Definitions, Licensure Procedure, Comprehensive Emergency Management Plan, Services, Surveillance, Prevention, and Control of Infection, Classification of Hospitals, Investigations and License, Life Safety and Validation Inspections, Patient Rights ...  

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    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

    NOTICE OF CORRECTION

    Notice is hereby given that the following correction has been made to the proposed rule in Vol. 39, No. 250, December 30, 2013 issue of the Florida Administrative Register.

     

    The following sections of the Notice should be corrected to read:

     

    SUMMARY: These rules are amended to:

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

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

    Rule 59A-3.254: 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    Rule 59A-3.255: correct rule references; correct reference to an outdated form; identify where the form can be found online; correct reference to the “Patient Care Record”; add requirements for reporting violations of emergency access, which were previously located in 59A-3.253.

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

    59A-3.280: specify statutory references.

     

    SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

    For proposed rule subsection 59A-3.066(3), F.A.C., license fees are increased by the Consumer Price Index pursuant to 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 $230,597.27.

    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. For rules where a SERC was not prepared, a checklist was prepared to determine the need for a SERC. Based on this information at the time of analysis and pursuant to s. 120.541, F.S., the rules will not require legislative ratification.

     

    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 22, 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

     

    The following sections of the proposed rule text should be corrected to read:

     

    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-.303, F.A.C.:

    (1) through (69) No change.

     

    59A-3.066 Licensure Procedure.

    (1) No change.

    (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 Health Care Licensing Application Hospitals, 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. The form is available from the Agency for Health Care Administration, 2727 Mahan Drive, Mail Stop 31, Tallahassee, Florida 32308, or on the web at: http://ahca.myflorida.com/MCHQ/Corebill/index.shmtl.

    (a) through (2)(e)1. No change.

    2. Approval from the Aagency 's Office of Plans and Construction, pursuant to Rule 59A-3.080 59A-3.07759A-3.081, F.A.C.

    (2)(f) No change.

    (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-.303.312, 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-3.30359A-3.312, F.A.C., and have received all approvals required by law, the Aagency shall issue a license.

    (2)(i) through (7) No change.

    (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-.303.312, 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 Chapter 395, Part Ithe statute and Rules 69A-3.012 59A-3.077–3.081 and 59A-3.065066-.303.312, 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.

    (9)(a) through (12) No change.

    (13) Data Collection DATA COLLECTION

    (13)(a) through (b) No change.

    Rulemaking Specific Authority 395.003, 395.004, 395.1055, 408.033, 408.819 FS. Law Implemented 395.003, 395.004, 395.1055, 408.033, 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) No change.

    (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. The form is available from the Agency for Health Care Administration, 2727 Mahan Drive, Mail Stop 31, Tallahassee, Florida 32308. At a minimum, the plan shall include:

    (2)(a) through (8) No change.

    (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, in accordance withpursuant to Rule 69A-3.012 Rules 59A-3.077, 59A-3.079 and 59A-3.081, F.A.C.

    (10) No change.

     

    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) through (5)(a) No change.

    1. Insofar as Rules 59A-3.110 and 59A-3.30059A-3.100 through 59A-3.30359A-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-3.28159A-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-3.28159A-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. through (11)(b)2. No change.

     

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

    (1) through (3)(c) No change.

    (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, BloodborneOccupational Exposure to Blood Borne Pathogens Final Rule, July 1995, and the Department of Environmental Protection Code Chapter 62-712 on Biomedical Waste, May 1995.

    (3)(e) through (5) No change.

     

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

    (1) No change.

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

    (a)Within 10 calendar days of the completion of the agency’s survey, the agency will 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) through (2)(c) No change.

    (d) The agency 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 demonstrate of the accrediting organization are determined by the agency 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.

    (3)(a) through (b) No change.

    (c)(e) Accredited hospitals shall Hospitals 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:

    New (3)(c)1. through new (5) No change.

    (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) Within 10 calendar days following the completion of a licensure validation survey, the Aagency will 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).

    (a)(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.

    (b)(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.

    New (7) through new (9) No change.

     

    59A-3.255 Emergency Care.

    (1) through (4)(a)3. No change.

    (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, Emergency Services Exemption Request, 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.

    (4)(c) through (6)(e)5. no corrections

    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, in accordance with as required by Rules 64J-1.001 and 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. through (7) No change.

     

    59A-3.270 Health Information Management.

    (1) through (3)(m) No change.

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

    (o) through (12) No change.

     

    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 Section Chapter 39.201, F.S.

    (1)(a) through (4) No change.

     

    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-3.110 and 59A-3.301 through 59A-3.303 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-3.110 and 59A-3.301 through 59A-3.303 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.