1. (1) Policy. It is the purpose of the Department, reflected in M.G.L. c. 123B, § 2, and 115 CMR 5.14, "to establish procedures and the highest practicable professional standards" for the treatment of persons with intellectual and developmental disability, and to assure the dignity, health, safety, of its clients. System-wide PBS is a widely accepted and utilized framework for both systems change and individual treatment which supports individuals to grow and reach their maximum potential. PBS emerged from three major sources:

   1. (a) applied behavior analysis;
   2. (b) the normalization/inclusion movement; and
   3. (c) person-centered values. Journal of Positive Behavior Interventions, Positive Behavior Support: Evolution of an

Applied Science," (Carr, Edward, Dunlap, Glen, Horner, Robert, et al.) Vol. 4, No. 1 (2002). PBS provides a means for selecting, organizing and implementing evidenced-based practices in the treatment of individuals. It focuses on clearly defined outcomes, data-based decision making and problem-solving processes that support practices with fidelity and durability. PBS emphasizes the use of positive behavior approaches and recognizes that behavior is often an individual's response or reaction to the environment and the need to communicate his or her preferences and wants to others. Therefore, PBS focuses on environmental modifications and antecedents. The strategies used to modify the behavior of individuals should involve PBS,

which promote the dignity and respect of individuals, and should not be unduly restrictive or intrusive. It is both sound law and policy to use only procedures which have been determined to be the least restrictive or least intrusive alternatives.

1. (2) Required Elements of Positive Behavior Support for All Providers. All programs services or supports operated, certified, licensed, contracted for or otherwise funded by the Department, shall have the following elements to support the implementation of PBS: a PBS Leadership Team; a PBS Action Plan; Universal Supports, as defined in 115 CMR 5.14(3); and a system of data-based decision making for both individual treatment decisions and for system decisions.
2. (3) Required Elements of Positive Behavior Supports for Providers with Individuals Needing Targeted or Intensive Supports. All programs proving supports to individuals needing Targeted or Intensive Supports shall have the following elements, in addition to those described in 115 CMR 5.14(2), to support the implementation of PBS: a referral plan for additional PBS support; a system to conduct functional behavior assessment, as described at 115 CMR 5.14(7), for each individual requiring Targeted or Intensive Supports; Targeted or Intensive Supports, based on individual needs; a PBSP for each individual requiring such supports; a PBS Qualified Clinician(s) to develop, implement, and monitor the PBSP; a system of coaching; and a systemic process for monitoring and quality improvement.

3. (4) PBS Leadership Team. The PBS Leadership Team is the organizational entity providing governance for all PBS activities. All providers are required to have a PBS Leadership Team.

   1. (a) Membership of the PBS Leadership Team must include: an individual in an executive leadership position with authority to implement changes in management, content, resources and/or training, a Senior PBS qualified clinician, and other agency personnel representing different functional units within the organization, such as human rights, quality assurance or clinical staff.
   2. (b) In accordance with their organization's practices with regard to stakeholder participation, providers should invite one or more representatives of stakeholders, including individuals served by the organization, and or family members of individuals served, to participate and/or provide advice on PBS.

   3. (c) The responsibilities of the PBS Leadership Team shall include:

      1. 1. developing a written organization-wide PBS Action Plan;
      2. 2. determining the configuration and number of PBS tiers based on population served and agency organizational structure, including Targeted or Intensive Team(s), as necessary;
      3. 3. ensuring that the Universal Tier of PBS is implemented, and strategies have been identified to implement the Targeted or Intensive Tiers if they are needed by specific individuals;
      4. 4. developing agency PBS goals and metrics to assess progress toward the goals;

      5. 5. using ongoing data based decision making to:

         1. a. assess the implementation of the PBS Action Plan(s) on an ongoing basis,
         2. b. assess the treatment integrity of PBS across all three tiers, and
         3. c. assess the effectiveness of implementation of PBS plans across all three tiers;
      6. 6. providing PBS training, coaching and oversight to staff within the organization.

4. (5) Tiers of Support. All providers must maintain such systems of support as are necessary to meet the needs of the individuals they serve. These must include a Universal tier team, Universal tier of supports, and may include one or more tiers of support.

   1. (a) Universal Tier of Supports. Universal Supports are practices in place at all times supporting all individuals. Universal Supports ensure appropriate expectations are developed in all settings, socially appropriate behavior is reliably encouraged, and individuals are given choices and have opportunity to engage in preferred activities. Universal Supports include teaching individuals replacement skills and/or modifying physical or social environments to prevent challenging behavior.

      1. 1. For individuals requiring interventions in addition to Universal Supports, providers must implement a standardized identification and referral process to refer an individual for Targeted or Intensive Supports.
      2. 2. For individuals requiring additional support at the Targeted or Intensive Supports level, Universal Supports shall be maintained.
      3. 3. Universal Supports include, but are not limited to, evidence-based practices such as praise, redirection, or use of schedules to provide structure to the environment.

   2. (b) Targeted Tier of Support.

      1. 1. All Targeted PBSPs must be in compliance with 115 CMR 5.14(8).
      2. 2. Targeted Supports are practices implemented fairly rapidly on an "as needed" basis for an individual or group of individuals at risk for developing challenging behavior and needing interventions in addition to Universal Supports. The initiation of Targeted Supports is a means to avoid serious challenging behavior. Targeted Supports are intended to support an individual(s) who is at risk for reduced quality of life due to his or her actions or the actions of another person. Reasons for initiating Targeted Supports may include responding to stressful life events or to address behaviors that are not immediately high risk.
      3. 3. The Targeted Supports available for inclusion in a PBSP are determined by a provider's PBS Leadership Team.
      4. 4. Targeted Supports include, but are not limited to, the least restrictive, evidence-based practices such as "check-in, check-out," self-monitoring, relaxation training, individualized schedule(s), positive-only token economies, or minimally intrusive decelerative consequences such as "planned ignoring" or voluntary time-out.
      5. 5. Notwithstanding anything contained in 115 CMR 5.14(5), providers may develop individualized, targeted supports unique to an individual but that do not meet the criteria for the Targeted Tier of Support set forth in 115 CMR 5.14(5)(b)2. Such individualized or "targeted supports" must be expressed in written guidelines, but do not require an abbreviated or informal functional behavior assessment and do not require a PBSP. An example of an individualized or targeted support would be a unique approach to transitions to avoid the development of a challenging behavior.

   3. (c) Intensive Tier of Support.

      1. 1. All Intensive Support Plans must be in compliance with 115 CMR 5.14(8).
      2. 2. Individuals are referred for Intensive Supports when there are concerns the health, safety, or emotional well-being of the individual, or others, is at risk, or the individual's quality of life is seriously impeded due to challenging behavior.
      3. 3. An Intensive PBSP may include, but are not limited, to restrictive procedures identified at 115 CMR 5.14(14). A PBSP containing a restrictive procedure(s) requires an Intensive PBSP and must meet the requirements for the same.
      4. 4. Intensive Supports typically are not implemented until Universal and Targeted Supports have been implemented with integrity and data have shown them to be insufficient to effect meaningful behavioral change. However, when there is danger of harm to an individual's self or others, Intensive Supports may be implemented immediately.
      5. 5. Intensive Supports may include the use of de-escalation techniques contained in the CPRR curriculum as defined in 115 CMR 5.02.

5. (6) General Principles of Positive Behavior Supports.

   1. (a) PBS should avoid the use of intrusive or restrictive interventions. There should be a focus on developing a comprehensive understanding of the individual, his or her life, health, and challenging behaviors through assessments including functional behavior assessment.
   2. (b) PBS require the use of evidence-based practices and peer-reviewed literature for interventions, the ongoing monitoring of individuals and ensuring treatment integrity, i.e. the use of practices that are effective and improve outcomes for individuals.
   3. (c) Targeted and Intensive Supports require a statement of the areas of concern, a functional behavior assessment (abbreviated or informal for Targeted Supports and formal for Intensive Supports) and a written PBSP. However, a PBSP is not required for "targeted supports" described at 115 CMR 5.14(5)(b)5.

6. (7) Functional Behavior Assessment.

   1. (a) Functional behavior assessment (FBA) is the process of gathering and analyzing information about an individual's behavior in order to determine the purpose or intent of the actions. FBA should include an assessment of the antecedents and consequences, and consider the individual's history, paying special attention to factors that may have contributed to the behavior(s). As part of the initial steps in FBA, consideration of explanations for the behavior(s), including medical, medication or psychiatric issues is required.
   2. (b) FBA looks beyond the behavior itself for the cause of the behavior (the function). FBA seeks to understand what the individual is trying to communicate through his or her behavior, and what the function of the behavior is in the environmental context in which it occurs.
   3. (c) An FBA should include the elements consistent with guidance provided by the Department.

7. (8) Positive Behavior Support Plans.

   1. (a) A written PBSP is required for Targeted or Intensive Supports. The PBSP must be designed and written by a PBS qualified clinician. A PBSP should include the elements consistent with guidance provided by the Department. The PBSP should describe procedures for preventing a problem from occurring and ongoing monitoring of individuals to ensure treatment integrity.
   2. (b) PBSPs may include other assessments as needed and will seek to identify the strengths, preferences and interests of the individual.
   3. (c) PBSPs shall consist of the most efficient and the fewest interventions and support strategies coupled with reinforcement. Success will be measured by the increase of desired behaviors, a reduction of challenging behaviors, and improvements in quality of life.
   4. (d) PBSPs should focus on alternative strategies that address people's needs and provide meaningful choices. PBSPs should document such strategies, including that consideration was given to eliminating, reducing or minimizing antecedents or environmental conditions causing or exacerbating challenging behavior by making environmental modifications; emphasizing teaching or strengthening effective replacement behaviors and reinforcing incompatible behaviors serving the same function as and replace the identified challenging behavior(s); implementing a formal skill acquisition plan and data collection procedure in order to assess the effectiveness of skill acquisition activities; increasing monitoring of all aspects of the plan; and initiating more frequent or external reviews of data to ensure treatment integrity.
   5. (e) PBSPs that incorporate restrictive procedures must focus on alternative strategies contained in 115 CMR 5.14(8)(d).
8. (9) Crisis Prevention, Response and Restraint Procedures. Crisis, Prevention, Response and Restraint (CPRR) procedures may be utilized as provided in 115 CMR 5.11 and may not be included in a PBSP. The goal of CPRR procedures is to ensure the safety of the individual and/or others. CPRR should terminate as quickly as possible.

9. (10) PBS Qualified Clinician.

   1. (a) A PBS qualified clinician shall:

      1. 1. be currently licensed in Massachusetts in accordance with applicable law as one of the following:

         1. a. a psychologist;
         2. b. an independent clinical social worker;
         3. c. an applied behavior analyst;
         4. d. a master's or doctorate level speech pathologist;
         5. e. a physician;
         6. f. a master's or doctorate level teacher with a certification in special education; or
         7. g. a licensed mental health counselor (LMHC); or be a doctorate level special education teacher actively teaching the topics of positive behavior support or applied behavior analysis at the college or university level;
      2. 2. have at least three years of training, including post graduate class work or formal training, and/or experience in function based behavioral assessment and treatment; and
      3. 3. have at least three years of clinical experience in the treatment of individuals with developmental disabilities.

   2. (b) A Senior PBS qualified clinician serving on a leadership team under 115 CMR 5.14(4) shall:

      1. 1. be a PBS Qualified Clinician as described at 115 CMR 5.14(10)(a);
      2. 2. have training in PBS, organizational strategies, and multi-tiered systems of support;
      3. 3. have at least five years of training, including post-graduate class work or formal training, and/or experience in function based behavioral assessment and treatment;
      4. 4. have at least five years of clinical experience in the treatment of individuals with developmental disabilities; and
      5. 5. be able to perform all duties of a PBS qualified clinician under 115 CMR 5.14(10)(c).

   3. (c) A PBS qualified clinician's duties include:

      1. 1. design and implementation of PBSPs, including making referrals to other clinicians;
      2. 2. monitoring individuals and data to ensure treatment integrity and to determine effectiveness of the PBSP;
      3. 3. making revisions to the PBSP as necessary; and

      4. 4. providing supervision of:

         1. a. clinicians who meet the criteria described in 115 CMR 5.14(10)(a)1. and 2. who do not have a minimum of three years of experience as described at 115 CMR 5.14(10)(a)3., and

         2. b. personnel with a bachelor's degree in:

            1. i. psychology;
            2. ii. social work;
            3. iii. applied behavior analysis;
            4. iv. speech and language pathology; or
            5. v. education (teacher) and at least one year of post graduate experience working with individuals with developmental disabilities.

10. (11) Quality Review and Monitoring.

    1. (a) All programs shall be responsible for implementing an internal quality review and monitoring process.
    2. (b) Quality review and monitoring processes should include the elements consistent with guidance provided by the Department.
    3. (c) The Department may periodically review a sample of PBS Action Plans, PBSPs and PBS internal monitoring plans to improve quality of systems and individual PBSPs.

11. (12) Peer Consultation and Peer Review.

    1. (a) Peer Consultation. Peer consultation is provided in order to improve the quality and skill of the qualified clinician or author of the activities associated with the provision of PBS. Peer consultation is a voluntary activity designed to offer consultation and support from a peer.

    2. (b) Peer Review. Peer review is provided in order to ensure compliance with regulatory standards applicable to PBS contained in 115 CMR 5.14. A PBSP containing restrictive procedures shall, in addition to the other requirements set forth at 115 CMR 5.14, be reviewed by a Peer Review Committee appointed by the program head or designee or, at the election of the provider, by a Peer Review Committee convened by the Department. Except in an emergency, such review shall occur and the comments of the Peer Review Committee, if any, shall be addressed by the treating clinician(s) prior to the implementation of the PBSP.

       1. 1. For each such review, the Peer Review Committee shall be composed of three or more PBS Qualified Clinicians with combined expertise in the care and treatment of individuals with needs similar to those served by the facility or program and in behavior analysis and behavioral treatment, at least one of whom shall be a licensed psychologist.
       2. 2. The Peer Review Committee shall be specially constituted so as to exclude any clinician responsible for the development or implementation of the Intensive PBSP.
       3. 3. The Peer Review Committee shall review an Intensive PBSP to determine if it conforms to the requirements for appropriate treatment established by 115 CMR 5.14.
       4. 4. The Peer Review Committee's review of an Intensive PBSP may include such record reviews, interviews, inspections, and other activity as the Peer Review Committee may in its discretion deem necessary, and may include requests that the Intensive PBSP be resubmitted for such periodic review as the Peer Review Committee may deem appropriate.
       5. 5. In the event that the Peer Review Committee concludes the Intensive PBPS or a part of the Intensive PBSP violates the requirements for appropriate treatment established by 115 CMR 5.14, the Intensive PBSP, or part thereof, shall not be implemented, unless the issue is resolved by the PBS qualified clinician responsible for the development or implementation of the Intensive PBSP.
       6. 6. The provider, and the Peer Review Committee, shall maintain a written record of the Intensive PBSPs reviewed at each Peer Review Committee meeting, and the results of each individual review. The records of changes, if any, to the Individual PBSP shall be available to Peer Review Committee members at each meeting.

12. (13) Human Rights Committee Review.

    1. (a) Positive Behavior Support Plan Review. New PBSPs containing restrictive procedures shall be submitted to the program's human rights committee established in accordance with 115 CMR 3.09: Protection of Human Rights/Human Rights Committees. The human rights committee shall monitor and review PBSPs containing restrictive procedures.
    2. (b) Frequency of Review. The human rights committee review of a new PBSP shall occur no later than the next meeting following the meeting at which the PBSP was first presented to the committee. However, provided the committee shall further expedite such review on request of the program head or designee for cases where the program head or designee determines immediate consideration of the proposed PBSP is necessary to protect the individual's health and safety. Except in an emergency, such review shall occur and the comments (if any) of the human rights committee shall be addressed by the treating clinician(s) prior to implementation of the PBSP.

    3. (c) PBSP Review. The human rights committee's review of an existing PBSP containing restrictive procedures shall occur:

       1. 1. upon the introduction of a new restrictive procedure; or
       2. 2. at least annually.

13. (14) Restrictive Procedures. PBSPs incorporating restrictive procedures must focus on alternative strategies and the elements contained in 115 CMR 5.14(8)(d). Restrictive procedures may be permitted only after positive approaches have been utilized and only in conjunction with an Intensive PBSP. Such restrictive procedures may include, but are not limited to:

    1. (a) "Time out" requiring physical removal over the individual's active resistance to the time out;
    2. (b) Overcorrection;
    3. (c) Response Cost;
    4. (d) Response blocking; and
    5. (e) Protective devices as described at 115 CMR 5.12(1)(b)2.

14. (15) Prohibited Practices.

    1. (a) The following procedures are prohibited:

       1. 1. corporal punishment;
       2. 2. any noxious, unpleasant, uncomfortable or distasteful stimuli;
       3. 3. chemical restraint;
       4. 4. forced exercise;
       5. 5. seclusion;
       6. 6. the locking of exits from buildings, except in accordance with 115 CMR 5.04 and 42 CFR 441.301(c)(4);
       7. 7. prone restraint; and any physical restraint which causes pressure or weight on the lungs, diaphragm or sternum causing chest compression or restricting the airway, or basket hold in a seated position on the floor;
       8. 8. removing, withholding, or taking away money;
       9. 9. denial of a nutritionally sound diet including withholding of a meal;
       10. 10. denial of adequate bedding or clothing; and
       11. 11. mechanical restraint.
    2. (b) A limited, short-term waiver of the prohibition on prone restraint for use in an emergency may be available from the Department Office of Policy and Planning on an individualized basis.
15. (16) Emergency Procedures. Nothing in 115 CMR 5.14 prohibits the use of emergency restraint, confiscation of any item used in a threatening manner, or removal from the environment for the purpose of protecting the individual and others around him or her. This includes the use of restraint procedures in the course of an established program, when the individual becomes a danger to him or herself or others, prior to staff being able to implement a lesser restrictive hierarchy. However, it is emphasized that emergency procedures may not be used at frequent intervals, becoming a routine method of intervention. If emergency procedures are utilized three times in a six-month period, the PBS qualified clinician will conduct a FBA and develop an appropriate plan of action.

5.14A Level III Interventions.

1. (1) 115 CMR 5.14A applies only to Level III interventions permitted pursuant to 115 CMR 5.14A(4)(b)4. Level III interventions are allowed under 115 CMR 5.14A subject to the provisions herein. Providers utilizing Level III Interventions must comply with all other requirements of 115 CMR 5.00, including 115 CMR 5.11 and 115 CMR 5.14 with the exception of 115 CMR 5.14(15)(a)1. and 2. Notwithstanding any provision of 115 CMR 5.14A, nothing in 115 CMR 5.14A is intended to contravene the obligations of the parties set forth in the Settlement Agreement in Behavior Research, Inst. v. Mary Kay Leonard, Civ. Action No. 86- 0018-GI (Rotenberg, J.) (Bristol County Probate Court) (filed Dec. 12, 1986), subject to any changes in said order or in applicable law.

2. (2) The following shall be deemed Level III Interventions for purposes of 115 CMR 5.14A, provided that no such Level III Intervention may be used except in accordance with the standards and procedures set forth in 115 CMR 5.14A(4) including, without limitation, the special certification requirement of 115 CMR 5.14A(4)(f) and the general requirement of 115 CMR 5.14A(4)(b) that a determination be made that the predictable risks, as weighed against the benefits of the procedure, would not pose an unreasonable degree of intrusion, restriction of movement, physical harm or psychological harm:

   1. (a) Any Intervention which involves the contingent application of physical contact aversive stimuli such as spanking, slapping, hitting or contingent skin shock.
   2. (b) Time Out wherein an individual is placed in a room alone for a period of time exceeding 15 minutes.
   3. (c) Any Intervention not listed in 115 CMR 5.14A which is highly intrusive and/or highly restrictive of freedom of movement.
   4. (d) Any Intervention which alone, in combination with other Interventions, or as a result of multiple applications of the same Intervention poses a significant risk of physical or psychological harm to the individual.

3. (3) Advisory Opinions. Any person may request the Commissioner or designee to provide an advisory opinion regarding the proper classification of particular Interventions not set forth in 115 CMR 5.14A(2), or for clarification of proper classification by Level in a particular instance involving a specific individual.

   1. (a) Upon receipt of any such request, the Commissioner or designee shall refer the request to the Advisory Panel.
   2. (b) The Commissioner or designee shall facilitate the Advisory Panel's review of the request and shall seek to obtain such additional information regarding the request as the Advisory Panel shall deem necessary.
   3. (c) Upon completing its review of the request, the Advisory Panel shall advise the Commissioner or designee regarding the matter and the Commissioner or designee shall thereupon issue an advisory opinion responding to the request and classifying the Intervention as appropriate.
   4. (d) The Commissioner or designee, and the Advisory panel, shall respond to each request as expeditiously as possible, and shall prioritize those requests that allege either that inappropriate treatment is resulting from an improper classification or that there is an urgent need for treatment that may be jeopardized if a prompt response is not received.

4. (4) Requirements for Level III Interventions.

   1. (a) Scope. 115 CMR 5.14A(4), establishes requirements for Level III Interventions that are used, or that are proposed for use, for behavior modification purposes.

      1. 1. Interventions that limit an individual's freedom of movement and that are consented to, approved, and implemented for treatment purposes as part of a behavior modification plan for an individual in accordance with the requirements of 115 CMR 5.14A(4), constitute reasonable limitations on freedom of movement. Such Interventions are not subject 115 CMR 5.11.
      2. 2. Procedures that are used, or that are proposed for use, for the purpose of protecting an individual or others from harm and not for behavior modification purposes may be used subject to 115 CMR 5.11, and are not subject to the provisions of 115 CMR 5.14A.
      3. 3. The prescription and administration of psychotropic medication are not subject to 115 CMR 5.14A.

   2. (b) General Requirements.

      1. 1. No behavior modification plan may provide for a program of treatment which denies the individual adequate sleep, a nutritionally sound diet, adequate bedding, adequate access to bathroom facilities, and adequate clothing.
      2. 2. No Level III Interventions shall be approved in the absence of a determination, arrived at in accordance with all applicable requirements of 115 CMR 5.14A, that the behaviors sought to be addressed may not be effectively treated by any less intrusive, less restrictive Intervention and that the predictable risks, as weighed against the benefits of the procedure, would not pose an unreasonable degree of intrusion, restriction of movement, physical harm or psychological harm.
      3. 3. General Prohibition on the Use of Level III Aversive Interventions. No program which is operated, funded or licensed by the department, shall employ the use of Level III Aversive Interventions to reduce or eliminate challenging behaviors, except as provided in 115 CMR 5.14A(4)(b)4.
      4. 4. Level III Aversive Interventions are prohibited except as specifically provided in 115 CMR 5.14A(4)(b)4. Individual-specific exceptions allowing the use of Level III Aversive Interventions to reduce or modify behavior may be granted only to individuals who, as of September 1, 2011, have an existing court-approved treatment plan which includes the use of Level III Aversive Interventions; provided further that any such exception may be granted each year thereafter if the exception is contained in the behavior treatment plan that has been approved by the court prior to September 1, 2011.
      5. 5. Such determination shall be made and the Level III Interventions shall be approved and consented to in accordance with the special requirements of 115 CMR 5.14A(4)(d) and (e).
      6. 6. Only those Interventions which are, of all available Interventions, least restrictive of the individual's freedom of movement and most appropriate given the individual's needs, or least intrusive and most appropriate, may be employed.
      7. 7. Any procedure designed to decrease inappropriate behaviors such as Level III Aversive Interventions, Deprivation Procedures and Time Out may be used only in conjunction with Positive Behavior Support Programs.
      8. 8. Level III Aversive Interventions that are allowed under 115 CMR 5.14A(4)(b)4. may be used only to address extraordinarily difficult or dangerous behavioral problems that significantly interfere with appropriate behavior and or the learning of appropriate and useful skills and that have seriously harmed or are likely to seriously harm the individual or others.
      9. 9. No Level III Intervention may be administered to any client in the absence of a written behavior modification plan. In the case of Level III Interventions, the plan shall conform to the special requirements of 115 CMR 5.14A(4)(c) and shall be subject to the special consent requirements of 115 CMR 5.14A(4)(e).

      10. 10. Programs using Time Out shall conform such use to the following standards and restrictions:

          1. a. The head of the facility or program or his/her designee shall approve the room or area as safe and fit for the purposes of Time Out.
          2. b. Behavior modification plans employing forms of Time Out that involve placing an individual alone in a room with an open door shall comply with all safety, checking, and monitoring requirements set forth at 115 CMR 5.11(1)(b)(2).
      11. 11. All behavior modification plans shall be developed in accordance with 115 CMR 5.14A and in accordance with the policies of the facility or program within which the plan is to be implemented, insofar as those policies do not conflict with 115 CMR 5.14A.
      12. 12. In the event of a serious physical injury to or death of a person who is the subject of a Level III Intervention, whether or not such injury or death occurs during the implementation of the behavior modification program, the injury or death shall be reported immediately to the Commissioner or designee who may thereupon initiate an investigation pursuant to 115 CMR 9.00: Investigations and Reporting Responsibilities.

   3. (c) Written Plan. All proposed uses of Level III Aversive Interventions for treatment purposes shall be set forth in a written plan containing at least the following:

      1. 1. A clear specification of the behaviors which the treatment program seeks to decelerate or decrease, a specification of the methods by which the behaviors are to be measured (using measures such as frequency, severity, duration, etc.) and the available data concerning the current state of the behaviors with respect to these methods of measurement.
      2. 2. A clear specification of the behaviors which the treatment program seeks to have replace the behaviors targeted for deceleration, the methods by which these behaviors are to be measured, and available data concerning the current state of the behaviors with respect to these methods of measurement.
      3. 3. A description and classification by Level of each Intervention to be used; a rationale, based on a comprehensive functional analysis of the antecedents and consequences of the targeted behavior, for why each Intervention has been selected; the conditions under which each Intervention will be employed; the duration of each Intervention, per application; the conditions or criteria under which an application of each Intervention will be terminated; in measurable terms, the behavioral outcome expected from the use of each proposed Intervention; the criteria for measuring success of each Intervention and the behavior modification plan as a whole and for revising and terminating the plan; the risks of harm to the individual with each Intervention and the plan as a whole; the individual's prognosis if the treatment is not provided; feasible treatment alternatives; and, a statement indicating the nature of the less restrictive or less intrusive Interventions which have been employed and the clinical results thereof, or those which have been considered and the reasons they have not been tried.
      4. 4. The name of the treating clinician or clinicians who will oversee implementation of the plan.
      5. 5. A procedure for monitoring, evaluating and documenting the use of each Intervention, including a provision that the treating clinician(s) who will oversee implementation of the plan shall review a daily record of the frequency of target behaviors, frequency of Interventions, safety checks, reinforcement data, and other such documentation as is required under the plan. Such treating clinician(s) shall review the plan for effectiveness at least weekly and shall record his/her assessment of the plan's effectiveness in achieving the stated goals.

   4. (d) Review and Approval. In addition to consent requirements stated in 115 CMR 5.14A(4)(e), the following reviews and approvals are required prior to the implementation of any behavior modification plan involving the use of Level III Interventions:

      1. 1. All such plans shall be developed by those clinicians who provide services to the individual, and such other clinicians as they may designate (the treating clinician(s)).
      2. 2. All such plans shall be classified, reviewed and approved prior to implementation by a clinician designated by the head of the program. Such clinician shall have a demonstrated history of experience and training in applied behavior analysis and behavioral treatment. Such clinician may be the same clinician as the clinician who develops the plan pursuant to 115 CMR 5.14A(4)(d)1.

      3. 3. Each such plan shall be reviewed by the program's human rights committee (i.e., a committee established in accordance with the provisions for human rights committees set forth at 115 CMR 3.09: Protection of Human Rights/Human Rights Committees). The committee's review shall occur no later than the next meeting following the meeting at which the plan is first presented to the committee, provided that the committee shall further expedite such review on request of the program head or designee for cases where the program head or designee determines that there is an urgent need for treatment that may be jeopardized if prompt attention is not given to the proposed plan. Except in an emergency (i.e., in circumstances where the treating clinician, subject to the approval of the program head, determines that the immediate application of the Interventions provided for by the proposed plan is necessary to prevent serious harm to the individual or to others), such review shall occur and the comments (if any) of the human rights committee shall be addressed by the treating clinician(s) prior to implementation of the plan.

         1. a. The committee shall review a plan to determine if it conforms to the requirements for protection of human rights established by 115 CMR 5.14A.
         2. b. The committee's review of a plan may be based on such record reviews, interviews, inspections, and other activity as the Committee may in its discretion deem necessary and may include requests that the plan be resubmitted for such periodic review as the Committee may deem appropriate.

         3. c. In the event that the human rights committee concludes that the plan or a part of the plan violates the requirements of 115 CMR 5.14A the plan or part thereof shall not be implemented unless:

            1. i. the problem is resolved informally with the treating clinician(s), or
            2. ii. the client or his or her representative or guardian initiate(s) an appeal under 115 CMR 6.30 through 6.34, and the plan or part thereof is determined pursuant to such appeal to conform to 115 CMR 5.14A.
      4. 4. Each such plan shall be reviewed by a physician or by a qualified health care professional working under a physician's supervision who shall determine whether, given the individual's medical characteristics, the Intervention is medically contraindicated. No Intervention that is medically contraindicated shall be implemented.

      5. 5. Each such plan shall, in addition to other requirements set forth in 115 CMR 5.14A, be reviewed by a Peer Review Committee appointed by the program head or designee. The Peer Review Committee shall conduct such review in a timely manner consistent with the individual's needs for treatment as represented by such plan, and shall further expedite its review on request of the program head or designee in cases where the program head or designee determines that there is an urgent need for treatment that may be jeopardized if prompt attention is not given to the proposed plan. Except in an emergency (i.e., in circumstances where the treating clinician, subject to the approval of the program head, determines that the immediate application of the Interventions provided for by the plan is necessary to prevent serious harm to the individual or to others), such review shall occur and the comments (if any) of the Peer Review Committee shall be addressed by the treating clinician(s) prior to implementation of the plan.

         1. a. For each such review, the Peer Review Committee shall be composed of three or more clinicians with combined expertise in the care and treatment of individuals with needs similar to those served by the facility or program and in behavior analysis and behavioral treatment, at least one of whom shall be a licensed psychologist.
         2. b. For reviews of Level III Aversive Interventions, the Committee shall be specially constituted so as to exclude any clinician serving as a treating clinician within the program proposing to use the Intervention.
         3. c. The Committee shall review a plan to determine if it conforms to the requirements for appropriate treatment established by 115 CMR 5.14A.
         4. d. The Committee's review of a plan may include such record reviews, interviews, inspections, and other activity as the Committee may in its discretion deem necessary and may include requests that the plan be resubmitted for such periodic review as the Committee may deem appropriate.

         5. e. In the event that the Peer Review Committee concludes that the plan or a part of the plan violates the requirements for appropriate treatment established by 115 CMR 5.14A, the plan or part thereof shall not be implemented unless:

            1. i. the problem is resolved informally with the treating clinician(s); or
            2. ii. the client or his or her representative or guardian or the treating clinician(s) initiate(s) an appeal under 115 CMR 6.30 through 6.34, and the plan or part thereof is determined pursuant to such appeal to conform to 115 CMR 5.14A.
      6. 6. The head of any program using or proposing to use a Level III Aversive Intervention shall notify the Commissioner or his or her designee upon the filing of any guardianship petition, temporary or permanent, seeking authorization by substituted judgment for such Intervention. The Commissioner may upon receipt of such notice, provide for an independent clinical review by one or more clinicians designated by the Commissioner or designee of the proposed treatment and may advise the court having jurisdiction of the matter of said clinician's treatment recommendations. Said program shall cooperate fully with said clinicians and shall afford full access to each individual, his or her record and the staff working with the individual.
      7. 7. In lieu of having the human rights and/or peer review functions specified in 115 CMR 5.14A performed by committees appointed by the same program that is proposing to use Level III Interventions, the director of such a program may request the Commissioner or designee to provide for the performance of such reviews by human rights committees and/or peer review committees established by the Commissioner or designee. The Commissioner or designee may provide for such reviews in response to such a request in the event that he or she determines that the program is unable to provide itself for such reviews or that the purposes of 115 CMR 5.14A will be served by the provision of such reviews by committees established by the Commissioner or designee.

   5. (e) Consent. In addition to consent requirements generally applicable to individual service plans, a behavior modification plan employing Level III Aversive Interventions may not be implemented, unless it has been consented to in accordance with the following requirements:

      1. 1. Where the individual is 18 years of age or older, or is deemed a mature minor under the applicable law, and is able to provide informed consent to a plan of treatment, the plan may be implemented upon his or her acceptance of its provisions. Before a plan involving the use of Level III procedures is implemented pursuant to such consent, the head of the program shall notify the Commissioner or his or her designee who shall be afforded an opportunity to evaluate the individual. In the event that the Commissioner or designee doubts the individual's ability to provide informed consent, a petition for the appointment of a temporary or permanent guardian shall be filed by the Commissioner or designee or by some other suitable person.

      2. 2. Where the individual is a minor and is not deemed a mature minor capable of giving informed consent:

         1. a. that portion of the plan which does not involve the use of Level III Procedures may be implemented upon a parent's or legal guardian's informed consent to its provisions.
         2. b. in the event that no parent or legal guardian exists or is available, then that portion of the plan which does not involve the use of Level III Procedures may be implemented upon its approval by the head of the program, provided that actions to initiate proceedings for the appointment of some suitable person as guardian or, where applicable, actions to provide for the availability of a temporarily unavailable parent or legal guardian are commenced by the head of the program concurrently with such approval.
         3. c. that portion of the plan which involves the use of Level III Interventions may be implemented only upon authorization of a court of competent jurisdiction utilizing the substituted judgment criteria.

      3. 3. Where the client is an adult, but is unable to provide informed consent to the implementation of the plan,

         1. a. that portion of the plan which does not involve the use of Level III Interventions may be implemented when informed consent is provided by the individual's temporary or permanent guardian.

            1. b. in the event that no permanent or temporary guardian has been appointed or is available, then that portion of the plan which does not involve the use of Level III Interventions may be implemented upon its approval by the head of the program, provided that actions to initiate proceedings for the appointment of some suitable person as guardian or, where applicable, actions to provide for the availability of a temporarily unavailable parent or legal guardian are commenced by the head of the program concurrently with such approval.
            2. c. that portion of the plan which involves the use of Level III Aversive Interventions may be implemented only upon authorization of a court of competent jurisdiction utilizing the substituted judgment criteria.

   6. (f) Special Certification Requirement for Programs Utilizing Level III Aversive Interventions. No behavior modification plans employing Level III Aversive Interventions may be implemented except in a program or a distinct part of a program that meets the standards established by 115 CMR 5.14A(4) and that is therefore specially certified by the Department as having authority to administer such treatment. The following standards and procedures shall govern all such certifications:

      1. 1. Only those programs or facilities which meet the following standard shall be certified under 115 CMR 5.14A(4): the program or facility must demonstrate that it has the capacity to safely implement such behavior modification plan in accordance with all applicable requirements of 115 CMR 5.14A.
      2. 2. Any program seeking such certification shall submit a written application to the Commissioner or designee.
      3. 3. Such application shall include a comprehensive statement of the program's policies and procedures for the development and implementation of plans employing Level III Aversive Interventions, including a description of the program's actual use, or proposed use, of such procedures, and of the program's policies and practices regarding the training and supervision of all staff involved in the use of such procedures, and further including current resumes of all members of the Peer Review Committee required by 115 CMR 5.14A(4)(d)5. and a description of the review procedures followed by such Committee.
      4. 4. Such application shall further include a certification by the program of its ability to comply 115 CMR 5.14A.
      5. 5. The Commissioner or designee shall review such application upon its receipt and, after a determination that the written application is complete and satisfies all applicable requirements, shall provide for an inspection of the program by authorized Department representatives.
      6. 6. In the course of any inspection pursuant to 115 CMR 5.14A(4)(f)5. or 115 CMR 5.14A(4)(f)10., inspection staff shall have access to the records of the program's clients (including any written plans required by 115 CMR 5.14A(4)(c) and 115 CMR 5.14(8) and data and information developed pursuant to such plan), the physical plant of the facility, the employees of the program, the professional credentials of such employees, and shall have the opportunity to observe fully the treatment employed by the program and to review with the program's staff the procedures for which certification was granted or is sought and the manner in which such procedures have been or are to be implemented.
      7. 7. After such review and inspection, the Commissioner or designee shall approve, approve with conditions, or disapprove the program's application and, if approved, shall certify the program subject to any applicable conditions based upon his or her determination of the program's compliance with all applicable requirements. The Commissioner or designee may, as a condition of approval, require appointment of one or more persons approved by the Commissioner or designee to the program's peer review committee or human rights committee in the event that he or she determines that such appointment or appointments are necessary to ensure performance by such committees of their review responsibilities consistent with the requirements established by 115 CMR 5.14A.
      8. 8. If disapproved, or if certification is revoked in accordance with 115 CMR 5.14A(4)(f)10., programs not operated by the Department shall have the right of appeal established by the applicable provisions of M.G.L. c. 19B and M.G.L. c. 30A.
      9. 9. Any such certification of a program shall be effective for a maximum of two years and may be renewed thereafter upon the Commissioner or designee's approval of a renewal application pursuant to the standards and procedures set forth in 115 CMR 5.14A(4)(f).
      10. 10. The performance of a provider certified for Level III Interventions may be reviewed as part of the survey required by the Department's regulations on certification and licensing, 115 CMR 8.00: Certification, Licensing and Enforcement, and shall be further subject to such additional inspections as the Commissioner in his or her discretion deems appropriate. Such Level III certification may be revoked, and the Department may revoke, suspend, limit, refuse to issue or refuse to renew a provider's Level III certification or license pursuant to 115 CMR 8.13: Suspension, Revocation, and Denial of a License or Renewal, upon a finding that the conditions for certification are no longer met, as well as for any of the grounds stated at 115 CMR 8.13.
      11. 11. A program shall be eligible for consideration for certification for use of Level III Interventions only if, prior to the effective date of 115 CMR 5.14A (formerly 115 CMR 5.14), the program had been using one or more Level III Interventions pursuant to a behavior modification plan for one or more clients of the program. This restriction on eligibility shall continue in effect indefinitely and shall be modified only by amendment of 115 CMR 5.14A. Such amendment shall only be proposed or adopted by the Commissioner in the event that he or she finds that there exists a compelling need for treatment with such Interventions that cannot be met within existing programs or through alternative programs.
      12. 12. When necessary to prevent discontinuity in existing programming or to provide for an emergency, the Commissioner may in his or her discretion provide for the interim certification of a program, provided that the application and review process required for certification by 115 CMR 5.14A shall be initiated and completed as soon as possible thereafter.