The purpose and effect of these rule revisions is to implement the provisions of Section 394.457(5)(b), F.S., regarding seclusion and restraint use in mental health facilities and programs. Section 394.457(5)(b), F.S., requires the department to ...

DEPARTMENT OF CHILDREN AND FAMILY SERVICES
Mental Health Program

RULE NO: RULE TITLE
65E-5.100: Definitions
65E-5.180: Right to Quality Treatment
PURPOSE AND EFFECT: The purpose and effect of these rule revisions is to implement the provisions of Section 394.457(5)(b), F.S., regarding seclusion and restraint use in mental health facilities and programs. Section 394.457(5)(b), F.S., requires the department to adopt rules governing the use of seclusion and restraint in mental health facilities. The proposed revisions are to comply with this statutory requirement.
SUMMARY: The proposed rule shall clarify the subject area addressed is Section 394.457(5)(b), F.S. The department must adopt rules governing the use of seclusion and restraint. The rule must: include provisions governing the use of restraint and seclusion which are consistent with recognized best practices and professional judgment; 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 program participants 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; and establish mandatory reporting, data collection, and data dissemination procedures and requirements; and require that each instance of the use of restraint or seclusion be documented in the record of the patient.
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: 394.457(5)(b), 394.46715 FS.
LAW IMPLEMENTED: 394.455(1), 394.457, 394.4573(1)(b), 394.459(2), 394.459(2)(d), 394.459(4), 394.4625, 394.4655, 394.467, 401.455, 491, 765.401 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
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: Wendy Scott, 1317 Winewood Blvd., Bldg. 6, Room 227, Tallahassee, Florida 32399-0700, [phone] or [e-mail]. 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., Bldg. 6, Room 227, Tallahassee, Florida 32399-0700, [phone] or [e-mail]

THE FULL TEXT OF THE PROPOSED RULE IS:

MENTAL HEALTH ACT REGULATION

65E-5.100 Definitions.

As used in this chapter the following words and phrases have the following definitions:

(1) through (10) No change.

(11) Personal Safety Plan is a form used to document information regarding calming strategies that the person identifies as being helpful in avoiding a crisis. The plan also lists triggers that are identified that may signal or lead to agitation or distress.

(12)(11) Pro re nata (PRN) means an individualized order for the care of an individual person which is written after the person has been seen by the practitioner, which order sets parameters for attending staff to implement according to the circumstances set out in the order. A PRN order shall not be used as an emergency treatment order.

(13)(12) Protective medical devices mean a specific category of medical restraint that includes devices, or combinations of devices, to restrict movement for purposes of protection from falls or complications of physical care, such as geri-chairs, posey vests, mittens, belted wheelchairs, sheeting, and bed rails. The requirements for the use and documentation of use of these devices are for specific medical purposes rather than for behavioral control.

(13) Restraint means the immobilization of a person’s body in order to restrict free movement or range of motion, whether by physical holding or by use of a mechanical device. For purposes of this chapter, restraint includes all applications of such procedures, specifically including emergency treatment orders and emergency medical procedures which includes protective medical devices for ambulating safety, or furniture used to protect mobility-impaired persons from falls and injury. The use of walking restraints when used during transportation under the supervision of trained staff is not considered restraint.

(14) Recovery Plan may also be referred to as a “service plan,” or “treatment plan.” A recovery plan is a written plan developed by the person and his or her recovery team to facilitate achievement of the person’s recovery goals. This plan is based on assessment data, identifying the person’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. Seclusion means an emergency response in which, as a means of controlling a person’s immediate symptoms or behavior, the person’s ability to move about freely has been limited by staff or in which a person has been physically segregated in any fashion from other persons. Seclusion requires a written emergency treatment order by a physician except as described and authorized in Rule 65E-5.1602, F.A.C., of this rule chapter.

(15) 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 a person’s recovery process. Team members may include the person, psychiatrist, guardian/guardian advocate, community case manager, family member, peer specialist and others as determined by the person’s needs and preferences.

(16) Restraint for behavior management purposes is defined in Section 394.455(28)(a), F.S. A drug used as a restraint is defined in Section 394.455(28)(b), F.S. Physically holding a person during a procedure to forcibly administer psychotropic medication is a physical restraint.

(17) Seclusion for behavior management purposes is defined in Section 394.455(29), F.S.

(18) Seclusion and Restraint Oversight Committee is a group of people at an agency or facility that monitors the use of seclusion and restraint at the facility. This committee is intended 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 no such person is employed by the facility, an external peer specialist or advocate may be appointed.

(19)(15) Standing order means a broad protocol or delegation of medical authority that is generally applicable to a group of persons, hence not individualized. As limited by this chapter, it prohibits improper delegations of authority to staff that are not authorized by the facility, or not permitted by practice licensing laws, to independently make such medical decisions; such as decisions involving determination of need, medication, routes, dosages for psychotropic medication, or use of restraints or seclusion upon a person.

Specific Authority 394.457(5), 394.46715 FS. Law Implemented 394.455(1), 394.457, 394.4573(1)(b), 394.459(2), 394.4625, 394.4655, 394.467, 491, 765.101, 765.401 FS. History–New 11-29-98, Amended 4-4-05,_________.

 

65E-5.180 Right to Quality Treatment.

The following standards shall be required in the provision of quality mental health treatment:

(1) through (6) No change.

(7) Bodily Control and Physical Management Techniques.

(a) All staff who have contact with persons served by the facility shall receive training, prior to providing direct services or assessment to persons in the facility, in:

1. Verbal de-escalation techniques designed to reduce confrontation; and

2. Use of bodily control and physical management techniques based on a team approach.

(b) All staff who have contact with persons served by the facility shall receive training in safe and effective techniques that are alternatives to seclusion and restraint for managing violent behavior. Training shall include techniques that are consistent with the age of persons served by the facility.

(c) Less restrictive verbal de-escalation interventions shall be employed before physical interventions, unless physical injury is imminent. Recommended form CF-MH 3124, Feb. 05, “Personal Safety Plan,” which is incorporated by reference and may be obtained pursuant to Rule 65E-5.120, F.A.C., of this rule chapter may be used for the purpose of guiding individualized intervention techniques. If used, this form shall be completed at admission.

(d) PRNs for the use of seclusion or restraints are not permitted.

(e) Each facility shall have written policies and procedures specifying the frequency of providing drink, toileting, and check of bodily positioning to avoid traumatizing persons and retaining the person’s maximum degree of dignity and comfort during the use of bodily control and physical management techniques.

(8) Isolation.

(a) Isolation means involuntarily imposed segregation of the person from others for a period of up to 15 minutes per event. A person in isolation shall not be behind closed doors. Isolation does not require a physician’s order.

(b) When a person requires more than a total of 60 minutes of segregation in a 24-hour period, a physician’s order for seclusion is required.

(c) Each use of isolation shall be documented in the person’s clinical record.

(7) Seclusion and Restraint for Behavior Management Purposes. All facilities, as defined in Section 394.455(10), F.S., are required to adhere to the standards and requirements of subsection (7).

(a) General Standards.

1. Each facility will provide a therapeutic milieu that supports a culture of recovery and individual empowerment and responsibility. Each person 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 practices will be particularly sensitive to persons with a history of trauma.

2. The health and safety of the person shall be the primary concern at all times.

3. Seclusion or restraint shall be employed only in emergency situations when necessary to prevent a person from seriously injuring self or others, and less restrictive techniques have been tried and failed, or if it has been clinically determined that the danger is of such immediacy that less restrictive techniques cannot be safely applied.

4. There is a high prevalence of past traumatic experience among persons 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: assessment of traumatic histories and symptoms; recognition of culture and practices that are re-traumatizing; processing the impact of a seclusion or restraint with the person; and addressing staff training needs to improve knowledge and sensitivity.

5. When a person 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.

6. Persons 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 person or others. To reduce the risk of positional asphyxiation, the person will be repositioned as quickly as possible.

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

8. Objects that impair respiration shall not be placed over a person's face. In situations where precautions need to be taken to protect staff, staff may wear protective gear.

9. Unless necessary to prevent serious injury, a person's hands shall not be secured behind the back during containment or restraint.

10. The use of walking restraints is prohibited except for purposes of off-unit transportation and may only be used under direct observation of trained staff. In this instance, direct observation means that staff maintains continual visual contact of the person and is within close physical proximity to the person at all times.

11. The person shall be released from seclusion or restraint as soon as he or she is no longer an imminent danger to self or others.

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

13. Seclusion and restraint may not be used simultaneously for children less than 18 years of age.

14. A person who is restrained must not be located in areas, whenever possible, subject to view by persons other than involved staff or where exposed to potential injury by other persons. This does not apply to the use of walking restraints.

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

(b) Staff training.

1. Staff must be trained as part of orientation and subsequently on at least an annual basis. Staff responsible for the following actions will demonstrate relevant competency in the following areas before participating in a seclusion or restraint event or related assessment, or before monitoring or providing care during an event:

a. Strategies designed to reduce confrontation and to calm and comfort people, including the development and use of a personal safety plan,

b. Use of nonphysical intervention skills as well as bodily control and physical management techniques, based on a team approach, to ensure safety,

c. Observing for and responding to signs of physical and psychological distress during the seclusion or restraint event,

d. Safe application of restraint devices,

e. Monitoring the physical and psychological well-being of the person 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. Clinical identification of specific behavioral changes that indicate restraint or seclusion is no longer necessary,

g. The use of first aid techniques, and

h. Certification in the use of cardiopulmonary resuscitation, including required periodic recertification. The frequency of training for cardiopulmonary resuscitation will be in accordance with certification requirements, notwithstanding provision subparagraph (7)(b)1.

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

1. Prior intervention shall include individualized theraputic actions such as those identified in a personal safety plan (such as recommended form CF-MH 3124) that address individual triggers leading to psychiatric crisis. Prior interventions may also include verbal de-escalation and calming strategies. Non physical interventions shall be the first choice unless safety issues require the use of physical intervention.

2. A personal safety plan shall be completed or updated as soon as possible after admission and filed in the person’s medical record.

a. This form shall be reviewed by the recovery team, and updated if necessary, after each incident of seclusion or restraint.

b. 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 person's medical record after each use of seclusion or restraint.

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

(d) Implementation of Seclusion or Restraint.

1. 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 oneself or others is imminent. An order for seclusion or restraint must be obtained from the physician or Advanced Registered Nurse Practitioner (ARNP)/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 not ordered by the person’s treating physician.

2. An examination of the person will be conducted within one hour by the physician or may be delegated to an Advanced Registered Nurse Practitioner, Physician’s Assistant, or Registered Nurse (RN), if authorized by the facility and trained in seclusion and restraint procedures as described in paragraph (7)(b). This examination shall include a face-to face assessment of the person's medical and behavioral condition, a review of the clinical record for any pre-existing medical diagnosis and/or physical condition which may contraindicate the use of seclusion or restraint, a review of the person’s medication orders including an assessment of the need to modify such orders during the period of seclusion or restraint, and an assessment of the need or lack of need to elevate the person’s head and torso during restraint. The comprehensive examination must determine that the risks associated with the use of seclusion or restraint are significantly less than not using seclusion or restraint and whether to continue or terminate the intervention. A licensed psychologist may conduct only the behavioral assessment portion of the comprehensive assessment if authorized by the facility and trained in seclusion and restraint procedures as described in paragraph (7)(b). Documentation of the comprehensive examination, including the time and date completed, shall be included in the person’s medical record. If the face to face evaluation is conducted by a trained Registered Nurse, the attending physician who is responsible for the care of the person must be consulted as soon as possible after the evaluation is completed.

3. Each written order for seclusion or restraint is limited to four hours for adults, age 18 and over; two hours for children and adolescents age nine through 17; or one hour for children under age nine. A seclusion or restraint order may be renewed in accordance with these limits for up to a total of 24 hours, after consultation and review by a physician/ARNP/PA in person, or by telephone with a Registered Nurse who has physically observed and evaluated the person. When the order has expired after 24 hours, a physician/ARNP/PA must see and assess the person 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.

4. All orders must be signed within 24 hours of the initiation of seclusion or restraint.

5. The 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 person’s release.  Additionally, for restraint, the order shall contain the type of restraint ordered and the positioning of the person, including possibly elevating the person's head for respiratory and other medical safety considerations. Consideration shall be given to age, physical fragility, and physical disability when ordering restraint type.

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

7. In order to protect the safety of each person served by a facility, each person shall be searched for contraband before or immediately after being placed into seclusion or restraints.

8. The person shall be clothed appropriately for temperature and at no time shall a person be placed in seclusion or restraint in a nude or semi-nude state.

9. Every secluded or restrained person shall be immediately informed of the behavior that resulted in the seclusion or restraint and the behavior and the criteria reflecting absence of imminent danger that is necessary for release.

10. For persons under the age of 18, the facility must notify the parent(s) or legal guardian(s) of the person who has been restrained or placed in seclusion as soon as possible, but no later than 24 hours, after the initiation of each seclusion or restraint event.  This notification must be documented in the person's medical record, including the date and time of notification and the name of the staff person providing the notification.

11. For each use of seclusion or restraint, the following information shall be documented in the person’s medical record: the emergency situation resulting in the seclusion or restraint event; alternatives or other less restrictive interventions attempted, as applicable, or the clinical determination that less restrictive techniques could not be safely applied; the name and title of the staff member initiating the seclusion or restraint; the date/time of initiation and release; the person’s response to seclusion or restraint, including the rationale for continued use of the intervention; and that the person was informed of the behavior that resulted in the seclusion or restraint and the criteria necessary for release.

(e)  During Seclusion or Restraint Use.

1. When restraint is initiated, nursing staff shall see and assess the person as soon as possible but no later than 15 minutes after initiation and at least every hour thereafter. The assessment shall include checking the person's circulation and respiration, including necessary vital signs (pulse and respiratory rate at a minimum).

2. The person over age 12 who is secluded shall be observed by trained staff every 15 minutes. At least one observation an hour will be conducted by a nurse.  Restrained persons must have continuous observation by trained staff.  Secluded children age 12 and under must be monitored continuously by face to face observation or by direct observation through the seclusion window for the first hour and then at least every 15 minutes thereafter.

3. Monitoring the physical and psychological well-being of the person who is secluded or restrained shall include but is not limited to: respiratory and circulatory status; signs of injury; vital signs; skin integrity; and any special requirements specified by facility policies. This monitoring shall be conducted by trained staff as required in paragraph (7)(b).

4. During each period of seclusion or restraint, the person must be offered reasonable opportunities to drink and toilet as requested. In addition, the person 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, and check of bodily positioning to avoid traumatizing a person and retaining the person’s maximum degree of dignity and comfort during the use of bodily control and physical management techniques.

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

(f) Release from Seclusion or Restraint and Post-Release Activities.

1. Release from seclusion or restraint shall occur as soon as the person no longer appears to present an imminent danger to themselves or others. Upon release from seclusion or restraint, the person’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 person; and the date and time of release.

2. 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 person and to provide support.

a. Each facility shall develop policies to address:

(i) A review of the incident with the person who was secluded or restrained. The person 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 person and either the recovery team or another preferred staff member. This review shall seek to understand the incident within the framework of the person's life history and mental health issues. It should assess the impact of the event on the person and help the person 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 person’s medical record.

(ii) 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 and/or alternatives to seclusion and restraint attempted, staff response to the incident, and ways to effectively support the person’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, and

(iii) Support for other persons served and staff, as needed, to return the unit to a therapeutic milieu.

b. Within 2 working days after any use of seclusion or restraint, the recovery team shall meet and review the circumstances preceding its initiation and review the person'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 recovery team shall also assess the impact the event had on the person and provide any counseling, services, or treatment that may be necessary as a result. The recovery team shall analyze the person’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 person’s release from seclusion. 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 person's clinical record.

c. The Seclusion and Restraint Oversight Committee shall conduct timely reviews of each use of seclusion and restraints and monitor patterns of use, for the purpose of assuring least restrictive approaches are utilized to prevent or reduce the frequency and duration of use.

(g) Reporting.

1. All facilities, as defined in Section 394.455(10), Florida Statutes, 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 are: Provider tax identification number; Person's social security number and identification number; date and time the seclusion or restraint event was initiated; discipline of the person ordering the seclusion or restraint; discipline of the person implementing the seclusion or restraint; reason seclusion or restraint was initiated; type of restraint used; whether significant injuries were sustained by the person; and date and time seclusion or restraint was terminated. Facilities shall report seclusion and restraint events on a monthly basis. Events that result in death or significant injury either to a staff member or person shall be reported to the department’s web based system in accordance with department operating procedures.

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

a. While a person is restrained or secluded

b. Within 24 hours after release from seclusion or restraint,

c. 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 person’s death.

Each death described in this section shall be reported to CMS by telephone no later than the close of business the next business day following knowledge of the persons' death. A report shall simultaneously be submitted to the Mental Health Program Office headquarters in Tallahassee, FL. The address is: 1317 Winewood Blvd., Tallahassee, FL 32399-0700. A contact person to receive these notices will be appointed.

3. 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.

(h) 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 persons in accordance with Section 401.445, F.S.

(9) Seclusion.

(a) As used in this subsection, seclusion means any time a person’s ability to move about freely has been limited by staff or the person has been segregated in any fashion from other persons, as a means of controlling the person’s immediate symptoms or behavior. The seclusion process shall evidence consideration that alternatives such as those listed in recommended form CF-MH 3124, “Personal Safety Plan,” as referenced in paragraph 65E-5.180(7)(c), F.A.C., have been considered by implementing staff. In order to enhance safety of all persons served by the facility, each person shall be searched for contraband before ordering the person into seclusion.

(b) Isolation shall be attempted prior to imposing seclusion, whenever possible.

(c) In order to assure safety, a written order by a physician shall be required for each use of seclusion.

(d) In an emergency, any registered nurse or the highest level staff member who is immediately available and who is trained in seclusion procedures, may initiate seclusion if in accord with specific written facility policies. If imposed without a prior written order, an order must be obtained from a physician and written within 1 hour after initiation of seclusion or the person must be immediately released from seclusion. All verbal orders for seclusion must be signed within 24 hours after the initiation of seclusion by an authorizing physician. If seclusion is initiated by a staff member other than an advanced registered nurse practitioner or a

registered nurse, an advanced registered nurse practitioner or a registered nurse shall assess the need for seclusion and document it in the chart within 15 minutes of initiation. Persons released from seclusion due to the lack of an order or without the nursing assessment may not again be ordered into seclusion within the following 12 hours without an accompanying order.

(e) Physicians authorized by the facility to order seclusion in a receiving or treatment facility, shall exercise this authority under the oversight of the facility’s medical oversight committee.

(f) Where seclusion is ordered, it may only be ordered by a physician and it may be ordered for a period up to:

1. One hour for minors under 9 years of age;

2. Two hours for minors 9 years of age up to the age of 18; and

3. Four hours for adults.

(g) A seclusion order may be extended, if the emergency continues to exist, by repeating these timeframes after review by a physician or advanced registered nurse practitioner.

(h) Where seclusion is to be used upon the occurrence of specific behavior, this intervention must comply with the provisions of Rule 65E-5.1602, F.A.C., of this rule chapter.

(i) Each use of seclusion and the name of the person initiating the seclusion must be documented in a unit log book or similar automated registry maintained for this purpose; each use and explicit reason for seclusion shall also be recorded in the person’s clinical record. Upon initiation of seclusion, the log book shall sequentially record all uses of seclusion, and for each use, the date and time of initiation and release, and elapsed time.

(j) During each period of seclusion, the person must:

1. Be offered opportunity to drink and to toilet as requested, and to have range of motion as needed.

2. Be observed by staff trained in this function at least every 15 minutes, for injury and respiration, and the findings immediately documented. Documentation of the observations and the staff person’s name shall be recorded at the time the observation takes place. At least once every hour, such documented observation shall be conducted by a nurse.

(k) Every secluded person shall be immediately informed of the behavior that caused his or her seclusion and the behavior and conditions necessary for their release. It shall be documented in the person’s clinical record that the person was informed of the cause of his or her seclusion and the conditions necessary for release.

(l) Facilities shall develop and staff shall use criteria to guide early termination from seclusion. When seclusion is terminated early and the same symptomatic behavior which caused the application of seclusion is still evident, the original order can be reapplied.

(m) Upon release from seclusion, the person’s physical condition shall be observed, evaluated, and documented. After the person’s release, a therapeutic debriefing led by a senior staff member not involved in the incident, shall take place to review the existing documentation of the incident, interview staff and other’s present during the incident to determine what alternative interventions could have been used. The person released from seclusion shall be included in the debriefing unless a physician documents that the person’s presence at the debriefing is not in the person’s best interest. The results of this debriefing shall be documented in the person’s clinical record.

(n) If 2 or more incidents of seclusion of a person are necessary within a 24-hour period, the treatment team shall analyze the person’s clinical record for trends or patterns relating to conditions, events, or individuals present immediately before or upon the onset of the behavior warranting the seclusion, and of the conditions presented upon the person’s release from seclusion. The treatment team shall review the effectiveness of the emergency intervention and develop more appropriate therapeutic interventions. Documentation of this review shall be placed in the person’s clinical record.

(10) Restraints.

(a) In imposing restraints on a person, use of age and physical fragility sensitive techniques shall be utilized. If a device is used for age or fragility reasons, it should be so documented in the person’s clinical record.

(b) Walking restraints may only be used during transportation under the supervision of trained staff. The use of walking restraints is prohibited except for purposes of off-unit transportation.

(c) Restraints are an emergency psychiatric measure to be used only for the immediate physical protection of the person or others and may be imposed only upon the order of a physician. The order shall include the specific behavior prompting the use of restraints, the type of restraint ordered, time limit for restraint use, the positioning of the person for respiratory and other medical safety considerations, and the behavior necessary for the person’s release from restraint. Any use of restraint shall be in accordance with the federal regulations governing hospital conditions of participation for patients’ rights found in 42 CFR 482.13 and with facility policies and procedures which shall require staff proficiency in age and fragility-sensitive appropriate techniques, including medical risk considerations of positioning the person. The restraint process shall evidence consideration that individual’s choice alternatives as identified in the recommended form CF-MH 3124, “Personal Safety Plan,” as referenced in paragraph 65E-5.180(7)(c), F.A.C., have been considered.

(d) In an emergency, a registered nurse or the highest level staff member who is immediately available and who is trained in restraint procedures, may initiate restraints. However, an order by a physician must be obtained and written within the person’s clinical record within one hour after initiation or the person must be immediately released from the restraints. If restraints are initiated by a staff member other than a nurse, the nurse shall assess the need for restraints and document it in the chart within 15 minutes after initiation. All orders for restraint must be signed within 24 hours after the initiation of the restraints.

(e) If a physician is authorized to order restraints in a receiving or treatment facility, such physician shall practice under the oversight of the facility’s medical oversight committee.

(f) Where restraint is ordered, it may only be ordered by a physician and it may be ordered for an initial period up to:

1. One hour for minors under 9 years of age;

2. Two hours for minors 9 years of age up to the age of 18; and

3. Four hours for adults.

(g) A restraint order may be extended by repeating these timeframes, after review by a physician or an advanced registered nurse practitioner.

(h) In order to protect the safety of each person served by a facility, each person shall be:

1. Searched for contraband before or immediately after being placed into restraints; and

2. Evaluated medically to determine the need or lack of need to elevate the person’s head and torso during restraint prior to placing the person into restraints. Such evaluation of the need or lack of need shall be documented in the order for restraints.

(i) Each use of restraint and the name of the person initiating the restraint must be documented in a unit log book or similar automated registry maintained for this purpose; each use and explicit reason for restraint shall also be recorded in the person’s clinical record. Upon initiation of restraints, the log book shall sequentially record all uses of restraints, and for each use, the date and time of initiation, release, and elapsed time.

(j) During each period of restraint, the person must:

1. Be offered opportunity to drink and to toilet as requested, and to have range of motion as needed;

2. Be located in areas, whenever possible, not subject to view by individuals other than staff or where they are exposed to potential injury by other persons; and

(k) Every restrained person shall be informed of the behavior that caused his or her restraint and the behavior and conditions necessary for their release. Within 15 minutes of reaching specified criteria the person shall be released from restraints.3. Be observed by staff trained in this skill at least every 15 minutes, for circulation, injury, and respiration, and the findings immediately documented. Documentation of the observations and the staff person’s name shall be recorded at the time the observation takes place. At least once every hour, such documented observation shall be conducted by a nurse.

(l) Facilities shall develop and staff shall use criteria to guide early termination from restraint. When restraint is terminated early and the same behavior which caused the application of restraints is still evident, the original order can be reapplied.

(m) Upon release from restraints, the person’s physical condition shall be observed, evaluated, and documented. After the person’s release, a therapeutic debriefing led by a senior staff member not involved in the incident, shall take place to review the existing documentation of the incident, interview staff and other’s present during the incident to determine what alternative interventions could have been used. The person released from restraints shall be included in this debriefing unless a physician documents that the person’s presence at the debriefing is not in the person’s best interest. The results of this debriefing shall be documented in the person’s clinical record.

(n) Since restraint is an emergency procedure, within 48 hours after any use of restraint, the circumstances preceding its imposition and the person’s treatment plan must be reviewed to determine whether changes in the plan are advisable in order to prevent the further use of restraint.

(o) Nothing herein shall effect 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 persons in accordance with Section 401.445, F.S.

(8)(11) Use of Protective Medical Devices with Frail or Mobility Impaired Persons.

(a) When ordering safety or protective devices such as posey vests, geri-chairs, mittens, and bed rails which also restrain, facility staff shall consider alternative means of providing such safety so that the person’s need for regular exercise is accommodated to the greatest extent possible.

(b) Where frequent or prolonged use of safety or protective devices are required, the person’s treatment plan shall address debilitating effects due to decreased exercise levels such as circulation, skin, and muscle tone and the person’s need for maintaining or restoring bowel and bladder continence.

(c) The treatment plan shall include scheduled activities to lessen deterioration due to the usage of such protective medical devices.

(9)(12) Elevated Levels of Supervision. Receiving and treatment facilities shall ensure that where one-on-one supervision is ordered by a physician, it shall be continuous and shall not be interrupted as a result of shift changes or due to conflicting staff assignments. Such supervision shall be continuous until documented as no longer medically necessary by a physician.

(13) Seclusion and Restraint Oversight. Each facility utilizing seclusion or restraint procedures shall establish and utilize a committee, that includes medical staff, to conduct timely reviews of each use of seclusion and restraint, and monitor patterns of use, for the purpose of assuring least restrictive approaches are utilized to reduce the frequency and duration of use upon persons served by the facility.

Specific Authority 394.457(5), 394.457(5)(b) FS. Law Implemented 394, Part I, 394.459(2)(d), (4), 401.455 FS. History–New 11-29-98, Amended 4-4-05, 2-8-07,_________.

NAME OF PERSON ORIGINATING PROPOSED RULE: Wendy Scott, Government Operations Consultant III, Mental Health, Department of Children and Families
NAME OF SUPERVISOR OR PERSON WHO APPROVED THE PROPOSED RULE: Sally Cunningham, Chief, State Mental Health Treatment Facilities, Mental Health, Department of Children and Families
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: December 10, 2007
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: January 18, 2008