The purpose is to modify existing rules to add and delete definitions; updates references to outdated forms which have been revised and are incorporated in rule; update license fee; delete requirements that are duplicative; and add references to ...

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Health Facility and Agency Licensing

RULE NOS.:RULE TITLES:

59A-3.065Definitions

59A-3.066Licensure Procedure

59A-3.078Comprehensive Emergency Management Plan

59A-3.110Services

59A-3.250Surveillance, Prevention, and Control of Infection

59A-3.252Classification of Hospitals

59A-3.253Investigations and License, Life Safety and Validation Inspections

59A-3.254Patient Rights and Care

59A-3.255Emergency Care

59A-3.270Health Information Management

59A-3.273Management and Administration

59A-3.274Anatomical Gifts, Routine Inquiry

59A-3.279Itemized Patient Bill

59A-3.280Child Abuse and Neglect

59A-3.281Spontaneous Fetal Demise

59A-3.300Licensure Procedure

59A-3.301Goals, Policies and Procedures

59A-3.302Personnel

PURPOSE AND EFFECT: The purpose is to modify existing rules to add and delete definitions; updates references to outdated forms which have been revised and are incorporated in rule; update license fee; delete requirements that are duplicative; and add references to align with our uniform licensure statute and rule.

SUMMARY: These rules are amended to:

Rule 59A-3.065: correct rule and statutory references; update to coincide with definitions in Chapter 59A-35, F.A.C., and Chapter 408, Part II, F.S.

Rule 59A-3.066: correct rule references; update reference to a revised form; update licensure fee amount; move requirements for Data Collection from Rule 59A-3.253, F.A.C.

Rule 59A-3.078: reference an accrediting organization; update the Agency’s address and phone number; and update rule references.

Rule 59A-3.110: rename and renumber the rule to clarify requirements apply only to Residential Treatment Facilities for Children and Adolescents and not all hospitals.

Rule 59A-3.250: delete references to rules that no longer exist.

Rule 59A-3.252: correct rule and statutory references.

Rule 59A-3.253: delete duplicative requirements; delete subsection (5); remove reference to an annual life safety inspection in subsection (9); minor edits for clarification and technical changes; delete requirements for Data Collection.

Rule 59A-3.254: add and renumber subsection 59A-3.254(1); add a requirement of evaluating prescription medications to ensure availability after discharge; correct statutory references.

Rule 59A-3.255: correct rule references; correct reference to an outdated form; identify where the form can be found online; correct form reference to the “Patient Care Record”; add requirements for reporting violations of emergency access.

59A-3.270: remove reference to an outdated form (correct reference to the “Patient Care Record”); correct a rule reference; correct a department name.

59A-3.273: correct a rule reference.

59A-3.274: delete paragraph (3)(i); correct statutory reference.

59A-3.279: delete subsection (4).

59A-3.280: further define statutory references.

Rule 59A-3.281: change a reference to the mother’s medical record.

Rule 59A-3.300: change the rule name title (to clarify the requirements apply only to IRTFs and not all hospitals); remove an accrediting organization by name; correct rule and statutory references.

Rule 59A-3.301: change the rule name title.

Rule 59A-3.302: change the rule name title; delete the provision allowing persons occupying the administrator position on or before the effective date of the rule to continue in the position without the required experience.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will 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 been prepared by the agency.

The Agency has determined that this will have an adverse impact on small business however will not 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 been prepared by the agency.

A statement of estimated regulatory costs has been prepared for proposed rule revisions in Rule 59A-3.066 and is available from the person listed below. The following is a summary of the SERC:

For proposed rule subsection 59A-3.066(3), F.A.C., license fees are increased by the Consumer Price Index as required in Section 408.805(2), F.S. The biennial licensure fee will increase by $65.13 per hospital or an increase of $1.46 per bed, whichever is greater. Based on the number of currently licensed beds the total impact over 5 years will be $449,043.04.

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 been prepared by the agency.

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: 383.33625(6), 395.003, 395.004, 395.0161, 395.1031, 395.1041, 395.1055, 395.3015, 408.033, 408.819, 765.522, 873.01(3)(a) FS.

LAW IMPLEMENTED: 381.0031, 381.0098, 383.33625, 395.001, 395.002, 395.003, 395.004, 395.0161, 395.0191, 395.0197, 395.1023, 395.1025, 395.1031, 395.1041, 395.1055, 395.1065, 395.3015, 395.3025, 401.024, 408.035, 408.036, 408.805, 415.1034, 765.522, 873.01(3)(a) 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: January 16, 2014, 10:00 a.m. – 11:00 a.m.

PLACE: Agency for Health Care Administration, Ft. Knox Bldg. 3, Conference Room D, 2727 Mahan Drive, 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 7 days before the workshop/meeting by contacting: Kim Stewart via e-mail at [e-mail] or by phone at [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: Kim Stewart via e-mail at [e-mail] or by phone at [phone]

 

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 – 3.310 59A-3.300–3.312, F.A.C.:

(1) “Accepted Medical Standards” means the current professional standards pursuant to Section 766.102, F.S., which are utilized by affiliated organ procurement organizations (OPO), tissue banks and eye banks to determine the suitability of organs, tissues, and eyes for the purposes of transplantation, medical research or instruction.

(2) “Accrediting organization organizations” means a national accreditation organization that is approved by the Centers for Medicare and Medicaid Services per Title 42 Part 488.4 Code of Federal Regulations to offer a deemed status option and whose standards incorporate comparable licensure regulations as determined by the Agency. the Joint Commission on Accreditation of Healthcare Organizations, and the American Osteopathic Association.

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

(4) “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.

(5) “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 subsection 59A-3.065, F.A.C.

(6) “Bassinet” means special accommodations with supporting services for newborn infants after transfer from the delivery or recovery suites. These accommodations are not considered hospital beds for licensing purposes except when part of an intensive neonatal care unit approved pursuant to Chapter 59C-1, F.A.C.

(7) “Biomedical waste” means any solid or liquid waste which may present a threat of infection to humans, as defined in Chapter 64E-16, F.A.C.

(8) “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.

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

(10) “Child abuse or neglect” means harm, pursuant to Section 39.01(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.

(11) “Child protection team” means a team of professionals established by the Department of Health and Rehabilitative Services to receive referrals from the single intake and protective services staff of the children, youth and families program and to provide specialized and supportive services to the program in processing child abuse and neglect cases. A child protection team shall provide consultation to other persons on child abuse and neglect cases pursuant to Section 39.303, F.S.

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

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

(14) “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.

(15) “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.

(16) “Directly involved” for the purposes of reporting of adverse incidents to the Aagency means any employee or independent contractor of a hospital or member of a hospital’s medical staff who could exercise control over the event which is reportable as an adverse or untoward incident.

(17) “District intake counselor” means Department of Children and Families’ Health and Rehabilitative Services’ staff responsible for the investigation of suspected abuse or neglect.

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

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

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

(21) “Emergency department” means for the purposes of Section 395.1041, F.S., any department of any general hospital when a request is made for emergency services and care for any emergency medical condition which is within the service capability of the hospital.

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

(23) “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.

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

(25) “General acute care hospital” means a general hospital which has an average length of stay of 25 days or less for all inpatient beds.

(26) “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.

(27) “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.

(28) “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.

(29) “Hospital” means any establishment that:

(a) Offers services more intensive than those required for room, board, personal services, and general nursing care, and offers facilities and beds for use beyond 24 hours by individuals requiring diagnosis, treatment, or care for illness, injury, deformity, infirmity, abnormality, disease or pregnancy; and

(b) Regularly makes available at least clinical laboratory services, diagnostic x-ray services, and treatment facilities for surgery or obstetrical care, or other definitive medical treatment of similar extent. However, the provisions of this chapter shall not apply to any institution conducted by or for the adherents of any well-recognized church or religious denomination that depends exclusively upon prayer or spiritual means to heal, care for, or treat any person.

(30) “Hospital emergency services” means: For the purposes of Section 395.1041, F.S., hospital emergency services are any services within the service capability of the hospital.

(31) “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.

(32) “Intensive residential treatment facility programs for children and adolescents (IRTF)” means a specialty hospital accredited by an accrediting organization the Joint Commission on Accreditation of Healthcare Organizations which provides 24-hour care and which has the primary functions of diagnosis and treatment of patients under the age of 18 having psychiatric disorders in order to restore them to an optimal level of functioning.

(33) “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.

(34) “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 Rule 59C-1.002(28), F.A.C.

(35) “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.

(36) “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.

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

(38) “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.

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

(40) “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.

(41) “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.

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

(43) “Parts” means any organs, tissues, fluids or other portions of a human body including the organs or tissues described in subsections (39) (34) and (66) (57) of this section, as well as bone, arteries and blood.

(44) “Patient grievance” means any written complaint by a patient relating to patient care or the quality of medical services, except for those matters pertaining to the cost of care.

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

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

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

(48) “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.

(49) “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.

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

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

(52) “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 (DSM III-R) is a psychiatric disorder, as defined in Rule 59C-1.040, F.A.C.

(53) “Psychiatric program” means psychiatric or substance abuse programs.

(54) “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.

(55) “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.

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

(57) “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.

(58) “Regular license” means an unrestricted license issued to a hospital in recognition of compliance with rules and standards of these Rules and Chapter 395, F.S.

(58)(59) “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 paragraph 59C-1.039(2)(c), F.A.C.

(59)(60) “Relieve or eliminate the emergency medical condition” means, for the purposes of Sections 395.002 and 395.1041, F.S., provision of care, treatment or surgery consistent with the applicable standard of care, by a physician, necessary to either eliminate the emergency medical condition or to eliminate the likelihood that the emergency medical condition will deteriorate or recur without further medical attention within a reasonable period of time.

(60)(61) “Routine Inquiry Form” means a reporting document used to indicate that a request for donation of organs, tissues, or eyes was made.

(61)(62) “Rural hospital” means a general hospital which meets the definition of paragraph 395.602(2)(e), F.S.

(62)(63) “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.

(63)(64) “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.

(64)(65) “Specialty hospital” means any facility which meets the provisions of subsection (25), and which regularly makes available either:

(a) The range of medical services offered by general hospitals, but restricted to of a defined age or gender group of the population;

(b) A restricted range of services appropriate to the diagnosis, care, and treatment of patients with specific categories of medical or psychiatric illnesses or disorders; or

(c) Intensive residential treatment programs for children and adolescents as defined in subsection (32) (28).

(65)(66) “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, as defined in the Diagnostic and Statistical Manual of Mental Disorders is a substance abuse disorder defined under paragraph 59C-1.041(2)(u), F.A.C.

(66)(67) “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.

(67)(68) “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.

(68)(69) “Transfer” means, for the purposes of Section 395.1041, F.S., the movement, including the discharge, of an individual from a hospital’s facilities at the direction of any person employed by, or affiliated or associated, directly or indirectly with, the hospital who has the authority to do so under the hospital’s policies and procedures, but does not include such a movement of an individual who has been declared dead or who leaves the facility without permission or against medical advice.

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

Rulemaking Specific Authority 381.0031, 395.1025, 395.1055 FS. Law Implemented 381.0031, 381.006, 381.0098, 381.231, 395.001, 395.002, 395.1023, 395.1025, 395.1055, 408.035, 408.036, 415.1034 415.503, 415.5055 FS. History–New 9-4-95, Formerly 59A-3.201, Amended________.

 

59A-3.066 Licensure Procedure.

(1) No person or governmental unit shall establish, conduct, or maintain a hospital in this state without first obtaining a license.

(2) All persons requesting licensure for the operation of a hospital under the provisions of Chapter 395, F.S., shall make application to the Aagency, on provided, AHCA Form 3130-8003-January 1995, and AHCA Form 3130-8001, September 2013, which is incorporated by reference, -January 1995, and shall receive a standard regular or provisional license prior to the acceptance of patients for care or treatment.

(a) Each hospital applying for a license shall be designated by a distinctive name, and the name shall not be changed without first notifying the licensing agency and receiving approval in writing. Duplication of an existing hospital name is prohibited in new hospitals. The following documents shall be prepared at the time of the initial application, and shall be available for review by the Aagency at the initial licensure inspection:

1. Governing authority bylaws, rules and regulations, or other written organization plan;

2. Organized professional staff bylaws, rules and regulations;

3. The hospital’s fire and Comprehensive Emergency Management Plans;

4. Roster of organized medical staff members;

5. Nursing procedure manual; and

6. Roster of registered nurses, licensed practical nurses, emergency medical technicians and paramedics with current registration number.

(b) The following documents shall accompany the initial application:

1. The hospital’s zoning certificate;

2. Articles of incorporation;

3. Registration of a fictitious name;

4. The name and address of the ultimate owner of the hospital;

5. A valid certificate of need or letter of exemption as required by Sections 408.031 through 408.045, F.S.;

6. Approval for licensure from the Aagency’s Office of Plans and Construction; and

7. Evidence of medical malpractice insurance through the Patient Compensation Fund or other means of demonstrating financial responsibility as provided for under Chapter 766, F.S.

8. A copy of the child abuse and neglect policy as specified in Rule 59A-3.280, F.A.C.

(c) All applications for change of ownership shall include:

1. A signed agreement to correct physical plant deficiencies listed in the most recent licensure inspection to conform to the most recently adopted, nationally recognized life-safety code, unless otherwise modified herein;

2. Written verification of the transaction, which must include an effective date and the signatures of both the buyer and the seller;

3. Registration of a fictitious name;

4. The name and address of the ultimate owner of the hospital;

5. Evidence of payment of, or arrangement to pay, any liability to the state pursuant to Section 395.003(3)(b)2. and Section 408.807(3)(b), F.S., and

6. A valid certificate of need as specified in Sections 408.031 through 408.045, F.S., and Chapter 59C-1, F.A.C.

(d) An application for biennial licensure renewal must be accompanied by:

1. A copy of the hospital’s most recent accreditation report, if the hospital is accredited by an accrediting organization and the hospital seeks to substitute evidence of accreditation in lieu of an Aagency licensure inspection, and

2. Evidence of medical malpractice insurance through the Patient Compensation Fund or other means of demonstrating financial responsibility as provided for under Chapter 766, F.S.

(e) An application for the addition of beds, or off-site outpatient facilities, off-site emergency department or a change in classification to a hospital’s license must include:

1. A valid certificate of need or letter of exemption or notification as required by Sections 408.031 through 408.045, F.S., and

2. Approval from the Aagency 's Office of Plans and Construction, pursuant to Rules 59A-3.080 59A-3.077–59A-3.081, F.A.C.

(f) Evidence of medical malpractice insurance through the Patient Compensation Fund or other means of demonstrating financial responsibility as provided for under Chapter 766, F.S., must be submitted annually to the Aagency.

(g) Upon receipt of a completed initial application the Aagency shall conduct an inspection a survey of the facility to determine compliance with Chapter 395, F.S., Part I, and Rules 69A-3.012, 59A-3.077-.081 and 59A-3.065 3.066 – .310.312, F.A.C.

(h) When the applicant and hospital are in compliance with Chapter 395, F.S., Part I and Rules 69A-3.012 59A-3.077 through 59A-3.081 and 59A-3.065 through 59A-3.310 59A-3.312, F.A.C., and have received all approvals required by law, the Aagency shall issue a license.

(i) A single license will be issued to a licensee for facilities located on separate premises, upon request of the applicant. The license will specifically state the location of the facilities, their services, and the licensed beds available on each separate premises. Such a license shall also specifically identify the general or specialty classification of hospitals located on separate premises.

(3) A license fee of $1,565.13 $1,500 per hospital, or $31.46 $30 per licensed bed, whichever is greater, shall accompany an application for an initial, biennial renewal, or change of ownership license. An application for the addition of beds to a license shall be accompanied by a license fee of $31.46 $30 per additional bed. All permanent additions to the constructed bed capacity occurring after the issuance of the license shall require licensure prior to occupancy effective the date surveyed and approved for occupancy, and require payment of the necessary additional fee on a per bed basis. The license fee shall be made payable to the Agency for Health Care Administration. No license shall be issued without payment of the requisite fee, and, if the request for licensure is withdrawn, the license fee is not refundable. Where licenses are denied in whole or part, the license fee is not refundable. Those hospitals operated by the Department of Health, Department of Children and Families, and Rehabilitative Services and the Department of Corrections are not required to pay a license fee.

(4)(a) In the event of a change in licensure classification, suspension or revocation of a license, or voluntary cessation of services which are required by Section 395.002(12), F.S., the facility license shall be returned to the Aagency by the licensee. A license returned to the Aagency will be terminated upon receipt by the Aagency, and the facility may not operate as a hospital until licensure is obtained. For continued operation, the licensee must apply for a new license in compliance with the requirements for initial licensure specified in this section, and subject to the provisions of the certificate of need program as specified in Sections 408.031 through 408.045, F.S., and Chapter 59C-1, F.A.C.

(b) In the event of an intended change in ownership, as described in Section 408.807 395.003(3)(b)1., F.S., an application for an amended a new license must be submitted at least 60 days prior to the change, consistent with the requirements of paragraph (2)(c) of this section.

(5) A licensee shall notify the Aagency of impending closure of a hospital 30 90 days prior to such closure. The hospital shall be responsible for advising the licensing agency as to the placement of patients and disposition of medical records.

(6) Each license shall specifically state the name of the licensed operator of the hospital, the class of hospital, and the name and location of the hospital. Any beds in the hospital which are regulated under the certificate of need program, as specified in Chapter 59C-1, F.A.C., shall be listed, including the number of licensed beds by type. The license for hospitals having facilities on more than one premises shall specifically state the location of each facility, their general or specialty classification, their services, and the licensed beds available on each separate premises.

(7) Licenses shall be posted in a conspicuous place on the licensed premises, and copies of licenses shall be made available for inspection to all persons. In the case of a single license issued for facilities on more than one premises, a copy of the license shall be retained and posted in a conspicuous place at each separate premises.

(8) A license, unless sooner suspended or revoked, shall automatically expire two years from date of issuance, and shall be renewable biennially upon application for renewal and payment of the fee prescribed by these rules, provided that the applicant and hospital meet the requirements established under the Chapter 395, Part I, F.S., and Rules 69A-3.012 59A-3.077-.081 and 59A-3.065066-.310312, F.A.C. Application for renewal of license shall be made not less than 60 90 days prior to expiration of a license, on forms prescribed provided by the Agency, AHCA Form 3130-8003-January 1995, and AHCA Form 3130-8001- January 1995. If an application is received after the required filing date and exhibits a hand-canceled postmark obtained from a United States Post Office or other postal carrier dated on or before the required filing date, no fine will be levied.

(9) The Agency AHCA shall issue a provisional license for any hospital in substantial compliance with the statute and Rules 69A-3.012 59A-3.077–3.081 and 59A-3.065066 –.310312, F.A.C. Provisional licenses are issued only after the Agency AHCA is satisfied that preparations are being made by the hospital to qualify for standard regular license, and that the health and safety of patients will not be endangered during the interim. Any new hospital will be issued a provisional license prior to opening date, provided plans and specifications for the building have been approved by the licensing agency and the hospital has been inspected surveyed and found to meet construction standards and health and safety inspections surveys.

(a) A provisional license shall be granted for a period of no more than one (1) year and shall expire automatically at the end of its term. A provisional license may not be renewed.

(b) A standard regular license may be issued after the proposed hospital becomes operational and a reinspection resurvey has been made to determine compliance with the rule set forth herein.

(10) No licensed facility shall continuously operate a number of hospital beds greater than the number indicated by the Agency AHCA on the face of the license.

(11) Hospitals shall not lease a portion of their licensed beds to another entity or facility, except for hospices licensed pursuant to Chapter 400, Part IV, F.S.

(12) The collocation of any residential program on the premises of a licensed hospital requires prior approval from the Aagency, based on the following criteria:

(a) Health, safety, and welfare cannot be jeopardized for any individual;

(b) The essential needs of patients must be met; and

(c) The facility must be staffed to meet the essential needs of patients.

(13) DATA COLLECTION.

(a) All hospitals shall comply with the Agency requirements for data submission as authorized under Section 395.1055, F.S. and Chapters 408, F.S. This data, which does not have to be resubmitted to the Agency’s hospital licensing office as a provision of this part, includes:

1. Certificate of need reviews required under Sections 408.031 through 408.045, F.S., and at such intervals as required by Chapter 59C-1, F.A.C.;

2. Quality of care patient outcome data as required by Sections 408.061(1) and 395.1055(1)(g), F.S., and as mandated by rules adopted by the Aagency;

(b) All hospitals shall make available on their Internet websites a description of and link to the Agency’s webpage which contains the hospital patient charge and performance outcome data that is collected pursuant to Section 408.061(1), F.S. and, if requested, hospitals shall provide a hard copy of the description and the link.

Rulemaking Specific Authority 395.003, 395.004, 395.1055, 408.033, 408.819 FS. Law Implemented 395.003, 395.004, 395.1055, 408.035, 408.036, 408.805 FS. History–New 9-4-95, Amended 6-18-96, Formerly 59A-3.203, Amended________.

 

59A-3.078 Comprehensive Emergency Management Plan.

(1) Each hospital shall develop and adopt a written comprehensive emergency management plan for emergency care during an internal or external disaster or an emergency, which is reviewed and updated annually.

(2) The emergency management plan shall be developed in conjunction with other agencies and providers of health care services within the local community pursuant to Section 252.32(2), F.S., and in accordance with the “Emergency Management Planning Criteria for Hospitals,” AHCA Form 3130-8005-September 94, which is incorporated by reference. At a minimum, the plan shall include:

(a) Provisions for internal and external disasters and emergencies, pursuant to Section 252.34, F.S.;

(b) A description of the hospital’s role in community wide emergency management plans;

(c) Information about how the hospital plans to implement specific procedures outlined in the hospital’s emergency management plan;

(d) Precautionary measures, including voluntary cessation of hospital admissions, to be taken by the hospital in preparation and response to warnings of inclement weather, or other potential emergency conditions;

(e) Provisions for the management of patients, including the discharge of all patients that meet discharge requirements, in the event of an evacuation order, at the direction of the hospital administrator, or when a determination is made by the Aagency that the condition of the facility or its support services is sufficient to render it a hazard to the health and safety of patients and staff, pursuant to Chapter 59A-3, F.A.C. Such provisions shall address moving patients within the hospital and relocating patients outside the hospital, including the roles and responsibilities of the physician and the hospital in the decision to move or relocate patients whose life or health is threatened;

(f) Education and training of personnel in carrying out their responsibilities in accordance with the adopted plan;

(g) A provision for coordinating with other hospitals that would receive relocated patients;

(h) Provisions for the management of staff, including the distribution and assignment of responsibilities and functions, and the assignment of staff to accompany those patients located at off-site locations;

(i) Provisions for the individual identification of patients, including the transfer of patient records;

(j) Provisions to ensure that a verification check will be made to ensure relocated patients arrive at designated hospitals;

(k) Provisions to ensure that medication needs will be reviewed and advance medication for relocated patients will be forwarded to respective hospitals, when permitted by existing supplies, and state and federal law;

(l) Provisions for essential care and services for patients who may be relocated to the facility during a disaster or an emergency, including staffing, supplies and identification of patients;

(m) Provisions for contacting relatives and necessary persons advising them of patient location changes. A procedure must also be established for responding to inquiries from patient families and the press;

(n) Provisions for the management of supplies, communications, power, emergency equipment, security, and the transfer of records;

(o) Provisions for coordination with designated agencies including the Red Cross and the county emergency management office; and

(p) Plans for the recovery phase of the operation, to be carried out as soon as possible.

(3) The plan, including the “Emergency Management Planning Criteria for Hospitals,” shall be submitted annually to the county emergency management agency for review and approval. A fee may be charged for the review of the plan as authorized by Section 252.35(2)(m)(l) and 252.38(1)(e), F.S.

(a) The county office of emergency management has 60 days in which to review and approve the plan, or advise the facility of necessary revisions. If the county emergency management agency advises the facility of necessary revisions to the plan, those revisions shall be made and the plan resubmitted to the county office of emergency management within 30 days of notification by the county emergency management agency.

(b) The county office of emergency management shall be the final administrative authority for emergency plans developed by hospitals.

(4) The hospital shall test the implementation of the emergency management plan semiannually, either in response to a disaster or an emergency or in a planned drill, and shall evaluate and document the hospital’s performance to the hospital’s safety committee. As an alternative, the hospital may test its plan with the frequency specified by an accrediting organization the Joint Commission on Accreditation of Healthcare Organizations.

(5) The emergency management plan shall be located for immediate access by hospital staff.

(6) In the event a disaster or emergency conditions have been declared by the local emergency management authority, and the hospital does not evacuate the premises, a facility may provide emergency accommodations above the licensed capacity for patients. However, the following conditions must be met:

(a) The facility must report being over capacity and the conditions causing it to the Aagency area office within 48 hours or as soon as practical. As an alternative, the facility may report to the Aagency central office, Hospital and Outpatient Services Unit Section, at [phone] [phone];

(b) Life safety cannot be jeopardized for any individual;

(c) The essential needs of patients must be met; and

(d) The facility must be staffed to meet the essential needs of patients.

(7) If the hospital will be over capacity after the declared disaster or emergency situation ends, the Aagency shall approve the over capacity situation on a case-by-case basis using the following criteria:

(a) Life safety cannot be jeopardized for any individual;

(b) The essential needs of patients must be met; and

(c) The facility must be staffed to meet the essential needs of patients.

(8) If a facility evacuates during or after a disaster or an emergency situation, the facility shall not be reoccupied until a determination is made by the hospital administrator that the facility can meet the needs of the patients.

(9) A facility with significant structural damage shall relocate patients until approval is received from the Aagency’s Office of Plans and Construction that the facility can be safely reoccupied, pursuant to Rule 69A-3.012 Rules 59A-3.077, 59A-3.079 and 59A-3.081, F.A.C.

(10) A facility that must evacuate the premises due to a disaster or emergency conditions shall report the evacuation to the Aagency area office within 48 hours or as soon as practical. The administrator or designee is responsible for knowing the location of all patients until the patient has been discharged from the facility. The names and location of patients relocated shall be provided to the local emergency management authority or it’s designee having responsibility for tracking the population at large. The licensee shall inform the Aagency area office of a contact person who will be available 24 hours a day, seven days a week, until the facility is reoccupied.

Rulemaking Specific Authority 395.1055 FS. Law Implemented 395.1055(1)(c) FS. History–New 1-1-77, Formerly 10D-28.78, 10D-28.078, Amended 9-3-92, 12-28-94,_________.

 

59A-3.110 Intensive Residential Treatment Facility Services.

Services shall be designed to meet the needs of the emotionally disturbed patient and must conform to stated purposes and objectives of the program.

(1) Intake and Admission.

(a) Acceptance of a child or adolescent for inpatient treatment shall be based on the assessment, arrived at by the multidisciplinary clinical staff involved and clearly explained to the patient and the family. Whether the family voluntarily requests services or the patient is referred by the court, the special hospital shall involve the family’s participation to the fullest extent possible. Discharge planning shall begin at the time of intake and admission.

(b) Acceptance of the child or adolescent for treatment shall be based on the determination that the child or adolescent requires treatment of a comprehensive and intensive nature and is likely to benefit by the programs that the facility has to offer.

(c) Admission shall be in keeping with stated policies of the special hospital and shall be limited to those patients for whom the special hospital is qualified by staff, program and equipment to give adequate care.

(d) Staff members who will be working with the patient, but who did not participate in the initial assessment shall be oriented regarding the patient and the patient's anticipated admission prior to meeting the patient. When the patient is to be assigned to a group, the other patients in the group shall be prepared for the arrival of the new member. There shall be a specific staff member assigned to the new patient to observe him and help with the unit orientation period.

(e) The admission procedure shall include documentation concerning:

1. Responsibility for and amount of financial support;

2. Responsibility for medical and dental care, including consent for medical and surgical care and treatment;

3. Arrangements for appropriate family participation in the program, phone calls and visits when indicated;

4. Arrangements for clothing, allowances and gifts; and

5. Arrangements regarding the patient’s leaving the facility with or without medical consent.

(f) Decisions for admission shall be based on the initial assessment of the patient made by the appropriate multidisciplinary clinical staff. This assessment must be documented on the record of treatment on admission.

(g) The admission order must be written by a staff or consultant physician.

(2) Assessment and Treatment Planning Including Discharge.

(a) Assessment. The facility is responsible for a complete assessment of the patient, some of which may be required just prior to admission, by professionals acceptable to the facility’s staff. The complete assessment shall include:

1. Physical. Subparagraphs a., b. and c. must be completed by a physician on the staff of the facility prior to admission or within 24 hours after admission.

a. Complete medical history, including history of medications;

b. General physical examinations;

c. Neurological assessment;

d. Motor development and functioning;

e. Dental assessment;

f. Speech, hearing and language assessment;

g. Vision assessment;

h. Review of immunization status and completion according to the U.S. Public Health Service Advisory Committee on Immunization Practices and the Committee on Control of Infectious diseases of the American Academy of Pediatrics;

i. Laboratory workup including routine blood work and analysis;

j. Chest x-ray and/or tuberculin test;

k. Serology; and

l. Urinalysis.

m. If any of the physical health assessments indicate the need for further testing or definitive treatment, arrangements shall be made to carry out or obtain the necessary evaluations or treatment by clinicians or physicians trained as applicable, and plans for these treatments shall be coordinated with the patient’s overall treatment plan.

2. Psychiatric/Psychological.

a. The assessment includes direct psychiatric evaluation and behavioral appraisal, evaluation of sensory, motor functioning, a mental status examination appropriate to the age of the patient and a psychodynamic appraisal. A psychiatric history, including history of any previous treatment for mental, emotional or behavioral disturbances shall be obtained, including the nature, duration and results of the treatment, and the reason for termination.

b. The psychological assessment includes appropriate testing.

3. Developmental/Social.

a. The developmental history of the patient includes the prenatal period and from birth until present, the rate of progress, developmental milestones, developmental problems, and past experiences that may have affected the development. The assessment shall include an evaluation of the patient’s strengths as well as problems. Consideration shall be given to the healthy developmental aspects of the patient, as well as to the pathological aspects, and the effects that each has on the other shall be assessed. There shall be an assessment of the patient’s current age, appropriate developmental needs, which shall include a detailed appraisal of his peer and group relationships and activities.

b. The social assessment includes evaluation of the patient’s relationships within the structure of the family and with the community at large, and evaluation of the characteristics of the social, peer group, and institutional settings from which the patient comes. Consideration shall be given to the patient’s family circumstances, including the constellation of the family group, their current living situation, and all social, religious, ethnic, cultural, financial, emotional and health factors. Other factors that shall be considered are past events and current problems that have affected the patient and family; potential of the family’s members meeting the patient’s needs; and their accessibility to help in the treatment and rehabilitation of the patient. The expectations of the family regarding the patient’s treatment, the degree to which they expect to be involved, and their expectations as to the length of time and type of treatment required shall be assessed.

4. Nursing. The nursing assessment shall be performed by a person, who at a minimum, is duly licensed in the State of Florida to practice as a registered nurse and shall include the evaluation of:

a. Self-care capabilities including bathing, sleeping, eating;

b. Hygienic practices such as routine dental and physical care and establishment of healthy toilet habits;

c. Dietary habits including a balanced diet and appropriate fluid and calorie intake;

d. Response to physical diseases (e.g., acceptance by the patient of a chronic illness as manifested by his compliance with prescribed treatment);

e. Responses to physical handicaps (e.g., the use of prostheses for coping patterns used by the visually handicapped); and

f. Responses to medications (e.g., allergies or dependence).

5. Educational/Vocational. The patient’s current educational/vocational needs in functioning, including deficits and strengths, shall be assessed. Potential educational impairment and current and future educational vocational potential shall be evaluated using, as indicated, specific educational testing and special educators or others.

6. Recreational. The patient’s work and play experiences, activities, interests and skills shall be evaluated in relation to planning appropriate recreational activities.

(b) Treatment Planning. An initial treatment plan shall be formulated, written and interpreted to the staff and patient within 72 hours of admission. The comprehensive treatment plan shall be developed for each child by a multidisciplinary staff, within 14 days of admission. This plan must be reviewed at least monthly, or more frequently if the objectives of the program indicate. Review shall be noted in the record. A psychiatrist as well as multidisciplinary professional staff must participate in the preparation of the plan and any major revisions.

1. The treatment plan shall be based on the assessment and shall include clinical consideration of the physical, developmental, psychological, chronological age, family, education, social and recreational needs. The reason for admission shall be specified as shall specific treatment goals, stated in measurable terms, including a projected time frame, treatment modalities to be used, staff who are responsible for coordinating and carrying out the treatment, and expected length of stay and designation of the person or agency to whom the child will be discharged.

2. The degree of the family's involvement (parent or parent surrogates) shall be defined in the treatment planning program.

3. Collaboration with resources and significant others shall be included in treatment planning, when the treatment team determines it will not interfere with the child’s treatment.

4. Procedures that place the patient at physical risk or pain shall require special justification. The rationale for their use shall be clearly set forth in the treatment plan and shall reflect the prior involvement and specific review of the treatment plan by a child psychiatrist. When potentially hazardous procedures or modalities are contemplated for treatment, there shall be additional program specific policies governing their use to protect the rights and safety of the patient. The facility shall have specific written policies and procedures governing the use of electroconvulsive therapy or other forms of convulsive therapy. If such procedures are to be used they shall be carried out in a setting with emergency equipment available and shall be administered only by medical personnel who have been trained in the use of such equipment. Policies and procedures shall insure that:

a. Electroconvulsive therapy or other forms of convulsive therapy shall not be administered to any patient unless, prior to the initiation of treatment, two child psychiatrists with training or experience in the treatment of adolescents, who are not affiliated with the treating facility, have examined the patient, consulted with the responsible child psychiatrist and have written and signed reports which show concurrence with the administration of such treatment. Such reviews shall be carried out only by American Board of Psychiatry certified or American Board of Psychiatry eligible child psychiatrists;

b. All signed consultation reports, either recommending or opposing the administration of such treatment, shall be made a part of the patient’s clinical record;

c. Written informed consent of members of the family authorized to give consent, and where appropriate the patient’s consent shall be obtained and made a part of the patient’s clinical records. The person who is giving such consent may withdraw consent at any time;

d. Lobotomies or other surgical procedures for intervention or alterations of a mental, emotional or behavioral disorder shall not be performed on patients.

(c) Discharge. Discharge planning begins at the time of admission. A discharge date shall be projected in the treatment plan. Discharges shall be signed by a staff physician of the facility. A discharge summary shall be included in the records. Discharge planning shall include input from the multidisciplinary staff and will include family participation.

1. Discharge planning shall include a period of time for transition into the community (e.g., home visits gradually lengthened) for those patients who have been in the program for six months or longer. There must be a written plan for follow-up services, either by the facility or by another agency.

(3) Staff Coverage. There shall be a master clinical staffing pattern which provides for adequate clinical staff coverage at all times.

(a) There shall be at least one registered nurse on duty at all times. Services of a registered nurse shall be available for all patients at all times.

(b) A physician shall be on call twenty-four (24) hours a day and accessible to the facility within forty-five (45) minutes.

(c) Special attention shall be given to times which probably indicate the need for increased direct care (e.g., weekends, evenings, during meals, transition contained herein, and substantiated by the results between activities, and waking hours).

(d) Staff interaction shall insure that there is adequate communication of information regarding patients (e.g., between working shifts or change of personnel) with consulting professional staff for routine planning and patient review meetings. These interactions shall be documented in writing.

(4) Program Activities. Program goals of the facility shall include those activities designed to promote the physical and emotional growth and development of the patients, regardless of pathology or age level. There should be positive relationships with general community resources, and the facility staff shall enlist the support of these resources to provide opportunities for patients to participate in normal community activities as they are able. All labeling of vehicles used for transportation of patients shall be such that it does not call unnecessary attention to the patients.

(a) Group Size. The size and composition of each living group shall be therapeutically planned and depend on the age, developmental level, sex and clinical conditions. It shall allow for staff-patient interaction, security, close observation and support.

(b) Routine Activities. Basic routine shall be delineated in a written plan which shall be available to all personnel. The daily program shall be planned to provide a consistent well structured yet flexible framework for daily living and shall be periodically reviewed and revised as the needs of the individual patient or the living group change. Basic daily routine shall be coordinated with special requirements of the patient’s treatment plan.

(c) Social and Recreation Activities. Program of recreational and social activities shall be provided for all patients for daytime, evenings and weekends, to meet the needs of the patients and goals of the program. There shall be documentation of these activities as well as schedules maintained of any planned activities.

(d) Religious Activities. Opportunity shall be provided for all patients to participate in religious services and other religious activities within the framework of their individual and family interests and clinical status. The option to celebrate holidays in the patient's traditional manner shall be provided and encouraged.

(e) Education. The facility shall arrange for or provide an educational program for all patients receiving services in that facility.

1. The particular educational needs of each patient shall be considered in both placement and programming.

2. Children or adolescents placed in the special hospital by a public agency or at the expense of a public agency shall receive education consistent with the requirements of Chapter 6A-15 or Chapter 6A-6, F.A.C., as applicable.

(f) Vocational Programs. The facility shall arrange for, or provide, vocational or prevocational training for patients in the facility for whom it is indicated.

1. If there are plans for work experience developed as part of the patient’s overall treatment plan, the work shall be in the patient’s interest with payment where appropriate, as determined by the treatment facility and the vocational program, and never solely in the interest of the facility’s goals or needs.

2. Patients shall not be solely responsible for any major phase or institutional operation or maintenance, such as cooking, laundering, housekeeping, farming or repairing. Patients shall not be considered as substitutes for employed staff.

(g) Nutrition and Standards. There shall be a provision of planning and preparation of special diets as needed (e.g., diabetic, bland, high calorie). Menus shall be evaluated by a consultant dietitian relative to nutritional adequacy at least monthly, with observation of food intake and changes seen in the patient.

(5) Physical Care. The facility shall have available, either within its own organizational structure or by written agreements or contracts with outside health care clinicians or facilities, a full range of services for the treatment of illnesses and the maintenance of general physical health.

(a) The facility shall develop a written plan for medical services which delineates the ways the facility obtains or provides all general and specialized medical, surgical, nursing, pharmaceutical and dental services.

1. Insofar as Rules 59A-3.300 59A-3.100 through 59A-3.310 59A-3.111, F.A.C., are intended to establish minimum requirements for intensive residential treatment facilities programs for children and adolescents that have a primary purpose of treating emotional and mental disorders, such facilities are not required to establish and maintain medical buildings and equipment required of general or specialty hospitals as specified in Rules 59A-3.065 59A-3.200 through 59A-3.281 59A-3.232, F.A.C. Services which require such specialized buildings and equipment may be obtained from outside health care providers by written agreement or contract. This shall not preclude the facility from maintaining a medical services area or building which does not meet the requirements of Rules 59A-3.065 59A-3.200 through 59A-3.281 59A-3.232, F.A.C., for the purpose of isolating patients with contagious diseases, conducting physical examinations, providing preventive medical care services, or providing first aid services.

2. If the facility chooses to establish and operate a specialty or general hospital for the purposes of offering medical care more intensive than those specified in subsection 59A-3.065(32) 59A-3.201(32), F.A.C., the plans for construction shall be submitted for review in accordance with Rule 59A-3.080, F.A.C., and such facilities shall be required to be licensed, built and operated in accordance with Rules 59A-3.065 59A-3.200 through 59A-3.281 59A-3.232, F.A.C.

(b) Patients who are physically ill may be cared for on the grounds of the facility if medically feasible as determined by a physician. If medical isolation is necessary, there shall be sufficient and qualified staff available to provide care and attention.

(c) Provisions shall be made in writing for patients from the facility to receive care from outside health care providers and hospital facilities, in the event of serious illness which the facility cannot properly handle. Such determinations shall be made by a licensed physician.

(d) Every patient shall have a complete physical examination annually and more frequently if indicated. This examination shall be as inclusive as the initial examination. Efforts shall be made by the institution to have physical defects of the patients corrected through proper medical care. Immunization shall be kept current (DT, polio, measles, mumps, M-M-R).

(e) Each member of the program staff shall be trained to recognize common symptoms of the illnesses of patients, and to note any marked dysfunctions of patients.

(f) Staff shall have knowledge of basic health needs and health problems of patients, such as mental health, physical health and nutritional health. Staff shall teach attitudes and habits conducive to good health through daily routines, examples and discussion, and shall help the patients to understand the principles of health.

(g) Each program shall have a planned program of dental care and dental health which shall be consistently followed. Each patient shall receive a dental examination by a qualified dentist and prophylaxis at least once a year. Reports of all examinations and treatment shall be included in the patient’s clinical record.

(6) Emergency Services. All clinical staff shall have training in matters related to handling emergency situations.

(a) Policies and procedures shall be written regarding handling and reporting of emergencies and these shall be reviewed at least yearly thereafter by all staff.

(b) There shall be a physician on call twenty-four (24) hours a day; his name and where he can be reached shall be clearly posted in accessible places for program staff.

(c) All direct service program staff must maintain current first aid certificate.

(d) An emergency medication kit shall be made available and shall be constituted to meet the needs of the facility. The emergency medication kit shall contain items selected by the staff or consultant medical doctor and staff or consultant pharmacist which shall be maintained and safeguarded in accordance with federal and state laws and regulations pertaining to the specific drug items included.

(e) There shall be an adequate number of first aid kits available to program staff at all times. Contents of the first aid kits shall be selected by the staff or consultant medical personnel and shall include items designed to meet the needs of the facility.

(f) The program shall have written policies and procedures of obtaining emergency diagnosis and treatment of dental problems. The program shall have written agreement with a licensed dentist(s) who is a consultant or a member of the staff for emergency dental care.

(g) The facility shall have a written plan to facilitate emergency hospitalization in a licensed medical facility. The facility shall make available a written agreement from a licensed hospital verifying that routine and emergency hospitalization will be provided.

(h) The special hospital shall have a written plan for providing emergency medical and psychiatric care.

1. There shall be a written posted plan which shall clearly specify who is available and authorized to provide necessary emergency psychiatric or medical care, or to arrange for referral or transfer to another facility to include ambulance arrangements, when necessary.

2. There shall be a written plan regarding emergency notification to the parents or legal guardian. This plan and arrangements shall be discussed with all families or guardians of patients upon admission.

(7) Pharmaceutical Services. Pharmaceutical services, if provided, shall be maintained and delivered as described in the applicable sections of Chapter 465, F.S., and Chapter 893, F.S., Chapter 500, F.S., and Board of Pharmacy Chapter 21S, F.S.

(8) Laboratory and Pathology Services.

(a) The facility shall provide clinical and pathology services within the institution, or by contractual arrangement with a laboratory commensurate with the facility’s needs and which is registered under the provisions of Chapter 483, F.S.

1. Provision shall be made for the availability of emergency laboratory services 24 hours a day, 7 days a week, including holidays.

2. All laboratory tests shall be ordered by a physician.

3. All laboratory reports shall be filed in the patient’s medical record.

4. The facility shall have written policies and procedures governing the collection, preservation and transportation of specimens to assure adequate stability of specimens.

(b) Where the facility depends on an outside laboratory for services, there shall be a written contract detailing the conditions, procedures and availability of work performed. The contract shall be reviewed and approved by the medical staff, administrator and the governing body.

(9) Patients’ Rights. Every effort shall be made to safeguard the legal and civil rights of patients and to make certain that they are kept informed of their rights, including the right to legal counsel and all other requirements of due process.

(a) Individual dignity and human rights are guaranteed to all clients of mental health facilities in Florida by the Florida Mental Health Act, known as the “Baker Act,” Chapter 394, F.S.

(b) Each facility shall be administered in a manner that protects the client’s rights, his life, and his physical safety while under treatment.

1. The special hospital’s space and furnishings should be designed and planned to enable the staff to respect the patient’s right to privacy and, at the same time, provide adequate supervision according to the development and clinical needs of the patients. Provisions for an individual patient’s rights regarding privacy shall be made explicit to the patient and family. A written policy concerning patient’s rights shall be provided to the patient of authentic research or studies, or innovations of client’s record.

2. The special hospital center’s policies shall allow patient visitation and communication with all members of the family and other visitors as clinically indicated and when such visits are consistent with the facility’s program. When therapeutic considerations recommended by the responsible licensed psychologist or physician necessitate restriction of communication or visits, as set forth in the programs policies and procedures, these restrictions shall be evaluated at least weekly by the clinical staff for their continuing effectiveness. These restrictions shall be documented and signed by the responsible psychologist or physician and be placed in the patient’s record. The special hospital shall make known to the patient, the family and referring agency its policies regarding visiting privileges on and off the premises, correspondence and telephone calls. These policies shall be stated in writing and shall be provided to the patient and family and updated when change in policy occurs. When limitations on such visits, calls or other communications are indicated by practical reason, e.g., the expense of travel or telephone calls, such limitations shall be determined with participation of the patient’s family or guardian.

3. Patients shall be allowed to request an attorney through their parents or guardians. This shall be established as written policy, and the policy shall be provided to families and patients.

4. Patient’s opinions and recommendations shall be considered in the development and continued evaluation of the therapeutic program. The special hospital shall have written policies to carry out appropriate procedures for receiving and responding to patient communications concerning the total program.

5. The special hospital shall have written policies regarding methods used for control of patients’ behavior. Such written policies shall be provided to the appropriate staff and to the patient and his family. Only staff members responsible for the care and treatment of patients shall be allowed to handle discipline. Patients shall not be subject to cruel, severe, unusual or unnecessary punishment. Patients shall not be subjected to remarks which ridicule them or their families, or others.

6. Protective restraint consists of any apparatus or condition which interferes with the free movement of the patient. Only in an emergency shall physical holding be employed unless there are physician’s orders for a mechanical restraint. Physical holding or mechanical restraints, such as canvas jackets or cuffs, shall be used only when necessary to protect the patient from injury to himself or others. Use of mechanical restraints reflect a psychiatric emergency and must be ordered by the responsible staff/consultant physician, be administered by trained staff and be documented in the patient’s clinical records. The need for the type of restraint used and the length of time it was employed and condition of the patient shall be recorded in the patient’s record. An order for a mechanical restraint shall designate the type of restraint to be used, the circumstance under which it is to be used and the duration of its use. A patient in a mechanical restraint shall have access to a staff member at all times during the period of restraint.

7. The facility shall have written policies and procedures which govern the use of seclusion. The use of seclusion shall require clinical justification and shall be employed only to prevent a patient from injuring himself or others, or to prevent serious disruption of the therapeutic environment. Seclusion shall not be employed as punishment or for the convenience of staff. A written order from a physician shall be required for the use of seclusion for longer than one hour. Written orders for seclusion shall be limited to twenty-four (24) hours. The written approval of the medical director or the director of psychiatrist services shall be required when seclusion is utilized for more than twenty-four (24) hours. Staff who implement written orders for seclusion shall have documented training in the proper use of the procedures. Appropriate staff shall observe and visually monitor the patient in seclusion every fifteen (15) minutes, documenting the patient’s condition and identifying the time of observation. A log shall be maintained which will record on a quarter- hour basis the observation of the patient in seclusion, and will also indicate when the patient was taken to the bathroom, when and where meals were served, when other professional staff visited, etc., and shall be signed by the observer. The need or reason for seclusion shall be made clear to the patient and shall be recorded in the patient’s clinical record. The length of time in seclusion shall also be recorded in the clinical record, as well as the condition of the patient. A continuing log shall be maintained by the facility that will indicate by name the patients placed in seclusion, date, time, specified reason for seclusion and length of time in seclusion. In an emergency, orders may be given by a physician over the telephone to a registered professional nurse. Telephone orders must be reviewed within twenty-four (24) hours by the director of psychiatric services.

8. The special hospital shall not exploit a patient or require a patient to make public statements to acknowledge his gratitude to the treatment center.

9. Patients shall not be required to perform at public gatherings.

10. The special hospital shall not use identifiable patients’ pictures without written consent. The signed consent form shall be on file at the facility before any such pictures are used. A signed consent form must indicate how pictures shall be used and a copy shall be placed in the patient’s clinical record.

(10) Records. The form and detail of the clinical records may vary but shall minimally conform to the following standards:

(a) Content. All clinical records shall contain all pertinent clinical information and each record shall include but not be limited to:

1. Identification data and consent forms; when these are not obtainable, reason shall be noted;

2. Source of referral;

3. Reason for referral, example, chief complaint, presenting problem;

4. Record of the complete assessment;

5. Initial formulation and diagnosis based upon the assessment;

6. Written treatment plan;

7. Medication history and record of all medications prescribed;

8. Record of all medication administered by facility staff, including type of medication, dosages, frequency of administration, persons who administered each dose, and route of administration;

9. Documentation of course of treatment and all evaluations and examinations, including those from other facilities, for example, emergency rooms or general hospitals;

10. Periodic treatment summaries; updated at least every 90 days;

11. All consultation reports;

12. All other appropriate information obtained from outside sources pertaining to the patient;

13. Discharge or termination summary report; and

14. Plans for follow-up and documentation of its implementation.

(b) Identification data and consent form shall include the patient’s name, address, home telephone number, date of birth, sex, next of kin, school and what grade, date of initial contact or admission to the program, legal status and legal document, and other identifying data as indicated.

(c) Progress Notes. Progress notes shall include regular notations at least weekly by staff members, consultation reports and signed entries by authorized identified staff. Progress notes by the clinical staff shall:

1. Document a chronological picture of the patient’s clinical course;

2. Document all treatment rendered to the patient;

3. Document the implementation of the treatment plan;

4. Describe each change in each of the patient’s conditions;

5. Describe responses to and outcome of treatment; and

6. Describe the responses of the patient and the family or significant others to significant inter-current events.

(d) Discharge Summary. The discharge summary shall include the initial formulation and diagnosis, clinical resume, final formulation and final primary and secondary diagnoses, the psychiatric and physical categories. The final formulation shall reflect the general observations and understanding of the patient’s condition during appraisal of the fundamental needs of the patients. The relevant discharge diagnoses shall be recorded and coded in the standard nomenclature of the current “Diagnostic and Statistical Manual of Mental Disorders,” published by the American Psychiatric Association, and the latest edition of the “International Classification of Diseases,” regardless of the use of other additional classification systems. Records of discharged patients shall be completed following discharge within a reasonable length of time, and not to exceed 15 days. In the event of death, a summation statement shall be added to the record either as a final progress note or as a separate resume. This final note shall take the form of a discharge summary and shall include circumstances leading to death. All discharge summaries must be signed by a staff or consultant physician.

(e) Recording. Entries in the clinical records shall be made by staff having pertinent information regarding the patient, consistent with the facility policies, and authors shall fully sign and date each entry. When mental health trainees are involved in patient care, documented evidence shall be in the clinical records to substantiate the active participation of supervisory clinical staff. Symbols and abbreviations shall be used only when they have been approved by the clinical staff and when there is an explanatory notation. Final diagnosis, both psychiatric and physical, shall be recorded in full, and without the use of either symbols or abbreviations.

(f) Policies and Procedures. The facility shall have written policies and procedures regarding clinical records which shall provide that:

1. Clinical records shall be confidential, current and accurate;

2. The clinical record is the property of the facility and is maintained for the benefit of the patient, the staff and the facility;

3. The facility is responsible for safeguarding the information in the record against loss, defacement, tampering or use by unauthorized persons;

4. The facility shall protect the confidentiality of clinical information and communication between staff members and patients;

5. Except as required by law, the written consent of the patient, family, or other legally responsible parties, is required for the release of clinical record information;

6. Records may be removed from the facility's jurisdiction and safekeeping only according to the policies of the facility or as required by law; and

7. That all staff shall receive training, as part of new staff orientation and with periodic update, regarding the effective maintenance of confidentiality of the clinical record. It shall be emphasized that confidentiality refers as well to discussions regarding patients inside and outside the facility. Verbal confidentiality shall be discussed as part of all employee training.

(g) Maintenance of Records. Each facility shall provide for a master filing system which shall include a comprehensive record on each patient’s involvement in every program aspect.

1. Appropriate records shall be kept on the unit where the patient is being treated or be directly and readily accessible to the clinical staff caring for the patient;

2. The facility shall maintain a system of identification and coding to facilitate the prompt location of the patient’s clinical records;

3. There shall be policies regarding the permanent storage, disposal or destruction of the clinical records of disclosure of confidential information later in life;

4. The clinical record services required by the facilities shall be directed, staffed and equipped to facilitate the accurate processing, checking, indexing, filing, retrieval and review of all clinical records. The clinical records service shall be the responsibility of an individual who has demonstrated competence and training or experience in clinical record administrative work. Other personnel shall be employed as needed, in order to effect the functions assigned to the clinical record services;

5. There shall be adequate space, equipment and supplies, compatible with the needs of the clinical record service, to enable the personnel to function effectively and to maintain clinical records so that they are readily accessible.

(11) Program and Patient Evaluation. The staff shall work towards enhancing the quality of patient care through specified, documented, implemented and ongoing the designing professions having as their purpose processes of clinical care evaluation studies and utilization review mechanisms.

(a) Individual Case Review.

1. There shall be regular staff meetings or unit meetings to review and monitor the progress of the individual child or adolescent patient. Each patient’s case shall be reviewed within a month after admission and at least monthly during residential treatment. This shall be documented. This meeting may also be used for review and revision of treatment plans.

2. The facility shall provide for a follow-up review on each discharged patient to determine effectiveness of treatment and disposition.

(b) Program Evaluation.

1. Clinical Care Evaluation Studies. There shall be evidence of ongoing studies to define standards of care consistent with the goals of the program effectiveness of the program, and to identify gaps and inefficiencies in service. Evaluation shall include follow-up studies. Studies shall consist of the following elements:

a. Selection of an appropriate design;

b. Specification of information to be included;

c. Collection of data;

d. An analysis of data with conclusions and recommendations;

e. Transmissions of findings; and

f. Follow-up on recommendations.

2. Utilization Review. Each facility shall have a plan for and carry out utilization review. The review shall cover the appropriateness of admission to services, the provision of certain patterns of services, and duration of services. There shall be documentation of utilization review meetings either in minutes or in individual clinical records. The improvement of patient care, shall receive special consideration following a request and documentation of the proposed project by the individual sponsor.

Rulemaking Specific Authority 395.1055 FS. Law Implemented 395.001, 395.1055 FS. History–New 1-1-77, Formerly 10D-28.92, 10D-28.110, Amended 9-4-95,________.

 

59A-3.250 Surveillance, Prevention, and Control of Infection.

(1) Each hospital shall establish an infection control program involving members of the organized medical staff, the nursing staff, other professional staff as appropriate, and administration. The program shall provide for:

(a) The surveillance, prevention, and control of infections among patients and personnel;

(b) The establishment of a system for identifying, reporting, evaluating and maintaining records of infections;

(c) Ongoing review and evaluation of all septic, isolation and sanitation techniques employed in the hospital; and

(d) Development and coordination of training programs in infection control for all hospital personnel.

(2) Each hospital shall have written policies and procedures reflecting the scope of the infection control program outlined in subsection (1). The written policies and procedures shall be reviewed at least every two years by the infection control program members, dated at the time of each review, revised as necessary, and enforced.

(3) The policies and procedures devised by the infection control program shall be approved by the governing body, and shall contain at least the following:

(a) Specific policies for the shelf life of all stored sterile items.

(b) Specific policies and procedures related to occupational exposure to blood and body fluids.

(c) Specific policies and procedures related to admixture and drug reconstitution, and to the manufacture of intravenous and irrigating fluids.

(d) Specific policies related to the handling and disposal of biomedical waste in accordance with Chapter 64E-16, F.A.C., May 1995, OSHA 29 CFR Part 1910.1030 Occupational Exposure to Blood Borne Pathogens Final Rule, July 1995, and the Department of Environmental Protection Code Chapter 62-712 on Biomedical Waste, May 1995.

(e) Specific policies related to the selection, storage, handling, use and disposition of disposable items.

(f) Specific policies related to decontamination and sterilization activities performed in central services and throughout the hospital, including a requirement that steam gas (ETO) and hot air sterilizers be tested with live bacterial spores at least weekly.

(g) Specific policies regarding the indications for universal precautions, body substance isolation, CDC isolation guidelines, or equivalent and the types of isolation to be used for the prevention of the transmission of infectious diseases.

(h) A requirement that soiled linen is collected in such a manner as to minimize microbial dissemination into the environment.

(i) A requirement that all cases of communicable diseases as set forth in Chapter 64D-3, F.A.C., be promptly and properly reported in accordance with the provisions of that rule.

(4) The individuals involved in the infection control program shall meet at least quarterly, shall maintain written minutes of all meetings, and shall make a report at least annually to the assigned professional staff and the governing body.

(5) Each hospital shall establish an employee health policy to minimize the likelihood of transmission of communicable disease by both employees and patients. Such policies shall include work restrictions for an employee whenever it is likely that communicable disease may be transmitted until such time as a medical practitioner certifies that the employee may return to work.

Rulemaking Specific Authority 395.1055 FS. Law Implemented 395.1011, 395.1055 FS. History–New 9-4-95, Formerly 59A-3.215, Amended________.

 

59A-3.252 Classification of Hospitals.

(1) The Aagency will license four classes of facilities:

(a) Class I or general hospitals which includes;

1. General acute care hospitals with an average length of stay of 25 days or less for all beds;

2. Long term care hospitals, which meet the provisions of subsection 59A-3.065(34), F.A.C.; and

3. Rural hospitals designated under Section 395, Part III, F.S.

(b) Class II specialty hospitals offering the range of medical services offered by general hospitals, but restricted to a defined age or gender group of the population which includes;

1. Specialty hospitals for children; and

2. Specialty hospitals for women.

(c) Class III specialty hospitals offering a restricted range of services appropriate to the diagnosis, care, and treatment of patients with specific categories of medical or psychiatric illnesses or disorders which include;

1. Specialty medical hospitals;

2. Specialty rehabilitation hospitals;

3. Specialty psychiatric hospitals, which may include beds licensed to offer Intensive Residential Treatment programs;

4. Specialty substance abuse hospitals, which may include beds licensed to offer Intensive Residential Treatment programs; and

(d) Class IV specialty hospitals restricted to offering Intensive Residential Treatment Facility services Programs for Children and Adolescents, pursuant to Section 395.002(15)(16), F.S. and subsection 59A-3.065(32), F.A.C.

(2) In addition to other requirements specified in these rules, all licensed hospitals shall have at least the following:

(a) Inpatient beds;

(b) A governing authority legally responsible for the conduct of the hospital;

(c) A chief executive officer or others similarly titled official to who the governing authority delegates the full-time authority for the operation of the hospital in accordance with the established policy of the governing authority;

(d) An organized medical staff to which the governing authority delegates responsibility for maintaining proper standards for medical and other health care;

(e) A current and complete medical record for each patient admitted to the hospital;

(f) A policy requiring that all patients be admitted on the authority of and under the care of a member of the organized medical staff;

(g) Facilities and professional staff available to provide food to patients to meet their nutritional needs;

(h) A procedure for providing care in emergency cases;

(i) A method and policy for infection control; and

(j) An on-going organized program to enhance the quality of patient care and review the appropriateness of utilization of services.

(3) In addition to the requirements of subsection (2) and other requirements of these rules, Class I, and Class II hospitals shall have at least the following:

(a) One licensed registered nurse on duty at all times on each floor or similarly titled part of the hospital for rendering patient care services;

(b) A pharmacy supervised by a licensed pharmacist either in the facility or by contract sufficient to meet patient needs;

(c) Diagnostic imaging services either in the facility or by contract sufficient to meet patient needs;

(d) Clinical laboratory services either in the facility or by contract sufficient to meet patient needs;

(e) Operating room services; and

(f) Anesthesia service.

(4) In addition to the requirements of subsection (2) and other requirements of these rules, all Class II, Class III, and Class IV hospitals shall provide the treatment services, equipment, supplies and staff appropriate to the particular category of patients treated at the facility.

(5) All Class III hospitals, in addition to meeting the requirements of subsection (2) and other requirements of these rules, must provide:

(a) For at least one qualified staff person at all times on each floor or similarly titled part of the hospital for rendering patient care services;

(b) A pharmacy supervised by a licensed pharmacist either in the facility or by contract sufficient to meet patient needs;

(c) Diagnostic imaging services either in the facility or by contract sufficient to meet patient needs;

(d) Clinical laboratory services, either in the facility or by contract sufficient to meet patient needs; and

(e) Any other services, when provided by a Class III or Class IV hospital, shall meet the standards pertinent to that particular service as promulgated in Rules 59A-3.065 through 59A-3.310 59A-3.312, F.A.C., as applicable.

Rulemaking Specific Authority 395.1055 FS. Law Implemented 395.002, 395.1055, 408.035, 408.036 FS. History–New 9-4-95, Formerly 59A-3.202, Amended________.

 

59A-3.253 Investigations and License, Life Safety and Validation Inspections.

(1) INSPECTIONS. – The Agency AHCA shall conduct periodic inspections of hospitals in order to ensure compliance with all licensure requirements in accordance with Section 395.0161, F.S., and as it deems necessary to carry out the functions of the agency. Inspections shall be conducted for the following reasons:

(a) To assure compliance with the licensure and life safety requirements of this Chapter;

(b) To validate the inspection process of hospital accrediting organizations;

(c) To respond to licensure, life safety, and emergency access complaints; or

(d) To protect the public health and safety.

(2) NON-ACCREDITED HOSPITALS. – Hospitals which are not accredited by an a hospital accrediting organization shall will be subject to a scheduled annual licensure inspection survey.

(a) Upon Within 10 calendar days of the completion of the Aagency’s inspection survey, the Aagency will send mail a copy of the survey findings to the hospital. For those hospitals determined not in compliance with state licensure requirements, the notification shall include a statement of deficiencies.

(b) Within 10 calendar days of the receipt of the statement of deficiencies, the hospital must prepare and mail a plan of correction for review and approval by the agency. The plan of correction must address the action planned by the hospital to correct each deficiency, the individuals or entities responsible for implementing the corrective action, and the date by which each corrective action will be completed.

(c) The agency will, if necessary, conduct a follow-up visit to a hospital with an acceptable plan of correction within 30 days of the completion date for all deficiencies contained in the plan of correction, or will review pertinent materials submitted by the hospital, to determine compliance with the approved plan of correction.

(b)(d) The Aagency will work with hospitals to ensure compliance with standards of care through the implementation of acceptable plans of correction. Those hospitals which fail to implement an approved plan of correction will be subject to sanctions imposed under Section 395.1065, F.S.

(3) ACCREDITED HOSPITALS. – The Aagency shall accept the survey report of an accrediting organization in lieu of an annual licensure inspection for accredited hospitals and for hospitals seeking accreditation by a hospital accrediting organization, provided that the standards included in the survey report of the accrediting organization are determined by the Aagency to document that the hospital is in substantial compliance with state licensure requirements, and the hospital does not meet the criteria specified under subparagraphs (c)(e)1. and 2.

(a) Upon receipt of the accrediting organization’s survey report, the Aagency will review the findings to determine if the hospital is in substantial compliance with state licensure requirements.

(b) The Aagency shall notify the hospital within 60 days of the receipt of the accrediting organization’s survey report regarding the Aagency’s determination of the hospital's compliance or non-compliance with state licensure requirements. For hospitals that are determined not in compliance with licensure requirements, the notification will include a statement of deficiencies.

(c) Hospitals determined by the agency to be not in substantial compliance with licensure requirements, based on the accreditation report, shall submit a plan of correction to the agency within 10 calendar days of receipt of the statement of deficiencies.

(d) The agency shall review the plan of correction in accordance with the procedures specified under paragraphs (2)(a) through (d).

(c)(e) Hospitals shall that are determined by the agency to be in substantial compliance with licensure requirements will not be subject to an annual licensure inspection except under the following circumstances:

1. The hospital has been denied accreditation or has received a provisional or conditional accreditation from an a hospital accrediting organization on its most recent accreditation report survey, and has not submitted an acceptable plan of correction to the accrediting organization and the agency;

2. The hospital has received full accreditation but has not authorized the release of the report to the Aagency, or has not ensured that the Aagency received the accrediting organization’s survey report prior to the Aagency scheduling a licensure inspection.

(4) LICENSURE INSPECTION FEES. – With the exception of state-operated licensed facilities, the licensure inspection fee shall be $12.00 per hospital bed, provided that no licensed facility shall be assessed less than $400.00 per inspection for licensure, and further provided that a separate fee for the licensure inspection shall be charged for each hospital located on a separate premises, regardless of its inclusion on a single license.

(5) LIFE SAFETY INSPECTIONS. – The AHCA shall conduct a scheduled annual life safety inspection of all licensed hospitals to ensure physical plant compliance with life safety codes and requirements for disaster preparedness, pursuant to this Chapter, unless:

(a) The hospital was surveyed during an accreditation survey by a Florida accredited life safety inspector, and found to be in compliance with life safety requirements by the accrediting organization, and;

(b) The report of that survey has been released to and received by the AHCA prior to the agency scheduling a life safety inspection.

(5)(6) LIFE SAFETY INSPECTION FEES. – With the exception of state-operated licensed facilities, the fee for a life safety inspection shall be $1.50 per hospital bed, provided that no licensed facility shall be assessed less than $40 for a life safety inspection, and further provided that a separate fee for the life safety inspection shall be charged for each hospital located on a separate premises, regardless of its inclusion on a single license. A separate fee for a life safety inspection will not be assessed when conducted as part of a licensure or a Centers for Medicare and Medicaid Services certification validation inspection.

(6)(7) VALIDATION INSPECTIONS. – Each year, the Aagency shall conduct validation inspections on a minimum of five percent of those hospitals that have undergone a full accreditation inspection from an a hospital accrediting organization, within 60 days of the accreditation survey, to determine ongoing compliance with licensure requirements.

(a) Upon Within 10 calendar days following the completion of a licensure validation inspection survey, the Aagency will send mail a copy of its findings to the hospital. For those hospitals determined not in compliance with licensure requirements, the notification will include a statement of deficiencies.

(b) Facilities found not in compliance based on a validation inspection shall submit a plan of correction as specified under paragraphs (2)(a) through (d).

(b)(c) If the Aagency determines, based on the results of validation inspection survey findings, that a fully accredited hospital is not in substantial compliance with licensure requirements, the Aagency shall report its findings to the accrediting organization and shall conduct a full licensure inspection on that hospital during the following year.

(c)(d) The fee for conducting a licensure validation inspection shall be the same as that specified for licensure inspections under subsection (4). A separate fee for a validation inspection survey will not be assessed when conducted in conjunction with a Centers for Medicare and Medicaid Services certification inspection survey.

(7)(8) COMPLAINT INSPECTIONS. – The Aagency shall conduct investigations of complaints regarding violations of licensure and life safety standards in accordance with Sections 395.0161 and 408.811, F.S., and emergency access requirements in accordance with Section 395.1046, F.S. Complaint investigations will be unannounced. An entrance conference must be conducted upon arrival, by Aagency personnel investigating the complaint, to inform the hospital’s administrator about the nature of the complaint investigation and to answer questions from hospital staff. An exit conference must be provided at the conclusion of the on-site investigation to inform the hospital of the scope of the investigation and to receive any additional information that the hospital wishes to furnish.

(a) Upon receipt of a complaint, the Aagency shall review the complaint for allegations of non-compliance with licensure requirements compliance with licensure issues, and in addition, shall take the following action:

1. Complaints involving accredited hospitals shall be reported to the appropriate accrediting organization;

2. Complaints involving Medicare certified hospitals shall be referred to the Centers for Medicare and Medicaid Services Health Care Finance Administration for a determination as to the need for an investigation under certification standards.

3. Complaints involving diagnostic radiology equipment or personnel, or biomedical sanitation, waste disposal, or food preparation shall be referred to the Department of Health and Rehabilitative Services for investigation.

(b) Upon a determination that further investigation of a complaint is warranted, the Aagency shall conduct an investigation within 90 days, unless there is an immediate threat, in which case an immediate inspection will be undertaken.

(c) Upon conclusion of a complaint investigation by the agency, the agency shall notify the affected parties in writing within 10 calendar days of its determination as to the validity of the complaint and any actions to be taken to resolve violations or sanctions imposed against the hospital.

(d) Hospital personnel and physicians shall report any apparent violations of emergency access requirements under Section 395.1041, F.S., to the agency, and shall include all relevant information. Reports shall be made within 30 days following the occurrence. Medical personnel reasonably believed by the agency to be in violation of these rules will immediately be referred by the agency to their respective licensing boards. Violations include failure to report when on-call or intentionally misrepresenting the patient’s condition in cases of medically necessary transfers or in determining the presence or absence of an emergency medical condition or rendering appropriate emergency services and care, or failure or refusal to sign a certificate of transfer as required by this section.

(8)(9) CONFORMANCE WITH ACCREDITATION STANDARDS. – In all hospitals where the Aagency does not conduct an annual licensure inspection, by reason of the hospital’s accreditation status, either an annual licensure inspection or an annual life safety inspection, the hospital shall continue to conform to the standards of accreditation throughout the term of accreditation, or shall notify the Aagency of the areas of non-conformance. Where the Aagency is notified of non-conformance, it shall take appropriate action as specified under subsection (3) 59A-3.253(6), F.A.C.

(10) DATA COLLECTION. – All hospitals shall comply with the agency requirements for data submission as authorized under Section 395.1055, F.S., Chapters 408 and 732, F.S. This data, which does not have to be resubmitted to the agency’s hospital licensing office as a provision of this part, includes:

(a) Certificate of need reviews required under Sections 408.031 through 408.045, F.S., and at such intervals as required by Chapter 59C-1, F.A.C.;

(b) Quality of care patient outcome data as required by Sections 408.061(1) and 395.1055(1)(g), F.S., and as mandated by rules adopted by the agency;

(c) Completion of the Specialty Care and Referrals Report, as required by rules adopted by the agency; and

(d) Each hospital shall submit a quarterly report to the agency summarizing the number of requests made by the hospital for organ donation in accordance with Chapter 732, F.S.

(e) All hospitals shall make available on their Internet websites a description of and link to the Agency for Health Care Administration webpage which contains the hospital patient charge and performance outcome data that is collected pursuant to Section 408.061(1), F.S. and, if requested, hospitals shall provide a hard copy of the description and the link.

(9)(11) SANCTIONS. – The Aagency shall impose sanctions, in accordance with Section 395.1065, F.S., on those hospitals which fail to submit an acceptable plan of correction or implement actions to correct deficiencies identified by the Aagency or an appropriate accrediting organization which are specified in an approved plan of correction or as identified as a result of a complaint investigation.

Rulemaking Specific Authority 395.0161, 395.1055, 408.819 FS. Law Implemented 395.003, 395.0161, 395.1055, 395.1065, 408.035, 408.036 FS. History–New 9-4-95, Formerly 59A-3.204 Amended 5-16-06,________.

 

59A-3.254 Patient Rights and Care.

(1) Patient Assessment. Each hospital shall develop and adopt policies and procedures to ensure an initial assessment of the patient’s physical, psychological and social status, appropriate to the patient’s developmental age, is completed to determine the need and type of care or treatment required, and the need for further assessment. The scope and intensity of the initial assessment shall be determined by the patient’s diagnosis, the treatment setting, the patient’s desire for treatment, and response to previous treatment.

(a) Such policies shall:

1. Specify the time period preceding or following admission within which the initial assessment shall be conducted;

2. Require that the initial assessment be documented in writing in the patient’s medical record;

(b) The initial assessment shall determine the need for an assessment of the patient’s nutritional and functional status, as well as discharge planning needs, when appropriate;

(c) The hospital shall have policies and procedures to ensure that periodic reassessments of the patient are conducted based on changes in either the patient’s condition, diagnosis, or response to treatment;

(d) The hospital shall ensure that care and treatment decisions are based on the patient’s identified needs and treatment priorities;

(e) An individualized treatment plan shall be developed for each patient based upon the initial assessment and other diagnostic information as appropriate.

(2) Coordination of Care. Each hospital shall develop and implement policies and procedures on discharge planning which address:

(a) Identification of patients requiring discharge planning;

(b) Initiation of discharge planning on a timely basis;

(c) Evaluation of prescription medications, ensuring the continued availability of medications for at least three days after discharge;

(d)(c) The role of the physician, other health care givers, the patient, and the patient’s family in the discharge planning process; and

(e)(d) Documentation of the discharge plan in the patient’s medical record including an assessment of the availability of appropriate services to meet identified needs following hospitalization.

(3) Patient and Family Education.

(a) General Provisions. Each hospital shall develop a systematic approach to educating the patient and family to improve patient outcomes by promoting recovery, speedy return to function, promoting healthy behaviors, and involving patients in their care and care decisions.

(b) Each hospital shall provide the patient and family with education specific to the patient’s assessed needs, capabilities, and readiness. Such education shall include when indicated:

1. An assessment when indicated, of the educational needs, capabilities, and readiness to learn based on cultural and religious practices, emotional barriers, desire and motivation to learn, physical and cognitive limitations, and language barriers;

2. Instruction in the specific knowledge or skills needed by the patient or family to meet the patient's ongoing health care needs including:

a. The use of medications.

b. The use of medical equipment.

c. Potential drug or food interactions, and nutritional intervention or modified diets.

d. Rehabilitation techniques.

e. Available community resources.

f. When and how to obtain further treatment; and

g. The patient’s and family’s responsibilities in the treatment process.

3. Information about any discharge instructions given to the patient or family shall be provided to the organization or individual responsible for providing continuing care.

4. Each hospital shall plan and support the provision and coordination of patient and family education activities by ensuring that:

a. Educational resources required are identified and made available; and

b. The educational process is interdisciplinary, as appropriate to the plan of care.

(4) Patient Rights. Each hospital shall develop and adopt policies and procedures to ensure the following rights of the patient:

(a) The right to refuse treatment and life-prolonging procedures as specified under Section 765.302 765.1105, F.S.;

(b) The right to formulate advance directives and designate a surrogate to make health care decisions on behalf of the patient as specified under Chapter 765, F.S. The policies shall not condition treatment or admission upon whether or not the individual has executed or waived an advance directive. In the event of conflict between the facility’s policies and procedures and the individual’s advance directive, provision should be made in accordance with Section 765.302 765.308, F.S. Policies shall include:

1. Provide each adult individual, at the time of the admission as an inpatient, with a copy of “Health Care Advance Directives – The Patient’s Right to Decide,” effective 1-11-93, which is hereby incorporated by reference, or with a copy of some other substantially similar document which is a written description of Chapter 765, F.S., regarding advance directives;

2. Providing each adult individual, at the time of admission as an inpatient, with written information concerning the health care facility’s policies respecting advance directives; and

3. The requirement that documentation of the existence of an advance directive be contained in the medical record. A health care facility which is provided with the individual’s advance directive shall make the advance directive or a copy thereof a part of the individual’s medical record.

(c) The right to information about patient rights as set forth in Section 381.026, F.S., and procedures for initiating, reviewing and resolving patient complaints;

(d) The right to participate in the consideration of ethical issues that arise in the care of the patient;

(e) The right to personal privacy and confidentiality of information including access to information contained in the patient’s medical records as specified under Section 395.3025, F.S.;

(f) The right of the patient’s next of kin or designated representative to exercise rights on behalf of the patient;

(g) The right to an itemized patient bill upon request as specified under Section 395.301, F.S.;

(h) The right to be free of restraints consistent with the rights of mentally ill persons or patients as provided in Section 394.459, F.S.

(5) In addition to the provisions of this section, hospitals must comply with Section 381.026, F.S., which remains in effect.

Rulemaking Specific Authority 395.003, 395.1055 FS. Law Implemented 395.003, 395.1055 FS. History–New 4-17-97, Formerly 59A-3.2055, Amended________.

 

59A-3.255 Emergency Care.

(1) SIGNAGE REQUIREMENTS.

(a) Each hospital offering emergency services and care shall post, in a conspicuous place in the emergency service area, a sign clearly stating a patient’s right to emergency services and care as set forth in Section 395.1041, F.S. The sign shall be posted in both English and in Spanish.

(b) Each hospital offering emergency services and care shall post a sign identifying the service capability of the hospital. The categories of services listed on the sign may be general in nature if the sign refers patients to another location within that facility where a list of the subspecialties is available. The sign identifying the service capability of the hospital and the additional listing of subspecialties, if a separate subspecialty list is maintained, shall be in both English and in Spanish.

(c) The signs required by this rule section shall be posted in a location where individuals not yet admitted to the hospital would reasonably be expected to present themselves for emergency services and care.

(2) TRANSFER PROCEDURES. Each hospital providing emergency services and care shall establish policies and procedures which incorporate the requirements of Chapter 395, F.S., relating to emergency services. The policies and procedures shall incorporate at a minimum:

(a) Decision protocols identifying the emergency services personnel within the hospital responsible for the arrangement of outgoing and incoming transfers;

(b) Decision protocols stating the conditions that must be met prior to the transfer of a patient to another hospital. These conditions are:

1. If a patient, or a person who is legally responsible for the patient and acting on the patient’s behalf, after being informed of the hospital’s obligation under Chapter 395, F.S., and of the risk of transfer, requests that the transfer be effected; or

2. If a physician has signed a certification that, based upon the reasonable risks and benefits to the patient, and based upon the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another hospital outweigh the increased risks to the individual’s medical condition from effecting the transfer; or

3. If a physician is not physically present in the emergency services area at the time an individual is transferred, a qualified medical person may sign a certification that a physician with staff privileges at the transferring hospital, in consultation with such personnel, has determined that the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweigh the increased risks to the individual’s medical condition from effecting the transfer. The certification shall summarize the basis for such determination. The consulting physician must sign the certification within 72 hours of the transfer.

(c) A provision providing that all medically necessary transfers shall be made to the geographically closest hospital with the service capability, unless another prior arrangement is in place or the geographically closest hospital is at service capacity as stated in Section 395.1041(3)(e), F.S.

(d) Protocols for maintaining records of patient transfers made or received for a period of five years. Patient transfer information shall be incorporated separately in transfer logs and into the patient’s permanent medical record as stated in Section 395.1041(4)(a)1., F.S.

(e) Documentation of all current transfer arrangements that have been made with other hospitals and physicians.

(f) A copy of Section 395.1041, F.S., Access to Emergency Services and Care, and a copy of these rules.

(g) Provisions for informing hospital emergency services personnel and medical staff of the hospital’s emergency service policies and procedures, having at a minimum, the requirement to provide emergency services and care pursuant to Section 395.1041, F.S.

(3) INVENTORY REPORTING.

(a) Pursuant to Section 395.1041, F.S., the Aagency is responsible for compiling an inventory of hospitals with emergency services. This inventory shall list all services within the service capability of the hospital. A copy of this inventory is available on the Agency’s website at:

http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Hospital_Outpatient/hospital.shtml .

may be obtained by contacting the Agency for Health Care Administration, Division of Health Quality Assurance, Ft. Knox Office Building, 2727 Mahan Drive, Tallahassee, Florida, 32308. The per page duplication costs will be computed in accordance with Chapter 119, F.S.

(b) Every hospital offering emergency services and care shall report to the Aagency for inclusion in the inventory those services which are within the service capability of the hospital. The following services, when performed on an infrequent and short time limited basis, are not considered to be within the service capability of the hospital:

1. Services performed for investigative purposes under the auspices of a federally approved institutional review board; or

2. Services performed for educational purposes; or

3. Emergencies performed by physicians who are not on the active medical staff of the reporting hospital.

(c) Any addition of service shall be reported to the Aagency prior to the initiation of the service. The Aagency will act accordingly to include the service in the next publication of the inventory and to add the service on the face of the hospital license.

(d) If the Aagency has reason to believe that a hospital offers a service and the service was not reported on the inventory, the Aagency will notify the hospital and provide the hospital with an opportunity to respond. The Aagency shall arrange for an on-site visit prior to the Aagency’s determination of capability, with advance notice of the on-site visit. If, after investigation, the Aagency determines that a service is offered by the hospital as evidenced by the patient medical records or itemized bills, the Aagency shall amend the inventory and the face of the hospital license.

(4) EXEMPTIONS.

(a) Every hospital providing emergency services shall ensure the provision of services within the service capability of the hospital, 24 hours per day, 7 days per week either directly or indirectly through:

1. An agreement with another hospital made prior to receipt of a patient in need of the service; or

2. An agreement with one or more physicians made prior to receipt of a patient in need of the service; or

3. Any other arrangement made prior to receipt of a patient in need of the service.

(b) If a hospital has determined that it is unable to provide a service on a 24 hour per day, 7 day per week basis, either directly or indirectly through arrangement with another hospital or physician(s), the hospital must file an application with the Aagency to request a service exemption. The application must identify the service for which the hospital is requesting an exemption. This information shall be submitted to the Aagency on AHCA Form 3000-1, November 2013 effective July 1993 which is incorporated by reference and available from the Agency at http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Hospital_Outpatient/hospital.shtml. for Health Care Administration, Division of Health Quality Assurance, Ft. Knox Office Building, 2727 Mahan Drive, Tallahassee, Florida 32308. The Aagency will make a determination of exemption status pursuant to the procedures in paragraph (5) of this rule and notify the hospital of the determination within 45 days of receipt of the request.

(c) Upon receipt of a hospital exemption request, the Aagency must act to approve or deny the exemption request within 45 days, during which time deemed exemption status does not exist. If the Aagency fails to notify the hospital of the status of the exemption request within the 45 day time frame, the hospital is deemed to be exempt from offering the service until such time that the Aagency acts to deny the request.

(d) When a hospital has been providing 24 hour per day, 7 day per week coverage either directly or indirectly through an agreement with another hospital or physician(s) for a specialty service as evidenced by the inventory and hospital license, and the circumstances significantly change such that the hospital can no longer provide the service on a 24 hour per day, 7 day per week basis, the hospital must apply for an exemption from the Aagency. The Aagency will make a determination of exemption status pursuant to paragraph (5) of this rule and notify the hospital of the determination within 45 days of receipt of the request.

(e) When a hospital has been granted an exemption from providing a specialty service 24 hours per day, 7 days per week, either directly or indirectly through an agreement with another hospital or physician(s), and the Aagency has information to indicate that the circumstances forwarded by the hospital, and accepted by the Aagency, as the basis for the granting of the exemption have changed, the Aagency will notify the hospital of this information and shall provide the hospital with an opportunity to respond. If the change in circumstances is confirmed and the hospital failed to report the change, the Aagency will amend the inventory accordingly and add the service capability to the face of the hospital license accordingly. Revocation of exemption status shall be effective upon the expiration of 21 days following the hospital's receipt of the Aagency decision or the entry of a final order if appealed.

(f) Each hospital shall immediately report any change in the conditions which led to the granting of an exemption.

(5) AGENCY REVIEW PROCESS. The review process for exemption requests shall be as follows:

(a) Upon receipt of application, the Aagency shall schedule an on-site visit at the hospital when deemed necessary to verify the facts as set forth in the application. The hospital will be notified of the date of the visit in advance. The Aagency shall have access to all records necessary for the confirmation and substantiation of the information submitted in the application and to any other records deemed necessary by the Aagency to make a determination.

(b) Upon receipt of an application, the Aagency shall publish, in the next available Florida Administrative Weekly, notice of receipt of the application, identifying the applicant and the service(s) for which exemption is requested. Comments submitted within 15 days of the date of publication will be considered by the Aagency prior to making a determination of exemption status.

(c) Within 45 days of receipt of application, the Aagency shall determine if the hospital has demonstrated that it meets the requirements for service exemption set forth in Section 395.1041, F.S. The Aagency shall notify the applicant in writing of its decision, and shall provide the applicant with specific reasons in the event that the request is denied.

(d) If the Aagency fails to notify the hospital of the status of the exemption request within the required 45 day time frame, pursuant to Section 395.1041(3)(d)4., F.S., the hospital is deemed to be exempt from offering the service until such time that the Aagency acts to deny the request.

(6) SERVICE DELIVERY REQUIREMENTS.

(a) Every hospital offering emergency services and care shall provide emergency care available 24 hours a day within the hospital to patients presenting to the hospital. At a minimum:

1. Emergency services personnel shall be available to ensure that emergency services and care are provided in accordance with Section 395.002(10), F.S.

2. At least one physician shall be available within 30 minutes through a medical staff call roster; initial consultation through two-way voice communication is acceptable for physician presence.

3. Specialty consultation shall be available by request of the attending physician or by transfer to a designated hospital where definitive care can be provided.

(b) When a patient is transferred from one hospital to another, all pertinent medical information shall accompany the patient being transferred.

(c) Every hospital offering emergency services and care shall maintain a transfer manual, which shall include in addition to the requirements in paragraph (2) of this rule:

1. Decision protocols for when to transfer a patient;

2. A list of receiving hospitals with special care capabilities, including the telephone number of a contact person;

3. A list of all “on-call” critical care physicians available to the hospital, including their telephone numbers; and

4. Protocols for receiving a call from a transferring hospital, including:

a. Requirements for specific information regarding the patient’s problem;

b. Estimated time of patient arrival;

c. Specific medical requirements;

d. A request to transfer the patient’s medical record with the patient; and

e. The name of the transporting service.

(d) Both transferring and receiving hospitals shall assign a specific person on each shift who shall have responsibility for being knowledgeable of the transfer manual and maintaining it.

(e) Each hospital offering emergency services and care shall maintain written policies and procedures specifying the scope and conduct of emergency services to be rendered to patients. Such policies and procedures must be approved by the organized medical staff, reviewed at least annually, revised as necessary, dated to indicate the time of last review, and enforced. Such policies shall include requirements for the following:

1. Direction of the emergency department by a designated physician who is a member of the organized medical staff.

2. A defined method of providing for a physician on call at all times.

3. Supervision of the care provided by all nursing service personnel with the emergency department by a designated registered nurse who is qualified by relevant training and experience in emergency care.

4. A written description of the duties and responsibilities of all other health personnel providing care within the emergency department.

5. A planned formal training program on emergency access laws, and participation, by all health personnel working in the emergency department.

6. A control register adequately identifying all persons seeking emergency care be established, and that a medical record be maintained on every patient seeking emergency care that is incorporated into the patient’s permanent medical record and that a copy of the Florida EMS Report, Patient Care Record HRS 1894, as required by Rule 64J-1.014 64E-2.013, F.A.C., be included in the medical record, if the patient was delivered by ambulance. The control register must be continuously maintained and shall include at least the following for every individual seeking care:

a. Identification to include patient name, age and sex;

b. Date, time and means of arrival;

c. Nature of complaint;

d. Disposition; and

e. Time of departure.

(f) Every hospital offering emergency services and care shall have a method for assuring that a review of emergency patient care is performed and documented at least monthly, using the medical record and preestablished criteria.

(g) Every hospital offering emergency services and care shall insure the following:

1. That clinical laboratory services with the capability of performing all routine studies and standard analyses of blood, urine, and other body fluids are readily available at all times to the emergency department.

2. That an adequate supply of blood is available at all times, either in-hospital or from an outside source approved by the organized medical staff, and that blood typing and cross-matching capability and blood storage facilities are readily available to the emergency department.

3. That diagnostic radiology services within the service capability of the hospital are readily available at all times to the emergency department.

4. That the following are available for immediate use to the emergency department at all times:

a. Oxygen and means of administration;

b. Mechanical ventilatory assistance equipment, including airways, manual breathing bag, and ventilator;

c. Cardiac defibrillator with synchronization capability;

d. Respiratory and cardiac monitoring equipment;

e. Thoracentises and closed thoracostomy sets;

f. Tracheostomy or cricothyrotomy set;

g. Tourniquets;

h. Vascular cutdown sets;

i. Laryngoscopes and endotracheal tubes;

j. Urinary catheters with closed volume urinary systems;

k. Pleural and pericardial drainage set;

l. Minor surgical instruments;

m. Splinting devices;

n. Emergency obstetrical pack;

o. Standard drugs as determined by the facility, common poison antidotes, syringes and needles, parenteral fluids and infusion sets, and surgical supplies;

p. Refrigerated storage for biologicals and other supplies requiring refrigeration, within the emergency department; and

q. Stable examination tables.

(h) Hospital personnel and physicians shall report any apparent violations of emergency access requirements under Section 395.1041, F.S., to the Agency, and shall include all relevant information. Reports shall be made within 30 days following the occurrence. Medical personnel reasonably believed by the Agency to be in violation of these rules will immediately be referred by the Agency to their respective licensing boards. Violations include failure to report when on-call or intentionally misrepresenting the patient’s condition in cases of medically necessary transfers or in determining the presence or absence of an emergency medical condition or rendering appropriate emergency services and care, or failure or refusal to sign a certificate of transfer as required by this section.

(7) Each hospital offering emergency services and care shall have the capability to communicate via two-way radio with licensed EMS providers and their primary communications centers. The two-way radio communications system must meet the following provisions:

(a) Conform to the State EMS Communications Plan applicable to emergency room or department communications; and

(b) Any new communications system or an expansion of an existing communication system shall be approved by the Department of Management Services, Division of Communications, prior to purchasing, as required in Section 401.024, F.S.

Rulemaking Specific Authority 395.1031, 395.1041, 395.1055 FS. Law Implemented 395.1031, 395.1041, 395.1055, 401.024 FS. History–New 9-4-95, Formerly 59A-3.207, Amended________.

 

59A-3.270 Health Information Management.

(1) Each hospital shall establish processes to obtain, manage, and utilize information to enhance and improve individual and organizational performance in patient care, governance, management, and support processes. Such processes shall:

(a) Be planned and designed to meet the hospital’s internal and external information needs;

(b) Provide for confidentiality, security and integrity;

(c) Provide uniform data definitions and methods for capturing and storing data, including electronic mediums and optical imaging;

(d) Provide education and training in information management principles to decision-makers and other hospital personnel who generate, collect, and analyze information;

(e) Transmit information in a timely and accurate manner; and

(f) Provide for the manipulation, communication and linkage of information.

(2) All hospitals involved in the transplantation of organs or tissues shall maintain a centralized tracking system to record the receipt and disposition of all organs and tissues transplanted within the hospital.

(a) The tracking system must be kept separate from patients’ medical records, and shall include at a minimum:

1. The organ or tissue type;

2. The donor identification number;

3. The name and license number of the procurement or distribution center supplying the organ or tissue;

4. Recipient information, including, at a minimum the patient’s name and identification number;

5. The name of the physician who performed the transplant;

6. The date the organ or tissue was received by the hospital; and

7. The date the organ or tissue was transplanted.

(b) This information must be provided, on a quarterly basis, to the organ procurement organization or tissue bank that originally provided the organ or tissue.

(3) Each hospital shall maintain a current and complete medical record for every patient seeking care or service. The medical record shall contain information required for completion of birth, death and still birth certificates, and shall, at a minimum contain the following information:

(a) Identification data;

(b) Chief complaint or reason for seeking care;

(c) Present illness;

(d) Personal medical history;

(e) Family medical history;

(f) Physical examination report;

(g) Provisional and pre-operative diagnosis;

(h) Clinical laboratory reports;

(i) Radiology, diagnostic imaging, and ancillary testing reports;

(j) Consultation reports;

(k) Medical and surgical treatment notes and reports;

(l) Evidence of appropriate informed consent;

(m) Evidence of medication and dosage administered;

(n) A copy of the Patient Care Record Florida EMS Report, HRS Form 1894, given to the hospital as defined required by Rule 64J-1.001(18) 64E-2.013, F.A.C., if the patient was delivered to the hospital by ambulance;

(o) Tissue reports;

(p) Physician and nurse progress notes;

(q) Principal diagnosis, secondary diagnoses and procedures when applicable;

(r) Discharge summary;

(s) Appropriate social work services reports, if provided;

(t) Autopsy findings when performed;

(u) Individualized treatment plan;

(v) Clinical assessment of the patients needs;

(w) Certifications of transfer of the patient between hospitals as specified by Rule 59A-3.255, F.A.C.; and

(x) Routine Inquiry Form regarding request for organ donation in the event of the death of the patient.

(4) For patients undergoing operative or other invasive procedures the medical record policies shall also require:

(a) The recording of preoperative diagnoses prior to surgery;

(b) That operative reports be recorded in the health record immediately following surgery or that an operative progress note is entered in the patient record to provide pertinent information; and

(c) Postoperative information shall include vital signs, level of consciousness, medications, blood components, complications and management of those events, identification of direct providers of care, discharge information from the post-anesthesia care area.

(5) Medical records for ambulatory care patients shall consist of the information specified in subsections 59A-3.2085(7)(i), F.A.C.

(6) Each hospital shall have a patient information system, medical records department or similarly titled unit with administrative responsibility for medical records. The medical records department shall:

(a) Maintain a system of identification and filing to ensure the prompt location of a patient’s medical record. Patient records may be stored on electronic medium such as optical imaging, computer, or microfilm;

(b) Centralize all appropriate clinical information relating to a patient’s hospital stay in the patient’s medical record;

(c) Index, and maintain on a current basis, all medical records according to disease, operation and physician.

(7) Patient records shall have a privileged and confidential status and shall not be disclosed without the consent of the person to whom they pertain pursuant to Section 395.3025(4), F.S., but appropriate disclosure may be made without such consent to:

(a) Hospital personnel for use in connection with the treatment of the patient;

(b) Hospital personnel only for internal hospital administrative purposes associated with the treatment, including risk management and quality assurance functions;

(c) The Agency for Health Care Administration; or

(d) In any civil or criminal action, unless otherwise prohibited by law, upon the issuance of a subpoena from a court of competent jurisdiction and proper notice by the party seeking such records to the patient or his legal representative.

(8) The Department of Health and Rehabilitative Services may examine patient records of a licensed facility for the purpose of epidemiological investigations, provided that the unauthorized release of information by agents of the department which would identify an individual patient constitutes a misdemeanor of the second degree, punishable as provided in Sections 775.082 or 775.083, F.S.

(9) Any licensed facility shall, upon request, and only after discharge of the patient, furnish to any patient admitted or treated in the facility, or to any patient’s guardian, curator, or personal representative, or to anyone designated by the patient in writing, a true and correct copy of all of the patient’s records, including X-rays, which are in the possession of the licensed facility, provided the person requesting such records agrees to pay a reasonable charge for copying the records, pursuant to Section 395.3025, F.S. The per page fee is applicable to each page generated during copying of the medical record by the facility or from a copy service providing these services on behalf of the facility. Progress notes and consultation reports of a psychiatric or substance abuse nature concerning the care and treatment performed by the licensed facility are exempted from this requirement. The licensed facility shall further allow any such person to examine the original records in its possession, or microfilms or other suitable reproductions of the records stored on electronic mediums, upon such reasonable terms imposed to assure that the records will not be damaged, destroyed, or altered.

(a) The provisions of this section do not apply to any licensed facility whose primary function is to provide psychiatric care or substance abuse treatment to its patients.

(b) Disclosure of the medical records of inmates of any institution, facility or program of the Department of Corrections shall be made in conformance with Chapter 945, F.S., and applicable rules adopted thereunder.

(10) Each hospital operated by the Department of Children and Families and the Department of Corrections shall use a problem oriented medical record for each patient, which shall be initiated at the time of intake or admission and which shall contain all pertinent information required by this section.

(11) Each problem oriented medical record maintained by hospitals operated by the Department of Children and Families and the Department of Corrections shall be standardized within each hospital and shall be capable of providing easy comparison of basic information on medical records at all such hospitals. Each problem oriented medical record maintained by these hospitals shall contain at least the following information:

(a) A patient data base which compiles all known facts about the patient which have relevance to his health care, and which in addition to the other requirements of this section contains:

1. Comments and complaints as spoken by the patient or other persons significant in the patient’s life, including relatives, friends and caretakers;

2. A patient profile, including health related habits, social, nutritional and educational information, and a review of physical systems;

3. Relevant legal documents, including but not limited to status forms, forensic forms, consent forms, authority permits, and Baker Act forms; and

4. A medical diagnosis listed according to the International Classification of Diseases and a mental illness diagnosis listed according to the Diagnosis and Statistical Manual of Mental Disorders, as relevant to the patient’s condition.

(b) A problem list, which is a table of contents to the patient’s record, which identifies by number, date and description of the patients problems.

(c) A plan of care which shall specify the specific course of action to be taken to address the problem(s) described, including diagnosis, diagnostic and therapeutic orders, treatment, examination, patient education, referral, and other necessary activities.

(d) Progress notes which shall document the activity and follow-up undertaken for each problem in a structured format which is dated, titled and numbered according to the problem to which it relates.

(12) The discharge summary of each problem oriented medical record in hospitals operated by the Department of Children and Families and the Department of Corrections shall be completed, signed and dated within 15 days following the patient’s discharge. The summary shall include:

(a) The reason for admission;

(b) A recapitulation of the patient’s hospitalization;

(c) A statement of the patient’s progress and condition upon discharge;

(d) The facility or person, including the patient himself when relevant, assuming responsibility for the patient after discharge; and

(e) Recommendations, when necessary, for after care, follow-up, referral or other action necessary to help the patient deal with problems.

Rulemaking Specific Authority 395.1055, 395.3015 FS. Law Implemented 395.1055, 395.3015, 395.3025 FS. History–New 9-4-95, Formerly 59A-3.214, Amended________.

 

59A-3.273 Management and Administration.

(1) Each hospital shall be under the direction of a chief executive officer appointed by the governing body, who is responsible for the operation of the hospital in a manner commensurate with the authority conferred by the governing body.

(2) The chief executive officer shall take all reasonable steps to provide for:

(a) Compliance with applicable laws and regulations; and

(b) The review of and prompt action on reports and recommendations of authorized planning, regulatory, and inspecting agencies.

(3) The chief executive officer shall provide for the following:

(a) Establishment and implementation of organized management and administrative functions, including:

1. Clear lines of responsibility and accountability within and between department heads and administrative staff;

2. Effective communication mechanisms among departments, medical staff, the administration and the governing body;

3. Internal controls;

4. Coordination of services with the identified needs of the patient population;

5. A policy on patient rights and responsibilities;

6. A mechanism for receiving and responding to complaints concerning patient care;

7. A policy on withholding resuscitative services;

8. Policies and procedures on identification and referral of organ and tissue donors including notification of organ and tissue procurement agencies when organs and tissues become available as specified under Rule 59A-3.274 59A-3.219, F.A.C.;

9. Policies and procedures for meeting the communication needs of multicultural populations and persons with impaired hearing or speaking skills;

10. Policies and procedures on discharge planning;

11. A policy to assist in accessing educational services for children or adolescents when treatment requires a significant absence from school;

12. Policies and procedures to assure that the treatment, education and developmental needs of neonates, children and adolescents transferred from one setting to another are assessed;

13. Dissemination and enforcement of a policy prohibiting the use of smoking materials in hospital buildings and procedures for exceptions authorized for patients by a physician’s written authorization;

14. A policy regarding the use of restraints and seclusion; and

15. A comprehensive emergency management plan which meets the requirements of paragraph 395.1055(1)(c), F.S., and Rule 59A-3.078, F.A.C.

(b) Personnel policies and practices which address:

1. Non-discriminatory employment practices;

2. Verification of credentials including current licensure and certification;

3. Periodic performance evaluations; and

4. Provision of employee health services.

(c) Financial policies and procedures;

(d) An internal risk management program which meets the requirements of Section 395.0197, F.S., and Chapter 59A-10, F.S.C., and

(e) Assurance of compliance with educational requirements on human immunodeficiency virus and acquired immune deficiency syndrome pursuant to Sections 381.0034 and 381.0035, F.S., and Chapter 64D-2, F.A.C., September 1994.

Rulemaking Specific Authority 395.1055 FS. Law Implemented 395.0197, 395.1055 FS. History–New 9-4-95, Formerly 59A-3.218, Amended________.

 

59A-3.274 Anatomical Gifts, Routine Inquiry.

(1) Each Class I and Class II hospital shall establish a mechanism whereby the next of kin of all patients who are deemed medically acceptable and who die in Florida hospitals are given the opportunity to consider the donation of organs, tissues and eyes for transplantation and research.

(2) Education and Training of Designee. The hospital administrator or designee making the request of the next of kin for organ, tissue and eye donations shall be trained in the request procedures used in organ and tissue donation. The Organ Procurement Organization (OPO), tissue bank and eye bank shall, in conjunction with their affiliated hospitals, develop a requester training curriculum that will meet the individual needs of each affiliated hospital. The Agency AHCA shall assist, if requested, in the implementation of the requester training curriculum in conjunction with an OPO, tissue bank and eye bank where the OPO, tissue bank and eye bank do not have adequate resources for the implementation of the requester training curriculum within their affiliated hospitals. This training shall include the following minimum basic curriculum:

(a) The criteria used by the affiliated OPO, tissue bank, and eye bank for determining the acceptability of patients as organ, tissue, or eye donors;

(b) The requirements of Florida law to be met in order for a donation to be allowed to proceed including:

1. Explanatory information regarding the family’s rights to allow or refuse a donation, to donate specific organs, tissues or eyes and to designate the organs, tissues or eyes for the purpose of transplantation, medical research or instruction, and

2. The criteria for determining whether a particular death falls within the scope of Section 406.11, F.S., necessitating close communication with the Medical Examiner’s office, and permission from the Medical Examiner when required;

(c) Necessary basic information regarding the process and procedures related to organ, tissue, and eye donation and transplantation including the following:

1. The procedures and techniques used in the recovery and preservation of organs, tissues and eyes;

2. The success rates of currently accepted transplant procedures;

3. The numbers of patients presently awaiting these procedures; and

4. The financial procedures and arrangements applicable to the donation of organs, tissues and eyes.

(d) The various approaches which can be used in dealing with a family in a grief situation and offering them the opportunity of organ, tissue, or eye donation. These approaches shall be based on the criteria of the affiliated OPO, tissue bank, and eye bank, which shall not be inconsistent with these guidelines;

(e) Notification of the affiliated OPO, tissue bank and eye bank; and

(f) Training regarding the administrative rules and guidelines promulgated by the Aagency for the purpose of implementing the Routine Inquiry provisions of the Anatomical Gift Act.

(3) Each Class I and Class II hospital or its designee shall, using the criteria of the affiliated OPO, tissue bank, and eye bank, implement the following procedures:

(a) Establish and publish a formal written policy and procedure for the identification and referral of organ, tissue, and eye donors. This policy shall include the procedure to be followed for the determination of brain death.

(b) Identify and designate the personnel or organization which will make the request for organ, tissue, or eye donation. These personnel shall be trained as required in paragraph (2) above and shall be available on a 24-hour “on call” basis to make the initial evaluations of donor suitability, request, and referrals.

(c) The Hospital Administrator or designee shall ensure that the District Medical Examiner is contacted in all medical examiners’ cases regarding the wishes of the family as to organ, tissue, and eye donation and to determine whether or not the medical examiner has released such organs, tissues or eyes for transplantation, medical research or instruction. This contact shall be recorded on the Routine Inquiry Form and placed in the patient’s medical record. When completion of the Routine Inquiry Form is designated by the hospital administrator and accepted by the affiliated procurement agency, the contact shall be noted in the records of the affiliated procurement agency. This notation shall indicate that request for donation of organs, tissue or eyes was made.

(d) The hospital administrator or designee shall ensure that all identified potential organ, tissue, or eye donors meeting the criteria of brain death as defined in Section 382.009, F.S., or cardiorespiratory death as defined in subsection 59A-3.065(9), F.A.C., shall be referred to the affiliated OPO, tissue bank, or eye bank for evaluation and recovery of the organs, tissues, or eyes to be donated according to the medical standards of the affiliated OPO, tissue bank and eye bank. This referral shall be recorded on the Routine Inquiry Form and placed in the patient's medical record. When completion of the Routine Inquiry Form is designated by the hospital administrator and accepted by the affiliated procurement agency, the referral shall be noted in the records of the affiliated procurement agency.

(e) The hospital shall work with the affiliated OPO, tissue bank, and eye bank to evaluate the patient as a potential organ, tissue, or eye donor. The medical acceptability of such organs, tissues, and eyes shall be determined according to the medical standards of the affiliated procurement agency. The hospital administrator may designate personnel of the affiliated OPO, tissue bank, or eye bank who shall make the request for donation. Where non-hospital personnel are designated to make the request for organ, tissue or eye donation, the affiliated OPO, tissue bank, or eye bank shall be given the opportunity to approach the next of kin about donation and shall utilize the following procedure when approaching the next of kin:

1. The affiliated OPO shall be given the opportunity to approach the next of kin about donation of organs in all suitable vascular organ donor cases when the potential donor meets the medical standards of the affiliated OPO. Where the suitable vascular organ donor also meets the medical standards of the affiliated tissue bank or eye bank, and in the absence of a contrary agreement between the affiliated OPO, tissue bank, and eye bank, the affiliated OPO may represent the affiliated tissue bank and eye bank and approach the next of kin about donation in all suitable tissue and eye donor cases.

2. The affiliated tissue bank shall be given the opportunity to approach the next of kin about donation in all suitable tissue donor cases where the potential donor meets the medical standards of the affiliated tissue bank and where the affiliated OPO has not already approached the next of kin for donation of tissues and eyes in all non-suitable vascular organ donor cases. Where the suitable tissue donor also meets the medical standards of the affiliated eye bank, and in the absence of a contrary agreement between the affiliated tissue bank and eye bank, the affiliated tissue bank may represent the affiliated eye bank and approach the next of kin about donation in all suitable eye donor cases.

3. The affiliated eye bank shall be given the opportunity to approach the next of kin about donation in all suitable eye donor cases where the potential donor meets the medical standards of the affiliated eye bank, and where the affiliated OPO or tissue bank has not already approached the next of kin for donation of eyes. Where the suitable eye donor also meets the medical standards of the affiliated tissue bank, and in the absence of a contrary agreement between the affiliated eye bank and tissue bank, the affiliated eye bank may represent the affiliated tissue bank and approach the next of kin about donation in all suitable tissue donor cases.

(f) The request for organ, tissue, or eye donation shall be made at or near the time of death, and in a manner which is conducive to the discussion of organ, tissue, and eye donation with the grieving next of kin according to the priority specified in Section 765.512, F.S.

(g) A Routine Inquiry Form shall be completed upon every patient death occurring within the hospital and shall become a part of each patient’s medical record.

1. The form shall document whether the patient was deemed medically suitable for donation of organs, tissues and eyes, and if the patient is not medically suitable for donation, the form shall document the specific reason according to the criteria of the affiliated procurement agency.

2. If the patient is deemed medically acceptable for donation, the form shall document that the patient’s appropriate next of kin was approached, as well as the outcome of the patient’s expressed wishes, if known, regarding the donation of organs, tissues, and eyes. If the family allows donation, a specific consent form shall be signed or completed by means of telegraphic, recorded telephonic, or other recorded message by the appropriate next of kin as specified in Section 765.512, F.S.

3. If a request for donation is deemed to be exempted according to paragraph (4) of this section, or the medical standards of the affiliated OPO, tissue bank, and eye bank, the form shall document the specific reason for the lack of a request.

(h) The lack of request and a complete written explanation shall be noted on the Routine Inquiry Form and made a part of the patient’s medical record or if designated by the hospital administrator, and accepted by the affiliated procurement agency, in the affiliated procurement agency’s records. If the affiliated procurement agency has been designated, the patient’s medical record shall document the referral of the potential donor to the affiliated procurement agency. All Routine Inquiry Forms maintained by the affiliated procurement agency shall be complete and include the patient’s name and medical record number. These records shall be made available to the hospital during normal working hours. A copy of the form shall be sent to the AHCA for data analysis. The referral of the affiliated procurement agency shall be documented in the patient’s medical record. This documentation shall include the name of the procurement agency and time and date of the referral. This referral shall be documented in the patient’s death record.

(i) Each Class I and Class II hospital or designee shall, on a quarterly basis, aggregate the statistical data relating to organ, tissue, and eye donation requests as required by the agency and forward them to the agency on the Donation Request Summary Data Form, AHCA Form 3130-8006-February 94, which is incorporated by reference. The affiliated OPO, tissue bank and eye bank may agree to be designated by the hospital administrator to aggregate and forward the required AHCA forms to the agency. This form shall be submitted on a quarterly basis, due on April 15, July 15, October 15 and January 15, for the respective previous quarters. This information shall be made available by the agency upon written request from an OPO, tissue bank or eye bank.

(4) Request Exemptions.

(a) The appropriate next of kin as defined by Section 765.512 732.912, F.S., of patients deemed medically acceptable by the medical standards of the affiliated OPO, tissue bank and eye bank, and dying in the hospital shall be asked about organ, tissue, and eye donation except as follows:

1. There is on record notification of prior objection by the individual, or the appropriate next of kin as defined by Section 765.512 732.912, F.S., or

2. The appropriate next of kin is in a violent state, or cannot be found after a reasonable search; or

3. No positive identification of the potential donor has been found; or

4. The medical examiner has denied permission; or

5. The hospital or designee, in accordance with a request for the affiliated procurement agency, has agreed to delay the request until the family has left the hospital.

Rulemaking Specific Authority 765.522, 873.01(3)(a) FS. Law Implemented 765.522, 873.01(3)(a) FS. History–New 9-4-95, Formerly 59A-3.219, Amended________.

 

59A-3.279 Itemized Patient Bill.

(1) Within seven days following discharge or release from a licensed hospital not operated by the state, or within seven days after the earliest date at which the loss or expense from the service may be determined, the licensed hospital providing the service shall, upon request, submit to the patient, or to his survivor or legal guardian as may be appropriate, an itemized statement detailing in language comprehensible to an ordinary layman the specific nature of charges or expenses incurred by the patient, which in the initial billing shall contain a statement of specific services received and expenses incurred for such items of service, enumerating in detail the constituent components of the services received within each department of the licensed facility and including unit-price data on rates charged by the licensed facility.

(2) Each such statement shall:

(a) Not include charges of hospital-based physicians if billed separately.

(b) Not include any generalized category of expenses such as “other” or “miscellaneous” or similar categories.

(c) List drugs by brand or generic name and not refer to drug code numbers when referring to drugs of any sort.

(d) Specifically identify therapy treatment as to the date, type, and length of treatment when therapy treatment is a part of the statement. Any person receiving a statement pursuant to this section shall be fully and accurately informed as to each charge and service provided by the institution preparing the statement.

(3) On each such itemized statement there shall appear the words “A FOR-PROFIT (or NOT-FOR-PROFIT or PUBLIC) HOSPITAL LICENSED BY THE STATE OF FLORIDA” or substantially similar words sufficient to identify clearly and plainly the ownership status of the licensed facility.

(4) Each hospital shall document a procedure for providing, on a random sample basis, delivery of itemized bills to physicians and other members of the organized medical staff. Such procedure shall provide for the delivery of no less than 10 bills per year.

(4)(5) In any billing for services subsequent to the initial billing for such services, the patient, or his survivor or legal guardian, may elect, at his option, to receive a copy of the detailed statement of specific services received and expenses incurred for each such item of service as provided in subsection (1).

Rulemaking Specific Authority 395.1055 FS. Law Implemented 395.1055, 395.301 FS. History–New 9-4-95, Formerly 59A-3.232, Amended________.

 

59A-3.280 Child Abuse and Neglect.

(1) Every hospital admitting or treating shall adopt and incorporate a policy that requires every staff member to report any case of actual or suspected child abuse or neglect pursuant to Chapter 39.201, F.S.

(a) Each report of actual or suspected child abuse or neglect shall be made immediately to the Department of Children and Family Services’ Florida Abuse Hotline, statewide toll free number 1(800) 962-2873 or to the local office of the Department of Children and Family Services responsible for investigating such reports.

(b) Any person required to report suspected child abuse or neglect, who has reasonable cause to suspect that a child died as a result of abuse or neglect, shall report his suspicion to the local medical examiner.

(2) Physician Liaison. Each hospital admitting or treating children shall designate, at the request of the Department of Children and Family Services, a staff physician to act as a liaison between the hospital, the child protective investigator and the child protection team.

(3) Child Abuse and Neglect Policy Reporting. Each hospital admitting or treating children shall formulate a child abuse and neglect policy and shall submit a copy of this policy to the Department of Children and Family Services, Office of Family Safety, 1317 Winewood Boulevard – Building 1, Tallahassee, Florida 32399-0700.

(4) Remedies. Failure to comply with these rules will result in a fine being imposed in accordance with the provisions of Sections 395.1023 and 39.205, F.S.

Rulemaking Authority 395.1055 FS. Law Implemented 39.303, 395.002, 395.1023, 395.1055 FS. History–New 4-17-97, Formerly 59A-3.0465, Amended________.

 

59A-3.281 Spontaneous Fetal Demise.

When a spontaneous fetal demise occurs after a gestation of less than 20 completed weeks, the health care facility identified in Section 383.33625(4), F.S., shall follow the provisions of that section and shall provide AHCA Form 3100-0006, January 2005, Notification of Disposition of Fetal Demise, to the mother for her completion. AHCA Form 3100-0006, January 2005 is incorporated in this rule by reference and available at http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Hospital_ Outpatient/hospital.shtml, or from the Hospital and Outpatient Services Unit at 2727 Mahan Drive MS #31, Tallahassee, FL 32308. A copy of the signed and completed form shall by retained in the mother’s medical record birth center file and shall be available for review by the Agency or Department of Health.

Rulemaking Specific Authority 383.33625(6) FS. Law Implemented 383.33625, 395.1055(1)(b), 395.3025(4)(c) FS. History–New 4-27-06, Amended________.

 

59A-3.300 Licensure Procedure for Intensive Residential Treatment Facilities.

Facilities Programs desiring licensure under this rule shall follow the procedure as described in Rule 59A-3.066, F.A.C., and shall comply with the provisions of Rules 59A-3.301 through 59A-3.310 59A-3.312, F.A.C., which establishes the minimum standards for the voluntary licensure as a Class IV specialty special hospital. of Joint Commissionon Accreditation of Healthcare Organizations (JCAHO) accredited Intensive Residential Treatment Programs for Children and Adolescents. These rules emphasize the programmatic requirements designed to meet the needs of the patient in a safe therapeutic environment and are intended to be used in licensing intensive residential treatment facilities for children and adolescents as specialty hospitals pursuant to Section 395.002(15)(16), F.S. Unless otherwise specified, Rules 59A-3.301 through 59A-3.310 59A-3.312, F.A.C., supersede the requirements of Rules 59A-3.065 59A-3.300 through 59A-3.281 59A-3.312, F.A.C., for the purpose of licensing intensive treatment facilities for children and adolescents as specialty hospitals.

Rulemaking Specific Authority 395.003, 395.004, 395.0161, 395.1055 FS. Law Implemented 395.002, 395.003, 395.004, 395.0161, 395.0191, 395.1055 FS. History–New 2-15-82, Amended 8-14-86, Formerly 10D-28.101, Amended 9-4-95, 4-17-97, Formerly 59A-3.101, Amended________.

 

59A-3.301 Goals, Policies and Procedures for Intensive Residential Treatment Facilities.

Each program shall have a written statement of its purpose and objectives, which will include but not be limited to a formal, long range plan adopted to guide and schedule steps leading to attainment of its projected objectives. This plan shall include an officially promulgated description of the services the program offers so that there is a frame of reference for judging the various aspects of the program. Proposed changes in treatment programs must be reported to and approved by the appropriate licensing agency. The plan shall also include but not be limited to the following:

(1) A description of the target population including but not limited to age, types of disorders, sex, and financial requirements;

(2) The initial screening process;

(3) The intake/admission process;

(4) Methods for involving family members or significant others (i.e., guardians, counselors, friends) in assessment, treatment, discharge, and follow-up care plans;

(5) An organizational chart with a description of each unit or department and its services, goals, policies and procedures, staffing patterns and its relationship to other services and departments and how these are to contribute to the priorities and goals of the program;

(6) Ways in which the program carries out any community education consultation programs; and

(7) Ways in which the program provides or makes referrals or arrangements for other medical, health care, dental, special assessment and therapeutic services. This shall be in the plan for:

(a) Clinical services;

(b) Emergency services and crisis intervention;

(c) Educational services for all residents; and

(d) Discharge and follow-up care and evaluation.

Rulemaking Specific Authority 395.003, 395.005, 395.1055 FS. Law Implemented 395.002, 395.003, 395.005 FS. History–New 2-15-82, Formerly 10D-28.105, 59A-3.105, Repromulgated________.

 

59A-3.302 Personnel for Intensive Residential Treatment Facilities.

(1) Composition. The composition of the staff shall be determined by the needs of the patients being served and the goals of the facility, and shall have available a sufficient number of mental health professionals, health care workers, program staff and administrative personnel to meet these goals.

(a) The administrator of the facility shall have a master’s degree in administration or be of a professional discipline related to child and adolescent mental health and have at least three (3) years administrative experience. A person with a baccalaureate degree may also qualify for administrator with seven (7) years experience of child and adolescent mental health care with no less than three (3) years administrative experience. Persons occupying this position on or before the effective date of these rules may be allowed to continue in this position.

(b) The clinical director shall be at least board eligible in psychiatry with the American Board of Psychiatry with experience in child and adolescent mental health.

(c) If the clinical director is not full-time, then there shall be a full-time service coordinator who is a mental health professional with at least a master’s degree who is experienced in child and adolescent mental health and is responsible for the coordination of treatment aspects of the program.

(d) Mental health professionals shall include, but are not limited to, psychiatrists, psychologists, and social workers. These persons, if not on a full-time basis, must be on a continuing consulting basis. The authority and participation of such mental health professionals shall be such that they are able to assume responsibility for supervising and reviewing the needs of the patients and the services being provided. Such individuals shall participate in specific functions, e.g., assessment, treatment planning, treatment plan and individual case reviews, and program planning and policy and procedure development and review.

(e) Other professional and paraprofessional staff shall include, but not be limited to, physicians, registered nurses, educators and 24-hour a day mental assistants. Also included on a regular staff basis, or as consultants on a continuing basis, shall be activity staff and vocational counselors; and

(f) Consultation shall be available as needed from dieticians, speech, hearing and language specialists, or other specialists.

(2) Organization. The program shall have an organizational plan which clearly explains the responsibilities of the staff. This plan shall also include:

(a) Lines of authority, accountability and communication;

(b) Committee structure and reporting or dissemination of material; and

(c) Established requirements regarding the frequency of attendance at general and departmental/service or team/unit meetings.

(3) Policies and Records. Personnel policies and practices shall be designed, established and maintained to promote the objectives of the program and to insure that there are personnel to support a high quality of patient care.

(a) Each program shall have a written personnel practice plan covering the following areas: job classification; pay plan; personnel selection; probation or work-test period; tenure of office; dismissal; salary increases; procedure for health evaluations; holidays; leave policies; training programs; work evaluation procedures; additional employment benefits; and personnel records. Each new employee shall be given a copy of personnel practices when hired and documentation of receipt shall be maintained in the employee’s personnel file. A procedure shall be established for notifying employees of changes in established policies.

(b) There shall be clear job descriptions for all personnel. Each description shall contain the position title, immediate supervisor, responsibilities and authority. These shall also be used as a basis for periodic evaluations by the supervisor.

(c) Accurate and complete personnel records shall be maintained on each employee. Content shall be established to include but not be limited to the following:

1. Current background information, including the application, references and any accompanying documentation sufficient to justify the initial and continued employment of the individual and the position for which he was employed. Applicants for the positions requiring a licensed person shall be employed only after the facility has obtained verification of their licenses. Where accreditation is a requirement, this shall also be verified. Evidence of renewal of license as required by the licensing agent shall be maintained in the employee’s personnel record;

2. Current information relative to work performance evaluation;

3. Records of pre-employment health examinations and subsequent health services rendered to employees, as are necessary to ensure that all facility employees are physically and emotionally able to perform their duties;

4. Medical reports that verify the absence of active communicable disease in facility employees; and

5. Record of any continuing education or staff development programs completed.

(4) Staff Development. The program must provide opportunities and motivation for continuous staff training to enable each member to add to his knowledge and skills and thus improve the quality of services offered. This must be documented.

(a) Programs shall be facility-based with a designated person or committee who is responsible, on a continuing basis, for planning and insuring that Plans are implemented. The facility shall also make use of educational programs outside the facility such as workshops, and seminars; and

(b) There shall be appropriate orientation and training programs available for all new employees.

Rulemaking Specific Authority 395.003, 395.1055 FS. Law Implemented 395.002, 395.003, 395.1055 FS. History–New 2-15-82, Formerly 10D-28.106, 59A-3.106, Amended________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Kimberly Stewart

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Elizabeth Dudek

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: December 20, 2013

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: May 4, 2012