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

(1) Inspections. The Agency shall conduct periodic inspections of hospitals in order to ensure compliance with all licensure requirements in accordance with Section 395.0161, F.S.

(2) Non-accredited hospitals. Hospitals which are not accredited by an accrediting organization shall be subject to a licensure inspection.

(3) Accredited hospitals. The Agency shall accept the report of an accrediting organization in lieu of an annual licensure inspection for accredited hospitals and for hospitals seeking accreditation, provided that the standards included in the report demonstrate that the hospital is in compliance with state licensure requirements found in Chapters 395 and 408, F.S., and Chapters 59A-3 and 59A-35, F.A.C., and the hospital does not meet the criteria specified under subparagraphs (c)1. and 2.

(a) Upon receipt of the accrediting organization’s report, the Agency will review the findings to determine if the hospital is in 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.

(c) Accredited hospitals shall be subject to a licensure inspection under the following circumstances:

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

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 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 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 inspection.

(6) 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 an accrediting organization to determine ongoing compliance with licensure requirements.

(a) If the Agency determines, based on the results of validation inspection findings, that a fully accredited hospital is not in 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.

(b) 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 will not be assessed when conducted in conjunction with a Centers for Medicare and Medicaid Services certification inspection.

(7) Complaint inspections. The Agency shall conduct investigations of complaints regarding violations of licensure and life safety standards in accordance with Sections 395.0161 and 408.811, 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 onsite 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 allegations of non-compliance with licensure requirements, and 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 for a determination as to the need for an investigation under certification standards.

3. Complaints involving diagnostic radiology equipment or personnel, or biomedical, waste disposal shall be referred to the Department of Health for investigation.

(b) Upon a determination that investigation of a complaint is warranted, the Agency shall conduct an investigation.

(8) Conformance with accreditation standards. In all hospitals where the Agency does not conduct a licensure inspection, by reason of the hospital’s accreditation status, 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 (3).

(9) 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.

Rulemaking Authority 395.1055, 408.819 FS. Law Implemented 395.0161, 395.1055, 395.1065, 408.811 FS. History–New 9-4-95, Formerly 59A-3.204 Amended 5-16-06, 10-16-14, 3-19-17.