59A-5.004. Validation, Licensure, & Life Safety Inspections and Complaint Investigations

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

(2) Non-accredited ambulatory surgical centers. Centers which are not accredited by an accrediting organization shall be subject to a scheduled licensure inspection. The fee for conducting a licensure inspection shall be $400.00.

(3) Accredited ambulatory surgical centers. The Agency shall accept the report of an accrediting organization in lieu of a licensure inspection for accredited centers and for centers seeking accreditation, provided that the standards used by the accrediting organization are determined by the Agency to incorporate comparable state licensure requirements, found in Chapters 395 and 408, F.S. and Chapters 59A-5 and 59A-35, F.A.C., and the center 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 center is in compliance with state licensure requirements.

(b) The Agency shall notify the center within 60 days of the receipt of the accrediting organization’s report regarding the Agency’s determination of the center’s compliance or non-compliance with state licensure requirements.

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

1. The center 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 center 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’s scheduled inspection.

(d) The fee for a licensure inspection shall be $400.00 for any accredited center subject to inspection pursuant to paragraph (c).

(4) Life safety inspection fee. A separate fee of $40.00 shall be assessed for a life-safety inspection, except when conducted as part of a licensure or a Centers for Medicare and Medicaid Services certification inspection.

(5) Validation inspection. Each year, the Agency shall conduct validation inspections on a minimum of five percent of those centers that have undergone an accreditation inspection from an accrediting organization, to determine ongoing compliance with state licensure requirements.

(a) Upon completion of a validation inspection, the Agency will send a copy of its findings to the center. For those centers determined not to be in compliance with state licensure requirements the notification will include a statement of deficiencies.

(b) If the Agency determines, based on the results of validation inspection findings, that an accredited center 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 center during the following year.

(c) The fee for conducting a licensure validation inspection shall be $400.00. 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.

(6) Complaint investigations. 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 shall be conducted upon arrival, by Agency personnel investigating the complaint, to inform the center’s administrator about the nature of the complaint investigation and to answer questions from the center’s staff. An exit conference shall be provided at the conclusion of the onsite investigation to inform the center of the scope of the investigation and to receive any additional information that the center 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 actions:

1. Complaints involving any center shall be reviewed and sent to the appropriate Agency local office for investigation, if it is determined that the allegations could constitute a violation of state licensure or federal certification;

2. If allegations are more appropriately addressed by another state agency or entity, the complaint will be referred accordingly.

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

(7) Conformance with accreditation standards. In all centers where the Agency does not conduct a licensure inspection, by reason of the center’s accreditation status, the center 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).

(8) Sanctions. The Agency shall impose penalties pursuant to Section 395.1065, F.S., on those centers which fail to submit an acceptable plan of correction or implement actions to correct deficiencies identified by the Agency or an 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, 395.0161, 48.819 FS. Law Implemented 395.003, 395.0161, 395.1065, 408.811 FS. History–New 6-14-78, Formerly 10D-30.04, 10D-30.004, Amended 11-13-95, 9-17-14, 3-19-17.