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Document Citation: 59A-3.253, F.A.C.
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FLORIDA ADMINISTRATIVE CODE
TITLE 59 AGENCY FOR HEALTH CARE ADMINISTRATION
59A HEALTH FACILITY AND AGENCY LICENSING
CHAPTER 59A-3 HOSPITAL LICENSURE
Date:
08/31/2009
Document:
59A-3.253 Investigations and License, Life Safety and Validation Inspections.
(1) INSPECTIONS.--The AHCA shall conduct periodic inspections of hospitals in order to ensure compliance with all licensure requirements, 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 a hospital accrediting organization will be subject to 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) 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.
(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 agency 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 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 (e)1. and 2.
(a) Upon receipt of the accrediting organization's survey report, the agency will review the findings to determine if the hospital is in substantial compliance with state licensure requirements.
(b) The agency shall notify the hospital within 60 days of the receipt of the accrediting organization's survey report regarding the agency'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).
(e) 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:
1. The hospital has been denied accreditation or has received a provisional or conditional accreditation from a hospital accrediting organization on its most recent accreditation 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 agency, or has not ensured that the agency received the accrediting organization's survey report prior to the agency 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.
(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 validation inspection.
(7) VALIDATION INSPECTIONS. - Each year, the agency shall conduct validation inspections on a minimum of five percent of those hospitals that have undergone a full accreditation inspection from 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 agency 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).
(c) If the agency determines, based on the results of validation survey findings, that a fully accredited hospital is not in substantial compliance with licensure requirements, the agency shall report its findings to the accrediting organization and shall conduct a full licensure inspection on that hospital during the following year.
(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 survey will not be assessed when conducted in conjunction with a Medicare certification survey.
(8) COMPLAINT INSPECTIONS. - The agency shall conduct investigations of complaints regarding violations of licensure and life safety in accordance with Section 395.0161, 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 agency 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 agency shall review the complaint for 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 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, 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 agency 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.
(9) CONFORMANCE WITH ACCREDITATION STANDARDS.--In all hospitals where the agency does not conduct, 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 agency of the areas of non-conformance. Where the agency is notified of non-conformance, it shall take appropriate action as specified under subsection 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., Chapter 408, F.S., and Chapter 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 paragraph 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.
(11) SANCTIONS. - The agency 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 agency or an appropriate accrediting organization which are specified in an approved plan of correction or as identified as a result of a complaint investigation.
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