii)
Applicants who do not file a federal income tax return
may submit documentation of financial assistance, income, or retirement benefits.
(2)
Incomplete application. Any application which does not
meet all of the requirements of paragraph (1) of this subsection is incomplete.
Incomplete applications may be returned to the submitting person or entity
for correction or completion.
(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. Exception: The eligibility date for in-center dialysis patients
for transportation services will be the first day of the month following the
KHC eligibility effective date.
(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)
KHC allowable out-patient drugs and drug products included
on the Texas Drug Code Index (TDCI) (a list of KHC allowable drugs is available
upon request from KHC, Texas Department of Health, 1100 West 49th Street,
Austin, Texas 78756);
(2)
covered transportation;
(3)
access surgery (hospital charges, ambulatory surgical center
charges, surgeon's fees, assistant surgeon's fees, anesthesiologist's fees,
Certified Registered Nurse Anesthetist's fees);
(4)
out-patient chronic maintenance dialysis treatments;
(5)
in-patient chronic maintenance dialysis treatments (excluding
treatment for emergency/acute dialysis); and
(6)
Medicare Part A and B premiums, if qualified. To qualify
for this benefit, recipients:
(A)
cannot be eligible for:
(i)
"premium free" Part A coverage; or
(ii)
Medicaid to pay their Medicare premiums;
(B)
shall apply and be accepted for Medicare hospital and medical
insurance; and
(C)
shall promptly submit all Medicare premium due notice statements
to KHC for payment.
(b)
All KHC benefits are limited to services received in Texas
except for:
(1)
covered services received from an out-of-state participating
provider; and
(2)
KHC allowable drugs submitted by any participating out-of-state
pharmacy.
(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)
available funds;
(2)
established limits for covered services by type or category;
(3)
an agreement between the department and the recipient's
participating provider;
(4)
the reimbursement rates established by the department;
(5)
any co-pay KHC may apply to client service benefits; and
(6)
any third-party liability.
(d)
Recipients eligible for immunosuppressive drug (ISD) coverage
under Medicare are not eligible to receive KHC ISD coverage.
(e)
Recipients eligible for drug coverage under a private/group
health insurance plan are not eligible to receive KHC drug benefits. A recipient
that has exhausted drug coverage under a private/group health insurance plan
may be eligible to receive drug benefits from KHC.
(f)
Access surgery benefits are payable only if the services
were performed on or after the date Texas residency was established and not
more than 180 days prior to the recipient's KHC eligibility effective date.
(g)
KHC medical benefits are payable during the Medicare three-month
qualifying period to recipients who do not have Medicare coverage. Benefits
are payable for services received on or after the KHC eligibility effective
date. The three-month qualifying period shall be calculated from the first
day of the month the recipient begins chronic maintenance dialysis. If a recipient
becomes eligible for Medicare during the three-month period, KHC medical benefits
shall not be payable from the date of Medicare eligibility.
(h)
Limited medical benefits are available beyond the qualifying
period for eligible recipients who have applied for and have been denied Medicare
coverage based on end-stage renal disease (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.
(i)
Recipients eligible for hospital and medical benefits from
Medicare, the Veterans Administration, the military, or other government programs
which cover the treatment of ESRD are not eligible to receive KHC medical
benefits.
(j)
Recipients eligible for hospital and medical benefits from
private/group health insurance which covers the treatment of ESRD are not
eligible for KHC medical benefits.
(k)
KHC is payor of last resort. All third parties must be
billed prior to KHC. The Commissioner may waive this requirement in individually
considered cases where its enforcement will deny services to a class of ESRD
patients because of conflicting state or federal laws or regulations, under
the Texas Health and Safety Code, Chapter 42, §42.009.
(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 designated
claims processor for Kidney Health Care (KHC) by the participating pharmacy,
except when paper submissions are allowed or required.
(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 shall be submitted to
KHC by the recipient or the participating provider performing outpatient dialysis
services. Claims shall be submitted electronically through the KHC Automated
System for Kidney Information Tracking (ASKIT), or any other designated claims
payment system, except when KHC allows or requires paper submissions.
(d)
Payments will be made using rates in effect on the date
services were rendered, and not prospectively.
§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 until they are completed or
corrected. Claims which are not received by KHC within the deadlines established
in this section will be denied payment.
(b)
Claims for in-patient hospital 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 explanation of
benefits (EOB), but not later than 180 days from the date of discharge; or
(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 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;
(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 agreement approval letter
for newly approved participating providers, but not later than 180 days from
the date of service.
(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)
95 days from the last day of the month in which services
were provided; or
(2)
60 days from the date on the KHC notice of eligibility
for newly approved recipients.
(f)
Claims for drug charges shall be submitted to the designated
claims processor for KHC in accordance with claim filing deadlines contained
in 1 Texas Administrative Code, §354.1901, (relating to Pharmacy Claims).
(g)
Resubmitted claims, other than drug claims, shall be received
by KHC within the deadlines established under subsections (b), (c), (d), and
(e) of this section, or within 30 days from the date of the KHC return letter
or KHC EOB, whichever is later. Resubmitted claims shall:
(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 Providers.
(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 shall execute an agreement
with KHC, and shall meet the following criteria:
(A)
have Medicare certification and a Medicare end-stage renal
disease (ESRD) provider number;
(B)
be a current Texas Medicaid provider;
(C)
be licensed by the Texas Department of Health (department)
as an ESRD facility;
(D)
reimburse KHC for any overpayments made to the facility
by KHC upon request. KHC may withhold payment on claims submitted by the facility
to recoup any overpayments; and
(E)
not currently be on suspension as a KHC participating provider,
as a Texas Medicaid provider, as a Medicare certified ESRD facility, or as
a licensed Texas ESRD facility.
(2)
KHC may enter into an agreement 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 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 agreement to the facility. If interim approval lapses, the unexecuted
agreement will be nullified and a new 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 a fully executed
agreement with the facility. Claim filing deadlines will apply, as contained
in §61.8 of this title (relating to Claim Filing Deadlines).
(4)
Pharmacies, including mail order pharmacies, shall enter
into an agreement to participate in KHC through the Health and Human Services
Commission Pharmacy Contracts unit or designated contractor.
(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)
be a current Texas Medicaid provider;
(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, and allow KHC to apply 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)
if a physician, be licensed to practice medicine in the
state in which services are provided, or if a CRNA, be certified to practice
within the scope of their certification in the state in which services are
provided;
(B)
be a current Texas Medicaid provider;
(C)
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
(D)
reimburse KHC for any overpayments made to the physician
or CRNA by KHC upon request, and allow KHC to apply payment on claims submitted
by the physician or CRNA to recoup any overpayments.
(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 applicable laws to provide hospital
or ASC services in the State of Texas;
(B)
be a current Texas Medicaid provider;
(C)
have Medicare approval;
(D)
not currently be on suspension as a KHC participating provider,
as a hospital authorized under applicable law 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
or ASC; and
(E)
reimburse KHC for any overpayments made to the hospital
or ASC by KHC upon request, and allow KHC to apply 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)
be a current Texas Medicaid provider;
(C)
have Medicare certification;
(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 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 or ASC; and
(E)
reimburse KHC for any overpayments made to the hospital
or ASC by KHC upon request, and allow KHC to apply 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
agreements shall be on or after the Medicare ESRD certification date.
(2)
The effective date of all pharmacy agreements shall be
determined by the Health and Human Services Commission Pharmacy Contracts
unit or designated contractor.
(3)
The effective date of all other provider agreements, listed
in subsection (a)(5), (6), (7), and (8) of this section, shall be the first
day of the sixth month prior to the KHC receipt of the completed and signed
provider agreement.
(c)
Reasons for suspension or termination from participation
in KHC are as follows.
(1)
Any participating provider may be terminated or suspended
for:
(A)
loss of approval or exclusion from participation in the
Medicare program;
(B)
exclusion from participation in the Medicaid program;
(C)
providing false or misleading information regarding any
participation criteria;
(D)
a material breach of any contract or agreement with KHC;
(E)
filing false or fraudulent information or claims for KHC
benefits;
(F)
failure to submit a payable claim to KHC during a minimum
period of 12 consecutive months; or
(G)
failure to maintain the participation criteria contained
in subsection (a) of this section.
(2)
A participating provider may appeal a termination or suspension
through the department's fair hearings process, as contained in §§1.51
- 1.55 of this title (relating to Fair Hearing Procedures).
(A)
KHC may not terminate KHC participation until a final decision
is rendered under the department's fair hearings process.
(B)
KHC may withhold payments on claims pending final decision
under the department's fair hearings process.
(C)
KHC shall release any withheld payments and reinstate participation
in KHC if the final determination is in favor of the participating provider.
(D)
KHC shall not enter into, extend, or renew an agreement
with a participating provider until a final decision is rendered under the
department's fair hearings process.
(E)
A participating provider may not appeal a termination of
an agreement which results from limitations in appropriations or funding for
covered services or benefits or which terminates under its own terms.
This agency hereby certifies that the adoption
has been reviewed by legal counsel and found to be a valid exercise of the
agency's legal authority.
Filed with the Office of
the Secretary of State on July 2, 2004.
TRD-200404365
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 22, 2004
Proposal publication date: March 26, 2004
For further information, please call: (512) 458-7236
25 TAC §§61.5, 61.10, 61.11
The repeals are adopted under the Health and Safety Code, §42.003,
which provides the Texas Board of Health (board) 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 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.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed
with the Office of the Secretary of State on July 2, 2004.
TRD-200404366
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 22, 2004
Proposal publication date: March 26, 2004
For further information, please call: (512) 458-7236
25 TAC §§61.21 - 61.24
The Texas Department of Health (department) adopts amendments
to §§61.21- 61.24, concerning the Diabetic Eye Disease Program (DEDP).
Sections 61.21, and 61.23-61.24 are adopted with changes to the proposed text
as published in the January 30, 2004, issue of the
Texas Register
(29 TexReg 774). Section 61.22 is adopted without changes
and will not be republished.
Government Code, §2001.039, requires that each state agency conduct
a review of its rules every four years and consider for readoption each rule
adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative
Procedure Act). The sections have been reviewed and the department has determined
that reasons for readopting the sections continue to exist. Necessary revisions
to the rules are reflected in this preamble.
The department published a Notice of Intention to Review for §§61.21-61.24
in the January 7, 2000, issue of the
Texas Register
(25 TexReg 218). No comments were received as a result of the publication
of the notice.
The amended sections update language, clarify eligibility requirements
and procedures for eligible persons, and update program benefits.
Amended §61.21 updates language, provides current contact information,
and clarifies the scope of coverage.
Amended §61.22 clarifies patient/client eligibility criteria and changes
the financial eligibility reference from the department's guidelines for clinical
health services to the Health and Human Services-Texas Department of Health
(HHS-TDH) poverty guidelines.
Amended §61.23 includes editorial changes and clarifies that the reimbursement
rate for funduscopic eye exams is up to $60 as recommended by the Texas Diabetes
Council rather than the previously published $40.
Amended §61.24 is editorial for consistent terminology and provides
updated contact information.
The department received no public comments during the comment period for
these amendments. However, the department is making the following minor changes
due to staff comments to clarify the intent and improve the accuracy of the
following sections.
Change: Concerning §61.21(a), a comma was inadvertently omitted after
the words "Hispanics/Latinos" and after the words "Asian Americans." The last
sentence was corrected to state "For these reasons, the Texas Department of
Health (department), or its successor, and the Texas Diabetes Council support
diabetic eye disease screening activities".
Change: Concerning §61.21(b), the acronym "DEDP" was introduced after
the words "Diabetic Eye Disease Program."
Change: Concerning §61.21(c), the phrase "Texas Board of Optometry"
was changed to "Texas Optometry Board" to reflect the correct name of that
agency.
Change: Concerning §61.21(c), (d), §61.24(a) and (g), the references
to "Texas Department of Health" or "TDH" were deleted or replaced with the
words "Texas Diabetes Program" or "department" because the name of the agency
will be changed effective September 1, 2004.
Change: Concerning §61.21(d), the phrase "any additional examinations,"
was deleted in the last sentence because it conflicts with the language in §61.23(b).
Change: Concerning §61.23(b), a period was deleted after the phrase
"twelve month period if needed."
Change: Concerning §61.24(a), the phrase "information requested on
the department's fee-for-service contract and return the completed contract
to the Texas Diabetes Program" replaced "State of Texas...Prevention Program."
This change was made because completion of the Form AP-107 is no longer necessary.
Change: Concerning §61.24(c), the reference to §61.21(e) was
corrected to §61.21(d) because subsection (e) was deleted.
Change: Concerning §61.24(e)(2), the phrase "benefits of" was deleted
because the extra words are not needed.
Change: Concerning §61.24(f)(1), a syntax error exists, and the word
"claims" was changed to read "claim."
Change: Concerning §61.24(h), this subsection is being deleted because
the due process hearing will be addressed in the provider fee-for-service
contract.
Change: Concerning §61.21 and 61.24, the reference to "Texas Department
of Health or its successor (department)" was added, and references to "TDH"
were deleted or amended to the "department" because TDH will have a new agency
name.
After careful consideration of alternatives, the department believes these
rules are the best compromise to maintain this important screening service
to an underserved population, keep the program fiscally sound, and attract
participating providers.
The amendments are adopted under the Health and Safety Code, §103.13,
which requires affected state agencies to implement recommendations of the
Texas Diabetes Council; and §12.001, which provides the Texas Board of
Health (board) with the authority to adopt rules for the performance of each
duty imposed by law on the board, the department, and the commissioner. The
review of the rules implements Government Code, §2001.039.
§61.21.General Information.
(a)
Background. Diabetes is a major cause of blindness in the
United States and in Texas. It is estimated that up to 50% of blindness due
to proliferative diabetic retinopathy could be prevented, or at least delayed,
by prompt detection and treatment. Annual funduscopic examinations are recommended
for nearly all people with diabetes to detect retinopathy before vision is
compromised. Unfortunately, many people with diabetes are not presently being
referred to ophthalmic specialists to receive these annual examinations. While
several factors contribute to the problem, lack of resources is a significant
factor. The prevalence of diabetes is greater among minority populations.
Specifically, the prevalence of diabetes is higher among Hispanics/Latinos,
American Indians, Asian Americans, and African Americans than non-Hispanic
whites. Existing evidence also indicates that minority populations suffer
disproportionately higher rates of complications from diabetes. For these
reasons, the Texas Department of Health or its successor (department), and
the Texas Diabetes Council support diabetic eye disease screening activities.
(b)
Introduction. The purpose of the Diabetic Eye Disease Program
(DEDP) is to provide dilated funduscopic examinations to eligible persons
with diabetes who might otherwise not receive services so that vision-threatening
conditions, such as retinopathy, can be identified and treated. These services
are provided to Texas residents who are at high risk for vision loss due to
diabetes, and who meet the program's income eligibility criteria for services.
(c)
Participating providers. Health care professionals providing
DEDP services must have a current Texas license to practice ophthalmology
or optometry and must be in good standing with the Texas Board of Medical
Examiners or Texas Optometry Board, whichever is applicable. Persons wishing
to become providers should complete the information requested on the department's
fee-for-service contract and return the completed contract to the Texas Diabetes
Program, 1100 West 49th Street, Austin, Texas 78756.
(d)
Procedures for eligible persons receiving services from
the DEDP. Individuals must be referred by regional department staff, local
health departments, or others who have been approved as nominators by the
program. The nominator's responsibility is to assess whether a prospective
client with diabetes meets DEDP eligibility criteria, and to refer the client
to a participating provider. Nominators should also assist in follow-up with
clients and providers regarding missed appointments and any need for subsequent
treatment for eye disease. The nominator will then refer the client and send
a tracking form to the provider. This form is the written authorization for
the provider to perform services. Upon completion of the client's examination,
the provider will forward a copy of the tracking form to the DEDP office and
retain a copy for the provider's record. If treatment is recommended and the
client is to be referred to another facility for treatment, then the provider
will forward a copy of the tracking form to the treatment facility. If the
provider is also performing treatment, the results of the treatment will be
documented on the tracking form and sent to the Texas Diabetes Program in
Austin. However, the DEDP will pay only for the funduscopic eye exam and is
not authorized to pay for eyeglasses, contact lenses, or any indicated follow-up
care.
§61.23.Program Benefits.
(a)
Scope of services.
(1)
Reimbursement will be limited to a maximum of $60 per examination
for a complete dilated funduscopic examination on both eyes.
(2)
These examinations will also include acuity testing, tonometry,
and assessment of lens opacity.
(b)
Maximum allowable benefits. Maximum allowable benefits
per client per year are limited to one annual screening examination. In instances
where eye disease (retinopathy, maculopathy) is detected in the initial exam,
a maximum of two additional follow-up exams may be administered within any
given twelve month period if needed, unless written approval is obtained from
the DEDP.
(c)
Funding limitations. Payment will not be made for any diagnostic
test, corrective lenses, or treatment of eye disease.
§61.24.Payment for Services.
(a)
Payee identification number. Payment for services is made
to providers who have a State of Texas payee identification number. To obtain
a payee identification number, providers must complete the information requested
on the department's fee-for-service contract and return the completed contract
to the Texas Diabetes Program, 1100 West 49th Street, Austin, Texas 78756.
(b)
Conditions for payment. The DEDP will pay providers only
for approved services that have been authorized by the nominator prior to
the performance of such services. Payment for any service will be made only
after the delivery of the service. Providers must agree to accept program
fees as payment in full for service rendered, although such fee may be less
than usual and customary charges.
(c)
Time limit. The eye examination must be completed within
60 days of the service approval date and the signed tracking forms described
in §61.21(d) of this title (relating to General Information) must be
received by the DEDP within 75 days of the date service was authorized.
(d)
Procedures for claims payment. The procedures for claims
payment shall be in accordance with the DEDP-developed publication titled
Manual for Providers of Services.
(e)
Claim denials. Payment for eye examinations will not be
made if:
(1)
the patient is ineligible;
(2)
the services provided were not specifically covered by
the DEDP;
(3)
the patient failed to appear for treatment and no service
was rendered (no-shows); or
(4)
claims for the same eye examination were previously paid
for by the DEDP (duplicate claims).
(f)
Reconsideration of denied claims. A claim that has been
denied in error by the DEDP will be reconsidered for payment if:
(1)
the original claim with the error identified and corrected
is returned to the DEDP within 30 days from receipt of the notice of denial;
and
(2)
the claim is accompanied by a copy of the DEDP notice of
denial.
(g)
Payment of claims that exceed time limit. Eye examinations
must be completed within 60 days from the date services were approved and
the tracking form must be forwarded to the Texas Diabetes Program within 75
days of the date that service was authorized. If special or extenuating circumstances
exist that make it impossible or impractical for the provider to complete
services within that time period, such claims will be evaluated by the department's
Bureau of Chronic Disease and Tobacco Prevention, on an individual basis,
with due consideration given to the circumstances.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on July 5, 2004.
TRD-200404380
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 25, 2004
Proposal publication date: January 30, 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) adopts amendments
to §§123.3, 123.4, 123.6, 123.7, 123.9, 123.10, and 123.12 and new §123.16,
concerning the regulation and certification of respiratory care practitioners.
Sections 123.4, 123.6, and 123.16 are adopted with changes to the proposed
text as published in the March 26, 2004, issue of the
Texas Register
(29 TexReg 3106). Sections 123.3, 123.7 123.9, 123.10,
and 123.12 are adopted without changes, and will not be republished.
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. House Bill 2292, 78th Legislative Session, 2003, §2.42,
added Health and Safety Code, §12.0111, which requires the department
to charge a fee sufficient to cover the cost of administering and enforcing
a license, and Health and Safety Code §12.0112, which requires that the
term for licenses issued or renewed after January 1, 2005, will be 2 years.
Government Code Chapter 2054, Subchapter K, which requires the department
to participate in an electronic system for occupational licensing transactions
directs all department administered licensing programs to participate in 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.
No comments were received during the public comment period.
The department made the following changes due to staff comments to improve
the accuracy of the sections.
Change: Concerning §123.4(1)(A)-(B), new language reflects applicable
fees on applications filed on or before December 31, 2004, and January 1,
2005. Subsequent subparagraphs are renumbered, and a capitalization corrected
from "For" to "for" in new subparagraph (N) and (O) was made.
Change: Concerning §123.6(b)(3)(B), the word "thirty" was replaced
with "30" for consistency among the paragraphs of the subsection.
Change: Concerning §123.6(b)(3)(B)(ii), the word "day" was changed
to "days" for clarity.
Change: Concerning §123.6(b)(4)(B)(i), the word "a" was inserted for
clarity.
Change: Concerning §123.6(f)(3), the word "one" replaces "on" to correct
a misspelling in proposed.
Change: Concerning §123.16(b), the second sentence " The department
shall implement the terms of a final court or attorney general's order suspending
a license without additional review or hearing" was deleted because it was
repeated twice in the same subsection.
The amendments and new section are adopted 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.
§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 for applications
filed on or before December 31, 2004--$60;
(B)
application (includes initial certificate) fee for applications
filed on or after January 1, 2005--$120;
(C)
for a license issued for a one year term is $45;
(D)
for a license issued for a two year term is $90;
(E)
certificate and/or identification card replacement fee--$20;
(F)
NBRC examination fee--the fee designated by the NBRC at
the time of examination or reexamination;
(G)
certificate fee for upgrade of temporary permit--$30;
(H)
written verification of certification status--$10;
(I)
returned check fee--$50;
(J)
annual inactive status fee--$25;
(K)
reinstatement fee for a license that was suspended for
failure to pay child support--$50;
(L)
one to 90 days late renewal fee--one and one half times
the normally required renewal fee;
(M)
91days to one year late renewal fee--two times the normally
required renewal fee;
(N)
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
(O)
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)
Schedule of fees for a temporary permit as a respiratory
care practitioner:
(A)
application (including initial permit) fee--$50;
(B)
temporary permit extension fee--$20;
(C)
temporary permit and/or identification card replacement
fee--$20;
(D)
written verification of certification status--$10;
(E)
returned check fee--$50.
(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)
If the department's notice, as set out in paragraph 3 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.
(5)
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.
§123.6.Application Requirements and Procedures.
(a)
General.
(1)
Unless otherwise indicated, an applicant must submit all
required information and documentation of credentials on official department
forms.
(2)
The department shall not consider an application as officially
submitted until the applicant pays the application fee and the fee clears
the appropriate financial institution. The fee must accompany the application
form.
(3)
The administrator shall send a notice listing the additional
materials required to an applicant who does not complete the application in
a timely manner. An application not completed within 30 days after the date
of the notice shall be invalid.
(b)
Required application materials.
(1)
Application form. The application form shall contain:
(A)
specific information regarding personal data, social security
number, birth month and day, place of employment, other state licenses and
certifications held, misdemeanor and felony convictions, educational and training
background, and work experience;
(B)
a statement that the applicant has read the Act and these
sections and agrees to abide by them;
(C)
the applicant's permission to the department to seek any
information or references it deems fit to determine the applicant's qualifications;
(D)
a statement that the applicant, if issued a certificate
or temporary permit, shall return the certificate or temporary permit and
identification card(s) to the department upon the revocation or suspension
of the certificate or temporary permit;
(E)
a statement that the applicant understands that fees submitted
are nonrefundable;
(F)
a statement that the applicant understands that materials
submitted become the property of the department and are nonreturnable (unless
prior arrangements have been made);
(G)
a statement that the information in the application is
truthful and that the applicant understands that providing false information
of any kind may result in the voiding of the application and failure to be
granted a certificate or permit, or the revocation of a certificate or permit
issued;
(H)
a statement that if issued a certificate or permit the
practitioner shall keep the department advised of his or her current mailing
address; and
(I)
the signature of the applicant which has been dated;
(J)
a full-face color photograph signed on the reverse side
with the applicant's signature as it appears on the application. The photograph
must have been taken within the two year period prior to application to the
department and the minimum size is one and one-half inches by one and one-half
inches.
(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 30 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 days of the completion date.
(4)
Examination results.
(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 a 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)
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.
(6)
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.
(c)
Information/Documentation form. Persons applying for any
certificate or permit who are licensed, registered, or otherwise regulated
in any profession at the time of application to the department must submit
with their applications a properly completed information/documentation form
signed by an agency official.
(d)
Application processing.
(1)
Time periods. The department shall comply with the following
procedures in processing applications for a permit or certificate.
(A)
The following periods of time shall apply from the date
of receipt of an application until the date of issuance of a written notice
that the application is complete and accepted for filing or that the application
is deficient and additional specific information is required. A written notice
stating that the application has been approved may be sent in lieu of the
notice of acceptance of a complete application. The time periods are as follows:
(i)
letter of acceptance of application for permit or certification--14
working days. The notice of acceptance may include a statement that an application
for temporary permit received more than 45 days from the date of the applicant's
graduation will be held pending until the applicant is within 45 days of graduation;
and
(ii)
letter of application deficiency--14 working days.
(B)
The following periods of time shall apply from the receipt
of the last item necessary to complete the application until the date of issuance
of written notice approving or denying the application. The time periods for
denial include notification of the proposed decision and of the opportunity,
if required, to show compliance with the law, and of the opportunity for a
formal hearing. The time periods are as follows:
(i)
letter of approval--14 working days; and
(ii)
letter of denial of permit or certificate--180 working
days.
(2)
Reimbursement of fees.
(A)
In the event an application is not processed in the time
periods stated in paragraph (1) of this subsection, the applicant has the
right to request reimbursement of all fees paid in that particular application
process. Requests for reimbursement shall be made to the program administrator.
If the program administrator does not agree that the time period has been
violated or finds that good cause existed for exceeding the time period, the
request will be denied.
(B)
Good cause for exceeding the time period is considered
to exist if the number of applications for licensure and licensure renewal
exceeds by 15% or more the number of applications processed in the same calendar
quarter the preceding year, another public or private entity relied upon by
the department in the application process caused the delay, or any other condition
exists giving the department good cause for exceeding the time period.
(3)
Appeal. If a request reimbursement under paragraph (2)
of this subsection is denied by the program administrator, the applicant may
appeal to the commissioner of health for a timely, resolution of any dispute
arising from a violation of the time periods. The applicant shall give written
notice to the commissioner of health at the address of the department that
he or she requests full reimbursement of all fees paid because his or her
application was not processed within the applicable time period. The program
administrator shall submit a written report of the facts related to the processing
of the application and of any good cause for exceeding the applicable time
period. The commissioner of health shall provide written notice of the decision
to the applicant and the program administrator. An appeal shall be decided
in favor of the applicant if the applicable time period was exceeded and good
cause was not established. If the appeal is decided in favor of the applicant,
full reimbursement of all fees paid in that particular application process
shall be made.
(4)
Contested cases. The time periods for contested cases related
to the denial of licensure renewals are not included with the time periods
stated in paragraph (1) of this subsection. The time period for conducting
a contested case hearing runs from the date the department receives a written
request for a hearing and ends when the decision of the department is final
and appealable. a hearing may be completed within one to four months, but
may extend for a longer period of time depending on the particular circumstances
of the hearing.
(e)
Application approval.
(1)
The department shall be responsible for reviewing all applications.
(2)
The department 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.
(f)
Disapproved applications.
(1)
The department shall disapprove the application if the
person:
(A)
has not completed the requirements in subsection (b) of
this section;
(B)
has failed to pass the examination prescribed by the board
as set out in §123.8 of this title (relating to Examination) during the
period for which the temporary certificate, or temporary permit or temporary
permit extension, was valid, if applicable;
(C)
has failed to remit any applicable fees required in §123.4
of this title (relating to Fees);
(D)
has failed or refused to properly complete or submit any
application form(s) or endorsement(s), or presented false information on the
application form, or any other form or document required by the department
to verify the applicant's qualifications;
(E)
has been in violation of the Act, §123.14 of this
title (relating to Violations, Complaints, and Subsequent Actions), the code
of ethics as set out in §123.12 of this title (relating to Professional
and Ethical Standards), or any other applicable provision of this chapter;
(F)
has been convicted of a felony or misdemeanor, if the crime
directly relates to the duties and responsibilities of a respiratory care
practitioner as set out in §123.13 of this title (relating to Certifying
or Permitting Persons with Criminal Backgrounds To Be Respiratory Care Practitioners);
(G)
holds a license, certification, or registration to practice
respiratory care in another state or jurisdiction and that license, certification,
or registration has been suspended, revoked, or otherwise restricted by the
licensing entity in that state or jurisdiction for reasons to the person's
professional competence or conduct which could adversely affect the health
and welfare of a patient;
(H)
is not currently practicing, or has not practiced within
the 12-month period preceding the date of application, respiratory care, as
set out in §123.7(d)(1)(B) of this title (relating to Types of Certificates
and Temporary Permits and Applicant Eligibility); or
(I)
has submitted a copy of a National Board for Respiratory
Care, Inc. (NBRC) certificate in lieu of examination results in accordance
with subsection (b)(4)(B)(i) of this section, but is not recognized by the
NBRC as a certified respiratory therapist or registered respiratory therapist.
(2)
If after review the administrator determines that the application
should not be approved, the administrator shall give the applicant written
notice of the reason for the proposed decision and of the opportunity for
a formal hearing. The formal hearing shall be conducted according to the Administrative
Procedure Act, Texas Government Code 2001, et seq. Within 10 days after receipt
of the written notice, the applicant shall give written notice to the administrator
that the applicant either waives the hearing, or wants the hearing. Receipt
of the written notice is deemed to occur on the tenth day after the notice
is mailed unless another date of receipt is reflected on a United States Postal
Service return receipt. If the applicant fails to respond within 10 days after
receipt of the notice of opportunity, or if the applicant notifies the administrator
that the hearing be waived, the applicant is deemed to have waived the hearing.
If the hearing has been waived, the department shall disapprove the application.
(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 one 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.
§123.16.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 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 adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on July 2, 2004.
TRD-200404352
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 22, 2004
Proposal publication date: March 26, 2004
For further information, please call: (512) 458-7236
The Texas Department of Health (department) adopts 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. Sections 125.2, 125.12,
125.31, 125.32, 125.82, 125.83, 125.91 - 125.95 are adopted with changes to
the proposed text as published in the March 26, 2004, issue of the
Texas Register
(29 TexReg 3109). Sections 125.1, 125.3, 125.11, 125.13
- 125.15, 125.33 - 125.35, 125.51, 125.61, 125.62, 125.71 - 125.73, 125.81,
and 125.96 are adopted without changes, and therefore the sections will not
be republished.
These rules are adopted 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 a rule on
this subject is needed; however, the rules needed revision as described in
this preamble. The repeals and new sections are required as a result of the
provisions of Senate Bill (SB) 1152, 78th Legislature, Regular Session, 2003,
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, Regular Session, 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 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
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 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 the proposed repeal of §125.6.
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 I, 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.
The following comments were received concerning the proposed sections during
the comment period. Following each comment is the department's response and
any resulting change(s).
Comment: Concerning §125.2, one commenter requested the department
add definitions for "advanced practice nurse" and "practitioner" in order
to be consistent with other statutes, regulations, and current practice. The
commenter stated that nurse practitioners and clinical nurse specialists are
two types of advanced practice nurses who frequently work with physicians
in providing medical care in hospitals and nursing and hospice facilities
in accordance with state law and Centers for Medicare and Medicaid Services
regulations and guidelines.
Response: The department agrees and has added the requested definitions
for "advanced nurse practitioner" and "practitioner." The new definitions
are provided in §125.2(1) and (25).
Comment: Concerning §125.2(17) of the proposed rules, one commenter
pointed out that both registered nurses and licensed vocational nurses are
now included under Occupations Code, Chapter 301, and recommended that the
definition reflect this change. The commenter further stated that both registered
and vocational nurses are licensed by the Board of Nurse Examiners and recommended
that the definition reflect the change.
Response: The department agrees with the commenter and has changed Occupations
Code, Chapter 302 to Occupations Code, Chapter 301, and has deleted the word
"Vocational" to reflect the correct name of the licensing board, Board of
Nurse Examiners. The paragraph is renumbered §125.2(18).
Comment: Concerning §125.32(b)(3), one commenter suggested that the
word "notify" be changed to "notifying" in the paragraph.
Response: The department agrees and has replaced the incorrect word as
suggested.
Comment: Concerning §125.32(c) in general, one commenter recommended
changes be made throughout the subsection so that references to physicians
would also include other practitioners, and that nurses in special care facilities
should be permitted to accept orders from physicians, dentists, podiatrists,
physician assistants and advanced practice nurses in accordance with Board
of Nurse Examiners rules and position papers.
Response: The department agrees with the commenter and has made the recommended
changes in §125.32(c)(1), (3), (7) and (8).
Comment: Concerning §125.32(c)(7)(B), one commenter recommended the
phrase "or controlled substances" be inserted after "dangerous drugs" in the
subparagraph because the Health and Safety Code definition of "dangerous drugs"
excludes controlled substances.
Response: The department agrees and has inserted the suggested phrase in
the rule.
The department is making the following minor changes due to staff comments
to clarify the intent and improve the accuracy of the sections.
Change: Concerning §125.2(7) and (10), renumbered as §125.2(8)
and (11), "or its successor" was added after "Health" because the agency name
will change and the Board of Health will be dissolved on September 1, 2004.
Change: Concerning §125.2(27), renumbered as §125.2(29), the
reference to the section relating to Residential AIDS Hospice Designation
was corrected to §125.35.
Change: Concerning §125.12(a)(2), the reference to §125.95 of
this title was changed to reflect the correct title, which is Construction,
Inspections, and Approval of Projects for New or Existing Facilities in the
Absence of Local Codes and Regulations.
Change: Concerning Chapter 125, the name of Subchapter C was changed to
Operational Requirements.
Change: Concerning §125.31(a)(3)(A)(ii), the comma was deleted following
"and" in conjunction with
Texas Register
format.
Change: Concerning §125.82(a), the catch title in subsection (a) was
eliminated to be consistent with the formatting in the section.
Change: Concerning §125.83(a), superfluous language was deleted from
the end of the subsection.
Change: Concerning §125.83(a)(2)(B), the first sentence of the subparagraph
was reorganized for clarification.
Change: Concerning §125.91(c)(3)(D)(vi)(II), the reference to the
section relating to Preparation, Submittal, Review and Approval of Plans was
corrected to §125.94, and the comma was removed after the word "Review"
to reflect the correct punctuation in the title of the section.
Change: Concerning §125.92(g)(1), the first sentence of the paragraph
was reworded for clarification.
Change: Concerning §125.93(f)(2), the measurement for the elevator
car door opening was changed from inches to feet for consistency with other
measurements in the subsection.
Change: Concerning §125.94(a)(2)(C), the word "be" was added to correct
a grammatical error.
Change: Concerning §125.95(b), the word "surveys" was changed to "inspections"
for consistency with the terminology in the subsection.
Change: Concerning §125.95(b)(1), the word "inspection" was changed
to "inspections" to correct a grammatical error.
Change: Concerning §125.95(b)(3), the word "a" was changed to "an"
for grammatical correctness.
Change: Concerning §125.95(c), the word "or" was changed to "and"
to clarify that the department must also approve the structure prior to occupancy.
The commenter was the Coalition for Nurses in Advanced Practice. The commenter
was neither for nor against the rules in their entirety; however, the commenter
expressed concerns and made recommendations for change as discussed in the
summary of comments.
25 TAC §§125.1 - 125.9
The repeals are adopted 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.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on July 5, 2004.
TRD-200404371
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 25, 2004
Proposal publication date: March 26, 2004
For further information, please call: (512) 458-7236
Subchapter A. GENERAL PROVISIONS
25 TAC §§125.1 - 125.3
The new sections are adopted 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.
§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)
Advanced practice nurse--A registered nurse approved by
the Texas Board of Nurse Examiners to practice as an advanced practice nurse.
The term includes a nurse practitioner, nurse-midwife, nurse anesthetist,
and a clinical nurse specialist.
(2)
Applicant--The person legally responsible for the operation
of the facility, whether by lease or ownership, who seeks a license from the
department.
(3)
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.
(4)
AIDS--Acquired immune deficiency syndrome.
(5)
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.
(6)
Bereavement--The process by which a survivor of a deceased
person mourns and experiences grief.
(7)
Bereavement services--Support services offered to a family
during bereavement. Family includes a significant other(s).
(8)
Board--The Texas Board of Health or its successor.
(9)
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.
(10)
Dangerous drugs--Any dangerous drug as defined in the
Texas Dangerous Drug Act, Health and Safety Code, §483.001.
(11)
Department--The Texas Department of Health or its successor.
(12)
Dietitian--A person who is currently licensed by the Texas
State Board of Examiners of Dietitians.
(13)
Director--The director of the Health Facility Licensing
and Compliance Division of the Texas Department of Health or his or her designee.
(14)
Facility--A special care facility.
(15)
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.
(16)
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.
(17)
Incident--An unusual or abnormal event or occurrence in,
at, or affecting the facility or the residents of the facility.
(18)
Licensed vocational nurse--An individual who is currently
licensed as a licensed vocational nurse (LVN) by the Board of Nurse Examiners
in accordance with Texas Occupations Code, Chapter 301.
(19)
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.
(20)
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.
(21)
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.
(22)
Palliative care--Services that focus primarily on the
reduction or abatement of physical, psychosocial, and spiritual symptoms of
a terminal illness.
(23)
Pharmacist--A person who is licensed to practice pharmacy
by the Texas Board of Pharmacy in accordance with Texas Occupations Code,
Chapter 558.
(24)
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.
(25)
Practitioner--A physician, podiatrist, dentist, or an
advanced practice nurse or physician assistant to whom a physician has delegated
authority to sign a prescription order, when relating to pharmacy services.
(26)
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.
(27)
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.
(28)
Resident--An individual accepted for care in a special
care facility.
(29)
Residential AIDS hospice--A special care facility licensed
and designated as a residential AIDS hospice in accordance with §125.35
of this title (relating to Residential AIDS Hospice Designation).
(30)
Social worker--A person who is currently licensed as a
social worker in accordance with Texas Occupations Code, Chapter 505.
(31)
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.
(32)
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.
This agency hereby certifies that the adoption has been
reviewed by legal counsel and found to be a valid exercise of the agency's
legal authority.
Filed
with the Office of the Secretary of State on July 5, 2004.
TRD-200404372
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 25, 2004
Proposal publication date: March 26, 2004
For further information, please call: (512) 458-7236
25 TAC §§125.11 - 125.15
The new sections are adopted 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.
§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 Projects for New or Existing
Facilities in the Absence of Local Codes and Regulations).
(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.
This agency hereby certifies that the adoption has been
reviewed by legal counsel and found to be a valid exercise of the agency's
legal authority.
Filed
with the Office of the Secretary of State on July 5, 2004.
TRD-200404373
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 25, 2004
Proposal publication date: March 26, 2004
For further information, please call: (512) 458-7236
25 TAC §§125.31 - 125.35
The new sections are adopted 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.
§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 notifying the attending physician.
(c)
Medications.
(1)
Medications shall be provided as required for those residents
on a physician or practitioner-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 or an advanced
practice nurse working in collaboration with 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 or controlled
substances 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
or practitioner. 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 or practitioner.
(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 or practitioner'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 or practitioner 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.
This agency hereby certifies that the adoption has been
reviewed by legal counsel and found to be a valid exercise of the agency's
legal authority.
Filed
with the Office of the Secretary of State on July 5, 2004.
TRD-200404374
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 25, 2004
Proposal publication date: March 26, 2004
For further information, please call: (512) 458-7236
25 TAC §125.51
The new section is adopted 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.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed
with the Office of the Secretary of State on July 5, 2004.
TRD-200404375
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 25, 2004
Proposal publication date: March 26, 2004
For further information, please call: (512) 458-7236
25 TAC §125.61, §125.62
The new sections are adopted 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.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed
with the Office of the Secretary of State on July 5, 2004.
TRD-200404376
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 25, 2004
Proposal publication date: March 26, 2004
For further information, please call: (512) 458-7236
25 TAC §§125.71 - 125.73
The new sections are adopted 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.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed
with the Office of the Secretary of State on July 5, 2004.
TRD-200404377
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 25, 2004
Proposal publication date: March 26, 2004
For further information, please call: (512) 458-7236
25 TAC §§125.81 - 125.83
The new sections are adopted 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.
§125.82.Emergency Preparedness.
(a)
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.
(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, as the term is defined in §125.3(b)(2)
of this title, the fire evacuation classification rating 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 adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed
with the Office of the Secretary of State on July 5, 2004.
TRD-200404378
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 25, 2004
Proposal publication date: March 26, 2004
For further information, please call: (512) 458-7236
25 TAC §§125.91 - 125.96
The new sections are adopted 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.
§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 §125.94
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)
If the SCF houses both male and female residents, all bedrooms
shall have separate private, connecting, or general toilet rooms for each
sex. 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 four feet 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 be 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 inspections.
(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 inspections 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
an 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 and 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.
This agency hereby certifies that the adoption has been
reviewed by legal counsel and found to be a valid exercise of the agency's
legal authority.
Filed
with the Office of the Secretary of State on July 5, 2004.
TRD-200404379
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 25, 2004
Proposal publication date: March 26, 2004
For further information, please call: (512) 458-7236
The Texas Department of Health (department) adopts amendments to §§128.3,
128.9, and 128.11-128.12, the repeal of §128.5, and new §128.5,
concerning the regulation of persons filling contact lens prescriptions without
changes to the proposed text as published in the April 30, 2004, issue of
the
Texas Register
(29 TexReg 4052), and therefore
the sections will not be republished.
The repeal and new rule implement the "Fairness to Contact Lens Consumers
Act", Public Law 108-164, a change in federal law affecting the dispensing
of contact lenses. The amendments are necessary to implement House Bill 2985,
78th Legislature, 2003, which added Occupations Code, Chapter 101, Subchapter
G, which establishes the Office of Patient Protection within the Health Professions
Council and requires additional fees to fund it; Senate Bill 1152, 78th Legislature,
2003, which amended Government Code, Chapter 2054, to require participation
in Texas Online; House Bill 2292, 78th Legislature, 2003, which revised Health
and Safety Code, §§12.0111 and 12.0112, and requires two-year licenses
effective January 1, 2005; and Senate Bill 161, 78th Legislature, 2003, which
amends Occupations Code, Chapter 353, relating to emergency suspension. The
amendments also clarify the department's current complaint process.
The department received no public comments during the comment period for
these amendments.
25 TAC §§128.3, 128.5, 128.9, 128.11, 128.12
The amendments and new section are adopted under the Occupations
Code, Chapter 353, which authorizes the Board of Health (board) to adopt rules
necessary to implement the section; 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.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on July 1, 2004.
TRD-200404342
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 21, 2004
Proposal publication date: April 30, 2004
For further information, please call: (512) 458-7236
25 TAC §128.5
The repeal is adopted under the Occupations Code, Chapter
353, which authorizes the Board of Health (board) to adopt rules necessary
to implement the section; 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.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed
with the Office of the Secretary of State on July 1, 2004.
TRD-200404343
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 21, 2004
Proposal publication date: April 30, 2004
For further information, please call: (512) 458-7236
25 TAC §§129.4, 129.7 - 129.9, 129.11
The Texas Department of Health (department) adopts amendments
to §§129.4, 129.7 - 129.9, and 129.11, concerning the voluntary
registration of opticians. Section 129.4 is adopted with changes to the proposed
text as published in the April 30, 2004, issue of the
Texas Register
(29 TexReg 4053). Sections 129.7 - 129.9, and 129.11
are adopted without changes, and therefore the sections will not be republished.
The amendments are necessary to implement House Bill 2985, 78th Legislature,
2003, which added Occupations Code, Chapter 101, Subchapter G, which establishes
the Office of Patient Protection within the Health Professions Council and
requires additional fees to fund it; Senate Bill 1152, 78th Legislature, 2003,
which amended Government Code, Chapter 2054, to require participation in Texas
Online; House Bill 2292, 78th Legislature, 2003 which revised Health and Safety
Code, §12.0111 and §12.0112, and requires two-year licenses effective
January 1, 2005; and Senate Bill 161, 78th Legislature, 2003 which amends
Occupations Code, Chapter 352, relating to emergency suspension.
The department received no public comments during the comment period for
these amendments. However, the department made minor editorial changes due
to staff comments to clarify the amendment to §129.4.
Change: Concerning §129.4(a)(1), the fee for an initial registration
issued for a two-year term is increased to twice the fee required to issue
a registration for a term of one year.
Change: Concerning §129.4(a)(2), the fee for an initial dual registration
issued for a two-year term is increased to twice the fee required to issue
a registration for a term of one year.
The amendments are adopted under the Occupations Code, Chapter
352, which authorizes the Board of Health (board) to adopt procedural and
substantive rules in accordance with the statute; 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.
§129.4.Fees.
(a)
Schedule of fees. The fees are as follows:
(1)
application and registration fee:
(A)
for a registration issued for one year--$50;
(B)
for a registration issued for two years--$100;
(2)
initial dual application and registration fee:
(A)
for a registration issued for one year--$80;
(B)
for a registration issued for two years--$160;
(3)
registration renewal fee;
(A)
for a registration issued for one year--$50;
(B)
for a registration issued for two years--$100;
(4)
dual registration renewal fee;
(A)
for a registration issued for one year--$80;
(B)
for a registration issued for two years--$160;
(5)
late registration fee--a fee that is one and one-half times
the registration renewal fee if renewed within 90 days of expiration or a
fee that is two times the registration renewal fee if renewed more than 90
days but less than one year after expiration;
(6)
duplicate certificate fee--$20; and
(7)
examination fee--the then current fee assessed by the Texas
Department of Health's (department's) designee for the examination.
(b)
Payment of fees. If paid by mail, all fees shall be submitted
in the form of a personal check, certified check for guaranteed funds or a
money order made payable to the Texas Department of Health. If submitted in
person, cash may be accepted by the department's cashier.
(c)
Nonrefundable fees. All fees submitted to the department
are nonrefundable.
(d)
For all applications and renewal applications, the department
is authorized to collect fees to fund the Office of Patient Protection, Health
Professions Council, as mandated by law.
(e)
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.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on July 1, 2004.
TRD-200404346
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 21, 2004
Proposal publication date: April 30, 2004
For further information, please call: (512) 458-7236
25 TAC §§130.4, 130.11, 130.12, 130.15, 130.20
The Texas Department of Health (department) adopts amendments
to §§130.4, 130.11, 130.12. 130.15, and 130.20, concerning the registration
of code enforcement officers. Section 130.4 is adopted with changes to the
proposed text as published in the April 30, 2004, issue of the
Texas Register
(29 TexReg 4055) as a result of staff recommendations.
Sections 130.11, 130.12, 130.15, and 130.20 are adopted without changes, and
therefore the sections will not be republished.
The amendments are necessary to implement House Bill 2985, 78th Legislature,
2003, which added Occupations Code, Chapter 101, Subchapter G, which establishes
the Office of Patient Protection within the Health Professions Council and
requires additional fees to fund it; Senate Bill 1152, 78th Legislature, 2003,
which amended Government Code, Chapter 2054, to require participation in Texas
Online; House Bill 2292, 78th legislature, 2003 which revised Health and Safety
Code, §§12.0111 and 12.0112, and requires two-year licenses effective
January 1, 2005; and Senate Bill 161, 78th Legislature, 2003, which amends
Occupations Code, Chapter 1952, relating to administrative penalties.
Amendments to §130.4 clarify that the application fee for a registration
with a two-year term will be equal to the fee required for a renewal for a
two-year term.
The department received no public comments during the comment period for
these amendments. However, the department made a minor editorial change due
to staff comments to clarify the rules in the amendment to §130.4.
Change: Concerning §130.4(a)(1), the application fee for a registration
issued for a two-year term is increased to equal the fee required to renew
a registration for a term of two years.
The amendments are adopted under the Occupations Code, Chapter
1952, which authorizes the Board of Health (board) to adopt standards, education
requirements, and fees by rule for the registration of code enforcement officers;
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.
§130.4.Fees.
(a)
The schedule of fees is as follows:
(1)
application fee (includes initial registration):
(A)
for a registration issued for a one year term--$50; and
(B)
for a registration issued for a two year term--$100;
(2)
renewal fee:
(A)
for a registration issued for a one year term--$50; and
(B)
for a registration issued for a two year term--$100;
(3)
reinstatement fee--$50;
(4)
registration fee for an upgrade (for code enforcement officers
in training)--$20;
(5)
certificate or identification card replacement fee--$20
each;
(6)
examination fees:
(A)
department administered--$50; or
(B)
administered by department's designee--the amount specified
in the contract between the department and the designee, not to exceed $50;
and
(7)
reexamination fee--$50.
(b)
All fees are nonrefundable.
(c)
All fees shall be submitted in the form of certified checks
for guaranteed funds; money orders; checks from state agencies, municipalities,
counties; or other political subdivisions of the state made payable to the
department.
(d)
For all applications and renewal applications, the department
is authorized to collect fees to fund the Office of Patient Protection, Health
Professions Council, as mandated by law.
(e)
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.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on July 1, 2004.
TRD-200404345
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 21, 2004
Proposal publication date: April 30, 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) adopts an amendment
to §169.26, concerning facilities for the quarantining or impounding
of animals. Section 169.26 is adopted without changes to the proposed text
as published in the March 26, 2004, issue of the
Texas Register
(29 TexReg 3141) and will not be republished.
The section is amended to clarify 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.
The following comments were received concerning the proposed amendment.
Following the comments are the department's response and any resulting change(s).
Comment: Three commenters agree with proposed §169.26 in its entirety.
Response: The department agrees with the commenters. No change was made
as a result of the comments.
Three individual commenters were in favor of the rule in its entirety.
After careful consideration of the alternatives, the department adopts
these amendments as the best compromise between preserving public health,
humane treatment of quarantined and impounded animals, and the economic limitations
of the entities which operate these facilities.
The amendment is adopted under Texas Health and Safety Code,
Chapter 826, "Rabies," §826.011, which requires the Texas Board of Health
(board) to administer this program; §826.051, which requires the board
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.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on July 1, 2004.
TRD-200404347
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 21, 2004
Proposal publication date: March 26, 2004
For further information, please call: (512) 458-7236
The Texas Department of Health (department) adopts 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. Sections 181.1 and 181.28
are adopted with changes to the proposed text as published in the March 26,
2004, issue of the
Texas Register
(29 TexReg
3141). The amendments to §§181.2, 181.5-181.8, 181.10, 181.13-181.14,
181.22-181.24, 181.26, 181.29-181.32, 181.44-181.45 and new §§181.33-181.34
are adopted without changes and will not be republished.
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.
There were no comments received concerning the proposed rules, however,
minor revisions were made due to staff comments.
Change: Concerning §181.1(4), the word "Certification" was changed
to "Certified" for clarity.
Change: Concerning §181.28(c)(1), the word "document" was replaced
with the word "documents" to correct grammar.
Subchapter A. MISCELLANEOUS PROVISIONS
25 TAC §§181.1, 181.2, 181.5 - 181.8, 181.10, 181.13, 181.14
The amendments are adopted 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.
§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)
Applicant--A person who requests a service pertaining to
a record of birth or death, verification of marriage or divorce, or release
of personal data. (Also, see definition for properly qualified applicant).
(2)
Birth records--Records governing births filed pursuant
to the Texas Vital Statistics Act, the Health and Safety Code, Title 3.
(3)
Bureau of Vital Statistics (Bureau)--The office within
the Texas Department of Health charged with the implementation of the Texas
Vital Statistics Act.
(4)
Certified--A certified statement, form, or letter, of the
facts stated on the form or document as filed in the Bureau of Vital Statistics,
certified by the state registrar or duly appointed designee, over the respective
signature and may bear the seal of the Bureau of Vital Statistics.
(5)
Certified copy--An abstract or photocopy of the original
record issued as filed with the Bureau of Vital Statistics, and issued on
a designated form or security paper which shall bear the "state seal", the
Texas Department of Health-Bureau of Vital Statistics or the seal of their
office, and the facsimile signature of the State Registrar or the local registration
official.
(6)
Dead body--A lifeless human body or such parts of the human
body or the bones thereof from the state of which it may be reasonably concluded
that death occurred.
(7)
Disinterment--To exhume, unbury, or take out of the grave.
(8)
Death records--Records governing deaths and fetal deaths
filed pursuant to the Texas Vital Statistics Act.
(9)
Department--The Texas Department of Health.
(10)
Embalming--The act of disinfecting or preserving a human
dead body, entire or in part, by the use of chemical substances, fluids, or
gases in the body; or by the introduction of the same into the body by vascular
or hypodermic injection; or by direct application into the organs or cavities;
or by any other method intended to disinfect or preserve a dead body or restore
body tissues and structures.
(11)
Fetal death (stillbirth)--Death prior to the complete
expulsion or extraction from its mother of a product of conception, irrespective
of the duration of pregnancy; the death is indicated by the fact that after
such separation, the fetus does not breathe or show any other evidence of
life such as beating of the heart, pulsation of the umbilical cord, or definite
movement of voluntary muscles.
(12)
Genealogist--An individual who traces the descent of persons
or families. He or she may be an individual family member or a person hired
by the family to trace a family tree or do family research.
(13)
Identification of applicant--Each applicant must present
a current form of government issued photo identification along with his or
her application. If the applicant is unable to present a current form of photo
identification, two valid supporting forms of identification may be presented,
one of which bears the applicant's signature.
(14)
Immediate family member--The registrant, his or her guardian,
or the children, spouses, parents, siblings, or grandparents of the registrant.
(15)
Indexes--An index to or listing of birth records, death
records, applications for marriage licenses, and reports of divorce or annulment
of marriage.
(A)
Consolidated indexes--These indexes are vital records consisting
of more than one event year. Consolidated indexes may be prepared for any
vital event at the discretion of the State Registrar in the form prescribed.
(B)
General birth and death indexes--These indexes are maintained
or established by the bureau of vital statistics or a local registration official
which shall be prepared by event year, in alphabetical order by surname of
the registrant, followed by any given names or initials, the date of the event,
the county of occurrence, the state or local file number, the name of the
father, the maiden name of the mother, and sex of the registrant.
(C)
Summary birth and death index--These indexes are maintained
or established by the Bureau of Vital Statistics or a local registration official
which shall be prepared by event year, in alphabetical order by surname of
the registrant, followed by any given names or initials, the date of the event,
the county of occurrence, and sex of the registrant.
(16)
Interment--Burial or the act of placing in a grave.
(17)
Legal representative (personal representative or agent)--An
attorney in fact, a funeral director, or any other person designated by affidavit,
contract, or court order acting on behalf and for the benefit of the registrant
or his or her immediate family. In order to determine the need for protection
for personal property rights when the legal representative is acting on behalf
and for the benefit of the registrant or the registrant's immediate family
or other entity having a direct and tangible interest in the record, the state
registrar, local registrar, or county clerk shall require a designation document
or an attested statement to that effect.
(18)
Live birth--The complete expulsion or extraction from
its mother of a product of conception, irrespective of the duration of pregnancy,
which, after such separation, breathes or shows any other evidence of life
such as beating of the heart, pulsation of the umbilical cord, or definite
movement of voluntary muscles, whether or not the umbilical cord has been
cut or the placenta is attached; each product of such a birth is considered
live born.
(19)
Local registration official--A county clerk or person
authorized by the Vital Statistics Act to maintain a duplicate system of records
for each birth, death, or fetal death that occurs in the person's jurisdiction.
(20)
Non-institutional Birth--A birth occurring outside a hospital
or birthing center licensed by the Texas Department of Health.
(21)
Person in charge of interment--Any person who places or
causes to be placed a fetus, dead body or the ashes, after cremation, in a
grave, vault, urn, or other receptacle, or otherwise disposes thereof.
(22)
Properly qualified applicant (qualified applicant)--The
registrant, or immediate family member either by blood, marriage or adoption,
his or her guardian, or his or her legal agent or representative. Local, state
and federal law enforcement or governmental agencies and other persons may
be designated as properly qualified applicants by demonstrating a direct and
tangible interest in the record when the information in the record is necessary
to implement a statutory provision or to protect a personal legal property
right. A properly qualified applicant may also be a person who has submitted
an application for a request to release personal information and has been
approved as outlined in §181.11 of this title (relating to Requests for
Personal Data).
(23)
Registrant--The individual named on the certificate of
birth, death, or fetal death; application for marriage license; or report
of divorce or annulment of marriage.
(24)
Registrar--The State Registrar or a local registrar as
recognized by the Texas Department of Health, Bureau of Vital Statistics.
(25)
Research copy--A plain paper noncertified reproduction
of the complete original document or a portion of the original document.
(26)
Search--The act of examining the files and/or indexes
maintained by the Bureau of Vital Statistics for a specific record or information.
(27)
Signature--The name of a person written with his or her
own hand; or by an electronic process approved by the State Registrar.
(28)
State Registrar--The Chief, Bureau of Vital Statistics,
Texas Department of Health.
(29)
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.
(30)
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.
(31)
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.
(32)
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.
(33)
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.
(34)
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.
(35)
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.
(36)
Vital Statistics Act--The Health and Safety Code, Title
3.
This agency hereby certifies that the adoption has been
reviewed by legal counsel and found to be a valid exercise of the agency's
legal authority.
Filed with the Office of
the Secretary of State on July 2, 2004.
TRD-200404361
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 22, 2004
Proposal publication date: March 26, 2004
For further information, please call: (512) 458-7236
25 TAC §§181.22 - 181.24, 181.26, 181.28 - 181.34
The amendments and new rules are adopted 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.
§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)
a full reproduction of the legal portion of the original
record as filed in their office with any addendum(s); or
(B)
an abstract of birth facts, taken from the original record.
Probate records and delayed records may not be abstracted. An abstract shall
be issued in one of four styles:
(i)
a standard certified abstract;
(ii)
a wallet-sized certified abstract;
(iii)
a typewritten certified abstract prepared in accordance
with Health and Safety Code, §192.005 or §192.011, or when the condition
of the original record does not permit full reproduction; or
(iv)
an heirloom style certified abstract which may only be
issued by the State Registrar.
(2)
Each certified copy of a record, or abstract of birth facts,
shall be issued over the signature or facsimile thereof of the officer to
whom the record is entrusted, and shall bear the seal of their office, and
a statement of certification:
(A)
either as a part of the custodian's files; or
(B)
as authorized to be issued from the state registrar's file.
(3)
All certified copies of birth records shall include the
following information, if known:
(A)
state or local file number;
(B)
given name(s);
(C)
surname;
(D)
date of birth;
(E)
state, and city or county of birth;
(F)
sex;
(G)
father's name;
(H)
mother's maiden name;
(I)
date of filing;
(J)
date certified copy issued;
(K)
certification statement;
(L)
signature or facsimile signature of the custodian; and
(M)
the seal of their office.
(b)
Death certificates.
(1)
The state registrar, local registrar, or county clerk shall
issue only two types of certified copies:
(A)
a full reproduction of the original record and any addenda
as filed in their office; or
(B)
a certified abstract of death facts, taken from the original
record.
(2)
All certified copies of death records shall include:
(A)
state or local file number;
(B)
given name(s);
(C)
surname;
(D)
date of death;
(E)
date of birth;
(F)
state, city or county of death;
(G)
sex;
(H)
date of filing;
(I)
date certified copy issued;
(J)
certification statement;
(K)
signature or facsimile signature of the custodian; and
(L)
the seal of their office.
(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 - documents 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)
Record retention. A record of the date issued, document
number, name and address and form of identification to whom issued shall be
made and maintained for a period of three years from the date issued. The
application form, with the document number inserted, used to apply for a record
will fulfill this requirement.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed
with the Office of the Secretary of State on July 2, 2004.
TRD-200404362
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 22, 2004
Proposal publication date: March 26, 2004
For further information, please call: (512) 458-7236
25 TAC §181.44, §181.45
The amendments are adopted 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.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed
with the Office of the Secretary of State on July 2, 2004.
TRD-200404363
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 22, 2004
Proposal publication date: March 26, 2004
For further information, please call: (512) 458-7236
The Texas Department of Health (department) adopts the repeal of §§229.181
- 229.184 and new §§229.181 - 229.184, concerning the licensure
of food manufacturers, food wholesalers, and warehouse operators. New §§229.182
- 229.184 are adopted with changes to the proposed text as published in the
April 30, 2004, issue of the
Texas Register
(29
TexReg 4066). New §229.181 and the repeal of §§229.181 - 229.184
are adopted without changes and will not be republished.
The new rules are adopted to implement Senate Bill (SB) 1152, 78th Legislature,
2003, which amended Government Code, Chapter 2054, to require participation
in Texas Online; House Bill 2292, 78th Legislature, 2003, which revised Health
and Safety Code, §12.0111 and §12.0112, and requires two-year licenses
effective January 1, 2005; SB 381, 78th Legislature, 2003, which amended Health
and Safety Code, Chapter 431, to create an exception from licensing for certain
restaurants; SB 1826, 78th Legislature, 2003, which amended Health and Safety
Code, Chapter 431, to change the definition of manufacture to include relabeling,
and increased criminal penalties for violations of the chapter; and SB 1803,
78th Legislature, 2003, which amended Health and Safety Code, Chapter 431,
to increase criminal penalties for violations of the chapter, and established
authority to license warehouse operators and register certain food wholesalers
who meet the requirements of the chapter. The new rules rename the subchapter,
reorganize the sections, and clarify license requirements and fees.
The department received no public comments during the comment period for
the proposal. The department is making the following minor changes due to
staff comments to clarify the intent and improve the accuracy of the sections.
Change: Concerning proposed §§229.182(a), (c), (d), (f), (g),
(g)(2), (h), and (h)(2)(A), 229.183(2), and 229.184(a), the word "registration"
is added to clarify that these rules also cover registration.
Change: Concerning proposed §229.182(a)(7), the department "or its
successor" language is added.
Change: Concerning proposed §229.182(b)(1) - (9), the language is
changed to clarify that a license expires either one or two years from the
start date of the regulated activity rather than the expiration date printed
on the license or registration; §229.182(b)(5) and (6) were also changed
to add the word "food," to clarify the type of wholesaler required to be licensed
under those subsections.
Change: Concerning proposed §229.182(c) and (h)(2)(C), the language
regarding contacting the department is clarified.
Change: Concerning proposed §229.182(d)(1)(B) and (C), unnecessary
language concerning the physical and mailing addresses is deleted.
Change: Concerning §229.182(d)(2)(B), the words "addresses" and "warehouses"
are being clarified.
Subchapter L. LICENSURE OF FOOD MANUFACTURERS AND FOOD WHOLESALERS--INCLUDING GOOD MANUFACTURING PRACTICES AND GOOD WAREHOUSING PRACTICES IN MANUFACTURING, PACKING AND HOLDING HUMAN FOOD
25 TAC §§229.181 - 229.184
The repeals are adopted under the Health and Safety Code, §431.241,
which provides the Board of Health (board) with the authority to adopt rules
for the efficient enforcement of Chapter 431; 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.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on July 1, 2004.
TRD-200404348
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 21, 2004
Proposal publication date: April 30, 2004
For further information, please call: (512) 458-7236
25 TAC §§229.181 - 229.184
The new rules are adopted under the Health and Safety Code, §431.241,
which provides the Board of Health (board) with the authority to adopt rules
for the efficient enforcement of Chapter 431; 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.
§229.182.Licensing/Registration Fee and Procedures.
(a)
License/registration required.
(1)
A person who manufactures food must obtain a food manufacturer's
license for each place of business as described in subsection (b)(1) or (2)
of this section; also, a food manufacturer who distributes its own food, and/or
food from another manufacturer must only obtain a food manufacturer's license.
When calculating the amount of the licensing fee, the manufacturer must include
the total for all food manufactured and wholesaled from the place of business.
(2)
A person who distributes food, but who does not manufacture
food, must obtain a food wholesaler's license for each place of business as
described in subsection (b)(3) or (4) of this section.
(3)
A person who distributes food, but who does not manufacture
food, and who chooses to store that food with a warehouse operator licensed
under subsection (b)(8) or (9) of this section, must register as a food wholesaler
under subsection (b)(7) of this section.
(4)
A person who distributes food and drugs, food and medical
devices, or food and drugs and medical devices, must obtain a wholesaler with
combination products license, as described in subsection (b)(5) or (6) of
this section, for each place of business; this license is required even if
the products are stored in a separate warehouse or with a warehouse operator
licensed under subsection (b)(8) or (9) of this section.
(5)
A warehouse operator storing food for a registered food
wholesaler must obtain a warehouse operator license as described in subsection
(b)(8) or (9) of this section for each such warehouse. A warehouse operator
who distributes only food is required to obtain only a warehouse operator
license. A warehouse operator who distributes combination products (food and
drugs, food and medical devices, or food, drugs, and medical devices) and
is also required to obtain a wholesaler's license under subsection (b)(5)
or (6) of this section will be issued only one license. The license fee to
be paid will be the higher of the two applicable fees.
(6)
A warehouse operated by a food manufacturer which is totally
separate from any manufacturing location, including locations from which foods
are held for limited periods of time for distribution, must obtain a warehouse
operator license as described in subsection (b)(8) or (9) of this section
for each such warehouse.
(7)
A retail food store that also manufactures food and is
required to be permitted by the Texas Department of Health or its successor
(department) pursuant to Health and Safety Code, Chapter 437, and the Texas
Food Establishment Regulations, §229.370 and §229.371 of this title
(relating to Permitting Retail Food Establishments), will be issued only one
license or permit. The license or permit fee to be paid will be the higher
of the two applicable fees.
(8)
A wholesaler who distributes combination products and who
is also required to be licensed as a warehouse operator under this section
will be issued only one license. The license fee to be paid will be the higher
of the two applicable fees.
(9)
A food manufacturer required to be licensed exclusively
pursuant to Health and Safety Code, Chapter 432, relating to Food, Drug, Device
and Cosmetic Salvage, Chapter 433, relating to Meat and Poultry Inspection,
Chapter 435, relating to Dairy Products, Chapter 436, relating to Aquatic
Life, or Chapter 440, relating to Frozen Desserts, is not required to license
pursuant to this chapter.
(b)
Licensing and registration fees.
(1)
Food manufacturer. This subsection applies to all new and
renewal applications received by the department prior to January 1, 2005.
Licenses issued under this subsection expire one year from the start date
of the regulated activity. All food manufacturers in Texas shall obtain a
license annually with the department and shall pay a license fee as follows:
(A)
$25 for each place of business having gross annual manufactured
food sales of $0.00 - $9,999.99;
(B)
$50 for each place of business having gross annual manufactured
food sales of $10,000 - $24,999.99;
(C)
$100 for each place of business having gross annual manufactured
food sales of $25,000 - $99,999.99;
(D)
$250 for each place of business having gross annual manufactured
food sales of $100,000 - $199,999.99;
(E)
$400 for each place of business having gross annual manufactured
food sales of $200,000 - $999,999.99;
(F)
$500 for each place of business having gross annual manufactured
food sales of $1 million - $9,999,999.99; and
(G)
$750 for each place of business having gross annual manufactured
food sales greater than or equal to $10 million.
(2)
Food manufacturer. This subsection applies to all new and
renewal applications received by the department on or after January 1, 2005.
Licenses issued under this subsection expire two years from the start date
of the regulated activity. All food manufacturers in Texas shall obtain a
license every two years with the department and shall pay a license fee as
follows:
(A)
$50 for each place of business having gross annual manufactured
food sales of $0.00 - $9,999.99;
(B)
$100 for each place of business having gross annual manufactured
food sales of $10,000 - $24,999.99;
(C)
$200 for each place of business having gross annual manufactured
food sales of $25,000 - $99,999.99;
(D)
$500 for each place of business having gross annual manufactured
food sales of $100,000 - $199,999.99;
(E)
$800 for each place of business having gross annual manufactured
food sales of $200,000 - $999,999.99;
(F)
$1000 for each place of business having gross annual manufactured
food sales of $1 million - $9,999,999.99; and
(G)
$1500 for each place of business having gross annual manufactured
food sales greater than or equal to $10 million.
(3)
Food wholesaler. This subsection applies to all new and
renewal applications received by the department prior to January 1, 2005.
Licenses issued under this subsection expire one year from the start date
of the regulated activity. All food wholesalers in Texas shall obtain a license
annually with the department. Except as provided for in paragraph (5) of this
subsection, food wholesalers shall pay a license fee as follows:
(A)
$100 for each place of business having gross annual food
sales of $0.00 - $199,999.99;
(B)
$200 for each place of business having gross annual food
sales of $200,000 - $499,999.99;
(C)
$300 for each place of business having gross annual food
sales of $500,000 - $999,999.99;
(D)
$400 for each place of business having gross annual food
sales of $1 million - $9,999,999.99; and
(E)
$600 for each place of business having gross annual food
sales of greater than or equal to $10 million.
(4)
Food wholesaler. This subsection applies to all new and
renewal applications received by the department on or after January 1, 2005.
Licenses issued under this subsection expire two years from the start date
of the regulated activity. Except as provided for in paragraph (7) of this
subsection, all food wholesalers in Texas shall obtain a license every two
years with the department and shall pay a license fee as follows:
(A)
$200 for each place of business having gross annual food
sales of $0.00 - $199,999.99;
(B)
$400 for each place of business having gross annual food
sales of $200,000 - $499,999.99;
(C)
$600 for each place of business having gross annual food
sales of $500,000 - $999,999.99;
(D)
$800 for each place of business having gross annual food
sales of $1 million - $9,999,999.99; and
(E)
$1200 for each place of business having gross annual food
sales of greater than or equal to $10 million.
(5)
Wholesaler with combination products. This subsection applies
to all new and renewal applications received by the department prior to January
1, 2005. Licenses issued under this subsection expire one year from the start
date of the regulated activity. A food wholesaler who is required to be licensed
under this section and who is also required to be licensed as a wholesale
distributor of drugs under §229.252(a)(1) of this title (relating to
Licensing Fee and Procedures) and/or as a device distributor under §229.439(a)(1)
of this title (relating to Licensure Fees) shall pay a combined licensure
fee for each place of business. The licensure fee shall be based on the combined
gross annual sales of these regulated products (foods, drugs, and/or devices)
as follows:
(A)
$200 for each place of business having combined gross annual
sales of $0.00 - $199,999.99;
(B)
$300 for each place of business having combined gross annual
sales of $200,000 - $499,999.99;
(C)
$400 for each place of business having combined gross annual
sales of $500,000 - $999,999.99;
(D)
$500 for each place of business having combined gross annual
sales of $1 million - $9,999,999.99; and
(E)
$750 for each place of business having combined gross annual
sales greater than or equal to $10 million.
(6)
Wholesaler with combination products. This subsection applies
to all new and renewal applications received by the department on or after
January 1, 2005. Licenses issued under this subsection expire two years from
the start date of the regulated activity. A food wholesaler who is required
to be licensed under this section and who is also required to be licensed
as a wholesale distributor of drugs under §229.252(a)(1) of this title
or as a device distributor under §229.439(a)(1) of this title shall pay
a combined licensure fee for each place of business. The licensure fee shall
be based on the combined gross annual sales of these regulated products (foods,
drugs, and/or devices) as follows:
(A)
$400 for each place of business having combined gross annual
sales of $0.00 - $199,999.99;
(B)
$600 for each place of business having combined gross annual
sales of $200,000 - $499,999.99;
(C)
$800 for each place of business having combined gross annual
sales of $500,000 - $999,999.99;
(D)
$1000 for each place of business having combined gross
annual sales of $1 million - $9,999,999.99; and
(E)
$1500 for each place of business having combined gross
annual sales greater than or equal to $10 million.
(7)
Food wholesaler registration. Except as provided in paragraphs
(5) and (6) of this subsection, a food wholesaler is not required to obtain
a license under this section for a place of business if all of the food distributed
from that place of business will be stored in a warehouse licensed under this
section. A food wholesaler that is not required to obtain a license for a
place of business under this section shall register each place of business
with the department pursuant to subsection (d)(2) of this section, but only
one registration fee must be paid by each such food wholesaler. A food wholesaler
who meets this subsection's requirements shall pay a registration fee as follows:
(A)
$50 for a one year registration, on a form received by
the department prior to January 1, 2005. A registration issued under this
subsection expires one year from the start date of the regulated activity;
(B)
$100 for a two-year registration, on a form received by
the department on or after January 1, 2005. A registration issued under this
subsection expires two years from the start date of the regulated activity;
(8)
Warehouse operator. This subsection applies to all new
and renewal applications received by the department prior to January 1, 2005.
Licenses issued under this subsection expire one year from the start date
of the regulated activity. All warehouse operators in Texas shall obtain a
license annually with the department. The fee paid must be based on the maximum
amount of square feet dedicated to food storage during the licensing period.
A warehouse operator shall pay a license fee as follows:
(A)
$175 for each place of business having food storage of
0 - 6,000 square feet;
(B)
$350 for each place of business having food storage of
6,001 - 24,000 square feet;
(C)
$525 for each place of business having food storage of
24,001 - 75,000 square feet;
(D)
$700 for each place of business having food storage of
75,001 - 250,000 square feet; and
(E)
$1000 for each place of business having food storage of
250,001 or more square feet.
(9)
Warehouse operator. This subsection applies to all new
and renewal applications received by the department on or after January 1,
2005. Licenses issued under this subsection expire two years from the start
date of the regulated activity. All warehouse operators in Texas shall obtain
a license every two years with the department. The fee paid must be based
on the maximum amount of square feet dedicated to food storage during the
licensing period. A warehouse operator shall pay a license fee as follows:
(A)
$350 for each place of business having food storage of
0 - 6,000 square feet;
(B)
$700 for each place of business having food storage of
6,001 - 24,000 square feet;
(C)
$1,050 for each place of business having food storage of
24,001 - 75,000 square feet;
(D)
$1,400 for each place of business having food storage of
75,001 - 250,000 square feet; and
(E)
$2,000 for each place of business having food storage of
250,001 or more square feet.
(10)
A firm that has more than one business location may request
a one-time proration of fees when applying for a license for each new location.
Upon approval by the department, the expiration date of the license for the
new location will be established the same as the firm's previously licensed
locations.
(11)
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.
(12)
All license/registration fees paid under this section
are non-refundable.
(13)
If the license/registration category changes during the
license period, the license shall be renewed in the proper category at the
time of renewal.
(c)
License/registration forms. License/registration forms
may be obtained from the department, located at 1100 West 49th Street, Austin,
Texas 78756-3182, or from the website at www.tdh.state.tx.us/bfds/lic/apps.html.
(d)
License/registration application. All food manufacturers,
food wholesalers, and warehouse operators shall file a license application
on a form authorized by the department.
(1)
The application form shall be signed and verified, and
shall contain the following information:
(A)
the name of the legal entity to be licensed, including
the name under which the business is conducted;
(B)
the physical address of the place of business;
(C)
the mailing address of the place of business;
(D)
if a sole proprietorship, the name of the proprietor; if
a partnership, the names of all partners; if a corporation, the name of the
corporation, the date and place of incorporation and name and address of its
registered agent in the state; or if any other type of association, the names
of the principals of such association;
(E)
the names of those individuals in an actual administrative
capacity which, in the case of a sole proprietorship shall be the managing
proprietor; in a partnership, the managing partner; in a corporation, the
officers and directors; in any other association, those in a managerial capacity;
and
(F)
a list of categories of gross annual sales or square footage
as applicable, which must be marked and adhered to by the licensee in the
determination and paying of the license fee.
(2)
Food wholesalers who meet the requirements to register
under subsection (b)(7) of this section, must submit a registration form authorized
by the department which shall be signed and verified, and contain the following
information:
(A)
the name of the legal entity to be registered, including
the name under which the business is conducted;
(B)
the name, telephone number, and physical addresses of the
licensed warehouses where the food wholesaler's food products are or will
be stored;
(C)
the physical address where the food wholesaler's distribution
records are located and available for review upon inspection;
(D)
the mailing address and telephone number where the food
wholesaler may be contacted; and
(E)
a description of the type of food products being distributed
by the food wholesaler.
(e)
Two or more establishments. If the food manufacturer, food
wholesaler, or warehouse operator operates more than one place of business,
each place of business shall be licensed separately by listing the name and
address of each place of business on the license application.
(f)
Issuance of license/registration. As applicable, the department
may license/register a manufacturer, food wholesaler, or warehouse operator
who meets the requirements of this section and §229.183 of this title
(relating to Minimum Standards for Licensure/Registration).
(1)
The initial license/registration shall be valid for one
year from the start date of the regulated activity which becomes the anniversary
date, for all applications received by the department prior to January 1,
2005, and for two years from the anniversary date for all applications received
on or after January 1, 2005.
(2)
The renewal license/registration shall be valid for one
year from the anniversary date, unless an amendment occurs, for all applications
received by the department prior to January 1, 2005, and for two years from
the anniversary date for all applications received on or after January 1,
2005.
(3)
A current license/registration shall only be issued when
all past due fees and late fees are paid.
(g)
Renewal of license/registration.
(1)
For each licensing/registration period, the food manufacturer,
food wholesaler, or warehouse operator shall renew its license/registration
as applicable following the requirements of this section and §229.183
of this title.
(2)
A person who holds a license/registration issued by the
department under the Health and Safety Code shall renew the license/registration
by filing an application for renewal on a form authorized by the department
accompanied by the appropriate licensing/registration fee. A licensee/registrant
must file for renewal before the expiration date of the current license. A
person who files a renewal application after the expiration date must pay
an additional $100 as a delinquency fee.
(3)
Failure to submit the renewal during the licensing/registration
period may subject the food manufacturer, food wholesaler, or warehouse operator
to the offense provisions under the Health and Safety Code, Chapter 431, to
the provision of §229.184 of this title (relating to the Refusal, Revocation,
or Suspension of License/Registration), and to the provisions of §229.222
of this title (relating to Penalties).
(h)
Amendment of license/registration.
(1)
Fees. A license or registration that is amended during
the licensing or registration period, including a change of name, ownership
(change in legal entity), or a notification of a change in the location of
a licensed or registered place of business required under the Health and Safety
Code, §431.2251, will require a new application and submission of license
or registration fees as outlined in subsection (b) of this section.
(2)
Change in name, ownership, status, or location of business.
(A)
Not later than the 31st day before the date of the change
in the name, status, or location of a licensed/registered place of business,
the license/registration holder shall provide written notice to the department
of the intended change. The notice shall include, as applicable:
(i)
The new name of the legal entity to be licensed or registered,
including the name under which the business is conducted;
(ii)
The physical and mailing address of the new location;
(iii)
The name and physical address of the licensed warehouse
where the food wholesaler's food products will be stored;
(iv)
The physical address where the food wholesaler's distribution
records are located and available for review upon inspection; and
(v)
The mailing address and telephone number where the food
wholesaler may be contacted.
(B)
Not later than the 10th day after completion of the change
of location, the licensee or registrant shall forward to the department the
name and residence address of the individual in charge of the new place of
business.
(C)
Notice is considered adequate if the licensee or registrant
provides the intent and verification notices to the department by certified
mail, return receipt requested, mailed to the department at 1100 West 49th
Street, Austin, Texas 78756-3182.
(i)
This section does not apply to:
(1)
a person, firm, or corporation that harvests, packages,
washes, or ships raw fruits or vegetables;
(2)
a direct seller who is not otherwise engaged in manufacturing;
(3)
a person engaged solely in the distribution of alcoholic
beverages in sealed containers by holders of licenses or permits issued under
the Alcoholic Beverage Code, Chapters 19, 20, 21, 23, 64, or 65;
(4)
a food service establishment or a commissary which distributes
food primarily intended for immediate consumption on the premises of a retail
outlet under common ownership unless the business regularly engages in the
labeling, combining, and purifying of food which is either sold for resale
or packaged for sale in other than individual portions; or
(5)
a restaurant that provides food for immediate human consumption
to a political subdivision or to a licensed nonprofit organization if the
restaurant would not otherwise be considered a food wholesaler.
§229.183.Minimum Standards for Licensure/Registration.
Food manufacturers, food wholesalers, and warehouse operators.
(1)
All food manufacturers, and warehouse operators in Texas
shall comply with §§229.211 - 229.221 of this title (relating to
Current Good Manufacturing Practice and Good Warehousing Practice in Manufacturing,
Packing, or Holding Human Food) in addition to the existing standards contained
in the Health and Safety Code, Chapters 431, 434, and 438.
(2)
All food wholesalers in Texas, including those food wholesalers
registered under §229.182 of this title (relating to Licensing/Registration
Fees and Procedures), shall comply with §§229.211 - 229.219 of this
title, in addition to the existing standards contained in the Health and Safety
Code, Chapters 431, 434, and 438.
(3)
Living areas. No manufacturing or holding of foods for
distribution shall be conducted in any room used as living or sleeping quarters.
All food manufacturing and storage shall be separated from any living or sleeping
quarters by complete partitioning.
(4)
Food labeling. If a person, firm, or corporation labels
an article of food, the label shall meet the requirements of the Health and
Safety Code, Chapter 431.
§229.184.Refusal, Revocation, or Suspension of Licensure/Registration.
(a)
Basis. The department may, after providing an opportunity
for a hearing, refuse an application for a license/registration from a food
manufacturer, food wholesaler, or warehouse operator, or may revoke or suspend
a license/registration for violations of the requirements in §229.182
of this title (relating to Licensing/Registration Fee and Procedures), and §229.183
of this title (relating to Minimum Standards for Licensure/Registration),
or for interference with the department in the performance of its duty under
these rules.
(b)
Hearings. Any hearings for the refusal, revocation, or
suspension of a license/registration are governed by §§1.21, 1.23,
1.25, and 1.27 of this title (relating to Formal Hearing Procedures).
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed
with the Office of the Secretary of State on July 1, 2004.
TRD-200404349
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 21, 2004
Proposal publication date: April 30, 2004
For further information, please call: (512) 458-7236
Subchapter K. REGISTRATION OF SANITARIANS
Subchapter B. DIABETIC EYE DISEASE DETECTION INITIATIVE
Chapter 123.
RESPIRATORY CARE PRACTITIONER CERTIFICATION
Chapter 125.
SPECIAL CARE FACILITIES
Chapter 125.
SPECIAL CARE FACILITIES
Subchapter B. FACILITY LICENSING
Subchapter C. OPERATIONAL REQUIREMENTS
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 128.
PERMITS FOR CONTACT LENS DISPENSERS
Chapter 129.
OPTICIANS' REGISTRY
Chapter 130.
CODE ENFORCEMENT REGISTRY
Chapter 169.
ZOONOSIS CONTROL
Chapter 181.
VITAL STATISTICS
Subchapter B. VITAL RECORDS
Subchapter C. CENTRAL ADOPTION REGISTRY
Chapter 229.
FOOD AND DRUG
Subchapter L. LICENSURE OF FOOD MANUFACTURERS, FOOD WHOLESALERS, AND WAREHOUSE OPERATORS
Chapter 265.
GENERAL SANITATION