Texas Administrative Code Title 40

Social Services and Assistance: As effective August 6, 2010

Chapter 5

Subchapter A

§5.1: Purpose

(a) The purpose of this subchapter is to establish standards for prescribing psychoactive medication to patients served by the state mental health and mental retardation system in Texas.

(b) This subchapter is not a clinical guide to prescribing psychoactive medication and is not the only source of information concerning related issues of appropriate practice.

(c) Accepted guidelines, as defined in §415.3 of this title (relating to Definitions) supplement the use of this subchapter.

Comments

Source Note: The provisions of this §5.1 adopted to be effective August 31, 2004, 29 TexReg 8325; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.2: Application

(a) The provisions of this subchapter apply to the employees and contractors of:

(1) the facilities of the Texas Department of Mental Health and Mental Retardation (TDMHMR); and

(2) TDMHMR local authorities.

(b) The provisions of this subchapter may not apply to prescribing practice in research projects that have been approved in accordance with TDMHMR's policies and procedures concerning the review and approval of research involving human subjects.

Comments

Source Note: The provisions of this §5.2 adopted to be effective August 31, 2004, 29 TexReg 8325; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.3: Definitions

The following words and terms, when used in this subchapter, have the following meanings:

(1) Accepted guidelines--The Texas Implementation of Medication Algorithms (TIMA) or an alternative guideline formally approved in writing by the TDMHMR medical director. In cases in which none are formally approved, current professionally recognized clinical guidelines or accepted standards of care are considered the accepted guidelines.

(2) Child psychiatrist--A physician who is certified by the American Board of Psychiatry and Neurology and holds a subspecialty certificate in child and adolescent psychiatry, or who is board eligible, i.e., has an active approved application on file in the board office, or who is currently in training in an approved residency and is supervised by a board eligible or board-certified child and adolescent psychiatrist.

(3) DSM--The current edition of The Diagnostic and Statistical Manual of Mental Disorders published by the American Psychiatric Press.

(4) Legally authorized representative (LAR)--A person authorized by law to act on behalf of an individual with regard to a matter described in this subchapter, who may be a parent, guardian, or managing conservator of a minor, or the guardian of an adult.

(5) Local authority (LA)--The entity designated by TDMHMR to plan, facilitate, coordinate, and ensure the provision of services to individuals with mental illness or mental retardation.

(6) Medication error--Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional.

(7) Physician--A doctor of medicine or osteopathy who holds a current license or institutional permit to practice medicine in Texas.

(8) Plan of care--The written document specifying how comprehensive care of the person with mental illness or mental retardation is to be carried out (sometimes called the "multidisciplinary treatment plan" or "interdisciplinary plan of care").

(9) Polypharmacy--Concurrent use of more than one psychoactive medication having identical or very similar mechanisms of action.

(10) Prescribing professional--A physician or other health care professional who, as authorized by statute, may prescribe under the supervision of a physician.

(11) PRN--As needed (pro re nata).

(12) Psychiatric emergency--A situation in which, in the opinion of the physician, it is immediately necessary to administer medication to a patient to ameliorate the signs and symptoms of that patient's mental illness and to prevent:

(A) imminent probable death or substantial bodily harm to the patient because the patient:

(i) overtly or continually is threatening or attempting to commit suicide or serious bodily harm; or

(ii) is behaving in a manner that indicates that the patient is unable to satisfy the patient's need for nourishment, essential medical care, or self-protection; or

(B) imminent physical or emotional harm to others, because of threats, attempts, or other acts the patient makes or commits.

(13) Psychiatrist--A physician who is certified by the American Board of Psychiatry and Neurology or who is board eligible, i.e., has an active approved application on file in the board office, or a physician who is currently in training in such a program and is supervised by a board eligible or board certified psychiatrist.

(14) Psychoactive medication--Medication whose primary intended therapeutic effect is to treat or ameliorate the signs or symptoms of mental disorder or to modify mood, affect, perception, or behavior, consistent with THSC, Chapter 574, Subchapter G, §574.101.

(15) Service setting--A state mental health facility, state mental retardation facility, a local authority (LA) site, or a service site contracted to one of these entities.

(16) Team--The patient, patient's LAR, and with the patient's consent, the patient's family members, and the group of professionals and direct care workers responsible for the care of the patient, sometimes called the "multidisciplinary team" or "interdisciplinary team."

Comments

Source Note: The provisions of this §5.3 adopted to be effective August 31, 2004, 29 TexReg 8325; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.4: Philosophy

The standard of care for psychoactive medication use in patients should not vary according to service setting. The variations in treatment should be individualized according to patient needs.

Comments

Source Note: The provisions of this §5.4 adopted to be effective August 31, 2004, 29 TexReg 8325; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.5: General Principles

(a) All state facilities and LAs will establish and implement written policies and procedures as approved by their medical staff in accordance with this subchapter.

(b) The prescribing professional will practice within the scope of his or her license with supervision as appropriate to that license.

(c) The prescribing of psychoactive medication will be in accordance with accepted guidelines. Use of psychoactive medication that falls outside accepted guidelines may be permissible if the clinical rationale is documented in the patient record.

(d) In no case will psychoactive medication be used for punishment, for convenience of staff, as a substitute for appropriate psychosocial treatments, or in amounts that interfere with a patient's quality of life or plan of care.

(e) The patient's plan of care will reflect any use of psychoactive medication as part of an integrated treatment approach aimed at increasing the patient's functioning and quality of life.

(f) The prescribing professional will document the rationale for initiating, continuing, or discontinuing psychoactive medication in the clinical record.

(g) Medications traditionally considered psychoactive may be prescribed for nonpsychiatric indications if such use is supported by accepted guidelines and the provisions of this subchapter would not apply.

(h) If a service setting must meet other standards (external or otherwise), the more stringent standards will prevail.

(i) The service setting will have policies and procedures governing the scope of practice regarding prescription of psychoactive medications when the prescribing professional is not a psychiatrist. These policies and procedures must require involvement of a psychiatrist and describe the nature, extent, and time frame of this involvement regarding the following:

(1) initiation of any psychoactive medication;

(2) significant changes in the medication regimen other than simple titration or substitution of equivalent medications;

(3) institution of polypharmacy under §415.7(e)(4) of this title (relating to Prescribing Parameters); and

(4) prescription of any regimen that falls outside accepted guidelines, including dosing guidelines.

(j) Each service setting must ensure psychiatric consultation is available at all times.

Comments

Source Note: The provisions of this §5.5 adopted to be effective August 31, 2004, 29 TexReg 8325; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.6: Evaluation and Diagnosis

(a) Prior to initiating psychoactive medication according to accepted guidelines, the prescribing professional will:

(1) assess and document the medical history including the chief complaint, psychiatric history, substance use history, and medication history along with medication allergies of the patient;

(2) conduct and document a mental status examination of the patient according to accepted guidelines;

(3) assess and document the current physical status and general health of the patient in detail sufficient for safe prescription of the medication contemplated and may include a reference to a physical examination conducted within the past 12 months, a physical examination by the physician, or a referral of the patient for a more thorough examination as appropriate to health status and service setting;

(4) assess and document the need for laboratory screening and other procedures to gather relevant clinical information; and

(5) make and document the psychiatric diagnosis in accordance with the DSM and within the scope of the professional's license.

(b) The prescribing professional will solicit input and discuss with the team the the proposed treatment with psychoactive medication.

(c) If psychoactive medication known to cause movement disorders is contemplated, an appropriately trained and competent staff will screen the patient for abnormal involuntary movements using a standardized procedure such as the Abnormal Involuntary Movement Scale (AIMS) or Dyskensia Identification System Condensed User Scale (DISCUS), as appropriate, and document the result of the examination prior to initiation of the medication.

(d) In a psychiatric emergency, the assessments and documentation required by this section will take place as soon as is feasible after the emergency. If the patient has already received such assessments during this treatment episode, then the prescribing professional will document only those assessments and decisions that directly relate to the emergency.

Comments

Source Note: The provisions of this §5.6 adopted to be effective August 31, 2004, 29 TexReg 8325; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.7: Prescribing Parameters

(a) Target signs and symptoms. The prescribing professional will identify and document the target signs and symptoms along with their initial frequency and severity for each medication prescribed prior to its initial use.

(b) Choice of psychoactive medication. The prescribing professional will choose the psychoactive medication in accordance with accepted guidelines.

(c) Laboratory and screenings. The prescribing professional will identify, order, and follow up any laboratory tests, screenings, or other procedures indicated by the proposed psychoactive medication and the physical condition of the patient in accordance with accepted guidelines.

(d) Dose and route of administration. The prescribing professional will choose doses at or below the maximum doses indicated in the TDMHMR Formulary. Higher doses or unusual routes of administration may be used with documentation in the patient record of appropriate supporting clinical rationale. The use of nasogastric intubation requires consultation with a second physician with documentation of the consultation in the supporting clinical rationale.

(e) Polypharmacy. The prescribing professional will not prescribe polypharmacy as a mechanism to avoid single drug dosage recommendations, adequate monotherapy drug trials, or adequate psychosocial treatment or programming. Polypharmacy is acceptable practice when:

(1) overlapping medications are used as part of a change from one medication to another;

(2) currently prescribed medication is not available in the route most appropriate to a psychiatric emergency situation;

(3) documentation exists of inadequate patient response after simpler and safer regimens have been attempted following accepted guidelines; or

(4) accepted guidelines provide no guidance and appropriate single drug trials have failed, provided the rationale for determining the choice to prescribe polypharmacy is documented to support the situation, and:

(A) the prescribing professional is privileged through the medical staff privileging process to prescribe psychoactive medication; and

(B) the prescribing professional is a psychiatrist, or in the case of a child patient, a child psychiatrist, or consults with a psychiatrist or a child psychiatrist as appropriate prior to initiating polypharmacy.

(f) Orders not written in person. The service setting will have policies and procedures which govern orders not written in person (such as verbal, telephone, fax, or electronic orders) by the prescribing professional. These will address who may give orders, who may accept them, and how orders will be documented in the patient record. Orders will be authenticated by the prescribing professional within a time frame appropriate to the service setting as set forth in that setting's approved policies and procedures.

(g) PRN orders. The prescribing professional may write PRN orders in accordance with accepted guidelines and Chapter 414, Subchapter I of this title (relating to Consent to Treatment with Psychoactive Medication-Mental Health Services). The service setting will have policies and procedures for PRN orders that address:

(1) indications;

(2) appropriate medication classes and dosing, including maximum dose in 24 hours; and

(3) time frames for:

(A) medication administration;

(B) order duration;

(C) assessment of effectiveness;

(D) continued PRN use; and

(E) documentation standards that apply to the order itself and the assessments.

(h) Psychiatric emergency orders. The physician may order a single, immediate administration of a psychoactive medication(s) for a psychiatric emergency. The service setting will have policies and procedures for emergency use of psychoactive medications in accordance with accepted guidelines and Chapter 414, Subchapter I of this title, governing Consent to Treatment with Psychoactive Medication-Mental Health Services, and Chapter 412, Subchapter H, governing Standards and Quality Assurance for Mental Retardation Community Services and Supports as appropriate that address:

(1) indications;

(2) appropriate medication classes and dosing, including maximum dose in 24 hours;

(3) assessment of effectiveness;

(4) patient education;

(5) review with consideration of changing the current plan of care if a pattern of use of psychiatric emergency orders emerges; and

(6) documentation time frames and standards that address the incident, the use of medications, and the outcome.

Comments

Source Note: The provisions of this §5.7 adopted to be effective August 31, 2004, 29 TexReg 8325; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.8: Emergency Use of Psychoactive Medication

(a) Emergency psychoactive medications are used to treat the signs and symptoms of mental illness in a psychiatric emergency when other interventions are ineffective or inappropriate.

(b) The selection of the medication should take into account the patient's current medication regimen. Using a medication that the patient is currently prescribed is preferable, if clinically indicated.

(c) All required documentation will be entered into the patient's record as soon as the emergency abates.

Comments

Source Note: The provisions of this §5.8 adopted to be effective August 31, 2004, 29 TexReg 8325; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.9: Consent and Patient Education

(a) Informed consent for treatment with a psychoactive medication will be obtained in accordance with the provisions of Chapter 414, Subchapter I of this title (relating to Consent to Treatment with Psychoactive Medication - Mental Health Facilities) or Chapter 405, Subchapter I of this title (relating to Consent to Treatment with Psychotropic Medication - Mental Retardation Facilities), as appropriate.

(b) The use of PRN medication requires an appropriate consent process in accordance with the provisions referred to in subsection (a) of this section.

(c) The service setting will provide individual and group medication education when appropriate to patients, their families, and LARs according to accepted guidelines (e.g., TIMA patient and family education guidelines). If accepted guidelines do not exist, the education will discuss characteristics of the medication, including expected benefits, potential adverse or side effects, dosage, standard alternative treatments, legal rights, and any questions the patient, family, or LAR may have. Education is also provided to address significant changes in the patient's medication regimen.

(d) The service setting will have policies and procedures to address medication education and documentation standards.

Comments

Source Note: The provisions of this §5.9 adopted to be effective August 31, 2004, 29 TexReg 8325; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.10: Medication Monitoring

(a) All patients receiving psychoactive medication will receive timely ongoing face-to-face evaluation and documentation by the prescribing professional of:

(1) data collected since the last follow-up, including data about the frequency, severity, and timing of target signs and symptoms;

(2) effectiveness of the medication in treating target signs and symptoms; and

(3) assessment for side effects and adverse effects.

(b) Using the assessment data and with input from the team, the prescribing professional will continue or alter the medication regimen to maximize the benefit to the patient.

(c) At initiation of a new medication or significant change in medication regimen, medication monitoring will occur as often as medically necessary and for the period of time needed to stabilize the clinical response. Such monitoring will occur at least weekly for one month in hospitals and crisis stabilization units (unless discharged in the interim) and at least monthly in outpatient and residential settings. Rationale for less frequent monitoring will be documented.

(d) Further minimum frequencies of medication monitoring in patients are:

(1) state mental health facility settings--monthly as described in subsections (a) and (b) of this section. Also, every 90 days, the medication monitoring includes review of consent issues and long-term consequences of psychoactive medication;

(2) state mental retardation facility settings--monthly review of data with appropriate members of the team and every third month (quarterly) face-to-face evaluation of the patient. Rationale for less frequent monitoring will be documented;

(3) LA programs--medication monitoring appointments will be scheduled quarterly as described in subsections (a) and (b) of this section. Rationale for less frequent monitoring will be documented.

(e) For medications known to cause movement disorders, appropriately trained and competent staff will screen the patient quarterly for abnormal involuntary movements using a standardized procedure such as AIMS, document the results, and arrange for any appropriate follow-up with a psychiatrist or neurologist, if indicated.

(f) Clinically significant adverse effects or side effects will be evaluated by a physician, managed according to accepted guidelines, and addressed in the plan of care.

(g) Laboratory testing or other procedures needed for the continued safe and effective use of medication will be ordered according to accepted guidelines.

(h) In any service setting that operates a pharmacy, the pharmacist will evaluate medication orders and patient medication records in accordance with the rules of the Texas State Board of Pharmacy (Texas Administrative Code, Title 22, Part 15) and will include a review for dosage range according to the TDMHMR Formulary, polypharmacy, and PRN use. The service setting will have policies and procedures in place for doing this review and the documentation and outcome of any questions arising out of this review.

Comments

Source Note: The provisions of this §5.10 adopted to be effective August 31, 2004, 29 TexReg 8325; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.11: Special Populations

Special populations will be managed according to accepted guidelines as appropriate to their special needs.

(1) Patients with dyskinesias, including tardive dyskinesia.

(A) A diagnosis of a dyskinesia will be verified by a psychiatrist or neurologist and documented in the patient record along with suspected or known duration and severity.

(B) The patient and, as appropriate, family and LAR will receive relevant education about the diagnosis and its implications for psychoactive medication use.

(C) Risks and benefits of continued psychoactive medication use will be assessed and communicated to the patient and, as appropriate, family or LAR. If continued use is recommended, a new consent for medication will be obtained.

(D) If continued use of psychoactive medication is contemplated, then the prescribing professional, if not a psychiatrist or neurologist, must obtain and document consultation from a psychiatrist or neurologist.

(2) Children.

(A) Except in an emergency, if the prescribing professional is not a child psychiatrist, then prescribing psychoactive medication which falls outside accepted guidelines requires consultation from a child psychiatrist in addition to any other requirements.

(B) If the prescribing professional is a child psychiatrist, then use of polypharmacy is governed as indicated in §415.7 of this title (relating to Prescribing Parameters).

(3) Patients with mental retardation.

(A) A specific psychiatric diagnosis will be made in accordance with the DSM prior to initiating psychoactive medication. If it is not possible to make a specific diagnosis in accordance with the DSM, clinical justification for initiating psychoactive medication will be documented.

(B) Except in an emergency or acute psychiatric hospitalization, psychoactive medications are prescribed only after behavioral and clinical baselines have been established.

(C) Specific target behaviors or clinical signs and quality of life outcomes must be objectively defined, quantified, and tracked using recognized empirical measurement methods appropriate to the service setting in order to monitor psychoactive medication efficacy.

(4) Patients with substance use disorders.

(A) Service settings will assess the occurrence of co-occurring psychiatric and substance use disorders during evaluations for medication, initiation of medication, and medication monitoring, and will have policies and procedures which address the assessment .

(B) Provision of medication services to this population will be in accordance with accepted guidelines for patients with these comorbid conditions and will be in collaboration and coordination with other treatments that the patient may be receiving for substance use.

(5) Pregnant or nursing patients.

(A) Informed consent for use of psychoactive medication in this population must specifically document that the risk and benefits of that use on the fetus or infant have been discussed with the patient and, as appropriate, LAR and family.

(B) Prior to prescribing psychoactive medication, the prescribing professional will seek to collaborate with the physician or clinic providing prenatal, postnatal, or pediatric care to include providing, with consent, appropriate documentation of diagnoses and plan of care to that service provider.

(6) Geriatric patients. Service settings will have policies and procedures for prescribing psychoactive medication which are responsive to the special needs of geriatric patients..

(7) Other special populations. Prescribing professionals will be aware that other populations exist that may have particular clinical or special risk factors associated with their treatment with psychoactive medications. Consultation with an appropriate specialist or expert will be considered when treating these populations.

Comments

Source Note: The provisions of this §5.11 adopted to be effective August 31, 2004, 29 TexReg 8325; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.12: Quality Improvement

(a) Each service setting will have in place policies and procedures that address standards monitoring and related procedures for quality management of provision of psychoactive medication related services.

(b) At a minimum, psychoactive medication utilization in each service setting must be reviewed and evaluated at least semiannually and strategies for improvement identified using accepted guidelines.

(c) Required areas of review include:

(1) appropriateness of prescribing (including choice of medication, dose, and route);

(2) documentation;

(3) polypharmacy;

(4) emergency use of psychoactive medication;

(5) PRN use;

(6) medication errors;

(7) adverse drug reactions; and

(8) frequency of medication monitoring.

(d) Medication utilization will be reviewed by the medical staff and necessary strategies for improvement approved by the medical staff for implementation.

Comments

Source Note: The provisions of this §5.12 adopted to be effective August 31, 2004, 29 TexReg 8325; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.13: References

The following statutes and TDMHMR rules are referenced in this subchapter:

(1) Texas Administrative Code, Title 25, Part II, Chapter 414, Subchapter I, relating to Consent to Treatment with Psychoactive Medications - Mental Health Services; and

(2) Texas Administrative Code Title 25, Part II, Chapter 405, Subchapter I, relating to Consent to Treatment with Psychotropic Medication.

Comments

Source Note: The provisions of this §5.13 adopted to be effective August 31, 2004, 29 TexReg 8325; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.14: Distribution

This subchapter is distributed to:

(1) all members of the Texas Mental Health and Mental Retardation Board;

(2) executive, management, and program staff of Central Office;

(3) CEOs and medical directors of all facilities and LAs;

(4) advocacy organizations; and

(5) any person on request.

Comments

Source Note: The provisions of this §5.14 adopted to be effective August 31, 2004, 29 TexReg 8325; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

Subchapter C

§5.101: Purpose

The purpose of this subchapter is to provide policies and procedures governing the use and maintenance of the TDMHMR Drug Formulary.

Comments

Source Note: The provisions of this §5.101 adopted to be effective February 6, 2002, 27 TexReg 755; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.102: Application

(a) This subchapter applies to TDMHMR facilities, Central Office, local authorities, and their respective contractors for medications and medication-related services funded by the Texas Department of Mental Health and Mental Retardation (TDMHMR). (The TDMHMR Drug Formulary in its entirety applies to all TDMHMR facilities in all circumstances except when an individual receives acute care services of limited duration in a general hospital.)

(b) TDMHMR facilities, Central Office, and local authorities are responsible for amending the contracts of their contractors that provide TDMHMR-funded medications and medication-related services to ensure their compliance with this subchapter.

Comments

Source Note: The provisions of this §5.102 adopted to be effective February 6, 2002, 27 TexReg 755; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.103: Definitions

The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:

(1) Adverse drug reaction--Any adverse symptom or sign that is an unexpected reaction to medication and that is noxious, unintended, and occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.

(2) Contractor--An entity that provides TDMHMR-funded mental health or mental retardation services pursuant to a contract with a service system component or TDMHMR.

(3) Drug entity--A specific chemical compound and all of its pharmaceutically equivalent salt forms which are used in the treatment or mitigation of disease.

(4) Emergency--A situation in which it is immediately necessary to administer medication to an individual to prevent:

(A) imminent probable death or substantial bodily harm to the individual because the individual:

(i) overtly or continually is threatening or attempting to commit suicide or serious bodily harm; or

(ii) is behaving in a manner that indicates that the individual is unable to satisfy the individual's need for nourishment, essential medical care, or self-protection; or

(B) imminent physical or emotional harm to others because of threat, attempts, or other acts the individual overtly or continually makes or commits.

(5) Individual--Any person receiving services from a service system component or contractor.

(6) Local authority--An entity designated by the TDMHMR commissioner in accordance with the Texas Health and Safety Code, §533.035(a).

(7) Practitioner--A person who acts within the scope of a professional license to prescribe, distribute, administer, or dispense a prescription drug or device, (e.g., a physician, nurse, nurse practitioner, pharmacist, dentist).

(8) Pharmacy and therapeutics committee--A TDMHMR facility committee composed of physicians, pharmacists, registered nurses, and others as appointed by the facility CEO that recommends drug-related policy to the facility's clinical/medical director and CEO.

(9) Reserve drug--A formulary drug with specific guidelines for use as described in the formulary.

(10) Service system component--A TDMHMR facility or local authority.

(11) State mental health facility--A state hospital or a state center with an inpatient component that is operated by TDMHMR.

(12) State mental retardation facility--A state school or a state center with a mental retardation residential component that is operated by TDMHMR.

(13) TDMHMR--The Texas Department of Mental Health and Mental Retardation.

(14) TDMHMR Drug Formulary or formulary--A continually revised printed listing by nonproprietary name of all drugs approved for use by service system components and their contractors.

(15) TDMHMR facility--A state mental health facility or a state mental retardation facility.

Comments

Source Note: The provisions of this §5.103 adopted to be effective February 6, 2002, 27 TexReg 755; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.104: General Requirements

(a) The Texas Department of Mental Health and Mental Retardation maintains a closed formulary (TDMHMR Drug Formulary) that lists drugs approved by the Executive Formulary Committee for use by service system components and their contractors.

(b) A drug is not available for general use by service system components or their contractors unless it is approved by the Executive Formulary Committee. Drugs not listed in the TDMHMR Drug Formulary or the Interim Formulary Update may not be used except under the limited circumstances described in §415.110 of this title (relating to Prescribing Non-formulary Drugs).

(c) The use of formulary drugs in unusual clinical situations or the use of unusual drug combinations must be accompanied by written justification in the individual's medical record. Additional clinical consultation in these situations should occur as deemed necessary by the prescribing physician.

(d) Reserve drugs, as defined in §415.103 of this title (relating to Definitions), may be prescribed for use outside the guidelines described in the formulary if the prescription is justified in the individual's medical record and reviewed in routine audits of reserve drug use conducted by the service system component.

(e) Drug research conducted at a TDMHMR facility is governed by Chapter 414, Subchapter P of this title (concerning Research at TDMHMR Facilities). Local authorities conducting drug research must comply with all applicable state and federal laws, rules, and regulations, including Title 45, Code of Federal Regulations, Part 46 (Protection of Human Subjects), as required by §412.309(f) of this title (relating to Rights and Responsibilities) of Chapter 412, Subchapter G of this title (concerning Mental Health Community Services Standards).

Comments

Source Note: The provisions of this §5.104 adopted to be effective February 6, 2002, 27 TexReg 755; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.105: Organization of Tdmhmr Drug Formulary

Drugs are listed in the TDMHMR Drug Formulary by nonproprietary name. The list is based on a modified format of the American Hospital Formulary Service Drug Information and includes an alphabetical index. Proprietary names may follow in parentheses for information only; the listing of proprietary names is not an endorsement. Cost comparisons and prescribing information are provided as determined necessary by the Executive Formulary Committee. The American Hospital Formulary Service Drug Information serves as a standard reference in addition to the approved Food and Drug Administration product labeling. The TDMHMR Drug Formulary notes limitations recommended by the Executive Formulary Committee regarding the use of a drug, including specific limitations or guidelines for the use of a reserve drug.

Comments

Source Note: The provisions of this §5.105 adopted to be effective February 6, 2002, 27 TexReg 755; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.106: Executive Formulary Committee

(a) Composition.

(1) The chairperson is a physician appointed by the TDMHMR medical director.

(2) The TDMHMR pharmacy discipline head serves as the permanent secretary of the committee and is responsible for preparing the agenda and minutes of committee meetings.

(b) Membership. Members of the Executive Formulary Committee are appointed by the TDMHMR medical director, which consists of:

(1) two state mental health facility physicians;

(2) two state mental retardation facility physicians;

(3) four local authority practitioners;

(4) two TDMHMR facility pharmacy directors;

(5) one TDMHMR facility clinical pharmacologist;

(6) one TDMHMR facility director of nursing;

(7) one TDMHMR facility registered nurse;

(8) the TDMHMR pharmacy discipline head;

(9) the following ex officio members:

(A) the TDMHMR medical director;

(B) the TDMHMR associate medical director for mental retardation/ developmental disability;

(C) the TDMHMR associate medical director for mental health;

(D) the TDMHMR director, state mental health facilities;

(E) the TDMHMR director, state mental retardation facilities;

(F) the TDMHMR deputy commissioner, community programs; and

(G) the TDMHMR director, central contracting and procurement support; and

(10) other persons as appointed by the TDMHMR medical director.

(c) Term of service. With the exception of the TDMHMR pharmacy discipline head, which is a standing membership position, members serve staggered three-year terms and may be reappointed to one additional term. Ex officio members may be reappointed as specified by the TDMHMR medical director.

(d) Meetings. The Executive Formulary Committee meets at least quarterly.

(e) Administrative support. The TDMHMR medical director's office provides administrative support to the Executive Formulary Committee.

Comments

Source Note: The provisions of this §5.106 adopted to be effective February 6, 2002, 27 TexReg 755; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.107: Responsibilities of the Executive Formulary Committee

(a) The Executive Formulary Committee maintains and updates the TDMHMR Drug Formulary by:

(1) recommending standards of drug use that discourage unnecessary duplication of therapeutic alternatives and encourage the highest standards of medical and pharmacy practice;

(2) periodically reviewing the drugs listed in the formulary to ensure consistency with need, effectiveness, risk, and cost;

(3) consulting with experts in clinical pharmacy, pharmacology, and other medical specialties as necessary to objectively assess drugs under consideration; and

(4) considering the applications submitted in accordance with §415.108 of this title (relating to Applying to Have a Drug Added to the Formulary) or as:

(A) presented by committee members; or

(B) submitted by other qualified persons at the invitation of the Executive Formulary Committee chairperson.

(b) The Executive Formulary Committee makes other recommendations concerning drug use and policy as requested by the TDMHMR medical director.

(c) Approval of a drug entity for inclusion in the TDMHMR Drug Formulary does not imply approval of all formulations for that drug. The Executive Formulary Committee designates the formulations that are allowed for general use by service system components and their contractors.

(d) Approval of a drug formulation constitutes approval of all brands of the product that have been proven to be bioequivalent as listed in the Approved Drug Products with Therapeutic Equivalence Evaluations.

(e) For a drug entity that has known bioequivalency problems, the Executive Formulary Committee may limit its use to a specific brand based on objective clinical pharmacokinetics data.

Comments

Source Note: The provisions of this §5.107 adopted to be effective February 6, 2002, 27 TexReg 755; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.108: Applying to Have a Drug Added to the Formulary

(a) Any member of the Executive Formulary Committee, any service system component practitioner, or any contract practitioner may apply to have a drug added to the TDMHMR Drug Formulary by completing the New Drug Application Form DF-1, referenced as Exhibit A in §415.112 of this title (relating to Exhibit) and including:

(1) published articles in biomedical literature that substantiate the efficacy and safety of the proposed drug;

(2) information on the advantages of the proposed drug compared with similar formulary drugs;

(3) a list of formulary drugs that the proposed drug would replace or supplement; and

(4) cost effectiveness data.

(b) Submitting the application.

(1) If the person submitting the application is a TDMHMR facility practitioner or a TDMHMR facility contract practitioner, then that practitioner submits the application to the facility's pharmacy and therapeutics committee for approval. If the committee approves the application, then it forwards the application to the Executive Formulary Committee.

(2) If the person submitting the application is a non-facility service system component practitioner or a non-facility service system component contract practitioner, then that practitioner submits the application to the component's clinical/medical director or designee who determines if the application is appropriate and complete, and if so, forwards the application to the Executive Formulary Committee.

(3) If the person completing the application is a member of the Executive Formulary Committee, then that person submits the application directly to Executive Formulary Committee.

(c) The Executive Formulary Committee considers the drug application and recommends:

(1) approving the proposed drug's inclusion and, if appropriate, approving audit criteria and recommending dosage guidelines;

(2) approving the proposed drug on a trial basis for a specified period of time;

(3) approving the proposed drug as a reserve drug, with guidelines;

(4) postponing the decision until a later meeting; or

(5) denying the proposed drug's inclusion.

Comments

Source Note: The provisions of this §5.108 adopted to be effective February 6, 2002, 27 TexReg 755; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.109: Changing the Tdmhmr Drug Formulary

(a) Changes to the TDMHMR Drug Formulary are based on need, effectiveness, risk, and cost as contained in current and unbiased biomedical literature.

(b) Recommendations by the Executive Formulary Committee for changes to the TDMHMR Drug Formulary, as reflected in the meeting's minutes, are submitted to the TDMHMR medical director.

(c) If the TDMHMR medical director or designee approves the recommendations, then the recommendations must be:

(1) identified as approved in writing before implementation; and

(2) listed in the Interim Formulary Update and distributed to the CEOs, clinical/medical directors, and pharmacy directors of all service system components, and to members of the Executive Formulary Committee.

Comments

Source Note: The provisions of this §5.109 adopted to be effective February 6, 2002, 27 TexReg 755; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.110: Prescribing Non-formulary Drugs

(a) Non-formulary drugs may be prescribed:

(1) if no formulary drug exists that is as safe or effective in the specified situation;

(2) if a limited trial of the drug appears to be safer or more effective than any drug listed in the formulary and the prescribing practitioner anticipates applying to have the drug added to the formulary;

(3) if the course of therapy established prior to the individual's admission would be interrupted; or

(4) in an emergency, as defined in §415.103 of this title (relating to Definitions).

(b) Each local authority shall develop and enforce written policies and procedures for monitoring and approving the prescribing of non-formulary drugs by its practitioners and its contract practitioners.

(c) TDMHMR shall develop and enforce written policies and procedures for monitoring and approving the prescribing of non-formulary drugs by TDMHMR facility practitioners and facility contract practitioners. The written policies and procedures are contained in TDMHMR's Pharmacy Management Operating Instruction.

Comments

Source Note: The provisions of this §5.110 adopted to be effective February 6, 2002, 27 TexReg 755; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.111: Adverse Drug Reactions

(a) Each local authority shall develop written policies and procedures for reporting adverse drug reactions to the Food and Drug Administration.

(b) TDMHMR shall develop written policies and procedures for TDMHMR facilities when reporting adverse drug reactions to the Food and Drug Administration. The written policies and procedures are contained in TDMHMR's Pharmacy Management Operating Instruction.

Comments

Source Note: The provisions of this §5.111 adopted to be effective February 6, 2002, 27 TexReg 755; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.112: Exhibit

Exhibit A, the New Drug Application Form DF-1, referenced in this subchapter, may be obtained by contacting the Office of Policy Development, TDMHMR, P.O. Box 12668, Austin, TX 78711-2668, (512)206-4516.

Comments

Source Note: The provisions of this §5.112 adopted to be effective February 6, 2002, 27 TexReg 755; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.113: References

The following rules and policies, and federal statutes are referenced in this subchapter:

(1) Chapter 412, Subchapter G of this title (concerning Mental Health Community Services Standards);

(2) Chapter 414, Subchapter P of this title (concerning to Research in TDMHMR Facilities);

(3) Pharmacy Management Operating Instruction; and

(4) Title 45, Code of Federal Regulations, Part 46 (Protection of Human Subjects).

Comments

Source Note: The provisions of this §5.113 adopted to be effective February 6, 2002, 27 TexReg 755; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.114: Distribution

(a) This subchapter is distributed to:

(1) members of the Texas Mental Health and Mental Retardation Board;

(2) executive, management, and program staff of Central Office;

(3) CEO's of all TDMHMR facilities and local authorities; and

(4) advocacy organizations.

(b) The CEO of each service system component shall disseminate the information contained in this subchapter to all appropriate staff and contractors.

Comments

Source Note: The provisions of this §5.114 adopted to be effective February 6, 2002, 27 TexReg 755; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

Subchapter D

§5.151: Purpose

The purpose of this subchapter is to describe :

(1) the criteria and process to be followed by psychologists licensed to practice in Texas, TDMHMR-certified psychologists, and physicians licensed to practice in Texas when conducting a determination of mental retardation (DMR);

(2) the process to be followed by a mental retardation authority (MRA) when reviewing a DMR conducted by another entity;

(3) the process to be followed by an MRA when assessing whether an individual meets the criteria for a diagnosis of pervasive development disorder (PDD) or a related condition;

(4) the process to be followed by an MRA when assessing an individual's service and support needs;

(5) the criteria and process to be followed by an MRA when assessing an individual's appropriateness for services in a state mental retardation facility (state MR facility); and

(6) the criteria and process to be followed by the department when designating an employee of an MRA, state facility, or the department's Central Office as a TDMHMR-certified psychologist.

Comments

Source Note: The provisions of this §5.151 adopted to be effective December 1, 2000, 25 TexReg 11391; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.152: Application

This subchapter applies to:

(1) mental retardation authorities (MRAs);

(2) psychologists and physicians licensed to practice in Texas who conduct DMRs;

(3) TDMHMR-certified psychologists;

(4) state facilities; and

(5) employees of MRAs, state facilities, and the department's Central Office who seek certification by the department as TDMHMR-certified psychologists as described in §415.161 of this title (relating to TDMHMR-certified Psychologist).

Comments

Source Note: The provisions of this §5.152 adopted to be effective December 1, 2000, 25 TexReg 11391; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.153: Definitions

The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.

(1) Adaptive behavior--The effectiveness with or degree to which an individual meets the standards of personal independence and social responsibility expected of the individual's age and cultural group as assessed by a standardized measure.

(2) Adaptive behavior level--The categorization of an individual's functioning level based on a standardized measure of adaptive behavior. Four levels are used ranging from mild limitations in adaptive skills (I) through profound limitations in adaptive skills (IV).

(3) Commissioner--The commissioner of the department.

(4) Community center--A community mental health and mental retardation center established under the THSC, Chapter 534.

(5) Department--The Texas Department of Mental Health and Mental Retardation.

(6) Developmental period--Birth to 18 years of age.

(7) Diagnostic assessment--An assessment, including a DMR, conducted to determine if an individual meets the criteria for a diagnosis of mental retardation, a pervasive developmental disorder, or a related condition.

(8) DMR (determination of mental retardation)--An assessment conducted as described in §415.155 of this title (relating to Determination of Mental Retardation (DMR)) by a TDMHMR-certified psychologist, a psychologist licensed to practice in Texas, or a physician licensed to practice in Texas to determine if an individual meets the criteria for a diagnosis of mental retardation.

(9) DSM --The American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders.

(10) Individual--A person who is the focus of a diagnostic assessment or who has been determined to be in the mental retardation priority population.

(11) IDT (interdisciplinary team)--A group of people assembled by an MRA or state MR facility that assesses the treatment, training, and habilitation needs of an individual and makes recommendations for services and supports. The group typically includes:

(A) the individual;

(B) the individual's LAR, if any;

(C) other concerned persons whose inclusion is requested by the individual or LAR; and

(D) mental retardation professionals and paraprofessionals designated by the MRA or state MR facility.

(12) LAR (legally authorized representative)--A person authorized by law to act on behalf of an individual with regard to a matter described in this subchapter, and may include a parent, guardian, or managing conservator of a minor individual, a guardian of an adult individual, or a personal representative of a deceased individual.

(13) Mental retardation--Consistent with THSC, §591.003, significantly subaverage general intellectual functioning existing concurrently with deficits in adaptive behavior and manifested during the developmental period.

(14) Mental retardation priority population--Those individuals who meet one or more of the following descriptions :

(A) have mental retardation;

(B) have a pervasive developmental disorder (PDD);(C) have a related condition and be eligible for services in a Medicaid program operated by the department;

(D) be a nursing facility resident who is eligible for specialized services for mental retardation or a related condition pursuant to §1919(e)(7) of the Social Security Act; or

(E) be a child who is eligible for early childhood intervention (ECI) services provided in accordance with Chapter 621 of this title (relating to Early Childhood Intervention Services).

(15) MRA (mental retardation authority)--Consistent with THSC, §533.035, an entity designated by the commissioner to which the Texas Mental Health and Mental Retardation Board delegates its authority and responsibility for planning, policy development, coordination, and resource allocation, and resource development for and oversight of services and supports in one or more local service areas.

(16) Permanency planning--A philosophy and planning process that focuses on the outcome of family support by facilitating a permanent living arrangement with the primary feature of an enduring and nurturing parental relationship.

(17) Pervasive developmental disorder (PDD)--As described in the most current edition of the DSM, a severe and pervasive impairment in the developmental areas of reciprocal social interaction skills or communication skills, or the presence of stereotyped behaviors, interests, and activities manifested during the developmental period, usually before 10 years of age.

(18) Related condition--As defined in the Code of Federal Regulations (CFR), Title 42, §435.1009, a severe and chronic disability that:

(A) is attributable to:

(i) cerebral palsy or epilepsy; or

(ii) any other condition, other than mental illness, found to be closely related to mental retardation because the condition results in impairment of general intellectual functioning or adaptive behavior similar to that of persons with mental retardation, and requires treatment or services similar to those required for those persons with mental retardation;

(B) is manifested before the person reaches age 22; and

(C) is likely to continue indefinitely; and

(D) results in substantial functional limitation in three or more of the following areas of major life activity:

(i) self-care;

(ii) understanding and use of language;

(iii) learning;

(iv) mobility;

(v) self-direction; and

(vi) capacity for independent living.

(19) Services and supports--Programs and assistance funded through the department that are provided or contracted for by an MRA or state MR facility for the mental retardation priority population. As described in THSC, §593.003, the programs or assistance may include a DMR, interdisciplinary team recommendations, education, special training, supervision, care, treatment, rehabilitation, residential care, and counseling, but does not include those services or programs that have been explicitly delegated by law to other state agencies.

(20) Significantly subaverage general intellectual functioning--Consistent with THSC, §591.003, measured intelligence on standardized general intelligence tests of two or more standard deviations (not including standard error of measurement adjustments) below the age-group mean for the tests used.

(21) State facility--A state school, state hospital, or state center operated by the department.

(22) State MR facility (state mental retardation facility)--A state school or state center operated by the department that provides residential services to persons with mental retardation.

(23) TDMHMR-certified psychologist--An employee of an MRA, state facility, or the department's Central office who is certified by the department as described in §415.161 of this title (relating to TDMHMR-certified Psychologist).

(24) THSC--Texas Health and Safety Code.

Comments

Source Note: The provisions of this §5.153 adopted to be effective December 1, 2000, 25 TexReg 11391; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.154: General Provisions

(a) Except as described in subsection (c) of this section, an individual must have been determined to be in the mental retardation priority population before receiving services and supports.

(b) An MRA or state facility must make appropriate accommodations when conducting a diagnostic assessment for an individual:

(1) who does not speak English;

(2) for whom English is a second language; or

(3) for whom communication devices and/or techniques (including sign language) are necessary.

(c) An individual may receive the following services and supports without being in the mental retardation priority population:

(1) emergency services provided in accordance with Texas Health and Safety Code (THSC), §§593.027 or 593.0275;

(2) respite care in a residential care facility provided in accordance with THSC, §593.028;

(3) in-home and family support services as described in Chapter 401, Subchapter L of this title (relating to In-Home and Family Support Program); and

(4) services in a state MR facility ordered in accordance with Texas Family Code, §§55.33 or 55.52.

Comments

Source Note: The provisions of this §5.154 adopted to be effective December 1, 2000, 25 TexReg 11391; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.155: Determination of Mental Retardation (DMR)

(a) An individual or the individual's LAR may make a written request for a DMR to:

(1) the MRA serving the area in which the individual resides;

(2) a psychologist licensed to practice in Texas; or

(3) a physician licensed to practice in Texas.

(b) Only an individual receiving services from a state facility may have a DMR conducted at that state facility.

(c) A DMR must be conducted as described in this subsection. Best Practices Guidelines, a compilation of suggestions for conducting diagnostic assessments as described in this subchapter, can be obtained on the department's website at www.mhmr.state.tx.us/CentralOffice/LongTermServicesSupports or from the Office of Long Term Services and Supports, Texas Department of Mental Health and Mental Retardation, P.O. Box 12668, Austin, Texas 78711 .

(d) At an MRA or state facility, the DMR must be conducted by :

(1) a psychologist licensed to practice in Texas who is employed by or contracting with the MRA or state facility who has completed:

(A) one year of employment experience in the field of mental retardation; and

(B) graduate course work or one year of supervised experience in individual intellectual and behavior assessment;

(2) a physician licensed to practice in Texas who is employed by the MRA or state facility who has completed:

(A) one year of employment experience in the field of mental retardation; and

(B) an internship or residency that includes specialized training in individual intellectual or behavioral assessment or 12 hours of specialized continuing education in individual intellectual or behavior assessment; or

(3) a TDMHMR-certified psychologist who is employed by the MRA or state facility.

(e) The psychologist, TDMHMR-certified psychologist, or physician who conducts a DMR must:

(1) interview the individual; and

(2) perform a professional assessment that, at a minimum, includes:

(A) a standardized measure of the individual's intellectual functioning using the most appropriate test for the characteristics of the individual;

(B) a standardized measure of the individual's adaptive behavior level;

(C) a review of evidence supporting the origination of mental retardation during the individual's developmental period, which should include, as available:

(i) reports concerning the cause of the suspected mental retardation;

(ii) results of all or several previous assessments that are representative of the individual's typical functioning;

(iii) types of services the individual has received or is receiving that are indicative of mental retardation;

(iv) reports by other people, including the individual's family members and friends; and

(v) educational history and classifications; and

(D) a review of the individual's psychological and psychiatric treatments and diagnoses.

(f) The interview and assessment described in subsection (e) of this section must be conducted using diagnostic techniques adapted to the individual's age, cultural background, ethnic origins, language, and physical or sensory disabilities.

(g) A previous assessment, social history, or relevant record from another entity, including a school district, public or private agency, or another psychologist, TDMHMR-certified psychologist, or physician may be used as part of a DMR if the person who conducts the DMR considers the assessment, social history, or relevant record to be a valid reflection of the individual's current level of functioning.

(h) Within 30 days of completing the interview and assessment described in subsection (e) of this section, the person who conducted the DMR must provide the person who requested the DMR with a written report that is dated, signed, and includes the licensure/certification number of the person who conducted the DMR unless denying access to the report is authorized by federal or state statute or rule, including Chapter 414, Subchapter A of this title (relating to Client-Identifying Information). The written report must contain:

(1) background information summarizing the individual's:

(A) developmental history, including a description of the evidence of origination of mental retardation during the individual's developmental period; and

(B) psychological and psychiatric treatments and diagnoses;

(2) results of current intellectual and adaptive behavior assessments with:

(A) instrument names and scores;

(B) overall intellectual and adaptive behavior levels; and

(C) individual scale scores, if available;

(3) a narrative description of:

(A) test results, including relative strengths and weaknesses;

(B) testing conditions; and

(C) any relevant negative impact on the test results because of the individual's:

(i) cultural background;

(ii) primary language;

(iii) communication style;

(iv) physical or sensory impairments;

(v) motivation;

(vi) attentiveness; and

(vii) emotional factors; and

(4) conclusions, diagnoses (to include DSM codes), and recommendations, including a statement of:

(A) whether the individual meets the criteria for mental retardation; and

(B) if the individual does not meet the criteria for mental retardation, whether individual meets the criteria for PDD or a related condition.

(i) If a DMR is conducted at an MRA or state facility, the MRA or state facility must:

(1) inform the person who applied for the DMR of the right to :

(A) an additional, independent DMR to be conducted at the person's expense if the person questions the validity or results of the DMR; and

(B) an administrative hearing to contest the findings as described in Chapter 403, Subchapter N of this title (relating to Administrative Hearings Arising under the Persons with Mental Retardation Act); and

(2) document that the person who applied for the DMR was informed orally and in writing of these rights.

(j) If a DMR has been ordered by a court for guardianship proceedings, the person who conducts the DMR:

(1) should submit the written findings and recommendations as specified in the court's order; and

(2) may submit a current capacity assessment of the individual conducted as described in §411.61 of this title (relating to Memorandum of Understanding Concerning Capacity Assessment for Self Care and Financial Management).

(k) An MRA must charge for a DMR in accordance with the provisions of Chapter 403, Subchapter B of this title (related to Charges for Community-based Services).

Comments

Source Note: The provisions of this §5.155 adopted to be effective December 1, 2000, 25 TexReg 11391; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.156: Review and Endorsement of a Dmr

(a) If an individual has been determined to have mental retardation by a person who is not employed by or contracting with the MRA at which the individual or the individual's LAR seeks services and supports, the DMR report must be reviewed by :

(1) a psychologist employed by or contracting with that MRA; or

(2) a TDMHMR-certified psychologist employed by that MRA.

(b) A psychologist who contracts with the MRA to review DMR reports or is employed by the MRA must not review the report of a DMR conducted by that psychologist outside the psychologist's role as a contractor or employee of the MRA.

(c) If a DMR report reviewed as described in subsection (a) of this section is endorsed by the psychologist or TDMHMR-certified psychologist, the MRA shall:

(1) document the outcome of the review;

(2) inform the individual or the individual's LAR orally and in writing of the outcome of the review;

(3) assess the individual's appropriateness for services and supports as described in §415.159 this title (relating to Assessment of Individual's Need for Services and Supports); and

(4) if services in a state MR facility are requested by the individual or the individual's LAR, convene an interdisciplinary team (IDT) as described in §415.160 of this title (relating to IDT Assessment of Whether Individual Can Be Served Most Appropriately in a State Mental Retardation Facility).

(d) If a DMR report reviewed as described in subsection (a) of this section is not endorsed by the psychologist or TDMHMR-certified psychologist, the MRA shall:

(1) document outcome of the review; and

(2) inform the individual or the individual's LAR orally and in writing of the:

(A) outcome of the review; and

(B) opportunity to have the MRA conduct a DMR at no expense to the individual or the individual's LAR.

(e) The documentation of the review must be provided to the individual or the individual's LAR within 30 calendar days after the review is completed.

Comments

Source Note: The provisions of this §5.156 adopted to be effective December 1, 2000, 25 TexReg 11391; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.157: Pervasive Developmental Disorder (PDD)

(a) If an individual requesting services and supports or for whom services and supports are requested is determined not to have mental retardation, information from the DMR may be used to diagnose the individual as having a pervasive development disorder (PDD) by a psychologist employed by or contracting with an MRA, a physician employed by an MRA, or a TDMHMR-certified psychologist using criteria from the current edition of the DSM.

(b) At a minimum, a diagnosis of PDD must be based on:

(1) the individual exhibiting severe and pervasive impairment in the developmental areas of:

(A) reciprocal social interaction skills;

(B) communication skills; or

(C) stereotyped behaviors, interests, and activities;

(2) qualitative impairments that define these conditions which are distinctly different relative to the individual's developmental age or mental age; and

(3) evidence of onset before 10 years of age which will include, as available:

(A) results of previous assessments that are representative of the individual's typical functioning;

(B) types of services the individual has received or is receiving which are indicative of a PDD; and

(C) reports by other people, including the individual's family members and friends, that indicate a developmental history of a PDD.

(c) If an individual has been diagnosed as having PDD by a person who is not employed by or contracting with the MRA at which the individual or the individual's LAR seeks services and supports, the diagnosis must be reviewed by :

(1) a psychologist employed by or contracting with that MRA; or

(2) a TDMHMR-certified psychologist employed by that MRA.

(d) A psychologist who contracts with the MRA to review diagnoses of PDD or is employed by the MRA will not be permitted to review a diagnosis made by that psychologist outside of the psychologist's role as a contractor or employee of the MRA.

(e) If a diagnosis reviewed as described in subsection (c) of this section is endorsed by the psychologist or TDMHMR-certified psychologist, the MRA shall:

(1) document the outcome of the review in the individual's record;

(2) inform the individual or the individual's LAR orally and in writing of the outcome of the review;

(3) assess the individual's appropriateness for services and supports as described in §415.159 this title (relating to Assessment of Individual's Service and Support Needs).

(f) If a diagnosis reviewed as described in subsection (c) of this section is not endorsed by the psychologist or TDMHMR-certified psychologist, the MRA shall:

(1) document the outcome of the review ; and

(2) inform the individual or the individual's LAR orally and in writing of the outcome of the review.

(g) The documentation of the review must be provided to the individual or the individual's LAR within 30 calendar days after the review is completed.

(h) An individual who is diagnosed as having PDD may be eligible for services and supports funded by general revenue appropriations from the Texas Legislature.

Comments

Source Note: The provisions of this §5.157 adopted to be effective December 1, 2000, 25 TexReg 11391; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.158: Related Condition (RC)

If an individual requesting services and supports or for whom services and supports are requested is found not to have mental retardation, information from the DMR may be used to establish eligibility for Medicaid services and supports based on the existence of a related condition, as described in Chapter 406, Subchapter E of this title (relating to Eligibility and Review).

Comments

Source Note: The provisions of this §5.158 adopted to be effective December 1, 2000, 25 TexReg 11391; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.159: Assessment of Individual's Need for Services and Supports

(a) A representative of the MRA serving the area in which an individual resides must ascertain the types of services and supports being requested and the individual's interests, choices, and needs by interviewing:

(1) the individual and the individual's LAR; or

(2) the persons actively involved with the individual, if the individual does not have an LAR and the MRA representative believes the individual does not have the ability to understand the process and its ramifications.

(b) The MRA representative along with the individual or the individual's LAR or, for the individual who is unable to provide legally adequate consent and does not have an LAR, persons actively involved with the individual function as a planning team to develop an initial plan for services and supports. The plan may include referrals by the MRA to other appropriate service agencies.

(c) If the individual or LAR is seeking residential mental retardation services, the MRA representative must provide to the individual, LAR, and, unless the LAR is a family member, at least one family member (if possible) both an oral and written explanation of the services and supports for which the individual may be eligible.

(1) As required by THSC, §533.038, the explanation must address:

(A) Intermediate Care Facilities for Persons with Mental Retardation (ICF/MR) Program services--both state mental retardation facilities and community-based facilities;

(B) waiver services under §1915(c) of the Social Security Act, including a waiver program operated by another state agency; and

(C) other community-based services and supports.

(2) The MRA must give a copy of the written explanation to the individual, LAR, and any family member to whom the explanation was given and retain the original in the individual's record. The written explanation must:

(A) describe the program and service preferences of the individual or LAR; and

(B) be signed and dated by the individual, LAR, or family member to indicate that the explanation was provided.

(3) If the services and supports requested by the individual or LAR are not available, the MRA must:

(A) assist the individual or LAR in gaining access to alternative services and supports and appropriate waiting lists, including a waiver program operated by another state agency;

(B) document efforts undertaken by the MRA to obtain the requested services and supports, including the names and addresses of programs and facilities to which the individual or LAR was referred, including a waiver program operated by another state agency; and

(C) document the services and supports for which the individual is waiting.

Comments

Source Note: The provisions of this §5.159 adopted to be effective December 1, 2000, 25 TexReg 11391; amended to be effective March 31, 2002, 27 TexReg 2459; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.160: Idt Assessment of Whether Individual Can Be Served Most Appropriately in a State Mental Retardation Facility

(a) As required by THSC, §593.013, an individual will not be admitted for voluntary services or committed to a state MR facility unless an IDT convened by the MRA serving the area in which the individual resides:

(1) determines that the individual meets the criteria for admission or commitment to the state MR facility; and

(2) recommends the admission or commitment.

(b) The IDT shall:

(1) interview the individual or the individual's LAR;

(2) review the individual's:

(A) social and medical history;

(B) medical assessment, which shall include an audiological, neurological, and vision screening;

(C) psychological and social assessment; and

(D) determination of adaptive behavior level;

(3) determine the individual's need for additional assessments, including educational and vocational assessments;

(4) obtain any additional assessments necessary to plan services;

(5) recommend services to address the individual's needs that consider the individual's interests, choices, and goals, and, for the individual who is a minor , include permanency planning as a goal in the service plan;

(6) give the individual and the individual's LAR an opportunity to participate in IDT meetings;

(7) if desired, use a previous assessment, social history, or other relevant record from a school district, public or private agency, or appropriate professional if the IDT determines that the assessment, social history, or record is valid; and

(8) prepare a written report of its findings and recommendations that is signed by each IDT member and send a copy of the report within 30 calendar days to the individual or LAR, as appropriate.

(c) If the individual is being considered for court commitment to a state MR facility, the IDT report must have been completed within six months prior to the date of the court hearing. An IDT report ordered by a court shall be submitted promptly to the:

(1) court as directed in the court's order; and

(2) individual or the individual's LAR.

(d) An individual may be admitted to a state MR facility on an emergency basis without a DMR and an IDT recommendation under the provisions of the THSC, §593.027(c). However, within 30 days of an admission for emergency services:

(1) a DMR must be performed as described in §415.155 of this title (relating to Determination of Mental Retardation (DMR)); and

(2) an IDT must assess the individual and make a recommendation as described in this section.

Comments

Source Note: The provisions of this §5.160 adopted to be effective December 1, 2000, 25 TexReg 11391; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.161: Tdmhmr-Certified Psychologist

(a) An employee of an MRA, state facility, or the department's Central Office who is not a licensed psychologist may apply to become a TDMHMR-certified psychologist by submitting:

(1) a written request for certification to the department's commissioner or designee, Texas Department of Mental Health and Mental Retardation, P.O. Box 12668, Austin, Texas 78711-2668; and

(2) documentation of:

(A) current employment by an MRA, state facility, or in Central Office;

(B) provisional licensure as a psychologist or licensure as a psychological associate or specialist in school psychology;

(C) successful completion of graduate course work in individual intellectual assessment;

(D) supervised experience in adaptive behavior assessment; and

(E) one year of employment in the field of mental retardation.

(b) The department's commissioner or designee will review the documentation submitted as described in subsection (a) of this section. If the documentation is determined to be acceptable, the department's commissioner or designee will issue a certificate designating the person as a TDMHMR-certified psychologist.

(c) A person certified as an associate psychologist and employed by an MRA, state facility, or Central Office as of the effective date of this subchapter will be designated as a TDMHMR-certified psychologist without the submission of the documentation required in subsection (a)(2) of this section, if a written request to do so is submitted by the person's supervisor. The department will issue a new certificate designating that person as a TDMHMR-certified psychologist.

(d) A TDMHMR-certified psychologist is permitted to conduct DMRs only while functioning as an employee of an MRA, state facility, or the department's Central Office.

(e) A person's designation as a TDMHMR-certified psychologist will become ineffective if the person fails to maintain active licensure status as described in subsection (a)(2)(B) of this section, unless the person's designation was granted as described in subsection (c) of this section.

Comments

Source Note: The provisions of this §5.161 adopted to be effective December 1, 2000, 25 TexReg 11391; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.162: References

Reference is made in this subchapter to the following statutes, federal regulations, rules of the department and of other state agencies, and other relevant documents:

(1) Social Security Act, §1915(b);

(2) Code of Federal Regulations, Title 42, §435.1009;

(3) THSC, Chapter 534, §§533.038, 591.003, 592.018, 593.003, 593.013, 593.027, 593.0275, 593.028;

(4) Texas Family Code, §§55.33 or 55.52;

(5) Chapter 401, Subchapter L of this title (relating to In-Home and Family Support Program);

(6) Chapter 403, Subchapter B of this title (related to Charges for Community-based Services);

(7) Chapter 403, Subchapter N of this title (relating to Administrative Hearings Arising Under the Persons with Mental Retardation Act);

(8) Chapter 406, Subchapter E of this title (relating to Eligibility and Review);

(9) §411.61 of this title (relating to Memorandum of Understanding Concerning Capacity Assessment for Self Care and Financial Management);

(10) Chapter 621 of this title (relating to Early Childhood Intervention Services); and

(11) The American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders.

Comments

Source Note: The provisions of this §5.162 adopted to be effective December 1, 2000, 25 TexReg 11391; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.163: Distribution

(a) This subchapter is distributed to:

(1) members of the Texas Mental Health and Mental Retardation Board;

(2) executive, management, and program staff in the department's Central Office;

(3) superintendents/directors of state facilities;

(4) chairs of boards of trustees of community centers;

(5) executive directors of mental retardation authorities;

(6) interested advocates and advocacy organizations

(7) all county and juvenile court judges; and

(8) commissioners of the following state agencies:

(A) Texas Department of Health;

(B) Texas Department of Human Resources;

(C) Texas Department of Protective and Regulatory Services;

(D) Texas Health and Human Services Commission;

(E) Texas Education Agency;

(F) Texas Rehabilitation Commission; and

(G) Texas Youth Commission.

(b) The superintendent/director of each state facility and the executive director of each MRA is responsible for distributing copies of this subchapter to appropriate staff.

(c) A copy of this subchapter will be provided to any person who requests it.

Comments

Source Note: The provisions of this §5.163 adopted to be effective December 1, 2000, 25 TexReg 11391; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

Subchapter H

§5.351: Purpose

The purpose of this subchapter is to:

(1) ensure that the rights and physical well-being of an individual residing in a state mental retardation facility (state MR facility) are protected during the use of restraint; and

(2) outline policies and procedures for initiating, monitoring, and reporting the use of restraint.

Comments

Source Note: The provisions of this §5.351 adopted to be effective June 23, 2004, 29 TexReg 5922; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.352: Application

This subchapter applies to state MR facilities.

Comments

Source Note: The provisions of this §5.352 adopted to be effective June 23, 2004, 29 TexReg 5922; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.353: Definitions

The following words and terms, when used in this subchapter, have the following meanings unless the context clearly indicates otherwise.

(1) Behavior therapy--Systematic efforts to increase adaptive behaviors and to modify maladaptive or problem behaviors and replace them with behaviors that are adaptive and socially acceptable.

(2) Behavioral emergency--A situation in which severely aggressive, destructive, violent, or self-injurious behavior exhibited by an individual:

(A) poses a substantial risk of imminent probable death of, or substantial bodily harm to, the individual or others;

(B) has not abated in response to attempted preventive de-escalatory or redirection techniques;

(C) could not reasonably have been anticipated;

(D) is not addressed in a behavior therapy program; and

(E) does not occur during a medical or dental procedure.

(3) CFR (Code of Federal Regulations)--The compilation of federal agency regulations.

(4) IDT (interdisciplinary team)--Mental retardation professionals and paraprofessionals and other concerned persons, as appropriate, who assess an individual's treatment, training, and habilitation needs and make recommendations for services.

(A) Team membership always includes:

(i) the individual;

(ii) the individual's LAR, if any; and

(iii) persons specified by a state MR facility who are professionally qualified and/or certified or licensed with special training and experience in the diagnosis, management, needs, and treatment of individuals with mental retardation.

(B) Other participants in IDT meetings may include:

(i) other concerned persons whose inclusion is requested by the individual or the LAR; and

(ii) at the discretion of the state MR facility, persons who are directly involved in the delivery of mental retardation services to the individual.

(5) Individual--A person with mental retardation who resides in a state MR facility.

(6) IPP (individual program plan)--A plan developed by an individual's IDT that identifies the individual's training, treatment, and habilitation needs and describes appropriate services and supports to meet those needs.

(7) LAR (legally authorized representative)--A person authorized by law to act on behalf of an individual with regard to a matter described in this subchapter, and may include a parent, guardian, managing conservator of a minor individual, or a guardian of an adult individual.

(8) Legally adequate consent--A term consistent with provisions of the Texas Health and Safety Code (THSC), Title 7, §591.006, which states, in essence, that consent obtained from an individual with mental retardation is legally adequate when each of the following conditions has been met:

(A) legal status: The individual giving the consent:

(i) is 18 years of age or older, or younger than 18 years of age and is or has been married or had the disabilities of minority removed for general purposes by court order as described in the Texas Family Code, Chapter 31; and

(ii) has not been determined by a court to lack capacity to make decisions with regard to the matter for which consent is being sought.

(B) comprehension of information: The individual giving the consent has been informed of and comprehends the nature, purpose, consequences, risks, and benefits of and alternatives to the procedure, and the fact that withholding or withdrawal of consent shall not prejudice the future provision of care and services to the individual with mental retardation; and

(C) voluntariness: The consent has been given voluntarily and free from coercion and undue influence.

(9) Mechanical device--A piece of equipment or an apparatus used in the safe and relatively comfortable restraint of individuals.

(10) Medical emergency--A situation in which acute, non-psychiatric signs and symptoms, including severe pain, exhibited by an individual require immediate attention by a physician or nurse:

(A) to preclude serious impairment to normal functioning of one or more of the individual's body parts or organs; or

(B) if the individual is a pregnant woman, to prevent irreversible harm to the woman or the woman's unborn child.

(11) Medical intervention--Treatment by a licensed medical doctor, osteopath, podiatrist, dentist, physician's assistant, or advanced practice nurse (APN). For the purposes of this subchapter, the term does not include first aid, an examination, diagnostics (e.g., x-ray, blood test), or the prescribing of oral or topical medication.

(12) Non-serious physical injury--Any injury requiring minor first aid and determined not to be serious by a registered nurse, advanced practice nurse (APN), or physician.

(13) PMAB (Prevention and Management of Aggressive Behavior)--The department's proprietary risk management curriculum that is intended to reduce the likelihood of injuries caused by the aggressive behavior of individuals receiving department services. The curriculum presents a graduated system of interventions that rely on the least restrictive approaches possible to respond to a behavioral emergency.

(14) Qualified mental retardation professional (QMRP)--A state MR facility employee responsible for integrating, coordinating, and monitoring an individual's IPP who meets the requirements of 42 CFR §483.430.

(15) Restraint--The use of manual pressure, except for physical guidance or prompting of brief duration, or a mechanical device to restrict:

(A) the free movement or normal functioning of the whole or a portion of an individual's body; or

(B) normal access by the individual to a portion of the individual's body.

(16) Restraint monitor--An employee of the state MR facility who:

(A) has experience working directly with persons with mental retardation;

(B) is designated to:

(i) go to a site where restraint in a behavioral emergency is implemented; and

(ii) provide supervision and oversight; and

(C) meets the training requirements described in §415.363 of this title (relating to Staff Training in the Use of Restraint).

(17) Serious physical injury--Any injury requiring medical intervention or hospitalization or any injury determined to be serious by a physician or advanced practice nurse (APN).

(18) State MR facility--A state mental retardation facility, i.e., a state school or state center operated by the department that provides residential services to individuals with mental retardation.

Comments

Source Note: The provisions of this §5.353 adopted to be effective June 23, 2004, 29 TexReg 5922; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.354: General Provisions

(a) Each state MR facility must have and implement written policies and procedures that:

(1) do not conflict with this subchapter or those provisions of the Conditions of Participation for Intermediate Care Facilities for Persons with Mental Retardation (42 CFR §483.410-483.480, et. seq.) concerning the management of inappropriate behavior;

(2) emphasize the department's commitment to:

(A) providing treatment that is the least restrictive and most effective alternative available for an individual;

(B) staff training that emphasizes early recognition of situations and behaviors that, if not appropriately addressed, could necessitate the use of restraint in a behavioral emergency; and

(C) reducing the necessity for the use of restraint;

(3) detail requirements for documenting and reporting the use of restraint, including instances when an individual:

(A) receives a serious physical injury or dies while in restraint during a behavioral emergency or as part of a behavior therapy program; or

(B) dies within 24 hours after being released from a restraint used during a behavioral emergency or as part of a behavior therapy program; and

(4) detail the training and demonstration of competence requirements for state MR facility staff.

(b) The standards in this subchapter take precedence over other applicable standards, including the ICF/MR Conditions of Participation, whenever the other applicable standards are less restrictive.

Comments

Source Note: The provisions of this §5.354 adopted to be effective June 23, 2004, 29 TexReg 5922; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.355: General Principles for the Use of Restraint

(a) The general principles listed in this subsection apply to the use of restraint in each of the following circumstances, unless explicitly stated otherwise:

(1) in a behavioral emergency;

(2) as an intervention in a behavior therapy program that addresses inappropriate behavior exhibited voluntarily by an individual (e.g., prevention of gouging of the individual's own eyes through the use of elbow immobilizers);

(3) during a medical or dental procedure if necessary to protect the individual or others and as a follow-up after a medical or dental procedure or following an injury to promote the healing of wounds;

(4) to protect the individual from involuntary self-injury (e.g., helmet for an individual who, during seizures, looses consciousness, falls to the floor, and risks head injuries), although not all techniques used by a state MR facility to protect an individual from involuntary self-injury constitute the use of restraint; and

(5) to provide postural support to the individual or to assist the individual in obtaining and maintaining normative bodily functioning, although not all techniques used by a state MR facility to provide postural support or assist in obtaining and maintaining normative bodily functioning constitute the use of restraint (e.g., placement of wedges, bolsters, or cushions to position an individual in a bed or chair).

(b) Upon an individual's admission to a state MR facility, an IDT must:

(1) with the involvement of a physician, identify:

(A) the individual's known physical or medical conditions that might constitute a risk to the individual during the use of restraint; and

(B) other factors that must be taken into account if the use of restraint is considered including, but not limited to, the individual's cognitive functioning level, size, weight, emotional condition (including whether the individual has a history of having been physically or sexually abused), and age; and

(2) document the identified conditions and factors and, as applicable, limitations on specific techniques or mechanical devices for restraint, in the individual's record.

(c) At least annually, or when significant changes occur to the extent and nature of the identified conditions and factors documented in the individual's record, the IDT must ensure that a physician, advanced practice nurse, or physician assistant reviews and updates, as necessary, the identified conditions, factors, and limitations on specific techniques or mechanical devices for restraint documented in the individual's record.

(d) Before restraint is used with an individual, state MR facility staff must determine that less restrictive, less intrusive interventions will be ineffective.

(e) Staff are prohibited from using restraint:

(1) for disciplinary purposes;

(2) for the convenience of staff or other individuals; or

(3) as a substitute for effective treatment or habilitation.

(f) Staff may use restraint only for the shortest period of time necessary to ensure:

(1) protection for the individual or others in a behavioral emergency; and

(2) therapeutic effectiveness;

(A) as part of a behavior therapy program;

(B) as part of a medical or dental procedure; and

(C) in protecting against involuntary self-injury.

(g) Staff are prohibited from using restraint in a way that:

(1) obstructs the individual's airway;

(2) impairs the individual's breathing by putting pressure on the individual's torso; or

(3) interferes with the individual's ability to communicate.

(h) Staff may use restraint only in a manner that:

(1) takes into consideration the individual's known physical or medical conditions that might constitute a risk to the individual during restraint, as documented in the individual's record in accordance with subsections (b)(2) and (c) of this section;

(2) takes into consideration other factors, including the individual's cognitive functioning level, size, weight, known physical, medical, and emotional condition, and age, as documented in the individual's record in accordance with subsections (b)(2) and (c) of this section;

(3) is consistent with the limitations on specific techniques or mechanical devices for restraint documented in the individual's record in accordance with subsections (b)(2) and (c) of this section;

(4) reduces the risk of injury or undue physical discomfort to the individual; and

(5) safeguards the individual's dignity, privacy, and well-being.

(i) Staff must implement restraint:

(1) with only the minimal amount of force or pressure that is reasonable and necessary to ensure the safety of the individual and others.

(2) without securing the individual to a stationary object while the individual is in a standing position;

(3) without causing pain that restricts the individual's movement; and

(4) without violating the individual's rights as described in §405.625 of this title (relating to Rights of Clients Receiving Residential Mental Retardation Services).

(j) Staff may use restraint only if it is authorized as described in:

(1) §415.356 of this title (relating to Use of Restraint in a Behavioral Emergency);

(2) §415.357 of this title (relating to Use of Restraint in a Behavior Therapy Program);

(3) §415.358 of this title (relating to Use of Restraint During Medical or Dental Procedures and to Promote Healing);

(4) §415.359 of this title (relating to Use of Restraint with a Mechanical Device to Protect an Individual from Involuntary Self-Injury); or

(5) §415.360 of this title (relating to Use of Restraint with a Mechanical Device to Provide Postural Support).

(k) When an individual is restrained, staff must ensure that the individual is:

(1) provided immediate relief, which may include immediate release from restraint, and checked by a nurse if the individual shows signs or symptoms of physical distress;

(2) provided with medications as prescribed;

(3) offered regular meals and snacks or, as appropriate, a nutritionally equivalent substitute; and

(4) monitored to the extent necessary, with consideration given to the individual's position, level of agitation, and the identified conditions and factors documented in the individual's record as described in subsection (b)(2) and (c) of this section to:

(A) prevent the individual from choking or aspirating food or fluid; and

(B) protect the individual from physical distress, self-injury, or injury by another individual. (For example, an individual in four-point restraint should be monitored continuously by staff, while an individual wearing a helmet or mittens may not require continuous monitoring.)

(l) At shift change, staff going off-duty must review the status of an individual who is in restraint as a result of a behavioral emergency or as part of a behavior therapy program with staff who are coming on-duty. The review must be documented in the individual's record and must address:

(1) time the restraint was initiated;

(2) individual's current physical, emotional, and behavioral condition;

(3) medications administered during the restraint; and

(4) type of care needed.

(m) All communication with an individual concerning the use of restraint must be:

(1) conducted in a language or method that is understandable by the individual;

(2) tailored to the individual's ability to comprehend; and

(3) responsive to any visual or hearing impairment the individual is known to have.

(n) If an individual in restraint experiences a medical emergency, staff must:

(1) release the individual from restraint as soon as possible as indicated by the medical emergency;

(2) ensure that the medical emergency is promptly addressed as described in the state MR facility's policies and procedures concerning management of a medical emergency; and

(3) obtain a new order for restraint, if the use of restraint at the time of the medical emergency had been in response to a behavioral emergency and the individual continues to exhibit behavior that constitutes a behavioral emergency.

(o) If an emergency evacuation or an evacuation drill occurs while an individual is in restraint, staff will respond as described in the state MR facility's policies and procedures to ensure the individual's safety.

(p) If an individual is involved in a program outside the state MR facility, e.g., attending public school or working, the state MR facility will:

(1) coordinate with staff from the outside program in the assessment and development of interventions with the goal of consistency in the use of restraint:

(A) in a behavioral emergency; and

(B) as an intervention in a behavior therapy program; and

(2) invite staff of the outside program to participate in IDT meetings at which interventions, including behavior therapy programs, are discussed.

(q) A state MR facility must ensure that at least one restraint monitor is on duty at all times to respond as described in §415.356(e)(2), (g), and (p) of this title (relating to Restraint in a Behavioral Emergency).

Comments

Source Note: The provisions of this §5.355 adopted to be effective June 23, 2004, 29 TexReg 5922; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.356: Use of Restraint in a Behavioral Emergency

(a) A physician must not issue a standing or "as needed" order for the use of restraint in a behavioral emergency.

(b) If an individual exhibits behavior that staff believe is likely to escalate into a behavioral emergency, staff first should attempt verbal or other de-escalative interventions in which they have been trained as described in §415.363(b) of this title (relating to Staff Training in the Use of Restraint).

(c) If the individual's behavior escalates into a behavioral emergency, one or more staff may initiate:

(1) personal restraint as instructed during Prevention and Management of Aggressive Behavior (PMAB) training provided by the state MR facility as described in §415.363(b) of this title (relating to Staff Training in the Use of Restraint); or

(2) in the rare situation when PMAB procedures cannot be safely applied, staff may take such actions as are reasonably believed to be immediately necessary to avoid imminent harm to the individual or others, including the use of a mechanical device:

(A) as long as those actions do not include acts of unnecessary force; and

(B) staff describe in the individual's record the actions that were taken and the reason why PMAB personal restraint techniques could not be safely applied.

(d) Unless a physician's order specifically directs otherwise as a result of the identified conditions and factors documented in the individual's record as described in §415.355(b)(2) and (c) of this title (relating to General Principles for the Use of Restraint), staff must:

(1) not place an individual in a prone or supine position during personal restraint; and

(2) if the individual in personal restraint rolls into a prone or supine position, restore the individual to a standing, sitting, or side position as soon as possible.

(e) Immediately after the individual is placed in restraint, staff must:

(1) explain to the individual that release from the restraint will occur as soon as the individual no longer poses a risk of imminent physical harm to self or to others; and

(2) notify a restraint monitor, who will:

(A) immediately go to the site of the restraint and ensure that the restraint is properly used;

(B) ensure that the individual is not at risk of serious physical injury or death and is receiving proper care;

(C) ensure that staff have explained to the individual that release from the restraint will occur as soon as the individual no longer poses a risk of imminent physical harm to self or others; and

(D) determine whether consultation by a professional is necessary (e.g., psychologist) and contact the appropriate professional, if deemed necessary.

(f) If notified by a restraint monitor that consultation is necessary, a professional (e.g., nurse or psychologist) will:

(1) determine the nature of the restraint monitor's concerns;

(2) go to the site of the restraint, if the professional determines this is warranted by the circumstances; and

(3) address the restraint monitor's concerns.

(g) As soon as reasonably possible, but in no case later than an hour after the individual was placed in restraint, the restraint monitor must report the use of restraint to a nurse with the following information:

(1) time the restraint was initiated;

(2) description of the specific behaviors which necessitated the use of restraint;

(3) the type of restraint;

(4) the duration of the restraint, if applicable; and

(5) the physical and apparent emotional condition of the individual.

(h) Upon being informed of the use of restraint, the nurse will:

(1) inform a physician, either in person or by phone, of the information described in subsection (g) of this section;

(2) document the physician's verbal order in the individual's record to include the:

(A) type of restraint;

(B) behaviors that necessitated the use of restraint;

(C) duration of the order, not to exceed 12 hours from the time the restraint was initiated;

(D) special instructions for the individual's care, if any, while in restraint; and

(E) time and date of the order; and

(3) within 30 minutes or as soon as reasonably possible of the individual's release from restraint or of being told of the individual's release from restraint, conduct a face-to-face evaluation of the individual for injuries and overall well-being.

(i) A physician will sign and date the order no later than the end of the next working day.

(j) While an individual is being restrained, staff must ensure that the individual is provided with:

(1) privacy to the extent possible without compromising the individual's safety or the safety of other individuals and staff; and

(2) an opportunity for a period of not less than five minutes during each one hour period:

(A) for movement and exercise if the restraint restricts the individual's range of motion in a limb or joint; and

(B) to use toilet facilities and drink fluids.

(k) If staff remove personal items, including clothing, from an individual to ensure the safety of the individual or others during the use of restraint in a behavioral emergency, staff must:

(1) ensure that the personal items are secured from damage, loss, or theft;

(2) provide clothing as appropriate to ensure the individual's dignity and privacy, if the personal items that were removed include clothing; and

(3) ensure that the personal items are returned to the individual immediately upon release from restraint.

(l) As the circumstances warrant, when releasing an individual from restraint to provide an opportunity for movement and exercise as described in subsection (j)(2)(A)-(B) of this section, staff may release one limb at a time.

(m) If an individual released from restraint as described in subsection (j)(2)(A)-(B) of this section demonstrates behavior that would constitute a behavioral emergency, staff will return the individual to restraint.

(n) Staff must release an individual from restraint:

(1) as soon as the individual no longer poses a risk of imminent physical harm to self or others; and

(2) when the individual falls asleep while being restrained with a mechanical device.

(o) After the individual is released from restraint, staff will:

(1) provide transition activities to facilitate the individual's re-assimilation into the social milieu;

(2) observe the individual for at least 15 minutes to ensure a smooth assimilation with documentation in the individual's record;

(3) if the individual's record directs that the individual be provided with an opportunity to discuss the use of restraint, inform the appropriate staff person; and

(4) complete the state MR facility's restraint checklist documenting the care of the individual while in restraint.

(p) The restraint monitor:

(1) will ensure that:

(A) all necessary documentation is completed;

(B) the individual's QMRP is notified and the notification is documented in the individual's record; and

(C) the appropriate professional staff (e.g., psychologist) is notified if the restraint occurred within 24 hours of another restraint of the individual in a behavioral emergency; and

(2) must debrief staff who actively participated in the use of restraint.

(q) The state MR facility will ensure that, within 24 hours of the individual's release from restraint, the individual's LAR (or the person listed in the individual's record as primary correspondent) is notified that the individual was restrained in a behavioral emergency with information about the type of restraint and the individual's condition. The notification will be documented in the individual's record.

(r) If staff must use restraint to address an individual's inappropriate behavior that escalates into a behavioral emergency while the individual is away from the state MR facility, staff must comply with §415.355 of this title (relating to General Principles for the Use of Restraint) and follow the procedures described in this section, with the following exceptions:

(1) Instead of notifying a restraint monitor as described in subsection (e)(2) of this section, staff who initiated the restraint must:

(A) report the use of restraint to a nurse at the state MR facility as soon as is reasonably possible; and

(B) provide the nurse with the information described in subsection (g) of this section.

(2) Upon returning to the state MR facility, staff must notify the restraint monitor who will comply with the provisions of subsection (p) of this section.

(s) An individual's IDT will meet to review alternative strategies, which may include developing a behavior therapy program that targets for modification or replacement those behaviors that resulted in behavioral emergencies, if the individual is restrained in a behavioral emergency:

(1) more often than twice within 30 calendar days;

(2) in two or more separate episodes of any duration within 12 hours; or

(3) for more than 12 continuous hours.

(t) Staff will follow the provisions of §405.31 of this title (relating to Emergency Use of Psychotropic Medications) if the use of psychotropic medications in a behavioral emergency is deemed necessary by a physician.

(u) The following procedures must not be used in a behavioral emergency, but may be used as part of an approved behavior therapy program, as described in Chapter 415, Subchapter I of this title (relating to Behavior Therapy in State Mental Retardation Facilities):

(1) use of a time out room; and

(2) restraint using a restraint board.

Comments

Source Note: The provisions of this §5.356 adopted to be effective June 23, 2004, 29 TexReg 5922; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.357: Use of Restraint in a Behavior Therapy Program

(a) The use of restraint as an intervention in a behavior therapy program must be approved and implemented as described in Chapter 415, Subchapter I of this title (relating to Behavior Therapy--State Mental Retardation Facilities).

(b) The provisions of this section must be followed by staff when implementing restraint as directed in an individual's behavior therapy program both on and off the state MR facility campus.

(c) Immediately after an individual is placed in restraint as directed in the individual's behavior therapy program, staff must explain to the individual the conditions under which the individual will be released from restraint, unless the behavior therapy program provides direction to the contrary.

(d) Unless a physician's instructions in the behavior therapy program specifically direct otherwise as a result of the identified conditions and factors documented in the individual's record as described in §415.355(b)(2) and (c) of this title (relating to General Principles for the Use of Restraint), staff must:

(1) not place an individual in a prone or supine position during personal restraint; and

(2) if the individual in personal restraint rolls into a prone or supine position, restore the individual to a standing, sitting, or side position as soon as possible.

(e) If staff determine that consultation by a professional (e.g., nurse or psychologist) is necessary, staff will contact the appropriate professional. The professional will:

(1) determine the nature of staff's concerns; and

(2) go to the site of the restraint, if the professional determines this is warranted by the circumstances.

(f) While an individual is being restrained, staff must ensure that the individual is provided with an opportunity for a period of not less than five minutes during each one hour period:

(1) for movement and exercise if the restraint restricts the individual's range of motion in a limb or joint; and

(2) to use toilet facilities and drink fluids.

(g) If an individual released from restraint as described in subsection (f) of this section demonstrates behavior that would constitute a behavioral emergency, staff will initiate restraint as described in §415.356 of this title (relating to Use of Restraint in a Behavioral Emergency.

(h) Unless the individual's behavior therapy program directs otherwise, a nurse must check the individual for injuries and overall well-being after the individual is released from restraint.

Comments

Source Note: The provisions of this §5.357 adopted to be effective June 23, 2004, 29 TexReg 5922; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.358: Use of Restraint During Medical or Dental Procedures and to Promote Healing

(a) Restraint may be used:

(1) during medical and dental procedures if necessary to protect the individual or others while the procedure is accomplished (e.g., body restraint during surgery; arm restraint during intravenous administration; restraint devices to carry out dental procedures, etc.);

(2) after medical and dental procedures to promote healing; and

(3) following treatment of an injury to promote healing or while recovering from an illness.

(b) Restraint may be used without a physician's written order only if its use is explicitly permitted in the state MR facility's written medical, dental, or nursing policies and procedures.

(1) A dentist may order restraint for dental procedures only.

(2) The use of restraint must be recorded in the individual's record. For restraint during a dental procedure, the information must be included in the dental section of the record.

(c) If a physician or dentist orders a use of restraint that is not explicitly permitted in the state MR facility's written medical, dental, or nursing policies and procedures, the physician or dentist must include in the written order:

(1) type of restraint;

(2) clinical justification for the use of restraint;

(3) duration of the order; and

(4) special instructions for the individual's care, if any, while in restraint.

(d) While an individual is being restrained as described in this section, staff must evaluate the individual periodically to ensure that the individual is not in physical distress and has not sustained an injury as a result of the restraint.

(e) If restraint is used during a medical or dental procedure other than a medical emergency, the IDT will consider what steps may be taken to reduce the need for restraint during medical or dental care in the future. Possible options include desensitization training, behavior shaping, intensive positive reinforcement, and environmental changes.

Comments

Source Note: The provisions of this §5.358 adopted to be effective June 23, 2004, 29 TexReg 5922; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.359: Use of Restraint with a Mechanical Device to Prevent Involuntary Self-injury

(a) Some techniques used by a state MR facility to protect an individual from an injury that might result from involuntary movements exhibited by the individual (e.g., falling and hitting head on floor as a result of a seizure) may constitute restraint with a mechanical device. An individual's IDT may authorize staff to use restraint with a mechanical device if:

(1) the IDT determines that less restrictive interventions are inappropriate;

(2) a physician concurs with the recommendation and signs an order for use of the mechanical device; and

(3) state MR facility staff obtains, for a period not to exceed one year:

(A) legally adequate consent from the individual who is able to provide legally adequate consent;

(B) consent from the individual's LAR; or

(C) authorization by the head of the state MR facility if:

(i) the individual is not able to provide legally adequate consent and does not have an LAR; or

(ii) the individual's LAR has:

(I) not responded to the state MR facility's attempts to obtain the LAR's consent; and

(II) been notified that the head of the state MR facility may authorize the use of restraint if the LAR does not respond.

(b) The IDT must document the following in the individual's record:

(1) a description of the involuntary movements which necessitate the use of restraint with a mechanical device;

(2) the less restrictive interventions and alternative strategies that have been attempted or considered;

(3) the specific mechanical device recommended; and

(4) instructions for safe use of the mechanical device.

(c) Mechanical devices used as described in this section may include:

(1) helmet for an individual with a seizure disorder;

(2) bedrails to prevent an individual from falling out of bed; and

(3) seat belt to prevent an individual from falling out of a wheelchairs.

(d) An individual's IDT must review the use of a mechanical device for restraint as described in this section at least annually and whenever changes in the extent and nature of the individual's involuntary movements occur.

(1) The IDT will consider whether less restrictive interventions might be appropriate to protect the individual from involuntary self-injury.

(2) The IDT may recommend continued use of the mechanical device only if it determines that less restrictive interventions continue to be inappropriate to protect the individual from involuntary self-injury.

(3) The IDT must document in the individual program plan any measures taken to alleviate the need for the mechanical device.

(4) If the IDT recommends a change in the type of mechanical device, the recommendation must be submitted to a physician for review.

(A) If the physician concurs with the recommendation, the physician will sign an order for use of the mechanical device.

(B) Staff must obtain consent or authorization as described in subsection (a)(3) of this section whenever the IDT recommends a change in the type of mechanical device for restraint.

Comments

Source Note: The provisions of this §5.359 adopted to be effective June 23, 2004, 29 TexReg 5922; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.360: Use of Restraint with a Mechanical Device to Provide Postural Support

(a) Some techniques used by a state MR facility if an individual requires assistance to maintain postural support may constitute restraint with a mechanical device. An individual's IDT may authorize staff to use restraint with a mechanical device if:

(1) the individual's IDT concurs with the recommendation of a licensed occupational therapist or physical therapist that less restrictive interventions are inappropriate and recommends the use of restraint with a mechanical device;

(2) a physician concurs with the IDT's recommendation and signs an order for use of the mechanical device; and

(3) state MR facility staff obtain, for a period not to exceed one year:

(A) legally adequate consent from the individual who is able to provide legally adequate consent;

(B) consent from the individual's LAR; or

(C) authorization by the head of the state MR facility if:

(i) the individual is not able to provide legally adequate consent and does not have an LAR; or

(ii) the individual's LAR has:

(I) not responded to the state MR facility's attempts to obtain the LAR's consent; and

(II) been notified that the head of the state MR facility may authorize the use of restraint if the LAR does not respond.

(b) The IDT must document the following in the individual's record:

(1) a description of the condition which necessitates the use of restraint with a mechanical device;

(2) the expected therapeutic outcome;

(3) the less restrictive interventions and alternative strategies that have been attempted or considered;

(4) the specific mechanical device recommended; and

(5) instructions for safe use of the mechanical device.

(c) Mechanical devices used as described in this section may include, but are not limited to, vests and seat belts. They are considered an adjunct to proper care of an individual and may not be used as a substitute for appropriate nursing care.

(d) An individual's IDT must review the use of a mechanical device for restraint as described in this section at least annually and whenever changes in the extent and nature of the individual's physical condition occur.

(1) The IDT will consider whether less restrictive interventions might be appropriate to assist the individual in maintaining postural support.

(2) The IDT may recommend continued use of the mechanical device only if it determines that less restrictive interventions continue to be inappropriate to assist the individual in maintaining postural support.

(3) The IDT must document in the IPP any measures taken to alleviate the need for the mechanical device.

(4) If the IDT recommends a change in the type of mechanical device, the recommendation must be submitted to a physician for review.

(A) If the physician concurs with the recommendation, the physician will sign an order for use of the mechanical device.

(B) Staff must obtain consent or authorization as described in subsection (a)(3) of this section whenever the IDT recommends a change in the type of mechanical device for restraint.

Comments

Source Note: The provisions of this §5.360 adopted to be effective June 23, 2004, 29 TexReg 5922; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.361: Mechanical Devices for Use in Restraint

(a) A state MR facility must use only those mechanical devices designed specifically for the safe and relatively comfortable restraint of humans, to include:

(1) commercially available devices; and

(2) devices developed independently by or on behalf of the state MR facility.

(b) A state MR facility may use a commercially available mechanical device that has been altered to accommodate an individual's specific physical needs (e.g., a physical impairment or obesity) or a mechanical device developed independently by or on behalf of the state MR facility only if its use has been approved by the director of State MR Facilities in the department's Central Office.

(1) Before the state MR facility requests approval from the director of State MR Facilities to use such a mechanical device, a written description of the mechanical device and its intended use (with pictures and sketches, as appropriate) must be reviewed and approved by a committee at the state MR facility that includes the following staff:

(A) medical director or designee;

(B) nursing director or designee;

(C) director of psychology;

(D) director of habilitation services;

(E) safety officer; and

(F) rights officer.

(2) If the committee approves the mechanical device, a written description of the mechanical device and its intended use (with pictures and sketches, as appropriate) will be submitted to the head of the state MR facility, who must decide within 10 working days whether to request approval from the director of State MR Facilities to use the mechanical device.

(3) Within 10 working days of receiving a request for approval to use a mechanical device, the director of State MR Facilities must review the request and notify the head of the state MR facility whether or not the request has been approved.

(c) Staff will inspect a mechanical device before and after each use to ensure the device is in good repair and without tears or protrusions that may cause injury. A damaged mechanical device must be repaired before it can be used in the restraint of an individual. If a damaged mechanical device cannot be repaired to make it safe for use in the restraint of an individual, it must be discarded.

(d) Staff must ensure that a mechanical device is not secured so tightly that the individual's circulation or breathing is impaired or so loosely that the individual's skin is chafed. Staff must exercise caution when using mechanical devices such as a camisole or straitjacket that may impair the individual's balance or interfere with the individual's ability to break a fall.

(e) Staff may use two or more mechanical devices simultaneously in the restraint of an individual in a behavioral emergency if a physician authorizes their use.

(f) The following mechanical devices may be used in the restraint of an individual.

(1) Anklets--Padded bands of cloth or leather that are secured around the individual's ankles or legs using hook-and-loop (e.g., Velcro brand) tape or buckle fasteners and attached to a stationery object (e.g., bed or chair frame).

(2) Arm splints or elbow immobilizers--Strips of any material with padding that extend from below to above the elbow and are secured around the arm with ties or hook-and-loop (e.g., Velcro brand) tape. If appropriate, they should be secured such that the individual has full use of the hands.

(3) Belts--A cloth or leather band that is fastened around the waist and secured to a stationery object (e.g., chair frame) or used for securing the arms to the sides of the body.

(4) Camisole--A sleeveless cloth jacket which covers the arms and upper trunk and is secured behind the individual's back.

(5) Chair restraint--A padded, stabilized chair which supports all body parts and is used with anklets or wristlets to prevent the individual from standing up without assistance.

(6) Helmets--A plastic, foam rubber, or leather head covering, such as sports helmets, that may include an attached face guard.

(7) Mittens--A cloth, plastic, foam rubber, or leather hand covering, such as boxing and other types of sport gloves, that are secured around the wrist or lower arm with elastic, hook-and-loop (e.g., Velcro brand) tape, ties, paper tape, pull strings, buttons, or snaps.

(8) Restraint board--A padded, rigid board to which an individual is secured face-up, unless that position is clinically contraindicated for that individual. This device will not be used in the restraint of an individual in a behavioral emergency.

(9) Restraining net--Mesh fabric that is placed over an individual's upper and lower trunk with the head, arms, and lower legs exposed; the net is secured over a mattress to a bed frame and is never placed over the individual's head.

(10) Straitjacket--A heavy canvas jacket that is open in the back and has sleeves that are stitched closed. The individual's arms are crossed in front and the sleeves secured with ties at the back.

(11) Ties--A length of cloth or leather used to secure approved mechanical restraints (i.e., mittens, wristlets, arm splints, belts, anklets, vests, etc.) to a stationary object (i.e., bed or wheelchair frame) or to other mechanical restraints.

(12) Transport jacket--A heavy canvas sleeveless jacket that encases the arms and upper trunk, fastens with hook-and-loop (e.g., Velcro brand) tape or roller buckles, and is held in place by a strap between the legs.

(13) Vest--A sleeveless cloth jacket which covers the upper trunk of the individual. The vest may be secured to a stationary object (e.g., bed or chair frame).

(14) Wristlets--Padded cloth or leather bands that are secured around the individual's wrists or arms using hook-and-loop (e.g., Velcro brand) tape or buckle fasteners and attached to a stationery object (e.g., bed or chair frame).

(g) The following mechanical devices must not be used in the restraint of an individual.

(1) metal wrist or ankle cuffs;

(2) rubber bands, ropes, and cords, unless part of an approved device;

(3) long ties and leashes, including halter leashes;

(4) restraining sheets attached to any stationary object other than a bed;

(5) padlocks; and

(6) barred enclosures with tops, including crib-style bed with mesh tops.

(h) A mechanical device that is not described in subsection (f) of this section but is not expressly forbidden in subsection (g) of this section may be used in the restraint of an individual if its use is approved as described in subsection (b) of this section.

Comments

Source Note: The provisions of this §5.361 adopted to be effective June 23, 2004, 29 TexReg 5922; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.362: Additional Reporting and Documentation Requirements

(a) Reports to head of the state MR facility.

(1) Staff will notify the head of the state MR facility or designee immediately, but in no case more than one hour after learning of a serious physical injury to or death of an individual that occurs while the individual is in restraint.

(2) Within one working day of receiving the notice described in paragraph (1) of this subsection, the head of the state MR facility or designee must:

(A) notify the State MR Facilities Division in Central Office of the serious physical injury or death; and

(B) name one or more staff to investigate the serious physical injury or death.

(3) The staff named to investigate the serious physical injury or death must submit a written report on the results of the investigation to the head of the state MR facility or designee no later than five working days after the notice of the serious physical injury or death required in paragraph (1)(A)-(B) of this subsection.

(A) The written report will be reviewed by the head of the facility, who will take prompt appropriate corrective action, if determined to be necessary.

(B) A copy of the report will be submitted to the State MR Facilities Division in Central Office.

(b) Reports to Texas Department of Family and Protective Services. If the serious physical injury or death is suspected to be the result of abuse or neglect, staff must make a verbal report immediately, but in no case more than one hour after suspicion or after learning of the incident, to the Texas Department of Family and Protective as described in §417.505 of this title (relating to Reporting Responsibilities of all TDMHMR Employees, Agents, and Contractors: Reports to the Texas Department of Protective and Regulatory Services (TDPRS)).

(c) Reports required by MOU. If the serious physical injury or death is a reportable incident as described in the memorandum of understanding titled "Reportable Incidents in State Schools, State Centers, State Operated Community-based MHMR Services, and Community Mental Health and Mental Retardation Centers with Intermediate Care Facilities for the Mentally Retarded (ICF/MR)" dated March 25, 1996, the head of the state MR facility will report the incident as described in the MOU.

(d) Reports to Central Office. Each state MR facility must prepare and submit to the State Mental Retardation Facilities division in Central Office a quarterly report on the state MR facility's use of restraint in behavioral emergencies, as part of behavior therapy programs, and to prevent involuntary self-injury. The report must include the following:

(1) number of incidents and types of restraint and the number of individuals restrained during each month of the fiscal year quarter, with designation of how many individuals were under 18 years of age;

(2) the number of serious physical injuries and non-serious physical injuries and the injury rate for each month of the fiscal quarter, with designation of how many individuals were under 18 years of age; and

(3) number of deaths that occur within 24 hours of the use of restraint for each month of the fiscal quarter, with designation of how many individuals were under 18 years of age.

(e) Analysis of data. The head of the state MR facility must ensure ongoing analysis of data collected as described in subsection (d) of this section to identify issues or emerging trends and to develop appropriate responses.

Comments

Source Note: The provisions of this §5.362 adopted to be effective June 23, 2004, 29 TexReg 5922; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.363: Staff Training in the Use of Restraint

(a) The state MR facility must inform each employee whose work responsibilities involve direct contact with individuals of the employee's roles and responsibilities under this subchapter and under written facility policy and procedures.

(b) Before an employee assumes work responsibilities that might require the employee to participate in restraint, the state MR facility will ensure that the employee receives training and demonstrates the competencies:

(1) in the department's approved restraint training program as outlined in the course descriptions in the TDMHMR Operating Instructions of Internal Facilities Management for Human Resources: Minimum Training Requirements (407. 12: §7);

(2) in sections of the PMAB training program as appropriate to the employee's position and responsibilities, and as required under the TDMHMR Operating Instructions of Internal Facilities Management for Human Resources: Minimum Training Requirements (407. 12. §7); and

(3) related to the state MR facility's written policies and procedures as appropriate to the employee's position and responsibilities.

(c) An employee who is a restraint monitor must:

(1) have successfully completed those sections of the department's PMAB curriculum that address the procedures used at the state MR facility and successfully complete subsequent refresher training annually; and

(2) have successfully completed the state MR facility's training in the following:

(A) cardiopulmonary resuscitation (CPR) and successfully complete subsequent refresher training every two years;

(B) rights of an individual and successfully complete subsequent refresher training annually;

(C) abuse and neglect and successfully complete subsequent refresher training annually;

(D) use of restraint, to include the mechanical devices utilized by the state MR facility and successfully complete subsequent refresher training annually; and

(E) conducting and documenting the debriefing of an employee who actively participated in the restraint of an individual during a behavioral emergency.

(d) Before a nurse or physician assumes work responsibilities that require participation in requesting, ordering, evaluating, or documenting restraint, the state MR facility will ensure that the nurse or physician receives training and demonstrates competence in:

(1) recognizing facility procedures for requesting, ordering, evaluating, or documenting restraint;

(2) recognizing facility-approved personal restraint procedures and mechanical devices;

(3) identifying contraindications specific to facility-approved personal restraint procedures and mechanical devices; and

(4) recalling reporting procedures for restraint-related injuries and deaths.

(e) The state MR facility will ensure that each employee whose work responsibilities require the employee to participate in restraint must demonstrate competence annually in the areas described in subsection (b)(1)-(3) of this section.

(f) Documentation of training and demonstrated competence for each employee will be kept by the state MR facility's human resource development office. Documentation shall include the name of the training, the date of training, the name of the instructor or person who assessed competence, a list of successfully demonstrated knowledge and skills and the date knowledge and skills were assessed.

Comments

Source Note: The provisions of this §5.363 adopted to be effective June 23, 2004, 29 TexReg 5922; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.364: Enforcement

(a) The head of the state MR facility is responsible for the enforcement of this subchapter.

(b) The state MR facility will take appropriate disciplinary action if an employee violates the provisions of this subchapter.

Comments

Source Note: The provisions of this §5.364 adopted to be effective June 23, 2004, 29 TexReg 5922; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.365: References

Reference is made to the following statutes and rules of the department:

(1) 42 CFR §§483.410-483.480 et. seq., (Conditions of Participation for Intermediate Care Facilities for Persons with Mental Retardation);

(2) 42 CFR §483.430;

(3) Chapter 405, Subchapter B of this title (relating to Prescribing of Psychotropic Medication--Mental Retardation Facilities);

(4) §405.31 of this title (relating to Emergency Use of Psychotropic Medications);

(5) §405.625 of this title (relating to Rights of Clients Receiving Residential Mental Retardation Services);

(6) Chapter 415, Subchapter I of this title (relating to Behavior Therapy in State Mental Retardation Facilities);

(7) §417.505 of this title (relating to Reporting Responsibilities of all TDMHMR Employees, Agents, and Contractors: Reports to the Texas Department of Protective and Regulatory Services (TDPRS)); and

(8) "Reportable Incidents in State Schools, State Centers, State Operated Community-based MHMR Services, and Community Mental Health and Mental Retardation Centers with Intermediate Care Facilities for the Mentally Retarded (ICF/MR)" dated March 25, 1996.

Comments

Source Note: The provisions of this §5.365 adopted to be effective June 23, 2004, 29 TexReg 5922; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.366: Distribution

(a) This subchapter shall be distributed to:

(1) members of the Texas Mental Health and Mental Retardation Board;

(2) executive, management, and program staff in Central Office;

(3) heads of state mental retardation facilities; and

(4) individual advocates and advocacy organizations.

(b) The heads of state mental retardation facilities shall ensure that appropriate staff receive copies of this subchapter.

(c) A copy of this subchapter shall be made available upon request to:

(1) an individual;

(2) the LAR of an individual;

(3) the counsel of record of an individual or LAR;

(4) an actively involved family member or friend of an individual;

(5) a state MR facility employee; or

(6) any interested party.

Comments

Source Note: The provisions of this §5.366 adopted to be effective June 23, 2004, 29 TexReg 5922; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

Subchapter I

§5.401: Purpose

The purpose of this subchapter is to:

(1) ensure that the health, safety, welfare, rights, and privileges of an individual residing in a state mental retardation facility (state MR facility) are protected when staff recommend utilizing highly restrictive procedures or restricting rights or privileges to address the individual's inappropriate behavior;

(2) outline policies and procedures for developing, implementing, monitoring, and reporting behavior therapy programs; and

(3) describe principles that support and enhance the practice of applied behavior analysis and behavior therapy.

Comments

Source Note: The provisions of this §5.401 adopted to be effective June 23, 2004, 29 TexReg 5939; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.402: Application

This subchapter applies to state MR facilities.

Comments

Source Note: The provisions of this §5.402 adopted to be effective June 23, 2004, 29 TexReg 5939; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.403: Definitions

The following words and terms when used in this subchapter shall have the following meanings unless the context clearly indicates otherwise.

(1) Behavior services director--A person appointed by the head of the state MR facility to chair the facility's behavior therapy committee and consult with program directors and who:

(A) is knowledgeable in the specifics of behavior therapy principles and theory;

(B) is qualified to evaluate published behavior therapy research studies; and

(C) has applied experience with behavior therapy techniques.

(2) Behavior therapy--The application of applied behavior analysis principles, cognitive therapies, and skills acquisition to clinical problems with the intent of increasing adaptive behaviors and modifying or replacing targeted behaviors with behaviors that are adaptive and socially acceptable.

(3) Behavior therapy committee--Persons designated by a state MR facility who are knowledgeable about applied behavior analysis and who:

(A) review, approve, and monitor behavior therapy programs; and

(B) review, monitor, and make suggestions concerning the state MR facility's policies and procedures concerning behavior therapy.

(4) CFR (Code of Federal Regulations)--The compilation of federal agency regulations.

(5) Functional analysis--An assessment of environmental and biological factors that may influence inappropriate behavior exhibited by an individual.

(6) Head of the state MR facility--The superintendent of a state school or the executive director of a state center.

(7) Highly restrictive procedures--

(A) Restraint--The use of manual pressure, except for physical guidance or prompting of brief duration, or a mechanical device to restrict:

(i) the free movement or normal functioning of the whole or a portion of an individual's body; or

(ii) normal access by the individual to a portion of the individual's body.

(B) Use of timeout room--Placement of an individual alone and under constant, direct staff supervision in an enclosed area in which positive reinforcement is not available and from which egress is denied by a closed door in accordance with Code of Federal Regulations (CFR), Title 42, §483.450(c), concerning timeout rooms. The term does not include circumstances in which staff remain in close proximity to an individual who has been directed to an area that is removed from regular activities.

(C) Application of aversive stimuli--Application of any stimulus that may be unpleasant or noxious, startling, or painful such that its intended effect is the suppression of the targeted behavior upon which it is immediately contingent. Such stimuli include olfactory, auditory, gustatory, tactile, and other stimuli that may result in physical discomfort or pain.

(D) Effortful task--An activity requiring physical effort by an individual that is directed or manually guided by staff. Examples of effortful tasks include, but are not limited to:

(i) Required exercise--A procedure whereby an individual performs and may be guided by staff to perform a series of physical movements that are incompatible with the undesirable response they systematically follow. An example would be the guided movement of a self-injurious individual's arms through a series of positions away from the body.

(ii) Negative practice--A procedure whereby an individual is required to repeatedly engage in an effortful task that is topographically similar to the undesirable response the procedure systematically follows. An example is a program in which an individual who strikes others is required to repeatedly hit a punching bag following each occurrence of striking others.

(iii) Restitutional overcorrection--A procedure whereby an individual is required to correct the consequences of a disruptive response by performing a task that restores the environment to a state even more improved than existed before the disruptive behavior. An example would be the requirement that a disruptive individual polish all the tables in the residence as a consequence of knocking over one of them.

(iv) Positive practice overcorrection--A procedure whereby an individual is required to repeatedly engage in an appropriate behavior related to the function of the undesirable response the procedure systematically follows. An example is a program in which an individual is required to repeatedly practice an appropriate social behavior contingent upon exhibition of a targeted behavior.

(8) Human Rights Committee (HRC)--Persons designated by a state MR facility in accordance with 42 CFR §483.440(f)(3), concerning specially constituted committee, who review, approve and monitor behavior therapy programs and review, monitor, and make suggestions about the state MR facility's policies, procedures, and practices concerning behavior therapy programs.

(9) Interdisciplinary team (IDT)--Mental retardation professionals and paraprofessionals and other concerned persons, as appropriate, who assess an individual's treatment, training, and habilitation needs and make recommendations for services.

(A) Team membership always includes:

(i) the individual;

(ii) the individual's LAR, if any; and

(iii) persons specified by a state MR facility who are professionally qualified and/or certified or licensed with special training and experience in the diagnosis, management, needs, and treatment of individuals with mental retardation.

(B) Other participants in IDT meetings may include:

(i) other concerned persons whose inclusion is requested by the individual or the LAR; and

(ii) at the discretion of the state MR facility, persons who are directly involved in the delivery of mental retardation services to the individual.

(10) Individual--A person with mental retardation who resides in a state MR facility.

(11) LAR (legally authorized representative)--A person authorized by law to act on behalf of an individual with regard to a matter described in this subchapter, and may include a parent, guardian, or managing conservator of a minor individual, or a guardian of an adult individual.

(12) Legally adequate consent--A term consistent with provisions of the Texas Health and Safety Code (THSC), §591.006, which states, in essence, that consent obtained from an individual with mental retardation is legally adequate when each of the following conditions has been met:

(A) legal status: The individual giving the consent:

(i) is 18 years of age or older, or younger than 18 years of age and is or has been married or had the disabilities of minority removed for general purposes by court order as described in the Texas Family Code, Chapter 31; and

(ii) has not been determined by a court to lack capacity to make decisions with regard to the matter for which consent is being sought.

(B) comprehension of information: The individual giving the consent has been informed of and comprehends the nature, purpose, consequences, risks, and benefits of and alternatives to the procedure, and the fact that withholding or withdrawal of consent shall not prejudice the future provision of care and services to the individual with mental retardation; and

(C) voluntariness: The consent has been given voluntarily and free from coercion and undue influence.

(13) State MR (mental retardation) facility--A state school or state center operated by the department that provides residential services to individuals with mental retardation.

(14) Targeted behavior--An inappropriate behavior exhibited by an individual that the IDT has identified for modification or reduction.

Comments

Source Note: The provisions of this §5.403 adopted to be effective June 23, 2004, 29 TexReg 5939; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.404: General Provisions

(a) Each state MR facility must have and implement written policies and procedures concerning behavior therapy that:

(1) do not conflict with this subchapter or 42 CFR §483.450(b), concerning the management of inappropriate behavior;

(2) emphasize the department's commitment to:

(A) providing treatment and habilitation to an individual that is:

(i) the least restrictive, least intrusive, and most effective alternative available; and

(ii) supportive and positive; and

(B) reducing the necessity for the use of highly restrictive procedures or other restrictions of the rights and privileges of an individual in behavior therapy programs;

(3) describe the process to be followed for obtaining, as appropriate, legally adequate consent from an individual, consent from an individual's LAR, or authorization from the head of the state MR facility before implementing a behavior therapy program or a functional analysis that requires a written protocol; and

(4) detail the training and demonstration of competence requirements for state MR facility staff.

(b) The standards in this subchapter take precedence over other applicable standards, including the Conditions of Participation for Intermediate Care Facilities for Persons with Mental Retardation (42 CFR §§483.410-483.480 et. seq.), whenever the other applicable standards are less prescriptive.

Comments

Source Note: The provisions of this §5.404 adopted to be effective June 23, 2004, 29 TexReg 5939; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.405: General Principles for Behavior Therapy Programs

A state MR facility will ensure that the following general principles are incorporated in its written polices and procedures developed as described in §415.404 of this title (relating to General Provisions) and followed during the development, implementation, and monitoring of behavior therapy programs for individuals.

(1) The health, safety, welfare, rights, and privileges of an individual must protected.

(2) Only the least intrusive or restrictive intervention that effectively modifies or replaces a targeted behavior will be employed as part of a behavior therapy program.

(3) Staff do not exercise control over an individual; rather, staff offer an individual the needed and appropriate support that enables the individual to modify or reduce inappropriate behavior.

(4) Staff must attempt to understand an individual's motivation for engaging in inappropriate behavior in order to effectively develop a strategy for making changes to the individual's environment that will result in a modification of or reduction in the inappropriate behavior.

(5) Staff must ensure that an individual who exhibits inappropriate behavior is treated with compassion and respect, in addition to being provided with effective and appropriate services.

Comments

Source Note: The provisions of this §5.405 adopted to be effective June 23, 2004, 29 TexReg 5939; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.406: Development, Implementation, and Monitoring of Effectiveness of Behavior Therapy Programs

(a) When a behavior therapy program must be developed. An individual's treating psychologist, with input from the individual's interdisciplinary team (IDT), must develop a written behavior therapy program for the individual if:

(1) the IDT recommends the use of a highly restrictive procedure or other restriction of the individual's rights or privileges to modify or replace a targeted behavior; or

(2) the individual is receiving medications intended primarily for the treatment of a psychiatric disorder.

(b) Functional analysis.

(1) The individual's treating psychologist must implement a functional analysis before developing a behavior therapy program.

(2) If an individual participates in a program outside the state MR facility (e.g., attending public school or working), the functional analysis must involve the outside program. The state MR facility must invite staff of the outside program to participate in the functional analysis.

(3) The individual's treating psychologist must develop a written protocol if the functional analysis will involve any of the following:

(A) systematic changes in environmental and biological factors that might adversely impact the individual;

(B) evaluation of a highly restrictive procedure; or

(C) a significant risk of injury to the individual or others (e.g., the targeted behavior involves severe self-injury or aggression towards others).

(4) A written protocol, as required in paragraph (3) of this subsection, must:

(A) be developed by the treating psychologist;

(B) describe the specific procedures or environmental variables to be manipulated;

(C) describe the length of time required for each phase; and

(D) be reviewed and approved by:

(i) the individual's IDT;

(ii) the state MR facility's behavior services director; and

(iii) the chair of the state MR facility's Human Rights Committee (HRC).

(5) Before implementing a functional analysis that requires a written protocol a state MR facility must ensure that staff:

(A) obtain legally adequate consent, consent, or authorization in accordance with §415.407(a) or (b) of this title (relating to Requirement to Obtain Legally Adequate Consent, Consent, or Authorization); and

(B) document the legally adequate consent, consent, or authorization in the individual's record.

(c) Development of behavior therapy program.

(1) If an individual participates in a program outside the state MR facility (e.g., attending public school or working), the individual's IDT must invite staff of the outside program to participate in the development of a behavior therapy program that will be implemented while the individual is on the state MR facility campus.

(2) If the individual's treating psychologist and IDT determine that an individual's behavior therapy program should include a highly restrictive procedure, then the determination of which procedure to use must be based on:

(A) evidence documented in professional and scientific literature of the probability that the specific technique or procedure:

(i) will be effective in modifying or replacing a targeted behavior; and

(ii) is appropriate for an individual's cognitive functioning level, size, weight, known physical, medical, and emotional condition, and age; and

(B) the results of the functional analysis.

(3) As required by 40 TAC §90.42(e)(4)(A) (relating to Standards for Facilities Serving Persons with Mental Retardation or Related Conditions), if restraint is the highly restrictive procedure being considered by the individual's IDT as an intervention in a behavior therapy program, a physician must participate on the IDT concur with the IDT's recommendation concerning the use of restraint.

(4) An individual's behavior therapy program must be developed and implemented as described in this subchapter and 42 CFR §483.450 (Condition of Participation: Client Behavior and Facility Practices).

(5) The written behavior therapy program must:

(A) describe the targeted behavior;

(B) describe reliable and representative baseline data indicating the frequency and severity of the targeted behavior;

(C) summarize the results of the functional analysis;

(D) specify behavioral objectives;

(E) describe detailed procedures for implementation of the behavior therapy program to include:

(i) the chosen intervention;

(ii) the recommended replacement behavior and how it is to be introduced; and

(iii) the techniques to prevent the occurrence of the targeted behavior;

(F) provide instructions for an evaluation of the individual by a nurse for injuries and overall well-being after the individual is released from restraint, if restraint is the chosen intervention and the IDT determines that an evaluation by a nurse is necessary;

(G) describe methods for evaluating the program's effectiveness to include collection and analysis of data;

(H) describe procedures for making timely revisions to the program based on an analysis of data if the specified behavioral objectives are not met; and

(I) specify the timeframes for reviewing the program.

(d) Review and approval of and consent to a behavior therapy program. Prior to implementation of a behavior therapy program, the state MR facility must ensure that:

(1) the behavior therapy program is reviewed and approved by:

(A) the individual's IDT;

(B) the state MR facility's HRC; and

(C) the state MR facility's behavior therapy committee;

(2) staff obtain legally adequate consent, consent, or authorization in accordance with §415.407(a) or (b) of this title (relating to Requirement to Obtain Legally Adequate Consent, Consent, or Authorization); and

(3) staff document the legally adequate consent, consent, or authorization in the individual's record.

(e) Use of a highly restrictive procedure.

(1) Except as described in paragraph (2) of this subsection, a behavior therapy program utilizing a highly restrictive procedure will not be approved by an individual's IDT, the state MR facility's HRC, or the state MR facility's behavior therapy committee unless a behavior therapy program that utilizes less restrictive procedures has been systematically attempted and failed to modify or replace the targeted behavior. Procedures for teaching replacement behaviors must be implemented simultaneously.

(A) If a highly restrictive procedure is being considered, evidence must be present in the individual's record that describes other less restrictive and less intrusive interventions, including verbal or other de-escalative interventions, that have been utilized and found to be ineffective in modifying or replacing the targeted behavior.

(B) If the highly restrictive procedure being considered is restraint the individual's IDT must:

(i) obtain written authorization from a physician, advanced practice nurse, or physician assistant stating that the individual has no known physical or medical condition that would constitute a risk to the individual during the use of restraint;

(ii) consider other factors that might be contraindications to the use of restraint, including the individual's cognitive functioning level, size, weight, emotional condition, including whether the individual has a history of having been physically or sexually abused, and age; and

(iii) limitations on specific techniques or mechanical devices for restraint as documented in the individual's record in accordance with §415.355(b)(2) and (c) of this title (relating to General Principles for the Use of Restraint).

(C) If the individual's medical condition changes and becomes a contraindication to the use of restraint, the physician must review the authorization.

(D) The state MR facility's HRC must approve any significant increase in the intensity or duration of a highly restrictive procedure, unless the behavior therapy program specifies the conditions under which an increase may occur.

(2) If an individual's inappropriate behavior is so severe (i.e., life threatening) or of such duration that other therapeutic approaches are currently precluded, the individual's IDT, the HRC, and the behavior therapy committee may approve and the state MR facility may implement a behavior therapy program that utilizes a highly restrictive procedure without first attempting a behavior therapy program that utilizes less restrictive procedures.

(f) Monitoring by qualified mental retardation professional (QMRP).

(1) The individual's QMRP, as defined in 42 CFR §483.430(a), concerning qualified mental retardation professional, must review the behavior therapy program to assess whether the specified behavioral objectives are being met:

(A) during the quarterly review of the Individual Plan of Care; or

(B) more frequently, if the QMRP believes changes in the individual's behavior, functioning level, or physical, or medical condition warrant it.

(2) If the individual's QMRP determines that the behavioral objectives specified in the program are not being met, or that significant changes in the individual's behavior, functioning level, or physical or medical condition have occurred, the QMRP must notify the individual's treating psychologist.

Comments

Source Note: The provisions of this §5.406 adopted to be effective June 23, 2004, 29 TexReg 5939; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.407: Requirement to Obtain Legally Adequate Consent, Consent, or Authorization

(a) Except as provided in subsection (b) of this section, a state MR facility must obtain legally adequate consent or consent in accordance with this subsection before implementing a functional analysis that requires a written protocol or a behavior therapy program.

(1) If an individual has the ability to provide legally adequate consent, the state MR facility will attempt to obtain legally adequate consent from the individual.

(2) If an individual lacks the ability to provide legally adequate consent and has an LAR, the state MR facility will make reasonable attempts to obtain consent from the LAR.

(3) Efforts taken by the state MR facility to obtain legally adequate consent from an individual or consent from an LAR must be documented in the individual's record.

(b) The head of the state MR facility, in accordance with Texas Health and Safety Code, §592.054, may authorize implementation of a functional analysis that requires a written protocol or a behavior therapy program only if:

(1) the individual lacks the ability to provide legally adequate consent and does not have an LAR; or

(2) the individual lacks the ability to provide legally adequate consent and the individual's LAR:

(A) has not responded to the state MR facility's attempts to obtain the LAR's consent; and

(B) has been notified that the head of the state MR facility may authorize implementation of a behavior therapy program if the LAR does not respond.

(c) An individual with the ability to provide legally adequate consent or the LAR of an individual who lacks the ability to provide legally adequate consent may:

(1) withhold consent to the implementation of a functional analysis that requires a written protocol or a behavior therapy program; or

(2) withdraw consent at any time to the continued implementation of a functional analysis that requires a written protocol or a behavior therapy program.

(d) If legally adequate consent is withheld or withdrawn by an individual or if consent is withheld or withdrawn by an LAR as described in subsection (c) of this section:

(1) state MR facility staff must document in the individual's record the time, date, and circumstances under which the withholding or withdrawal of consent occurred; and

(2) the individual's IDT must convene to discuss alternative interventions to address the targeted behavior.

(e) The consent or authorization to implement a behavior therapy program must be reviewed by the individual's IDT and the state MR facility's HRC at least annually and upon any substantive modification of the program or significant change in the individual's medical condition.

Comments

Source Note: The provisions of this §5.407 adopted to be effective June 23, 2004, 29 TexReg 5939; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.408: Use of Restraint

If restraint is used as part of a behavior therapy program, it must be implemented as described in §415.355 of this title (relating to General Principles for the Use of Restraint) and §415.357 of this title (relating to Use of Restraint in a Behavior Therapy Program).

Comments

Source Note: The provisions of this §5.408 adopted to be effective June 23, 2004, 29 TexReg 5939; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.409: Documenting and Reporting Behavior Therapy Programs That Use Highly Restrictive Procedures

Each state MR facility must prepare and submit to the State Mental Retardation Facilities division in Central Office a report for each fiscal year quarter detailing the implementation of behavior therapy programs that utilize highly restrictive procedures, to include:

(1) the number of individuals 18 years of age or older for whom approved behavior therapy programs were in place during each month of the fiscal year quarter;

(2) the number of individuals under 18 years of age for whom approved behavior therapy programs were in place during each month of the fiscal year quarter; and

(3) a description of highly restrictive procedures utilized in those programs.

Comments

Source Note: The provisions of this §5.409 adopted to be effective June 23, 2004, 29 TexReg 5939; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.410: Staff Training in Behavior Therapy

(a) The state MR facility must inform each employee whose work responsibilities involve direct contact with individuals of the employee's role and responsibilities under this subchapter and under the state MR facility's written policies and procedures related to this subchapter.

(b) Before an employee assumes work responsibilities that might require the employee to implement procedures described in a behavior therapy program, the state MR facility will ensure that the employee receives training and demonstrates competence in the specific procedures required by the behavior therapy program.

(c) The state MR facility will ensure that each employee whose work responsibilities require the employee to implement procedures described in a behavior therapy program must demonstrate competence in those procedures at least annually, and whenever the procedures required by a behavior therapy program are changed. If an employee does not demonstrate competence in the required procedures, the state MR facility will ensure that the employee receives training and demonstrates competence in those procedures.

(d) Documentation of training and demonstrated competence for each employee will be kept by the state MR facility.

Comments

Source Note: The provisions of this §5.410 adopted to be effective June 23, 2004, 29 TexReg 5939; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.411: References

Reference is made to the following statutes and regulations:

(1) 42 CFR §§483.410-483.480 et. seq., (Conditions of Participation for Intermediate Care Facilities for Persons with Mental Retardation);

(2) 42 CFR §483.430(a), concerning qualified mental retardation professional;

(3) 42 CFR §483.440(f)(3), concerning specially constituted committee;

(4) 42 CFR §483.450 (Condition of Participation: Client Behavior and Facility Practices);

(5) 42 CFR §483.450(b), concerning the management of inappropriate behavior;

(6) 42 CFR §483.450(c), concerning timeout rooms;

(7) Texas Family Code, Chapter 31;

(8) Texas Health and Safety Code (THSC), §591.006;

(9) THSC, §592.054;

(10) §415.355 of this title (relating to General Principles for the Use of Restraint) and §415.357 of this title (relating to Use of Restraint in a Behavior Therapy Program); and

(11) 40 TAC §90.42(e)(4)(A) (relating to Standards for Facilities Serving Persons with Mental Retardation or Related Conditions).

Comments

Source Note: The provisions of this §5.411 adopted to be effective June 23, 2004, 29 TexReg 5939; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.412: Distribution

(a) This subchapter shall be distributed to:

(1) members of the Texas Mental Health and Mental Retardation Board;

(2) executive, management, and program staff in Central Office;

(3) heads of state MR facilities;

(4) individual advocates and advocacy organizations, and

(5) Texas Department of Human Services, Long Term Care Division.

(b) The head of the state MR facility shall ensure that appropriate staff receive copies of this subchapter.

(c) A copy of this subchapter shall be made available upon request to:

(1) an individual;

(2) the LAR of an individual;

(3) the counsel of record of an individual or LAR;

(4) an actively involved family member or friend of an individual;

(5) a state MR facility employee; or

(6) any interested party.

Comments

Source Note: The provisions of this §5.412 adopted to be effective June 23, 2004, 29 TexReg 5939; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

Subchapter J

§5.451: Purpose

The purpose of this subchapter is to describe the responsibilities of local mental health and mental retardation authorities (MHMRAs) for providing specialized services and alternate placement services to nursing facility residents who have been identified through the Preadmission Screening and Resident Review (PASARR) process as needing such services.

Comments

Source Note: The provisions of this §5.451 adopted to be effective January 5, 2003, 27 TexReg 12236; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.452: Application

The provisions of this subchapter apply to MHMRAs.

Comments

Source Note: The provisions of this §5.452 adopted to be effective January 5, 2003, 27 TexReg 12236; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.453: Definitions

The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise.

(1) Alternate placement services--Assistance provided to a nursing facility resident by an MHMRA service coordinator to locate and secure services chosen by the resident or LAR that meet the resident's basic needs in a setting other than a nursing facility. The services include the identification of specific services and supports available through alternate resources for which the resident may be eligible and an explanation of the possible consequences of selecting an alternate service.

(2) Basic needs--Adequate food, clothing, safe and sanitary shelter, support services, and medical services to sustain life.

(3) CFR (Code of Federal Regulations)--The compilation of federal agency regulations.

(4) Dementia--A degenerative disease of the central nervous system as diagnosed by a physician in accordance with the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM).

(5) IDT (interdisciplinary team)--The team described in 40 TAC §19.2500(e)(4).

(6) LAR (legally authorized representative)--A person authorized by law to act on behalf of a nursing facility resident with regard to a matter described in this subchapter, and may include a parent, guardian, or managing conservator of a minor, a guardian of an adult, and surrogate decision-maker (SDM).

(7) Local mental health and mental retardation authority (MHMRA)--An entity to which the Texas Board of Mental Health and Mental Retardation delegates its authority and responsibility for planning, policy development, coordination and resource development and allocation, and for supervising and ensuring the provision of mental health and mental retardation services in one or more local service areas.

(8) Mental illness--A current primary or secondary diagnosis of a major mental disorder (as defined in the Diagnostic and Statistical Manual of Mental Disorders, third edition, revised in 1987 (DSM-III-R). A major mental disorder is a schizophrenic, mood, paranoid, panic, or other severe anxiety disorder; somatoform disorder; personality disorder; other psychotic disorder; or another mental disorder that may lead to a chronic disability without a primary diagnosis of dementia (including Alzheimer's disease or a related disorder). The disorder results in functional limitations in major life activities within the past three to six months that would be appropriate to the individual's developmental stage. The individual typically has serious difficulty in at least one of the following areas on a continuing or intermittent basis: interpersonal functioning, and/or concentration, persistence, and pace; or adaptation to change. Within the past two years, the disorder has required psychiatric treatment more intensive than outpatient care and/or the individual has experienced an episode of significant disruption to the normal living situation for which supportive services were required to maintain functioning at home or in a residential treatment environment or which resulted in intervention by housing or law enforcement officials.

(9) Mental retardation--A diagnosis of mental retardation (mild, moderate, severe, or profound) as described in Classification in Mental Retardation, American Association on Mental Deficiency, 1983 Revision, i.e., mental retardation is significantly subaverage general intellectual functioning existing concurrently with deficits in adaptive behavior and manifested during the developmental period.

(10) Nursing facility--A Medicaid-certified facility that is licensed in accordance with Texas Health and Safety Code, Chapter 242.

(11) Preadmission Screening and Resident Review (PASARR)--The process of evaluating, reviewing, and establishing a person's need for nursing facility services and for specialized services by staff of the Texas Department of Human Services (TDHS) in accordance with 40 TAC §19.2500 (relating to Preadmission Screening and Resident Review (PASARR)).

(12) PASARR determination--A decision made by Texas Department of Human Services (TDHS) PASARR Determination Program professional staff to establish if a person requires the level of services provided in a nursing facility, as defined by medical necessity, and if the person has a need for specialized services for mental illness, mental retardation, and/or a related condition. The decisions are based on information included in the Level II PASARR Assessment.

(13) Related condition--A severe, chronic disability as defined in 42 CFR §435.1009, that:

(A) is attributable to:

(i) cerebral palsy or epilepsy; or

(ii) any other condition including autism, but excluding mental illness, found to be closely related to mental retardation because this condition results in impairment of general intellectual functioning or adaptive behavior similar to that of persons with mental retardation, and requires treatment or services similar to those required for these persons;

(B) is manifested before the person reaches age 22;

(C) is likely to continue indefinitely; and

(D) results in substantial functional limitations in three or more of the following areas of major life activity:

(i) self-care;

(ii) understanding and use of language;

(iii) learning;

(iv) mobility;

(v) self-direction; or

(vi) capacity for independent living.

(14) Service coordinator--A staff member of an MHMRA who ensures that a nursing facility resident eligible to receive specialized services or alternate placement services receives such services as chosen by the resident or LAR.

(15) Specialized services--

(A) For a person with mental illness, the implementation of an individualized plan of care developed under and supervised by an (IDT).

(B) For a person with mental retardation or a related condition, the implementation of an aggressive, continuous, and individualized program of specialized and generic training, treatment, health services, and related services that is directed toward acquisition of the behaviors necessary for the person to function with as much self-determination and independence as possible and prevention or deceleration of regression or loss of current optimal functional status. It does not include services to maintain generally independent people who are able to function with little supervision or in the absence of a continuous program of specialized services.

(16) Support services--Services which may include social, psychological, habilitative, rehabilitative, or other assistance appropriate to the person's needs as determined by the IDT.

(17) TDHS--Texas Department of Human Services.

(18) THSC (Texas Health and Safety Code)--Texas statutes relating to health and safety.

Comments

Source Note: The provisions of this §5.453 adopted to be effective January 5, 2003, 27 TexReg 12236; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.454: Pasarr Determination Process

A PASARR determination is a professional decision based upon written criteria and objective information and made in accordance with the rules of the Texas Department of Human Services at 40 TAC §19.2500 (relating to Preadmission Screening and Resident Review (PASARR)). The MHMRAs must provide specialized services to those residents determined through this process to need specialized services for mental illness, mental retardation, or a related condition.

Comments

Source Note: The provisions of this §5.454 adopted to be effective January 5, 2003, 27 TexReg 12236; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.455: Provision of Specialized Services and Alternate Placement Services

(a) An MHMRA must provide specialized services and alternate placement services as described in the TDMHMR OBRA PASARR Policy and Procedure Manual for Specialized Services and Alternate Placement Services and in 40 TAC §19.2500(e) (relating to Preadmission Screening and Resident Review (PASARR)).

(b) A nursing facility resident's service coordinator must convene an interdisciplinary team (IDT) meeting in accordance with 40 TAC §19.2500(e)(4) to develop a plan for specialized services and alternate placement services, if alternate placement services are requested by the resident or the resident's LAR.

(1) Communication techniques and devices should be utilized as appropriate to facilitate the resident's participation in all aspects of service planning.

(2) The resident or the resident's LAR may identify individuals to be invited to the meeting and indicate that certain members may not attend. However, written information will be received from and reviewed by all IDT members.

(c) The service coordinator must:

(1) provide a copy of the specialized services plan and any changes to the plan to the resident's nursing facility, as required by 40 TAC §19.2500(e)(8) (relating to Preadmission Screening and Resident Review);

(2) inform the resident or the resident's LAR that the resident may request orally and the LAR may submit a written request to receive a copy of the specialized services plan and any changes to the plan; and

(3) if the resident makes an oral request or the LAR a written request, provide a copy of the specialized services plan and any change to the plan to the resident or LAR.

(d) The service coordinator must:

(1) provide a monthly written report to the nursing facility and attending physician regarding the delivery of specialized services or alternate placement services as specified in 40 TAC §19.2500(e)(5) (relating to Preadmission Screening and Resident Review (PASARR));

(2) inform the resident or the resident's LAR that the resident may request orally and the LAR may submit a written request to receive a copy of the monthly written report regarding the delivery of specialized services or alternate placement services; and

(3) if the resident makes an oral request or the LAR a written request, provide a copy of the written report regarding the delivery of specialized services or alternate placement services to the resident or LAR monthly until the request is withdrawn orally by the resident or in writing by the LAR.

(e) When the resident or the resident's LAR selects an alternate placement located by the service coordinator, the service coordinator must:

(1) obtain written agreement for the specific alternate placement from the resident or the resident's LAR; or

(2) if the resident who does not have an LAR is unable to provide written agreement, document the resident's oral agreement for the specific alternate placement.

(f) An MRA must provide specialized services and alternate placement services in compliance with:

(1) TDMHMR OBRA PASARR Policy and Procedure Manual;

(2) Chapter 412, Subchapter J, of this title (relating to Service Coordination); and

(3) Chapter 419, Subchapter L, of this title (relating to Medicaid Rehabilitative Services).

Comments

Source Note: The provisions of this §5.455 adopted to be effective January 5, 2003, 27 TexReg 12236; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.456: Assistance for Applicants Denied Nursing Facility Admission

If an applicant to a nursing facility is denied admission to the nursing facility based on a PASARR determination and the applicant or the applicant's LAR requests that the MHMRA provide assistance in locating alternate support services, the MHMRA must provide assistance to the applicant as it would to any other person seeking such services.

Comments

Source Note: The provisions of this §5.456 adopted to be effective January 5, 2003, 27 TexReg 12236; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.457: References

Reference is made in this subchapter to the following laws, regulations, standards, and manuals:

(1) 42 CFR §435.1009;

(2) Chapter 412, Subchapter J, of this title (relating to Service Coordination);

(3) Chapter 419, Subchapter L, of this title (relating to Medicaid Rehabilitative Services);

(4) 40 TAC §19.2500 (relating to Preadmission Screening and Resident Review (PASARR));

(5) International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM);

(6) Diagnostic and Statistical Manual of Mental Disorders, Third Edition, revised in 1987 (DSM-III-R);

(7) Classification in Mental Retardation, American Association on Mental Deficiency, 1983 Revision; and

(8) TDMHMR OBRA PASARR Policy and Procedure Manual for Specialized Services and Alternate Placement.

Comments

Source Note: The provisions of this §5.457 adopted to be effective January 5, 2003, 27 TexReg 12236; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841

§5.458: Distribution

This subchapter shall be distributed to:

(1) members, Texas Mental Health and Mental Retardation Board;

(2) management and program staff in TDMHMR Central Office;

(3) superintendents/directors, state mental health and mental retardation facilities;

(4) executive directors, local mental health and mental retardation authorities;

(5) chairs, boards of trustees, local mental health and mental retardation authorities;

(6) Texas Department of Human Services;

(7) Texas Department of Health;

(8) Texas Health and Human Services Commission; and

(9) advocacy organizations and interested individuals.

Comments

Source Note: The provisions of this §5.458 adopted to be effective January 5, 2003, 27 TexReg 12236; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8841