Notice of Proposed Rule

DEPARTMENT OF CHILDREN AND FAMILY SERVICES
Agency for Persons with Disabilities
RULE NO: RULE TITLE
65G-8.001: Definitions
65G-8.002: Approved Emergency Procedure Curriculum
65G-8.003: Reactive Strategy Policy and Procedures
65G-8.004: Initial Assessments
65G-8.005: Authorizations for Specific Reactive Strategies
65G-8.006: Authorizations for Specific Reactive Strategies
65G-8.007: Seclusion and Restraint
65G-8.008: Chemical Restraint
65G-8.009: Prohibited Procedures
65G-8.010: Documentation and Notification
65G-8.011: Access to Rules
65G-8.012: Enforcement
PURPOSE AND EFFECT: This rule will implement subsection 393.13(4)(h) and 916.1093(2), F.S., by establishing standards and procedures relating to the use of restraint and seclusion.
SUMMARY: The proposed rules comply with the legislative directive for rulemaking at subsection 393.13(4)(h) and legislative authorization for rules at Section 916.1093(2), F.S., with regard to the following subject matter areas: prohibiting inherently dangerous restraint or seclusion procedures; limitations on the use and duration of restraint and seclusion; measures ensuring the safety of clients and staff during an incident of restraint or seclusion; procedures for staff to following before, during, and after incidents of restraint and seclusion; professional qualifications and training; facility data collection and reporting; documentation of use in a facility or program record; and procedures for incorporating these rules into staff training and making them available to clients, parents, guardians, guardian advocates, and staff members.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 393.501(1) FS.
LAW IMPLEMENTED: 393.13(4)(h), 916.1093(2) FS.
A HEARING WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:
DATE AND TIME: March 20, 2008, 1:00 p.m. – 4:00 p.m.
PLACE: Room 301, 4030 Esplanade Way, Tallahassee, Florida 32399-0950
Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 3 days before the workshop/meeting by contacting: Ron Drake, at (850)414-8096. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Steve Coleman, Senior Behavior Analyst, at the above address and at (850)414-8695

THE FULL TEXT OF THE PROPOSED RULE IS:

REACTIVE STRATEGIES

65G-8.001 Definitions.

(1) “Approved emergency procedure curriculum” means a course of instruction in procedures and techniques for intervening in behavioral emergency situations, approved by the Agency for Persons with Disabilities (“Agency”), and incorporated into a facility’s or program’s policy for utilizing reactive strategies.

(2) “Authorizing agent” means an individual authorized by the facility or program manager to approve use of a reactive strategy.

(3) “Authorized staff person” means an employee of a facility or program that has completed training in the approved emergency procedure curriculum and is approved by the authorizing agent to use restraint and seclusion procedures.

(4) “Local Review Committee” means the committee required by subsection 65G-4.008(3), F.A.C., to oversee and review all behavior analysis services provided to clients to ensure that the services are designed and approved in accordance with Florida Statutes and agency rules.

(5) “Behavioral protective device” means a device used as a means of interfering with or preventing specific results of a targeted behavior as part of a behavior program approved by the Local Review Committee.

(6) “Facility” means a residential operation serving Agency clients funded or licensed under Chapter 393, F.S., and includes separate and secure facilities serving forensics clients pursuant to Chapter. 916, Part III, F.S.

(7) “Implementation plan” means an individualized plan utilizing services to assist a client with developmental disabilities in acquiring skills that enable the client to improve his or her physical, mental, and social functioning.

(8) “Medical protective equipment” means health-related protective devices prescribed by a physician or dentist for use during specific medical or surgical procedures, or for use as client protection in response to an existing medical condition.

(9) “Reactive strategies” means the procedures or physical crisis management techniques of seclusion or manual, mechanical, or chemical restraint utilized for control of behaviors that create an emergency or crisis situation.

(10) “Mechanical restraint” means a physical device used to restrict an individual’s movement or restrict the normal function of the individual’s body. The definition does not include the following:

(a) Medical protective equipment as defined by this rule;

(b) Physical equipment or orthopedic appliances, surgical dressings or bandages, or supportive body bands or other restraints necessary for medical treatment, routine physical examinations, or medical tests;

(c) Restraints necessary to support functional body position or proper balance, or to prevent a person from falling out of bed; or

(d) Restraints used for safety during transportation, such as seatbelts or wheelchair tie-downs.

(11) “Chemical restraint” means the use of medication to effect immediate control of an individual’s behavior. It does not include the medication administered as treatment for a medical or psychiatric condition.

(12) “Manual restraint” means the use of hands or body to immobilize a person’s freedom of movement or normal access to his or her body for more than fifteen continuous seconds. It does not include physically guiding or transporting a client during skill training for up to two minutes. Repeated applications and releases of manual restraint in order to circumvent the fifteen-second and two-minute criteria are prohibited.

(13) “Seclusion” means enforced isolation or confinement of an individual in a room or area. It does not mean “time out” or “time out from positive reinforcement” procedures as defined by this rule, or isolation resulting from medical conditions or symptoms of illness.

(14) “Time out” or “time out from positive reinforcement” means a procedure designed to interrupt a specific behavior of an individual by temporarily removing that individual to a separate area or room, or by screening him or her from others, or by signaling that the individual is in “time out.” “Time out” is not a reactive strategy regulated by these rules. “Time out” procedures differ from the reactive strategy of seclusion through the following characteristics:

(a) A “time out” is of short duration, as brief as one minute and never longer than twenty consecutive minutes;

(b) It is implemented only in response to a specified behavior;

(c) It is part of a written program that includes a functional assessment and is approved by a Local Review Committee; and

(d) The program is implemented either by a psychologist licensed under Chapter 490, F.S.; or a clinical social worker, mental health counselor, or therapist licensed under Chapter 491, F.S.; or a behavior analyst certified by the Behavior Analyst Certification Board; or a behavior analyst certified under Chapter 65G-4, F.A.C.;

(e) “Time out” data is collected for assessment, evaluation, and analysis;

(f) It is not used as a disciplinary act, threat, or as a tool for staff’s convenience;

(g) A termination criterion (e.g., “one minute of calm”) ends the time out period, ensuring that termination of the time out is under the control of the person in time out; and

(h) After termination, the individual returns to his or her previous activity.

NOTE: Use of time-out for a period exceeding twenty minutes constitutes the reactive strategy of seclusion.

(15) “Client” means any person with a developmental disability receiving services in the State of Florida.

(16) “Licensed medical professional” means a physician licensed under Chapter 458 or 459, F.S.; or registered nurse, licensed practical nurse, or Advanced Registered Nurse Practitioner licensed under Chapter 464, F.S.

(17) “Containment” means immobilizing an individual with any technique for the purpose of behavioral control.

Specific Authority 393.501 FS. Law Implemented 393.13(4)(h), 916.1093(2) FS. History–New_________.

 

65G-8.002 Approved Emergency Procedure Curriculum.

(1) All providers, facilities, and programs that use reactive strategies must utilize an emergency procedure training curriculum approved by the Agency, and require all staff to be trained in that curriculum.

(2) The training curriculum must meet the following minimum requirements for approval:

(a) It has a history of applied use to persons with developmental disabilities;

(b) It includes an ongoing training program;

(c) It requires certification of the persons administering the curriculum training;

(d) It provides for periodic review of both trainer and participant competency;

(e) It does not include reactive strategy procedures prohibited by this rule chapter or any other Florida law or rule;

(f) It requires at least sixteen direct training hours;

(g) It includes non-physical crisis intervention techniques;

(h) The curriculum incorporates training in the provisions of this rule chapter;

(i) It provides for supervised practice and performance-based competency evaluation, including a written test with a minimum passing achievement score of 80%;

(j) It includes training in criteria for use of reactive strategies, and methods for reducing physical interventions;

(k) It incorporates quality assurance and safety measures as well as incident data collection and review;

(l) It provides participants with a certificate displaying the name of the curriculum, the name of the trainer, the date(s) of training; and the date of certificate expiration;

(m) It incorporates transportation procedures that require the cooperation of the person being transported;

(n) It includes a “release” criterion (e.g., a stated period of calm behavior) that is of short duration and that is client-driven or initiated.

(3) Staff must be certified through an Agency-approved emergency procedure curriculum before being authorized or permitted to administer a reactive strategy technique. Providers and facilities must maintain copies of all staff training certificates and make the certificates available to the Agency upon request.

(4) Training certification is valid for one year. Before the certificate expires, staff must undertake a full training curriculum to obtain new certification.

(5) In order to obtain Agency approval for a proposed curriculum, the provider must submit a copy of the curriculum materials and an “Emergency Procedure Training Curriculum Application,” APD Form 65G8-001 (00/00/00), incorporated herein by reference. A copy of the form may be obtained by writing or calling the Agency for Persons with Disabilities, at 4030 Esplanade Way, Suite 380, Tallahassee, FL 32399-0950; main telephone number (850)488-4527.

(6) The Senior Behavior Analyst will refer the proposed curriculum to a multidisciplinary committee or a Peer Review Committee for additional review and comment.

(7) Review of a proposed emergency procedure curriculum must include:

(a) Verification of the curriculum’s compliance with the minimum criteria established in this rule chapter;

(b) Direct observation of the reactive strategy techniques incorporated in the curriculum;

(c) Review of available data related to implementation of the curriculum;

(d) Committee recommendations to the Senior Behavior Analyst for either accepting or rejecting the proposed curriculum.

(8) Following review, the Senior Behavior Analyst will make a final determination to either accept or reject the proposed curriculum and provide notification of the determination in writing, stating the reasons for rejection. If the proposed curriculum is rejected, it may be resubmitted with appropriate modifications to meet minimum requirements provided by this rule chapter.

(9) No changes to approved curriculum materials or procedures may be incorporated until the curriculum, along with the proposed changes, is resubmitted to the Agency and approved.

(10) The Agency may deny or withdraw approval for any of the following acts or omissions:

(a) Obtaining or attempting to obtain course approval through fraud, false statements, deceit, or misrepresentation of material facts, whether those representations or statements are made knowingly or negligently;

(b) Failure to provide complete and accurate information in the initial application for approval or in any notification for a change in information;

(c) Failure to notify the Agency within six weeks of a change in the information required for course approval;

(d) Failure to maintain the curriculum format and content as approved by the Agency.

Specific Authority 393.501 FS. Law Implemented 393.13(4)(h), 916.1093(2) FS. History–New_________.

 

65G-8.003 Reactive Strategy Policy and Procedures.

(1) All facilities or programs subject to this rule shall develop and implement policies and procedures consistent with the provisions of this rule chapter, including adoption of an approved emergency procedure curriculum, appropriate staff training, record maintenance, reporting and recording the use of any reactive strategy, training in the provisions of this rule chapter, data collection, and maintenance of reactive strategy consent information in patient records, and any other requirements established in this rule chapter.

(2) Facility or program policies may not include reactive strategies not provided in the Agency-approved curriculum or vary from the requirements of these rules without an Agency-approved variance or waiver obtained in advance through Section 120.542, F.S.

(3) Providers, facilities and programs that employ reactive strategies are required to implement procedures to ensure the safety of staff and clients during the use of reactive strategies and to ensure that Agency clients are not placed at risk because of existing medical conditions.

(4) All staff implementing reactive strategies must be certified in advance for all reactive strategy techniques used or approved for use by the facility, program, or provider.

(5) A variation of a specific reactive strategy may be employed only if it is designed for a specific client with documented evidence of need and benefit, and only if evaluated and approved in advance of implementation by the Local Review Committee and the Agency’s Senior Behavior Analyst.

(6) The program or facility must conduct an internal review of its emergency procedures at least annually with a written evaluation that addresses the following issues:

(a) Proposed methods of reducing the use of reactive strategies;

(b) Policy evaluations and proposals to ensure that all applications of reactive strategies are being conducted in accordance with the Agency-approved emergency procedure curriculum, administered in a safe manner;

(c) Compliance with this rule chapter, including appropriate records and reports of reactive strategies.

The facility, program, or provider must maintain this written evaluation for a minimum of five years and make it available to the Agency upon request.

Specific Authority 393.501 FS. Law Implemented 393.13(4)(h), 916.1093(2) FS. History–New_________.

 

65G-8.004 Initial Assessments.

(1) Upon an individual’s admission to a facility or program and at least annually thereafter, the facility or program provider must obtain information and documents relevant to the use of reactive strategies from a variety of sources for the individual’s records. Appropriate sources include the individual, his or her family members, treating medical professionals, and other informants familiar with the individual. The individual’s records must include the following documentation:

(a) A medical release stating that the individual has no medical conditions or physical limitations that would place him or her at risk of physical injury during restraint or seclusion, as permitted by this rule chapter; or;

(b) A physician’s report of any physical limitations that would preclude the use of one or more reactive strategies; and

(c) Documentation of any history of trauma, such as a history of sexual or physical abuse, that the informants, individual, facility, or providers believe to be relevant to the use of reactive strategies; and

(2) Medical conditions or physical limitations that might create a risk to the individual include, but are not limited to, the following:

(a) Obesity;

(b) Cardiac conditions;

(c) Pregnancy;

(d) Asthma or other respiratory conditions;

(e) Impaired gag reflex;

(f) Back conditions or spinal problems;

(g) Seizure disorders;

(h) Deafness;

(i) Blindness;

(j) Limitations on range of motion;

(k) Osteoporosis;

(l) Osteopenia; and

(m) Hemophilia.

(3) In addition to the annual review, the individual’s file information must be updated whenever there is a change in the individual’s physical or psychological condition that might affect his or her tolerance of one or more reactive strategies, or updated in compliance with any reassessments required by State or Federal law.

Specific Authority 393.501 FS. Law Implemented 393.13(4)(h), 916.1093(2) FS. History–New_________.

 

65G-8.005 Authorizations for Specific Reactive Strategies.

(1) Upon initiating any reactive strategy, staff must immediately notify the highest-level direct care supervisor.

(2) Each use of a reactive strategy requires continuous staff supervision.

(3) The following reactive strategies can be approved only by the following authorizing agents:

(a) The authorizing agent for medical protective equipment or chemical restraint must be a physician licensed under Chapter 458 or 459, F.S;

(b) The authorizing agent for behavioral protective devices must be either a psychologist licensed under Chapter 490, F.S.; a clinical social worker, marriage and family therapist, or mental health counselor licensed under Chapter 491, F.S.; or a Certified Behavior Analyst certified by the Behavior Analyst Certification Board; or a behavior analyst certified by the rule Chapter 65G-4, F.A.C.;

(c) The authorizing agent for mechanical restraint must be a physician licensed under Chapter 458 or 459, F.S., a psychologist licensed under Chapter 490, F.S.; a clinical social worker, marriage and family therapist, or mental health counselor licensed under Chapter 491, F.S.; or a Certified Behavior Analyst certified by the Behavior Analyst Certification Board; or a behavior analyst certified by the Rule Chapter 65G-4, F.A.C.;

(d) The authorizing agent or staff person with approval authority for seclusion must have at least a bachelor’s degree, two years of experience serving individuals with developmental disabilities, and certified in reactive strategies through an Agency-approved emergency procedure curriculum;

(e) The authorizing agent or staff person with approval authority for manual restraint must be certified in reactive strategies through an Agency-approved emergency procedure curriculum.

Specific Authority 393.501 FS. Law Implemented 393.13(4)(h), 916.1093(2) FS. History–New_________.

 

65G-8.006 Limitations on Use and Duration of Reactive Strategies.

(1) All authorizations for a reactive strategy must include a clear rationale for its use.

(2) Reactive strategies must not be implemented automatically or as part of a deceleration plan for undesirable behaviors, as punishment, as a substitute for an implementation plan, or for the convenience of staff.

(3) At the onset of seclusion or restraint implementation, staff will notify the appropriate authorizing agent of the conditions leading up to the use of the reactive strategy. The authorizing agent is responsible for terminating any procedure not in compliance with this rule.

(4) Each use of a reactive strategy requires continuous staff monitoring.

(5) A reactive strategy must provide for the least possible restriction consistent with its purpose.

(6) A reactive strategy must be terminated immediately when the emergency ends.

(7) Reactive strategies must be implemented in a manner that permits the greatest possible amount of comfort and protection from injury to the individual.

(8) The Agency may disapprove the use of any emergency procedure, system, strategy, or program that does not meet the above requirements or that contains procedures the Agency determines to be unsafe.

(9) If an individual exhibits behavior requiring a reactive strategy at a frequency of more than two times in any thirty-day period, or six times in any twelve-month period, then the facility or provider should submit a request for behavior analysis services for that individual, including documentation of the frequency of reactive strategy use.

(10) The facility or program must provide written behavioral criteria for termination of a reactive strategy, conforming to the Agency-approved emergency procedure curriculum, to all staff trained in those techniques.

(11) Reactive strategies must be terminated within five minutes after predetermined behavioral criteria have been met.  Providers and facilities may seek an exemption from this requirement through the variance and waiver process authorized by Section 120.542, F.S.

(12) Reactive strategies must be limited to one hour in duration; additional time for a reactive strategy requires reauthorization.

Specific Authority 393.501 FS. Law Implemented 393.13(4)(h), 916.1093(2) FS. History–New_________.

 

65G-8.007  Seclusion and Restraint.

(1) Every effort should be made to avoid unnecessary use of seclusion and restraint; therefore, staff should try to redirect and diffuse problem behavior before employing the reactive strategy of seclusion and restraint.

(2) Seclusion and restraint as a reactive strategy may be utilized only if adequate staff is available for safe implementation.

(3) Staff must continuously observe the client during restraint procedures, monitor respiration rate, and determine when release criteria have been met.

(4) Seclusion and restraint procedures exceeding one hour require approval by an authorizing agent.

(5) Seclusion and restraint may not exceed two hours without visual review and approval of the procedure by an authorizing agent or the agent’s on-site designee.

(6) Staff must obtain additional authorization for use of seclusion and restraint for a behavioral episode occurring more than fifteen minutes after termination of a prior restraint procedure, and document the additional use of restraint in the individual’s record.

(7) Before initiating a seclusion or restraint procedure, staff must inspect the environment and the individual to be restrained in order to ensure that any foreign objects that might present a hazard to the individual’s safety are removed.

(8) Any room in which the individual is held must be have sufficient lighting and ventilation to permit the individual to see and breathe normally, and must have enough space to permit him or her to lie down comfortably.

(9) The door to any room in which an individual is secluded without a caregiver must not be locked; however, the door can be held shut by a caregiver using a spring bolt, magnetic hold, or other mechanism that permits the individual in seclusion to leave the room if the caregiver leaves the vicinity. Forensic facilities may seek a waiver or variance from this requirement through Section 120.542, F.S.

(10) An individual mechanically restrained for more than one hour must be permitted an opportunity for motion and exercise for at least ten minutes of each hour that the individual is restrained.

Specific Authority 393.501 FS. Law Implemented 393.13(4)(h), 916.1093(2) FS. History–New_________.

 

65G-8.008 Chemical Restraint.

(1) Chemical restraint is used for behavioral control; it is not standard treatment for medical or psychiatric conditions.

(2) An individual may be given a chemical restraint only on the written order of an authorized physician who has determined that the chemical is the least restrictive, most appropriate alternative available.

(3) The authorizing physician either must be present at the onset of the emergency requiring restraint, or must provide telephone consultation with an authorized staff person who is present and has personally examined the individual.

(4) If the authorizing physician is not present to write the order, he or she must dictate the order’s contents to another on-site licensed medical professional;

(5) An order for chemical restraint must be recorded in the individual’s record on the same date it is issued, along with the expected results of the medication and a detailed description of the behaviors that justified the use of chemical restraint.

(6) A licensed medical professional must conduct a face-to-face evaluation of the individual within one hour of administration of a chemical restraint, if the restraint was authorized by telephone. The medical professional must record the results of this evaluation in the individual’s records and document whether the administration of medication achieved the expected results.

(7) Staff must monitor an individual who has been chemically restrained at least once every half-hour and record the effects of the restraint in the individual’s records.

Specific Authority 393.501 FS. Law Implemented 393.13(4)(h), 916.1093(2) FS. History–New_________.

 

65G-8.009 Prohibited Procedures.

The following reactive strategies are prohibited:

(1) Reactive strategies involving noxious or painful stimuli, as prohibited by Section 393.13(4)(g), F.S.;

(2) Untested or experimental procedures;

(3) Any physical crisis management technique that might restrict or obstruct an individual’s airway or impair breathing, including techniques whereby staff persons use their hands or body to place pressure on the client’s head, neck, back, chest, abdomen, or joints;

(4) Restraint of an individual’s hands, with or without a mechanical device, behind his or her back;

(5) Physical holds relying on the inducement of pain for behavioral control;

(6) Movement, hyperextension, or twisting of body parts;

(7) Any maneuver that causes a loss of balance without physical support (such as tripping or pushing) for the purpose of containment;

(8) Any reactive strategy in which a pillow, blanket, or other item is used to cover the individual’s face as part of the restraint process;

(9) Any reactive strategy that may exacerbate a known medical or physical condition, or endanger the individual’s life;

(10) Use of any immobilizing technique prior to obtaining a medical release that rules out increased risk to the individual by use of this position;

(11) Containment without continuous monitoring and documentation of vital signs and status with respect to release criteria;

(12) Use of any reactive strategy on a “PRN” or “as required” basis.

Specific Authority 393.501 FS. Law Implemented 393.13(4)(h), 916.1093(2) FS. History–New_________.

 

65G-8.010 Documentation and Notification.

(1) Staff must document the following information in the individual’s records immediately following the use of a reactive strategy:

(a) The behavior that necessitated a reactive strategy;

(b) The reactive strategy used;

(c) The date and time the reactive strategy was implemented and the time the strategy was terminated;

(d) The person(s) who initiated, applied, authorized, and terminated the reactive strategy;

(2) The authorizing agent must review and sign the reactive strategy documentation within twenty-four hours or by the end of the next business day.

(3) The service provider or facility must also document every use of a reactive strategy on the “Reactive Strategy Report,” APD Form 65G8-002 (00/00/00), incorporated herein by reference. A copy of the form may be obtained by writing or calling the Agency for Persons with Disabilities, at 4030 Esplanade Way, Suite 380, Tallahassee, FL 32399-0950; main telephone number (850)488-4527. These Reports must be submitted within thirty days to the Local Review Committee chairperson, or the chairperson’s designee, and copies of the Report made a part of the individual’s record.

(4) Agency Area Offices and Developmental Services Institutions must submit copies of these Reports electronically to the Central Office Senior Behavior Analyst on a monthly basis.

Specific Authority 393.501 FS. Law Implemented 393.13(4)(h), 916.1093(2) FS. History–New_________.

 

65G-8.011  Access to Rules.

(1) The program or facility employing reactive strategies must maintain on-site a copy of these rules and provide access to staff, clients, parents, guardians, and guardian advocates.

(2) The requirements established in this rule chapter are to be incorporated into all staff pre-service training programs related to the use of reactive strategies.

Specific Authority 393.501 FS. Law Implemented 393.13(4)(h), 916.1093(2) FS. History–New_________.

 

65G-8.012 Enforcement.

(1) Use of a reactive strategy not authorized by or in violation of this rule chapter or any other provision of law is a violation of Section 393.13, F.S., “The Bill of Rights of Persons with Disabilities,” or Section 916.107, F.S., and is subject to the enforcement proceedings, penalties, and private rights of action provided therein.

(2) A residential facility licensed under Section 393.067, F.S., that violates any reactive strategy provision or requirement of this rule chapter through the action of either facility management or staff, is subject to administrative disciplinary action authorized by Section 393.0673, F.S.

Specific Authority 393.501 FS. Law Implemented 393.13(4)(h), 916.1093(2) FS. History–New_________.


NAME OF PERSON ORIGINATING PROPOSED RULE: Steve Coleman
NAME OF SUPERVISOR OR PERSON WHO APPROVED THE PROPOSED RULE: Jane E. Johnson, Director, Agency for Persons with Disabilities
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: February 13, 2008
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: May 4, 2007