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

1. (1) Each receiving and treatment facility and service provider shall, using nationally accepted accrediting standards for guidance, develop written policies and procedures for planned program activities designed to enhance the person’s self image, as required by Section 394.459(2)(d), F.S. These policies and procedures shall include curriculum, specific content, and performance objectives and shall be delivered by staff with content expertise. Medical, rehabilitative, and social services shall be integrated and provided in the least restrictive manner consistent with the safety of the persons served.

2. (2) Each facility and service provider, using nationally accepted accrediting standards for guidance, shall adopt written professional standards of quality, accuracy, completeness, and timeliness for all diagnostic reports, evaluations, assessments, examinations, and other procedures provided to persons under the authority of Chapter 394, Part I, F.S. Facilities shall monitor the implementation of those standards to assure the quality of all diagnostic products. Standards shall include and specify provisions addressing:

   1. (a) The minimum qualifications to assure competence and performance of staff who administer and interpret diagnostic procedures and tests;
   2. (b) The inclusion and updating of pertinent information from previous reports, including admission history and key demographic, social, economic, and medical factors;
   3. (c) The dating, accuracy and the completeness of reports;
   4. (d) The timely availability of all reports to users;
   5. (e) Reports shall be legible and understandable;
   6. (f) The documentation of facts supporting each conclusion or finding in a report;
   7. (g) Requirements for the direct correlation of identified problems with problem resolutions that consider the immediacy of the problem or time frames for resolution and which include recommendations for further diagnostic work-ups;
   8. (h) Requirement that the completed report be signed and dated by the administering staff; and,
   9. (i) Consistency of information across various reports and integration of information and approaches across reports.

3. (3) Psychiatric Examination. Psychiatric examinations shall include:

   1. (a) Medical history, including psychiatric history, developmental abnormalies, physical or sexual abuse or trauma, and substance abuse;
   2. (b) Examination, evaluative or laboratory results, including mental status examination;
   3. (c) Working diagnosis, ruling out non-psychiatric causes of presenting symptoms of abnormal thought, mood or behaviors;

   4. (d) Course of psychiatric interventions including:

      1. Medication history, trials and results,

      2. Current medications and dosages,

      3. Other psychiatric interventions in response to identified problems,

   5. (e) Course of other non-psychiatric medical problems and interventions;
   6. (f) Identification of prominent risk factors including physical health, psychiatric and co-occurring substance abuse; and,
   7. (g) Discharge or transfer diagnoses.
4. (4) So that care will not be delayed upon arrival, procedures for the transfer of the physical custody of persons shall specify and require that documentation necessary for legal custody and medical status, including the person’s medication administration record for that day, shall either precede or accompany the person to his or her destination.

5. (5) Mental health services provided shall comply with the following standards:

   1. (a) In designated receiving facilities, the on-site provision of emergency psychiatric reception and treatment services shall be available 24-hours-a-day, seven-days-a-week, without regard to the person’s financial situation.
   2. (b) Assessment standards shall include provision for determining the presence of a co-occurring mental illness and substance abuse, and clinically significant physical and sexual abuse or trauma.
   3. (c) A clinical safety assessment shall be accomplished at admission to determine the person’s need for, and the facility’s capability to provide, an environment and treatment setting that meets the person’s need for a secure facility or close levels of staff observation.

   4. (d) The development and implementation of protocols or procedures for conducting and documenting the following shall be accomplished by each facility:

      1. Determination of a person’s competency to consent to treatment within 24 hours after admission,

      2. Identification of a duly authorized decision-maker for the person upon any person being determined not to be competent to consent to treatment,

      3. Obtaining express and informed consent for treatment and medications before administration, except in an emergency; and,

      4. Required involvement of the person and guardian, guardian advocate, or health care surrogate or proxy, in treatment and discharge planning.

   5. (e) Use of age sensitive interventions in the implementation of seclusion or in the use of physical force as well as the authorization and training of staff to implement restraints, including the safe positioning of persons in restraints. Policies, procedures and services shall incorporate specific provisions regarding the restraining of minors, elders, and persons who are frail or with medical problems such as potential problems with respiration.
   6. (f) Plain language documentation in the person’s clinical record of all uses of “as needed” or emergency applications of psychotropic medications, and all uses of physical force, restraints, seclusion, or “time-out” procedures upon persons, and the explicit reasons for their use.
   7. (g) The prohibition of standing orders or similar protocols for the emergency use of psychotropic medication, restraint, or seclusion.
   8. (h) Provision of required training for guardian advocates including activities and available resources designed to assist family members and guardian advocates in understanding applicable treatment issues and in identifying and contacting local self-help organizations.

6. (6) Each facility shall develop a written policy and procedure for receiving, investigating, tracking, managing and responding to formal and informal complaints by a person receiving services or by an individual acting on his or her behalf.

   1. (a) The complaint process shall be verbally explained during the orientation process and provided in writing in language and terminology that the person receiving services can understand. It will explain how individuals may address complaints informally through the facility staff and treatment team, and formally through the staff person assigned to handle formal complaints, as well as the administrator or designee of the facility. The person receiving services shall also be advised that he or she may contact the Local Advocacy Council, the Florida Abuse Registry, the Advocacy Center for Persons with Disabilities, or any other individual or agency at anytime during the complaint process to request assistance. The complaint process, including telephone numbers for the above named entities, shall be posted in plain view in common areas and next to telephones used by individuals receiving services. Any complaint may be verbal or written. Any staff person receiving an informal or formal complaint dealing with life-safety issues will take immediate action to resolve the matter.
   2. (b) Informal complaints are initial complaints that are usually made verbally by a person receiving services or by an individual acting on his or her behalf. If resolution cannot be mutually agreed upon, a formal written complaint may be initiated.

   3. (c) When the person receiving services, or a person acting upon that person’s behalf, makes a formal complaint a staff person not named in the complaint shall assist the person in initiating the complaint. The complaint shall include the date and time of the complaint and detail the issue and the remedy sought. All formal complaints shall be forwarded to the staff person, or designee, who is assigned to track and monitor formal complaints. All formal complaints shall be tracked and monitored for compliance and shall contain the following information:

      1. The date and time the formal complaint was originally received by staff,

      2. The date and time the formal complaint was received by the staff assigned to track formal complaints,

      3. The nature of the complaint,

      4. The name of the person receiving services,

      5. The name of the person making the complaint,

      6. The name of the individual assigned to investigate the complaint,

      7. The date the individual making the complaint was notified of the individual assigned to investigate the complaint,

      8. The due date for the written response; and,

      9. At closure, the written disposition of the formal complaint.

   4. (d) The investigation shall be completed within 7 days from the date of entry into the system for tracking complaints.
   5. (e) A written response must be given or mailed to the person receiving services within 24 hours of disposition. The individual acting on behalf of the person receiving services shall be notified of the completion of the investigation but will not be given specific details of the disposition unless they have a legal right to the information or a signed release of information is in place.
   6. (f) The disposition of a complaint may be appealed to the administrator of the facility. If appealed, the facility administrator or designee shall review the written complaint and the initial disposition. Within five working days, the facility administrator or designee will make a final decision concerning the outcome of the complaint and will provide a written response within 24 hours to the person receiving services. A copy of the written response shall also be given to the staff member assigned to track complaints.

7. (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).

   1. (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, 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.

   2. (b) Staff training.

      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:

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

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

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

      4. Safe application of restraint devices,

      5. 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,

      6. Clinical identification of specific behavioral changes that indicate restraint or seclusion is no longer necessary,

      7. The use of first aid techniques; and,

      8. 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 paragraph (7)(b).

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

      1. Prior intervention shall include individualized therapeutic actions such as those 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 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 techniques. 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.

   4. (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, Advanced Registered Nurse Practitioner (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 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 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, or 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, or 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 are 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.

   5. (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.

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

      1. (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.
      2. (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 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,

      3. (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.

      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:

   7. (g) Reporting.

      1. All facilities, as defined in Section 394.455(10), 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 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, 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:

      a. While a person is restrained or secluded,

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

      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 Director of Mental Health/Designee in the Mental Health Program Office headquarters in Tallahassee, FL. The address is: 1317 Winewood Blvd., Tallahassee, Florida 32399-0700.

      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.

   8. (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.

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

   1. (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.
   2. (b) Where frequent or prolonged use of safety or protective devices is 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.
   3. (c) The treatment plan shall include scheduled activities to lessen deterioration due to the usage of such protective medical devices.
9. (9) 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.

Rulemaking Authority 394.457(5), 394.457(5)(b), 394.459(4)(b), 394.879 FS. Law Implemented 394.457, 394.459(2)(d), (4), (4)(b)3., 394.879, 401.445 FS. History–New 11-29-98, Amended 4-4-05, 2-8-07, 5-7-08.