Part 1.
TEXAS DEPARTMENT OF HEALTH
Chapter 13.
HEALTH PLANNING AND RESOURCE DEVELOPMENT
Subchapter A. WAIVER OF VISA RECOMMENDATION FOR PHYSICIANS
25 TAC §§13.1 - 13.8
The Texas Department of Health (department) proposes new §§13.1-13.8,
concerning waiver of visa rules for physicians serving in health professional
shortage areas, who apply to the J-1 visa waiver program. Federal law (8 USC §§1182(e)
and 1184(l)) allows state departments of health to recommend waivers of visa
rules in certain cases involving physicians, and this is known as the J-1
visa waiver program. These recommendations are also addressed by Texas Education
Code, §51.949. The Health and Safety Code, §§12.031-12.032
allow the Texas Board of Health (board) to set public health service fees
for administrative services by rule. The purpose of these rules is to establish
the criteria the department will use to make the recommendations and establish
the fee allowed by these laws.
Specifically, the rules apply to waivers for faculty recommended under
the Education Code and also to waivers recommended by the department for non-faculty
positions.
Connie Berry, MA, Manager of Texas Primary Care Office, has determined
that for each year of the first five years that the sections will be in effect
there will be no fiscal implications to state or local governments as a result
of administering the sections as proposed because the fee for administering
this program is set in an amount equal to the costs of administration. The
department would need to work with the legislature to ensure that the department
receives appropriation authority to use the fees to support this program.
Connie Berry, MA, Manager of Texas Primary Care Office, has determined
that for each year of the first five years the sections are in effect the
public health benefit anticipated as a result of these rules will be greater
access by physicians to the waiver process allowed by federal law, clear criteria
for physicians who wish to serve this state in health professional shortage
areas under these provisions, and a greater chance that physicians can be
recruited to serve these areas as envisioned by state and federal law. There
is no anticipated cost to small businesses or micro-businesses because it
will affect only those individual physicians that qualify for the visa waiver.
The economic costs to a person who applies for a J-1 visa waiver may be up
to $2000. A professional organization or governmental entity that chooses
to financially support an application may incur the fee of $2000. There is
no impact on local employment.
Comments on the proposal may be submitted to Connie Berry, MA, Texas Department
of Health, Texas Primary Care Office, 1100 West 49th Street, Austin, Texas
78756, (512) 458-7518, or connie.berry@tdh.state.tx.us. Comments will be accepted
for 30 days after publication in the
Texas Register
.
The new rules are proposed under Health and Safety Code, §12.032
which allows the board to set fees by rule for public health services; §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 rules affect Education Code, Chapter 51; and Health and Safety
Code, Chapter 12.
§13.1.Definition of Terms.
The following words and terms when used in these sections, shall have
the following meaning.
(1)
Employer--A Director of a health care facility where the
physician will practice.
(2)
HPSA--Health Professional Shortage Area.
(3)
J-1 Visa Waiver--Removal of the requirement that a J-1
visa holder must return to their country of origin for two years at the end
of his/her training. The waiver allows the J-1 visa holder to remain in the
United States if they agree to practice in an underserved area.
(4)
MUA--Medically Underserved Area.
(5)
NHSC--National Health Service Corp.
(6)
Operational--Providing health care services to patients.
(7)
Primary Care Specialist--A physician who has a degree and
specialization in Internal Medicine, General Practice, Family Practice, Pediatrics,
or Obstetrics/Gynecology.
(8)
Provider--A physician requesting J-1 visa waiver.
§13.2.J-1 Visa Waiver Rules.
The following apply to faculty and non-faculty waivers.
(1)
The Texas Department of Health (department) will consider
a recommendation for a J-1 visa waiver in the area or areas designated by
the Secretary of Health and Human Services as a HPSA or a MUA and is not fully
served by J-1, NHSC or other primary care physicians. A MUA must have a population
to physician ratio of 3000:1 or greater.
(2)
Primary care specialists will be considered based on Primary
Care designated HPSAs or MUAs.
(3)
Psychiatrists will be considered based on Mental Health
designated HPSAs or MUAs that are not fully served by J-1 physicians, NHSC,
or other physicians.
(4)
The department will consider J-1 visa waivers for physicians
who are non-primary care specialists when additional documentation is submitted
supporting the need for the services of the specialist and the shortage of
that specialty in the service area.
(5)
The first 30 complete applications that meet Federal and
State requirements will be considered for recommendation. The submission of
a complete waiver application to the department does not ensure that the department
will recommend a waiver to the United States Department of State.
(6)
The employer or the employer's representative must submit
the J-1 waiver request applications to the department.
§13.3.Employer Rules.
(a)
The department will not accept requests from employers
who are physicians currently fulfilling their waiver obligation.
(b)
The department will not recommend a waiver for a relative
or acquaintance of the employer.
§13.4.Site Requirements.
(a)
The health care facility named as the site of service in
the application must be operational at the time of application.
(b)
A waiver request must include letters of support from community
leaders, local physicians, hospital administrators, and/or the local health
department, where applicable.
§13.5.Contract.
(a)
The contract must state that the physician will be guaranteed
the prevailing wage for the specialty for the area of practice. The "prevailing
wage" is set by the United States Department of Labor. See Department of Labor
website at: http://www.workforcesecurity.doleta.gov/foreign/wages.asp
(b)
The contract must state that the employer and the provider
agree that termination can be only for cause and not by mutual agreement.
(c)
The contract must contain the following information:
(1)
list of benefits, insurance;
(2)
field of practice;
(3)
practice site name and address;
(4)
hours;
(5)
leave; and
(6)
statements that amendments shall adhere to State and Federal
J-1 visa waiver requirements.
(d)
If applying under Education Code, §51.949, the applicant
must demonstrate compliance with its provisions.
§13.6.Verification.
(a)
The Department of State and the Immigration and Naturalization
Service shall be notified if the physician fails to begin practicing within
90 days of waiver, or is found to not be practicing 40 hours at site approved
for waiver.
(b)
The employer and/or the J-1physician must notify the department
if the contract is breached or terminated.
(c)
The department will verify the following:
(1)
90-day rule;
(2)
that physician and sponsor are fulfilling waiver obligation;
and
(3)
other information that supports the program goals.
§13.7.Application Fee.
The department shall collect a fee of $2000 from each applicant who
is granted a waiver of the two-year home residency requirement from the Immigration
and Naturalization Service. The fee shall be submitted to the department at
the time of application. Part of the fees may be returned under the following
circumstances:
(1)
if the department recommends the waiver, and Immigration
and Naturalization denies it, $1500 will be returned to the applicant;
(2)
if the applicant withdrawals the application before a recommendation
is submitted by the department, $1700 will be returned to the applicant;
(3)
if at the time the application is received by the department,
all 30 slots have been used for the fiscal year, $2000 will be returned to
the applicant.
§13.8.Other Federal or State Requirements.
All waiver request applications must meet applicable federal laws.
All waiver request applications for faculty physicians must meet applicable
state laws (Texas Education Code, §51.949). Letters of Support for Interested
Government Agencies must meet the agencies rules and requirements.
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 February 28, 2003.
TRD-200301479
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 13, 2003
For further information, please call: (512) 458-7236
Subchapter R. SCHOOL HEALTH ADVISORY COMMITTEE
25 TAC §37.350
The Texas Department of Health (department) proposes an amendment
to §37.350, concerning the School Health Advisory Committee (committee).
The purpose of the committee is to provide assistance to the Texas Board of
Health (board) in establishing a leadership role for the department in the
support for and delivery of school health services. The committee is established
under the Health and Safety Code, §11.016, which allows the board to
establish advisory committees. The committee is subject to Government Code,
Chapter 2110, concerning state agency advisory committees.
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 §37.350 and has determined that reasons for adopting the
section continue to exist; however, changes were necessary as described in
this preamble.
The department published a Notice of Intention to Review §37.350 in
the
Texas Register
on April 28, 2000 (25 TexReg
3799). No comments were received due to publication of this notice.
In 1993, the Texas Legislature passed Senate Bill 383 (now codified in
the Government Code, Chapter 2110) which requires that each state agency adopt
rules on advisory committees. The rules must state the purpose of the committee,
describe the tasks of the committee, describe the manner in which the committee
will report to the agency, and establish a date on which the committee will
be automatically abolished unless the governing body of the agency affirmatively
votes to continue the committee's existence.
In 1999, the board established a rule relating to the School Health Advisory
Committee. The rule states that the committee will automatically be abolished
on June 1, 2003. The board has now reviewed and evaluated the committee and
has determined that the committee should continue in existence until June
1, 2007.
This section amends provisions relating to the operation of the committee.
Specifically, language is revised to: continue the committee until June 1,
2007; specify that the committee appoints its presiding and assistant presiding
officers; include additional requirements regarding statements by members;
and clarify the components that the committee must include in an annual report
to the board.
Jacquelyn McDonald, Director of the Office of the Board of Health, has
determined that for each year of the first five years the section is in effect,
there will be no fiscal implications for state and local government as a result
of amending the section as proposed.
Ms. McDonald has also determined that for each year of the first five years
the section is in effect, the public benefit anticipated as a result of amending
the section will be continuation of the committee and continued advice to
the department on this important issue. There will be no costs to small business
or micro-business resulting from compliance with this section, as this section
addresses only continuance of the committee and terms of office. There are
no anticipated economic costs to persons who are required to comply with the
section proposed. There is no anticipated impact on local employment.
Comments may be submitted to Jacquelyn McDonald, Director, Office of the
Board of Health, Texas Department of Health, 1100 West 49th Street, Austin,
Texas 78756, (512) 458-7484. Comments on the proposed section will be accepted
for 30 days following publication in the
Texas Register
.
The amendment is proposed under 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;
and Government Code, §2110.005, which requires the department to adopt
rules stating the purpose and tasks of its advisory committees; and implements
Government Code, §2001.039.
The amendment affects the Health and Safety Code, Chapters 11 and 12, and
the Government Code, Chapter 2110.
§37.350.School Health Advisory Committee.
(a)-(d)
(No change.)
(e)
Review and duration. By June 1,
2007
[
(f)-(g)
(No change.)
(h)
Officers. The
committee
[
(1)
Each officer shall serve until May 31 of each odd-numbered
year. Each officer may holdover until his or her replacement is
elected
[
(2)
(No change.)
(3)
The assistant presiding officer shall perform the duties
of the presiding officer in case of the absence or disability of the presiding
officer. In case the office of presiding officer becomes vacant, the assistant
presiding officer will [
(4)
If the office of assistant presiding officer becomes vacant,
it may be filled [
(5)-(6)
(No change.)
(i)
Meetings. The committee shall meet
only as necessary
to conduct committee business
[
(1)-(7)
(No change.)
(j)-(m)
(No change.)
(n)
Statement by members.
(1)-(2)
(No change.)
(3)
A committee member should not
accept or solicit any benefit that might reasonably tend to influence the
member in the discharge of the member's official duties.
(4)
A committee member should not
disclose confidential information acquired through his or her committee membership.
(5)
A committee member should not
knowingly solicit, accept, or agree to accept any benefit for having exercised
the member's official powers or duties in favor of or against another person.
(6)
A committee member who has
a personal or private interest in a matter pending before the committee shall
publicly disclose the fact in a committee meeting and may not vote or otherwise
participate in the matter. The phrase "personal or private interest" means
the committee member has a direct pecuniary interest in the matter but does
not include the committee member's engagement in a profession, trade, or occupation
when the member's interest is the same as all others similarly engaged in
the profession, trade, or occupation.
(o)
Reports to board. The committee shall file an annual written
report with the board.
(1)
(No change.)
(2)
The report shall identify the costs related to the committee's
existence, including the cost of agency staff time spent in support of the
committee's activities
and the source of funds used to support the committee's
activities
.
(3)
(No change.)
(p)
(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 February 28, 2003.
TRD-200301490
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 13, 2003
For further information, please call: (512) 458-7236
The Texas Department of Health (department) proposes amendments to §§117.1-117.3,
117.11-117.17, 117.31-117.34, 117.41-117.46, 117.61-117.65, 117.81-117.86
and new §117.18 concerning the regulation of end stage renal disease
facilities.
Government Code §2001.039 requires that each state agency review and
consider for readoption each rule adopted by that agency pursuant to the Government
Code, Chapter 2001 (Administrative Procedure Act). 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 §§117.1-117.3,
117.11-117.17, 117.31-117.34, 117.41-117.46, 117.61-117.65, 117.81-117.86
in the
Texas Register
(25 TexReg 4195) on
May 5, 2000. There were no comments received by the department on the sections
following publication of the notice.
These amendments and new section are proposed based upon the department's
review of Texas Administrative Code, Chapter 117, as required by Government
Code §2001.039. The department was assisted in its review by an ad hoc
committee composed of physicians, nurses, administrators, social workers,
dieticians, dialysis technicians, and the End Stage Renal Disease Network
of Texas, assembled by the department.
Specifically, the amendment to §117.1 is editorial. The amendments
to §117.2 add definitions for action level, biofilm, dialysate, dialysate
supply system, empty bed contact time, governing body, LAL test, technical
supervisor, ultrafilter, water distribution systems and water treatment system;
delete the definition of chief technician as the term is no longer used in
the rules; amend the definitions of change of ownership, medical review board,
patient care plan, and presurvey conference to delete obsolete references
and for clarification purposes; and renumber definitions as necessary to accommodate
the added and deleted definitions. The amendments to §117.3 are editorial
and add the fee for a relocation.
The amendment to §117.11 is editorial. The amendments to §117.12
delete ambiguous language and add an additional requirement for licensure.
The amendment to §117.13 is editorial. The amendments to §117.14
are editorial and update references. The amendments to §§117.15,
117.16 and 117.17 are editorial. Section 117.18 is new language regarding
exceptions to the rules.
The amendments to §117.31 clarify the intent of the section, add new
language regarding water systems, and update references. The amendments to §117.32
clarify existing language, update references and add automated external defibrillator
to the list of emergency equipment. The amendments to §117.33 add new
language relating to water treatment and update references. The amendments
to §117.34 delete ambiguous language, update references, and add new
language to clarify existing language.
The amendment to §117.41 adds language regarding incidents. The amendments
to §117.42 add additional indicators for quality of care and is editorial.
The amendments to §117.43 add language regarding disruptive patients
or family members, patient care plans, emergency preparedness, medication
storage and administration, amend the maximum patient load per full-time equivalent
for dietitians, add new language relating to home dialysis, delete ambiguous
language, and is editorial. The amendments to §117.44 add language relating
to sharing of staff between facilities, add requirements of training curriculum
for technical staff, add new language to clarify existing language and is
editorial. The amendments to §117.45 add language regarding clinical
records and delete ambiguous language. The amendment to §117.46 is editorial.
The amendment to §117.61 is editorial. The amendments to §117.62
update references and add additional training requirements. The amendment
to §117.63 adds additional requirements to a checklist for dialysis technician
trainees. The amendment to §117.64 clarifies existing language. The amendments
to §117.65 are editorial and add additional acts prohibited for dialysis
technicians.
The amendments to §§117.81, 117.82, 117.83, 117.84, 117.85, and
117.86 are all editorial.
Nance Stearman, Acting Chief, Bureau of Licensing and Compliance, has determined
that for the first five years 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. Stearman 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 Christine Cordes, 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. GENERAL PROVISIONS
25 TAC §§117.1 - 117.3
The amendments are proposed under Health and Safety Code (HSC),
Chapter 251, Texas End Stage Renal Disease (ESRD) Facility Licensing Act;
which provides the Board of Health (board) with the authority to adopt rules
governing the licensing and regulation of ESRDs, 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 amendments affect Health and Safety Code, Chapters 251 and
12, and implement Government Code, §2001.039.
§117.1.Purpose.
(a)
The purpose of this chapter is to implement [
(b) - (c)
(No change.)
§117.2.Definitions.
The following words and terms, when used in this chapter, shall have
the following meanings, unless the context clearly indicates otherwise.
(1)
Action level - The point at
which steps should be taken to interrupt the trend towards unacceptable levels.
(2)
[
(3)
[
(4)
[
(A)
a corporation - includes each officer, consultant, stockholder
with a direct ownership of at least 5.0%, subsidiary, and parent company;
(B)
a limited liability company - includes each officer, member,
and parent company;
(C)
an individual - includes:
(i)
the individual's spouse;
(ii)
each partnership and each partner thereof of which the
individual or any affiliate of the individual is a partner; and
(iii)
each corporation in which the individual is an officer,
consultant, or stockholder with a direct ownership of at least 5.0%;
(D)
a partnership - includes each partner and any parent company;
and
(E)
a group of co-owners under any other business arrangement--includes
each officer, consultant, or the equivalent under the specific business arrangement
and each parent company.
(5)
[
(6)
Biofilm - A coating on surfaces
consisting of microcolonies of bacteria embedded in a protective extracellular
matrix. The matrix, a slimy material secreted by the cells, protects the bacteria
from antibiotics and disinfectants.
(7)
[
(8)
[
[
(9)
[
(10)
[
(11)
[
(12)
[
(13)
[
(14)
[
(15)
Dialysate - An aqueous fluid
containing electrolytes and usually dextrose, which is intended to exchange
solutes with blood during hemodialysis. The word "dialysate" is used throughout
this document to mean the fluid made from water and concentrate which is delivered
to the dialyzer by the dialysate supply system. Such phrases as "dialyzing
fluid" or "dialysis solution" may be used in place of dialysate. It does not
include peritoneal dialysis fluid.
(16)
Dialysate supply system -
Devices that prepare dialysate on line from water and concentrates or store
and distribute premixed dialysate; circulate the dialysate through the dialyzer;
monitor the dialysate for temperature, conductivity, pressure, flow and blood
leaks; and prevent dialysis during disinfection or cleaning modes. The term
includes reservoirs; conduits; proportioning devices for the dialysate; and
monitors, associated alarms, and controls assembled as a system for the characteristics
listed above. The dialysate supply system is often an integral part of single-patient
dialysis machines.
(17)
[
(18)
[
(19)
[
(20)
[
(21)
Empty bed contact time (EBCT)
- A measure of how much contact occurs between particles, such as activated
carbon, and water as the water flows through a bed of the particles.
(22)
[
(23)
[
(24)
[
(25)
[
(26)
[
(27)
Governing body - an identified
group, which includes the medical director and a representative(s) of the
owner of the facility, with full legal authority and responsibility for the
governance and operation of the facility.
(28)
[
(29)
[
(30)
[
(31)
[
(32)
LAL (Limulus Amoebocyte Lysate)
test - An assay used to detect endotoxin which exploits the immune response
of the horse shoe crab (Limulus polyphemus).
(33)
[
(34)
[
(35)
[
(36)
[
(A)
is board eligible or board certified in nephrology or pediatric
nephrology by a professional board; or
(B)
during the five-year period prior to September 1, 1996,
has served for at least 12 months as director of a dialysis program.
(37)
[
(38)
[
(39)
[
(40)
[
(A)
a corporation;
(B)
a limited liability company;
(C)
an individual;
(D)
a partnership if a partnership name is stated in a written
partnership agreement or an assumed name certificate;
(E)
all partners in a partnership if a partnership name is
not stated in a written partnership agreement or an assumed name certificate;
or
(F)
all co-owners under any other business arrangement.
(41)
[
(42)
[
(43)
[
(44)
[
(45)
[
(46)
[
(47)
[
(48)
[
(49)
[
(50)
[
(51)
[
(52)
[
(53)
[
(54)
[
(A)
is currently licensed as a social worker under the Human
Resources Code, Chapter 50, and holds a masters degree from a graduate school
of social work accredited by the Council on Social Work Education; or
(B)
has worked for at least two years as a social worker, one
year of which was in a dialysis facility or transplantation program prior
to September 1, 1976, and has established a consultative relationship with
a social worker who has a masters degree from a graduate school of social
work accredited by the Council on Social Work Education.
(55)
[
(A)
has at least 18 months experience as an RN, which includes
at least 12 months experience in dialysis which has been obtained within the
last 24 months; or
(B)
has at least 18 months experience as an RN and holds a
current certification from a nationally recognized board in nephrology nursing
or hemodialysis.
(56)
[
(57)
[
(58)
[
(59)
Technical supervisor - The
facility-based supervisor of the facility's mechanical, reuse and water treatment
systems.
(60)
Ultrafilter - A membrane filter
with a pore size in the range 0.001 to 0.05 µm. Performance is usually
rated in terms of a nominal molecular weight cut-off (MWCO), which is defined
as the smallest molecular weight species for which the filter membrane has
more than 90% rejection. Ultrafilters with a nominal MWCO of 20,000 or less
are generally adequate for endotoxin removal.
(61)
Water distribution systems
- Components to include any storage tanks and piping used to distribute the
product water from the purification cascade to or from its point of use, including
individual hemodialysis machines, dialyzer reprocessing equipment and dialysate
concentrate preparation systems.
(62)
Water treatment system - A
collection of water purification devices and associated piping, pumps, valves,
gauges, etc., that together produce purified water for hemodialysis applications
and deliver it to the point of use.
(63)
[
§117.3.Licensing Fees.
(a)
The schedule of fees for licensure of a facility is as
follows:
(1)
(No change.)
(2)
renewal license fee-
(A) - (B)
(No change.)
(C)
if the total number of treatments for the preceding 12
months multiplied by $.25 is greater than or equal to $2,500, then the license
fee is $2,500; [
(3)
change of ownership license fee-
$1,500; and
[
(4)
relocation license fee - $2,000.
(b) - (e)
(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 February 28, 2003.
TRD-200301481
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 13, 2003
For further information, please call: (512) 458-7236
25 TAC §§117.11 - 117.18
The amendments and new section are proposed under Health and
Safety Code (HSC), Chapter 251, Texas End Stage Renal Disease (ESRD) Facility
Licensing Act; which provides the Board of Health (board) with the authority
to adopt rules governing the licensing and regulation of ESRDs, 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 amendments and new section affect Health and Safety Code,
Chapters 251 and 12, and implement Government Code, §2001.039.
§117.11.General Requirements for a License.
(a) - (b)
(No change).
(c)
Requirements. An applicant for a facility license must
meet the requirements in this subsection.
(1) - (2)
(No change.)
(3)
A facility is required to apply for a separate license
for each place of business.
(A)
A license is issued to the applicant to operate a facility
at the physical location listed on the license application. A change in the
physical location of a facility requires the submission of
a relocation
[
(B)
(No change.)
(4)
A facility may not admit a patient for dialysis treatment
until [
(5) - (9)
(No change.)
§117.12.Application and Issuance of Temporary Initial License and First Annual License.
(a) - (b)
(No change.)
(c)
Application requirements. [
[
(1)
[
(2)
[
(A) - (B)
(No change.)
(C)
information on the applicant including name, [
(D)
the name, mailing address, and street address of the facility.
The
street
address provided on the application must be the address
from which the facility will be operating and providing services;
(E)
the telephone number of the facility [
(F) - (I)
(No change.)
(J)
a list of management and supervisory personnel [
[
(K)
[
(L)
[
(M)
[
(N)
[
[
(O)
[
(P)
[
(i)
the medical director or at least one physician on staff
at the facility who is qualified to serve as the medical director;
(ii)
the license number(s) of the physician(s); and
(iii)
if applicable, all physician assistants and advanced
practice nurses who will provide services at the facility;
(Q)
[
(i)
denial, suspension, or revocation of an end stage renal
disease facility license in any state; a license for any health care facility
or a license for a home and community support services agency (agency) in
any state; or any other enforcement action, such as (but not limited to) civil
or criminal court action in any state;
(ii)
denial, suspension, or revocation of or other enforcement
action against a facility license in any state, a license for any health care
facility in any state, or a license for an agency in any state which is or
was proposed by the licensing agency and the status of the proposal;
(iii)
surrender of a license before expiration of the license
or allowing a license to expire in lieu of the department proceeding with
enforcement action;
(iv)
federal or state (any state) criminal felony arrests or
convictions;
(v)
federal or state Medicaid or Medicare sanctions or penalties
relating to the operation of a health care facility or agency;
(vi)
operation of a health care facility or agency that has
been decertified or terminated from participation in any state under Medicare
or Medicaid; or
(vii)
debarment, exclusion, or contract cancellation in any
state from Medicare or Medicaid; and
(R)
[
(i)
federal or state (any state) criminal misdemeanor arrests
or convictions;
(ii)
federal or state (any state) tax liens;
(iii)
unsatisfied final judgement(s);
(iv)
eviction involving any property or space used as a facility
or health care facility in any state;
(v)
injunctive orders from any court; or
(vi)
unresolved final federal or state (any state) Medicare
or Medicaid audit exceptions.
(3)
[
(d)
Application processing. Upon receipt of the application,
including the required documentation described in paragraph (2) of this subsection
and the initial license fee from the applicant, the department shall review
the material to determine whether it is complete and correct.
(1)
(No change.)
(2)
If a facility receives a notice from the department that
some or all of the information required under subsection (c)(3) of this section
is deficient, the facility shall submit the required information no later
than
one year
[
(A)
A facility which fails to submit the required information
within
one year
[
(B)
(No change.)
(e)
Issuance of a temporary initial license.
(1) - (2)
(No change.)
(3)
Results of water cultures and
analysis of the product water must be submitted for review by the department
prior to issuance of the temporary license. The surveyor who reviews these
reports will notify the central office staff when the reports are found to
be within accepted parameters.
(4)
[
(A)
will issue a temporary initial license; or
(B)
may deny the temporary initial license if the facility
does not meet the requirements described in this section. The procedures for
denying a temporary initial license shall be in accordance with §117.84
of this title (relating to Disciplinary Action).
(f)
(No change.)
(g)
Withdrawal from the application process. An applicant may
withdraw its application for a temporary initial license at any time.
(1)
An applicant who decides to withdraw its application for
a temporary initial license during the application review process, shall submit
to the department its written request to withdraw. [
(2)
An applicant who decides to withdraw its application after
the department issues the temporary initial license shall return the license
certificate to the department with a written request to withdraw. [
(h)
Issuance of first annual license. The department shall
issue a first annual license to a facility if, after inspection and investigation
during the temporary initial license period, it finds the applicant meets
the requirements of this chapter. An inspection for the purposes of issuing
a first annual license shall be completed in accordance with §117.16(c)
of this title. The first annual license supersedes the temporary initial license
and shall expire one year from the date of issuance of the temporary initial
license.
[
[
(i)
(No change.)
§117.13.Application and Issuance of Annual Renewal License.
(a)
The Texas Department of Health (department) shall send
notice of expiration to an end stage renal disease facility (facility) 60
calendar
[
(b) - (g)
(No change.)
(h)
A facility that fails to make timely and sufficient application
for annual renewal of a license must cease operation upon expiration of the
facility's license.
(1) - (2)
(No change.)
(3)
If a licensee fails to timely renew his or her license
[
(A) - (G)
(No change.)
(i) - (l)
(No change.)
§117.14.Change of Ownership or Services.
(a)
(No change.)
(b)
Change in services.
(1)
A person shall notify the department in writing no later
than 30 calendar days prior to ceasing operation of a facility. The person
shall return the original license certificate to the department by mailing
or returning the original license certificate to the Health Facility Licensing
and Compliance
Division, End Stage Renal Disease Facility Licensing
Program, Texas Department of Health, 1100 West 49th Street, Austin, Texas,
78756-3199.
(2) - (3)
(No change.)
(4)
A facility shall obtain written approval by the department
prior to utilization
in order to add a service or increase the number
of stations which appear on the facility license.
(A) - (C)
(No change.)
(D)
No later than three weeks after initiating use of new stations,
the facility shall submit to the department laboratory reports of chemical
analysis and bacteriologic cultures of the product water demonstrating compliance
with §§
4.2.1
[
§117.15.Time Periods for Processing and Issuing a License.
(a)
(No change.)
(b)
Time Periods. An application from a facility for a temporary
initial license and a first annual license or an annual renewal license shall
be processed in accordance with the following time periods.
(1) - (2)
(No change.)
(c) - (e)
(No change.)
§117.16.Inspections.
(a) - (b)
(No change.)
(c)
Inspection procedures.
(1)
(No change.)
(2)
Evaluation of compliance. Except for the purposes of conducting
an inspection under subsection (b)(1), (4), (6), or (7) of this section, an
onsite inspection will include an evaluation to determine compliance with,
at a minimum, each of the requirements in:
(A)
(No change.)
(B)
§117.33 of this title (relating to Water Treatment
, Dialysate Concentrates
and Reuse);
(C) - (M)
(No change.)
(3)
(No change.)
(4)
Written notice of findings.
(A) - (B)
(No change.)
(C)
If the written notice of findings includes deficiencies,
the department and the facility shall comply with the procedure set out in
this subparagraph.
(i) - (v)
(No change.)
(vi)
The facility may challenge any deficiency cited after
receipt of the statement of deficiencies. A challenge to a deficiency(ies)
shall be in accordance with this subparagraph.
(I)
(No change.)
(II)
An initial challenge to a deficiency(ies) shall be submitted
in writing no later than five working days from the facility's receipt of
the statement of deficiencies to the Program Director, End Stage Renal Disease
Licensing
Program
[
(III)
If the initial challenge is favorable to the department,
the facility may request a review of the initial challenge by submitting a
written request to the Director or his or her designee, Health Facility Licensing
and Compliance
Division, Texas Department of Health, 1100 West 49th
Street, Austin, Texas 78756-3199. The facility shall submit its written request
for review of the initial challenge no later than five working days of its
receipt of the department's response to the initial challenge. The department
will not accept or review any documents that were not submitted with the initial
challenge. A determination by the Director of the Health Facility Licensing
and Compliance
Division relating to a challenge to a deficiency(ies)
is the department's final determination concerning the challenge.
(IV) - (IX)
(No change.)
§117.17.Optional Plan Review and Inspection.
(a)
Request for
a
plan review. Plans and specifications
covering the construction of new buildings or alterations, additions, conversions,
modernizations or renovations to existing buildings may be submitted to the
Texas Department of Health (department) for review to determine compliance
with this chapter. Submission of plans and specifications is not mandatory.
(1) - (4)
(No change.)
(b)
(No change.)
§117.18.Exceptions to These Rules.
(a)
While all subject ESRD facilities are required to maintain
continuous compliance with these rules, these rules do not prohibit the use
of alternative concepts, methods, procedures, techniques, equipment, facilities,
personnel qualifications of the conducting of pilot projects or research.
Requests for temporary exceptions to these rules must:
(1)
be submitted to the department in writing;
(2)
identify the specific rule for which an exception is requested;
(3)
describe in detail the specific circumstances which are
believed by facility administration to justify the exception;
(4)
describe in detail what alternatives were considered, if
any, and why alternatives (including compliance with the rule) were not selected;
(5)
demonstrate that the proposed exception is desirable to
maintain or improve the health and safety of the patients, will not jeopardize
patient health and safety, and will maintain patient access to care; and
(6)
describe the proposed duration of the exception.
(7)
exceptions to staffing requirements:
(A)
may only be granted in an emergency situation for a maximum
of 120 days, with a single renewal period for an additional 120 days;
(B)
the facility shall develop an action plan to resolve the
staffing crisis situation;
(C)
the facility shall submit the action plan to the department
within 60 days of the granting of the exception; and
(D)
during the period of exception to staffing requirements,
the facility shall monitor outcome data related to quality of care and report
these outcomes on a monthly basis to the department.
(b)
Requests for exceptions to the rules shall be submitted
to the applicable zone office.
(c)
The department may conduct a survey and consult with the
MRB prior to approving an exception.
(d)
Upon finding that the facility has satisfied the conditions
of this rule, the department may grant an exception, to include the duration
of the exception. The department will respond to a waiver request within 90
days.
(e)
The facility may implement an exception only after written
approval from the department.
(f)
Granting of an exception is considered public information,
is subject to disclosure, and may be posted on the department web site.
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 February 28, 2003.
TRD-200301482
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 13, 2003
For further information, please call: (512) 458-7236
25 TAC §§117.31 - 117.34
The amendments are proposed under Health and Safety Code (HSC),
Chapter 251, Texas End Stage Renal Disease (ESRD) Facility Licensing Act;
which provides the Board of Health (board) with the authority to adopt rules
governing the licensing and regulation of ESRDs, 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 amendments affect Health and Safety Code, Chapters 251 and
12, and implement Government Code, §2001.039.
§117.31.Design and Space Requirements.
(a)
General.
(1)
The standards in this section shall apply
to all facilities
that provide outpatient dialysis services. Dialysis facilities in operation
on or before September 1, 2003 shall meet the design and space requirements
of this section which were in effect at the time the facility was constructed.
[
(2)
(No change.)
(3)
A facility shall comply with Chapter
38
[
(4)
Water distribution systems
shall be configured as a continuous recirculation loop and designed to minimize
bacterial proliferation and biofilm. A minimum of three feet per second water
flow must be achieved in the distribution loop. This rule shall apply only
to new facilities.
(5)
Water treatment systems shall
include a minimum of two carbon tanks, with each tank providing a minimum
of five minutes of empty bed contact time.
(6)
[
(7)
[
(8)
[
(9)
[
(10)
[
(11)
[
(12)
[
(13)
[
(14)
[
(15)
[
(16)
[
(17)
[
(18)
[
(19)
[
(20)
[
(21)
[
(b)
Storage areas.
(1) - (3)
(No change.)
(4)
A facility shall store oxygen in compliance with §4-3
of the National Fire Protection Association 99, Standard for Health Care Facilities,
1999
[
(c)
(No change.)
(d)
Fire protection.
(1)
All sprinkler systems, smoke detectors, and other fire-fighting
equipment shall be inspected and tested at least once each year to maintain
it in serviceable condition. If a facility has a sprinkler system, the sprinkler
system shall be installed and maintained in accordance with the National Fire
Protection Association 13, Standard for the Installation of Sprinkler Systems,
1999
[
(2)
A facility shall have an emergency lighting system capable
of providing sufficient illumination to allow safe evacuation from the building.
Battery pack systems shall be maintained and tested quarterly. If a facility
maintains a back-up generator, the generator must be installed, tested and
maintained in accordance with the National Fire Protection Association 110,
Standard for Emergency and Standby Power Systems,
1999
[
(3)
A facility housed in or adjacent to a building classified
as a "high hazard industrial occupancy," as defined in
§40-1.4.1
[
(e) - (f)
(No change.)
§117.32.Equipment.
(a)
All equipment used by a facility, including backup equipment,
shall be operated within manufacturer's specifications, and maintained free
of defects which could be a potential hazard to patients, staff, or visitors.
Maintenance and repair of all equipment shall be performed by qualified staff
or contract personnel.
(1)
(No change.)
(2)
Medical equipment that malfunctions must be
clearly
labeled and
immediately removed from service until the malfunction is
identified and corrected.
(3)
(No change.)
(4)
After repairs or alterations are made to any equipment
or system, the equipment or system shall be thoroughly tested for proper operation
before returning to service.
This testing must be documented.
(5)
(No change.)
(b)
(No change.)
(c)
At least one complete dialysis machine shall be available
on-site as backup for every ten dialysis machines in use. At least one of
these backup machines must be completely operational during hours of treatment.
Machines not in use during a patient shift may be counted as backup except
at the time of an initial or an expansion survey.
(d)
(No change.)
(e)
All equipment and appliances shall be properly grounded
in accordance with the National Fire Protection Association 99, Standard for
Health Care Facilities, §§3-4.1 and 7-5.1,
1999
[
(f)
(No change.)
(g)
A facility shall have emergency equipment and supplies
immediately accessible in the treatment area.
(1)
At a minimum, the emergency equipment and supplies shall
include the following:
(A) - (C)
(No change.)
(D)
supplies specified by the medical director; [
(E)
electrocardiograph
; and
[
(F)
automated external defibrillator.
(2) - (3)
(No change.)
[
§117.33.Water Treatment , Dialysate Concentrates and Reuse.
(a)
Compliance required. A facility shall meet the requirements
of this section. A facility may follow more stringent requirements [
(1)
The facility owner and medical
director shall each demonstrate responsibility for the water treatment and
dialysate supply systems to protect hemodialysis patients from adverse effects
arising from known chemical and microbial contaminates that may be found in
improperly prepared dialysate, to ensure that the dialysate is correctly formulated
and meets the requirements of all applicable quality standards.
(2)
The facility owner and medical
director must each assure that policies and procedures related to water treatment,
dialysate and reuse are understandable and accessible to the operator(s) and
that the training program includes quality testing, risks and hazards of improperly
prepared concentrate and bacterial issues.
(3)
The facility owner and medical
director must be informed prior to any alteration of, or any device being
added to, the water system.
(b)
Water treatment.
These requirements apply to water
intended for use in the delivery of hemodialysis, including the preparation
of concentrates from powder at a dialysis facility and dialysate, and for
reprocessing dialyzers for multiple use.
(1)
(No change.)
(2)
When a public water system supply is not used by a facility,
the source water shall be tested by the facility at monthly intervals in the
same manner as a public water system as described in 30 Texas Administrative
Code, §290.104 (Control Tests), §290.105 (Maximum Contaminant Levels
(MCLs) for Microbiological Contaminants), and §290.106 (Bacteriological
Monitoring) as adopted by the Texas
Commission on Environmental Quality
[
(3)
(No change.)
(4)
The water treatment system components shall be arranged
and maintained so that bacterial and chemical contaminant levels in the product
water do not exceed the standards for hemodialysis water quality described
in §
4.2.1
[
(5)
Written policies and procedures for the operation of the
water treatment system must be developed and implemented. Parameters for the
operation of each component of the water treatment system must be developed
in writing and known to the operator.
Each major water system component
shall be labeled in a manner that identifies the device; describes its function,
how performance is verified and actions to take in the event performance is
not within an acceptable range.
[
(6)
The materials of any components
of water treatment systems (including piping, storage, filters and distribution
systems) that contact the purified water shall not interact chemically or
physically so as to affect the purity or quality of the product water adversely.
Such components shall be fabricated from unreactive materials (e.g. plastics)
or appropriate stainless steel. The use of materials that are known to cause
toxicity in hemodialysis, such as copper, brass, galvanized material, or aluminum,
is prohibited.
(7)
Chemicals infused into the
water such as iodine, acid, flocculants, and complexing agents shall be shown
to be nondialyzable or shall be adequately removed from product water. Monitors
or specific test procedures to verify removal of additives shall be provided
and documented.
(8)
[
(A)
Reverse osmosis membranes, if used, shall meet the standards
in §
4.3.7
[
(B)
Deionization systems [
(i)
Deionization systems, if used,
shall be monitored continuously to produce water of one megohm-cm or greater
specific resistivity (or conductivity of one microsiemen/cm or less) at 25
degrees Celsius. An audible and visual alarm shall be activated when the product
water resistivity falls below this level and the product water stream shall
be prevented from reaching any point of use.
(ii)
Patients shall not be dialyzed
on deionized water with a resistivity less than 1.0 megohm-cm measured at
the output of the deionizer.
(iii)
A minimum of two deionization
(DI) tanks in series shall be used with resistivity monitors including audible
and visual alarms placed pre and post the final DI tank in the system. The
alarms must be audible in the patient care area.
(iv)
Feed water for deionization
systems shall be pretreated with activated carbon adsorption, or a comparable
alternative, to prevent nitrosamine formation.
(v)
If a deionization system is
the last process in a water treatment system, it shall be followed by an ultrafilter
or other bacteria and endotoxin reducing device.
(C)
Carbon tanks.
[
(i)
The carbon tanks must contain
acid washed carbon, 30-mesh or smaller with a minimum iodine number of 900.
(ii)
A minimum of two carbon adsorption
beds shall be installed in a series configuration.
(iii)
The total empty bed contact
time (EBCT) shall be at least ten minutes, with the final tank providing at
least five minutes EBCT. Carbon adsorption systems used to prepare water for
home dialysis or for portable dialysis systems are exempt from the requirement
for the second carbon and a ten minute EBCT if removal of chloramines to below
0.1 mg/1 is verified before each treatment.
(iv)
If carbon tanks are placed
in parallel, flow through the tanks must be monitored and recorded at least
daily to assure the required EBCT of all tanks is maintained.
(v)
A means shall be provided to
sample the product water immediately prior to the final bed(s). Water from
this port(s) must be tested for chlorine/chloramine levels immediately prior
to each patient shift.
(vi)
All samples for chlorine/chloramine
testing must be drawn when the water treatment system has been operating for
at least 15 minutes.
(vii)
Tests for total chlorine,
which include both free and combined forms of chlorine, may be used as a single
analysis with the maximum allowable concentration of 0.1 mg/L. Test results
of greater than 0.5 parts per million (ppm) for chlorine or 0.1 ppm for chloramine
from the port between the initial tank(s) and final tank(s) shall require
testing to be performed at the final exit and replacement of the initial tank(s).
(viii)
In a system without a holding
tank, if test results at the exit of the final tank(s) are greater than the
parameters for chlorine or chloramine described in this subparagraph, dialysis
treatment shall be immediately terminated to protect patients from exposure
to chlorine/chloramine and the medical director shall be notified. In systems
with holding tanks, if the holding tank tests <0.1 mg/L for total chlorine,
the reverse osmosis (RO) may be turned off and the product water in the holding
tank may be used to finish treatments in process. The medical director shall
be notified.
(ix)
If means other than granulated
carbon are used to remove chlorine/chloramine, the facility's governing body
must approve such use in writing after review of the safety of the intended
method for use in hemodialysis applications. If such methods include the use
of additives, there must be evidence the product water does not contain unsafe
levels of these additives.
[
(9)
[
[
(10)
Timers. If used, the face(s)
of timer(s) used to control any component of the water treatment or dialysate
delivery system shall be visible to the operator at all times. Written evidence
that timers are checked for operation and accuracy each day of operation must
be maintained.
(11)
[
(12)
Ultrafilters, or other bacterial
reducing filters, if used, shall be fitted with pressure gauges on the inlet
and outlet water lines to monitor the pressure drop across the membrane. Ultrafilters
shall be included in routine disinfection procedures.
(13)
Storage tanks. If used, storage
tanks shall have a conical or bowl-shaped base and shall drain from the lowest
point of the base. Storage tanks shall have a tight fitting lid and be vented
through a hydrophobic 0.2 micron air filter. Means shall be provided to effectively
disinfect any storage tank installed in a water distribution system.
(14)
Ultraviolet (UV) lights, if
used, shall be monitored at the frequency recommended by the manufacturer.
A log sheet shall be used to record monitoring.
(15)
Water treatment system piping
shall be labeled to indicate the contents of the pipe and direction of flow.
(16)
[
(17)
[
(18)
[
(19)
[
(A)
Frequency. Microbiological
testing shall be conducted monthly and following any repair or change to the
water treatment system. For a newly installed water distribution system, or
when a change has been made to an existing system, weekly testing shall be
conducted for one month to verify that bacteria and endotoxin levels are consistently
within the allowed limits.
(B)
Sample sites. At a minimum,
sample sites chosen for the testing shall include the beginning of the distribution
piping, the product water in the reuse room, at any site of dialysate mixing,
and the end of the distribution piping.
(C)
Technique. Samples shall be
collected immediately before sanitization/disinfection of the water treatment
system and dialysis machines. If dip plate samplers are used for in-house
testing, audits of the technique used in collection, incubation and reading
of results must be done quarterly by supervisory personnel and reported in
quality management minutes. Repeated results of "no growth" shall be validated
via an outside laboratory. A calibrated loop may not be used in microbiological
testing of water samples. Colonies shall be counted using a magnifying device.
(D)
Expected results. Product water
used to prepare dialysate, concentrates from powder, or to reprocess dialyzers
for multiple use, shall contain a total viable microbial count less than 200
CFU/ml and an endotoxin concentration less than 2 EU/ml. The action level
for the total viable microbial count in the product water shall be 50 CFU/ml
and the action level for the endotoxin concentration shall be 1 EU/ml.
(E)
Required action for unacceptable
results. If the action levels described at paragraph (D) are observed in the
product water, corrective measures shall be taken promptly to reduce the levels
into an acceptable range.
(F)
Records. All bacteria and endotoxin
results shall be recorded on a log sheet in order to identify trends that
may indicate the need for corrective action.
(20)
Ozone generators. If ozone
generators are used to disinfect any portion of the water or dialysate delivery
system, testing based on the manufacturer's direction shall be used to measure
the ozone concentration each time disinfection is performed, to include testing
for safe levels of residual ozone at the end of the disinfection cycle. Testing
for ozone in the ambient air shall be conducted on a periodic basis as recommended
by the manufacturer. Records of all testing must be maintained in a log.
(21)
Hot Water Disinfection Systems.
If used, hot water disinfection systems shall be monitored for temperature
and time of exposure to hot water as specified by the manufacturer. Temperature
of the water shall be recorded at a point furthest from the water heater,
where the lowest water temperature is likely to occur. The water temperature
shall be measured each time a disinfection cycle is performed. A record that
verifies successful completion of the heat disinfection shall be maintained.
(22)
After chemical disinfection,
means shall be provided to restore the equipment and the system in which it
is installed to a safe condition relative to residual disinfectant prior to
the product water being used for dialysis applications.
(23)
[
(A)
Samples for chemical analysis
shall be collected at the end of the water treatment components and at the
most distal point in each water distribution loop. All other outlets from
the distribution loops shall be inspected to ensure that the outlets are fabricated
from compatible materials. Appropriate containers and pH adjustments shall
be used to ensure accurate determinations.
(B)
Additional chemical analysis
shall be submitted if substantial changes are made to the water treatment
system or if the percent rejection of a reverse osmosis system decreased 5.0%
or more from the percent rejection measured at the time the water sample for
the preceding chemical analysis was taken.
(24)
[
(25)
[
(c)
Dialysate.
(1)
Quality control and quality assurance procedures
shall be established to ensure ongoing conformance to policies and procedures
regarding dialysate quality.
(2)
Each facility shall set all hemodialysis machines
to use only one family of concentrates. When new machines are put into service,
or the concentrate family or concentrate manufacturer is changed, samples
shall be sent to a laboratory for verification.
(3)
Prior to each patient treatment, staff shall
verify the dialysate conductivity and pH of each machine with an independent
device.
(4)
Bacteriological testing.
(A)
Frequency. Responsible facility staff shall
develop a schedule to ensure each hemodialysis machine is tested quarterly
for bacterial growth and the presence of endotoxins. Hemodialysis machines
of home patients shall be cultured monthly until results not exceeding 200
colony forming units per milliliter are obtained for three consecutive months,
then quarterly samples shall be cultured.
(B)
Acceptable limits. Dialysate shall contain less
than 200 CFU/ml and an endotoxin concentration of less than 2 EU/ml. The action
level for total viable microbial count shall be 50 CFU/ml and the action level
for endotoxin concentration shall be 1 EU/ml.
(C)
Action to be taken. Disinfection and retesting
shall be done when bacterial or endotoxin counts exceed the action levels.
Additional samples shall be collected when there is a clinical indication
of a pyrogenic reaction and/or septicemia.
(5)
When a licensed nurse uses an additive to increase
concentrations of specific electrolytes in the acid concentrate, mixing procedures
shall be followed as specified by the additive manufacturer. When additives
are prescribed for a specific patient, the container holding the prescribed
acid concentrate shall be labeled with the name of the patient, the final
concentration of the added electrolyte, the date the prescribed concentrate
was made, and the name of the person who mixed the additive.
(6)
Materials compatibility. All components used
in concentrate preparation systems (including mixing and storage tanks, pumps,
valves and piping) shall be fabricated from materials (e.g., plastics or appropriate
stainless steel) that do not interact chemically or physically with the concentrate
so as to affect its purity, or with the germicides used to disinfect the equipment.
The use of materials that are know to cause toxicity in hemodialysis such
as copper, brass, galvanized material and aluminum is prohibited.
(7)
Storage of acid concentrates. Facility policies
shall address means to protect stored acid concentrates from tampering or
from degeneration due to exposure to extreme heat or cold.
(8)
Bulk storage tanks. Procedures to control the
transfer of acid concentrates from the delivery container to the storage tank
and prevent the inadvertent mixing of different concentrate formulations shall
be developed, implemented and enforced. The storage tanks shall be clearly
labeled.
(9)
Concentrate mixing systems.
(A)
Concentrate mixing systems shall include a purified
water source, a suitable drain, and a ground fault protected electrical outlet.
(B)
Operators of mixing systems shall use personal
protective equipment as specified by the manufacturer during all mixing processes.
(C)
The manufacturer's instructions for use of a
concentrate mixing system shall be followed, including instructions for mixing
the powder with the correct amount of water. The number of bags or weight
of powder added shall be determined and recorded.
(D)
The mixing tank shall be clearly labeled to
indicate the fill and final volumes required to correctly dilute the powder.
(E)
Systems for preparing either bicarbonate or
acid concentrate from powder shall be monitored according to the manufacturer's
instructions.
(F)
Concentrates shall not be used, or transferred
to holding tanks or distribution systems, until all tests are completed.
(G)
If a facility designs its own system for mixing
concentrates, procedures shall be developed and validated using an independent
laboratory to ensure proper mixing.
(10)
Acid concentrate mixing systems.
(A)
Acid concentrate mixing tanks shall be designed
to allow the inside of the tank to be rinsed when changing concentrate formulas.
(B)
Acid mixing systems shall be designed and maintained
to prevent rust and corrosion.
(C)
Acid concentrate mixing tanks shall be emptied
completely and rinsed with product water before mixing another batch of concentrate
to prevent cross contamination between different batches.
(D)
Acid concentrate mixing equipment shall be disinfected
as specified by the equipment manufacturer or in the case where no specifications
are given, as defined by facility policy.
(E)
Records of disinfection and rinsing of disinfectants
to safe residual levels shall be maintained.
(11)
Bicarbonate concentrate mixing systems.
(A)
Bicarbonate concentrate mixing tanks shall have
conical or bowl-shaped bottoms and shall drain from the lowest point of the
base. The tank design shall allow all internal surfaces to be disinfected
and rinsed.
(B)
Bicarbonate concentrate mixing tanks shall not
be pre-filled the night before use.
(C)
If disinfectant remains in the mixing tank overnight,
this solution must be completely drained, the tank rinsed and tested for residual
disinfectant prior to preparing the first batch of that day of bicarbonate
concentrate.
(D)
Unused portions of bicarbonate concentrate shall
not be mixed with fresh concentrate.
(E)
At a minimum, bicarbonate distribution systems
shall be disinfected weekly. More frequent disinfection shall be done if required
by the manufacturer, or if dialysate culture results are above the action
level.
(F)
If jugs are reused to deliver bicarbonate concentrate
to individual hemodialysis machines:
(i)
jugs shall be emptied of concentrate, rinsed
and inverted to drain at the end of each treatment day;
(ii)
at a minimum, jugs shall be disinfected weekly,
more frequent disinfection shall be considered by the facility quality management
committee if dialysate culture results are above the action level; and
(iii)
following disinfection, jugs shall be drained,
rinsed free of residual disinfectant, and inverted to dry.
(12)
Labeling of concentrate containers. All mixing
tanks, bulk storage tanks, dispensing tanks and containers for single hemodialysis
treatments shall be labeled as to the contents.
(A)
Mixing tanks. Prior to batch preparation, a
label shall be affixed to the mixing tank that includes the date of preparation
and the chemical composition or formulation of the concentrate being prepared.
This labeling shall remain on the mixing tank until the tank has been emptied.
(B)
Bulk storage/dispensing tanks. These tanks shall
be permanently labeled to identify the chemical composition or formulation
of their contents.
(C)
Single-machine containers. At a minimum, single-machine
containers shall be labeled with sufficient information to differentiate the
contents from other concentrate formulations used in the facility and permit
positive identification by users of container contents.
(13)
Records of concentrate mixing. Permanent records
of batches produced shall be maintained to include the concentrate formula
produced, the volume of the batch, lot number(s) of powdered concentrate packages,
the manufacturer of the powdered concentrate, date and time of mixing, test
results, person performing mixing, test results, and expiration date (if applicable).
(14)
Maintenance of dialysate mixing systems. If
dialysate concentrates are prepared in the facility, the manufacturers' recommendations
shall be followed regarding any preventive maintenance. Records shall be maintained
indicating the date, time, person performing the procedure, and the results
(if applicable).
(d)
[
(1)
Reuse practice in a facility must comply with the American
National Standard, Reuse of Hemodialyzers, 1993 Edition published by the AAMI.
(2)
Dialyzer manufacturer's labeling
shall be reviewed to determine if a specific dialyzer requires special considerations.
(3)
[
(4)
[
(5)
[
(6)
[
(7)
[
(8)
[
(9)
[
(10)
[
(11)
[
(e)
[
(1)
appoint a medical director for the centralized reprocessing
facility;
(2)
require the use of automated reprocessing facility;
(3)
maintain responsibility and accountability for the entire
reuse process;
(4)
adopt, implement, and enforce policies to ensure that the
transfer and transport of used and reprocessed dialyzers to and from the off-site
location does not increase contamination of the dialyzers, staff, or the environment;
[
(5)
assure that each dialyzer is
returned to the appropriate facility or patient home and in the case of home
patients who participate in a dialyzer reprocessing program, a system shall
be established to verify that the correct dialyzers are being returned to
each patient's home; and
(6)
[
§117.34.Sanitary Conditions and Hygienic Practices.
(a)
(No change.)
(b)
Environmental infection control.
(1)
(No change.)
(2)
Specific procedures for equipment and dialysis machines.
(A)
Routine disinfection of active and backup dialysis machines
shall be performed according to facility defined protocol, accomplishing at
least intermediate level disinfection
, and then removed to acceptable
levels
.
[
(B)
[
(c)
Medical waste and liquid/sewage waste management.
(1)
The facility shall comply with the requirements set forth
by the department in §§1.131-1.137 of this title (relating to Definition,
Treatment and Disposition of Special Waste from Health Care Related Facilities)
and the Texas
Commission on Environmental Quality's
[
(2)
All sewage and liquid wastes shall be disposed of in a
municipal sewerage system or a septic tank system permitted by the Texas
Commission on Environmental Quality
[
(d)
Hepatitis B prevention.
(1)
Prevention requirements concerning staff.
The facility
shall offer hepatitis B vaccination to previously unvaccinated, susceptible
new staff members in accordance with 29 Code of Federal Regulations, §1910.1030(f)(1)-(2)
(concerning Bloodborne Pathogens). Staff vaccination records shall be maintained
in each staff member's health record.
[
[
[
[
[
[
(2)
Prevention requirements concerning patients.
(A) - (B)
(No change.)
(C)
Isolation procedures for the HBsAg-positive patient.
(i) - (ii)
(No change.)
(iii)
When a caregiver is assigned
to both HBsAg-negative and HBsAg-positive patients, the HBsAg-negative patients
assigned to this grouping must be Hepatitis B antibody positive. Hepatitis
B antibody positive patients are to be seated at the treatment stations nearest
the isolation station and be assigned to the same staff member who is caring
for the HBsAg+ patient.
(iv)
[
(v)
[
(I)
The
[
(II) - (III)
(No change.)
(e)
(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 February 28, 2003.
TRD-200301483
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 13, 2003
For further information, please call: (512) 458-7236
25 TAC §§117.41 - 117.46
The amendments are proposed under Health and Safety Code (HSC),
Chapter 251, Texas End Stage Renal Disease (ESRD) Facility Licensing Act;
which provides the Board of Health (board) with the authority to adopt rules
governing the licensing and regulation of ESRDs, 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 amendments affect Health and Safety Code, Chapters 251 and
12, and implement Government Code, §2001.039.
§117.41.Quality Assurance for Patient Care.
(a) - (f)
(No change.)
(g)
The facility's quality control and quality improvement
mechanisms shall include:
(1)- (3)
(No change.)
(4)
establishment and monitoring of quality assurance indicators
for key aspects of care. For each quality assurance indicator, the facility
shall establish and monitor a level of performance consistent with current
professional knowledge. At a minimum, the following indicators shall be monitored
on an ongoing basis:
(A) - (D)
(No change.)
(E)
incidents and rate of occurrence (accidents, medication
errors, adverse drug reactions, and other occurrences affecting patient(s),
patient(s) family member(s),visitor(s), or staff). These occurrences shall
include incidents required to be reported to the director under §117.46
of this title (relating to Reports to the Director)
. Review of these
occurrences shall include analysis of the patient history and specific circumstances
to identify potential ways to prevent recurrence;
(F)
mortality (review of each death and monitoring
modality
specific
mortality
rate(s)
[
(G) - (L)
(No change.)
(h)
(No change.)
§117.42.Indicators of Quality of Care.
(a)
Each facility shall submit an annual report to the Texas
Department of Health (department) or the department's designee to include
aggregrate data on specified indicators of the quality of care provided to
patients. Examples of indicators include:
(1)
anemia management
[
(2) - (3)
(No change.)
(4)
vascular access management;
(5)
bone disease management;
(6)
[
(7)
[
(b)
The form and data to be submitted will be specified annually
by the department. The department shall provide notice to a facility of the
required content for the report in sufficient time to enable facility staff
to collect the data. The form required by the department will be constructed
in consideration of the reports required by the
Centers for Medicare
and Medicaid Services
[
(c) - (d)
(No change.)
§117.43.Provision and Coordination of Treatment and Services.
(a)
Patient rights. Each facility shall adopt, implement, and
enforce policies and procedures appropriate to the patient population served
which ensure each patient is:
(1) - (11)
(No change.)
(12)
transferred
or discharged
only for medical
reasons, for the patient's welfare or that of other patients or staff members,
or for nonpayment of fees. A patient shall be given 30 calendar days advance
notice to ensure orderly transfer or discharge, except in cases where the
patient presents an immediate risk to others;
(13)
a facility shall establish,
implement and enforce a policy whereby a disruptive patient or family member
or non-compliant patient is given an opportunity and assistance to improve
the problematic behavior in lieu of dismissal from the facility. The policy
will include requirements at §117.43(b)(7);
(14)
[
(15)
[
(16)
[
(17)
[
(b)
Patient care plan.
(1)
(No change.)
(2)
The interdisciplinary team shall
engage in an interactive
conference in order to
develop a written, individualized, comprehensive
patient care plan that specifies the services necessary to address the patient's
medical, psychological, social, and functional needs, and includes treatment
goals.
(3)
(No change.)
(4)
The patient care plan shall include evidence of the patient's
(or patient's legal representative's) input and participation, unless they
refuse to participate. At a minimum, the patient care plan shall demonstrate
that the content was
discussed
[
(5)
(No change.)
(6)
A team conference may be conducted
via phone conferencing. A phone care plan conference conducted with the interdisciplinary
team and the patient (or their legal representative) must be documented as
a phone conference.
(7)
In the case of disruptive patients
or family members or non-compliant patients, the facility will establish,
implement and enforce a process for more intensive team intervention with
this patient to include assessment of needs and planned interventions to assist
the patient in adjusting to the requirements for safe care.
(c)
Emergency preparedness.
(1)
A facility shall implement written procedures which describe
staff and patient actions to manage potential medical and non-medical emergencies,
including but not limited to, fire, equipment failure, power outages, medical
emergencies, and natural
or other
disasters which are likely to
threaten the health or safety of facility patients, the staff, or the public.
(2) - (5)
(No change.)
(6)
A written disaster preparedness plan
for natural and
other disasters
specific to each facility shall be developed and in
place. The plan shall be based on an assessment of the probability and type
of disaster in each region and the local resources available to the facility.
The plan shall be reviewed by the governing body at least annually. Contact
shall be made annually with a local disaster management representative to
assess the need to revise the plan and to ensure that local agencies are aware
of the dialysis facility, its provision of life-saving treatment, and the
patient population served.
The plan shall include procedures designed
to minimize harm to patients and staff along with ensuring safe facility operations.
The plan and in-service programs for patients and staff shall include provisions
or procedures for responsibility of direction and control, communications,
alerting and warning systems, evacuation, and closure. Each staff member employed
by or under contract with the facility shall be able to demonstrate their
role or responsibility to implement the facility's disaster preparedness plan.
(7) - (8)
(No change.)
(d)
Medication storage and administration.
(1) - (5)
(No change.)
(6)
Medications shall
not
be prepared for administration
in the patient's immediate treatment area. The medication preparation
[
(7)
Multi-dose vials shall not
be taken to a patient station. Protocols approved by the Centers for Disease
Control must be used in those cases where single-use vials are entered more
than once.
(8)
[
(9)
[
(e)
Nursing services.
(1) - (3)
(No change.)
(4)
A nurse
or nurses
functioning in the charge
role shall be on site and available to the treatment area to provide patient
care during all dialysis treatments.
(5)
At least one licensed nurse shall be available on-site
to provide patient care for every twelve patients or portion thereof. This
may include the
nurse(s)
[
(6)
If pediatric dialysis is provided, a registered nurse with
experience or training in pediatric dialysis shall be available to provide
care for pediatric dialysis patients [
(7)
Sufficient direct care staff shall be on-site to meet the
needs of the patients.
(A)
The staffing level for a facility shall not exceed four
patients per licensed nurse or patient care technician per patient shift.
During treatment of eight or more patients,
one of
the licensed
nurses qualified to function
[
(B)
(No change.)
(8)
(No change.)
(9)
A licensed nurse or dialysis technician shall
collect
and document objective and subjective data for
[
(10)
The initial patient evaluation shall be initiated by a
licensed nurse
qualified to function
[
(f) - (g)
(No change.)
(h)
Nutrition services.
(1) - (4)
(No change.)
(5)
Each facility shall employ or contract with a dietitian(s)
to provide clinical nutrition services for each patient. One full-time equivalent
of dietitian time shall be available for up to 100 patients with the maximum
patient load per full-time equivalent of dietitian time being
125
[
(6)
(No change.)
(i)
Social services.
(1)
- (4) (No change.)
(5)
Each facility shall employ or contract with a social worker(s)
to meet the psychosocial needs of the patients.
One full-time equivalent
of qualified social worker time shall be available for each 100 patients.
If the facility provides additional staff who perform supportive services
(e.g. assistance with financial services/ transportation), the maximum patient
load per full-time equivalent of qualified social worker time may be 125 patients.
(6)
(No change.)
(j)
(No change.)
(k)
Home dialysis (self dialysis).
(1)
If a facility provides self dialysis training, a registered
nurse with at least 12 months
clinical
experience
and six
months experience
in
home dialysis
[
(2)
For a patient who performs self dialysis at home, the following
services shall be provided:
(A) - (D)
(No change.)
(E)
routine laboratory work according to facility policy; [
(F)
a mechanism to contact staff at any time in the event of
an emergent need
; and
[
(G)
surveillance of the patient's
home adaptation, including provisions for visits to the home.
(3)
The facility shall provide directly or under arrangement
the following services.
(A)
For hemodialysis, the required services are:
[
(i)
[
(ii)
[
(iii)
[
(iv)
[
(v)
[
(B)
(No change.)
(C)
For continuous cycling peritoneal dialysis, the required
services are:
[
(i)
[
(ii)
[
(iii)
[
(iv)
[
(l) - (r)
(No change.)
§117.44.Qualifications of Staff.
(a)
General.
(1) - (2)
(No change.)
(3)
In facilities with similar
policies and equipment, experienced staff oriented to one facility may be
shared with another facility after a shorter orientation period. Documentation
of current competency of any shared staff and delegation by that facility's
medical director to unlicensed technicians must be on file in each facility
where the shared employee works.
(4)
[
(A)
fluid, electrolyte and acid-base balance;
(B)
kidney disease and treatment;
(C)
dietary management of kidney disease;
(D)
principles of dialysis;
(E)
dialysis technology;
(F)
venipuncture technique;
(G)
care of the dialysis patient;
(H)
psychological, social, financial, and physical complications
of long-term dialysis;
(I)
prevention of hepatitis and other infectious diseases;
and
(J)
risks and benefits of reuse (if reuse is practiced).
(5)
[
(6)
[
(b)
(No change.)
(c)
Nursing staff.
(1) - (3)
(No change.)
(4)
If patient self-care training is provided, a registered
nurse who has at least 12 months
clinical
experience [
(d) - (e)
(No change.)
(f)
Technical staff. A facility shall have the technical staff
as described in this subsection. The facility's technical staff may be one
or more individuals (including nursing staff) employed by or under contract
with the facility as long as the individual(s) meets the minimum qualifications
for each required level of responsibility as described in this subsection.
(1)
All
staff assigned
technical
responsibilities
[
(A)
(No change.)
(B)
Any staff member assigned responsibilities in the
technical area
[
(C)
The technical staff shall demonstrate competency for the
required level of responsibility through written and skills testing annually.
Current certification by a national board in dialysis technology may substitute
for written testing.
Evidence of competency shall be documented in writing
and maintained in the personnel file.
(D)
(No change.)
(2)
(No change.)
(3)
Staff responsible for water treatment and dialysate
systems
[
(A)
Facility staff responsible for the water treatment
and dialysate systems
[
(B)
The staff responsible for the water treatment
and
dialysate systems
[
(i)
successful completion of the facility training course specific
to water treatment
, dialysate preparation
and related tasks. The
training course shall be approved by the medical director and follow a written
curriculum with stated objectives;
(ii)
completion of a training curriculum which includes the
following minimum components:
(I) - (XV)
(No change.)
(XVI)
purpose of each component
of dialysate to include electrolytes, glucose, acid, and buffer;
(XVII)
hazards of exposure of patients
to a dialysate containing a different concentration of electrolytes than prescribed;
(XVIII)
testing methods in use
to verify expected concentrations in any reconstituted components of the dialysate
are achieved;
(XIX)
action to take in the event
testing of a mixed batch of dialysate concentrate does not meet the expected
parameters;
(XX)
labeling employed to positively
identify each concentrate; and
(XXI)
procedures to ensure the
proper transfer of concentrates from the manufacturer's drums to the holding
tanks.
(iii)
(No change.)
(iv)
successful completion of the facility's orientation and
training course as established for the water treatment
and dialysate
preparation systems
[
(4) - (5)
(No change.)
§117.45.Clinical Records.
(a)
A facility shall establish and maintain a clinical record
system to assure that the care provided to each patient is completely and
accurately documented, readily available, and systematically organized to
facilitate the compilation and retrieval of information.
(1)
All information shall be centralized in the patient's clinical
record and be protected against loss or damage
in accordance with state
and Federal regulations
.
(2) - (4)
(No change.)
(5)
Clinical records may be preserved electronically.
Computerized records shall meet all requirements of paper records including
protection from casual access and retention for the specified period. Systems
shall assure that entries regarding the delivery of care may not be altered
without evidence and explanation of such alteration.
(6) - (7)
(No change.)
(b)
A
comprehensive
[
(c) - (f)
(No change.)
(g)
Clinical records are the property of the facility
and shall be safeguarded against loss, destruction, or unauthorized use.
[
(h)
(No change.)
(i)
Records
[
(j)
(No change.)
§117.46.Reports to the Director.
(a)
(No change.)
(b)
An occurrence listed in subsection (a) of this section
shall be reported to the Director, Health Facility Licensing
and Compliance
Division, 1100 West 49th Street, Austin, Texas, 78756-3199, telephone
number 512-834-6646, fax number 512-834-4514. The report to the director shall
be on a form provided by the department and include the information requested
on the form. The facility may reproduce the form as needed to maintain an
adequate supply.
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 February 28, 2003.
TRD-200301484
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 13, 2003
For further information, please call: (512) 458-7236
25 TAC §§117.61 - 117.65
The amendments are proposed under Health and Safety Code (HSC),
Chapter 251, Texas End Stage Renal Disease (ESRD) Facility Licensing Act;
which provides the Board of Health (board) with the authority to adopt rules
governing the licensing and regulation of ESRDs, 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 amendments affect Health and Safety Code, Chapters 251 and
12, and implement Government Code, §2001.039.
§117.61.General Requirements.
(a) - (b)
(No change.)
(c)
Until the successful completion of the competency evaluation,
the trainee may provide patient care only as part of
a
[
§117.62.Training Curricula and Instructors.
(a)
(No change.)
(b)
Components of training curricula. The training curricula
for dialysis technicians shall include the following minimum components:
(1) - (5)
(No change.)
(6)
water treatment to include:
(A)
standards for water treatment used for dialysis as described
in the American National Standard,
Water Treatment Equipment for Hemodialysis
Applications, August 2001
[
(B) - (D)
(No change.)
(7) - (10)
(No change.)
(c)
Additional responsibilities.
(1)
(No change.)
(2)
If a dialysis technician, other than a licensed vocational
nurse (LVN), is to cannulate access or administer normal saline, heparin,
or lidocaine, the following content must be included:
(A) - (E)
(No change.)
(F)
administration of oxygen to
include:
(i)
reasons for administration;
(ii)
method of administration;
(iii)
delivery of the ordered flow rate;
(iv)
potential complications and risks; and
(v)
information to report and record.
(d) - (e)
(No change.)
(f)
Written examination. The dialysis technician trainee shall
complete a written examination. The examination shall encompass the content
required in subsection (b) of this section. If the dialysis technician trainee
will cannulate access and administer medications, the examination shall encompass
the content described in subsection (c) of this section. A score of 80% is
required on the written examination(s) covering the required content
prior to the dialysis technician trainee's release from orientation
.
Other than the first examination for a specific responsibility in a facility,
current
[
(g)
Instructors. An instructor for the course to train an individual
as a dialysis technician shall be:
(1)
(No change.)
(2)
a registered nurse with at least 12 months of experience
in hemodialysis obtained within the last 24 months and a current competency
skills checklist on file in the facility or a registered nurse instructor
of a dialysis technician training course of an accredited college or university;
[
(3)
a qualified dietitian or social worker providing training
only within the person's area of expertise
; or
[
(4)
a technician qualified by training
and experience in water treatment, dialysate preparation, reprocessing or
other technical aspects of dialysis providing training within their area of
expertise.
(h) - (i)
(No change.)
§117.63.Competency Evaluation.
(a)
Each facility shall appoint a training review committee
to consist of at least the medical director, supervising nurse,
technical
supervisor
[
(b) - (d)
(No change.)
(e)
For dialysis technician trainees who will be cannulating
dialysis access and administering heparin and normal saline, the following
checklist shall also be completed satisfactorily:
(1) - (4)
(No change.)
(5)
administration of oxygen to
include:
(A)
verifying the ordered flow rate from the nurse
functioning in the charge role;
(B)
setting up the equipment; and
(C)
connecting the tubing for the patient.
(f)
If a dialysis technician other than an LVN is to cannulate
a dialysis access
,
[
§117.64.Documentation of Competency.
(a)
(No change.)
(b)
The document described in subsection (a) of this section
may be accepted by another facility that may later employ the dialysis technician.
Each employing facility shall have newly hired experienced dialysis technicians
complete a written test and a competency checklist in accordance with §117.63(c),
(d), and (e) of this title (relating to Competency Evaluation) within two
weeks of hire.
[
§117.65.Prohibited Acts.
(a)
(No change.)
(b)
Performance of the following acts by a dialysis technician
who is not a licensed vocational nurse is prohibited:
(1)
(No change.)
(2)
administration of medications other than normal saline,
heparin
,
[
(3) - (4)
(No change.)
(5)
acceptance of physician orders; [
(6)
provision of hemodialysis treatment to pediatric patients
[
(7)
alteration of the level of
electrolytes in dialysate through the use of additive(s) ("spiking"); or
(8)
initiation or discontinuation
of dialysis via an implantable port.
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 February 28, 2003.
TRD-200301485
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 13, 2003
For further information, please call: (512) 458-7236
25 TAC §§117.81 - 117.86
The amendments are proposed under Health and Safety Code (HSC),
Chapter 251, Texas End Stage Renal Disease (ESRD) Facility Licensing Act;
which provides the Board of Health (board) with the authority to adopt rules
governing the licensing and regulation of ESRDs, 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 amendments affect Health and Safety Code, Chapters 251 and
12, and implement Government Code, §2001.039.
§117.81.Corrective Action Plan.
(a)
(No change.)
(b)
Corrective action plan. A corrective action plan may be
used in accordance with §251.061 of the statute. This subsection is consistent
with §251.061 of the statute.
(1) - (7)
(No change.)
(8)
The department shall
approve
[
(A) - (C)
(No change.)
§117.82.Voluntary Appointment of a Temporary Manager.
(a) - (b)
(No change.)
(c)
An agreement under this section shall:
(1)
(No change.)
(2)
preserve all rights of [
(d) - (e)
(No change.)
§117.83.Involuntary Appointment of a Temporary Manager.
(a)
Under §251.092 of the statute, the
department
[
(1) - (6)
(No change.)
(b) - (c)
(No change.)
§117.84.Disciplinary Action.
(a)
The
department
[
(1) - (5)
(No change.)
(b) - (c)
(No change.)
(d)
If the department proposes to deny, suspend, or revoke
a license, the department shall notify the facility by certified mail, return
receipt requested, or personal delivery of the reasons for the proposed action
and offer the facility an opportunity for a hearing.
(1)
(No change.)
(2)
The request for a hearing shall be in writing and submitted
to the Director, Health Facility Licensing
and Compliance
Division,
Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756-3199.
(3) - (5)
(No change.)
(e) - (g)
(No change.)
§117.85.Administrative Penalties.
(a)
Under §§251.066-251.070 of the statute, the
department
[
(b) - (k)
(No change.)
§117.86.Recovery of Costs.
(a)
The
department
[
(b) - (e)
(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 February 28, 2003.
TRD-200301486
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 13, 2003
For further information, please call: (512) 458-7236
Subchapter B. MEAT AND POULTRY INSPECTION
25 TAC §221.15
The Texas Department of Health (department) proposes an amendment
to §221.15, concerning meat and poultry inspection. The proposed changes
clarify field slaughter and processing of exotic wild game animals
Under the proposed changes, inedible by-products are no longer required
to be placed in containers marked with the word "INEDIBLE" if they will not
be removed from the premises. However, the handling of inedible by-products
must be in a manner that does not result in insanitary conditions or attract
insects, vermin, or other pests. If inedible by-products are to be removed
from the premises for disposal or rendering, they must be adequately denatured
to preclude their use in human food and placed in containers conspicuously
marked "INEDIBLE."
The Health and Safety Code, Chapter 433 requires inspection of each livestock
animal before it is allowed to enter a processing establishment. Farm or ranch
raised domestic livestock are examined while at rest and in motion before
entering the slaughter department of a processing establishment. Due to their
wild nature, exotic livestock raised under free-range natural wildlife conditions
cannot always be presented for ante-mortem inspection. Trapping and holding
or transporting these animals is not practical. Under field conditions, there
may not be an opportunity to observe the animals in rest, in motion, and from
both sides.
Current harvesting practice includes harvesting the animals with the aid
of a helicopter. The game are located in the brush and chased out into an
opening where they are killed by a single shot to the head or neck. It is
not beneficial to the inspection process to observe animals that are fleeing.
It is beneficial to examine the freshly killed animal to ensure that the body
condition is that of a healthy animal and to determine that the animal was
indeed killed by being shot.
Historical data from more than ten years of harvesting exotic wild game
and the nature of the species indicate that exotic wild game available for
slaughter in their natural environment are very low risk for disease. Exotic
wild game has been harvested under inspection from Texas ranches since 1989
and none of the game has ever been condemned for health reasons or disease
conditions observed during ante-mortem inspection.
When exotic game animals are harvested in their natural environment, unhealthy
animals are not expected to be presented or available for harvesting. By nature,
as a matter of survival, animals that are unhealthy will not show signs of
illness or give indication that they are weaker than the rest of the herd.
Predators generally select weak animals as an easy target. Those animals that
are injured or ill enough to be symptomatic generally hide themselves until
they recover or die.
Lee C. Jan, D.V.M., Director, Meat Safety Assurance Division, has determined
that for each year of the first five years the proposed section is in effect,
there will be no fiscal implications to state or local government as a result
of enforcing or administering the rules as proposed.
Dr. Jan has also determined that for each year of the first five years
the section is in effect, the public benefit anticipated will be continued
assurance of consumer safety by enforcing the Texas Administrative Code as
it relates to meat and poultry slaughter and processing. There will be no
cost to micro-businesses, small businesses or individuals who are required
to comply with the proposed amendment because the amendment does not add new
or additional requirements for businesses, and only applies to businesses
that slaughter exotic animals. The amendment also changes how the department
performs its tasks related to field slaughter inspection, but those changes
do not impact the businesses. There will be no impact to local employment.
Comments on the proposal may be submitted to Lee C. Jan, D.V.M., Director,
Meat Safety Assurance Division, Texas Department of Health, 1100 West 49th
Street, Austin, Texas 78756, 512/719-0205. Comments will be accepted for 30
days following publication of the proposal in the
Texas Register
.
The amendment is proposed under the Health and Safety Code, Chapter
433, which provides the department with the authority to adopt necessary regulations
pursuant to the enforcement of Chapter 433; and §12.001, which provides
the Texas Board of Health (board) with the authority to adopt rules for the
performance of every duty imposed by law on the board, the department, and
the commissioner of health.
The amendment affects the Health and Safety Code, Chapter 433 and Chapter
12.
§221.15.Inspection of Alternate Source Food Animals.
(a)-(c)
(No change.)
(d)
Exotic animal.
(1)
Sanitation. All slaughter operations, including field slaughter,
are to be conducted in a way that precludes contamination. The following conditions,
as a minimum, shall be met.
(A)-(D)
(No change.)
(E)
Inedible by-products must be handled in a manner that
does not create an insanitary condition or adulteration and ensures inedibles
are not diverted to human food.
[
(2)
Ante-mortem procedures.
(A)
(No change.)
(B)
For mobile and field slaughter,
once an animal has
been shot, the animal will be bled as soon as possible in the field with a
properly sanitized knife.
The
[
(C)
For field slaughter,
environmental temperature may
affect
[
(3)-(5)
(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 February 28, 2003.
TRD-200301488
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 13, 2003
For further information, please call: (512) 458-7236
Subchapter C. TEXAS REGULATIONS FOR CONTROL OF RADIATION
25 TAC §289.130
The Texas Department of Health (department) proposes an amendment
to §289.130, concerning the Texas Radiation Advisory Board (board). The
board provides advice to the Texas Board of Health, the department's radiation
program, the Texas Commission on Environmental Quality, the Texas Railroad
Commission, and other state entities in the area of state radiation policies
and programs. The board is established under the Health and Safety Code, §11.016,
which allows the Texas Board of Health to establish advisory committees and
Health and Safety Code, §401.015, requiring the establishment of the
board. The board is governed by the Government Code, Chapter 2110, concerning
state agency advisory committees.
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 §289.130 and has determined that reasons for adopting the
section continue to exist; however, changes were necessary as described in
this preamble.
The department published a Notice of Intention to Review §289.130
in the
Texas Register
on August 13, 2002 (27
TexReg 7997). No comments were received due to publication of this notice.
In 1993, the Texas Legislature passed Senate Bill 383 (now codified in
the Government Code, Chapter 2110) which requires that each state agency adopt
rules on advisory committees. The rules must state the purpose of the committee,
describe the tasks of the committee, describe the manner in which the committee
will report to the agency, and establish a date on which the committee will
be automatically abolished unless the governing body of the agency affirmatively
votes to continue the committee's existence.
In 1997, the board established a rule relating to the Texas Radiation Advisory
Board. The rule states that the board will automatically be abolished on September
1, 2003. The Texas Board of Health has now reviewed and evaluated the committee
and has determined that the committee should continue in existence until September
1, 2007.
This section amends provisions relating to the operation of the board.
Specifically, language is revised to: continue the board until September 1,
2007; specify that the board appoints its presiding officers; amend language
regarding attendance; include additional requirements regarding statements
by members; and clarify the components that the board must include in an annual
report to the Texas Board of Health.
Jacquelyn McDonald, Director of the Office of the Board of Health, has
determined that for each year of the first five years the section is in effect,
there will be no fiscal implications for state and local government as a result
of amending the section as proposed.
Ms. McDonald has also determined that for each year of the first five years
the section is in effect, the public benefit anticipated as a result of amending
the section will be to provide a continuance of the committee and continued
advice to the department on this important issue. There will be no costs to
small business or micro-business resulting from compliance with this section,
as this section addresses only continuance of the committee and terms of office.
There are no anticipated economic costs to persons who are required to comply
with the section proposed. There is no anticipated impact on local employment.
Comments may be submitted to Jacquelyn McDonald, Director, Office of the
Board of Health, Texas Department of Health, 1100 West 49th Street, Austin,
Texas 78756, (512) 458-7484. Comments on the proposed section will be accepted
for 30 days following publication in the
Texas Register
.
The amendment is proposed under Health and Safety Code, §12.001
which provides the Texas Board of Health with the authority to adopt rules
for the performance of every duty imposed by law on the Texas Board of Health,
the department, and the commissioner; and Government Code, §2110.005
which requires the department to adopt rules stating the purpose and tasks
of its advisory committees.
The amendment affects the Health and Safety Code, Chapter 11, 12 and 401,
and the Government Code, Chapter 2110, and implements Government Code, §2001.039.
§289.130.Radiation Advisory Board.
(a)-(b)
(No change.)
(c)
Purpose. The purpose of the board is to provide advice
to the Texas Board of Health, the Texas Department of Health's (department)
radiation program, the
Texas Commission on Environmental Quality
[
(d)
Tasks.
(1)
The board shall advise the Texas Board of Health and the
department's radiation program concerning rules relating to state regulation
of radiation.
(2)
The board shall:
(A)
(No change.)
(B)
make recommendations and furnish technical advice as may
be required on matters relating to development, use, and regulation of sources
of radiation to the department, the
Texas Commission on Environmental
Quality
[
(C)
(No change.)
(e)
Review and duration. By September 1,
2007
[
(f)-(g)
(No change.)
(h)
Officers. The board shall elect a chairman, vice-chairman
and secretary at its first meeting after August 31st of each year. [
(1)-(4)
(No change.)
(i)
(No change.)
(j)
Attendance. Members shall attend board meetings as scheduled.
Members shall attend meetings of subcommittees to which the member is assigned.
(1)
(No change.)
(2)
It is grounds for removal from the board if a member cannot
discharge the member's duties for a substantial part of the term for which
the member is appointed because of illness or disability,
or
is
absent from more than half of the board [
(3)
(No change.)
(k)-(m)
(No change.)
(n)
Statement by members.
(1)
(No change.)
(2)
The board and its members may not participate in legislative
activity in the name of the Texas Board of Health or the department except
with approval through the department's legislative process. Board members
are not prohibited from representing
the board's decisions,
themselves
,
or other entities in the legislative process.
(3)
A board member should not accept
or solicit any benefit that might reasonably tend to influence the member
in the discharge of the member's official duties.
(4)
A board member should not disclose
confidential information acquired through his or her board membership.
(5)
A board member should not knowingly
solicit, accept, or agree to accept any benefit for having exercised the member's
official powers or duties in favor of another person.
(6)
A board member who has a personal
or private interest in a matter pending before the board shall publicly disclose
the fact in a board meeting and may not vote or otherwise participate in the
matter. The phrase "personal or private interest" means the board member has
a direct pecuniary interest in the matter but does not include the board member's
engagement in a profession, trade, or occupation when the member's interest
is the same as all others similarly engaged in the profession, trade, or occupation.
(o)
Reports to Texas Board of Health. The board shall file
an annual written report with the Texas Board of Health.
(1)
(No change.)
(2)
The report shall identify the costs related to the board's
existence, including the cost of department staff time spent in support of
the board's activities
and the source of funds used to support the board's
activities
.
(3)
(No change.)
(p)
(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 February 28, 2003.
TRD-200301489
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 13, 2003
For further information, please call: (512) 458-7236
Subchapter A. HAZARD COMMUNICATION
25 TAC §§295.1 - 295.9, 295.11 - 295.13
The Texas Department of Health (department) proposes amendments
to §§295.1-295.9 and §§295.11-295.13 concerning the requirements
for public employers (tax base-supported employers and agencies created by
state law) to take actions to protect their employees from hazardous chemicals.
The sections cover workplace chemical lists, material safety data sheets,
labeling of containers, written hazard communication programs, employee education
and training programs, complaints and investigations, reporting fatalities
and injuries, administrative penalties, employee notices, rights of employees,
and the standard for physician treatment.
Government Code, §2001.039 requires that each state agency review
and consider for readoption each rule adopted by that agency pursuant to the
Government Code, Chapter 2001 (Administrative Procedure Act). Sections 295.1-295.9
and 295.11-295.13 have been reviewed and the department has determined that
reasons for adopting the sections continue to exist. Section 295.10 was repealed,
effective August 15, 1999.
Specifically, the amendment to §295.1 eliminates an outdated effective
date established in the previous rule. The amendments to §295.2 add one
new definition, delete one definition, and amend five others to clarify the
intent of the rules. The amendments to §295.3 reflect a change in the
Division name and provide the program's toll free telephone number. The amendments
to §295.4 clarify that a model workplace chemical form is now available
to employers from the department. The amendment to §295.5 reduces the
amount of time that a hazardous chemical manufacturer or distributor will
have to provide a material safety data sheet (MSDS) to an employer after receipt
of the employer's written request for this document. Since manufacturers and
distributors can now send MSDSs to employers by electronic mail or facsimile
transmission with improved verification of receipt, this time reduction is
reasonable. The reduction is being proposed to ensure that employers can receive
hazardous chemical information by the most efficient means possible. The amendments
to §295.6 specify the federal citation for the standard that manufacturers
and distributors of hazardous chemicals must meet in providing container labels
and clarify that employers are responsible for re-labeling a hazardous chemical
container when the label is missing. The amendments to §295.7 notify
employers of the availability of a model written hazard communication program
from the department and clarify that this model is a recommended format. The
amendments to §295.8 clarify that an employer's refusal to allow an inspection
is a violation of both the Health and Safety Code, Chapter 502, and the rules.
The amendments to §295.9 reflect the change in the Division name. The
amendments to §295.11 clarify that an employer's written response to
the department's written notice of proposed administrative penalties must
conform to at least one of the options listed in the written notice. The amendments
to §295.11 also clarify that a hazardous chemical manufacturer's or distributor's
failure to provide an MSDS within three business days of an employer's written
request is an example of a severe violation of Chapter 502. The amendments
to §295.12 notify employers of the availability of the department's electronic
and Spanish versions of the workplace notice. The amendments to §295.13
clarify that nurses, as well as physicians, may obtain trade secret information
for a hazardous chemical when that information is needed for medical treatment
during an emergency.
A notice of intention to review rules was published for §§295.1-295.9
and 295.11-295.13 in the January 24, 2003, issue of the
Texas Register
(28 TexReg 761) for the state agency review of rules
in accordance with Government Code, §2001.039.
Charles Branton, Director, Product Safety Division, has determined that
for each year of the five years 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. 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 decreased hazardous chemical exposures for
public employees. There will be no costs to micro-businesses or small businesses
to comply with the sections as proposed since the proposed amendments are
only applicable to public employers. 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 Charles Branton, Product Safety
Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas,
78756, (512) 834-6773, extension 2260, fax (512) 834-6766. Comments will be
accepted for 30 days following publication of this proposal in the
Texas Register
. In addition, a public hearing on the proposed sections
will be held at 9:00 a.m., Wednesday, April 9, 2003, in the Texas Department
of Health Auditorium, Room K-100, 1100 West 49th Street, Austin, Texas.
The amendments are proposed under the Health and Safety Code, §502.019,
which provides the Texas Board of Health (board) with the authority to adopt
necessary rules to administer and enforce Chapter 502; §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; and implements Government Code, §2001.039.
The amendments affect the Health and Safety Code, Chapter 502.
§295.1.Purpose and Scope.
The purpose of these sections is to provide employers and employees
with guidance needed to comply with the Texas Hazard Communication Act. [
§295.2.Definitions.
The following words and terms, when used in these sections, shall have
the following meanings unless the context clearly indicates otherwise.
(1)-(4)
(No change.)
(5)
Categories of hazardous chemicals--A grouping of hazardous
chemicals with similar
hazard
properties.
(6)
Commissioner of Health - the
director of the Texas Department of Health, as referenced in the Health and
Safety Code, §502.003(8).
(7)
[
(8)
[
[
(9)
(No change.)
(10)
Employee education and training program - Actual instruction,
regardless of the technology or method used to deliver it, provided by the
employer to employees as required by the Act, §502.009. This program
is the [
(11)
Employer - The overall organizational public entity rather
than individual facilities or workplaces. Examples of public employers are
an entire state agency, a county, a city, a public school district, a public
university, a public college or community college, a river authority, a public
hospital, or a volunteer emergency service organization. Each university,
college, or community college in a university or college system shall be considered
as a separate employer under the Act [
(12)-(13)
(No change.)
(14)
Label - Any written, printed, or graphic material displayed
on or affixed to containers of hazardous chemicals [
(15)
(No change.)
(16)
Stationary
process container
[
(17)-(18)
(No change.)
§295.3.Responsibility for Implementation of Program.
The
commissioner's
[
§295.4.Workplace Chemical List.
(a)-(b)
(No change.)
(c)
Employers may use the department's
[
§295.5.Material Safety Data Sheets.
(a)-(c)
(No change.)
(d)
A chemical manufacturer or distributor must provide an
appropriate MSDS to an employer within
three
[
(e)
(No change.)
§295.6.Labeling of Containers.
(a)
Employers shall rely on the manufacturers or distributors
of their hazardous chemicals to provide container labels which meet the requirements
of the OSHA Standard
at 29 CFR, 1910.1200(f)
and shall be responsible
for re-labeling a container only:
(1)
when the label is
missing or
illegible; or
(2)
(No change.)
(b)-(h)
(No change.)
§295.7.Written Hazard Communication Program and Employee Education and Training Program.
(a)
An employer is required to develop a written hazard communication
program which will describe how the employer will comply with those requirements
of the Act imposed on the employer. The written hazard communication program
must include a description of the procedures that the employer will follow
to achieve compliance with each applicable requirement of the Act. Employers
may develop written hazard communication programs that are specific to each
separate workplace or may develop a standard written program that could be
used or modified for each workplace.
Employers may use the department's
model program in developing written hazard communication programs for each
of their workplaces. This model program will provide a recommended format
for the written hazard communication program, but is not mandatory.
(b)-(i)
(No change.)
§295.8.Complaints and Investigations.
(a)
The
commissioner
[
(b)
The
commissioner
[
(c)
(No change.)
(d)
Upon request from a representative of the
commissioner
[
§295.9.Reporting Fatalities and Injuries.
(a)
(No change.)
(b)
Such employee accidents may be reported to the Texas Department
of Health,
Product Safety
[
§295.11.Administrative Penalties.
(a)
Inspections may be conducted by the
commissioner
[
(b)
(No change.)
(c)
Penalties shall be due after an order is issued by the
commissioner
[
(d)-(h)
(No change.)
(i)
Examples of violations for the various severity levels
include, but are not limited to:
(1)-(2)
(No change.)
(3)
Severe violation:
(A)-(F)
(No change.)
(G)
failure by a chemical manufacturer or distributor to provide
an MSDS to an employer within
three
[
(H)
(No change.)
(4)
(No change.)
§295.12.Employee Notice; Rights of Employees.
(a)
Employers covered by the Act must post and maintain workplace
notices specified in this section. The wording of the required workplace notice
may be changed by the
commissioner [
Figure: 25 TAC §295.12(a) (.pdf format)
(b)-(d)
(No change.)
(e)
To assist employers in providing the workplace notice information,
the department shall make original copies of the workplace notice available
for photocopying by employers.
The department shall also make an electronic
version of the workplace notice available to employers.
A Spanish translation
of the workplace notice
is
[
(f)-(i)
(No change.)
§295.13.Standard for Physician Treatment.
The citation of the OSHA Standard for physicians treating employees
that is provided in the Act, §502.018, is in error. The correct citation
for this standard is 29 CFR, 1910.1200(i)(2).
This standard allows nurses,
as well as physicians, to obtain the chemical identity of a trade secret hazardous
chemical when that information is needed for medical treatment during an emergency.
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 3, 2003.
TRD-200301513
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 13, 2003
For further information, please call: (512) 458-7236
Chapter 37.
MATERNAL AND INFANT HEALTH SERVICES
2003
], the board will initiate and complete a review of the committee
to determine whether the committee should be continued, consolidated with
another committee, or abolished. If the committee is not continued or consolidated,
the committee shall be abolished on that date.
chairman of the
board
] shall
select from its members the
[
appoint a
] presiding officer and an assistant presiding officer to begin serving
on June 1 of each odd-numbered year.
appointed by the chairman of the board
].
serve until a successor is appointed to
]
complete the unexpired portion of the term of the office of presiding officer.
temporarily
] by vote of the committee [
until a successor is appointed by the chairman of the board
].
at least twice each year
]
.
Chapter 117.
END STAGE RENAL DISEASE FACILITIES
the
]
Health and Safety Code, Chapter 251, which requires an end stage renal disease
facility providing routine, repetitive, outpatient dialysis to be licensed
by the Texas Department of Health.
(1)
] Advanced practice nurse - A
registered nurse approved by the Board of Nurse Examiners for the State of
Texas to practice as an advanced practice nurse on the basis of completion
of an advanced educational program. The term includes a nurse practitioner,
nurse midwife, nurse anesthetist, and clinical nurse specialist.
(2)
] Administrator - A person who
is delegated the responsibility for the implementation and proper application
of policies, programs, and services established for the end stage renal disease
facility.
(3)
] Affiliate - An applicant or
owner which is:
(4)
] Applicant - The owner of an
end stage renal disease facility which is applying for a license under the
statute. This is the person in whose name the license is issued.
(5)
] Board - The Texas Board of
Health.
(6)
] Change of ownership - A sole
proprietor who transfers all or part of the facility's ownership to another
person or persons; the removal, addition, or substitution of a person or persons
as a partner in a facility owned by a partnership
and the tax identification
number of the partnership changes
; or a corporate sale, transfer, reorganization,
or merger of the corporation which owns the facility if sale, transfer, reorganization,
or merger causes a change in the facility's ownership to another person or
persons
and the tax identification number of the corporation changes
.
(7)
Chief technician - The facility-based
supervisor of the facility's mechanical, reuse and water treatment systems.]
(8)
] Commissioner - The commissioner
of health.
(9)
] Competency - The demonstrated
ability to carry out specified tasks or activities with reasonable skill and
safety that adheres to the prevailing standard of practice.
(10)
] Core staff members - The
facility's medical director, supervising nurse, dietitian, social worker,
administrator, and chief technician.
(11)
] Corrective action plan -
A written strategy for correcting a licensing violation. The corrective action
plan is developed by the facility and addresses the system(s) operation(s)
of the facility as the system(s) operation(s) applies to the deficiency.
(12)
] Delegation - The transfer
to a qualified and properly trained individual of the authority to perform
a selected task or activity in a selected situation.
(13)
] Department - The Texas Department
of Health.
(14)
] Dialysis - A process by which
dissolved substances are removed from a patient's body by diffusion, osmosis
and convection (ultrafiltration) from one fluid compartment to another across
a semipermeable membrane.
(15)
] Dialysis technician - An
individual who is not a registered nurse or physician and who provides dialysis
care under the direct supervision of a registered nurse or physician. If unlicensed,
this individual may also be known as a patient care technician.
(16)
] Dietitian - A person who
is currently licensed under the laws of this state to use the title of licensed
dietitian, is eligible to be a registered dietitian, and has one year of experience
in clinical dietetics after becoming eligible to be a registered dietitian.
(17)
] Director - The director of
the Health Facility Licensing
and Compliance
Division of the department
or his or her designee.
(18)
] End stage renal disease -
That stage of renal impairment that appears irreversible and permanent and
that requires a regular course of dialysis or kidney transplantation to maintain
life.
(19)
] End stage renal disease (ESRD)
facility - A facility that provides dialysis treatment or dialysis training
to individuals with end stage renal disease.
(20)
] Full-time - The time period
established by a facility as a full working week, as defined and specified
in the facility's policies and procedures.
(21)
] Full-time equivalent - Work
time equivalent to 2,080 hours per 12 consecutive months.
(22)
] Health care facility - Any
type of facility or home and community support services agency licensed to
provide health care in any state or is certified for Medicare (Title XVIII)
or Medicaid (Title XIX) participation in any state.
(23)
] Hospital - A facility that
is licensed under the Texas Hospital Licensing Law, Health and Safety Code,
Chapter 241, or if exempt from licensure, certified by the United States Department
of Health and Human Services as in compliance with conditions of participation
for hospitals in Title XVIII, Social Security Act (42 United States Code, §1395
et [
.
] seq.).
(24)
] Interdisciplinary team -
A group composed of the patient and the primary physician, the registered
nurse, the dietitian and the social worker who are responsible for planning
care for the patient.
(25)
] Intermediate level disinfection
- A surface treatment using chemical germicides or disinfectants which are
capable of inactivating various classes of microorganisms including, but not
limited to, viruses (primarily medium to large viruses and lipid-containing
viruses), fungi, and actively growing bacteria (including tubercle bacteria)
when such chemical germicides or disinfectants are used in accordance with
the manufacturer's instructions or per established guidelines. Intermediate
level disinfection is generally not effective in inactivating or eliminating
bacterial endospores. Examples of intermediate level disinfectants include
bleach, 70-90% ethanol or isopropanol, and certain phenolic or iodophor preparations.
(26)
] Inspection - An investigation
or survey conducted by a representative of the department to determine if
an applicant or licensee is in compliance with this chapter.
(27)
] Licensed nurse - A registered
nurse or licensed vocational nurse.
(28)
] Licensed vocational nurse
(LVN) - A person who is currently licensed under Texas Civil Statutes, Article
4528c to use the title licensed vocational nurse and who may provide dialysis
treatment after meeting the competency requirements specified for dialysis
technicians.
(29)
] Manager - An individual approved
or selected by the department who assumes overall management of an end stage
renal disease facility to ensure adequate and safe services are provided to
patients.
(30)
] Medical director - A physician
who:
(31)
] Medical review board (MRB)
- A medical review board that is appointed by a renal disease network organization
which includes this state, with the network having a contract with the
Centers for Medicare and Medicaid Services
[
Health Care Financing
Administration
] of the United States Department of Health and Human
Services under 42 United States Code §1395rr.
(32)
] Monitor - An individual approved
or selected by the department who observes, supervises, consults, and educates
a facility to correct identified violations of the statute or this chapter.
(33)
] Notarized copy(ies) - A sworn
affidavit stating that attached copy(ies) is a true and correct copy(ies)
of the original documents.
(34)
] Owner - One of the following
which holds or will hold a license issued under the statute in the person's
name or the person's assumed name:
(35)
] Patient - An individual receiving
dialysis treatment or training from an end stage renal disease facility.
(36)
] Patient care plan -
Documentation of the interactive process whereby the interdisciplinary team
and the patient develop a plan to assist the end stage renal disease patient
in managing the disease and its complications.
[
A written document
prepared by the interdisciplinary team for a patient receiving end stage renal
disease services.
]
(37)
] Pediatric patient - An individual
18 years of age or younger under the care of a facility.
(38)
] Person - An individual, corporation,
or other legal entity.
(39)
] Physician - An individual
who is licensed to practice medicine under the Medical Practice Act, Texas
Civil Statutes, Article 4495b.
(40)
] Physician assistant - A person
who is licensed as a physician assistant under the Physician Assistant Licensing
Act, Texas Civil Statutes, Article 4495b-1.
(41)
] Presurvey conference - A
conference held with department staff and the applicant or his or her representatives
to review licensure standards and survey documents and provide consultation
prior to the
issuance of the temporary license
[
on-site licensure
inspection
]. The applicant's representatives shall include an individual
who will be responsible for the day-to-day supervision of care by the facility.
(42)
] Product water - The effluent
water from the last component of the facility's water treatment system.
(43)
] Progress note - A dated and
signed written notation by a facility staff member summarizing facts about
care and a patient's response during a given period of time.
(44)
] Quality - The degree to which
health services for individuals and populations increase the likelihood of
desired outcomes that are consistent with current professional knowledge.
(45)
] Quality assurance - An ongoing,
objective, and systematic process of monitoring, evaluating, and improving
the quality, appropriateness, and effectiveness of care. The term includes
the quality management and quality improvement processes.
(46)
] Quality management - A management
philosophy used to plan and achieve desired processes and outcomes based upon
a quality plan, which establishes quality objectives and the means to achieve;
quality control, which is a process to evaluate actual performance against
expected performance; and quality improvement, which is a process to identify,
plan, and implement change for improvement.
(47)
] Registered nurse (RN) - A
person who is currently licensed under the Nursing Practice Act, Texas Civil
Statutes, Article 4513 et seq. as a registered nurse.
(48)
] Social worker - A person
who:
(49)
] Supervising nurse (also may
be known as the director of nursing) - An RN who:
(50)
] Supervision - Authoritative
procedural guidance by a qualified person for the accomplishment of a function
or activity with initial direction and periodic inspection of the actual act
of accomplishing the function or activity. Immediate supervision means the
supervisor is actually observing the task or activity as it is performed.
Direct supervision means the supervisor is on the premises but not necessarily
immediately physically present where the task or activity is being performed.
Indirect supervision means the supervisor is not on the premises but is accessible
by two-way communication and able to respond to an inquiry when made, and
is readily available for consultation.
(51)
] Statute - The Health and
Safety Code, Chapter 251.
(52)
] Training - The learning of
tasks through on-the-job experience or instruction by an individual who has
the capacity through education or experience to perform the task or activity
to be delegated.
(53)
] Working day - Any day of
the calendar week excluding Saturday or Sunday.
and
]
1,500.
]
Subchapter B. APPLICATION AND ISSUANCE OF A LICENSE
an
] application and related fee and the issuance of a temporary
initial license for the new location.
it has received
] a temporary initial license
has been
issued by the department
.
The applicant shall submit
the information listed in paragraph (3) of this subsection to the department
within six months from the date the department mails the application packet
to the applicant.
]
(1)
If the department does not
receive the information listed in paragraph (3) of this subsection within
six months from the mailing date, the applicant must request a new application
packet.]
(2)
] An applicant shall not misstate
a material fact on any documents required to be submitted under this section.
(3)
] The following items shall be
submitted with the original application form and shall be originals or notarized
copies:
street
address,
] mailing address,
and
social security number or
[
franchise
] tax identification number [
, date of birth, and
driver's license number
];
, the telephone
number where the administrator can usually be reached when the facility is
closed,
] and if the facility has a fax machine, the fax number;
,
and a job description for each administrative and supervisory position
];
(K)
a notarized statement attesting
that the applicant is capable of meeting the requirements of this chapter;
]
(L)
] a notarized attestation that
each dialysis technician on staff has completed the training and competency
evaluation programs. [
This attestation may be consolidated with the attestation
described in subparagraph (K) of this paragraph
];
(M)
] a written plan for the orderly
transfer of care of the applicant's patients and clinical records if the applicant
is unable to maintain services under the license;
(N)
] a copy of an approved fire
safety inspection report from the local fire authority in whose jurisdiction
the facility is based that is dated no earlier than 12 months prior to the
date of the application;
(O)
] an organizational structure
of the staffing for the facility;
(P)
if an applicant is a corporation,
a current letter from the state comptroller's office stating the corporation
is in good standing or a notarized certification that the tax owed to the
state under the Tax Code, Chapter 171, is not delinquent or that the corporation
is exempt from the payment of the tax and is not subject to the Tax Code,
Chapter 171;]
(Q)
] the organizational structure
of the applicant which includes written full disclosure of the names and addresses
of all owners and persons controlling any ownership interest in the facility.
In the case of corporations, holding companies, partnerships, and similar
organizations, the names and addresses of officers, directors, and stockholders,
both beneficial and of record, when holding any percent, shall be disclosed;
(R)
] the name(s) and credentials
of:
(S)
] the following data concerning
the applicant, the applicant's affiliates, and the managers of the applicant:
(T)
] for the two-year period preceding
the application date, the following data concerning the applicant, the applicant's
affiliates, and the managers of the applicant:
(4)
] The applicant shall retain
a copy of all documentation that is submitted to the department.
six months
] from the date of the notice.
six months
] from the notice date is
considered to have withdrawn its application for a temporary initial license.
The license fee will not be refunded.
(3)
] Issuance of license. After
completion of the presurvey conference
,
[
and the
] design
and space inspection described in paragraph (2) of this subsection,
and approval of water reports by the surveyor,
the department:
The department shall
acknowledge receipt of the request to withdraw.
] The license fee will
not be refunded.
The
department shall acknowledge receipt of the request to withdraw.
] The
license fee will not be refunded.
(1)
If the temporary initial license
is issued on the first day of a month, the first annual license expires on
the last day of the preceding month of the next year.]
(2)
If the temporary initial license
is issued on the second or any subsequent day of a month, the first annual
license expires on the last day of the month of issuance of the next year.]
working
] days before the expiration date of a first
annual or an annual renewal license. If the facility has not received notice
of expiration from the department 45 calendar days prior to the expiration
date, it is the duty of the facility to notify the department and request
a renewal application for a license.
on or after August 1, 1990,
] because the licensee is or was on
active duty with the armed forces of the United States of America serving
outside the State of Texas, the licensee may renew the license pursuant to
this paragraph.
3.2.1
] (relating to Water Bacteriology)
and
4.2.2
[
3.2.2
] (relating to
Maximum
Level
of Chemical Contaminants) of the American National Standard,
Water Treatment
Equipment for Hemodialysis Applications, August 2001
[
Hemodialysis
Systems, March 1992
] Edition, published by the Association for the Advancement
of Medical Instrumentation,
1110 North Glebe Road, Suite 200,
[
3330 Washington Boulevard, Suite 400,
] Arlington, Virginia 22201, [
1-800-
] 703-525-4890.
Section
] or his or her designee,
Health Facility Licensing
and Compliance
Division, Texas Department
of Health, 1100 West 49th Street, Austin, Texas, 78756-3199, (512) 834-6646.
Subchapter C. MINIMUM STANDARDS FOR DESIGN AND SPACE, EQUIPMENT, WATER TREATMENT AND REUSE, AND SANITARY AND HYGIENIC CONDITIONS
only to a facility which initiates the provision of end stage
renal disease services on or after September 1, 1996; or to the area of a
facility affected by design and space modifications or renovations completed
after September 1, 1996.
]
26
] of the National Fire Protection Association 101, Code for Safety
to Life from Fire in Buildings and Structures,
2000
[
1994
] Edition (NFPA 101), relating to new business occupancies, published
by the National Fire Protection Association. All documents published by the
NFPA as referenced in this section may be obtained by writing or calling the
NFPA at the following address and telephone number: Post Office Box 9101,
Batterymarch Park, Quincy, Massachusetts 02169, 1-800-344-3555.
(4)
] A facility shall provide a
reception and information counter or desk and a waiting room separate from
the patient treatment area. The waiting room shall provide adequate seating.
(5)
] The patient treatment area
shall be designed and equipped to provide proper and safe treatment as well
as privacy and comfort for patients. At a minimum, patient treatment stations
shall be 70 square feet, with the smallest dimension at seven feet. The 70
square feet may include aisles or counters.
(6)
] If hepatitis B positive patients
are treated, a separate room with its own designated machine(s), clamp(s),
blood pressure cuff(s), sink(s) and other equipment shall be used.
(7)
] A facility shall provide a
call system in patient areas outside the treatment area (e.g., patient restrooms,
training rooms, and examination rooms) which is usable by a collapsed patient
lying on the floor (e.g., inclusion of a pull cord). Calls shall register
at and activate a visible signal in the central nurses station. Call systems
which provide two-way communication shall be equipped with an indicating light
at each call station which lights and remains lighted as long as the voice
circuit is operating.
(8)
] A facility shall have separate
toilet and lavatory facilities for staff and patients.
(9)
] A facility shall provide a
private area for meetings with patients or family members.
(10)
] A facility shall have a room
for medical examinations which includes an examination table, a work counter,
and a hand washing sink or lavatory.
(11)
] Telephone access shall be
available in the facility to patients and family members.
(12)
] A facility located above
the ground floor must have an elevator of sufficient size to accommodate a
gurney available at all times.
(13)
] A facility shall provide
two exits remote from each other in accordance with NFPA 101,
§7-5.1.3
[
§5-5.1.3
]. At least one exit door shall be accessible
by an ambulance from the outside. This door may also serve as an entry for
loading or receiving goods.
(14)
] A facility shall provide
a separate room for peritoneal dialysis patients if the facility provides
on-site peritoneal dialysis training. This room shall include a lavatory or
sink for hand washing.
(15)
] Doors to an isolation room
or peritoneal dialysis room shall not be lockable from inside the room.
(16)
] Public corridor widths and
all other areas where patients may traverse shall accommodate wheel chair
or gurney passage.
(17)
] Items such as drinking fountains,
telephone booths, vending machines and portable equipment (including patient
care equipment) shall be located so that they do not project into, restrict,
or obstruct exit corridor traffic.
(18)
] A facility shall utilize
a ventilation system which provides adequate comfort to patients during treatment
and which minimizes the potential of insect access.
(19)
] Floors that are subject to
traffic while wet shall have nonslip surfaces.
1993
] Edition (NFPA 99) published by the National Fire
Protection Association.
1994
] Edition, published by the National Fire Protection
Association.
1993
] Edition (NFPA 110), published by the National Fire Protection Association.
§28-1.4.1
] of the NFPA 101, must have a special feature
such as a two-hour fire wall between the facility and the other occupancy
and written approval by the fire authority having jurisdiction.
1990
] Edition (NFPA 99), published by the National Fire Protection Association.
All documents published by the NFPA as referenced in this section may be obtained
by writing or calling the NFPA at the following address and telephone number:
Post Office Box 9101, Batterymarch Park, Quincy, Massachusetts 02169, 1-800-344-3555.
and
]
.
]
(h)
If a facility employs a central
delivery system for glucose-containing bicarbonate dialysate, the system must
be drained at the end of each treatment day and cultured weekly to identify
potential bacterial contamination. If cultures demonstrate more than 2,000
colony forming units (CFUs) per milliliter, the bicarbonate delivery system
must be disinfected and recultured.]
for water treatment and reuse of hemodialyzers
] than the minimum standards
required by this section.
Natural Resources Conservation Commission, effective January
1991
].
3.2.1
] (concerning
Water Bacteriology
[
Hemodialysis Systems
]) and §
4.2.2
[
3.2.2
] (concerning Maximum Level of Chemical Contaminants) of the American
National Standard,
Water Treatment Equipment for Hemodialysis Applications
[
Hemodialysis Systems
],
August 2001
[
March
1992
] Edition, published by the Association for the Advancement of Medical
Instrumentation (AAMI). All documents published by the AAMI as referenced
in this section may be obtained by writing the following address:
1110
North Glebe Road, Suite 220
[
3330 Washington Boulevard, Suite 400
], Arlington, Virginia 22201.
The facility shall establish and
post in the water area written procedures describing the action to be taken
when parameters are not met.
]
(6)
] Each water treatment system
shall include reverse osmosis membranes or deionization tanks and a minimum
of two carbon tanks in series. If the source water is from a private supply
which does not use chlorine/chloramine, the water treatment system shall include
reverse osmosis membranes or deionization tanks and a minimum of one carbon
tank.
3.2.3.5
] (concerning Reverse Osmosis)
of the American National Standard,
Water Treatment Equipment for Hemodialysis
Applications, August 2001
[
Hemodialysis Systems, March 1992
]
Edition, published by the AAMI.
, if used, shall meet the standards
in §§3.2.3.3 (concerning Regenerated or Reconstituted Devices) and
3.2.3.4 (concerning Deionization) of the American National Standard, Hemodialysis
Systems, March 1992 Edition, published by the AAMI
].
The carbon tanks must contain
acid washed 30-mesh or smaller carbon placed in series with a minimum empty
bed contact time of three minutes for each tank or bank of tanks and a testing
port between the tanks or bank of tanks. Water from this port(s) must be tested
for chlorine/chloramine levels prior to each patient shift. The first test
each treatment day for chlorine/chloramine shall be done no sooner than 15
minutes after start-up of the water treatment system.
]
(D)
Test results of greater than
0.5 parts per million (ppm) for chlorine or 0.1 ppm for chloramine from the
port between the initial tank(s) and final tank(s) shall require testing to
be performed at the final exit and replacement of the initial tank(s). If
test results at the exit of the final tank(s) are greater than the parameters
for chlorine or chloramine described in this subparagraph, dialysis treatment
shall be immediately terminated to protect patients from exposure to chlorine/chloramine
and the medical director shall be notified.]
(7)
] Water softeners, if used, shall
be tested at the end of the treatment day to verify their
[
have
the
] capacity to treat a sufficient volume of water to supply the facility
for the entire treatment day
and shall be fitted with a mechanism to
prevent water containing the high concentrations of sodium chloride used during
regeneration from entering the product water line during regeneration
.
(8)
Cartridge filters, if used,
shall be made of material (e.g., pure polypropylene) which will not leach
surfactants, formaldehyde, or other material which has been used in their
manufacture.]
(9)
]
Filter
[
Cartridge
filter
] housings, if used during disinfectant procedures, shall include
a means to clear the lower portion of the housing of the disinfecting agents.
Filter housings shall be opaque.
(10)
] The water treatment system
must be continuously monitored during patient treatment and be guarded by
audible and visual alarms which can be seen and heard in the dialysis treatment
area should water quality drop below specific parameters. Quality monitor
sensing cells shall be located as the last component of the water treatment
system and at the beginning of the distribution system. No water treatment
components that could affect the quality of the product water as measured
by this device shall be located after the sensing cell.
(11)
] When deionization tanks do
not follow a reverse osmosis system, parameters for the rejection rate of
the membranes must assure that the lowest rate accepted would provide product
water in compliance with §
4.2.2
[
3.2.2
] (concerning
Maximum Level of Chemical Contaminants) of the American National Standard,
Water Treatment Equipment for Hemodialysis Applications, August 2001
[
Hemodialysis Systems, March 1992
] Edition published by the AAMI.
(12)
] A facility shall maintain
written logs of the operation of the water treatment system for each treatment
day. The log book shall include each component's operating parameter and the
action taken when a component is not within the facility's set parameters.
(13)
] Microbiological testing of
product water [
shall be conducted monthly and following any repair or
change to the water treatment system. The results must demonstrate that water
quality meets §3.2.1 (concerning Hemodialysis Systems) of the American
National Standard, Hemodialysis Systems, March 1992 Edition, published by
the AAMI. Sample sites chosen for the testing shall include the beginning
of the distribution piping, the product water in the reuse room, and the end
of the distribution piping. If the results do not meet the AAMI standard described
in this paragraph, the water system shall be immediately disinfected and recultured.
If after disinfection, the cultures do not meet the AAMI standards described
in this paragraph, the facility shall determine the source of contamination
by immediately reculturing the sample sites, all patient stations, any water
storage tanks, water used to mix dialysate, and product water from the final
component of the water treatment system. A calibrated loop may not be used
in microbiological testing of water samples
].
(14)
]
Water Analysis. Samples
[
A sample
] of product water must be submitted for chemical
analysis every six months and must demonstrate that
the quality of the
product water used to prepare dialysate, concentrates from powder, or to reprocess
dialyzers for multiple use,
[
water quality
] meets §
4.2.2
[
3.2.2
] (concerning Maximum Level of Chemical Contaminants)
of the American National Standard,
Water Treatment Equipment for Hemodialysis
Applications, August 2001
[
Hemodialysis Systems, March 1992
]
Edition, published by the AAMI. [
The sample water for chemical analysis
shall be drawn after the quality monitoring sensing cell. Additional chemical
analysis shall be submitted if substantial changes are made to the water treatment
system or if the percent rejection of a reverse osmosis system decreases 5.0%
or more from the percent rejection measured at the time the water sample for
the preceding chemical analysis was taken.
]
(15)
] Facility records must include
all test results and evidence that the medical director has reviewed the results
of the water quality testing and directed corrective action when indicated.
(16)
] Only persons qualified by
the education or experience described in §117.44(f) of this title (relating
to Qualifications of Staff) may operate, repair, or replace components of
the water treatment system.
(c)
] Reuse of hemodialyzers and
related devices.
(2)
] A transducer protector shall
be replaced when wetted during a dialysis treatment and shall be used for
one treatment only.
(3)
] Arterial lines may be reused
only when the arterial lines are labeled to allow for reuse by the manufacturer
and the manufacturer-established protocols for the specific line have been
approved by the United States Food and Drug Administration.
(4)
] The water supply in the reuse
room shall incorporate a check valve to prevent chemical agents used from
inadvertently back flowing into the water distribution system.
(5)
] Ventilation systems in the
reuse room shall be connected to an exhaust system to the outside which is
separate from the building exhaust system, have an exhaust fan located at
the discharge end of the system, and have an exhaust duct system of noncombustible
corrosion-resistant material as needed to meet the planned usage of the system.
Exhaust outlets shall be above the roof level and arranged to minimize recirculation
of exhaust air into the building.
(6)
] A facility shall establish,
implement, and enforce a policy for dialyzer reuse criteria (including any
facility-set number of reuses allowed) which is included in patient education
materials and posted in the waiting room and patient treatment areas.
A dialyzer may be reused only if that dialyzer's original volume is measured
and recorded prior to its first use and the volume of that dialyzer is used
as the basis for discard for that dialyzer.
(7)
] A facility shall consider and
address the health and safety of patients sensitive to disinfectant solution
residuals.
(8)
] A facility shall provide each
patient with information regarding the reuse practices at the facility, the
opportunity to tour the reuse area, and the opportunity to have questions
answered.
(9)
] A facility shall restrict
the reprocessing room to authorized personnel.
(10)
] A facility shall obtain written
informed consent of the patient or legal representative.
(d)
] Centralized dialyzer reprocessing.
If a facility participates in centralized reprocessing in which dialyzers
from multiple facilities are reprocessed at one site, the facility shall:
and
]
(5)
] provide department staff access
to the off-site reprocessing site as part of a facility inspection.
(B)
Samples of dialysate from
machines chosen at random shall be cultured monthly, and culture results shall
not exceed 2,000 colony forming units per milliliter. Hemodialysis machines
of home patients shall be cultured monthly until results not exceeding 2,000
colony forming units per milliliter are obtained for three consecutive months,
then quarterly samples shall be cultured.]
(C)
] Between patient shifts, facility
staff shall clean machine exteriors, treatment chairs, tourniquets, and hemostats.
Blood pressure cuffs which become contaminated with blood shall be removed
from service, disinfected, and allowed to dry prior to being returned to use.
Natural
Resource Conservation Commission's
] requirements in Title 30, Texas
Administrative Code, §330.1004 (Generators of Medical Waste).
Natural Resource Conservation
Commission
] in accordance with Title 30, Texas Administrative Code,
Chapter 285 (On-site
Sewage Facilities
[
Wastewater Treatment
]).
(A)
Hepatitis B vaccination.]
(i)
The facility shall offer hepatitis B vaccination
to previously unvaccinated, susceptible new staff members in accordance with
29 Code of Federal Regulations, §1910.1030(f)(1)-(2) (concerning Bloodborne
Pathogens).]
(ii)
Staff vaccination records shall be maintained
in each staff member's health record.]
(B)
Serologic screening of staff.]
(i)
New staff members shall be screened for hepatitis
B surface antigen (HBsAg) and the results reviewed prior to the staff providing
patient care, unless the new staff member provides the facility documentation
of positive serologic response to hepatitis B vaccine.]
(ii)
The facility shall establish, implement and
enforce a policy for repeated serologic screening of staff. The repeated serologic
screening shall be based on each staff member's HBsAg/antibody to HBsAg (anti-HBs),
and shall be congruent with Appendices i and ii of the National Surveillance
of Dialysis Associated Disease in the United States, 1993, published by the
United States Department of Health and Human Services (USDHHS). This document
when referenced in this section may be obtained by writing or calling the
USDHHS at the following address and telephone number: Public Health Service,
Centers for Disease Control and Prevention, National Center for Infectious
Diseases, Hospital Infection Program, Mail Stop C01, Atlanta, Georgia 30333,
404-639-2318.]
(iii)
] If an HBsAg-positive patient
is discharged, the equipment which had been reserved for that patient shall
be given intermediate level disinfection prior to use for a patient testing
negative for HBsAg.
(iv)
]
In the case of patients
[
A patient
] new to dialysis or
a patient
returning
to a facility after extended hospitalization or absence of 30 calendar days
or longer
, if these patients are
[
and who is
] admitted
for treatment before results of HBsAg or anti-HBs testing are known
,
these patients
shall undergo treatment as if the HBsAg test results
were potentially positive, except that
they
[
such a patient
] shall not be treated in the HBsAg isolation room, area, or machine.
If a central delivery system is used
by the facility, the
] facility shall treat potentially HBsAg-positive
patients
in a location in the treatment area which is outside of traffic
patterns
[
on the last machine on the loop
] and may not reuse
the dialyzer until the HBsAg test results are known.
Subchapter D. MINIMUM STANDARDS FOR PATIENT CARE AND TREATMENT
rate
]);
hematocrit level
];
(4)
] peritonitis rate; and
(5)
] hospitalization rate.
Health Care Financing Administration
]
and Centers for Disease Control to reduce or eliminate redundancy. The department
may request data to validate the aggregate information contained in the annual
report. All information gathered will be available to the department for review.
(13)
] provided protection from
abuse, neglect, or exploitation as those terms are defined in §1.204
of this title (relating to Abuse, Neglect, and Exploitation Defined);
(14)
] provided information regarding
advance directives and allowed to formulate such directives to the extent
permitted by law. This includes documents executed under the Natural Death
Act, Health and Safety Code, Chapter 672; Civil Practice and Remedies Code,
Chapter 135 concerning durable power of attorney for health care; and Health
and Safety Code, Chapter 674 concerning out-of-hospital do-not-resuscitate;
(15)
] aware of the mechanisms and
agencies to express a complaint against the facility without fear of reprisal
or denial of services. A facility shall provide to each individual who is
admitted to the facility a written statement that informs the individual that
a complaint against the facility may be directed to the department. The statement
shall be provided at the time of admission and shall advise the patient that
registration of complaints may be filed with the director, Health Facility
Licensing
and Compliance
Division, Texas Department of Health,
1100 West 49th Street, Austin, Texas 78756-3199,
1-888-973-0022
[
1-800-228-1570
]. Correctional institutions shall not be required to
include the 1-
888
[
800
] number in information provided
to patients in these facilities; and
(16)
] fully informed of the rights
listed in this subsection, the responsibilities established by the facility,
and all rules and regulations governing patient conduct and responsibilities.
A written copy of the patient's rights and responsibilities shall be provided
to each patient or the patient's legal representative upon admission and a
copy shall be posted with the facility license certificate.
shared
] with the patient
or the patient's legal representative
by a member of the interdisciplinary
team
.
in an area which includes a work counter and a sink. This
] area shall
be located in such a manner as to prevent contamination of medicines being
prepared for administration
and shall include a work counter and a sink.
(7)
] Medications not given immediately
shall be labeled with the patient's name, the name of the medication, the
dosage prepared, and the initials of the person preparing the medication.
All medications shall be administered by the individual who prepares them.
(8)
] All medications shall be administered
by licensed nurses, physician assistants, or physicians except that intravenous
normal saline, intravenous heparin, [
and
] subcutaneous lidocaine
, and oxygen
may be administered as part of a routine hemodialysis treatment
by dialysis technicians qualified according to §117.62(b) and (f) of
this title (relating to Training Curricula and Instructors) and §117.63(b),
(c) and (e) of this title (relating to Competency Evaluation). Such administration
by dialysis technicians shall be in compliance with the Medical Practice Act,
Texas Civil Statutes, Article 4495b, §3.06(d), concerning the delegation
of medical acts by a licensed physician in the State of Texas.
nurse
] functioning in the
charge role required by paragraph (4) of this subsection.
younger than 14 years of age or
] smaller than 35 kilograms in weight.
nurse functioning
] in the charge
role shall not be included in this ratio.
evaluate
]
each patient before and after treatment according to facility policy and the
staff member's level of training.
Written protocols may identify parameters
which would require a patient be referred to a nurse for evaluation.
A
registered nurse shall conduct a patient assessment when indicated by a question
relating to a change in the patient's status or at the patient's request.
functioning
] in
the charge role or a registered nurse at the time of the first treatment in
the facility and completed by a registered nurse within the first three treatments.
150
] patients.
the applicable dialysis
modality (hemodialysis or peritoneal dialysis)
] shall be responsible
for training the patient or family. When other personnel assist in the training,
supervision by the registered nurse shall be demonstrated.
and
]
.
]
(i)
surveillance of the patient's
home adaptation, including provisions for visits to the home;]
(ii)
] consultation for the patient
with a registered nurse, social worker and a dietitian;
(iii)
] a record keeping system
which assures continuity of care;
(iv)
] installation and maintenance
of equipment;
(v)
] testing and appropriate treating
of the water used for dialysis; and
(vi)
] ordering of supplies on an
ongoing basis.
(i)
surveillance of the patient's
home adaptation, including provisions for visits to the home;]
(ii)
] consultation for the patient
with a registered nurse, a social worker and a dietitian;
(iii)
] a record keeping system
which assures continuity of care;
(iv)
] installation and maintenance
of equipment; and
(v)
] ordering of supplies on an
ongoing basis.
(3)
] A facility shall provide registered
nurses with no previous dialysis experience an orientation program of a minimum
of six weeks. For these registered nurses, the six-week orientation program
shall contain at least the following subject content specific to the management
of the end stage renal disease patient and appropriate to the population served
by the facility:
(4)
] Each licensed nurse and dialysis
technician shall demonstrate competency through written and skills testing
annually. Evidence of competency shall be documented in writing and maintained
in personnel files.
Current certification by a nationally recognized
board may substitute for the annual written test.
(5)
] A facility shall maintain documentation
to demonstrate that each staff member providing patient care completes at
least five hours of continuing education related to end stage renal disease
annually. Continuing education may be provided by facility staff.
in dialysis
] and
six months
experience in
home dialysis
[
the applicable dialysis modality
] shall be responsible for training
the patient or family. When other personnel assist in the training, supervision
by the registered nurse shall be demonstrated.
staff
]. Only individuals qualified by training, education,
or experience may operate, repair, or replace components of the systems utilized
in providing dialysis treatment or reprocessing dialyzers.
The technical staff trainee(s)
] shall pass
a written competency examination, demonstrate skills related to the required
level of responsibility and be certified by the
facility's
medical
director as competent to perform their
assigned
duties.
Current
certification by a national board in dialysis technology may substitute for
written testing.
Water treatment system staff
].
system
] shall demonstrate understanding
of the risks to patients of exposure to water which has not been treated so
as to remove contaminants and impurities. Documentation of training to assure
safe operation of the water treatment
and dialysate systems
[
system
] shall be maintained for each individual who operates (regularly
or intermittently)
these systems
[
the system
].
system
] shall meet the education, training,
and experience requirements described in paragraph (1) of this subsection
and shall demonstrate competency by:
system
] technician trainee prior to
the trainee's initial assumption of responsibility.
patient's
] medical
history and physical shall be completed 30 days before or within two weeks
after
any patient's
admission to the facility.
For a patient
new to dialysis, the physician(s) responsible for the dialysis care shall
complete the history and physical. For an established dialysis patient, the
history and physical may be completed by a nurse practitioner or physician
assistant.
Prior to the first treatment in the facility, the physician
shall inform the nurse functioning in the charge role of at least the patient's
diagnoses, medications, hepatitis status, allergies, and dialysis prescription.
The clinical record shall include this data.
and shall not be removed from the premises except by subpoena or court order,
or for protection in disaster situations, except as described in subsection
(a)(6) of this section.
]
Original records
] shall
be retained by a facility for a minimum of five years after the discharge
of the patient
and in accordance with state and Federal regulations
.
The facility may not destroy clinical records that relate to any matter that
is involved in litigation if the facility knows the litigation has not been
finally resolved.
Subchapter E. DIALYSIS TECHNICIANS
the
] training program and under the immediate supervision of a registered
nurse or an assigned preceptor. A preceptor shall be a licensed nurse or dialysis
technician who has one year of experience in hemodialysis obtained within
the last 24 months, a recommendation by the supervising nurse to be a preceptor
and a current competency skills checklist on file in the facility.
Hemodialysis Systems, March 1992
]
Edition, published by the American Association for the Advancement of Medical
Instrumentation (AAMI),
1110 North Glebe Road, Suite 220,
[
3330 Washington Boulevard, Suite 400,
] Arlington, Virginia 22201;
Current
] certification as a dialysis technician
by a nationally recognized testing organization may be substituted for the
written examination.
or
]
.
]
chief technician
], and administrator. This committee
shall review the training records of each trainee, including tests and skills
checklists, hear comments from the training instructor(s) and preceptor(s),
and validate that the trainee has successfully completed the training program.
or
] administer normal saline, heparin,
[
or
] lidocaine
or oxygen,
the medical director shall
verify and document competency of the dialysis technician to perform these
tasks and delegate authority to the technician in accordance with the Medical
Practice Act, Article 4495b, §3.06(d).
The competency evaluation documentation may only
be accepted for a period of six months after the date of completion. After
that date, a competency skills checklist shall be recompleted in accordance
with §117.63(c), (d), and (e) of this title (relating to Competency Evaluation).
]
or
] lidocaine
, or oxygen
, which
may only be administered in the course of a routine dialysis treatment;
or
]
under 14 years of age or
] under 35 kilograms
;
[
or .
]
Subchapter F. CORRECTIVE ACTION PLAN AND ENFORCEMENT
select
]
the monitor for a corrective action plan. The monitor shall be an individual
or team of individuals and may include a professional with end stage renal
disease experience or a member of the MRB.
the
] individuals served
by the facility granted by law.
Texas Department of Health (department)
] may request the
attorney general to bring an action in the name and on behalf of the state
for the appointment of a temporary manager to manage a facility if:
Texas Department of Health
(department)
] may deny, suspend, or revoke a license if the applicant
or facility:
Texas Department of Health (department)
] may
assess an administrative penalty against a person who violates the statute
or this chapter.
Texas Department of Health
(department)
] may assess reasonable expenses and costs against a person
in a administrative hearing if, as a result of the hearing, the person's license
is denied, suspended, or revoked or if administrative penalties are assessed
against the person.
Chapter 221.
MEAT SAFETY ASSURANCE
A sufficient number of inedible
barrels must be available during each harvest.
]
When containers
are used to remove inedibles from the premises, such containers
[
Barrels
] shall be marked "INEDIBLE" in letters at least two inches high.
An adequate amount of denaturant
in accordance with 9 CFR §314.3
will be used on all products placed in the "INEDIBLE"
containers
[
barrels
].
the
] assigned inspector
will
examine and inspect
[
perform ante-mortem inspection of
the live animals
]
each animal
prior to
its entry into
the processing facility
[
slaughter
] to assure that the animals
being harvested appear
to have been
healthy
and were killed
by the harvester
. [
Once an animal has been shot, the animal will
be bled as soon as possible in the field with a properly sanitized knife.
]
the inspector shall designate
] the
time that
may lapse
[
number of animals that may be slaughtered
] before
it is necessary to return to the mobile slaughter unit or processing facility
for skinning and eviscerating. [
The time lapse will depend on several
factors such as environmental temperature and the anatomical site of bullet
entry.
] High environmental temperature may shorten the time lapse prior
to dressing, as dressing must begin before [
the abdomen of
] the
carcass becomes distended due to [
intestinal
] gas formation
in the interstitial tissues or in the small intestine
. The TDH inspector
has the final decision in determining the actual time allowed between bleeding
and skinning; however, a two and one half hour time lapse shall not be exceeded.
Chapter 289.
RADIATION CONTROL
Texas Natural Resource Conservation Commission
], the Railroad Commission,
and other state
entities
[
agencies
] in the area of state
radiation policies and programs.
Texas Natural Resource Conservation Commission
],
the Railroad Commission of Texas, and other state
entities
[
agencies
]; and
2003
], the Texas Board of Health will initiate and complete a review
of the board to determine whether a recommendation should be made to appropriate
government officials to continue the board, consolidate the board with another
advisory board or committee, or abolish the board.
As of September 1, 1999, the governor shall designate the chairman to serve
at the will of the governor.
]
and subcommittee
] meetings
during a calendar year
without an excuse approved by a majority vote
of the advisory board.
[
, or is absent from at least three consecutive
board meetings.
]
Chapter 295.
OCCUPATIONAL HEALTH
These sections shall take effect September 1, 1999.
]
(6)
] Container - Any bag, barrel,
bottle, box, can, cylinder, drum, reaction vessel, storage tank, or the like
that contains a hazardous chemical or contains multiple smaller containers
of an identical hazardous chemical. The term "container" does not mean pipes
or piping systems, nor does it mean engines, fuel tanks, or other operating
systems in a vehicle. A primary container is the one in which the hazardous
chemical is received from the supplier. A secondary container is one to which
the hazardous chemical is transferred after receipt from the supplier.
(7)
] Department - The Texas Department
of Health.
(8)
Director - The Commissioner
of Health.]
actual
] instruction of employees and records of training,
as opposed to a written plan for training.
, §502.003(11)
].
,which includes the
same name as on the material safety data sheet
].
Process
Container
] - A tank, vat, or other such container which holds different
hazardous chemicals at different times.
director's
] responsibilities
under the Act are carried out through the Texas Department of Health,
Product Safety
[
Toxic Substances Control
] Division, Hazard
Communication Branch. Routine inquiries regarding this Act shall be addressed
to: Texas Department of Health,
Product Safety
[
Toxic Substances
Control
] Division, Hazard Communication Branch, 1100 West 49th Street,
Austin, Texas 78756
, at toll free telephone number 1-800-452-2791
.
The
department shall make available a
] model form [
to assist employers
] in developing workplace chemical lists. This form will provide a recommended
format for the workplace chemical list, but is not mandatory.
seven
]
business days of receipt of the employer's written request.
director
] or his
representative shall investigate in a timely manner any complaint relating
to an alleged violation of the Act. Such complaints do not have to be submitted
to the department in writing and may be anonymous. An inspection based on
a complaint is not limited to the specific allegations of the complaint. An
employer who refuses to allow such an investigation shall be in violation
of the Act.
director
] or his
designated representatives may enter a workplace at all reasonable times to
conduct random compliance inspections. An employer who refuses to allow such
an inspection
is
[
shall be
] in violation of the Act
and these rules
.
director
], an employer shall make or allow photocopies
of documents to be made and permit the representative to take photographs
required to verify the compliance status of the employer. Such requests may
be made during a compliance inspection or in a written Notice of Violation
issued by the department.
Toxic Substances Control
]
Division, Hazard Communication Branch, at toll free telephone number 1-800-452-2791.
Reports shall be submitted either orally or in writing no later than 48 hours
after the occurrence of the accident. Written reports may be transmitted via
facsimile or electronic means.
director
] or his representative to determine if an employer is in violation
of the Act or the rules [
adopted by the board to enforce the Act
].
An employer will be notified in writing of any alleged violations.
The
employer shall send
[
When an employer receives written notification
alleging violations of the Act,
] a written response [
shall be sent
by the employer
] to the department within 15 business days of receipt
of the notification. The employer's response must conform to
at least
one of the options listed in the notification from the department
[
one or more of the options provided in the Act, §§502.014(d), (e)
and/or (f)
].
director
]. An order may be issued on or after
the 16th business day following the date that a written notification of violations
is received by the employer, unless the department receives a written response
which documents that each violation has been corrected or that an informal
conference or a formal hearing has been requested. If an informal settlement
conference is requested, the employer must respond
that each violation
has been corrected
within 11 business days after the employer receives
a summary letter
following
[
about
] the informal conference.
seven
] business
days of receipt of the employer's written request; or
director] as needed.
may be made
] available
from
[
by
] the department.