Current through Reg. 50, No. 187; September 24, 2024
The following standards shall be required in the provision of
quality mental health treatment:
(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) 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:
(a) The minimum qualifications to assure
competence and performance of staff who administer and interpret diagnostic
procedures and tests;
(b) The
inclusion and updating of pertinent information from previous reports,
including admission history and key demographic, social, economic, and medical
factors;
(c) The dating, accuracy
and the completeness of reports;
(d) The timely availability of all reports to
users;
(e) Reports shall be legible
and understandable;
(f) The
documentation of facts supporting each conclusion or finding in a
report;
(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;
(h) Requirement that the completed report be
signed and dated by the administering staff; and,
(i) Consistency of information across various
reports and integration of information and approaches across
reports.
(3) Psychiatric
Examination. Psychiatric examinations shall include:
(a) Medical history, including psychiatric
history, developmental abnormalities, physical or sexual abuse or trauma, and
substance abuse;
(b) Examination,
evaluative or laboratory results, including mental status
examination;
(c) Working diagnosis,
ruling out non-psychiatric causes of presenting symptoms of abnormal thought,
mood or behaviors;
(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,
(e) Course of other non-psychiatric medical
problems and interventions;
(f)
Identification of prominent risk factors including physical health, psychiatric
and co-occurring substance abuse; and,
(g) Discharge or transfer
diagnoses.
(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) Mental health services provided shall
comply with the following standards:
(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.
(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.
(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.
(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.
(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.
(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.
(g) The prohibition of standing orders or
similar protocols for the emergency use of psychotropic medication, restraint,
or seclusion.
(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) 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.
(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.
(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.
(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.
(d) The investigation shall be completed
within 7 days from the date of entry into the system for tracking
complaints.
(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.
(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)
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, 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.
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).
(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.
(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.
(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 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),
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.
(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) 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 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.
(c) The treatment plan shall include
scheduled activities to lessen deterioration due to the usage of such
protective medical devices.
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.
New 11-29-98, Amended 4-4-05, 2-8-07,
5-7-08.