Part 1.
TEXAS DEPARTMENT OF HEALTH
Chapter 14.
COUNTY INDIGENT HEALTH CARE PROGRAM
The Texas Department of Health (department) proposes amendments to §§14.1,
14.101, 14.104, 14.105, 14.201, and 14.204 concerning the County Indigent
Health Care Program (CIHCP).
To comply with state law, the proposed amendment to §14.1 clarifies
the distribution of state assistance funds to eligible counties to increase
access to the appropriate funding source of Medicaid and also include a wording
change and a spelling correction to make minor clarifications.
The proposed amendment to §14.101 includes a minor punctuation change,
an acronym change, and word changes regarding a complete application including
the names of all other household members to be analogous with Temporary Assistance
to Needy Families (TANF) and to make minor clarifications.
To be analogous with TANF, changes in §14.104 have been made regarding
exemptions for cash gifts and contributions and overpayments for military
pay, Unemployment Insurance Benefits (UIB), and Veterans' Association (V.A.)
benefits and regarding deductions for costs related to producing income gained
from illegal activities.
The proposed amendment to §14.105 includes changes concerning the
exemption of income-producing property to be analogous with the TANF program.
Minor editorial changes improve the accuracy for a proposed amendment to §14.201.
Proposed amendment to §14.204 will increase access to the appropriate
funding source of Medicaid along with minor clarifications due to each county's
judge signing a confidentiality contract with the department in order to submit
claims for Texas Medicaid or Vendor Drug Program reimbursement and by shifting
responsibility from the counties to the department for determining the Medicaid
eligibility status of all eligible residents who are also SSI/SSDI appellants.
Gerald Cannaday, Bureau Chief of Support Services for the Associateship
for Family Health, has determined that for each year of the first five-year
period the sections are in effect, there will be no fiscal implications to
state or local government as a result of enforcing or administering the sections
as proposed.
Mr. Cannaday has also determined that for the first five years the sections
are in effect, the public benefit anticipated will be simplified administration
of the program and compliance with state law. There will be no impact on small
businesses or micro-businesses to comply with these sections as proposed.
This was determined by interpretation of the rules that small businesses and
micro-businesses will not be required to alter their business practices in
order to comply with the rules as proposed. There are no anticipated economic
costs to persons who are required to comply with the sections as proposed.
There is no anticipated impact on local employment.
Comments on the proposed sections may be submitted to Kathy McCormick,
Program Specialist, Indigent Health Care Division, Texas Department of Health
Mail Code Y-990, 1100 West 49th Street, Austin, Texas 78756-6405, within 30
days of publication in the
Texas Register
.
A public hearing on the proposed sections will be also held at 10:00 a.m.
on April 26, 2002, in the Public Hearing Room, Texas Department of Health,
12555 Riata Vista Circle, Austin, Texas to accept comments on the proposal.
Subchapter A. COUNTY PROGRAM ADMINISTRATION
25 TAC §14.1
The section is proposed under Health and Safety Code, Chapter
61 and Human Resources Code, Chapters 22 and 32. The department has rule making
authority for CIHCP under Health and Safety Code Chapter 61.
The proposed section affects the Health and Safety Code, Chapter 61, and
the Human Resources Code, Chapters 22 and 32.
§14.1.County Program Administration.
(a) - (b)
(No change.)
(c)
General administrative requirements. Each county required
to administer a program must:
(1) - (5)
(No change.)
(6)
determine eligibility within 14 days after the date a
complete
[
(7) - (13)
(No change.)
(d) - (e)
(No change.)
(f)
Eligibility requirements for counties applying for state
assistance.
(1)
Each county that plans to credit expenditures toward eligibility
for the state assistance fund must:
(A) - (I)
(No change.)
(J)
report the county's GRTL, as shown in county records on
July 31 of each year, to the State Property Tax Board not later than October
1 of the same year. If part of the county is served by a hospital district,
request the county appraisal district to determine the GRTL of county property
located outside the area served by a hospital district. If this report is
not received by the State Property Tax Board by December 1 of the same year,
a county may not be eligible for state assistance funds that state fiscal
year
;
[
(K)
submit claims for Texas Medicaid or Vendor
Drug Program reimbursement for services provided to an otherwise eligible
SSI/SSDI appellant if the services are provided by a Texas Title XIX Medicaid-enrolled
provider; if the SSI/SSDI appellant is later determined to be retroactively
eligible for SSI/Medicaid; and the appellant and the provider assign reimbursement
rights by completing the appellant/provider assignment form.
(2) - (3)
(No change.)
(g)
Determining county eligibility for state assistance.
(1)
(No change.)
(2)
If the eligibility systems review does not identify any
deficiencies in the county's eligibility system, the county is eligible for
state assistance when it reaches the 8.0% expenditure level. If deficiencies
are identified, the county must correct the deficiencies within five workdays
of written notice before claiming state assistance funds. If serious deficiencies
that cannot be corrected are identified, the county is not eligible for state
assistance funds. Serious deficiencies are consistent misapplication of policy
as stated in these rules and the County Indigent Health Care
Program
Handbook.
(h) - (i)
(No change.)
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of
the Secretary of State on March 25, 2002.
TRD-200201825
Susan Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 5, 2002
For further information, please call: (512) 458-7236
25 TAC §§14.101, 14.104, 14.105
The sections are proposed under Health and Safety Code, Chapter
61 and Human Resources Code, Chapters 22 and 32. The department has rule making
authority for CIHCP under Health and Safety Code Chapter 61.
The proposed sections affect the Health and Safety Code, Chapter 61, and
the Human Resources Code, Chapters 22 and 32.
§14.101.Application Processing.
(a)
The following words and terms, when used in Subchapters
(B)-(E) of this chapter (relating to Determining Eligibility, Providing Services,
and Case Management
)
, shall have the following meanings, unless
the context clearly indicates otherwise:
(1) - (2)
(No change.)
(3)
Complete application-An application with:
(A) - (B)
(No change.)
(C)
the names of all other household members [
(D) - (I)
(No change.)
(4) - (9)
(No change.)
(b) - (k)
(No change.)
(l)
If eligibility staff determine an identifiable application
is incomplete because it is missing some components of a complete application,
other than verification of ineligibility for
TANF
[
(1) - (2)
(No change.)
(m) - (o)
(No change.)
§14.104.Income.
(a) - (b)
(No change.)
(c)
Types of Income. Eligibility staff must count or exempt
types of income as follows:
(1) - (2)
(No change.)
(3)
Cash
gifts and
contributions. Cash
gifts
and
contributions are counted as unearned income
unless they are
made by a private, nonprofit organization on the basis of need; and total
$300 or less per household in a federal fiscal quarter. The federal fiscal
quarters are January-March, April-June, July-September, and October-December.
If these contributions exceed $300 in a quarter, count the excess amount as
income in the month received.
[
(4) - (15)
(No change.)
(16)
Job training. Payments made under the Workforce Investment
Act (WIA) are exempt, except On The Job (OJT) payments funded under [
(17) - (18)
(No change.)
(19)
Military pay and allowances. Military pay and allowances
for housing, food, base pay, and flight pay are counted as earned income
less pay withheld to fund education under the G. I. bill
.
(20) - (26)
(No change.)
(27)
Property Income. Income from renting, leasing, or
selling property on an installment plan is self-employment income. Property
includes equipment, vehicles, and real property. For earned income, also allow
the work-related expense. For unearned income, deduct only the expenses associated
with producing the income. If the client sells property on an installment
plan, count the payments as income. Exempt the balance of the note as an inaccessible
resource. Count income from property as:
[
(A)
earned if the:
(i)
person spends an average of at least 20 hours per week
in management or maintenance activities; or
(ii)
income is from noncommercial boarding situations.
(B)
unearned if the person spends an average
of less than 20 hours per week in management or maintenance activities.
(28) - (29)
(No change.)
(30)
Unemployment compensation. Unemployment compensation is
counted as unearned income
less any amount being recouped for an Unemployment
Insurance Benefits (UIB) overpayment
.
(31)
(No change.)
(32)
Veterans Administration (VA) benefits. These benefits
are counted as unearned income
less any amount being recouped for a VA
overpayment
. Benefits that meet a special need are exempt.
(33) - (35)
(No change.)
(d)
Net income test and deductions. The net income test is
used to determine eligibility.
(1)
(No change.)
(2)
Earned income deductions. Eligibility staff must make the
following deductions from gross earned income. These deductions must be made
in the order listed.
(A) - (C)
(No change.)
(D)
Do not deduct costs related to producing
income gained from illegal activities, such as prostitution and the selling
of illegal drugs.
(e)
Budgeting.
(1) - (3)
(No change.)
(4)
How to budget stepparent, spouse, or legal parent income.
The policy in this paragraph only applies to family units that include a stepparent,
spouse, or one or both parents who are excluded from a Medicaid group. Eligibility
staff must:
(A) - (B)
(No change.)
(C)
deduct from the spouse's or parent's income, computed in
subparagraph (B) of this paragraph, an amount equal to the maximum income
limit for the Medicaid household's size as corresponds to the current
TANF
[
(D)
(No change.)
(5)
(No change.)
(f)
(No change.)
§14.105.Resources.
(a) - (c)
(No change.)
(d)
Types of resources. The following resources are countable
or exempt. Eligibility staff must count the equity value of any resource not
specifically exempt in this subsection.
(1) - (5)
(No change.)
(6)
Income-producing property. [
(A)
Exempt property that:
(i)
is essential to a household member's employment or self-employment
(examples: tools of a trade, farm machinery, stock, and inventory). Continue
to exempt this property during temporary periods of unemployment if the client
expects to return to work;
(ii)
annually produces income consistent with its fair market
value, even if used only on a seasonal basis; or
(iii)
is necessary for the maintenance or use of a vehicle
exempted as income-producing or as necessary for transporting a physically
disabled household member. Exempt the portion of the property used for this
purpose.
(B)
For farmers or fishermen, continue to
exempt the value of the land or equipment for one year from the date that
the self-employment ceases.
(7) - (20)
(No change.)
(e) - (g)
(No change.)
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on March 25, 2002.
TRD-200201826
Susan Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 5, 2002
For further information, please call: (512) 458-7236
25 TAC §14.201, §14.204
The sections are proposed under Health and Safety Code, Chapter
61 and Human Resources Code, Chapters 22 and 32. The department has rule making
authority for CIHCP under Health and Safety Code Chapter 61.
The proposed sections affect the Health and Safety Code, Chapter 61, and
the Human Resources Code, Chapters 22 and 32.
§14.201.Required and Optional Services, and Their Definitions.
(a)
Except as specified in §14.202 of this title (relating
to Exclusions and Limitations), counties are required to provide the following
services to eligible households by reimbursing providers of services who meet
the requirements of the Indigent Health Care and Treatment Act, this chapter,
and the responsible
entity
[
(1)
Inpatient hospital services. Services must be medically
necessary and:
(A)
provided in a licensed
Texas Title XIX Medicaid-enrolled
acute care
hospital;
(B) - (D)
(No change.)
(2)
Outpatient hospital services. Services must be medically
necessary and:
(A)
must be diagnostic, therapeutic,
or
rehabilitative[
(B)
provided
[
(C)
provided
[
(D)
provided
[
(3) - (11)
(No change.)
(b)
The following services are optional services. A county
must notify the department of the county's intent to provide any of the following
services prior to the beginning of a state fiscal year. If the services are
approved by the department or if the department fails to notify the county
of the department's disapproval before the 31st day after the date the department
receives the county's request, the county may credit the services toward eligibility
for state assistance for the state fiscal year following the date of the request.
A county must notify the department in writing if they decide to discontinue
providing any of the optional services that were department approved. [
(1)
Ambulatory surgical center (ASC) services. These services
must be provided in a
Texas
Title XIX Medicaid
-
enrolled
ASC, and are limited to items and services
provided
[
(2)
Federally Qualified Health Center (FQHC) services. These
services must be provided in an approved
Texas Title XIX Medicaid-enrolled
FQHC by a physician, a physician's assistant, a nurse practitioner,
a clinical psychologist, or a clinical social worker.
(3) - (7)
(No change.)
(8)
Diabetic medical supplies and equipment. These supplies
and equipment must be medically necessary and prescribed by a physician. The
county may require the supplier to receive prior authorization. Items covered
are lancets, alcohol prep pads,
insulin
syringes, test strips,
humulin pens
and the needles required for humulin pens,
and glucometers.
These supplies and equipment may also be prescribed by an APN if this is within
the scope of their practice in accordance with the standards established by
the Board of Nurse Examiners and published in 22 Texas Administrative Code §221.13.
(9) - (14)
(No change.)
§14.204.Services and Payment Liability, Limitations, and Options.
(a) - (g)
(No change.)
(h)
Only counties not fully served by a public hospital or
hospital district may submit claims for Texas Medicaid or Vendor Drug Program
reimbursement to the department for basic and department approved optional
services provided to an otherwise eligible SSI/SSDI appellant if the services
are
provided
[
(1) - (2)
(No change.)
(3)
Once a month the county shall submit to
the department a list of all eligible residents who are SSI/SSDI appellants.
The list shall include the name, the date of birth, and the social security
number for each appellant. The department will check the Medicaid eligibility
status of the names on the list and notify the county.
[(3)
The county determines the Medicaid eligibility
status of all eligible residents who are also SSI/SSDI appellants by using
the automated inquiry system established by the state at least once a month.]
[(A)
To use the automated inquiry system, the county requests
a telephone access code number from the department in writing. Upon receipt
of the county's written request, the department sends the county the access
code number and instructions for using the automated inquiry system toll-free
number from a touch-tone telephone.]
[(B)
The automated inquiry system provides the county with
information about the SSI/SSDI appellant's current Medicaid eligibility.]
[(C)
The county must follow all procedures established by the
department for CIHCP counties accessing the automated inquiry system.]
(4)
Within
95 days of the date the client's Medicaid eligibility
was added to the eligibility file system (the add date)
[
(A) - (B)
(No change.)
(C)
separately claim reimbursement for prescription drugs and
non-prescription services provided during the period of retroactive
Texas
Medicaid eligibility by:
(i) - (ii)
(No change.)
(iii)
enclosing the original bills
or copies of the original
bills
for all paid basic or department approved optional services
that are within the dates of Medicaid eligibility
.
(5)
(No change.)
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed
with the Office of the Secretary of State on March 25, 2002.
TRD-200201827
Susan Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 5, 2002
For further information, please call: (512) 458-7236
25 TAC §§127.1 - 127.4
The Texas Department of Health (department) proposes amendments
to §§127.1 - 127.4, concerning the registry for providers of health-related
services.
Government Code §2001.039 requires that each state agency review and
consider for readoption each rule adopted by that agency pursuant to the Government
Code, Chapter 2001 (Administrative Procedure Act). The department has reviewed
Chapter 127 in its entirety and has determined that reasons for adopting the
sections continue to exist; however, amendments to the sections are necessary
to improve draftsmanship and make the rules more accessible, understandable,
and usable.
Additionally, §127.2 was amended to require that at least 50 participants
must remain on each occupation's registry to ensure that costs associated
with the administration of each registry will be covered. Currently, one registry
exists for medical laboratory practitioners and there are five participants
on the registry. The 2001 fee study reflects that the program covers 27.7%
of its costs.
The department published a Notice of Intention to Review §§127.1
- 127.4 as required by Government Code §2001.039 in the
Texas Register
on February 8, 2002 (27 TexReg 989).
Rebecca Berryhill, Chief, Bureau of Licensing and Compliance, has determined
that the fiscal impact on state government for each year of the first five
years the sections are in effect, will result in revenue of approximately
$6,000 should the number of participants on the medical laboratory practitioner
registry increase to 50. It is anticipated that this will adequately cover
the cost of operation. There will be no fiscal implication for local governments.
Ms. Berryhill has also determined that for each year of the first five
years the sections are in effect, the public benefit anticipated as a result
of enforcing the sections will be to provide a means by which the public can
identify certain providers in an efficient and cost-effective manner. The
amendments, as proposed, are not expected to have an impact on small businesses
or micro-businesses because the purpose of the health-related registry is
to provide a mechanism for persons in professions not otherwise regulated
to be identified. Inclusion of an occupation on a registry does not constitute
regulation of the scope of practice of the profession. There are no anticipated
economic costs to persons who are required to comply with the sections as
proposed, because medical laboratory practitioners will be removed from the
registry. The anticipated economic costs to persons who choose to be placed
on future registries is $120 per year. There is no anticipated impact on local
employment.
Comments on the proposal may be submitted to Heather Muehr, Program Administrator,
Professional Licensing and Certification Division, Texas Department of Health,
1100 West 49th Street, Austin, Texas 78756-3783, (512) 834-6661. Comments
will be accepted for 30 days following publication of this proposal in the
The amendments are proposed under the Health and Safety Code, §12.014,
which provides the Board of Health (board) with the authority to adopt rules;
and Health and Safety Code, §12.001, which provides the board with authority
to adopt rules to implement every duty imposed by law on the board, the department
and the commissioner of health.
The amendments affect the Health and Safety Code, Chapter 12, and implement
Government Code, §2001.039.
§127.1.Request for Placement of an Occupation on a [
(a)
(No change.)
(b)
The following persons or entities may file a request under
subsection (a) of this section:
(1)
(No change.)
(2)
at least 200 persons who are employed or used as a provider
of a specific health-related service at the time
the request is filed
[
(c)
The Texas Board of Health shall consider whether to approve
or disapprove the
placement of an occupation on a registry
[
(d) - (e)
(No change.)
§127.2.Approved Occupations.
(a)
(No change.)
(b)
Inclusion of an occupation of providers of a specific health-related
service on a registry does not constitute an evaluation of a provider's training
or competency or a regulation of the scope of the practice of the provider,
and is not a requirement that a provider within the included occupation actually
register.
A provider's participation
[
(c)
A
provider
[
(d)
(No change.)
(e)
Once an occupation is approved for placement
on a registry, a minimum of 50 persons must be maintained on the registry
or the occupation will be removed.
§127.3.Application and Approval of an Individual's Placement on a Registry.
(a) - (e)
(No change.)
(f)
If an application is disapproved, the applicant may request
informal reconsideration of the determination by the chief, bureau of licensing
and
compliance
[
(g)
Upon approval of an application, the applicant's name shall
be placed
on
[
(h)
A
provider
[
§127.4.Fees.
(a)
The schedule of fees shall be as follows:
(1)
request
for placement on the registry
[
(2)
initial application
for placement on the registry
--$120; and
(3)
annual reapplication (any category)
for placement
on the registry
--$120.
(b) - (c)
(No change.)
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of
the Secretary of State on March 25, 2002.
TRD-200201821
Susan Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 5, 2002
For further information, please call: (512) 458-7236
The Texas Department of Health (department) proposes amendments to §§135.1-135.29,
135.41, 135.42, and 135.51-135.54 concerning the regulation of ambulatory
surgical centers. The sections cover operating requirements, safety requirements,
and physical plant and construction requirements for new and existing ambulatory
surgical centers.
The amendments are proposed based upon the department's review of Texas
Administrative Code, Chapter 135, as required by Government Code §2001.039.
The department was assisted in its review by an ad hoc committee composed
of physicians, nurses, an ambulatory surgical center administrator, an architect,
an engineer, and a pharmacist assembled by the department.
Specifically, the amendment to §135.1 updates the statutory reference
to the Health and Safety Code, Chapter 243. The amendments to §135.2
add definitions for advanced practice nurse, dentist, disposal, electronic
signature, and prescriber; delete the definition of statute because it is
duplicative of the definition of act; amend the definitions of act, certified
registered nurse anesthetist, director, and health care practitioners to delete
obsolete references and for clarification purposes; and renumber definitions
as necessary to accommodate the added and deleted definitions. The amendment
to §135.3 is editorial. The amendments to §135.4 and §135.5
delete ambiguous language and clarify the intent of the sections. The amendments
to §135.6 require that all employee categories, not just allied health
professionals, be included in the personnel policies and that job descriptions
be developed for all. The amendments to §135.7 require health care practitioners
to practice their professions in accordance with state law and conform to
the standards and ethics of their professions; require patient care responsibilities
be delineated in accordance with recognized standards of practice; add a new
subsection (d) which requires qualified medical personnel to be available
for emergency treatment whenever there is a patient in the ASC who has received
services; and reletter the subsections to accommodate the new subsection.
The amendments to §135.8 delete the mandate for, and leaves to the discretion
of the ASC, the use of self-assessment methodologies to implement the quality
assurance program; and require a record be maintained of all transfers. The
amendments to §135.9 require compliance with current statute for the
retention, retirement, and release of medical records; add advanced practice
nurse wherever physician is mentioned concerning evidence of an order or evaluation
of a patient which must be included in the ASC record; delete the subsection
concerning the use of a physician's stamp; and reletter the remaining subsection.
The amendments to §135.10: delete certain emergency equipment required
to be maintained and readily accessible; and eliminate specific work areas
and facilities from the section because specific spatial requirements are
addressed in §§135.51 and 135.52 relating to physical plant and
construction requirements. The amendments to §135.11 substitute the terms
"anesthesia practitioner" and "qualified" for specific professional titles
in the requirements relating to anesthesia services, including supervision
and administration; require that policies and procedures for anesthesia services
be developed, implemented and enforced; delete specific requirements relating
to the topics that must be included in the policies and procedures; require
discharge criteria be approved by the governing board; require that advanced
life support be a qualification of the anesthesia practitioner who is required
to be present or immediately available until all patients have been discharged;
require that patients who receive conscious sedation be given written instructions
for self-care following surgery; and provide that an advanced practice nurse
as well as a physician may write an order that a patient may be dismissed
without the company of a responsible adult. The amendment to §135.12
requires compliance with the Texas State Board of Pharmacy rules. The amendments
to §135.13 add advanced practice nurse to the professionals who may order
other laboratory work; require an authorized rather than a written signature
by the pathologist interpreting tissue or positive cytology reports; and delete
a provision that prevents the use of a computerized signature or signature
stamp; other changes to the section are editorial. The amendments to §135.14
add dentist, advanced practice nurse or other authorized healthcare practitioner
as professionals who may order radiology services; and add a requirement that
policies and procedures for laser technology be established and implemented.
The amendments to §135.15 are editorial. The amendments to §135.16
include provisions that each required policy be developed, implemented, and
enforced. The amendment to §135.17 requires that research activities
be monitored by the governing body. The amendment to §135.18 is editorial.
The amendment to §135.19 is due to a change in the name of a section.
The amendments to §135.20 require that advanced practice nurses be included
in the number of staff an ASC applicant reports to the director, and add a
requirement that an ASC also report the number of surgical suites. The amendments
to §135.21 add change in location as a reason the department may conduct
an inspection; and add a reference to the act under which the department may
propose to deny, suspend, or revoke an existing license. The amendments to §135.22
delete the requirement for a self-survey; and provide the ASC an opportunity
to refute a cease to perform notification by submitting evidence of a timely
renewal. The amendments to §135.23 reduce the number of days an ASC is
required to notify the department of a change of ownership; and require that
an ASC submit an application and fee at least 60 days prior to a relocation.
The amendments to §135.24 rename the section, and update references.
The amendment to §135.25 is editorial and mirrors the statutory language
in Health and Safety Code §243.0115. The amendment to §135.26 removes
the number of days by which the department is required to furnish written
notice of a violation following a survey. The amendment to §135.27 requires
the ASC to furnish copies of all records pertinent to the investigation at
the department's request. The amendments to §135.28 are editorial and
clarify the conditions for reporting emergency transfers to a hospital. The
amendment to §135.29 updates a statutory reference.
The amendments to §§135.41 and 135.42 relating to safety requirements
provide current references to national codes, and update or delete obsolete
language.
The amendments to §§135.51 - 135.54 relating to physical plant
and construction requirements for new and existing ambulatory surgical centers
generally clarify the rule; provide current references to national codes,
and update and delete obsolete language.
The amendments to Table 4. Flame Spread and Smoke Production Limitations
for Interior Finishes, §135.54(d)(4) include changing a section reference
and the title of §135.52 was changed to reflect correct section title.
Government Code §2001.039 requires that each state agency review and
consider for readoption each rule adopted by that agency pursuant to the Government
Code, Chapter 2001 (Administrative Procedure Act). The sections have been
reviewed and the department has determined that reasons for adopting the sections
continue to exist, however, revisions to the sections are necessary.
The department published a Notice of Intention to Review for §§135.1-135.27,
135.41-135.42, and 135.51-135.54 in the
Texas Register
(25 TexReg 4359) on May 12, 2000. A Notice of Intent for §§135.28-135.29
was published in the February 15, 2002, issue of the
Texas Register
(27 TexReg1189). There were no comments received by
the department on the sections.
Becky Berryhill, Chief, Bureau of Licensing and Compliance, has determined
that for the first five year period the sections are in effect, there will
be no fiscal implications to state or local government as a result of enforcing
or administering the sections as proposed.
Ms. Berryhill has also determined that for each of the first five years
the sections are in effect, the public benefit anticipated as a result of
enforcing or administering the sections will be the continued oversight by
the department of the operation, safety and construction of ambulatory surgical
centers. There will be no cost to micro businesses or small businesses that
are ambulatory surgical centers to comply with the sections as proposed as
the amendments do not impose additional requirements that would result in
monetary impact. There are no anticipated economic costs to persons who are
required to comply with the sections as proposed. There is no anticipated
impact on local employment.
Comments on the proposal may be submitted to Cecil Jones, Program Director,
Consolidated Licensing Program, Health Facility Licensing and Compliance Division,
Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, (512)
834-6646. Comments will be accepted for 30 days following publication of this
proposal in the
Texas Register
.
Subchapter A. OPERATING REQUIREMENTS FOR AMBULATORY SURGICAL CENTERS
25 TAC §§135.1 - 135.29
The amendments are proposed under Health and Safety Code (HSC),
Chapter 243, Texas Ambulatory Surgical Center Licensing Act; which provides
the Board of Health (board) with the authority to adopt rules governing the
licensing and regulation of ASCs, and HSC §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 commissioner of health.
The proposed sections affect Health and Safety Code, Chapters 243 and 12,
and implement Government Code, §2001.039.
§135.1.Purpose and Scope.
(a)
The purpose of these sections is to implement
Health
and Safety Code, Chapter 243
[
(b)
(No change.)
(c)
The standards pertaining to the construction and design,
the qualifications of the professional staff and other personnel, the equipment
essential to the health and welfare of the patients, sanitary and hygienic
conditions, and the quality assurance program may not exceed the minimum standards
for certification under the Social Security Act, Title XVIII,
42 United
States Code (U.S.C.) Section 1395 et seq.
[
§135.2.Definitions.
The following words and terms, when used in these sections, shall have
the following meanings, unless the context clearly indicates otherwise.
(1)
Act -- Texas Ambulatory Surgical Center Licensing Act,
Health and Safety Code, Chapter 243
[
(2)
Administrator -- A person who is a physician, registered
nurse, [
(3)
Advanced Practice Nurse (APN) -- A professional
nurse, currently licensed in Texas, who is prepared for advanced nursing practice
by virtue of knowledge and skills obtained in an advanced educational program
of study acceptable to the board, who meets requirements of Rule 221 and/or
Rule 222 as defined by the Texas Board of Nurse Examiners, and has received
authorization to practice as an APN in Texas.
(4)
[
(5)
[
(6)
[
(7)
[
(8)
[
(A)
A sole proprietor who transfers all or part of the ASC's
ownership to another person or persons;
(B)
The removal, addition, or substitution of a person or persons
as a general, managing, or controlling partner in an ASC owned by a partnership;
or
(C)
A corporation that transfers all or part of the corporate
stock which represents the ASC's ownership to another person or persons.
(9)
Dentist -- A person who is currently licensed
under the laws of this state to practice dentistry.
(10)
[
(11)
[
(12)
Disposal -- The discharge, deposit, injection,
dumping, spilling, leaking, or placing of any solid waste or hazardous waste
(whether containerized or uncontainerized) into or on any land or water so
that such solid waste or hazardous waste or any constituent thereof may enter
the environment or be emitted into the air or discharge into any waters, including
ground waters.
(13)
Electronic Signature -- Signature produced
or generated on a computer.
(14)
[
(15)
[
(16)
[
(17)
[
(18)
[
(19)
[
(20)
Prescriber -- A person who is legally
authorized to write an order or prescription for a health care service, medical
device, or drug.
(21)
[
[(17)
Statute -- Texas Civil Statutes, Article
4437f-2.]
(22)
[
§135.3.Fees.
(a)
The Texas Board of Health has established the following
schedule of fees for licensure as an
ASC
[
(1) - (2)
(No change.)
(b) - (c)
(No change.)
(d)
All fees shall be paid to the Texas Department of
Health.
[
(e)
(No change.)
§135.4.Governance of a Licensed ASC.
(a)
The
ASC
[
(b)
(No change.)
(c)
The governing body shall address and is fully responsible,
either directly or by appropriate professional delegation, for the operation
and performance of the ASC. Governing body responsibilities include, but are
not limited to:
(1) - (5)
(No change.)
(6)
assuring that the quality of care is evaluated and that
identified problems are [
(7) - (9)
(No change.)
(10)
developing, implementing, and enforcing
[
(11) - (15)
(No change.)
(d) - (i)
(No change.)
§135.5.Rights of Patients in a Licensed ASC.
(a) - (b)
(No change.)
(c)
Patient
[
(d) - (e)
(No change.)
(f)
Information shall be available to patients and staff concerning:
(1) - (6)
(No change.)
(7)
patient's
right
[
(8)
(No change.)
(g)
(No change.)
§135.6.Administration of a Licensed ASC.
(a) - (d)
(No change.)
(e)
All employee categories
[
§135.7.Quality of Care in a Licensed ASC.
(a)
(No change.)
(b)
Health care practitioners shall practice
in accordance
with applicable state law and conform to the standards and ethics of
their professions [
(c)
Patient care responsibilities shall be delineated
in accordance with recognized standards of practice.
[
(d)
There shall be qualified medical personnel
available for emergency treatment whenever there is a patient in the ASC who
has received services.
(e)
[
(1)
accessible and available health services;
(2)
appropriate and timely diagnostic procedures;
(3)
treatment that is consistent with clinical impression or
working diagnosis;
(4)
appropriate and timely consultation;
(5)
absence of clinically unnecessary diagnostic or therapeutic
procedures;
(6)
provision for services when the ASC is not open;
(7)
appropriate, accurate, and complete medical record entries;
and
(8)
adequate transfer of information when patients are transferred
to and from other health care providers.
(f)
[
(g)
[
(1)
Adequate specialty consultation services shall be made
available by prior arrangement.
(2)
Referral to another health care practitioner shall be clearly
outlined to the patient and arranged with the accepting health care practitioner
prior to transfer.
(h)
[
(1)
the relevance of health care services to the needs of the
patients;
(2)
the absence of duplicative diagnostic procedures;
(3)
the appropriateness of treatment frequency; and
(4)
the use of ancillary services that are consistent with
patients' needs.
(i)
[
§135.8.Quality Assurance in a Licensed ASC.
(a) - (d)
(No change.)
(e)
Problem identification and resolution activities shall
be conducted as part of an ongoing, organized quality assurance program in
which all practitioners in all clinical disciplines have an opportunity to
participate. A variety of self-assessment methodologies
may
[
(f)
Quality assurance activities shall address the following.
(1)
(No change.)
(2)
The frequency, severity, and source of suspected problems
or concerns shall be assessed.
(A) - (B)
(No change.)
(C)
A
record
[
(3) - (5)
(No change.)
(g) - (h)
(No change.)
§135.9.Medical Records in a Licensed ASC.
(a) - (b)
(No change.)
(c)
All clinical information relevant to a patient shall be
readily available to health care practitioners
involved in the care of
that patient
.
(d) - (e)
(No change.)
(f)
Policies concerning medical records shall
follow current
statute in regard to retention of active records, retirement of inactive records
and the release of information contained in the record.
[
[(1)
the retention of active records;]
[(2)
the retirement of inactive medical records;]
[(3)
the timely entry of data in medical records;
and]
[(4)
the release of information contained
in medical records.]
(g) - (i)
(No change.)
(j)
The
ASC
[
(1) - (4)
(No change.)
(5)
preop diagnostic studies entered before surgery, if required
by policy or ordered by a physician
or advanced practice nurse
;
(6) - (7)
(No change.)
(8)
anesthesia administration record that includes either general
,
[
(9)
(No change.)
(10)
evidence of evaluation of the patient by a physician
or advanced practice nurse
prior to dismissal; and
(11)
evidence that the patient was dismissed in the company
of a responsible adult unless a physician
or advanced practice nurse
writes an order that the patient may be dismissed without the company
of a responsible adult.
(k) - (p)
(No change.)
[(q)
A physician's signature stamp may be
used within the ASC only for x-ray reports in accordance with the following
regulations.]
[(1)
The physician using the signature stamp shall supply the
ambulatory surgical center with a letter, to be kept on file, notifying the
ambulatory surgical center of the use of the stamp.]
[(2)
The signature stamp shall be in the possession of the
physician at all times, or shall be locked up with the key in the physician's
possession.]
[(3)
No one but the physician shall use the signature stamp.]
[(4)
When a signature stamp is used, the physician shall initial
the signature stamp as it is used.]
(q)
[
§135.10.Facilities and Environment in a Licensed ASC.
(a) - (c)
(No change.)
(d)
Appropriate emergency equipment and supplies shall be maintained
and readily accessible to all areas of each building and shall include the
following:
(1) - (2)
(No change).
(3)
mechanical ventilatory assistance equipment, including
airways
and
[
(4) - (5)
(No change.)
[(6)
chest tubes and bottle;]
[(7)
tracheostomy set;]
(6)
[
(7)
[
(8)
[
(e) - (g)
(No change.)
(h)
Sufficient space, equipment, and supplies shall be provided
to perform the volume of work with optimal accuracy, precision, efficiency,
and safety in the laboratory and x-ray.
The ASC shall furnish equipment
for basic diagnostic purposes, depending on the extent of services provided.
Dressing area(s) shall be required, depending on services provided, with convenient
access to toilets and may be shared with patient changing/preop rooms.
[(1)
Work space may be located in the preop
area or in a separate room. The work space shall contain laboratory work counter(s),
with a sink and electric services, storage cabinet(s), or closet(s).]
[(2)
There shall be work space available for
specimen collections. Urine collection rooms shall be equipped with a water
closet and lavatory. Blood collection area shall have space for a chair, work
counter, and hand wash facilities.]
[(3)
The ASC shall furnish equipment for basic
diagnostic purposes, depending on the extent of services provided. Dressing
area(s) shall be required, depending on services provided, with convenient
access to toilets and may be shared with patient changing/preop rooms.]
§135.11.Anesthesia and Surgical Services in a Licensed ASC.
(a)
Anesthesia services provided in the ASC shall be limited
to those techniques that are approved by the governing body upon the recommendation
of the
anesthesia practitioner
[
(b)
Supervision of anesthesia services shall be by a qualified
practitioner approved by the governing board upon recommendation of the ASC
medical staff.
[
(c)
Anesthesia shall be administered by
a qualified anesthesiologist,
[
(d)
(No change.)
(e)
Policies and procedures shall be developed for anesthesia
services
.
[
[(1)
education, training, and supervision
of personnel;]
[(2)
responsibilities of nonphysician anesthetists;]
[(3)
responsibilities of supervising physicians;
and]
[(4)
use and degree of supplemented local
anesthesia.]
(f)
Anesthesia shall not be administered unless the operating
surgeon or
anesthesia practitioner
[
(g)
Patients who have received anesthesia shall be evaluated
by the operating surgeon or
anesthesia practitioner prior to discharge
[
(h) - (n)
(No change.)
(o)
Each operating room shall be designed and equipped so that
the types of surgery conducted can be performed in a manner that protects
the lives and assures the physical safety of all persons in the area. [
(1) - (2)
(No change.)
(p)
An
anesthesia practitioner
[
(q) - (x)
(No change.)
(y)
Protocols shall be established for instructing patients
in self-care after surgery, including written instructions to be given to
patients who receive
conscious sedation,
regional and general anesthesia.
(z)
Patients who have received anesthesia shall be dismissed
in the company of a responsible adult unless a physician
or advanced
practice nurse
writes an order that the patient may be dismissed without
the company of a responsible adult.
(aa)
(No change.)
§135.12.Pharmaceutical Services in a Licensed ASC.
(a)
The ASC shall provide drugs and biologicals in a safe and
effective manner in accordance with professional practices and shall be in
compliance with all state and federal laws and regulations. The ASC shall
be licensed as required by the
Texas
State Board of Pharmacy
and comply with 25 Texas Administrative Code §291.76 (relating to Class
C Pharmacies Located in a Freestanding Ambulatory Surgical Center)
.
(b)
(No change.)
§135.13.Pathology and Medical Laboratory Services in a Licensed ASC.
Pathological and clinical services shall be provided or made available
when appropriate to meet the needs of the patients and adequately support
the ASC's clinical capabilities.
(1)
(No change.)
(2)
Preoperative laboratory procedures may be required as follows.
(A)
It shall be at the discretion of the
governing body
[
(B)
If specific pre-operative laboratory work is required,
the medical staff shall approve them in accordance with the medical staff
by-laws. Other lab work shall be performed only
on the
[
(C) - (D)
(No change.)
(3) - (4)
(No change.)
(5)
If laboratory tests are performed on the premises, the
following shall be maintained:
(A)
(No change.)
(B)
a log book, which shall include patient name and identification
number,
practitioner's
[
(C) - (F)
(No change.)
(6) - (7)
(No change.)
(8)
The
ASC
[
(A)
Written criteria describing the length of time tests can
be done prior to surgery shall be
developed by the medical staff and
approved by the governing body.
[
(B)
Laboratory work shall be performed in a Medicare-approved
reference laboratory or in the patient's healthcare practitioner's office.
This shall be written in a policy accepted by the medical staff and governing
body.
[
[(C)
Laboratory work shall be performed in
a Medicare-approved reference laboratory or the patient's physician's office.
This shall be written in a policy accepted by the medical staff and governing
body.]
(9)
If it is the ASC's policy to administer blood, policies
shall be developed on administration of blood transfusions to include autologous
blood units in accordance with the ASC's operative procedures.
If the
operative procedure(s) performed in the ASC requires or may require the necessity
for transfusions, policies and procedures shall include provisions for stat
and routine transfusions. These policies and procedures shall include, but
are not limited to, collection, labeling, and transportation of specimen in
accordance with the ASC or contract service policies. All patient results
shall appear in the patient's chart.
[(A)
If the operative procedure(s) performed
in the ASC (i.e., cataract surgery) does not indicate the necessity for a
transfusion, the approved procedures must reflect this and be approved by
the medical staff and governing body with ultimate responsibility accepted
by the governing body.]
[(B)
If the operative procedure(s) performed
in the ASC requires or may require the necessity for transfusions, policies
and procedures shall include provisions for stat and routine transfusions.
These policies and procedures shall include, but are not limited to, collection,
labeling, and transportation of specimen in accordance with the ASC or contract
service policies. All patient results shall appear in the patient's chart.]
(10)
If the ASC performs surgery which incorporates the removal
of a tissue specimen or the freezing of a tissue specimen, the specimen shall
be submitted to a Medicare-approved reference laboratory. The following shall
be maintained:
(A)
(No change.)
(B)
documentation to include patient name and identification
number,
practitioner's
[
(C)
(No change.)
(11) - (12)
(No change.)
(13)
Pathology tissue reports and positive cytology reports
shall have the
authorized
[
§135.14.Radiology Services in a Licensed ASC.
(a) - (b)
(No change.)
(c)
Services shall be provided either directly within or through
[
[(1)
If services are provided through contractual
arrangement the ASC may instruct its patients to go directly to the facility
for x-ray service.]
[(2)
If services are provided by an outside
x-ray firm coming into the ASC, this portable x-ray firm must be Medicare
certified according to 42 Code of Federal Regulations Part 405, Subpart N, §§405.1411-405.1416.]
(d) - (e)
(No change.)
(f)
Policies shall address the quality aspects of radiology
services, including, but not limited to:
(1)
performing radiology services only upon the written order
of a physician
, dentist, advanced practice nurse or other authorized
healthcare practitioner
[
(2)
(No change.)
(g)
(No change.)
(h)
Laser equipment shall be licensed as required by the Texas
Department of Health, Bureau of Radiation Control.
Policies and procedures
shall be established and implemented for laser technology which include laser
safety programs, education and training of laser personnel, credentialing
for each specific laser and a requirement for all personnel working with lasers
to be adequately trained in the safety and use of each type of laser utilized.
§135.15.Nursing Services in a Licensed ASC.
(a)
There shall be an organized nursing service under the direction
of a qualified registered nurse
(RN)
and staffed to assure that
the nursing needs of all patients are met.
(b)
There shall be a plan of administrative authority for all
nursing services with responsibilities and duties of each category of nursing
personnel delineated and a written job description for each category. The
scope of nursing service shall include, but is not limited to, nursing care
rendered to patients preoperatively, intraoperatively, and postoperatively.
(1)
The responsible individual for nursing services shall be
a qualified
RN
[
(2)
(No change.)
(3)
Surgical technicians and licensed vocational nurses may
be permitted to serve as
the
scrub nurse under the direct supervision
of
an RN
[
(4)
(No change.)
(c)
There shall be an adequate number of
RNs
[
(1)
An RN
[
(2)
There shall be other nursing personnel in sufficient numbers
to provide nursing care not requiring the service of
an RN
[
§135.16.Teaching and Publication Activities in a Licensed ASC.
(a)
Policies concerning teaching activities shall
be developed,
implemented, and enforced which
address:
(1) - (3)
(No change.)
(b)
A
[
(c)
A policy
[
(1) - (2)
(No change.)
§135.17.Research Activities in a Licensed ASC.
(a)
Research activities shall be performed in accordance with
ethical and professional practices and legal requirements, and these activities
shall be periodically monitored
by the governing body
.
(b) - (f)
(No change.)
§135.18.Unlicensed Ambulatory Surgical Center.
(a) - (d)
(No change.)
(e)
If a person or facility fails to respond as required by
subsections (a) and (d) of this section, the provisions of §135.24(e)
and (g) of this title (relating to [
§135.19.Exemptions.
(a) - (g)
(No change.)
(h)
In the event that a person or facility does not comply
as required by subsection (g) of this section, the provisions of §135.24(e)
and (g) of this title (relating to [
§135.20.Application and Issuance of License for Initial Applicants.
(a)
(No change.)
(b)
Upon written request, the director shall furnish a person
with an application form for an ASC license. The applicant shall submit to
the director a completed original application and the nonrefundable license
fee.
(1)
The applicant shall provide:
(A) - (B)
(No change.)
(C)
the number of physicians, dentists, [
(D)
the name, Texas license number, and license expiration
date of the director of nursing of the ASC; [
(E)
whether the ASC has applied for certification under Title
XVIII of the Social Security Act
; and
[
(F)
number of surgery suites.
(2) - (4)
(No change.)
(5)
A department surveyor shall inspect the ASC within 90 days
after the issuance of the temporary license. An on-site inspection may, at
the department's discretion be waived for previously licensed
ASCs
[
(6) - (8)
(No change.)
(9)
If an ASC that is not participating in the Title XVIII
Program is determined not to be in compliance with minimum standards for a
license in accordance with these sections after an inspection, the ASC shall
come into compliance no later than 30 days prior to the expiration of the
temporary license. If the ASC is determined not to be in compliance with minimum
standards for licensure in accordance with these sections following a second
on-site inspection or mail investigation, 30 days prior to the expiration
date of the temporary license, the ASC shall be notified of the proposed denial
of the first annual license in accordance with §135.24 of this title
(relating to [
(10)
(No change.)
§135.21.Inspections.
(a)
The department shall conduct an initial on-site inspection
to determine if either the federal conditions of participation under Title
XVIII or the standards for licensing set forth in these sections are being
met. Prior to an inspection, the surveyor shall notify the applicant in writing
of the date and time of the inspection. The department will evaluate the ASC
on a standard-by-standard basis before the first annual license is issued,
unless waived in accordance with §135.20(b)(7) of this title (relating
to Application and Issuance of License for Initial Applicants). An on-site
inspection for ASCs that are not participating in the Title XVIII Program
may be conducted for license renewal. An on-site inspection for ASCs that
participate in the Title XVIII Program may be conducted once every three years.
An on-site inspection may be conducted if a change of ownership
or a
change in location
of a licensed ASC has occurred, if the ASC has not
demonstrated compliance with standards, or if complaints against an ASC have
been received by the department.
(b) - (c)
(No change.)
(d)
The survey report form shall be submitted as follows.
(1) - (6)
(No change.)
(7)
If the ASC does not timely come into compliance, the department
may propose to deny, suspend, or revoke the existing license in accordance
with
Health and Safety Code, §243.011, and
§135.24 of
this title (relating to [
§135.22.Renewal of Annual License.
(a)
(No change.)
(b)
The applicant shall submit to the department a renewal
application form and a nonrefundable license fee. [
(c)
The department shall issue a renewal license to a facility
which meets either the federal conditions of participation under Title XVIII
or the minimum standards for a license set forth in these sections. If
the
[
§135.23.Conditions of Annual License.
(a)
No license may be transferred or assigned from one person
to another person. If a change of ownership of a licensed ASC is anticipated,
in order to ensure continuity of patient services, the department shall be
informed in writing and the applicant shall submit a license application and
nonrefundable fee at least
30
[
(b)
No license may be transferred from one ASC location to
another [
(c) - (d)
(No change.)
§135.24.[
(a) - (c)
(No change.)
(d)
The department shall refuse to issue or renew a license
of an ASC that participates under Title XVIII, if the certifying body,
Centers for Medicare and Medicaid Services
[
(e)
If the director proposes to deny, suspend, or revoke a
license, the director shall give the applicant written notification of the
reasons for the proposed action and offer the applicant an opportunity for
a hearing. The applicant may request a hearing within 30 days after the date
the applicant receives notice. The request must be in writing and submitted
to the director, Health Facility
Licensing and Compliance
[
(f)
(No change.)
(g)
If the provisions of
Occupations Code, Chapter 53,
Consequences of Criminal Conviction
[
(h)
(No change.)
§135.25.Emergency Suspension.
(a)
(No change.)
(b)
An emergency suspension is effective immediately without
a hearing
on
[
(c)
(No change.)
§135.26.Administrative Penalties.
(a) - (b)
(No change.)
(c)
Report and notice of violation and penalty.
(1)
If the department initially determines that a violation
occurred, the department shall give written notice of the report by certified
mail to the person alleged to have committed the violation [
(2)
(No change.)
(d) - (l)
(No change.)
§135.27.Complaints.
(a)
In response to a complaint, the
[
(b) - (c)
(No change.)
(d)
Conduct of the investigation will include, but not limited
to:
(1) - (5)
(No change.)
(6)
a conference at the conclusion of the inspection between
the department's representative and the person who is in charge of the ASC.
(A)
(No change.)
(B)
Any records that are removed from an ASC (other than those
reproduced) shall be removed only with the consent of the ASC.
The ASC
shall furnish copies of all records pertinent to the investigation at the
department's request.
(e) - (f)
(No change.)
§135.28.Reporting of Incidents.
(a)
Reportable incidents that occur in an ASC include
the following.
[
(1)
Complications that result in the death
of a patient must be reported.
(2)
A condition for which the ASC does not
have the adequate equipment and or personnel to care for the patient, which
results in an emergency transfer to a hospital from the ASC must be reported.
(3)
Reports of any fire or other damage sustained
at the ASC must be reported.
(b)
(No change.)
[(c)
Reportable incidents include the following:]
[(1)
Complications that result in the death of a patient must
be reported.]
[(2)
Complications that result in emergency transfer of a patient
to a hospital from the ambulatory surgical center must be reported.]
[(3)
Reports of any fire or other damage sustained at the ASC
must be reported.]
(c)
[
§135.29.Confidentiality.
Request for information and access to records are governed by the
Texas
Public Information
[
(1) - (2)
(No change.)
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State on March 25, 2002.
TRD-200201828
Susan Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 5, 2002
For further information, please call: (512) 458-7236
25 TAC §135.41, §135.42
The amendments are proposed under Health and Safety Code (HSC),
Chapter 243, Texas Ambulatory Surgical Center Licensing Act; which provides
the Board of Health (board) with the authority to adopt rules governing the
licensing and regulation of ASCs, and HSC §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 commissioner of health.
The proposed sections affect Health and Safety Code, Chapters 243 and 12,
and implement Government Code, §2001.039.
§135.41.Fire Prevention, Protection, and Safety.
An ambulatory surgical center (ASC) shall comply with the provisions
of this section with respect to fire prevention, protection, and safety.
(1)
(No change.)
(2)
Fire reporting. An ASC shall report all occurrences of
fire in writing no later than 10 calendar days following the occurrence to
the director, Health Facility Licensing
and Compliance
Division
(HFLCD)
[
(3)
Smoking policy. An ASC shall adopt, implement and enforce
a written smoking policy. The policy shall include the minimum provisions
of National Fire Protection Association 101,
Life Safety
Code [
(4) - (11)
(No change.)
(12)
Electrical systems. Electrical systems shall be installed
and maintained in a safe condition in accordance with National Fire Protection
Association 70, National Electrical Code, 1996 edition (NFPA 70). [
§135.42.Handling and Storage of Gases, Anesthetics, and Flammable Liquids.
An ASC shall comply with the requirements of this section for handling
and storage of gas, anesthetics, and flammable liquids.
(1)
(No change.)
(2)
Flammable and nonflammable gases and liquids. The determination
of flammability of liquids and gases shall be in accordance with the National
Fire Protection Association
325,
"Guide to Fire Hazard Properties
of Flammable Liquids, Gases, and Volatile Solids," 1994 edition[
(A)
Nonflammable gases shall be stored and distributed in accordance
with National Fire Protection Association 99 [
(B) - (C)
(No change.)
(D)
Other flammable agents shall be stored in accordance with
NFPA 99, Chapter 6
"Materials"
.
(3)
(No change.)
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed
with the Office of the Secretary of State on March 25, 2002.
TRD-200201829
Susan Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 5, 2002
For further information, please call: (512) 458-7236
25 TAC §§135.51 - 135.54
The amendments are proposed under Health and Safety Code (HSC),
Chapter 243, Texas Ambulatory Surgical Center Licensing Act; which provides
the Board of Health (board) with the authority to adopt rules governing the
licensing and regulation of ASCs, and HSC §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 commissioner of health.
The proposed sections affect Health and Safety Code, Chapters 243 and 12,
and implement Government Code, §2001.039.
§135.51.Construction Requirements for an Existing Ambulatory Surgical Center.
(a)
Compliance.
(1)
(No change.)
(2)
In lieu of meeting the requirements in paragraph (1) of
this subsection, an existing licensed ASC may, instead, comply with National
Fire Protection Association (NFPA) 101,
Life Safety
Code
1997 Edition (NFPA 101),
[
(3)
(No change.)
(b)
Remodeling and additions. All remodeling, renovations,
additions and alterations to
or relocation of
an existing ASC shall
be done in accordance with the requirements for new construction in §135.52
of this title (relating to Construction Requirements for New Ambulatory Surgical
Centers). When existing conditions make such changes impractical, the department
may grant a conditional approval of minor deviations from the requirements
of §135.52 of this title, if the intent of the requirements is met and
if the care, safety and welfare of patients will not be jeopardized. The operation
of the ASC, accessibility of individuals with disabilities, and safety of
the patients shall not be jeopardized by a condition(s) which is not in compliance
with these sections.
(1)
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 ASC 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 §135.53 of this title
(relating to Preparation, Submittal,
Review
[
(2)
Minor remodeling or alterations. Minor remodeling or alterations
within an existing ASC 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 paragraph (3) of this
subsection are considered to be minor projects and require evaluation and
approval by the department. An ASC shall submit a written request for evaluation,
a brief description of the proposed changes, and sketches of the area being
remodeled. Based on such submittal, the department will evaluate and determine
whether any additional submittals or inspections are required. The department
will notify the ASC
of it's decision
[
(3)
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. An ASC shall comply with this paragraph prior to beginning construction
of major projects.
(A)
(No change.)
(B)
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)
(No change.)
(ii)
Construction, dust
, objectionable fumes
and
vapor barriers shall be provided to separate areas undergoing demolition and
construction from occupied areas.
(iii)
(No change.)
(c)
(No change.)
§135.52.Construction Requirements for New Ambulatory Surgical Centers.
(a)
Ambulatory surgical center (ASC) location. An ASC 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.
(1)
(No change.)
(2)
Means of egress. An ASC shall have at least two exits remotely
located in accordance with National Fire Protection Association (NFPA) 101,
Life Safety
Code [
(3) - (4)
(No change.)
(b)
ASC site. The ASC site shall include paved roads, walkways,
and parking in accordance with the requirements set out in this subsection.
(1)
(No change.)
(2)
Parking.
(A)
(No change.)
(B)
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
[
(c)
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, one of the following codes shall govern: Uniform Building Code,
1997 edition, published by the International Conference of Building Officials,
5360 Workman Mill Road, Whittier, California 90601, telephone (562) 699-0541;
or the Standard Building Code, 1997 edition, published by the Southern Building
Code Congress International, Inc., 900 Montclair Road, Birmingham, Alabama
35213-1206, telephone (205) 591-1853.
(1)
General architectural requirements. All new construction,
including conversion of an existing building to an ASC or establishing a separately
licensed ASC within another existing building, shall comply with NFPA 101, §12-6.
"New Ambulatory Health Care Facilities,"
and this section.
(A)
Construction types for multiple building occupancy.
(i)
When an ASC is part of a larger building which complies
with NFPA 101, §12-6.1.6.
"Minimum Construction Requirements"
for (fire resistance) construction type, the designated ASC shall be separated
from the remainder of the building with a minimum of 1-hour fire rated construction.
(ii) - (iii)
(No change.)
(B)
(No change.)
(2) - (3)
(No change.)
(4)
State handicapped requirements.
Special considerations
benefiting handicapped staff, visitors, and patients shall be provided. Each
ASC 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, Part 1191, Appendix A, Accessibility Guidelines for Buildings
and Facilities.
[
[(5)
Federal handicapped requirements. An
ASC shall comply with the Americans with Disabilities Act 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.]
(5)
[
(6)
[
(7)
[
(8)
[
[(10)
Energy conservation. In new facilities
or existing facilities with additions or renovated areas, mechanical, electrical,
and plumbing, systems and components shall be selected for efficient utilization
of energy which is determined by overall efficiency, operational cost, and
life cycle costing.]
(d)
Spatial requirements.
(1)
Administration and public areas.
(A)
Entrance. Entrances shall be located at grade level, be
accessible to individuals with disabilities, and protected
against
[
(B)
Waiting area. A waiting area or lobby shall be provided
which includes
having access to
the following rooms and items:
(i)
[
(ii)
[
(iii)
access to potable drinking water
[
(C) - (F)
(No change.)
(G)
General storage room.
(i)
A minimum of 50 square feet per operating room shall be
provided exclusive of soiled holding, sterile supplies, clean storage, drug
storage, locker rooms, and surgical equipment storage. General storage may
be located in one or more rooms or closets and shall be located
outside
of the patient treatment areas
[
(ii)
(No change.)
(H)
(No change.)
(2) - (3)
(No change.)
(4)
Laboratory.
(A)
General. Laboratory
services
[
(B) - (C)
(No change.)
(5)
Laundry and linen processing area(s). Laundry and linen
processing may be done within the center or off-site at a commercial laundry.
(A)
On-site linen processing. When on-site linen processing
is provided, 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:
(i) - (ii)
(No change.)
(iii)
supply storage cabinets in the soiled and clean linen
processing rooms; [
(iv)
hand washing facilities within the soiled linen processing
room
; and
[
(v)
a storage room for clean linen located
within the surgical suite. Clean linen storage may be combined with the clean
work room.
(B)
(No change.)
(6)
(No change.)
(7)
Preoperative patient holding room.
(A) - (B)
(No change.)
(C)
Patient toilet. A toilet room with
handicapped accessible
water closet and hand washing facilities shall be provided. The toilet
room may be shared with the recovery room, if conveniently located to both.
(D)
(No change.)
(8)
Radiology.
[(A)
General. Basic diagnostic procedures
shall be provided within the ASC or through a contractual arrangement with
a hospital or an accredited diagnostic service.]
(A)
[
(i)
film processing facilities
, if used
;
(ii)
viewing
capabilities
[
(iii)
storage facilities for exposed film
, if used,
located in rooms or areas constructed in accordance with the NFPA 101, §26-3.2.1
and §26-3.2.2.
(iv)
Dressing area(s) shall be required, depending
on services provided, with convenient access to toilets and may be shared
with patient changing/preop rooms.
(B)
[
(9)
Recovery room.
(A)
(No change.)
(B)
Patient station(s). A minimum of
one
[
(i) - (ii)
(No change.)
(C)
Patient toilet. A toilet room with
handicapped accessible
water closet and hand washing facilities shall be provided. The toilet
room may be shared with the preoperative patient holding area, if conveniently
located to both.
(D)
Second stage recovery. A separate supervised room or area
may
[
(i)
(No change.)
(ii)
When an open or ward area is provided for second stage
recovery, the minimum clearance from the bed or recliner to the side wall
may not be less than three feet; and a space of four feet shall [
(10)
Staff clothing change area.
(A)
General. The change area shall be designed to provide a
one-way traffic pattern so that personnel entering from outside the surgical
suite can change
into scrub attire
[
(B)
Staff changing area. A staff changing area shall [
(i)
[
[(ii)
female dressing room with lockers;]
(ii)
[
(iii)
[
(C)
(No change.)
(11)
(No change.)
(12)
Sterilizing facilities. A system for sterilizing equipment
and supplies shall be provided. Sterilizing procedures may be done on-site
or off-site, or disposables may be used to satisfy functional needs.
(A)
Off-site sterilizing. When sterilizing is provided off-site
and disposables and prepackage surgical supplies are used, the following rooms
shall be provided near the operating room.
(i)
(No change.)
(ii)
Clean workroom. A clean workroom shall be provided for
the exclusive use of the surgical suite. The workroom shall contain a work
counter, with space for receiving, disassembling and organizing clean [
(iii)
(No change.)
(B)
On-site sterilizing facilities. When sterilizing facilities
are provided on-site they shall be located near the operating room and provide
the following rooms.
(i)
Receiving/decontamination room. The receiving/decontamination
room shall be physically separate from all other areas of the surgical suite.
The room shall include a work counter(s) or table(s), clinical sink or equivalent
flushing type fixture, equipment for initial
washing/disinfection
[
(ii) - (iii)
(No change.)
[(iv)
Sterile equipment storage. An equipment
storage room shall be provided. Sterile storage equipment may be combined
with surgical equipment storage, but space provided for sterile equipment
must be in addition to the 30 square feet per operating room requirement in
paragraph (13)(B)(vii) of this subsection.]
(iv)
[
(13)
Surgical suite. The surgical suite shall be arranged to
preclude unrelated traffic through the suite. The surgical suite shall contain
at least one operating room and all surgical service areas required under
subparagraph (B) of this paragraph.
(A)
(No change.)
(B)
Surgical service areas.
[(i)
Control station. A control station shall
be located to permit direct visual surveillance of the restricted corridor
and traffic which enters the surgical suite.]
(i)
[
(I)-(VIII)
(No change.)
[(IX)
staff clothing change area;]
(IX)
[
(X)
[
(XI)
emergency eyewash.
(ii)
[
(iii)
[
(iv)
[
(v)
[
(vi)
[
[(viii)
Anesthesia workroom. When anesthesia
is administered, an anesthesia workroom shall be provided for cleaning, testing,
and storing anesthesia equipment. The room shall contain a work counter, hand
washing facilities, racks for cylinders, and separate storage for clean and
soiled items.]
(vii)
[
(viii)
[
(ix)
[
(14) - (15)
(No change.)
(16)
Medical waste
[
(e)
Details.
(1) - (3)
(No change.)
(4)
Toilet room accessories.
Grab bars shall be provided
at water closets and showers in accordance with the ADA
.
[(A)
Grab bars. Grab bars shall be provided
at water closets and showers in accordance with the TAS.]
[(B)
Mirrors. Mirrors may not be installed
at hand washing fixtures where asepsis control and sanitation requirements
would be lessened by hair combing.]
(5) - (6)
(No change.)
(7)
Radiation protection. Shielding shall be designed, tested,
and approved by a medical physicist licensed under the Medical Physics Act,
Occupations Code, Chapter 602
[
(8)
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.
(f)
(No change.)
(g)
Elevators. All buildings that have patient services located
on other than the main entrance floor shall have electric or electrohydraulic
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.
(1)
Requirements for new elevators. New elevators shall be
installed in accordance with the requirements of
Health and Safety Code,
Chapter 754, Elevators, Escalators, and Related Equipment, and ASME
A17.1, "Safety Code for Elevators and Escalators," 1990
latest
edition, published by the American Society of Mechanical Engineers and the
American National Standards Institute (ASME/ANSI A17.1). All new elevators
shall conform to the Fire Fighters' Service Requirements of ASME/ANSI A17.1
requirements of NFPA 101, Section 7-4.4. All documents published by the ASME/ANSI
as referenced in this section may be obtained by writing the ANSI, United
Engineering Center, 345 East 47th Street, New York, N.Y. 10017.
(2)
Requirements for existing elevators. Existing elevators
shall comply with the ASME/ANSI A17.1, Safety Code for [
(3)
(No change.)
(4)
Elevator car size.
(A)
(No change.)
(B)
When an operating room(s) is located on a floor other than
the preoperative and recovery floors a hospital-type elevator shall be provided.
Cars of hospital-type elevators shall be at least five feet eight inches wide
by
eight feet five inches
[
(5) - (8)
(No change.)
(9)
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
.
(10)
(No change.)
(11)
Testing. An ASC 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"
.
(12)
(No change.)
(h)
Mechanical requirements. This subsection 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.
(1) - (3)
(No change.)
(4)
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.
(A)
Material lists. Upon completion of the contract, the owner
shall
obtain from the construction contractor
[
(B)
Instructions. Upon completion of the contract, the owner
shall
obtain from the construction contractor
[
(5)
Heating, ventilating, and air conditioning (HVAC) systems.
(A)
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," 1996 edition, or
NFPA 90B, "Standard for the Installation of Warm Air Heating and Air-Conditioning
Systems," 1996 edition, as applicable and the requirements contained in this
subparagraph. Air handling units serving two or more rooms are considered
to be central units. [
(B)
Non-central air handling systems, i.e., individual room
units that are used for heating and cooling purposes (e.g., fan-coil units,
heat pump units
, and packaged terminal air conditioning units)
shall be equipped with permanent (cleanable) or replaceable filters. The filters
shall have
an average efficiency of 25-30% and an average arrestance
of 85% based on ASHRAE Test Standard 52.1-92
[
(C)
Ventilation system requirements. All rooms and areas in
the center shall have provision for positive ventilation. Fans serving exhaust
systems shall be located at the discharge end and shall be conveniently accessible
for service. Exhaust systems may be combined, unless otherwise noted, for
efficient use of recovery devices required for energy conservation. The ventilation
rates shown in Table 1 of §135.54(a) of this title shall be used only
as minimum requirements since they do not preclude the use of higher rates
that may be appropriate.
(i)
(No change.)
(ii)
Temperature
[
(iii)
Air handling duct requirements. Fully ducted supply,
return and exhaust air systems shall be provided for all patient care areas.
Combination systems, utilizing both ducts and plenums for movement of air
in these areas shall not be permitted.
Ductwork access panels shall be
labeled.
(I)
(No change.)
(II)
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
[
(-a-)
(No change.)
(-b-)
Interconnection of air handling fans and smoke dampers.
Air handling fans and smoke damper controls shall be
interlocked
[
(-c-)
(No change.)
(iv)
Outside air intake locations.
(I)
Outside air intakes shall be located at least 25 feet from
exhaust outlets of ventilating systems, combustion equipment stacks, medical-surgical
vacuum
system
[
(II)
(No change.)
(III)
The bottom of outside air intakes shall be located not
less than six feet above ground level. The bottom of outside air intakes located
on a roof shall be not less than three feet above
the adjacent
[
(v)
Air exhaust outlets. Exhaust outlets from areas
containing
[
(vi)
(No change.)
(vii)
Air Distribution Devices
[
(viii)
Ventilation start-up requirements. Air handling systems
shall not be operated without the proper installation of the filter in accordance
with the manufacturer recommendation or instruction. This includes the 90%
efficiency filters where required. Ducts shall be cleaned thoroughly by
a National Air Duct Cleaner Association (NADCA) certified
[
(ix)
(No change.)
(x)
Filtration requirements. All air handling units shall be
equipped with filters having efficiencies equal to, or greater than, those
specified in Table 2 of §135.54(b) of this title. Filter efficiencies
shall be average
dust spot
efficiencies tested in accordance with
American Society of Heating, Refrigerating, and Air-conditioning Engineers
(ASHRAE), Inc., Standard 52, "Gravimetric and Dust Spot Procedures for Testing
Air Cleaning Devices Used in General Ventilation for Removing Particulate
Matter," 1992 edition. All joints between filter segments, and between filter
segments and the enclosing ductwork, shall have gaskets and seals to provide
a positive seal against air leakage. All documents published by ASHRAE as
referenced in this section may be obtained by writing or calling the ASHRAE,
Inc. at the following address or telephone number: ASHRAE, Inc., 1791 Tullie
Circle, N. E., Atlanta, GA 30329; telephone (404) 636-8400.
(I)
(No change.)
(II)
Location of single filters. Where only one filter bed
is required by Table 2 of §135.54(b) of this title, it shall be located
upstream of the cooling and heating coils
[
(III)
Duct linings.
Friable internal
[
(xi) - (xii)
(No change.)
(D)
Thermal and acoustical insulation for air handling systems.
Asbestos
containing
insulation
materials
shall not be
used.
(i) - (ii)
(No change.)
(iii)
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, 1996 edition
.
(iv)
Friable
[
(6)
Piping systems and plumbing fixture requirements. All piping
systems and plumbing fixtures shall be designed and installed in accordance
with the requirements of the
Uniform Plumbing Code, 1997 Edition, published
by the International Conference of Building Officials, 5360 Workman Mill Road,
Whittier, California 90601, telephone (562) 699-0541; or the Standard Plumbing
Code, 1997 edition, published by the Southern Building Code Congress International,
Inc., 900 Montclair Road, Birmingham, Alabama 35213-1206, telephone (205)
591-1853.
[
(A)
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.
(i)
(No change.)
(ii)
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).
(iii) - (iv)
(No change.)
(B)
Fire sprinkler systems. When provided, fire sprinkler systems
shall comply with the requirements of NFPA 101, Section 7-7
"Automatic
Sprinklers and Other Extinguishing Equipment"
and the requirements of
this clause. 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," 1996 edition, and shall be certified as
required by §135.53(e)(4) of this title (relating to Preparation, Submittal
Review, and Approval of Plans).
(C)
Piped nonflammable medical gas and clinical vacuum systems.
When provided, piped nonflammable medical gas and clinical vacuum system installations
shall be designed, installed and certified in accordance with the requirements
of NFPA 99, Section 4-3 for
"Level 1 Piped Systems"
[
(i) - (xi)
(No change.)
(D)
(No change.)
(7)
Steam and hot water systems.
(A)
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. [
(i) - (ii)
(No change.)
(B)
Domestic hot
[
(i) - (ii)
(No change.)
(8)
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.
(A)
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) [
(B)
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[
(C)
Drains for chemical wastes. Separate drainage systems for
chemical wastes (acids and other corrosive materials) shall be provided. Materials
acceptable for chemical waste drainage systems shall include chemically resistant
borosilicate
glass pipe, high silicone content cast iron pipe,
polypropylene
[
(9)
Thermal insulation for piping systems and equipment. Asbestos
containing
insulation
materials
shall not be used.
(A)
Insulation.
Insulation shall be provided for
the following:
(i) - (v)
(No change.)
(B)
(No change.)
(10)
Plumbing fixtures. Plumbing fixtures shall be made of
nonabsorptive, acid resistant materials and shall comply with the
requirements
of the Uniform Plumbing Code, 1997
[
(A)
Sink and lavatory controls. All lavatories used by medical
and nursing staff and by patients shall be trimmed with valves
or electronic
controls
which can be operated without the use of hands. Blade handles
used for this purpose shall not be less than four inches in length. Single
lever or wrist blade devices may
also
be used.
(B) - (D)
(No change.)
(E)
Drinking fountain. Each drinking fountain shall be designed
so that the water issues at an angle from the vertical, the end of the water
orifice is above the rim of the bowl, and a guard is located over the orifice
to protect it from lip contamination
and in compliance with the American
Disabilities Act
.
(F) - (I)
(No change.)
(J)
Scrub sink controls. Freestanding scrub sinks and lavatories
used for scrubbing in procedure rooms shall be trimmed with foot, knee, or
electronic hands-free
[
(K) - (L)
(No change.)
(11)
Moisture sensor. A moisture sensor with
remote indicator light or drainage system shall be provided for the drain
pans located beneath the plumbing lines above operating rooms.
(i)
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," 1996 edition, §517-50; NFPA 99, Chapter 13; the requirements of
this subsection; 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.
(1) - (10)
(No change.)
(11)
Lighting.
(A)
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
[
(i) - (iii)
(No change.)
(B) - (F)
(No change.)
(12)
(No change.)
(13)
Equipment.
(A) - (B)
(No change.)
(C)
A "kill switch" shall be provided for
disconnection of each HVAC serving the building.
(14) - (16)
(No change.)
(17)
Essential electrical system. The essential electrical
system shall comply with the requirements of NFPA 99, §13-3.3.2.
(A)
A Type 1 essential electrical system shall be installed,
maintained and tested in each facility in accordance with requirements of
NFPA 99, Section 3-4; NFPA 101, §12.6.2.9; and National Fire Protection
Association 110, Standard for Emergency and Standby Power Systems, 1996 edition.
(i)
All autoclaving/sterilizing equipment
shall be connected to the emergency power system.
(ii)
One electrical outlet connected to the
life safety branch of the electrical system shall be provided adjacent to
(or on) the emergency generator.
(iii)
The battery charger for emergency lighting
at the emergency generator shall be connected to the life safety branch of
the electrical system.
(B)
(No change.)
(18)
(No change.)
§135.53.Preparation, Submittal, Review, and Approval of Plans.
(a)
General. [
(1)
ASC 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.
(2)
Before the department will perform a plan
review for a new ASC, the ASC owner or operator shall submit a license application
and license fee in accordance with §135.20 of this title (relating to
Application and Issuance of License for Initial Applicants).
(3)
Plans and specifications describing the
construction of new buildings and additions to or renovations and conversions
of existing buildings shall be prepared by design professionals.
(4)
Preliminary documents shall be prepared
and submitted in accordance with subsection (b) of this section.
(5)
Construction documents shall be prepared
and submitted in accordance with subsection (c) of this section.
(6)
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.
(7)
Department files will be closed after
one year from the date of receipt of plans for projects which have been placed
on hold.
(8)
The licensee or the owner shall notify
the department in writing when a project has been canceled or abandoned.
(b)
Preliminary documents. Preliminary documents shall consist
of
a functional program narrative,
preliminary plans, [
(1)
Functional program narrative. The narrative shall
be prepared by medical professionals and presented on ASC letterhead. The
narrative shall describe the medical procedure(s) to be performed, staffing,
patient types, hours of operation, function and space relationships, transfer
provisions and availability of offsite services, and the scope of the project,
type of construction (existing or proposed) as stated in National Fire Protection
Association 101, Life Safety Code, 1997 edition (NFPA 101), §12-6.1.6,
published by the National Fire Protection Association (NFPA), functional description
of each space (may be shown on plans), energy conservation measures included
in building, mechanical and electrical designs. 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 02269-9101, (800) 344-3555.
[
[(A)
Area map. A map of the area within a
500 foot radius of the ASC site shall be provided and any hazardous and undesirable
location noted in §135.52(a)(3) and (4) of this title (relating to Construction
Requirements for New Ambulatory Surgical Centers) shall be identified.]
[(B)
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. Any extreme variations in grade shall be indicated.]
[(C)
Floor plans.]
[(i)
New facilities. Each floor plan shall indicate and identify
all individual spaces, doors, windows and means of egress. The total floor
area on each level involved in construction shall be shown on the drawings.
Each smoke compartment area shall be calculated and shown.]
[(ii)
Existing facilities. 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 which shows
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)
Outline specifications. Outline specifications
shall contain a general description of the construction; materials; and finishes
not shown on the drawings; type of heating, ventilation and air conditioning
system; and type of essential electrical system.]
(2)
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)
Area map. A map of the area within a 500
foot radius of the ASC site shall be provided and any hazardous and undesirable
location noted in §135.52(a)(3) and (4) of this title (relating to Construction
Requirements for New Ambulatory Surgical Centers) shall be identified.
(B)
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. Any extreme variations in grade shall be indicated.
(C)
Floor plans.
(i)
New facilities. Each floor plan shall indicate and identify
all individual spaces, doors, windows and means of egress. The total floor
area on each level involved in construction shall be shown on the drawings.
Each smoke compartment area shall be calculated and shown.
(ii)
Existing facilities. 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 which shows
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)
Outline specifications. Outline specifications
shall contain a general description of the construction; materials; and finishes
not shown on the drawings; type of heating, ventilation and air conditioning
system; and type of essential electrical system.
(3)
Submission of preliminary plans. One set of preliminary
plans and outline specifications covering the construction of new buildings,
additions, or renovations to existing buildings,
a functional program
narrative, and an Application for Plan Review
shall be submitted to
the Texas Department of Health
, 1100 West 49th Street, Austin, Texas
78756
[
[(A)
Preliminary plans and specifications
must be accompanied by a completed Application for Plan Review.]
[(B)
All deficiencies noted in the preliminary
plan review shall be satisfactorily resolved. Written department approval
of preliminary plans must be obtained prior to proceeding with final plans
and specifications. This requirement also applies to fast-track projects.]
(4)
Preliminary plan review. All deficiencies
noted in the preliminary plan review shall be satisfactorily resolved. Written
department approval of preliminary plans must be obtained prior to proceeding
with final plans and specifications. This requirement also applies to fast-track
projects.
(c) - (e)
(No change.)
§135.54.Tables.
(a) - (c)
(No change.)
(d)
Table 4. Flame Spread and Smoke Production Limitations
for Interior Finishes.
Figure: 25 TAC, §135.54(d).
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on March 25, 2002.
TRD-200201830
Susan Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 5, 2002
For further information, please call: (512) 458-7236
Subchapter C. EMERGENCY MEDICAL SERVICES TRAINING AND COURSE APPROVAL
The Texas Department of Health (department) proposes the repeal of
and a new §157.38 concerning minimum standards and requirements for approval
of continuing education (CE) for emergency medical services (EMS) personnel.
Specifically, the new section addresses one of the options permitted for
the recertification process in §157.34 of this title (relating to Recertification).
In accordance with Health and Safety Code, Chapter 773, 76th Legislature,
1999, the department is required to adopt rules concerning minimum requirements
for recertification of EMS personnel. The benefit anticipated for the EMS
community is that the expanded content of CE categories and the increased
availability of CE resources will confront the obstacles of location and diversity
of resources, without compromising standards set to ensure the safety of the
public.
Kathryn C. Perkins, Bureau Chief, has determined that for the first five
years the proposed repeal and new rule is in effect there will be no fiscal
impact on state or local governments.
Ms. Perkins has also determined that for each of the first five years the
section is in effect, the public benefit anticipated as a result of enforcing
the section will be increased standards for the recertification of EMS personnel.
There will be no adverse economic effect on small businesses or micro-businesses.
This was determined by interpretation of the rule that small businesses and
micro-businesses will not be required to alter their business practices in
order to comply with the rule as proposed. There are no anticipated costs
to persons who are required to comply with the section proposed. There will
be no adverse impact on local employment.
Comments on the proposal may be submitted to Kathryn C. Perkins, Chief,
Bureau of Emergency Management, Texas Department of Health, 1100 West 49th
Street, Austin, Texas, 78756-3182, (512) 834-6700. Comments will be accepted
for 30 days following the date of publication of this proposal in the
25 TAC §157.38
(Editor's note: The text of the following section proposed for
repeal will not be published. The section may be examined in the offices of
the Texas Department of Health or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeal is proposed under the Texas Health and
Safety Code, Chapter 773, which provides the department with the authority
to adopt rules concerning the standards and requirements for recertification
of emergency medical services (EMS) personnel; and §12.001, which provides
the board with the authority to adopt rules for its procedure and for the
performance of each duty imposed by law on the board, the department, or the
commissioner of health.
The repeal affects the Health and Safety Code, Chapter 773.
§157.38.Continuing Education.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State on March 25, 2002.
TRD-200201822
Susan Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 5, 2002
For further information, please call: (512) 458-7236
25 TAC §157.38
The new rule is proposed under the Texas Health and Safety
Code, Chapter 773, which provides the department with the authority to adopt
rules concerning the standards and requirements for recertification of emergency
medical services (EMS) personnel; and §12.001, which provides the board
with the authority to adopt rules for its procedure and for the performance
of each duty imposed by law on the board, the department, or the commissioner
of health.
The new section affects the Health and Safety Code, Chapter 773.
§157.38.Continuing Education.
(a)
Purpose. The purpose of this section is to establish minimum
standards and guide- lines for educational activities that may be used by
EMS personnel to earn continuing education (CE) contact hours toward recertification
or relicensure in accordance with §157.34 of this title, (relating to
Recertification) and §157.40 of this title, (relating to Paramedic Licensure).
The EMS continuing education consists of educational activities designed to
promote and enrich knowledge, improve skills, and develop attitudes for the
enhancement of professional practice, thus improving the quality of emergency
medical services provided to the public.
(b)
Local Credentialing and Authorization to Practice. Nothing
in this section is intended to restrict the authority of EMS providers or
medical directors to establish higher standards and requirements for continuing
education activities that must be completed to acquire or maintain authorization
to practice within a local or regional EMS system.
(c)
Content requirements. Candidates at each certification
level shall, at a minimum, accrue department-approved CE in the following
content areas.
Figure: 25 TAC §157.38(c)
(d)
Definitions. The following words and terms, when used in
this section shall have the following meanings, unless the context clearly
indicates otherwise.
(1)
Accrediting agency--An organization approved by the department
as having met predetermined criteria to approve programs and providers of
EMS continuing education.
(2)
Approved--Recognized as having met established standards
and pre-determined criteria of the accrediting agencies which have been approved
by the department. Applies to EMS continuing education providers and programs.
(3)
Continuing Education Audit--Examination and verification
of EMS continuing education contact hours claimed to have been successfully
and timely completed by certified or licensed EMS personnel.
(4)
Classroom instruction--Workshops, seminars, conferences,
or short-term courses that an individual personally attends and which is directly
related to one of the content areas noted in subsection (c) of this section.
(5)
Clinical learning experiences--Faculty-planned and guided
learning experiences designed to assist students to meet course objectives
in the noted content areas of subsection (c) of this section and to apply
EMS knowledge and skills in the direct care of patients. These experiences
can include settings in laboratories, acute medical care facilities, extended
medical care facilities, and participation in other department approved health
related activities. Practica approved by the Texas Higher Education Coordinating
Board may also be considered a form of clinical experience under these rules.
(6)
Contact hour--Fifty consecutive minutes of participation
in a learning activity.
(7)
Continuing education--Educational activities that are related
to the content areas noted in subsection (c) of this section and are designed
to promote and enrich knowledge, improve skills, and develop attitudes for
the enhancement of professional practice, thus improving the quality of emergency
medical services provided to the public.
(8)
Continuing education program--An organized educational
activity designed and evaluated to meet a set of behavioral objectives, which
may be presented in one session, or a series of sessions, designed to enhance
or elevate EMS knowledge and practice of an EMS certificant or licensee.
(9)
Credit course--A specific set of learning experiences offered
at a regionally accredited institution of higher education. Semester and quarter
credit hours will be applied towards continuing education requirements as
follows: one quarter credit hour will be granted 11 continuing education contact
hours; one semester credit hour will be granted 16 continuing education contact
hours.
(10)
Continuing Education Provider--An individual, partnership,
organization, agency, or institution that offers EMS continuing education
programs, courses, credit courses, classroom instruction, or other EMS educational
activities.
(11)
Self-directed study--An educational activity in which
the learner takes the initiative and the responsibility for assessing, planning,
implementing, and evaluating the activity. Self-directed study may include
program development, home study, electronically programmed instruction, and
authorship.
(e)
Types of Acceptable Continuing Education.
(1)
In this section "approved educational activities" refers
to workshops, seminars, conferences, short-term courses, credit courses or
continuing education courses provided by accredited institutions of higher
education, clinical learning experiences, individualized instruction, distributive
learning courses, and other learning activities that are related to EMS or
that enhance the professional EMS practice of the certificant or licensee.
(2)
Continuing education contact hours applied toward EMS recertification
or relicensure may be earned by participating in approved educational activities
that are offered or sponsored by:
(A)
A continuing education provider, approved under subsection
(f) of this section.
(B)
A hospital or other health-care facility accredited by
the Joint Commission on Accreditation of Health Care Organizations.
(C)
A person, agency, entity, or organization approved by the
department as an EMS continuing education provider.
(D)
A person, agency, entity, or organization recognized by
a national association or organization representing members of the emergency
medical services profession that has been approved by the department.
(E)
A state or national organization in a related field such
as medicine, nursing, respiratory care, and similar fields of health care
practice that has been approved by the department.
(3)
Developing, teaching or presenting activities defined in
paragraph (e)(1) of this subsection.
(A)
Precepting students in the clinical or field internship
phases of Initial education. Contact hours for precepting of students may
be accrued only in Additional Approved Category content area.
(B)
Participating in a self-directed study of an EMS related
topic or issue that results in the written findings and conclusions of the
study accepted for publication in an EMS related textbook, or in a state or
national EMS related journal or magazine, or which results in the presentation
of the findings and conclusions of the study in a department approved workshop,
seminar, conference or class, and which is directed toward, or is applicable
to, the EMS profession.
(f)
Activities Unacceptable as Continuing Education. The following
activities are not acceptable toward re-certification or re-licensure.
(1)
Education incidental to the regular professional activities
of EMS personnel such as learning occurring from experience or personal research
which is not published.
(2)
Orientation programs sponsored by employers to provide
employees with information about the philosophy, goals, policies, procedures,
role expectations, and physical facilities of a specific workplace.
(3)
Meetings and activities such as in-service programs that
are required as part of employment unless the in-service training is a type
of acceptable continuing education under subsection (e) of this section.
(4)
Organizational activity such as serving on committees,
councils, or as an officer or board member in a professional organization.
(5)
Institutions of higher education credit courses that are
audited.
(6)
Courses in basic cardiopulmonary resuscitation or other
instructional activities designed for lay persons, including first aid courses.
(7)
Any experience that does not fit the types of acceptable
continuing education defined under subsection (e) of this section.
(8)
Any identical CE repeated more than once during the accrual
period.
(g)
Approval of Continuing Education Provider.
(1)
No person, agency, entity, or organization shall offer
continuing education for emergency medical services personnel unless the department
has authorized that person, agency, entity, or organization to be an approved
continuing education provider.
(2)
A person, agency, entity, or organization seeking approval
as a continuing education provider shall file an application with the department.
(3)
The applicant shall certify on the application that:
(A)
all programs offered by the provider for EMS continuing
education will comply with the appropriate criteria defined in subsection
(h) of this section; and
(B)
the provider shall be responsible for verifying successful
completion by a participant of each program and shall provide a certificate
of completion to the participants.
(4)
The department may require applicants for approval as continuing
education providers to.
(A)
Demonstrate they possess the financial, administrative,
and educational resources necessary to provide the type(s) of educational
activities proposed.
(B)
Provide evidence that they are capable of designing and
delivering educational activities that comply with the appropriate criteria
defined in subsection (h) of this section.
(h)
Criteria for Acceptable Continuing Education Activity.
(1)
The following criteria have been established to guide EMS
personnel in selecting appropriate programs and to guide providers of EMS
continuing education in planning and presenting activities. The following
criteria shall apply to all activities except those involving self-directed
study concluding in a published work or a presentation.
(A)
The program's content, teaching methodologies, and evaluation
methods shall be based on written learning objectives which are specific,
attainable, measurable, and descriptive of expected learner outcomes.
(B)
The target audience shall be identified and there shall
be evidence of program planning based on the needs of the potential target
audience.
(C)
Content shall be relevant to emergency medical services
practice and/or health care, shall be related to and consistent with the program's
objectives, and shall provide for the professional growth and/or maintenance
of the certificant or licensee.
(D)
Principles of adult education shall be used in the design
and delivery of the program.
(E)
There shall be documentation of the program developer's
expertise in the content area.
(F)
Learning experiences and teaching methods shall be appropriate
to achieve the objectives of the program.
(G)
Time allotted for each activity shall be sufficient for
the learner to meet the objectives of the program.
(H)
The program shall include activities to evaluate participant
achievement of the program's learning objectives with clearly defined, stated
criteria for successful completion.
(I)
Participants shall complete a written evaluation of the
program and instruction. State and/or National conferences may be exempt from
this requirement.
(J)
The continuing education provider shall furnish each participant
with a written record of the participant's successful completion of the EMS
educational activity. The record shall specify the name of the continuing
education provider, the title, date and location of the educational activity,
a description of the content area, the number of contact hours awarded, and
the name of the organization granting approval.
(K)
Program records of a continuing education provider shall
be maintained by the provider for a minimum period of five years from the
date of the program completion and shall include target audience, objectives,
and documentation of instructor qualifications, teaching strategies and materials,
evaluation instruments and results, and a list of names of participants.
(2)
Classroom Instruction. In addition to the criteria listed
in paragraph (1) of this subsection, programs consisting of or including a
component of classroom or laboratory instruction shall meet the following
criteria.
(A)
The program shall be at least one contact hour in length.
(B)
There shall be documentation of the instructor's expertise
in the content area.
(C)
A schedule of the program shall be provided which describes
content with corresponding time frames.
(D)
Facilities and educational resources shall be adequate
to implement the program.
(3)
Clinical Instruction. In addition to the criteria listed
in paragraph (1) of this subsection, programs consisting of or including a
component of clinical instruction shall meet the following criteria.
(A)
There shall be documentation of a formal relationship between
the program's provider and all facilities serving as sites for clinical instruction.
(B)
Facilities used for clinical instruction must provide access
to types of patients in sufficient variety and number to enable students to
meet the program's objectives.
(C)
Individuals who possess appropriate expertise and credentials
shall provide clinical supervision and instruction.
(D)
Continuing education student participants shall possess
appropriate insurance for professional liability while engaging in clinical
activities.
(4)
Individualized Instruction. In addition to the criteria
listed in paragraph (1) of this subsection, programs consisting of individualized
instruction, including programmed instruction, directed study, or directed
research shall meet the following criteria.
(A)
Instruction shall follow a logical sequence based on the
program's stated learning objectives.
(B)
Instruction shall involve the learner in an active response
to the educational materials presented.
(C)
The amount of instructional time applied shall be appropriate
to the learning objectives specified.
(D)
Provider shall insure that contact hour credit is awarded
to the actual certificant to whom intended.
(5)
Individual submission by the participant of study activity
for review by the department. The following information must be submitted
for review.
(A)
A course syllabus defining the content, the learning objectives,
the dates and times of presentation, and the number of contact hours.
(B)
A description of the presenters' qualifications and expertise.
(C)
Verification by the presenter of successful participation.
(i)
Additional Criteria for Specific Continuing Education Programs.
In addition to those listed in subsection (h) of this section, the following
guidelines shall apply to the selection and/or planning and implementation
of specific CE programs.
(1)
Semester or quarter credit hour courses.
(A)
The course shall be within the framework of a curriculum
that leads to degree in emergency medical services or any credit hour course
relevant to emergency health care.
(B)
Certificants, upon audit, shall be able to present an official
transcript indicating successful completion of the course with a passing grade.
(2)
Certificants, upon request by the department, shall provide
documentation on the accredited institution's letterhead giving the name of
program, location, dates, subjects taught, and total clock hours of teaching
or instruction for all continuing education activity, including credit hour
courses. Documentation may include course completion certificates, diplomas,
and/or transcripts.
(3)
Authorship.
(A)
A certificant or licensee may receive EMS continuing education
contact hours for participating in an approved self-directed study that results
in the written findings and conclusions of the study accepted for publication
in an EMS related textbook, or in a state or national EMS related journal
or magazine, or which results in the presentation of the findings and conclusions
of the study in a department approved workshop, seminar, conference or class,
and which is directed toward, or is applicable to, the EMS profession.
(B)
Continuing education contact hours shall be awarded only
once for the preparation of a specific written publication or oral presentation.
(4)
Out of state programs. A continuing education activity
successfully attended and completed or undertaken in a jurisdiction outside
Texas may be accepted for continuing education if all criteria are met and
if it is approved by the department.
(j)
Responsibilities of EMS certificants or licensees.
(1)
It shall be the responsibility of the EMS certificant or
licensee to select and participate in continuing education activities that
meet the criteria listed in subsections (h) and (i) of this section.
(2)
The EMS certificant or licensee shall be responsible for
maintaining written certifications of successful completions of EMS continuing
education courses or educational activities for five years after the dates
of completion. These records specify the name of the EMS continuing education
provider, the title, date, and location of the educational activity, a description
of the content area, the number of contact hours awarded, and the organization
granting approval and copies of these shall be submitted to the department
on audit.
(3)
Complete and accurate copies of these written certifications
shall be timely submitted to the department upon the department's request.
(k)
Audit.
(1)
The department may audit the records of individuals seeking
recertification through continuing education.
(2)
The department may audit a specific certificant in response
to a complaint, or if there is reason to suspect that a certificant may have
falsified the statement attesting that appropriate continuing education requirements
have been met.
(3)
An audit shall be automatic for a certificant who has been
found non-compliant in an immediately preceding audit.
(4)
Failure to notify the department of a current mailing address
shall not absolve the certificant from audit requirements.
(5)
Within 30 days following notification of audit, a certificant
shall submit documentation as specified in subsection (j)(2) of this section
and any additional documentation the department determines is necessary to
verify compliance with continuing education requirements.
(6)
The department may use on-site observation, audits of records,
and other appropriate methods to evaluate the performance of continuing education
providers. Evaluation of a continuing education provider may take place randomly,
in response to a complaint, or if there is reason to suspect that a continuing
education provider is not complying with the criteria established by subsections
(h) and (i) of this section.
(7)
Falsification of CE documentation shall be cause for reprimand,
probation, suspension, or revocation of a certificate or license as described
in §157.36 of this title (relating to Criteria for Denial and Disciplinary
Actions for EMS Personnel and Voluntary Surrender of a Certificate or License).
(8)
Falsification of CE documentation by a CE provider or failure
to comply with the criteria established by subsections (h) and (i) of this
section shall be cause for reprimand, probation, suspension, or revocation
of approval.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed
with the Office of the Secretary of State on March 25, 2002.
TRD-200201823
Susan Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 5, 2002
For further information, please call: (512) 458-7236
Subchapter D. INHALANT ABUSE
The Texas Department of Health (department) proposes the repeal of §205.51
and new §§205.51 - 205.66, concerning the regulatory requirements
for the retail sale of abusable volatile chemicals.
Government Code §2001.039 requires that each state agency review and
consider for readoption each rule adopted by that agency pursuant to Government
Code, Chapter 2001 (Administrative Procedure Act). Section §205.51 has
been reviewed and the department has determined that reasons for adopting
the section continue to exist in that rules on this subject are needed; however,
the section will be repealed and new rules are being proposed.
Section §205.51 covers the permitting requirements for sellers of
abusable glues and aerosol paints. Repeal of this section is necessary to
reformat the section by dividing §205.51 into multiple sections that
follow the order of the Health and Safety Code, Chapter 485.
Proposed new §§205.51 - 205.61 are required to replace the repealed
permitting requirements and to implement revisions to the Health and Safety
Code, Chapter 485, which was revised by the 77th Texas Legislature under House
Bill (HB) 2950 to expand coverage of regulated products to include nitrous
oxide and abusable volatile chemicals labeled as vapor harmful.
Proposed new §§205.62 - 205.66 are required by the Health and
Safety Code, Chapter 485, which was revised by the 76th Texas Legislature
under §§485.101 - 485.113 to implement administrative penalties.
New §205.62 includes prohibited actions listed as criminal offenses under
Chapter 485. New §205.63 describes the department's responsibility to
monitor and enforce compliance with Chapter 485 through compliance inspections.
New §§205.64 - 205.66 describe the conditions under which administrative
penalties will be assessed, and the department's options in assessing these
penalties. Three severity levels for violations are established, and examples
for each severity level are provided.
The department published a Notice of Intention to Review §205.51,
as required by Government Code §2001.039, in the
Texas Register
on March 2, 2001 (26 TexReg 1875). No comments were
received by the department on this section.
Charles Branton, Director, Product Safety Division, has determined that
for each year of the first five years the sections are in effect, there will
be fiscal implications as a result of enforcing or administering the sections
as proposed. The effect on state government from administering the administrative
penalty sections as proposed will be an increase in revenue of approximately
$5,000 for fiscal year 2002, and approximately $10,000 for each of the fiscal
years from 2003 to 2007. There will be no effect on local governments as a
result of administering the rules as proposed.
Mr. Branton has also determined that for each year of the first five years
the sections are in effect, the public benefit anticipated as a result of
enforcing the sections will be improved retailer compliance with Health and
Safety Code, Chapter 485 to prohibit the sale of abusable volatile chemicals
to minors.
The legislative changes to Health and Safety Code, Chapter 485 under HB
2950 affect small businesses or micro-businesses involved in the retail sale
of abusable volatile chemicals. Section 485.011 prohibits any person from
selling an abusable volatile chemical at retail unless the person holds, at
the time of the sale, a volatile chemical sales permit for the location of
the sale. Submission of a permit application and a $25 permit fee are required
to obtain a volatile chemical sales permit on an annual basis. The small businesses
or micro-businesses to be affected by this legislative requirement are approximately
2025 individually owned and operated retail outlets such as convenience stores,
service stations, and grocery markets located throughout the state. The economic
cost of obtaining a volatile chemical sales permit is determined by the difference
between the permit fee and the amount of revenue generated through the sale
of these products. Small businesses which do not generate sufficient revenue
to justify the purchase of a $25 annual permit may choose to discontinue sales
of these products. There are no additional economic costs to such persons
who are required to comply with these sections as proposed. There is no anticipated
impact on local employment.
Comments on the proposal may be submitted to Mr. Charles Branton, Director,
Product Safety Division, Texas Department of Health, 1100 West 49th Street,
Austin, Texas, 78756, (512) 834-6773. Comments will be accepted for 30 days
following publication of this proposal in the
Texas
Register
.
25 TAC §205.51
(Editor's note: The text of the following section proposed for
repeal will not be published. The section may be examined in the offices of
the Texas Department of Health or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeal is proposed under the Health and Safety
Code, §485.013, which provides the Texas Board of Health (board) with
the authority to adopt necessary rules to administer this chapter; and the
Health and Safety Code, §12.001, which provides the board with the authority
to adopt rules for the performance of every duty imposed by law on the board,
the department, and the commissioner of health.
The repeal affects the Health and Safety Code, Chapters 12 and 485.
§205.51.Permit for Sellers of Abusable Glues and Aerosol Paints.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State on March 25, 2002.
TRD-200201819
Susan Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 5, 2002
For further information, please call: (512) 458-7236
25 TAC §§205.51 - 205.66
The new sections are proposed under the Health and Safety
Code, §485.013, which provides the Texas Board of Health (board) with
the authority to adopt necessary rules to administer this chapter; and the
Health and Safety Code, §12.001, which provides the board with the authority
to adopt rules for the performance of every duty imposed by law on the board,
the department, and the commissioner of health.
The new sections affect the Health and Safety Code, Chapters 12 and 485.
§205.51.Purpose and Scope.
The purpose of these sections is to implement the provisions of the
Health and Safety Code, Chapter 485, concerning the retail sale of abusable
volatile chemicals. These sections cover definitions, applications for issuance
and renewal of permits to sell abusable volatile chemicals, permit fees, and
department procedures for approving, denying, and renewing permits. These
sections also cover the assessment of administrative penalties.
§205.52.Definitions.
The following words and terms, when used in these sections, shall have
the following meanings, unless the context clearly indicates otherwise.
(1)
Abusable volatile chemical--
(A)
A chemical, including aerosol paint that:
(i)
is packaged in a container subject to the labeling requirements
concerning precautions against inhalation established under the Federal Hazardous
Substances Act (15 U.S.C. §1261 et seq.), as amended, and regulations
adopted under that Act and is labeled with the statement of principal hazard
on the principal display panel "VAPOR HARMFUL" or other labeling requirement
subsequently established under that Act or by those regulations;
(ii)
when inhaled, ingested, or otherwise introduced into a
person's body, may:
(I)
affect the person's central nervous system;
(II)
create or induce in the person a condition of intoxication,
hallucination, or elation; or
(III)
change, distort, or disturb the person's eyesight, thinking
process, balance, or coordination; and
(iii)
is not:
(I)
a pesticide subject to Agriculture Code, Chapter 76 or
to the Federal Environmental Pesticide Control Act of 1972 (7 U.S.C. §136
et seq.), as amended;
(II)
a food, drug, or cosmetic subject to Health and Safety
Code, Chapter 431 or to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §301
et seq.), as amended; or
(III)
a beverage subject to the Federal Alcohol Administration
Act (27 U.S.C. §201 et seq.), as amended; or
(B)
nitrous oxide that is not:
(i)
a pesticide subject to Agriculture Code, Chapter 76 or
to the Federal Environmental Pesticide Control Act of 1972 (7 U.S.C. §136
et seq.), as amended;
(ii)
a food, drug, or cosmetic subject to Health and Safety
Code, Chapter 431 or to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §301
et seq.), as amended; or
(iii)
a beverage subject to the Federal Alcohol Administration
Act (27 U.S.C. §201 et seq.), as amended.
(2)
Act--The Abusable Volatile Chemical Act, Health and Safety
Code, Chapter 485.
(3)
Aerosol paint--An aerosolized paint product, including
a clear or pigmented lacquer or finish.
(4)
Board--The Texas Board of Health.
(5)
Commissioner--The commissioner of health.
(6)
Deliver--To make the actual or constructive transfer from
one person to another of an abusable volatile chemical, regardless of whether
there is an agency relationship. The term includes an offer to sell an abusable
volatile chemical.
(7)
Delivery--The act of delivering.
(8)
Department--The Texas Department of Health.
(9)
Inhalant paraphernalia--Equipment or materials of any kind
that are intended for use in inhaling, ingesting, or otherwise introducing
into the human body an abusable volatile chemical. The term includes a tube,
balloon, bag, fabric, bottle, or other container used to concentrate or hold
in suspension an abusable volatile chemical, or vapors of the chemical.
(10)
Permit--A volatile chemical sales permit.
(11)
Permit holder--A person who has a valid volatile chemical
sales permit.
(12)
Retailer--Any business or location which sells to the
general public, without restrictions to limit purchases to institutional or
industrial clients only.
(13)
Sell--Includes a conveyance, exchange, barter, or trade.
(14)
Volatile chemical sales permit--A permit authorizing a
retailer to sell at retail abusable volatile chemicals.
§205.53.Responsibility for Implementation of Program.
The department's responsibilities under the Act are carried out through
the Texas Department of Health, Product Safety Division. Inquiries regarding
this Act may be addressed to: Texas Department of Health, Product Safety Division,
1100 West 49th Street, Austin, Texas 78756.
§205.54.Permit Requirements and Conditions.
(a)
A person may not sell an abusable volatile chemical at
retail unless the person or the person's employer has, at the time of the
sale, a valid volatile chemical sales permit for the location of the sale.
A separate permit is required for each location at which an abusable volatile
chemical is sold. A permit is valid for one year and must be renewed annually.
(b)
To be eligible for the issuance or renewal of a volatile
chemical sales permit, an applicant or permit holder must:
(1)
hold a valid sales tax permit that has been issued to the
applicant;
(2)
complete and return an application form as required by
the department under §205.56 of this title (relating to Permit Application),
signing and dating the form attesting to the accuracy of all information contained
therein;
(3)
pay to the department a $25 application fee or a $25 renewal
fee for each location at which an abusable volatile chemical may be sold by
the applicant as required by the department under §205.57 of this title
(relating to Permit Fee);
(c)
A permit is not valid if the permit holder has been convicted
more than once in the preceding year of any offense that is committed:
(1)
at the location for which the permit is issued; and
(2)
under the Health and Safety Code, Chapter 485, §§485.031
- 485.033 (relating to Criminal Acts).
(d)
In addition to the requirements in subsections (a) and
(b) of this section, the following conditions shall be met by permit holders:
(1)
permit holder shall not sell or deliver abusable volatile
chemicals to a person under 18 years of age;
(2)
permit holder must have the permit or a copy of the permit
available for inspection at the location for which the permit is issued following
the requirements of §205.59 of this title (relating to Permit Available
for Inspection);
(3)
permit holder shall post a volatile chemical warning sign
at the location for which the permit is issued following the requirements
of §205.60 of this title (relating to Requirement to Post Warning Sign);
and
(4)
permit holder that displays aerosol paint at the location
for which the permit is issued or renewed shall restrict access to the aerosol
paint following the requirements of §205.61 of this title (relating to
Restriction of Access to Aerosol Paint).
(e)
A permit may not be transferred to a new location or to
a new owner.
§205.55.Issuance and Renewal of Permit.
(a)
The department shall issue a permit to a person who meets
the requirements of this section, §205.54 of this title (relating to
Permit Requirements and Conditions), §205.56 of this title (relating
to Permit Application), and §205.57 of this title (relating to Permit
Fee).
(b)
The permit holder may renew the permit by filing a renewal
application accompanied by a $25 renewal fee following the requirements described
in subsection (a) of this section.
(c)
At least 45 days before a permit expires the department,
as a service to the permit holder, will send a renewal notice to the last
known address of the permit holder. It is the responsibility of the permit
holder to keep the department informed of their current mailing address and
to timely renew their permit whether or not they have received the notification
from the department.
(d)
If a permit holder submits a completed permit renewal application
and fee to the department postmarked on or before the permit expiration date,
the existing permit does not expire until the application has been finally
determined by the department. If the application is denied or the terms of
the new permit are limited, the existing permit does not expire until the
last day for seeking review of the agency order or a later date fixed by order
of the reviewing court.
§205.56.Permit Application.
(a)
Application for an initial or renewal permit must be made
on an approved application form which may be obtained from the Product Safety
Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas
78756.
(b)
A separate application form must be completed and submitted
for each specific business location.
(c)
The application form shall be accurately completed and
signed by the applicant or its authorized representative and shall be accompanied
by the appropriate permit fee to be considered complete. The department shall
notify the applicant of any deficiencies in their application, and shall allow
the applicant or permit holder to provide the missing information or permit
fee within 30 days of the deficiency letter or the application will be denied
under §205.58 of this title (relating to Permit Denial). All blanks on
the application form shall be completely filled in or the application may
not be processed.
(d)
The department shall issue or deny a permit for retail
sale of abusable volatile chemicals within 60 days after the date on which
the department receives the completed application and appropriate fee.
(e)
The department may, after the filing of an application,
require additional information that the department considers necessary to
determine whether the permit should be issued.
§205.57.Permit Fee.
(a)
Each application form submitted for an initial permit or
to renew a permit shall be accompanied by a $25 fee.
(b)
The fee shall be paid by money order, certified check,
or personal check and shall be made payable to the Texas Department of Health.
Payment in cash shall not be accepted.
(c)
A separate $25 application fee is required for each retail
location.
(d)
The department may prorate permit fees to provide for a
common expiration date on request from persons holding and/or applying for
more than one permit.
§205.58.Permit Denial.
(a)
An application for an initial or renewal permit will be
denied by the department if the applicant fails to submit a completed application,
pay the appropriate permit fee, or provide requested information within 30
days after notification by the department as required under §205.56 of
this title (relating to Permit Application) and §205.57 of this title
(relating to Permit Fee).
(b)
If an application is denied, the department shall notify
the applicant or permit holder within 60 days of the receipt of the completed
application form and appropriate fee. The department shall include in the
notice the reasons for the denial. The application fee will not be returned.
(c)
A proceeding to contest the denial of a volatile chemical
sales permit under this section is governed by §§1.21 - 1.34 of
this title (relating to Formal Hearing Procedures) and the contested case
provisions of Government Code, Chapter 2001.
§205.59.Permit Available for Inspection.
A permit holder must have the volatile chemical sales permit or a copy
of the permit available for inspection by the public or the department at
each location where the permit holder sells an abusable volatile chemical.
§205.60.Requirement to Post Warning Sign.
(a)
A business establishment that sells abusable volatile chemicals
at retail shall display a volatile chemical warning sign, in English and Spanish,
that states the following: "It is unlawful for a person to sell or deliver
abusable volatile chemicals to a person under 18 years of age. Except in limited
situations, such an offense is a state jail felony. It is also unlawful for
a person to abuse a volatile chemical by inhaling, ingesting, applying, using,
or possessing with intent to inhale, ingest, apply, or use a volatile chemical
in a manner designed to affect the central nervous system. Such an offense
is a Class B misdemeanor."
(b)
A current version of the volatile chemical warning sign
shall be clearly posted in a conspicuous and prominent place at the location
where the permit holder sells abusable volatile chemicals.
(c)
The volatile chemical warning sign shall measure at least
8-1/2 by 11 inches and must be typed, typeset, or mechanically produced with
lettering that is clearly legible. The letters shall not be smaller than 12
characters per inch. The word "WARNING" shall be in included in bold capital
letters at least 1/3 inch high and located above the wording required in subsection
(a) of this section.
(d)
To assist permit holders in complying with subsection (a)
of this section, the department shall make warning signs available for use
and photocopying by permit holders. Warning signs may be obtained free of
charge from the Product Safety Division, Texas Department of Health, 1100
West 49th Street, Austin, Texas 78756.
(e)
Permit holders may add the following additional information
to the warning sign as long as the wording required by subsection (a) of this
section is included: the name, address, and telephone number of the business
establishment's contact for responding to questions from patrons.
§205.61.Restriction of Access to Aerosol Paint.
(a)
A business establishment that holds a volatile chemical
sales permit under §205.54 of this title (relating to Permit Requirements
and Conditions) and that displays aerosol paint shall display the paint:
(1)
in a place that is in the line of sight of a cashier or
in the line of sight from a workstation normally continuously occupied during
business hours;
(2)
in a manner that makes the paint accessible to a patron
of the business establishment only with the assistance of an employee of the
establishment; or
(3)
in an area electronically protected, or viewed by surveillance
equipment that is monitored, during business hours.
(b)
This section does not apply to a business establishment
that has in place a computerized checkout system at the point of sale for
merchandise that alerts the cashier that a person purchasing aerosol paint
must be over 18 years of age or older.
(c)
This section applies only to a business establishment that
is located in a county with a population of 75,000 or more.
§205.62.Prohibited Acts.
(a)
The department may impose an administrative penalty on
a person who sells abusable volatile chemicals at retail and who commits a
prohibited act under this section; no finding of intent is required to impose
an administrative penalty.
(b)
A person commits a prohibited act under this section if
the person sells or delivers an abusable volatile chemical to a person who
is younger than 18 years of age.
(c)
It is a defense to the violation listed in subsection (b)
of this section if:
(1)
the abusable volatile chemical that was delivered contains
additive material that effectively discourages intentional abuse by inhalation;
or
(2)
the person making the delivery is not the manufacturer
of the chemical and the manufacturer of the chemical failed to label the chemical
with the statement of principal hazard on the principal display panel "VAPOR
HARMFUL" or other labeling requirement subsequently established under the
Federal Hazardous Substances Act (15 U.S.C. §1261 et seq.), as amended,
or regulations subsequently adopted under that Act.
(d)
It is an affirmative defense to the violation listed in
subsection (b) of this section if:
(1)
the person making the delivery is an adult having supervisory
responsibility over the person younger than 18 years of age and:
(A)
the adult permits the use of the abusable volatile chemical
only under the adult's direct supervision and in the adult's presence and
only for its intended purpose; and
(B)
the adult removes the chemical from the person younger
than 18 years of age on completion of that use; or
(2)
the person to whom the abusable volatile chemical was sold
or delivered presented to the seller at retail an apparently valid Texas driver's
license or an identification certificate, issued by the Department of Public
Safety of the State of Texas and containing a physical description consistent
with the person's appearance, that purported to establish that the person
was 18 years of age or older.
(e)
A person commits a prohibited act under this section if
the person delivers or sells inhalant paraphernalia and at the time of the
act knows that the person who receives or is intended to receive the paraphernalia
intends that it be used to inhale, ingest, apply, use, or otherwise introduce
into the human body a substance containing a volatile chemical.
§205.63.Compliance Inspections.
(a)
The department shall monitor and enforce compliance with
the Act and any rule or order adopted by the board to administer the Act.
(b)
Compliance inspections or investigations may be conducted
by a department representative during normal operating hours to determine
if a person is in violation of the Act or a rule or order adopted by the board
to administer the Act.
(c)
A department representative, upon presenting the department
identification card, shall have the right to enter all retail facilities during
normal operating hours to inspect and investigate for compliance with these
sections, including to review records, to question any person, or to locate
or identify abusable volatile chemicals held for retail sale.
(d)
A department representative is not required to notify in
advance or seek permission to conduct inspections or investigations. It is
a violation of this chapter for a person to interfere with, deny, or delay
an inspection or investigation conducted by a department representative.
§205.64.Administrative Penalty.
(a)
The department may assess an administrative penalty against
a person who sells an abusable volatile chemical at retail who violates the
Act or a rule or order adopted under this Act.
(b)
A penalty collected under this subchapter shall be deposited
in the state treasury in the general revenue fund.
(c)
The amount of the penalty may not exceed $1,000 for each
violation, and each day a violation continues or occurs is a separate violation
for purposes of imposing a penalty. The total amount of the penalty assessed
for a violation continuing or occurring on separate days under this subsection
may not exceed $5,000.
(d)
In determining the amount of the administrative penalty,
the department shall consider:
(1)
the seriousness of the violation, including the nature,
circumstances, extent, and gravity of the violation;
(2)
the threat to health or safety caused by the violation;
(3)
the history of previous violations;
(4)
the amount necessary to deter a future violation;
(5)
whether the violator demonstrated good faith, including
when applicable whether the violator made good faith efforts to correct the
violation; and
(6)
any other matter that justice may require.
(e)
Violations will be classified in one of three severity
levels.
(1)
Critical Violation. Severity Level III includes violations
that are most significant and have a direct negative impact on public health
and safety. The penalty for a Level III violation on first occurrence is up
to $1000 per day, per violation. The same violation continuing for more than
one day is a separate violation. Examples of Level III violations include
but are not limited to:
(A)
operating without a valid volatile chemical sales permit
for the location at which abusable volatile chemicals are sold in violation
of §205.54 of this title (relating to Permit Requirements and Conditions);
(B)
operating under a permit issued to another person or for
another location, in violation of §205.54 of this title;
(C)
falsifying information required on the volatile chemical
sales permit application under §205.56 of this title (relating to Permit
Application);
(D)
failing to establish controls to restrict a person under
the age of 18 years from access to aerosol paints displayed for retail sale
at a business establishment as required under §205.61(a) of this title
(relating to Restriction of Access to Aerosol Paint);
(E)
interfering with, denying, or delaying department representatives
in conducting an inspection at the location at which abusable volatile chemicals
may be sold as required under §205.63 of this title (relating to Compliance
Inspections); or
(F)
committing any of the prohibited acts listed under §205.62
of this title (relating to Prohibited Acts).
(2)
Serious violation. Severity Level II includes violations
that are significant and which, if not corrected, could threaten public health
and safety. The penalty for a Level II violation on first occurrence is up
to $750 per day, per violation. The same violation continuing for more than
one day constitutes a separate violation. Examples of Level II violations
include, but are not limited to:
(A)
failing to have a volatile chemical sales permit available
for inspection by the public or department as required under §205.59
of this title (relating to Permit Available for Inspection);
(B)
failing to display a volatile chemical warning sign as
required under §205.60(a) of this title (relating to Requirement to Post
Sign); or
(C)
failing to ensure that the controls established under §205.61(a)
of this title are adequate to restrict a person under the age of 18 from access
to aerosol paints.
(3)
Significant violation. Severity Level I includes violations
that are of more than minor significance and, if left uncorrected, could lead
to more serious circumstances. The penalty for a Level I violation on first
occurrence is up to $500 per day, per violation. The same violation continuing
for more than one day constitutes a separate violation. Examples of Level
I violations include, but are not limited to:
(A)
failing to post a volatile chemical warning sign in a conspicuous
and prominent place as required under §205.60(b) of this title; or
(B)
posting a volatile chemical warning sign that does not
comply with the requirements under §205.60(c) of this title.
§205.65.Notice of Violation.
(a)
If the department initially determines that a violation
occurred, the department shall give written notice of the report by certified
mail to the person.
(b)
The notice must include:
(1)
a brief summary of the alleged violation;
(2)
a statement of the amount of the proposed penalty; and
(3)
a statement of the person's right to a hearing on the occurrence
of the violation, the amount of the penalty, or both.
(c)
Not later than the 20th day after the date on which the
notice is received, the person notified may, in writing:
(1)
accept the determination and recommended penalty of the
department;
(2)
request a settlement conference; or
(3)
request a hearing on the occurrence of the violation, the
amount of the penalty, or both. A person may request both a settlement conference
and a hearing in the same letter.
(d)
If the person accepts the determination and recommended
penalty or if the person fails to respond in a timely manner to the notice,
the commissioner or the commissioner's designee shall issue an order approving
the determination and imposing the recommended penalty.
§205.66.Administrative Hearing.
A proceeding to impose the penalty is considered to be a contested
case subject to the provisions of the Administrative Procedure Act, Texas
Government Code, Chapter 2001. The formal hearing procedures of the department
in Chapter 1 of this title (relating to the Board of Health) and the provisions
of the Act found in the Health and Safety Code, Chapter 485, Subchapter D
shall also apply.
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on March 25, 2002.
TRD-200201820
Susan Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 5, 2002
For further information, please call: (512) 458-7236
Chapter 402.
CLIENT ASSIGNMENT AND CONTINUITY OF SERVICES
Subchapter C. DETERMINATION OF MANIFEST DANGEROUSNESS
25 TAC §§402.71 - 402.83
(Editor's note: The text of the following sections proposed for
repeal will not be published. The sections may be examined in the offices
of the Texas Department of Mental Health and Mental Retardation or in the
Texas Register office, Room 245, James Earl Rudder Building, 1019 Brazos Street,
Austin.)
The Texas Department of Mental Health and Mental
Retardation (TDMHMR) proposes the repeals of §§402.71 - 402.83 of
Chapter 402, Subchapter C, concerning determination of manifest dangerousness.
New §§415.301 - 415.316 of Chapter 415, Subchapter G, concerning
the same, which would replace the repealed sections, are contemporaneously
proposed in this issue of the
Texas Register.
The repeals would allow for the adoption of new sections governing the
same matters.
Cindy Brown, chief financial officer, has determined that for each year
of the first five years the proposed repeals are in effect, the proposed repeals
do not have foreseeable implications relating to cost or revenue of the state
or local governments.
Kenny Dudley, director, state mental health facilities, has determined
that, for each year of the first five years the proposed repeals are in effect,
the public benefit expected as a result of the adoption of the new rules is
the promulgation of procedures that ensure individuals who exhibit dangerous
behaviors receive treatment to address those behaviors in the most appropriate
setting while providing for due process and the safety of others. It is anticipated
that there would be no economic cost to persons required to comply with the
proposed repeals.
It is anticipated that the proposed repeals will not affect a local economy.
It is anticipated that the proposed repeals will not have an adverse economic
effect on small businesses or microbusinesses because the rules did not place
requirements on small or microbusinesses.
Written comments on the proposal may be sent to Linda Logan, director,
Policy Development, Texas Department of Mental Health and Mental Retardation,
P.O. Box 12668, Austin, Texas 78711-2668, within 30 days of publication.
These sections are proposed for repeal under the Texas Health
and Safety Code, §532.015(a), which provides the Texas Mental Health
and Mental Retardation Board with broad rulemaking authority, and the Texas
Code of Criminal Procedure, Articles 46.02 and 46.03, which require the TDMHMR
commissioner to appoint a review board to determine whether a person committed
to the maximum security unit is manifestly dangerous.
These proposed sections would affect the Texas Code of Criminal Procedure,
Articles 46.02 and 46.03.
§402.71.Purpose.
§402.72.Application.
§402.73.Definitions.
§402.74.Review Boards.
§402.75.Persons Not Subject to Manifest Dangerousness Hearings by Facility Review Boards.
§402.76.Procedures for the Determination of Manifest Dangerousness by Facility Review Boards.
§402.77.Procedures for the Determination of Manifest Dangerousness by the TDMHMR Dangerousness Review Board.
§402.78.Transfer of Individuals.
§402.79.Procedures for Hearings.
§402.80.Request and Decision for New Hearing by CEO or Individual.
§402.81.Research Concerning Standards for Manifest Dangerousness.
§402.82.Distribution.
§402.83.References.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State on March 21, 2002.
TRD-200201770
Andrew Hardin
Chairman, Texas MHMR Board
Texas Department of Mental Health and Mental Retardation
Earliest possible date of adoption: May 5, 2002
For further information, please call: (512) 206-4516
Subchapter G. DETERMINATION OF MANIFEST DANGEROUSNESS
completed
] application is received;
.
]
Subchapter B. DETERMINING ELIGIBILITY
(excluding
AFDC, Medicaid, or SSI recipients)
] and their relationship to the applicant;
AFDC
],
SSI, or Medicaid:
, but are exempt if they are irregular
and unpredictable.
]
Title II, Section 204 (#) of
] the WIA
of 1998
are earned
income and counted for adults. OJT payments are exempt if received by a child
who is under 19 and under parental control of another household member.
Income from property.
This income is counted as unearned income, whether from rent, lease, or sale
on an installment plan. If the household sells property on an installment
plan, the payments are unearned income. The balance of the note is an inaccessible
resource. Income from boarding situations is earned income.
]
AFDC
] recognizable needs amounts; and
(except real property)
is exempt if it is essential to a household member's employment or self-employment
and annually produces income consistent with its fair market value, even if
used only on a seasonal basis. Such property will continue to be exempt during
temporary periods of unemployment if the client expects to return to work.
Property essential to self-employment is not exempt if earnings result from
an illegal activity.
]
Subchapter C. PROVIDING SERVICES
county
].
, or palliative
];
furnished
] to hospital
outpatients;
furnished
] by or under
the direction of a physician (MD or DO); and
furnished
] by a licensed
Texas Title XIX Medicaid-enrolled acute care
hospital [
facility
].
(For state fiscal year 2000 only, a county must notify the department of the
county's intent to provide any of the following services within 45 days of
the final adoption of these rules. If approved by the department, the county
may credit these services toward eligibility for state assistance the month
following the date of the approval.)
]
furnished
] in reference to an ambulatory surgical procedure, including those
services on the HCFA approved list and selected Medicaid-only procedures.
furnished
] by a
Texas
Title
XIX Medicaid-enrolled
[
XIX-enrolled
] provider; if the SSI/SSDI
appellant is later determined to be retroactively eligible for SSI/Medicaid;
and the appellant and the provider assign reimbursement rights by completing
the appellant/provider assignment form.
On approval of commissioners'
court, the county judge shall sign a confidentiality agreement with the department
in order for the county to submit claims for Texas Medicaid or Vendor Drug
Program reimbursement to the department.
10 workdays
of determining the SSI/SSDI appellant's current Medicaid eligibility
],
in accordance with paragraph (4) of this subsection, the county must:
Chapter 127.
REGISTRY FOR PROVIDERS OF HEALTH-RELATED SERVICES the ] Registry.
of the filing of the request
].
inclusion on a registry of the requested occupation
].
Placement
] on
a
[
the
] registry is voluntary.
person
] placed on
a
[
the
] registry may not represent in any manner that the
provider
[
person
] is licensed, certified, inspected or otherwise
regulated by the Texas Department of Health (department). A
provider
[
person
] in violation of this subsection may be referred
to the appropriate governmental agency for action under the Deceptive Trade
Practices Act, Business and Commerce Code, Chapter 17, or other applicable
law.
certification
]. The request shall be
made in writing to Chief, Bureau of Licensing and
Compliance
[
Certification
], Texas Department of Health, 1100 West 49th Street, Austin,
Texas 78756, within 10 days of the applicant's receipt of the notice of disapproval.
in
] the registry for the appropriate occupation
for a period of one year from the date of approval. The department shall issue
evidence of placement on the registry to each approved
provider
[
applicant
].
person
] must reapply
annually in accordance with subsections (a) and (b) of this section in order
to continue to remain on
a
[
the
] registry.
When
the registry of a specific occupation is removed, providers will be notified
at the time of annual reapplication that there is no longer a registry for
that occupation.
fee
]--$500;
Chapter 135.
AMBULATORY SURGICAL CENTERS
Texas Civil Statutes, Article 4437f-2,
] which
requires
[
require
] ambulatory surgical
centers to be licensed by the Texas Department of Health.
Public Law 89-87, 1965
]. Should the state standards exceed the federal requirements in these
areas, the federal requirements will control.
Texas Civil Statutes, Article
4437f-2
].
or
] has a baccalaureate or postgraduate degree in administration
or a health-related field
,
[
;
] or has one year of administrative
experience in a health care setting.
(3)
] Ambulatory Surgical Center
(ASC) -- A facility that operates primarily to provide surgical services to
patients who do not require overnight hospital care.
(4)
] Autologous blood units -- Units
of blood or blood products derived from the recipient.
(5)
] Available -- On the premises
and sufficiently free from other duties to enable the individual to respond
rapidly to emergency situations.
(6)
] Certified registered nurse
anesthetist (CRNA) -- A currently licensed registered nurse who has current
certification from the Council
on
[
of
] Certification[
- Recertification of the American Association
] of Nurse
Anesthetists
[
Anesthetist
] and who is currently
authorized to practice
as an Advanced Practice Nurse by the Board of Nurse Examiners
[
registered with the Board of Nurse Examiners as an advanced nurse practitioner
].
(7)
] Change of ownership --
(8)
] Department -- The Texas Department
of Health.
(9)
] Director -- The director of
the Health Facility
Licensing and Compliance
[
Licensure and
Certification
] Division of the Texas Department of Health or his or
her designee.
(10)
] FDA-approved blood bank --
A facility that has been licensed in accordance with the Food and Drug Administration
requirements in the preparation of blood and blood products.
(11)
] Health care practitioners
(Qualified Medical Personnel)
-- Individuals currently licensed under
the laws of this state who
are authorized to provide services in an ASC
[
may provide services in an ASC, including doctors of medicine,
doctors of osteopathy, doctors of dental surgery or dental medicine, doctors
of podiatric medicine, registered nurses, and licensed vocational nurses
].
(12)
] Licensed vocational nurse
-- A person who is currently licensed under the laws of this state to use
the title, licensed vocational nurse.
(13)
] Medicare-approved reference
laboratory -- A facility that has been certified and found eligible for Medicare
reimbursement, and includes hospital laboratories which may be Joint Commission
on Accreditation of
Healthcare Facilities
[
Hospitals
]
or American Osteopathic Association accredited or nonaccredited Medicare approved
hospitals, Medicare certified independent laboratories.
(14)
] Physician -- A person who
is currently licensed under the laws of this state to practice medicine and
who holds a doctor of medicine or a doctor of osteopathy degree.
(15)
] Person -- Any individual,
firm, partnership, corporation, or association.
(16)
] Registered nurse -- A person
who is currently licensed under the laws of this state as a registered nurse.
(18)
] Title XVIII -- Title XVIII
of the United States Social Security Act,
42 U.S.C. §1395 et seq.
[
Public Law 89-87, 1965
].
ambulatory surgical
center
]:
Any remittance submitted to the department in payment
of a required fee must be in the form of a certified check, money order, or
personal check and made out to the Texas Department of Health.
]
ambulatory surgical center
]
must have a governing body that sets policy and assumes full legal responsibility
for the total operation of the ASC.
appropriately
] addressed;
determining
] a policy on the rights of patients;
Patients' disclosures and
]
records shall be treated confidentially and, except when authorized by law,
patients shall be given the opportunity to approve or refuse their release.
rights
] to refuse
to participate in experimental research; and
The status of
each category of allied health professionals
] shall be included in personnel
policies and appropriate job descriptions shall be developed.
in an ethical and legal manner
].
for all nursing
service personnel. Nursing services shall be provided in accordance with recognized
standards of practice. There shall be a registered nurse available for emergency
treatment whenever there is a patient in the ASC.
]
(d)
] The provision of
quality
[
high-quality
] health care services shall be demonstrated
by at least the following:
(e)
] When clinically indicated,
patients shall be contacted as quickly as possible for follow-up regarding
significant problems and/or abnormal laboratory or radiologic findings that
have been identified.
(f)
] When the need arises, patients
shall be transferred from the care of one health care practitioner to another.
(g)
] Concern for the appropriateness
of care shall be governed by the following:
(h)
] Education activities shall
relate, in part, to the findings as quality assurance activities and shall
include cardiopulmonary resuscitation training.
shall
] be used to implement the quality assurance program. Assessment
techniques shall examine the structure, process, or outcome of care, and shall
be assessed prospectively, concurrently, or retrospectively.
log
] shall be maintained
of all fires, patient deaths,
and all
[
emergency and nonemergency
] transfers from the ASC to the hospital.
address,
but are not limited to:
]
ambulatory surgical center
]
record shall include the following:
or
] local
, or regional
anesthetic;
(r)
] All final tissue and abnormal
cytology reports from the Medicare approved reference laboratory shall be
signed by a pathologist.
,
] manual breathing bag[
, and ventilator
];
(8)
] laryngoscopes and endotracheal
tubes;
(9)
]
functioning
suction
equipment; and
(10)
] emergency drugs and supplies
specified by the medical staff.
anesthesiologist, surgeon,
or other physician(s)
].
Adequate supervision of anesthesia services provided
by the ASC shall be the responsibility of an anesthesiologist, surgeon, or
one or more qualified physicians who are approved by the governing body upon
the recommendation of the ASC medical staff.
]
anesthesiologists, other qualified physician or dentist anesthetists,
qualified
] certified registered nurse
anesthetist,
[
anesthetists,
]
qualified physician or dentist anesthetist,
or supervised
trainee
[
trainees
] in an approved educational
program.
which include, but are not limited to:
]
anesthesiologist
]
has evaluated the patient immediately prior to surgery to assess the risk
of the anesthesia relative to the surgical procedure to be performed.
anesthesiologist after recovery from anesthesia and prior to
discharge
].
Patients may be discharged from the ASC using discharge
criteria approved by the governing board upon the recommendation of qualified
healthcare practitioners.
At least one operating room shall be available for surgery.
]
anesthesiologist
] or [
another
] physician qualified in
advanced life
support and
resuscitative techniques shall be present or immediately
available until all patients operated on that day have been discharged.
ASC
] to require pre-operative laboratory orders.
upon
the written
] order of a physician, podiatrist, [
or
] dentist
or advanced practice nurse
and written on the patient's chart.
doctor's
] name, date the specimen
was drawn, test ordered, and results;
ASC's
] can allow laboratory
work to be performed and brought in from other Medicare-approved reference
laboratories or
practitioners'
[
physicians'
] offices
and the
reports shall be on the patient's charts before surgery
[
following shall be maintained
].
maintained. (In no case shall
lab work be performed more than 14 days prior to surgery for local anesthesia,
or seven days for general anesthesia.)
]
Final reports shall be on the patient's chart before surgery.
]
doctor's
] name, date the tissue
specimen was collected and referred to the Medicare-approved reference laboratory,
and date the final report came back from the Medicare-approved reference laboratory.
Final copies shall be placed in the patient's chart, with copies kept in the
ASC; and
written
] signature of the
pathologist interpreting the report. [
A computerized signature or signature
stamp cannot be used.
]
an effective contractual arrangement with
] a Medicare-approved
facility and the contracts shall be available for review.
If services
are provided by an outside x-ray firm coming into the ASC, this portable x-ray
firm must be Medicare certified according to 42 Code of Federal Regulations
Part 405, Subpart N, §§405.1411-405.1416.
or dentist
] (such orders must be
accompanied by a concise statement of the reason for the examination)[
. A written order is required if the x-ray procedure is an integral part of
the patient's surgery
]; and
registered nurse
] whose responsibility
and authority for nursing service shall be clearly defined and includes supervision
of both personnel performance and patient care.
a registered nurse
]; they shall not be permitted
to function as circulating nurses in the operating rooms, except in ASCs where
no general anesthesia is administered and when there is an adequate number
of RNs immediately available for an emergency situation. Licensed vocational
nurses and surgical technicians may assist in circulatory duties under the
supervision of a qualified RN during general
anesthesia
[
anesthetic
] cases.
registered nurses
] on duty to meet the following minimum staff requirements:
director of the department (or designee), and supervisory and staff personnel
for each service area to assure the immediate availability of
an RN
[
a registered nurse
] for emergency care or for any patient when
needed.
A registered nurse
] shall
assign the nursing care of each patient to other nursing personnel in accordance
with the patient's needs and the preparation and qualifications of the nursing
staff available.
a registered nurse
].
The
] policy concerning the provision
of health care by personnel in any student or postgraduate trainee status
shall
be developed, implemented, and enforced and
provide for close
and adequate supervision and for informing the patient of the status of the
provider.
Policies
]
shall be
developed, implemented, and enforced
concerning publishing activities
. The policy
shall address:
License
] Denial, Suspension,
or Revocation
of License
) will govern.
License
] Denial, Suspension,
or Revocation
of License
) will govern.
and/or
]
podiatrists
and advanced practice nurses
on staff at the ASC;
and
]
.
]
ASC's
] for which a change of ownership has occurred.
License
] Denial, Suspension, or Revocation
of License
).
License
] Denial, Suspension, or Revocation
of License
).
Those ASC's not participating
in the Title XVIII Program must also submit a self-survey.
] Those ASCs
that are under the Title XVIII Program will have the ASC's certification verified
by the department based upon the results of the current inspection report
on file with the department. These documents shall be submitted and postmarked
no later than 60 days prior to the expiration date of the license.
an
] applicant fails to timely submit an application
and fee
[
, fee, and self survey,
] in accordance with subsection
(b) of this section, the department shall notify the applicant that the ASC
must cease providing ambulatory surgical services
. If the facility can
provide the department with sufficient evidence that the submission was completed
in a timely manner and all dates were adhered to, the cease to perform will
be dismissed. If the facility cannot provide sufficient evidence, the facility
shall immediately thereafter return the license by certified mail.
[
on the expiration date of the license and immediately thereafter return the
license, by certified or registered mail, to the department.
]
If
[
if
] the applicant wishes to provide ambulatory surgical
services after the expiration date of the license, the applicant must reapply
for an annual license under
§135.20
[
§135.21
]
of this title (relating to Application and Issuance of License for Initial
Applicants).
90
] days prior to the
change of ownership of each ASC. The procedure shall be handled in accordance
with §135.20 of this title (relating to Application and Issuance of License
for Initial Applicants), with the exception of the presurvey conference and
the on-site inspection, unless deemed necessary by the department. A temporary
license will be issued for the newly acquired ASC effective on the date the
ownership changed. The previous license will be void on the date of acquisition.
without prior written approval from the department
]. If
an ASC is relocating, the ASC shall complete and submit a
license application
and non-refundable fee at least 60 days prior to the relocation of the ASC.
The procedure shall be handled in accordance with §135.20 of this title,
with the exception of the presurvey conference, unless deemed necessary by
the department. A temporary license will be issued for the relocated ASC effective
on the date the relocation occurred. The previous license will be void on
the date of relocation.
[
form provided by the department at least
30 days prior to the intended relocation. The department will provide written
notification to the ASC amending the current ASC license to reflect the new
location.
]
License ] Denial, Suspension, or Revocation of License .
Health Care Financing
Administration (HCFA)
], has terminated that ASC's provider agreement
under Title XVIII.
Licensure and Certification
] Division, Texas Department of Health, 1100
West 49th Street, Austin, Texas 78756. A hearing shall be conducted pursuant
to the
Government Code, Chapter 2001,
Administrative Procedure
[
and Texas Register
] Act, [
Texas Civil Statutes, Article 6252-13a
], and §§1.21
, 1.23, 1.25, and 1.27
[
-1.33
] of this title (relating to Formal Hearing Procedures). If a hearing
is not requested in writing within 30 days after receiving notice of the proposed
action, the applicant is deemed to have waived the opportunity for a hearing
and the proposed action shall be taken.
Texas Civil Statutes, Articles
6252-13c and 6252-13d
], apply to an ASC, any procedures covering the
denial, suspension, or revocation of a license shall be governed by the provisions
in those statutes.
or
] notice to the license holder.
not later
than 90 days
] following the survey exit date.
The
]
department or its authorized representative may enter the premises of an ASC
during normal business hours as necessary to assure compliance with the Act
and these sections. The investigation may be conducted on-site, unannounced
or announced, or may be investigated by phone or mail.
Certain situations and incidents that occur in
an ASC shall be reported directly to the department.
]
(d)
] Any theft of drugs and/or diversion
of controlled drugs shall be reported to the local police agency, the State
Board of Pharmacy, the Texas Department of Public Safety, and/or the Drug
Enforcement Administration, and the Texas Department of Health.
Open Records
] Act, Texas Government
Code, Chapter 552.
Subchapter B. SAFETY REQUIREMENTS FOR NEW AND EXISTING AMBULATORY SURGICAL CENTERS
HFL
], Texas Department of Health, 1100 West 49th
Street, Austin, Texas 78756 or
fax
[
faxed
] to
(512) 834-4514
[
(512) 834-6714
]. Any fire occurrence causing
injury to a person shall be reported no later than the next business day to
the director,
HFLCD
[
HFL
], by fax or overnight mail,
to the address or fax number previously mentioned in this paragraph.
for Safety to Life from Fire in Buildings and Structures
], 1997 edition
(NFPA 101), §12-7.4. All documents published by National Fire Protection
Association (NFPA) as referenced in this section may be obtained by writing
or calling the NFPA at the following address or telephone number: National
Fire Protection Association, 1 Batterymarch Park, P.O. Box 9101, Quincy, MA
02269-9101 or (800) 344-3555.
All
documents published by National Fire Protection Association (NFPA) as referenced
in this section may be obtained by writing or calling the NFPA at the following
address or telephone number: National Fire Protection Association, 1 Batterymarch
Park, P.O. Box 9101, Quincy, MA 02269-9101 or (800) 344-3555.
]
,
]
(NFPA 325). All documents published by National Fire Protection Association
(NFPA) as referenced in this section may be obtained by writing or calling
the NFPA at the following address or telephone number: National Fire Protection
Association, 1 Batterymarch Park, P.O. Box 9101, Quincy, MA 02269-9101 or
(800) 344-3555.
(NFPA 99), Chapter 4,
]
"Standard for Health Care Facilities," 1996 edition
(NFPA 99), Chapter
4
. Examples of nonflammable gases include, but are not limited to, oxygen
and nitrous oxide. Medical gases and liquefied medical gases shall be handled
in accordance with NFPA 99, Chapter 8, "Gas Equipment."
Subchapter C. PHYSICAL PLANT AND CONSTRUCTION REQUIREMENTS FOR NEW AND EXISTING AMBULATORY CENTERS
for Safety to Life from Fire in Buildings
and Structures,
] §13-6, "Existing Ambulatory Health Care Facilities"
[
1997 edition
].
Evaluation
]
and Approval of Plans).
upon approval
].
If not approved within 60 days after submission, the project may proceed subject
to compliance with the regulations.
for Safety to Life from Fire in Buildings and
Structures
], 1997 edition
(NFPA 101)
, §12-6.2.4.1. When
a required means of egress from the ASC 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 that other building. Such means
of egress shall be open, available, unlocked, unrestricted, and lighted at
all times during the ASC hours of operation.
All documents published
by National Fire Protection Association (NFPA) as referenced in this section
may be obtained by writing or calling the NFPA at the following address or
telephone number: National Fire Protection Association, 1 Batterymarch Park,
P.O. Box 9101, Quincy, MA 02269-9101 or (800) 344-3555.
Texas Accessibility Standards
of the Architectural Barriers Act, Texas Civil Statutes, Article 9102, administered
by the Texas Department of Licensing and Regulation (TDLR) and shall be in
addition to the parking spaces required by subparagraph (A) of this paragraph
].
An ASC shall be designed in accordance with the
Texas Accessibility Standards of the Architectural Barriers Act, Texas Civil
Statutes, Article 9102. The Texas Department of Licensing and Regulations
(TDLR) rules at Title 16 Texas Administrative Code, Chapter 68, require plans
to be submitted to TDLR for their approval. Proof of plan submittal to TDLR
shall be provided to the Texas Department of Health.
]
(6)
] 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.
(7)
] Exceeding minimum requirements.
Nothing in these sections shall be construed to prohibit a better type of
building construction, more exits, or otherwise safer conditions than the
minimum requirements specified in these sections.
(8)
] 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, and safety to those prescribed by these sections, provided technical
documentation which demonstrates equivalency is submitted to the department
for approval.
(9)
] Separate freestanding buildings
(not for patient use). Separate freestanding buildings for nonpatient use
which are located at least 20 feet from the ASC 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.
from
] inclement weather
from the point of passenger loading/unloading
to the building entrance
[
for loading and unloading passengers
]. When an ASC is located on a floor above grade level, elevators shall
be accessible and shall meet the requirements of subsection (g) of this section.
accessible
] public toilet facilities;
a public
] telephone(s)
for public use
; and
a drinking
fountain(s)
].
within the administrative and/or
public areas
].
facilities
] shall be provided within the ASC or through a
contract or other
[
contractual
] arrangement with a hospital or accredited
laboratory.
and
]
.
]
(B)
] Special requirements. When
radiology services are provided on-site, the following minimum facilities
shall be provided:
and administrative
areas
]; and
(C)
] Fluoroscopy room. When fluoroscopy
services are provided on site
in a dedicated fluoroscopy room
,
a toilet room with
handicapped accessible
water closet and hand
washing facilities shall be directly accessible to the room.
two
] patient
station
[
stations
] per operating
room
, plus one additional station,
shall be provided.
shall
] be provided for patients who are able to leave
the recovery/post-anesthesia room, but need additional time for all vital
signs to be stabilized to the point where the patient may leave the facility.
[
This area may be combined with the waiting area required by paragraph
(1)(B) of this subsection.
]
hall
] be provided at the foot of each bed or recliner. The minimum clearance
between beds or recliners may not be less than
three feet
[
four feet six inches
].
,gown,
] and move
directly into the restricted corridor of the surgical suite.
be provided. The area shall
] include the following rooms and accommodations:
male
] dressing room with lockers;
(iii)
] toilet room(s) with water
closet and hand washing facilities (may be shared if accessible to both male
and female dressing rooms); and
(iv)
]
a shower located somewhere
within the facility
[
shower room(s) (may be shared if accessible
to both male and female dressing rooms)
].
sterile
] supplies, storage cabinets or shelving, and hand washing facilities.
sterilization/disinfection
], and hand washing facilities. Pass-through
doors, windows, and washer/sterilizer decontaminators shall serve in delivering
material to the clean workroom. The receiving/decontamination room may be
combined with the surgical suite soiled workroom.
(v)
] Cart storage room or alcove.
The storage space for distribution carts shall be adjacent to clean and sterile
storage area(s) and close to main distribution points.
(ii)
] Restricted corridor. The restricted
corridor shall serve as the primary passageway for staff and patients within
the surgical suite. The following rooms and areas when provided or required
by NFPA 101 shall have direct access to the restricted corridor:
(X)
] anesthesia workroom; [
and
]
(XI)
] area for emergency crash cart
; and
[
.
]
(iii)
] Soiled workroom. A soiled
workroom shall be provided for the exclusive use of the surgical suite staff.
The workroom shall contain a clinical sink or equivalent flushing type fixture,
work counter, designated space for waste and linen receptacles, and hand washing
facilities. The soiled workroom may not have direct connection with operating
room(s) or other sterile activity room(s).
(iv)
] Clean linen storage. A storage
room or
alcove
[
closet
] shall be provided for storing
clean linen.
(v)
] Scrub facilities. A scrub
sink shall be provided near the entrance to each operating room. Scrub facilities
shall be arranged to minimize incidental splatter on nearby personnel or carts.
One scrub station with dual faucets and separate controls may serve two adjacent
operating rooms.
(vi)
] Janitor's closet. A janitor's
closet shall be provided for the exclusive use of the surgical suite. The
closet shall contain a floor receptor or service sink and storage space for
housekeeping supplies and equipment.
(vii)
] Equipment storage. A room,
alcove, or designated
area
shall be provided for storing equipment
and supplies used in the surgical suite. The storage room or area shall be
a minimum of
50
[
30
]square feet per operating room.
(ix)
] Medical gas storage room.
When provided or required by NFPA 101, a medical gas storage room shall comply
with the requirements of NFPA 99, Chapter
4-4 "Gas and Vacuum Systems"
[
4
].
(x)
] Area for emergency crash
cart. An area or alcove located out of traffic and convenient to the operating
room(s) shall be provided for an emergency crash cart.
(xi)
] Stretcher storage area. An
area or alcove shall be located convenient for use and out of the direct line
of traffic for the storage of stretchers
as required
. Stored stretchers
shall not encroach on corridor widths.
Waste
] processing.
Space and facilities shall be provided for the safe [
and sanitary
]
storage and disposal of waste [
by incineration, mechanical destruction,
compaction, containerization, removal, or a combination of these techniques
] as appropriate for the material being handled
and in compliance
with all applicable rules and regulations
.
Texas Civil Statutes, Article 4512n
]. The ASC must obtain
a
certificate of registration issued
by the Bureau of Radiation Control to use radiation machines.
Existing
]
Elevators and Escalators,
current edition, Part XII "Alterations, Repair,
Replacements, and Maintenance" and ASME A17.3 "Safety Code for Existing Elevators
and Escalators," current edition
[
1990 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, Section 7-4.5.
nine feet
] deep.
be provided
with
] parts lists and procurement information with numbers and description
for each piece of equipment.
be provided
with
] instructions in the operational use
and maintenance
of systems and equipment as required.
All documents published by NFPA as referenced in
this section may be obtained by writing or calling the NFPA at the following
address or telephone number: National Fire Protection Association, 1 Batterymarch
Park, P.O. Box 9101, Quincy, MA 02269-9101 or (800) 344-3555.
]
a minimum efficiency
of 68% weight arrestance
]. These units may be used as
air
recirculating units only. All outdoor air requirements shall be met by a separate
central air handling system with the proper filtration, as required in Table
1 in §135.54(a) of this title (relating to Tables).
Thermometers
] and humidity
gauges. Each operating room and recovery room shall have temperature and humidity
indicating devices mounted at
60 inches above finished floor within the
room
[
eye level
].
1-hour
] rated fire and smoke partitions required
by NFPA 101, §12-6.3.7
"Subdivision of Building Space"
(not
required in ASCs meeting the provisions of NFPA 101, §12-6.3.7.3, Exception).
interconnected
] so that closing of smoke dampers will not damage
the ducts.
systems
]
outlets
, plumbing
vents, or areas which may collect vehicular exhaust or other noxious fumes.
(Prevailing winds and proximity to other structures may require other arrangements).
a
] roof level.
having
] ethylene oxide sterilizers and other contaminants
, e.g. glutaraldehyde, shall terminate not less than eight feet above the
roof level (or be appropriately labeled as "hazardous exhaust")
[
shall be above the roof level
] and arranged to exhaust upward.
Supply grilles
].
Supply diffusers grilles located in operating rooms and other
anesthetizing locations
[
Supply grilles in operating rooms
]
shall be located on the ceiling or on a wall near the ceiling and bottoms
of return air grilles
in operating rooms and other anesthetizing locations
shall be located not more than 12 inches above the finished floor nor
less than six inches
above the finished floor
. At least two return
air outlets shall be provided in each operating room on opposing walls
or opposite corners
.
an
]
air duct cleaning contractor when the air handling systems have been operated
without the required filters in place. This includes construction operations.
downstream of the supply
fan
].
Internal
] linings shall not be used in ducts,
air
terminal
units
[
boxes
], or other air system components supplying operating
rooms and post anesthesia recovery rooms unless terminal filters of at least
90% efficiency are installed downstream of linings. This requirement shall
not apply to
air terminal units and sound attenuators that have approved
nonfriable coverings, e.g., foil facing,
[
mixing boxes and acoustical
traps that have approved nonabrasive coverings
] over such linings.
Frangible
] 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 [
or health
] problem
or occupant discomfort
.
National Standard Plumbing Code published by the National
Association of Plumbing-Heating-Cooling Contractors (PHCC), 1996 edition,
and this paragraph. The National Standard Plumbing Code may be obtained by
writing or calling the PHCC at the following address or telephone number:
Plumbing-Heating-Cooling Contractors, P.O. Box 6808, Falls Church, VA 22040;
telephone (800) 533-7694
].
Level
I systems
] and the requirements of this subparagraph.
The number and arrangement
of boilers shall be such that, when one boiler breaks down or routine maintenance
requires that one boiler be temporarily taken out of service, the capacity
of the remaining boiler(s) shall be sufficient to provide hot water service
for clinical and patient use; steam for sterilization; and heating for operating,
recovery, and critical care rooms. However, reserve capacity for facility
space heating of noncritical care areas such as administrative areas, is not
required in geographical areas where a design dry bulb temperature equals
25 degrees Fahrenheit or higher as based on the 99% design value shown in
the Handbook of Fundamentals, 1993 edition, published by ASHRAE, Inc.
]
Hot
] water system.
Hot water distribution system serving all patient care areas shall be under
constant recirculation to provide continuous hot water at each hot water outlet.
Schedule 40
] pipe[
, or galvanized
iron pipe
]. Buildings or portions of buildings remodeled to an ASC need
not comply with this requirement.
), or extra strength vitrified clay pipe (VCP)
with compression joints or couplings
]. Underground piping shall have
at least 12 inches of earth cover or comply with local codes. Existing building
or portions of buildings that are being remodeled need not comply with this
subparagraph.
VCP,
] plastic pipe, or plastic lined pipe.
recommendations of the National
Standard Plumbing Code, 1996
] edition, and this paragraph.
ultrasonic
] controls. Single lever
wrist blades are not acceptable at scrub sinks.
345 East 47th Street
], New York, NY
10005
[
10017
].
Plans and specifications describing the
construction of new buildings and additions to or renovations and conversions
of existing buildings shall be prepared by design professionals. A functional
program narrative which describes the medical procedures to be performed at
the facility shall be prepared and submitted by medical professionals.
]
a functional
program narrative
] and outline specifications. [
The functional
program shall describe, in detail, staffing, patient types, hours of operation,
function and space relationships, transfer provisions and availability of
offsite services.
] 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, services,
and the usage of all spaces, areas, and rooms on every floor level.
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.
]
Functional program narrative.
The narrative shall outline and describe the medical procedure(s) to be performed
and shall describe the scope of the project, type of construction (existing
or proposed) as stated in National Fire Protection Association 101, Code for
Safety to Life from Fire in Buildings and Structures, 1997 edition (NFPA 101), §12-6.1.6,
published by the National Fire Protection Association (NFPA), functional description
of each space (may be shown on plans), energy conservation measures included
in building, mechanical and electrical designs. 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 02269-9101, (800) 344-3555.
]
(department)
] for review and approval. For convenience,
preliminary plans may be of a reduced size or scale.
Chapter 157.
EMERGENCY MEDICAL CARE
Chapter 205.
PRODUCT SAFETY
Part 2.
TEXAS DEPARTMENT OF MENTAL HEALTH AND MENTAL RETARDATION
Chapter 415.
PROVIDER CLINICAL RESPONSIBILITIES