TITLE 25.HEALTH SERVICES

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 Proposed amendments to §§31.21, 31.32, and 31.34 - 31.36 were published in the same issue, but are being withdrawn and will not be adopted.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


Subchapter C. SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS, AND CHILDREN (WIC)

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


Chapter 229. FOOD AND DRUG

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


Subchapter G. MANUFACTURE, STORAGE, AND DISTRIBUTION OF ICE SOLD FOR HUMAN CONSUMPTION, INCLUDING ICE PRODUCED AT POINT OF USE

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


Chapter 448. STANDARD OF CARE

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


Subchapter G. CLIENT RIGHTS

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


Part 11. TEXAS CANCER COUNCIL

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


Chapter 704. TEXANS CONQUER CANCER PROGRAM

25 TAC §704.5, §704.7

The Texas Cancer Council adopts amendments to 25 TAC §704.5 and §704.7 concerning guidelines for expenditures and guidelines for awarding support services funds 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-200602559

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