The Agency is proposing to amend these rules to add clarifying language and requirements related to psychiatric, substance abuse, and comprehensive medical rehabilitation services per Laws of Florida Chapter 2018-24.

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Health Facility and Agency Licensing

RULE NOS.:RULE TITLES:

59A-3.065Definitions

59A-3.278Rehabilitation, Psychiatric and Substance Abuse Programs

PURPOSE AND EFFECT: The Agency is proposing to amend these rules to add clarifying language and requirements related to psychiatric, substance abuse, and comprehensive medical rehabilitation services per Laws of Florida Chapter 2018-24.

SUMMARY: Section 395.1055, F.S. tasks the Agency with licensure requirements for psychiatric, substance abuse, and comprehensive medical rehabilitation services within hospitals. Existing hospital rules and the proposed rules address all licensure requirements: quality of care, nurse staffing, physician staffing, physical plant, equipment, emergency transportation, and data reporting standards. In addition, the Agency is addressing an existing rule review by the Joint Administrative Procedures Committee.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: A SERC has not been prepared by the agency. For rules listed where no SERC was prepared, the Agency prepared a checklist for each rule to determine the necessity for a SERC. Based on this information at the time of the analysis and pursuant to section 120.541, Florida Statutes, the rule will not require legislative ratification.

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.

RULEMAKING AUTHORITY: 395.003, 395.1055, 408.036 FS.

LAW IMPLEMENTED: 395.1023, 395.1055, 408.036 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE HELD AT THE DATE,TIME AND PLACE SHOWN BELOW(IF NOT REQUESTED, THIS HEARING WILL NOT BE HELD):

DATE AND TIME: April 22, 2019, 2:30 pm – 4:00 pm

PLACE: Agency for Health Care Administration, 2727 Mahan Drive, Building #3, Conference Room D, Tallahassee, FL 32308

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: Jessica Munn, Bureau of Health Facility Regulation, 2727 Mahan Drive, Tallahassee, Florida, [phone]. 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: Jessica Munn at [phone] or email at [e-mail]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

59A-3.065 Definitions.

In addition to definitions contained in chapters 395 and 408, part II, F.S., the following definitions shall apply specifically to hospitals, as used in rules 59A-3.065-.310, F.A.C.:

(1) “Advanced Practice Registered Nurse” or “APRN” means a person licensed in the State of Florida under the provisions of chapter 464, F.S. to practice professional nursing and certified in advanced or specialized nursing practice.

(2) “Agency” means the Agency for Health Care Administration (AHCA).

(3) “Ambulatory care” means the delivery of care pertaining to non-emergency, adult, adolescent, and pediatric outpatient encounters, whether performed through the clinical departments of the hospital or an organized ambulatory program which is included as a component of the licensed hospital, regardless of the physical location of such services.

(4) “At or near the Time of Death” means that point in time in the care of the patient at which the procedures have begun for the determination and certification of brain death as defined under the provisions of section 382.009, F.S., or cardiorespiratory (cardiac) death as defined under the provisions of rule 59A-3.065, F.A.C.

(5) “Brain Death” means the determination of death under provisions of section 382.009, F.S., where there is irreversible cessation of the functioning of the entire brain, including the brain stem.

(6) “Cardiorespiratory Death” means the cessation of life which is manifested by the loss or absence of spontaneous heart beat and breathing.

(7) “Child abuse or neglect” means harm, pursuant to section 39.01­(35)(32), F.S., or threatened harm to a child’s physical or mental health or welfare by the acts or omissions of a parent, adult household member, or other person responsible for the child’s welfare, or, for purposes of reporting requirements, by any person.

(8) “Continuous” means available at all times without cessation, breaks or interruption.

(9) “Dentist” means a doctor of dentistry legally authorized to practice under chapter 466, F.S.

(10) “Designee or Requester” means a person or organization identified, designated, and delegated by the hospital administrator to carry out the provisions of this chapter and the responsibilities mandated by section 765.522, F.S., and to make the request to the patient or next of kin for the donation of organs, tissues and eyes.

(11) “Diagnostic imaging” means those ionizing and non-ionizing radiological procedures, including but not limited to x-rays, and computerized tomographic scanning, requiring the supervision and expertise of a physician with appropriate training or experience.

(12) “District Medical Examiner” means a physician who fills a position defined according to the provisions of section 406.06, F.S.

(13) “Donation” means the free and voluntary gift of one or more organs, tissues or eyes for the purpose of medical research or transplant surgery.

(14) “Donor” means a person from whom organs, tissues or eyes have been surgically removed for the purpose of transplantation.

(15) “Emergency Medical Technician (EMT)” means any person who is certified as an EMT pursuant to chapter 401, F.S.

(16) “Eye bank” means a public or private entity which is involved in the retrieval, processing or distribution of human eye tissue for transplantation and certified pursuant to section 765.541, F.S. Funeral homes or direct disposers engaged solely in the retrieval of eye tissue are not considered an eye bank for these purposes.

(17) “Facilities” means those objects, including physical plant, equipment and supplies, necessary for providing required services.

(18) “General hospital” as defined in section 395.002(10), F.S., means any facility which meets the provisions of subsection (29) and which regularly makes its facilities and services available to the general population.

(19) “Governing body” means the individual, agency, group or corporation appointed, elected, or otherwise designated, in which the ultimate responsibility and authority for the conduct of the hospital is vested.

(20) “Health professional” means a person specifically licensed to practice a health profession, or a person specifically trained to practice one or more aspects of a health profession by a school or program officially recognized by this State or accredited by a national accrediting organization.

(21) “Inpatient beds” means accommodations with supporting services for patients who are admitted by physician order with the expectation that the patient would stay in excess of 24 hours and occupy a bed.

(22) “Intensive residential treatment programs for children and adolescents” or “intensive residential treatment facilities” or “IRTF” means a specialty hospital restricted to providing intensive residential treatment programs for children and adolescents as defined in section 395.002(15), F.S.

(23) “Licensed practical nurse” means one who is currently licensed in the state of Florida to practice practical nursing as defined in chapter 464, F.S.

(24) “Long term care hospital” means a general hospital which:

(a) Meets the provisions of section 395.002(12), F.S.;

(b) Has an average length of inpatient stay greater than 25 days for all hospital beds; and,

(c) Meets the provisions of subsection 59C-1.002(28), F.A.C.

(25) “Medical Examiner’s Case” means any death occurring in the State and which is defined according to the provisions of section 406.11, F.S.

(26) “Nursing services” means those services pertaining to the curative, restorative, and preventive aspects of nursing care that are performed or supervised by a registered professional nurse under the direction of a physician.

(27) “On duty” means personnel within the hospital, appropriately dressed, continuously alert and responsive to patient needs.

(28) “Operating room suite” means a room, or set of physically contiguous rooms located on the same floor, used primarily for the purpose of performing operations and other physically invasive procedures on patients, as well as rooms for surgical supply and disinfecting.

(29) “Organ” means a body part such as a heart, kidney, pancreas, liver, or lung that requires vascular reanastomosis.

(30) “Organ Procurement Organization” means a public or private entity designated as an OPO by the Secretary of the U.S. Department of Health and Human Services (HHS) which is engaged in the process of recovering organs for the purposes of transplantation and certified pursuant to section 765.541, F.S.

(31) “Organized medical staff” means a formal organization of physicians and other health professionals approved by the governing body with the delegated responsibility to provide for the quality of all medical care, and other health care as appropriate, provided to patients, for planning for the improvement of that care, and for the ethical conduct and professional practices of its members. Nothing herein shall be construed to preclude a governing body from restricting membership on the organized medical staff to only those disciplines required to be included by Florida law.

(32) “Paramedic” means any person who is certified as a paramedic pursuant to chapter 401, F.S.

(33) “Pharmacist” means one who is licensed under chapter 465, F.S., and engages in the practice of the profession of pharmacy.

(34) “Physician” means a doctor of medicine or osteopathy legally authorized to practice under the provisions of chapter 458 or 459, F.S.

(35) “Physician Assistant” or “PA” means a person who is licensed to perform medical services delegated by the supervising physician pursuant to chapter 458 or 459, F.S.

(36) “Podiatrist” means a person legally authorized to practice podiatry under chapter 461, F.S.

(37) “Potential Donor” means any person approaching death or who has died in a Florida hospital and is deemed medically acceptable according to the medical standards of the affiliated OPO, tissue bank or eye bank for organ, tissue, or eye donation.

(38) “Premises” means those buildings, beds, and facilities located at the main address of the licensee and all other buildings, beds, and facilities for the provision of hospital care located in such reasonable proximity to the main address of the licensee as to appear to the public to be under the dominion and control of the licensee.

(39) “Provisional accreditation” means a determination by a hospital accrediting organization that substantial standards compliance deficiencies exist in a hospital.

(40) “Provisional license” means a restricted license issued to a hospital which does not meet requirements for a standard license, but is in compliance with the pertinent statutes and rules.

(41) “Psychiatric hospital” means a Class III specialty hospital primarily restricted to treating persons whose sole diagnosis, or in the event of more than one diagnosis, the principal diagnosis, as defined in the Diagnostic and Statistical Manual of Mental Disorders is a psychiatric disorder, is a mental illness as defined in section 394.455(28), F.S. rule 59C-1.040, F.A.C.

(42) “Qualified medical person” means for the purposes of section 395.1041, F.S., the licensed individual responsible for the operation of the emergency services area during the time of a transfer.

(43) “Quality improvement program” means a program of ongoing activities designed to objectively and systematically evaluate the quality of patient care and services, pursue opportunities to improve patient care and services, and resolve identified problems which applies standards of patient care to evaluate the quality of the hospital’s performance.

(44) “Registered dietitian” means one who meets the standards and qualifications established by the Commission on Dietetic Registration of the Academy of Nutrition and Dietetics and is currently registered with the Academy of Nutrition and Dietetics.

(45) “Registered professional nurse” means one who is currently licensed in the State of Florida to practice professional nursing as defined in chapter 464, F.S.

(46) “Rehabilitation hospital” means a Class III specialty hospital in which an organized program of integrated intensive care services is provided by a coordinated multidisciplinary team to patients with severe physical disabilities, as defined under rule paragraph 59C-1.039(2)(d)(c), F.A.C.

(47) “Routine Inquiry Form” means a reporting document developed by the hospital that is used to indicate that a request for donation of organs, tissues, or eyes was made.

(48) “Rural hospital” means a general hospital which meets the definition of section 395.602(2)(b)(e), F.S.

(49) “Selected Infectious Diseases” means Acquired Immunodeficiency Syndrome; anthrax; syphilis in an infectious stage; diphtheria; disseminated vaccinia; Hansen’s disease; hepatitis A; hepatitis B; hepatitis non-A, non-B; Legionnaire’s disease; malaria; measles; meningococcal meningitis; plague; poliomyelitis; psittacosis; pulmonary tuberculosis; Q fever; rabies; rubella; typhoid fever.

(50) “Special care unit” means a unit designated to provide acute care services, with a concentration of qualified professional staffing and supportive resources, to patients requiring extraordinary care on a concentrated and continuous 24-hour basis. Special care units include, but are not limited to burn, cardiac, cardiovascular surgery, neonatal, respiratory, renal care provided in the hospital, but not including ambulatory units, spinal injury units, trauma and multipurpose special care units, operating room suite, including medical-surgical intensive care or any combination of the above.

(51) “Substance abuse hospital” means a Class III specialty hospital primarily restricted to treating persons whose sole diagnosis, or in the event of more than one diagnosis, the principal diagnosis is substance abuse, as defined in section 397.311(46), F.S. the Diagnostic and Statistical Manual of Mental Disorders is a substance abuse disorder defined under ­ paragraph 59C-1.041(2)(u), F.A.C.

(52) “Tissue” means any non-visceral or non-vascularized collection of similar cells and their associated intercellular substances. There are four generally accepted basic body tissues:

(a) Epithelium (including corneal tissue);

(b) Connective tissues including blood, bone and cartilage;

(c) Muscle; and,

(d) Nerve tissue.

(53) “Tissue Bank” means a public or private entity certified pursuant to section 765.541, F.S., which is involved in at least one of the following activities:

(a) Procuring, processing, storing or distributing viable or nonviable human tissues to clinicians who are not involved in the procurement process;

(b) Procuring, processing, and storing human tissues in one institution and making these tissues available to clinicians in other institutions; or

(c) Procuring, processing, and storing human tissues for individual depositors and releasing these tissues to clinicians at the depositor’s request.

(54) “Transplantation” means the surgical grafting or implanting in its entirety or in part one or more tissues or organs taken from another person.

Rulemaking Authority 395.1055 FS. Law Implemented 395.1023, 395.1055 FS. History–New 9-4-95, Formerly 59A-3.201, Amended 10-16-14,­_______.

 

59A-3.278 Rehabilitation, Psychiatric and Substance Abuse Programs.

(1) All rehabilitation, psychiatric, and substance abuse programs provided by hospitals shall provide to the patient:

(a) An evaluation upon referral;

(b) Establishment of goals;

(c) Development of a plan of treatment, including discharge planning, in coordination with the referring individual and rehabilitation staff, and after discussion with the patient and family;

(d) Regular and frequent assessment, performed on an interdisciplinary basis, of the patient’s condition and progress, and of the results of treatment;

(e) Maintenance of treatment and progress records; and,

(f) At least a quarterly assessment of the quality and appropriateness of the care provided.

(2) When any rehabilitation activity, psychiatric or substance abuse treatment is provided from outside the hospital, the source shall be available whenever needed for patient care, meet all safety requirements, abide by all pertinent rules and regulations of the hospital and medical staff, and document the quality assurance measures to be implemented.

(3) The scope of services offered, and the relationship of the rehabilitation, psychiatric or substance abuse program to other hospital units, as well as all supervisory relationships within the program, shall be defined in writing. Responsibility for the performance of clinical services also shall be clearly defined. Delegation of authority within the program shall be specified in job descriptions and in organizational plans. Written policies and procedures to guide the operation of the rehabilitation program shall be developed and reviewed at least annually, revised as necessary, dated to indicate the time of last revision, and enforced.

(4) There shall be a current written plan of care for each patient receiving rehabilitative, psychiatric or substance abuse services. The plan shall state the diagnosis, and problem list when appropriate, pertinent to the rehabilitation or treatment process; precautions necessitated by the patient’s general medical condition or other factors; the short-term and long-term goals of the treatment program; and require monthly or more frequent review of the patient’s progress. The medical record and the written plan shall evidence a team approach, with participation of the professional and administrative staffs, the patient, and, as appropriate, the patient’s family. The medical record shall document the written instructions given to the patient and the family concerning appropriate care after discharge from the hospital.

(5) The rehabilitation, psychiatric or substance abuse program must have notes and log records that are separately identified from the other admission and discharge records in the hospital in which it is located, and are separately retrievable.

(6) The beds assigned to the program must be physically separate from and not commingled with beds not included in the unit. Rehabilitation, psychiatric or substance abuse programs and beds may be located on the same floor as other programs or beds.

(7) All rehabilitation, psychiatric, and substance abuse programs must have a protocol in place for the emergency transportation of medically necessary transfers. The protocol shall include transfer to the geographically closest hospital with the service capability, unless another prior arrangement is in place or the geographically closest hospital is at capacity. In addition to meeting the requirements of subsections (1) through (6) of this section, rehabilitation programs provided by hospitals must place responsibility for the medical direction of the rehabilitation program on a physician member of the organized medical staff who, on the basis of training, experience and interest, is knowledgeable in the rehabilitation services offered. Unless otherwise permitted by law, rehabilitation services shall be initiated by a physician. The written request for services shall include reference to the diagnosis or problems for which treatment is planned.

(8) Information on specifications, operation and maintenance of all equipment used in rehabilitation, psychiatric, and substance abuse programs shall be maintained. All equipment shall be operated according to manufacturer’s specifications, and a preventive and corrective maintenance program on such equipment shall be conducted and recorded.

(9)(8) In addition to meeting the requirements of subsections (1)-(6) of this section, Ppsychiatric, and or substance abuse rehabilitation programs provided by hospitals shall meet at least the following additional standards:

(a) The program, unit, service or similarly titled part shall treat only those patients whose primary reason for admission was a diagnosis contained in the third edition of the American Psychiatric Association Diagnostic and Statistical Manual.

(a)(b) The program, unit, service or similarly titled part shall have medical direction by a an appropriately qualified practitioner, including a physician who is certified by the American Board of Psychiatry and Neurology or is eligible for examination by the Board or similar specialty board recognized by the American Osteopathic Association, a clinical psychologist, or a licensed physician with postgraduate training and experience in the diagnosis and treatment of nervous and mental disorders.

(b)(c) The program, unit, service or similarly titled part shall furnish, through qualified personnel, psychological services, social work services, psychiatric nursing, occupational therapy, and recreational therapy, as appropriate to the needs of the patient.

(c)(d) The program, unit, service or similarly titled part shall have a charge nurse who is a registered professional nurse qualified in psychiatric or mental health nursing.

(10)(9) Rehabilitation programs provided by hospitals must place responsibility for the medical direction of the rehabilitation program on a physician member of the organized medical staff who, on the basis of training, experience and interest, is knowledgeable in the rehabilitation services offered. Unless otherwise permitted by law, rehabilitation services shall be initiated by a physician. The written request for services shall include reference to the diagnosis or problems for which treatment is planned. In addition to the medical direction required in subsection (7), Ooverall supervision and administration of the following specialty rehabilitation programs may be provided by staff with the following credentials:

(a) Physical Therapy – A qualified physical therapist who shall be a graduate of a physical therapy program approved by a nationally recognized accrediting body or have documented equivalent training or experience, and shall meet all any current requirements for licensure under Chapter 486, F.S. or registration, and shall be currently competent in the field.

(b) Occupational Therapy – A qualified occupational therapist who shall be a graduate of an occupational therapy program approved by a nationally recognized accrediting body; or shall currently hold certification by the American Occupational Therapy Association as an Occupational Therapist, Registered; or shall have documented equivalent training or experience; and shall meet all current requirements for licensure under Chapter 468, Part IV, F.S.

(c) Speech Pathology and Audiology – A qualified speech-language pathologist or audiologist who shall hold the Certificate of Clinical Competence or a Statement of Equivalence in either speech pathology or audiology issued by the American Speech-Language-Hearing Association, or have documented equivalent training or experience; and shall meet all current requirements for licensure under Chapter 468, Part II, F.S.

(d) Rehabilitation Nursing – A professionally qualified licensed registered nurse who shall have documented training in rehabilitation nursing and at least one year of rehabilitation nursing experience.

(e) Vocational or Educational Rehabilitation – A qualified individual who shall be a graduate of vocational rehabilitation program at the graduate level, or have documented equivalent training or experience.

(f) Comprehensive Medical Rehabilitation – A qualified physician who shall be a member of the organized professional staff and who is certified, or eligible for examination, either by the American Board of Physical Medicine and Rehabilitation or by a specialty related to rehabilitation.

(11)(10) Nothing in this section shall be construed to prevent a hospital from providing rehabilitation, psychiatric or substance abuse programs to its patients. However, no hospital shall have rehabilitation, psychiatric, intensive residential treatment program, or substance abuse beds unless it has obtained a valid certificate of need as required by Section 408.031 through 408.045, F.S., and meets the requirements of this section.

Rulemaking Authority 395.003, 395.1055, 408.036 FS. Law Implemented 395.1055, 408.036 FS. History–New 9-4-95, Formerly 59A-3.229. Amended,_______.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Jack Plagge

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Mary C. Mayhew

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: 03/14/2019

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: 10/02/2018