Part 1.
DEPARTMENT OF STATE HEALTH SERVICES
Chapter 31.
NUTRITION SERVICES
The Executive Commissioner of the Health and Human Services Commission
(commission) on behalf of the Department of State Health Services (department),
adopts amendments to §§31.11, 31.12, 31.22, 31.23, 31.25 - 31.31,
31.33, 31.37 and the repeal of §31.24, concerning the Farmers' Market
Nutrition Program (FMNP) and the Special Supplemental Nutrition Program for
Women, Infants, and Children (WIC). The amendments to §§31.31 and
31.37 are adopted with changes to the proposed text as published in the December
9, 2005, issue of the
Texas Register
(30 TexReg
8273). Sections 31.11, 31.12, 31.22, 31.23, 31.25 - 31.30, and 31.33 and the
repeal of §31.24 are adopted without changes and, therefore, the sections
will not be republished. Proposed amendments to §§31.21, 31.32,
and 31.34 - 31.36 were published in the same issue, but are being withdrawn
and will not be adopted.
BACKGROUND AND PURPOSE
Under federal and state enabling legislation, the WIC Program is funded
entirely by a combination of federal grant funds and by rebates from manufacturers
of infant formula and infant cereal that can only be expended to defray WIC
food costs. The FMNP is funded by a federal grant and a 30% state match for
the administrative portion of the federal grant. The United States Department
of Agriculture (USDA) awards federal grant funds to the department to administer
the programs, provided the department does so in accordance with federal law
and regulations and in accordance with the department's annual submission
of a state plan approved by USDA. The department issues rules governing the
two programs in accordance with the state plan.
The amendments also comply with Agriculture Code, Chapter 15, which requires
the department to adopt rules necessary for carrying out the requirements
of Chapter 15 concerning the FMNP. Numerous sections of the proposed rules
were revised to clarify, delete provisions that only restate federal regulations,
establish consistency in existing language, and reflect changes in department
structure and related terminology.
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 31.11
- 31.12 relating to FMNP and §§31.22, 31.23, 31.25 - 31.31, 31.33,
and 31.37 relating to WIC have been reviewed, and the department has determined
that reasons for adopting the sections continue to exist, in that rules on
these subjects are needed. However, the rules require revision as described
in this preamble. Section 31.24 has been reviewed, and the department has
determined that reasons for adopting the section no longer continue to exist.
SECTION-BY-SECTION SUMMARY
Amendments to §§31.11 - 31.12 delete and replace references to
the legacy agency name with references to the Department of State Health Services;
add definitions; and clarify the proper procedures for delivery of benefit
coupons to recipients and redemption of the coupons by sellers of the produce
for the FMNP. Amendments to §§31.22 - 31.23, 31.25 - 31.31, and
31.33 also update references to the agency name as well as the Office of Inspector
General, Health and Human Services Commission; eliminate duplicated federal
regulations governing the WIC Program; clarify client certification and enrollment
requirements; delete restrictions regarding delivery of food benefits to a
proxy designated by the recipient of WIC services; eliminate provisions concerning
internal administrative procedures; and eliminate procedures that affect only
those persons who choose to contract with the department and that do not affect
the general public. Amendments to §31.37 clarify the food benefits issued
to WIC recipients.
Section 31.24, regarding provision of immunizations to WIC applicants and
recipients, is being repealed because the section duplicates the provisions
of contracts between the department and WIC local service delivery providers.
COMMENTS
The department, on behalf of the commission, has reviewed and prepared
responses to the comments received regarding the proposed rules during the
comment period, which the commission has reviewed and accepts. The commenters
were USDA staff, program staff, individuals, associations, and/or corporations,
including the Gulf Coast Retailers Association and Wal-Mart Stores, Inc. The
commenters were not against the rules in their entirety; however, the commenters
suggested recommendations for change as discussed in the summary of comments.
Comment: Concerning §31.31(c), the commenter suggested that the word
"Services" should be changed to "Service."
Response: The commission agrees, and this spelling error has been corrected
in response to the comment.
Comment: Concerning the deletion of the components of "income" at §31.22(a)(3)(C)
and inclusion of only a reference to the federal regulations defining "income"
at 7 CFR §246.7, the commenter stated on behalf of the Food and Nutrition
Service, USDA, that the department must also ensure that the definition of
"income," including exclusions from income, is issued by policy to local service
delivery providers.
Response: The commission agrees and notes that current WIC Policy CS: 09.0,
Definition of Income, issued to service delivery providers, includes the provisions
of the federal regulations. No changes to the rule were made in response to
this comment.
Comment: Concerning §31.33, the commenter opposed deletion of the
detailed criteria applicable to the department's consideration of a retail
vendor's application for reauthorization if deletion of the criteria from
the rule means stakeholders will have no opportunity to comment on changes
to the criteria.
Response: Deletion of the reauthorization criteria from the rule will not
mean that stakeholders cannot comment on changes, because the criteria will
continue to be enforced by policy. The commission agrees that stakeholders
should have the opportunity to comment on any proposed changes in policies
concerning WIC vendor reauthorization criteria, to the extent possible. No
changes to the rule were made as a result of this comment.
The department staff on behalf of the commission provided comments, and
the commission has reviewed and agrees to the following changes.
Change: Concerning §§31.21, 31.32, and 31.34 - 31.36, even if
amended as proposed, the sections are likely to be inconsistent with polices
and clarifications yet to be issued by USDA concerning the Interim Rule on
WIC vendor cost containment published in the
Federal
Register
on November 29, 2005. The proposed amendments concerning management
of retail vendors authorized to participate in the WIC Program have been withdrawn
until final USDA directives are received.
Change: Concerning §31.37(l)(1)(B), the restriction concerning evaporated
milk as an allowable WIC food item was eliminated to accommodate children
who need an evaporated milk substitute due to an allergy to cow's and/or soy
milk, and who can tolerate goat's milk.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Cathy Campbell,
certifies that the rules, as adopted, have been reviewed by legal counsel
and found to be a valid exercise of the agencies' legal authority.
Subchapter B. FARMERS' MARKET NUTRITION PROGRAM
25 TAC §31.11, §31.12
STATUTORY AUTHORITY
The amendments are authorized under Agriculture Code, §15.005, which
authorizes the executive commissioner of the Health and Human Services Commission
to adopt rules necessary for carrying out the requirements of Chapter 15 concerning
the Farmers' Market Nutrition Program. Government Code, §531.0055(e),
and Health and Safety Code, §1001.075, also authorize the executive commissioner
of the Health and Human Services Commission to adopt rules and policies necessary
for the operation and provision of health and human services by the department
and for the administration of Chapter 1001, Health and Safety Code.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on May 15, 2006.
TRD-200602682
Cathy Campbell
General Counsel
Department of State Health Services
Effective date: June 4, 2006
Proposal publication date: December 9, 2005
For further information, please call: (512) 458-7111 x6972
25 TAC §§31.22, 31.23, 31.25 - 31.31, 31.33, 31.37
STATUTORY AUTHORITY
The amendments are authorized under Agriculture Code, §15.005, which
authorizes the executive commissioner of the Health and Human Services Commission
to adopt rules necessary for carrying out the requirements of Chapter 15 concerning
the Farmers' Market Nutrition Program. Government Code, §531.0055(e),
and Health and Safety Code, §1001.075, also authorize the executive commissioner
of the Health and Human Services Commission to adopt rules and policies necessary
for the operation and provision of health and human services by the department
and for the administration of Chapter 1001, Health and Safety Code.
§31.31.Selection of a Local Agency as a WIC Provider.
(a)
Selection of a local agency to provide WIC Program services
will be based on the local agency priority system as follows:
(1)
A public or private nonprofit health agency which can provide
ongoing routine pediatric and obstetric care or administrative services shall
receive first priority consideration.
(2)
A public or private nonprofit health or human service agency
which will enter into a written agreement with another agency for either ongoing
pediatric and obstetric care or administrative services shall receive second
priority consideration.
(3)
A public or private nonprofit health agency which will
enter into a written agreement with private physicians licensed by the state
to provide ongoing pediatric and obstetric care to a specific category of
participants (women, infants, or children) shall receive third priority consideration.
(4)
A public or private nonprofit human service agency which
will enter into a written agreement with private physicians licensed by the
state to provide ongoing routine pediatric and obstetric care shall receive
fourth priority consideration.
(5)
A public or private nonprofit human service agency which
will provide ongoing routine pediatric and obstetric care through referral
to a health provider shall receive fifth priority consideration.
(6)
No WIC Program funds shall be expended to reimburse private
physicians for the health services performed.
(b)
The state agency shall establish an affirmative action
plan each year to rank order each county's relative need for WIC Program services
based on the total number of potentially eligible persons in each county.
(c)
All WIC Program initiation and expansion shall be executed
utilizing a request for proposal (RFP) in accordance with state agency policy,
state law, USDA Food and Nutrition Service Instruction 802-1, and the state
agency's approved affirmative action plan under one of the following conditions:
(1)
the state agency determines it is in the best interests
of the state to initiate an open competitive statewide RFP;
(2)
an existing WIC Program local agency is either disqualified
as a provider of WIC Program services or does not wish to continue as a local
agency;
(3)
a state agency health services region wishes to transfer
direct WIC Program services to a local agency; or
(4)
a prospective agency satisfactorily documents to the state
agency that a specific geographical area is underserved and the current WIC
local agency providing services in that area is unable to provide services
to that geographical area and declines to develop a collaborative effort to
deliver services to meet the documented unmet need.
(d)
The state agency shall evaluate proposals to serve as a
WIC Program local agency submitted in response to an RFP.
(e)
The state agency shall advise respondent agencies of the
status of their applications to provide WIC Program services in accordance
with the schedule of events in the public notice and the RFP.
(f)
In the event of an emergency or unexpected interruption
of WIC Program services, the state agency WIC Director may waive any or all
parts of the application process if necessary to ensure uninterrupted delivery
of WIC services in a geographic area or areas.
§31.37.Selection of Allowable WIC Program Supplemental Foods.
(a)
Criteria for approving products for inclusion in the WIC
Program food package are based on federal regulations, packaging, cost, cultural
acceptability, and nutritive value.
(b)
A product shall meet the federal regulations governing
the WIC Program food package in order to be considered for approval through
the WIC Program.
(c)
The state agency may restrict the number of brands and
types of any products in order to contain the cost of the food package and
minimize the confusion for WIC participants. The state agency is not obligated
to authorize every available food that meets the federal requirements.
(d)
The state agency shall review the WIC Program list of allowable
foods annually to determine the need for adding or deleting food products.
(1)
If the state agency determines that the list of allowable
cereals or juices should be changed, the state agency shall notify both juice
and cereal manufacturers of that intent through a request for information
(RFI).
(2)
Juice and cereal manufacturers may contact the WIC Program
at any time during the year to request that their names and addresses be added
to the mailing list for an RFI.
(3)
Manufacturers of juice and cereal shall certify through
their RFI response that their products meet the requirements for nutritional
content as specified in federal regulations governing the program.
(e)
The state agency may restrict the size of packages and
types of containers of any products for any food type including limiting package
size and container type within brands of products in order to contain the
cost of the food package and minimize the confusion for WIC participant.
(f)
A product for any food type shall be available for retail
purchase in Texas on or before the effective date of the approved food list
or it will not be considered by the state agency for authorization.
(g)
The product form and marketing approach for any product
for any food type shall be consistent with the promotion of good nutrition
and education.
(h)
The state agency reserves the right to solicit rebates
for any eligible foods from manufacturers through a competitive bid process.
(i)
The state agency reserves the right to determine the numbers
and types of foods within a food type to be authorized.
(j)
In determining the number of brands and types of any products
to be approved, the state agency may consider consumer, cultural, and/or ethnic
acceptability, and suitability for children.
(k)
Products having similar names and package designs shall
not be approved if the similarity in name and/or packaging would cause substantial
confusion for vendors and/or participants.
(l)
Additional criteria for each food type are as follows:
(1)
Milk. Milk shall be:
(A)
unflavored, fresh, whole, reduced fat, low-fat or fat-free
(nonfat or skim) milk including cultured buttermilk fortified with vitamins
A and D to meet the federal standards;
(B)
whole, low-fat, or fat-free (nonfat) evaporated milk fortified
with vitamins A and D to meet the federal standards; and/or
(C)
nonfat, dry, powdered milk fortified with vitamins A and
D to meet the federal standards.
(2)
Cheese. Cheese shall be unflavored and pasteurized.
(3)
Cereals.
(A)
Cereal shall contain a minimum of 28 milligrams of iron
per 100 grams of dry cereal, and not more than 21.2 grams of sucrose and other
sugars per 100 grams of dry cereal (6 grams per ounce).
(B)
The state agency reserves the right to determine the number
and brands of cereals, which shall include at least one hot cereal and at
least one corn, wheat, oat, rice, and multi-grain cereal.
(4)
Juice.
(A)
Juices shall be single-strength fluid fruit or vegetable
juices containing a minimum of 30 milligrams of vitamin C per 100 milliliters
and/or concentrated fruit or vegetable juices containing a minimum of 30 milligrams
of vitamin C per 100 milliliters of reconstituted juice.
(B)
Juices shall be 100% juice and shall contain no added sugar,
or other natural or artificial sweeteners.
(C)
Juices packaged in a variety of containers, even though
made by the same manufacturer, shall be evaluated separately.
(5)
Eggs. Eggs shall be fresh grade A or grade AA large, medium,
or small.
(6)
Beans/Peas/Lentils. Beans, peas, and lentils shall be dry
with the exception of canned beans/peas/lentils which may be authorized only
for the homeless food package.
(7)
Peanut Butter. Peanut butter shall contain no other ingredients
such as jelly or candy pieces.
(8)
Tuna. Tuna shall be packed in water.
(9)
Carrots. Carrots shall be bagged, fresh, large carrots
without tops and/or canned, sliced carrots.
(10)
Infant formula. Infant formulas shall be registered with
the United States Food and Drug Administration as complying with the legal
definition of infant formula.
(11)
Infant cereal. Infant cereal shall contain a minimum of
45 milligrams of iron per 100 grams of dry cereal in dehydrated flake form.
This agency hereby certifies that the adoption has been
reviewed by legal counsel and found to be a valid exercise of the agency's
legal authority.
Filed
with the Office of the Secretary of State on May 15, 2006.
TRD-200602683
Cathy Campbell
General Counsel
Department of State Health Services
Effective date: June 4, 2006
Proposal publication date: December 9, 2005
For further information, please call: (512) 458-7111 x6972
25 TAC §31.24
STATUTORY AUTHORITY
The repeal is authorized under Agriculture Code, §15.005, which authorizes
the executive commissioner of the Health and Human Services Commission to
adopt rules necessary for carrying out the requirements of Chapter 15 concerning
the Farmers' Market Nutrition Program. Government Code, §531.0055(e),
and Health and Safety Code, §1001.075, also authorize the executive commissioner
of the Health and Human Services Commission to adopt rules and policies necessary
for the operation and provision of health and human services by the department
and for the administration of Chapter 1001, Health and Safety Code.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed
with the Office of the Secretary of State on May 15, 2006.
TRD-200602685
Cathy Campbell
General Counsel
Department of State Health Services
Effective date: June 4, 2006
Proposal publication date: December 9, 2005
For further information, please call: (512) 458-7111 x6972
Subchapter F. PRODUCTION, PROCESSING, AND DISTRIBUTION OF BOTTLED AND VENDED DRINKING WATER
25 TAC §§229.81 - 229.91
The Executive Commissioner of the Health and Human Services
Commission, on behalf of the Department of State Health Services (department),
adopts amendments to §§229.81 - 229.91, concerning the production,
processing, and distribution of bottled and vended drinking water without
changes to the proposed text as published in the February 3, 2006, issue of
the
Texas Register
(31 TexReg 647), and the
sections will not be republished.
BACKGROUND AND PURPOSE
The amendments are necessary to update vended water sampling requirements
and increase the examination fee to cover the cost of administering the Bottled
and Vended Water Certified Operator examination to applicants who do not make
a passing score, and apply to retake the exam.
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 229.81
- 229.91 have been reviewed and the department has determined the reasons
for adopting the sections continue to exist because rules are required by
the enabling statute, the department continues to regulate this activity,
and persons engaged in the activity are required to comply with the rules.
SECTION-BY-SECTION SUMMARY
An amendment to §229.81 reflects the department name change to "Department
of State Health Services". Amendments to §§229.82, 229.84, 229.87,
229.88, and 229.91 include grammatical corrections to improve sentence structure.
An amendment to §229.83 updates language for consistency within the sections
concerning water-hauling records. An amendment to §229.85 updates examples
for labeling and advertising. An amendment to §229.86 changes the sampling
frequency from monthly to once every 90-calendar days; revises the name of
the unit, phone number, and e-mail address; and deletes the requirement to
report coliform negative samples to the department. An amendment to §229.89
increases the reexamination fee from $25 to $50. An amendment to §229.90
deletes language relating to a three-year license prior to January 1, 2005,
because the department no longer issues three-year licenses, and updates the
department name change.
COMMENTS
The department, on behalf of the commission, did not receive any comments
regarding the proposed rules during the comment period.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Cathy Campbell,
certifies that the rules, as adopted, have been reviewed by legal counsel
and found to be a valid exercise of the agencies' legal authority.
STATUTORY AUTHORITY
The adopted amendments are authorized under the Health and Safety Code, §§431.241
and 441.003, which provide the department with the authority to adopt necessary
regulations pursuant to the enforcement of Chapters 431 and 441; and §12.0111,
which requires the department to charge fees for issuing or renewing licenses;
and Government Code, §531.0055, and Health and Safety Code, §1001.075,
which authorize the Executive Commissioner of the Health and Human Services
Commission to adopt rules and policies necessary for the operation and provision
of health and human services by the department and for the administration
of Health and Safety Code, Chapter 1001.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on May 15, 2006.
TRD-200602681
Cathy Campbell
General Counsel
Department of State Health Services
Effective date: June 4, 2006
Proposal publication date: February 3, 2006
For further information, please call: (512) 458-7111, x6972
25 TAC §§229.111 - 229.115
The Executive Commissioner of the Health and Human Services
Commission, on behalf of the Department of State Health Services (department),
adopts amendments to §§229.111 - 229.115, concerning the manufacture,
storage and distribution of ice sold for human consumption, including ice
produced at point of use without changes to the proposed text as published
in the February 3, 2006, issue of the
Texas Register
(31 TexReg 650), and the sections will not be republished.
BACKGROUND AND PURPOSE
The amendments revise ice manufacturing, storage and distribution requirements;
change the name of the department; and update regulatory references that have
been changed.
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 229.111
- 229.115 have been reviewed and the department has determined the reasons
for adopting the sections continue to exist because rules are required by
the enabling statute, the department continues to regulate this activity,
and persons engaged in the activity are required to comply with the rules.
SECTION-BY-SECTION SUMMARY
Amendments to §§229.111, 229.114, and 229.115 reflect grammatical
revisions to improve sentence structure. An amendment to §229.112 includes
grammatical revisions and provides the department's name change to the Department
of State Health Services. An amendment to §229.113 updates the reference
to the Texas Natural Resource Conservation Commission with the name change
to the Texas Commission on Environmental Quality.
COMMENTS
The department, on behalf of the Health and Human Services Commission,
did not receive any comments regarding the proposed rules during the comment
period.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Cathy Campbell,
certifies that the rules, as adopted, have been reviewed by legal counsel
and found to be a valid exercise of the agencies' legal authority.
STATUTORY AUTHORITY
The adopted amendments are authorized by the Health and Safety Code, §431.241,
which provides the department with the authority to adopt necessary regulations
pursuant to the enforcement of Chapter 431; and Government Code, §531.0055,
and Health and Safety Code, §1001.075, which authorize the Executive
Commissioner of the Health and Human Services Commission to adopt rules and
policies necessary for the operation and provision of health and human services
by the department, and for the administration of Health and Safety Code, Chapter
1001.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on May 15, 2006.
TRD-200602686
Cathy Campbell
General Counsel
Department of State Health Services
Effective date: June 4, 2006
Proposal publication date: February 3, 2006
For further information, please call: (512) 458-7111 x6972
The Executive Commissioner of the Health and Human Services Commission
(commission), on behalf of the Department of State Health Services (department),
adopts amendments to §§448.603, 448.701 and 448.706 concerning the
regulation of training, client bill of rights, and restraint and seclusion
in chemical dependency treatment facilities. The amendments to §§448.603
and 448.706 are adopted with changes to the proposed text as published in
the March 31, 2006, issue of the
Texas Register
(31
TexReg 2823). Section 448.701 is adopted without changes and, therefore, will
not be republished.
BACKGROUND AND PURPOSE
The rules amendments are necessary to implement legislation by the 79th
Legislature, Regular Session, 2005. Specifically, amendments to the Health
and Safety Code added Chapter 322 (Senate Bill (SB) 325), and, in particular,
Subchapter B, relating to the restraint and seclusion of residents in certain
health care facilities. These rules amendments implement statutory requirements
relating to chemical dependency treatment facilities, and are required by
SB 325 to be adopted by no later than June 1, 2006.
SECTION-BY-SECTION SUMMARY
Amendments to §448.603(d)(5) add requirements to the restraint and/or
seclusion training program. Amendments to §448.701(a) clarify the responsibility
of treatment facilities to implement and enforce client rights, and add to
the rights for which the facility is responsible the right of the client and
the client's legally authorized representative to be notified of the rules
and policies related to restraints and seclusion. Amendments to §448.706
add to existing regulation of restraint and seclusion a definition of small
residential facilities not subject to the new requirement for an observer
when a prone or supine hold is used and define practices to promote the safe,
limited, and appropriate use of restraint and seclusion in chemical dependency
treatment facilities. Amendments were added specifically governing the use
of a prone or supine hold; adding restrictions and safeguards relating to
interventions and restraints to reduce their frequency and minimize the risk
of harm; and requiring certain actions after an episode of restraint or seclusion
to help reduce the frequency and increase the safety of any future use of
restraint or seclusion. In addition, to avoid conflict with Health and Safety
Code, §322.052(c), language requiring the authorization of personal restraint
in certain facilities was removed from the rule. While removing the specific
requirement that personal restraint be authorized, the amendment should not
be read to prevent or discourage those facilities from retaining authorization
for the use of personal restraint, if it could be necessary in certain circumstances
to protect the safety of clients or others when less restrictive alternatives
have been exhausted, and thus to fulfill the facility's duty to maintain a
safe environment at all times and under all circumstances.
COMMENTS
The department, on behalf of the commission, has reviewed and prepared
responses to oral and written comments received during the comment period
regarding the proposed rules amendments, which the commission has reviewed
and accepts. The commenters were Phoenix Houses of Texas, Inc., Advocacy,
Inc., and Crisis Prevention Institute. The commenters were not against the
rules amendments in their entirety; however, the commenters made recommendations
for changes as discussed in the summary of comments.
Comment: Concerning §448.603(d)(5), Phoenix Houses of Texas, Inc.,
commented that few chemical dependency treatment facilities authorize the
use of mechanical restraint or seclusion and suggested that, if a training
requirement wholly relates to a type of restraint or seclusion which is not
authorized by the facility, that training requirement need not be included
in the facility's training program.
Response: The commission agrees with the commenter's suggestion. Section
448.603(d)(5) requires the listed training only where restraint or seclusion
is used or authorized by the facility, but, in §448.603(d)(5)(D)(v)-(x),
(xii) and (xiii), where the requirements are specific to restraint, seclusion,
or a particular type of restraint (personal or mechanical), clarifying language
has been added to require the training only if that type of restraint or seclusion
is used or authorized by the facility. Specifically, in §448.603(d)(5)(D)(v),
(vi), (x), (xii), and (xiii), the phrase "if the facility uses or authorizes
the use of restraint" has been added after references to "restraint" or "being
restrained"; in §448.603(d)(5)(D)(viii), the phrase "if the facility
uses or authorizes the use of personal restraint" has been added after a reference
to "personal restraint"; in §448.603(d)(5)(D)(vii), (x), (xii) and (xiii),
the phrase "if the facility uses or authorizes the use of seclusion" has been
added after references to "seclusion"; and, in §448.603(d)(5)(D)(ix),
the phrase "if the facility has on premises, authorizes the use of, or uses
any mechanical restraint devices" has been added after a reference to "restraint
devices."
Comment: Concerning §448.603(d)(5), Crisis Prevention Institute (CPI),
Inc., of Brookfield, WI. commented that CPI encourages competency-based testing
as a component of training and advocates for re-testing every six to twelve
months.
Response: The commission does not agree that testing and re-testing should
be mandated. Section 448.603(d)(5) is consistent with Interventions in Mental
Health Programs, §415.257, Subchapter F, Staff Training, that requires
staff demonstrate competency before assuming job duties and the commission
does not believe that it must reach the level of testing and re-testing if
the staff are trained and can demonstrate competency as required. No changes
were made based on this comment.
Comment: Concerning §448.603(d)(5)(D)(vi), Crisis Prevention Institute
(CPI), of Brookfield, WI. suggests including the "risks of ALL restraints"
since positional, compression, and restraint asphyxia may occur in positions
other than prone or supine. CPI also suggests adding education on all risks
of restraints: physical/physiological, psychological/emotional, and social
risks.
Response: The commission disagrees with the commenter. The rule does not
prohibit staff training that exceeds the minimum requirements. When a facility
identifies risks associated with their client population the facility must
include those risks into the staff-training program. No changes were made
based on this comment.
Comment: Concerning §448.701, Advocacy, Inc., commented that the patient
bill of rights notifies the client of the right to be told of the program's
rules and regulations but the rule does not state that they will be told.
The commenter understands that there are separate enforcement provisions of
this right in the rules, in §448.701(a), which provides that the facility
shall respect, protect, implement, and enforce each client right required
to be contained in the facility's client Bill of Rights, and in §448.802(b),
which provides that the facility shall obtain written authorization from the
consenter before providing any treatment or medication, including that the
consenter received and understood the their patient rights. The commenter
continued that the regulations are formatted in such a way that it makes it
difficult for public use.
Response: The commission appreciates the comments regarding the patient
bill of rights but disagrees with the commenter. Section 448.802(b) not only
ensures the client is told of their rights before any treatment is given it
requires documentation that client and consenter have received the information
and also understood the information. No changes were made based on this comment.
Comment: Concerning §448.706(f)(2), Advocacy, Inc., commented that
it believes it is unclear from the language that authorization for mechanical
restraint or seclusion still must be by a Qualified Credentialed Counselor
(QCC), even though the QCC authorization may be based on the face-to-face
evaluation of direct care staff initiating or implementing the procedure.
The commenter suggested wording such as "authorization by the QCC for mechanical
restraint or seclusion" to begin §448.706(f)(2), rather than simply "authorization
for mechanical restraint or seclusion." The commenter also thought that including
QCC in the term "direct care staff" authorized to perform the face-to-face
evaluation upon which authorization is based fails to give the QCC the preferred
role the QCC should have in performing the face-to-face evaluation, when available
to do so.
Response: The commission agrees in part and disagrees in part with the
commenter, and is making a change in response to the comment. With respect
to the commenter's first point, the term "authorization" is used repeatedly
in §448.706(f)(1)-(3) without repeating that it refers to authorization
by the QCC since §448.706(f) (1)-(3) are already subject to the mandate
for QCC authorization stated in §448.706(f). The commission therefore
did not make the commenter's suggested change in relation to the first point.
The commission agrees, however, with the commenter's second point and has
changed the proposed language for §448.706(f)(2) from "Authorization
for mechanical restraint or seclusion shall be based on a face-to-face evaluation
by the direct care staff initiating or implementing the procedure" to "Authorization
for mechanical restraint or seclusion shall be based on a face-to-face evaluation
by the authorizing QCC, if on site or reasonably available, or by the direct
care staff initiating or implementing the procedure." The added language,
which refers to the "authorizing QCC" also serves to address the commenter's
first point by referring to the "authorizing" QCC.
Comment: Concerning §448.706(g), Crisis Prevention Institute (CPI),
of Brookfield, WI suggests the release criteria be "as soon as possible when
the acting-out individual is no longer an imminent threat of harm to self
or others."
Response: The commission disagrees with the commenter. The phrase "as soon
as possible" is not definable and release based on criteria defined by the
facility serves to protect patients who have been restrained.
Comment: Concerning §448.706(j), Crisis Prevention Institute (CPI),
of Brookfield, WI cautions the specific description of a restraint hold, as
it may be difficult for an organization to determine if it is approved or
not. General restrictions such as a prohibition of a prone restraint are clear
and easily understood.
Response: The commission understands the commenter's concerns however,
Texas Senate Bill 325, 79th Legislature, Regular Session (2005), codified
at Health and Safety Code, Chapter 322, requires the department define acceptable
restraint holds. No changes were made based on the comment.
Comment: Concerning §448.706(m), Crisis Prevention Institute (CPI),
of Brookfield, WI recommends that this requirement apply to ALL residential
facilities.
Response: The commission appreciates the comment, however, Texas Senate
Bill 325, 79th Legislature, Regular Session (2005), codified at Health and
Safety Code, Chapter 322, carves out an exemption for "small residential facilities"
thereby limiting the department's authority to expand this particular requirement
to small residential facilities. No changes were made based on this comment.
Comment: Concerning §448.706(r)(2), Crisis Prevention Institute (CPI),
of Brookfield, WI recommends continuous monitoring for up to 24 hours following
the release of a restraint.
Response: The commission appreciates the comment, yet disagrees with the
commenter. Section 448.706(r)(2) is consistent with Interventions in Mental
Health Programs in §415.273(a)(2), Subchapter F, which requires staff
observe the individual for at least 15 minutes following release from restraint
or seclusion. No changes were made related to this comment.
Comment: Concerning §448.706(s), Crisis Prevention Institute (CPI),
of Brookfield, WI suggests that all persons involved in a restraint situation
be debriefed, including all staff and bystanders.
Response: The commission agrees with the commenter regarding the recommendation
that all staff be debriefed and as a result deleted the word "available".
The rule was changed from "§448.706(s) As soon as possible after an episode
of restraint or seclusion, "available" staff members involved in the episode,
supervisory staff, the client, the legally authorized representative, if any,
and, with the consent of the client, family members must meet to discuss the
episode." to "§448.706(s) As soon as possible after an episode of restraint
or seclusion, staff members involved in the episode, supervisory staff, the
client, the legally authorized representative, if any, and, with the consent
of the client, family members must meet to discuss the episode."
The commission disagrees that bystanders are not already included in the
rule regarding who will be debriefed. Section 448.706(s) provides that the
one of the purposes of the debriefing is, when clinically indicated or upon
the request of individuals who witnessed the restraint to debrief persons
who witnessed the restraint.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Cathy Campbell,
certifies that the rules, as adopted, have been reviewed by legal counsel
and found to be a valid exercise of the agencies' legal authority.
Subchapter F. PERSONNEL PRACTICES AND DEVELOPMENT
25 TAC §448.603
STATUTORY AUTHORITY
The amendment is authorized by Health and Safety Code, §464.009, which
authorizes the Executive Commissioner of the Health and Human Services Commission
(Executive Commissioner) to adopt rules governing chemical dependency treatment
facilities, including their policies and procedures, minimum staffing requirements,
protection of client rights, and requirements to ensure client safety, protection,
health and comfort; Health and Safety Code, §§322.051, 322.052,
and 322.053, which require rulemaking to implement Health and Safety Code,
Chapter 322, added by the 79th Legislature, Regular Session, 2005 (SB 325);
and Government Code, §531.0055, and Health and Safety Code, §1001.075,
which authorize the Executive Commissioner to adopt rules and policies necessary
for the operation and provision of health and human services by the department
and for the administration of Health and Safety Code, Chapter 1001.
§448.603.Training.
(a)
Unless otherwise specified, video, manual, or computer-based
training is acceptable if the supervisor discusses and documents the material
with the staff person in a face-to-face session to highlight key issues and
answer questions.
(b)
The facility shall maintain documentation of all required
training.
(1)
Documentation of external training shall include:
(A)
date;
(B)
number of hours;
(C)
topic;
(D)
instructor's name; and
(E)
signature of the instructor (or equivalent verification).
(2)
The facility shall maintain documentation of all internal
training. For each topic, the file shall include:
(A)
an outline of the contents;
(B)
the name, credentials, relevant qualifications of the person
providing the training, and
(C)
the method of delivery.
(3)
For each group training session, the facility shall maintain
on file a dated attendee sign-in sheet.
(c)
Prior to performing their duties and responsibilities,
the facility shall provide orientation to staff, volunteers, and students.
This orientation shall include information addressing:
(1)
TCADA rules;
(2)
facility policies and procedures;
(3)
client rights;
(4)
client grievance procedures;
(5)
confidentiality of client-identifying information (42 C.F.R.
pt. 2; HIPAA);
(6)
standards of conduct; and
(7)
emergency and evacuation procedures.
(d)
The following initial training(s) must be received within
the first 90 days of employment and must be completed before the employee
can perform a function to which the specific training is applicable. Subsequent
training must be completed as specified.
(1)
Abuse, Neglect, and Exploitation. All residential program
personnel with any direct client contact shall receive eight hours of face-to-face
training as described in Figure: 40 TAC §148.603(d)(1) which is attached
hereto and incorporated herein as if set forth at length. All outpatient program
personnel with any direct client contact shall received two hours of abuse,
neglect and exploitation training.
Figure: 25 TAC §448.603(d)(1) (No change.)
(2)
HIV, Hepatitis B and C, Tuberculosis and Sexually Transmitted
Diseases. All personnel with any direct client contact shall receive this
training. The training shall be based on the Texas Commission on Alcohol and
Drug Abuse Workplace and Education Guidelines for HIV and Other Communicable
Diseases.
(A)
The initial training shall be three hours in length.
(B)
Staff shall receive annual updated information about these
diseases.
(3)
Cardio Pulmonary Resuscitation (CPR).
(A)
All direct care staff in a residential program shall maintain
current CPR and First Aid certification.
(B)
Licensed health professionals and personnel in licensed
medical facilities are exempt if emergency resuscitation equipment and trained
response teams are available 24 hours a day.
(4)
Nonviolent Crisis Intervention. All direct care staff in
residential programs and outpatient programs shall receive this training.
The face-to-face training shall teach staff how to use verbal and other non-physical
methods for prevention, early intervention, and crisis management. The instructor
shall have documented successful completion of a course for crisis intervention
instructors or have equivalent documented training and experience.
(A)
The initial training shall be four hours in length.
(B)
Staff shall complete two hours of annual training thereafter.
(5)
Restraint and/or Seclusion. All direct care staff in residential
programs and programs accepting court commitments that use or authorize the
use of restraint or seclusion shall have face-to-face training and demonstrate
competency in the safe methods of the specific procedures before assuming
job duties involving direct care responsibilities. This includes programs
that accept adolescent residential and emergency detentions.
(A)
The initial training must be four hours in length.
(B)
Staff shall complete four hours of annual training thereafter.
(C)
The training shall include hands-on practice under the
supervision of a qualified instructor.
(D)
The training program shall include:
(i)
identifying the underlying causes of threatening behaviors
exhibited by the clients receiving services;
(ii)
identifying aggressive or threatening behavior;
(iii)
explaining how the behavior of personnel can affect the
behaviors of clients;
(iv)
using de-escalation, mediation, self-protection, and other
techniques;
(v)
recognizing and responding to signs of physical distress
in clients who are being restrained, if the facility uses or authorizes the
use of restraint;
(vi)
identifying the risks associated with positional, compression,
or restraint asphyxiation and with prone and supine holds, if the facility
uses or authorizes the use of restraint;
(vii)
the initiation of seclusion, if the facility uses or
authorizes the use of seclusion;
(viii)
the application of personal restraint, if the facility
uses or authorizes the use of personal restraint;
(ix)
the application of approved restraint devices, if the
facility has on premises, authorizes the use of, or uses any mechanical restraint
devices;
(x)
monitoring cardiac and respiratory status and interpreting
their relevance to the physical safety of the client in restraint, if the
facility uses or authorizes the use of restraint, or seclusion, if the facility
uses or authorizes the use of seclusion;
(xi)
addressing physical and psychological status and comfort,
including signs of distress;
(xii)
assisting clients in meeting behavioral criteria for
the discontinuation of restraint, if the facility uses or authorizes the use
of restraint, or seclusion, if the facility uses or authorizes the use of
seclusion;
(xiii)
recognizing readiness for the discontinuation of restraint,
if the facility uses or authorizes the use of restraint, or seclusion, if
the facility uses or authorizes the use of seclusion; and
(xiv)
recognizing when to contact emergency medical services
to evaluate and/or treat a client for an emergency medical condition.
(6)
Intake, Screening and Admission Authorization. All staff
who conduct intake, screening and authorize admission for applicants to receive
program services shall complete training in the program's screening and admission
procedures. The training shall include two hours of DSM diagnostic criteria
for substance-related disorders, and other mental health diagnoses.
(A)
The initial training shall be eight hours in length.
(B)
Staff shall complete eight hours of annual training thereafter.
(C)
The training shall be completed before staff screen or
authorize applicants for admission.
(7)
Self-administration of Medication. All personnel responsible
for supervising clients in self-administration of medication, who are not
credentialed to administer medication, shall complete this training before
performing this task.
(A)
Staff shall complete two hours initial one time training.
(B)
The training shall be provided by a physician, pharmacist,
physician assistant, or registered nurse before administering medication and
shall include:
(i)
prescription labels;
(ii)
medical abbreviations;
(iii)
routes of administration;
(iv)
use of drug reference materials;
(v)
storage, maintenance, handling, and destruction of medication;
(vi)
documentation requirements; and
(vii)
procedures for medication errors, adverse reactions,
and side effects.
This agency hereby certifies that the adoption
has been reviewed by legal counsel and found to be a valid exercise of the
agency's legal authority.
Filed with the Office of
the Secretary of State on May 12, 2006.
TRD-200602664
Cathy Campbell
General Counsel
Department of State Health Services
Effective date: June 1, 2006
Proposal publication date: March 31, 2006
For further information, please call: (512) 458-7111 x6972
25 TAC §448.701, §448.706
STATUTORY AUTHORITY
The amendments are authorized by Health and Safety Code, §464.009,
which authorizes the Executive Commissioner of the Health and Human Services
Commission (Executive Commissioner) to adopt rules governing chemical dependency
treatment facilities, including their policies and procedures, minimum staffing
requirements, protection of client rights, and requirements to ensure client
safety, protection, health and comfort; Health and Safety Code, §§322.051,
322.052, and 322.053, which require rulemaking to implement Health and Safety
Code, Chapter 322, added by the 79th Legislature, Regular Session, 2005 (SB
325); and Government Code, §531.0055, and Health and Safety Code, §1001.075,
which authorize the Executive Commissioner to adopt rules and policies necessary
for the operation and provision of health and human services by the department
and for the administration of Health and Safety Code, Chapter 1001.
§448.706.Restraint and Seclusion.
(a)
A small residential facility is defined as a treatment
facility with less than eight licensed beds.
(b)
The governing body shall adopt a policy to either authorize
or prohibit the use of personal restraint, mechanical restraint, and seclusion.
Any facility authorizing use of restraint or seclusion shall comply with and
have a written procedure that ensures compliance with Health and Safety Code,
Chapter 322, including its definition of seclusion; the rules adopted under
that chapter; and this section. Outpatient programs shall prohibit the use
of restraint or seclusion, except as it relates to court commitment clients.
(c)
In programs authorizing use of restraint or seclusion,
direct care staff shall be trained as described in the applicable provisions
of §448.603 of this title (relating to Training). Staff sufficient in
number and who have the training required by §448.603 of this title to
safely implement any permitted restraint or seclusion shall be on duty at
all times.
(d)
Staff shall not use restraint or seclusion unless it is
necessary to intervene to prevent imminent probable death or substantial bodily
harm to the client or imminent physical harm to another and less restrictive
methods have been tried and failed.
(e)
Staff shall not use more force than is necessary to prevent
imminent harm and shall ensure the safety, well-being, and dignity of clients
who are restrained or secluded, including attention for personal needs. Staff
shall not deny bathroom privileges, water, sleep, or regularly scheduled meals
and snacks.
(f)
Staff shall obtain authorization from the supervising Qualified
Credentialed Counselor (QCC) before starting restraint or seclusion or as
soon as possible after initiation or implementation.
(1)
The facility shall not use standing authorizations for
restraint or seclusion.
(2)
Authorization for mechanical restraint or seclusion shall
be based on a face-to-face evaluation by the authorizing QCC, if on site or
reasonably available, or by the direct care staff initiating or implementing
the procedure.
(3)
Each authorization shall include a specific time limit,
not to exceed 12 hours.
(4)
The QCC must take into consideration information that could
contraindicate or otherwise affect the use of restraint or seclusion, including
information obtained during the initial assessment of each client at the time
of admission or intake. This information includes, but is not limited to:
(A)
techniques, methods, or tools that would help the client
effectively cope with his or her environment;
(B)
pre-existing medical conditions or any physical disabilities
and limitations, including substance use disorders, that would place the client
at greater risk during restraint or seclusion;
(C)
any history of sexual or physical abuse that would place
the client at greater psychological risk during restraint or seclusion; and
(D)
any history that would contraindicate seclusion, the type
of restraint (personal or mechanical), or a particular type of restraint devise.
(g)
When the client has been safely restrained or secluded,
staff shall tell the client what behavior and timeframes are required for
release and shall release the client as soon as the criteria are met.
(h)
Clinical staff shall review and document alternative strategies
for dealing with behaviors necessitating the use of restraint or seclusion
for an individual client two or more times in any 30-day period.
(i)
The chief executive officer of the facility or designee
shall review all incident reports involving restraint or seclusion and take
action to address unwarranted use of these measures.
(j)
A client held in restraint shall be under continuous direct
observation. The facility shall ensure adequate breathing and circulation
during restraint and shall only use devices designed for therapeutic restraint.
An acceptable hold is one that engages one or more limbs close to the body
to limit or prevent movement and is performed in a manner consistent with
the requirements set forth in this section.
(k)
Seclusion rooms shall be constructed to prevent clients
from harming themselves and shall allow staff to observe clients easily in
all parts of the room. When a client is in seclusion, staff shall conduct
a visual check at least every 15 minutes.
(l)
Staff shall record the following information in the client
record within 24 hours:
(1)
the circumstances leading to the use of restraint or seclusion;
(2)
the specific behavior necessitating the restraint or seclusion
and the behavior required for release;
(3)
less restrictive interventions that were tried before restraint
or seclusion began;
(4)
the signed authorization of the supervising QCC;
(5)
the names of the staff members who implemented the restraint
or seclusion;
(6)
the date and time the procedure began and ended;
(7)
the behavior and timeframes required for release;
(8)
the client's response;
(9)
observations made, including the 15 minute checks; and
(10)
attention given for personal needs.
(m)
A prone or supine hold shall not be used except as a last
resort when other less restrictive interventions have proven to be ineffective.
The hold shall be used only to transition a client into another position,
and shall not exceed one minute in duration. Except in small residential facilities,
when the prone or supine hold is used, an observer, who is trained to identify
the risks associated with positional, compression, or restraint asphyxiation
and with prone and supine holds, and who is not involved in the restraint,
shall ensure the client's breathing is not impaired.
(n)
No intervention, voluntary or involuntary, shall be used:
(1)
as a means of discipline, retaliation, punishment, or coercion;
(2)
for the purpose of convenience of staff members or other
individuals; or
(3)
as a substitute for effective treatment.
(o)
A restraint shall not be used that:
(1)
secures a client to a stationary object while the client
is in a standing position;
(2)
causes pain to restrict a client's movement (pressure points
or joint locks);
(3)
restricts circulation;
(4)
obstructs a client's airway, including a procedure that
places anything in, on, or over a client's mouth or nose or puts pressure
on the torso;
(5)
impairs a client's breathing;
(6)
interferes with a client's ability to communicate; or
(7)
is inconsistent with training received in compliance with §448.603
of this title (relating to Training).
(p)
Use of chemical restraint is prohibited.
(q)
Use of restraint or seclusion solely as a behavior therapy
program or as part of a behavior therapy program is prohibited.
(r)
Immediately following the release of a client from restraint
or seclusion, a direct care staff must:
(1)
take appropriate action to facilitate the client's reentry
into the facility environment by providing the client with transition activities
and an opportunity to return to ongoing activities;
(2)
observe the client for at least 15 minutes; and
(3)
document observations of the client's behavior during this
transition period in the client's record.
(s)
As soon as possible after an episode of restraint or seclusion,
available staff members involved in the episode, supervisory staff, the client,
the legally authorized representative, if any, and, with the consent of the
client, family members must meet to discuss the episode. The purpose of the
debriefing is to:
(1)
identify what led to the episode and what could have been
handled differently;
(2)
identify strategies to prevent future restraint or seclusion,
taking into consideration suggestions from the client;
(3)
ascertain whether the client's physical well-being, psychological
comfort, and right to privacy were addressed;
(4)
counsel the client in relation to any trauma that may have
resulted from the episode;
(5)
when indicated, identify appropriate modifications to the
client's treatment plan; and
(6)
when clinically indicated or upon request of individuals
who witnessed the restraint debrief persons who witnessed the restraint.
This agency hereby certifies that the adoption has been
reviewed by legal counsel and found to be a valid exercise of the agency's
legal authority.
Filed
with the Office of the Secretary of State on May 12, 2006.
TRD-200602665
Cathy Campbell
General Counsel
Department of State Health Services
Effective date: June 1, 2006
Proposal publication date: March 31, 2006
For further information, please call: (512) 458-7111 x6972
Chapter 703.
PROJECT CONTRACTS AND GRANTS
25 TAC §§703.3, 703.5, 703.6, 703.10
The Texas Cancer Council adopts amendments to 25 TAC §§703.3,
703.5, 703.6, and 703.10 concerning the scope, project proposal submission,
review process, and funding restrictions without changes as published in the
March 10, 2006, issue of the
Texas Register
(31
TexReg 1596).
No public comments were received.
The amendments are adopted under the Texas Health & Safety
Code Annotated §102.0002 and §102.009, which provides the Texas
Cancer Council with the authority to develop, implement, and revise the Texas
Cancer Plan.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on May 9, 2006.
TRD-200602558
Sandra Balderrama
Executive Director
Texas Cancer Council
Effective date: May 29, 2006
Proposal publication date: March 10, 2006
For further information, please call: (512) 438-3029
Subchapter C. SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS, AND CHILDREN (WIC)
Chapter 229.
FOOD AND DRUG
Subchapter G. MANUFACTURE, STORAGE, AND DISTRIBUTION OF ICE SOLD FOR HUMAN CONSUMPTION, INCLUDING ICE PRODUCED AT POINT OF USE
Chapter 448.
STANDARD OF CARE
Subchapter G. CLIENT RIGHTS
Part 11.
TEXAS CANCER COUNCIL
Chapter 704.
TEXANS CONQUER CANCER PROGRAM