59A-1.009: Inspections; Plan of Corrective Action; Annual Reporting Requirements
PURPOSE AND EFFECT: The Agency proposes to amend Rule 59A-1.009, Florida Administrative Code. The proposed amendments will allow for the acceptance of certain accreditation organization inspection reports in lieu of Agency inspections and provide for off-site inspections.
SUMMARY: The proposed amendments to this rule identify the reports and accrediting organizations that will be accepted and the time frames and procedures for providing those reports to the Agency.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
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.
SPECIFIC AUTHORITY: 765.541(2) FS.
LAW IMPLEMENTED: 765.541 FS.
A HEARING WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:
DATE AND TIME: April 1, 2008, 1:00 p.m.
PLACE: Agency for Health Care Administration, 2727 Mahan Drive, Building #3, Conference Room B, 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 5 days before the workshop/meeting by contacting: Tara E. Ehlers by e-mail at ehlerst@ahca.myflorida.com or by phone at (850)922-0791. 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: Bill McCort, Bureau of Health Facility Regulation, 2727 Mahan Drive, Tallahassee, Florida, or call (850)487-0641
THE FULL TEXT OF THE PROPOSED RULE IS:
59A-1.009 Inspections; Acceptance of Accreditation Inspection Reports Plan of Corrective Action; Annual Reporting Requirements.
(1) The AHCA may inspect each organ procurement organization, tissue bank and eye bank on no less than a biennial period. AHCA is permitted at its sole discretion to inspect any organ procurement organization, eye bank or tissue bank by on-site inspection, off-site inspection or acceptance of documentation from an accreditation inspection that includes the approved accreditation organization inspector’s report of findings, the organization’s responses and the final determination. The purpose of these inspections is to: The AHCA shall make or cause to be made such unannounced inspections and investigations:
(a) Ensure To ensure compliance with the standards of Rule Chapter 59A-1, F.A.C.;
(b) Evaluate the accreditation organization’s process To evaluate the accrediting process of professional organizations; or
(c) Respond To respond to written complaints submitted to the AHCA.
(2) Acceptance of Accreditation Organization Inspection Reports.
(a) For certifying organ procurement activities, each accredited organ procurement organization shall submit the results of each Association of Organ Procurement Organization (AOPO) inspection report and proof of accreditation or reaccreditation to the Agency within 30 days of receipt of such reports and accreditation or reaccreditation.
(b) For certifying tissue banking activities, each accredited tissue bank organization shall submit the results of each American Association of Tissue Banks (AATB) inspection report and proof of accreditation or reaccreditation to the Agency within 30 days of receipt of such reports and accreditation or reaccreditation.
(c) For certifying eye bank activities, each accredited eye bank shall submit the results of each Eye Bank Association of
(d) If the certified organization voluntarily forfeits its accreditation by AOPO, AATB or EBAA, if the accrediatation is suspended or terminated, or if the certified organization is denied accreditation or re-accreditation by any of these accrediting organizations, the certified organization must provide written notification to AHCA within 30 days of the forfeiture or denial.
(e) Failure to submit the required accreditation inspection report and final determination or written notification of forfeiture, suspension, termination or denial of accreditation shall be considered a failure to submit to an inspection and will result in administrative action as provided in Chapter 408, Part II, F.S. and these rules.
(f) The AHCA shall conduct a biennial certification inspection of all agencies to ensure compliance with the standards in Rule 59A-1.005, F.A.C. All deficiencies to the standards will be submitted in writing to the agency by the AHCA. Within ten (10) working days of written notification by the AHCA, the agency shall submit to the AHCA for approval a written plan of correction, including a time table when corrections will be made. If a written plan of correction is insufficient to correct the deficiencies, The the AHCA shall conduct additional inspections to determine agency compliance with the standards. If an agency fails to correct the deficiencies noted in the plan of correction, the AHCA shall take administrative action as specified in Rule 59A-1.012, F.A.C.
(3) If, as the result of an inspection in response to a complaint, the AHCA determines that an agency is out of compliance with the standards in Rule 59A-1.005, F.A.C., or other sections of this rule, the AHCA shall take administrative action as specified in subsection 59A-1.012(1), F.A.C. If the agency remains out of compliance with the standards and rules of this chapter upon subsequent inspection by the AHCA, further administrative action as specified in subsection 59A-1.012(1), F.A.C., shall be taken. In addition, the agency shall submit a plan of correction to the AHCA for approval.completion of the plan of correction and.
(4) Each certified agency shall submit to the AHCA its most recently completed annual audit within 30 days after the anniversary date of certification.
(5) Each certified OPO shall submit to the AHCA the Annual Report for Organ Procurement, Distribution, Revenues and Expenses, AHCA Form 3140-2002-OCT 95, incorporated herein by reference, within 30 days after the anniversary date of certification.
(6) Each certified tissue bank shall submit to the AHCA the Annual Report for Tissue Procurement, Distribution, Revenues and Expenses, AHCA Form 3140-2004-OCT 95, incorporated herein by reference, within 30 days after the anniversary date of certification.
(7) Each certified eye bank shall submit to the AHCA the Annual Report for Eye Procurement, Distribution, Revenues and Expenses, AHCA FORM 3140-2005-OCT 95, incorporated herein by reference, within 30 days after the anniversary date of certification.
(8) These forms shall be available on the Agency website at: http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Laboratory_Licensure/organ.shtml, or from the Agency for Health Care Administration, Division of Health Quality Assurance, Laboratory Licensure Unit, 2727 Mahan Drive, MS# 32, Tallahassee, Florida 32308. The data to be submitted to the AHCA are described in subsection 59A-1.005(17)(18), F.A.C. All reported donor information shall be based on the previous calendar year. All revenue and expense information shall be based on the most recently completed fiscal or operational year.
Specific Authority 765.541(2) 381.6021(2) FS. Law Implemented 765.541 381.6021, 381.6023 FS. History–New 11-26-92, Amended 8-20-96,_________.