Notice of Proposed Rule

DEPARTMENT OF CHILDREN AND FAMILY SERVICES
Mental Health Program
RULE NO: RULE TITLE
65E-20.002: Definitions
65E-20.003: The Right to Individual Dignity
65E-20.014: Seclusion and Restraint for Behavior Management Purposes
PURPOSE AND EFFECT: Chapter 65E-20, F.A.C., is being revised to comply with Section 916.1093(2), F.S., requiring forensic facilities to adopt rules governing the use of seclusion and restraint.
SUMMARY: As mandated by statute, the revisions provide standards for the use of restraint and seclusion which are consistent with recognized best practices; prohibit inherently dangerous restraint or seclusion procedures; establish limitations on the use and duration of restraint and seclusion; establish measures to ensure the safety of clients and staff during an incident of restraint or seclusion; establish procedures for staff to follow before, during, and after incidents of restraint or seclusion; establish professional qualifications of and training for staff who may order or be engaged in the use of restraint or seclusion; provide data reporting and data collection procedures relating to the use of restraint or seclusion; and provide for the documentation of the use of restraint or seclusion in the client’s facility record.
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: 916.1093(2) FS.
LAW IMPLEMENTED: 916.105(4), 916.106(14), 916.106(16), 916.107(4)(b) FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE HELD AT THE DATE,TIME AND PLACE SHOWN BELOW(IF NOT REQUESTED, THIS HEARING WILL NOT BE HELD):
DATE AND TIME: September 30, 2009, 2:00 p.m.
PLACE: 1317 Winewood Blvd., Building 6, 2nd Floor, Conference Room A, Tallahassee, FL 32399-0700
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 5 days before the workshop/meeting by contacting: Wendy Scott, 1317 Winewood Blvd., Building 6, Rm. 227, Tallahassee, FL 32399-0700, (850)413-7282, email: wendy_scott@dcf.state.fl.us. 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: Wendy Scott, 1317 Winewood Blvd., Building 6, Rm. 227, Tallahassee, FL 32399-0700, (850)413-7282, email: wendy_scott@dcf.state.fl.us

THE FULL TEXT OF THE PROPOSED RULE IS:

65E-20.002 Definitions.

(1) Act: the Forensic Client Services Act.

(2) Treatment: mental health services which are provided to persons, individually or in groups, including: counseling, supportive therapy, chemotherapy, intensive psychotherapy, or any other accepted therapeutic process.

(2)(3) Client Representative: the client’s attorney of record, next of kin, or any other relative or person designated by the client. If none is designated, the attorney of record shall be the client representative.

(3)(4) Commitment: a court ordered involuntary hospitalization or placement of a forensic client according to the procedures of this act. It does not include voluntary admission of any client.

(4) Individual: a person with a mental illness who has been charged with a felony offense and is being served in a forensic facility. The term is synonymous with “client,” “patient,” or “resident.”

(5) Personal Safety Plan: a plan regarding strategies that the individual identifies as being helpful in avoiding a crisis. The plan also lists identified triggers that may signal or lead to agitation or distress.

(6) Physician: A medical practitioner licensed under Chapter 458, Florida Statutes or Chapter 459, Florida Statutes, who has experience in the diagnosis and treatment of mental and nervous disorders.

(7) Recovery Plan: may also be referred to as a “service plan” or “treatment plan.” A recovery plan is a written plan developed by the individual and his or her recovery team to facilitate achievement of the individual’s recovery goals. This plan is based on assessment data, identifying the individual’s clinical, rehabilitative and activity service needs, the strategy for meeting those needs, documented treatment goals and objectives, and documented progress in meeting specified goals and objectives.

(8) Recovery Team: may also be referred to as “service team” or “treatment team.” A recovery team is an assigned group of individuals with specific responsibilities identified on the recovery plan who support and facilitate an individual’s recovery process. Team members may include the individual, psychiatrist, guardian, community case manager, family member, peer specialist, and others as determined by the individual’s needs and preferences.

(9) Restraint: for behavior management purposes is defined in Section 916.106(14)(a), Florida Statutes. A drug used as a restraint is defined in Section 916.106(14)(b), Florida Statutes. Physically holding a person during a procedure to forcibly administer psychotropic medication is a physical restraint. It is the intent of the legislature to minimize and achieve an on-going reduction in the use of restraint.

(10) Seclusion: for behavior management purposes is defined in Section 916.106(16), Florida Statutes. It is the intent of the legislature to minimize and achieve an on-going reduction in the use of seclusion.

(11) Seclusion and Restraint Oversight Committee: a group at an agency or facility that monitors the use of seclusion and restraint at the facility. The purpose of this committee is to assist in the reduction of seclusion and restraint use at the agency or facility. Membership includes, but is not limited to, the facility administrator/designee, medical staff, quality assurance staff, and a peer specialist or advocate, if employed by the facility or otherwise available. If a peer specialist or advocate is not employed by the facility, an external peer specialist or advocate may be appointed.

(12) Treatment: mental health services which are provided to individuals, individually or in groups, including: counseling, supportive therapy, psychotherapeutic medication, intensive psychotherapy, or any other accepted therapeutic process.

Rulemaking Specific Authority 916,1093, 916.1093(2) 916.20(1) FS. Law Implemented 916.106, 916.106(14), 916.106(16) FS. History– New 9-29-86, Amended 7-1-96, Formerly 10E-20.002, Amended ________.

 

65E-20.003 The Right to Individual Dignity.

In addition to those elements of dignity and respect enumerated in Section 916.107(1), F.S., every forensic client is entitled to the following:

(1) Restraint or seclusion only insofar as clinically authorized as necessary to prevent imminent harm to self, others, or property, or as necessary to prevent an escape;

(1)(2) Freedom from neglect or abuse;

(2)(3) Reasonably Safe living conditions and protection from harm;

(3)(4) Appropriate seasonal attire; and

(4)(5) The opportunity to be outdoors and to participate in physical exercise at regular intervals, in the absence of medical or security considerations.

Rulemaking Specific Authority 916.1093 916.20(1) FS. Law Implemented 916.107(1) FS. History–New 9-29-86, Amended 7-1-96, Formerly 10E-20.003, Amended_________.

 

65E-20.014 Seclusion and Restraint for Behavior Management Purposes.

(1) General Standards.

(a) Each facility will provide a therapeutic milieu that supports a culture of recovery, individual empowerment, and responsibility. Each individual will have a voice in determining his or her treatment options. Treatment will foster trusting relationships and partnerships for safety between staff and individuals. Facility staff will be particularly sensitive to individuals with a history of trauma and use trauma informed care.

(b) The health and safety of the individual shall be the primary concern at all times.

(c) Seclusion or restraint shall be employed:

1. Only in emergency situations;

2. When necessary to prevent an individual from seriously injuring self or others; and

3. Less restrictive techniques have been tried and failed, or it has been clinically determined that the danger is such that less restrictive techniques cannot be safely applied.

(d) There is a high prevalence of past traumatic experience among individuals who receive mental health services. The response to trauma can include intense fear and helplessness, a reduced ability to cope, and an increased risk to exacerbate or develop a range of mental health and other medical conditions. The experience of being placed in seclusion or being restrained is potentially traumatizing. Seclusion and restraint practices shall be guided by the following principles of trauma-informed care: assessing trauma histories and symptoms; recognizing culture and practices that are re-traumatizing; processing the impact of a seclusion or restraint with the individual; and addressing staff training needs to improve knowledge and sensitivity.

(e) When an individual demonstrates a need for immediate medical attention in the course of an episode of seclusion or restraint, the seclusion or restraint shall be discontinued and immediate medical attention shall be obtained.

(f) Individuals will not be restrained in a prone position. Prone containment will be used only when required by the immediate situation to prevent imminent serious harm to the individual or others. To reduce the risk of positional asphyxiation, the individual will be repositioned as quickly as possible.

(g) Responders will pay close attention to the respiratory function of the individual during containment and restraint. All staff involved will observe the individual’s respiration, coloring, and other possible signs of distress and immediately respond if the individual appears to be in distress. Responding to the individual’s distress may include repositioning the individual, discontinuing the seclusion or restraint, or summoning medical attention.

(h) Objects shall not be placed over an individual’s face. In situations where precautions need to be taken to protect staff, staff may wear protective gear.

(i) Unless necessary to prevent serious injury, an individual’s hands shall not be secured behind the back during containment or restraint.

(j) The use of walking restraints is prohibited except for purposes of off-unit transportation and may only be used under direct observation of staff who have been trained for this purpose. Direct observation means that staff maintains continual visual contact of the individual and remains within close physical proximity to the individual at all times.

(k) The individual shall be released from seclusion or restraint as soon as he or she is no longer an imminent danger to self or others.

(l) Seclusion or restraint use shall not be based solely on a history of dangerous behavior or history of seclusion or restraint use. Dangerous behaviors include those behaviors that jeopardize the physical safety of oneself or others.

(m) Seclusion and restraint may not be used simultaneously for children less than 18 years of age. For individuals over the age of 18, simultaneous seclusion and restraint is only permitted if the individual is continually monitored face-to-face by an assigned, trained staff member or if the individual is continually monitored by trained staff using both audio and video equipment. Staff providing this monitoring must be in close proximity to the individual.

(n) An individual who is restrained must not be located in areas subject to view by individuals other than involved staff or where exposed to potential injury by other individuals. This does not apply to individuals in walking restraints.

(o) Each facility utilizing seclusion or restraint procedures shall establish and utilize a Seclusion and Restraint Oversight Committee.

(2) Staff Training. Staff must be trained during orientation and subsequently at least annually. Prior to using seclusion or restraint, staff will demonstrate specific knowledge of or relevant competency in the following areas:

(a) Employing strategies designed to reduce confrontation and to calm and comfort people, including the development and use of a personal safety plan;

(b) Using nonphysical intervention skills as well as body control and physical management techniques to ensure safety;

(c) Observing for and responding to signs of physical and psychological distress during the seclusion or restraint event;

(d) Applying restraint devices safely;

(e) Monitoring the physical and psychological well-being of the individual who is restrained or secluded, including but not limited to: respiratory and circulatory status, skin integrity, vital signs, and any special requirements specified by facility policy associated with the one hour face-to-face evaluation;

(f) Identifying the specific behavioral changes that indicate restraint or seclusion is no longer necessary;

(g) Using first aid techniques; and

(h) Being certified in the use of cardiopulmonary resuscitation (CPR), including required periodic recertification. The frequency of training for cardiopulmonary resuscitation will be in accordance with CPR certification requirements and facility policy.

(3) Prior to the Implementation of Seclusion or Restraint.

(a) Prior intervention shall include individualized therapeutic actions identified in a personal safety plan that address individual triggers leading to psychiatric crisis. Recommended form CF-MH 3124, Feb. 05, “Personal Safety Plan,” which is incorporated herein by reference, may be used for the purpose of guiding individualized techniques.

(b) Prior interventions should include verbal de-escalation, calming strategies, and environmental changes to reduce identified triggers. Non physical interventions must be the first choice unless safety issues require the use of physical intervention.

(c) A personal safety plan shall be completed or updated as soon as possible after admission and filed in the individual’s medical record:

1. The personal safety plan shall be reviewed by the recovery team, and updated if necessary, after each incident of seclusion or restraint;

2. Specific intervention techniques from the personal safety plan that are offered or used prior to a seclusion or restraint event shall be documented in the individual’s medical record after each use of seclusion or restraint; and

3. All staff shall be aware of and have ready access to each individual’s personal safety plan.

(d) Contraindications to the use of specific seclusion or restraint techniques due to medical conditions will be documented in the individual’s medical record as part of the individual’s admission and subsequent physical examination or psychiatric evaluation. Staff shall be informed of any contraindications as determined by the physician or Advanced Registered Nurse Practitioner (ARNP) and shall utilize other techniques as indicated on the individual’s personal safety plan.

(4) Implementation of Seclusion or Restraint.

(a) A registered nurse or highest level staff member, as specified by written facility policy, who is immediately available and who is trained in seclusion and restraint procedures may initiate seclusion or restraint in an emergency when danger to self or others is imminent.

(b) An order for seclusion or restraint must be obtained from the physician, ARNP, or Physician’s Assistant (PA), if permitted by the facility to order seclusion and restraint and stated within their professional protocol. The treating physician must be consulted as soon as possible if the seclusion or restraint was ordered by another physician.

(c) The individual must be seen face-to-face by a physician or ARNP within one hour after initiation of seclusion or restraint. The face-to-face exam may be delegated to a Registered Nurse (RN) or PA if authorized by the facility and the individual has been trained in seclusion and restraint procedures as described in subsection (2). The staff member conducting the face-to-face examination shall evaluate or review, and document the following within one hour:

1. The individual’s immediate situation;

2. The individual’s reaction to the intervention;

3. The individual’s medical and behavioral condition;

4. The individual’s medication orders, including an assessment of the need to modify such orders during the period of seclusion or restraint. If the face-to-face exam is completed by the RN or PA, the RN or PA shall consult with the physician or ARNP regarding the need to modify the resident’s medication orders;

5. The need or lack of need to elevate the individual’s head and torso during restraint;

6. Whether the risks associated with the use of seclusion or restraint are significantly less than not using seclusion or restraint; and

7. The need to continue or terminate the intervention.

(d) A licensed psychologist may only conduct the behavioral assessment portion of the face-to-face exam indicated in subparagraph (4)(c)3., if authorized by the facility and trained in seclusion and restraint procedures as described in subsection (2). If the face-to-face evaluation is conducted by a trained Registered Nurse or physician assistant, the attending physician who is responsible for the care of the individual must be consulted as soon as possible after the evaluation is completed.

(e) Documentation of the face-to-face examination described in subparagraphs (4)(c)1.-7., including the time and date completed, shall be included in the individual’s medical record.

(f) Each written order for seclusion or restraint is limited to four hours for adults, age 18 and over; and two hours for youth age 9 through 17. A seclusion or restraint order may be renewed every two hours for youth and every four hours for adults, after consultation and review by a physician, ARNP, or PA in person, or by telephone with a Registered Nurse who has physically observed and evaluated the individual. The order may only be renewed for up to a total of 24 hours. When the order has expired after 24 hours, a physician, ARNP, or PA must see and assess the individual before seclusion or restraint can be re-ordered. The results of this assessment must be documented. Seclusion or restraint use exceeding 24 hours requires the notification of the facility administrator or designee.

(g) Once seclusion or restraint has been terminated, a new order and subsequent assessments are required to place the individual back into seclusion or restraint as indicated in subsection (4) of this rule.

(h) Each seclusion or restraint order must be signed within 24 hours of the initiation of seclusion or restraint.

(i) The seclusion or restraint order shall include the specific behavior prompting the use of seclusion or restraint, the time limit for seclusion or restraint, and the behavior necessary for the individual’s release. Additionally, for restraint, the order shall contain the type of restraint ordered and the positioning of the individual, including possibly elevating the individual’s head for respiratory and other medical safety considerations. Consideration shall be given to the individual’s age, physical fragility, and physical disability when ordering restraint type.

(j) An order for seclusion or restraint shall not be issued as a standing order or on an as-needed basis.

(k) In order to protect all individuals served by a facility, each individual shall be searched for contraband before or immediately after being placed into seclusion or restraints.

(l) The individual shall be clothed appropriately for the current temperature and at no time shall an individual be placed in seclusion or restraint in a nude or semi-nude state.

(m) For youth under the age of 18, the facility must notify the parent(s) or legal guardian(s) of the individual who has been restrained or placed in seclusion within 24 hours after the initiation of each seclusion or restraint event. This notification must be documented in the individual’s medical record, including the date and time of notification and the name of the staff person providing the notification.

(n) Every secluded or restrained individual shall be immediately informed of the behavior that resulted in the seclusion or restraint and the behavior and the criteria necessary for release. Release criteria shall reflect that the individual is not an imminent danger to self or others.

(o) For each use of seclusion or restraint, the following information shall be documented in the individual’s medical record:

1. The emergency situation resulting in the seclusion or restraint event;

2. Alternatives or other less restrictive interventions attempted, as applicable, or the clinical determination that less restrictive techniques could not be safely applied;

3. The name and title of the staff member initiating the seclusion or restraint; the date/time of initiation and release;

4. The individual’s response to seclusion or restraint, including the rationale for continued use of the intervention; and

5. The individual was informed of the behavior that resulted in the seclusion or restraint and the criteria necessary for release.

(5) During Seclusion or Restraint Use.

(a) When restraint is initiated, except for walking/transport restraint, nursing staff shall see and assess the individual no later than 15 minutes after initiation and at least every hour thereafter. The assessment shall include checking the individual’s circulation and respiration, including vital signs (pulse and respiratory rate at a minimum).

(b) The individual who is secluded shall be observed by trained staff every 15 minutes. At least one observation an hour will be conducted by a nurse.

(c) Restrained individuals must have continuous observation by trained staff. Documentation of the resident’s condition will occur at least every 15 minutes.

(d) Monitoring the physical and psychological well-being of the individual who is secluded or restrained shall include but is not limited to: respiratory and circulatory status; signs of injury; vital signs; skin integrity; behavioral observations; verbal interactions; and any special requirements specified by facility policies. This monitoring shall be conducted by trained staff as required in subsection (2).

(e) During each period of seclusion or restraint, the individual must be offered reasonable opportunities to drink and toilet as requested. In addition, the individual who is restrained must be offered opportunities to have range of motion at least every two hours to promote comfort. Each facility shall have written policies and procedures specifying the frequency of providing drink, toileting, checking of body positioning to avoid traumatizing an individual, and retaining the individual’s maximum degree of dignity and comfort during the use of bodily control and physical management techniques.

(f) Documentation of the observations and the staff person’s name shall be recorded at the time the observation takes place.

(6) Release from Seclusion or Restraint and Post-Release Activities

(a) Release from seclusion or restraint shall occur as soon as the individual no longer appears or reports to present an imminent danger to self or others. Upon release from seclusion or restraint, the individual’s physical condition shall be observed, evaluated, and documented by trained staff. Documentation shall also include the name and title of the staff releasing the individual and the date and time of release.

(b) After a seclusion or restraint event, a debriefing process shall take place to decrease the likelihood of a future seclusion or restraint event for the individual and to provide support.

(c) Each facility shall develop policies to address:

1. A review of the incident with the individual who was secluded or restrained. The individual shall be given the opportunity to process the seclusion or restraint event as soon as possible but no longer than within 24 hours of release. This debriefing discussion shall take place between the individual and either the recovery team or another preferred staff member. This review shall address the incident within the framework of the individual’s life history and mental health issues. It shall assess the impact of the event on the individual and help the individual identify and expand coping mechanisms to avoid the use of seclusion or restraint in the future. The discussion will include constructive coping techniques for the future. A summary of this review should be documented in the individual’s medical record.

2. A review of the incident with all staff involved in the event and supervisors or administrators. This review shall be conducted as soon as possible after the event and shall address: the circumstances leading to the event; the nature of de-escalation efforts; alternatives to seclusion and restraint attempted; staff response to the incident; and ways to effectively support the individual’s constructive coping in the future and avoid the need for future seclusion or restraint. The outcomes of this review should be documented by the facility for purposes of continuous performance improvement and monitoring. The review findings will be forwarded to the Seclusion and Restraint Oversight Committee.

3. Support for other individuals served and staff, as needed, to return the unit to a therapeutic milieu.

(d) Within 2 working days after any use of seclusion or restraint, the recovery team shall meet and review the circumstances preceding the event and review the individual’s recovery plan and personal safety plan to determine whether any changes are needed in order to prevent the further use of seclusion or restraint. The individual who was secluded or restrained shall be provided an opportunity to participate in this meeting. The recovery team shall also assess the impact the event had on the individual and provide any counseling, services, or treatment that may be necessary. The recovery team shall analyze the individual’s clinical record for trends or patterns relating to conditions, events, or the presence of other persons immediately before or upon the onset of the behavior warranting the seclusion or restraint, and upon the individual’s release from seclusion or restraint. The recovery team shall review the effectiveness of the emergency intervention and develop more appropriate therapeutic interventions. Documentation of this review shall be placed in the individual’s clinical record.

(e) If an individual has had multiple seclusion or restraint events, the recovery team shall conduct a thorough clinical review, including a medication review, to determine if any changes to the recovery plan or overall treatment and services are needed.

(f) The Seclusion and Restraint Oversight Committee shall conduct at least weekly reviews of each use of seclusion and restraint event. The Committee shall also monitor patterns of use, for the purpose of ensuring least restrictive approaches are utilized, to prevent or reduce the frequency and duration of use.

(7) Reporting.

(a) All civil and forensic state mental health treatment facilities serving individuals committed pursuant to Chapter 916, F.S., are required to report each seclusion and restraint event to the Department of Children and Families. This reporting shall be done electronically using the Department’s web-based application, either directly via the data input screens, or indirectly via the File Transfer Protocol batch process. The required reporting elements include: provider tax identification number; individual’s social security number and identification number; date and time the seclusion or restraint event was initiated; discipline of the individual ordering the seclusion or restraint; discipline of the individual implementing the seclusion or restraint; reason seclusion or restraint was initiated; type of restraint used; whether significant injuries were sustained by the individual; and date and time seclusion or restraint was terminated. Facilities shall report seclusion and restraint events to the Department on a monthly basis. Events that result in death or significant injury, either to a staff member or individual, shall be reported to the department’s web-based system in accordance with department operating procedures and must also be reported according to the department’s incident reporting procedure.

(b) All facilities that are subject to the Conditions of Participation for Hospitals, 42 Code of Federal Regulations, part 482, under the Centers for Medicare and Medicaid Services (CMS), must report to CMS any death that occurs in the following circumstances:

1. While an individual is restrained or secluded;

2. Within 24 hours after release from seclusion or restraint; OR

3. Within one week after seclusion or restraint, where it is reasonable to assume that use of the seclusion or restraint contributed directly or indirectly to the individual’s death.

Each death described in paragraph (7)(b) shall be reported to CMS by telephone no later than the close of business the next business day following knowledge of the individuals’ death. A report shall simultaneously be submitted to the Director of Mental Health/Designee in the Mental Health Program Office headquarters in Tallahassee, FL. The address is: 1317 Winewood Blvd., Tallahassee, FL 32399-0700. Facilities that are not required to report these deaths to CMS shall report the death to the Department in accordance with Departmental operating procedures.

(c) The Department shall collect and review the data on a monthly basis. The Director of Mental Health shall be informed of any deaths or significant injuries related to seclusion or restraint, and significant trends regarding seclusion and restraint use.

(8) Nothing herein shall affect the ability of emergency medical technicians, paramedics or physicians, or any person acting under the direct medical supervision of a physician to provide examination or treatment of incapacitated individuals in accordance with Section 401.445, F.S.

Rulemaking Authority 916.1093(2) FS. Law Implemented 916.105(4), 916.107(4)(b), 916.1093(2) FS. History–New_________.


NAME OF PERSON ORIGINATING PROPOSED RULE: Wendy Scott
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Secretary George H. Sheldon
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: August 19, 2009
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: December 24, 2008