59A-1.004: Certification Procedure
PURPOSE AND EFFECT: The agency is proposing to amend the rule that incorporates the licensure application to reference application forms being created under Section 408.806, F.S., and proposed Chapter 59A-35, F.A.C.
SUMMARY: Revisions to the licensure applications that are incorporated by reference will be addressed. The Agency is adopting a licensure rule under Section 408.806, F.S., and this rule will be amended to align the requirements with those proposed in Chapter 59A-35, F.A.C.
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), 408.819 FS.
LAW IMPLEMENTED: 765.541, 765.542, 765.544, 873.01, 408.806 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:
DATE AND TIME: July 14, 2010, 10:00 a.m.
PLACE: Agency for Health Care Administration, Building 3, Conference Room C, 2727 Mahan Drive, 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: Dennis Hitchens, Laboratory Unit, 2727 Mahan Drive, Building 1, M.S. #32, Tallahassee FL 32308, (850)412-4377. 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: Dennis Hitchens, Laboratory Unit, 2727 Mahan Drive, Building 1, M.S. #32, Tallahassee FL 32308, (850)412-4377
THE FULL TEXT OF THE PROPOSED RULE IS:
59A-1.004 Certification Procedure.
(1) No person shall establish, operate, or maintain an OPO, tissue bank, or eye bank in this state without first being certified to operate by the AHCA. In addition, no OPO shall establish, operate or maintain an OPO without being designated as an OPO by the Secretary of the U.S. Department of Health and Human Services (HHS).
(2) Every OPO, tissue bank and eye bank engaged in procurement activities in Florida must not violate the provisions of Chapter 873, F.S., Sale of Anatomical Matter.
(3) A dentist or physician using tissue processed by a tissue bank, but who is not involved in the retrieval, processing and distribution of tissue, is not required to be certified pursuant to these rules. Funeral directors or direct disposers that retrieve eye tissue for an eye bank are exempt from the certification requirements under this subsection. A physician or OPO conducting the following activities in this state is exempt from state certification if:
(a) The organs are procured for an out-of-state patient who is listed on, or referred through, the United Network for Organ Sharing System; and
(b) The organs are procured through an agreement of an organ procurement organization certified by Florida.
(4) Application procedures. All persons contemplating procurement activities associated with an OPO, tissue bank, or eye bank shall submit to the AHCA a completed application, as specified in subsection 59A-35.060(1)(cc), F.A.C. AHCA Form 3140-2001-OCT 95, which is incorporated herein by reference and available from the Agency for Health Care Administration, Division of Health Quality Assurance, Ft. Knox Office Building, 2727 Mahan Drive, Tallahassee, Florida 32308. Application for certification shall be accompanied with a check or money order in the amount of $1,000 for an OPO or tissue bank and $500 for an eye bank. Such initial application fee is non-refundable and shall be made payable to the AHCA.
(5) Out-of-state OPOs, tissue banks and eye banks. No out-of-state OPO, tissue bank or eye bank may conduct procurement activities in Florida as defined in Chapter 381, F.S., without first obtaining certification. Existing out-of-state OPOs, tissue banks and eye banks conducting procurement activities in Florida shall submit an application for certification by October 1, 1996. Until October 1, 1996, out-of-state agencies currently engaged in procurement activities in Florida requesting certification shall be deemed to meet certification requirements until the AHCA acts to deny or grant the initial certification application. After October 1, 1996, upon receipt of an initial application from an out-of-state agency, the AHCA shall act to approve or deny the application request within 90 days, during which time deemed certification status does not exist.
(6) Site inspection. Upon receipt of a completed application, the AHCA shall conduct a site inspection or review the inspection report from an approved accreditation organization as specified in subsection 59A-1.009(2), F.A.C., to determine agency compliance with the standards.
(7) Certificate issuance. Agencies found in compliance with the standards shall be issued a certificate by the AHCA. Each certificate shall specifically state the certificate number, name of the agency, agency owner, city, county, state, type of agency, issue date of the certificate and expiration date of the certificate. A person having more than one agency, shall be issued a separate certificate for each agency. A certificate shall be posted in a conspicuous place on the certified premises, and copies of certificates shall be made available for inspection to all individuals.
(8) Mandatory certification exclusions. The AHCA shall not certify an individual or entity that has been convicted of a criminal offense related to the delivery of an item or service under Medicare or a state health care program, including the performance of management or administrative services relating to the delivery of items or services under any such program.
(9) Permissive certification exclusions.
(a) Circumstance for exclusion. The AHCA shall exclude an individual or entity convicted under federal or state law of a criminal offense relating to fraud, theft, embezzlement, breach of fiduciary responsibility, or other financial misconduct.
1. In connection with the delivery of any health care item or service, including the performance of management or administrative services relating to the delivery of such items or services; or
2. With respect to any act or omission in a program operated by, or financed in whole or in part by, any federal state or local government agency.
(10) Conviction relating to controlled substances.
(a) Circumstance for exclusion. The AHCA shall not issue a certificate to an individual or entity convicted under federal or state law of a criminal offense relating to the unlawful manufacture, distribution, prescription or dispensing of a controlled substance, as defined under federal or state law.
(b) For purposes of this section, the definition of controlled substance will be the definition that applies to the law forming the basis for the conviction.
(11) Certification revocation or suspension.
(a) The AHCA shall exclude an individual or entity that has:
1. Had a license or certificate to provide health care revoked or suspended by any state licensing or certification authority, or has otherwise lost such a license or certificate (including the right to apply for or renew such a license or certificate), for reasons bearing on the individual’s or entity’s professional competence, professional performance or financial integrity; or
2. Has surrendered such a license or certificate while a formal disciplinary proceeding concerning the individual’s or entity’s professional competence, professional performance or financial integrity was pending before a state licensing or certifying authority.
(12) Exclusion of entities owned or controlled by sanctioned person.
(a) A person with a relationship with such entity has been convicted of a criminal offense as described in Sections 1128(a) and 1128(b)(1), (2) or (3) of Title XIX of the Social Security Act;
(b) Has had civil money penalties or assessments imposed under Section 1128A of Title XIX of the Social Security Act;
(c) Has been excluded from participation in Medicare or any of the state health care programs and such person or entity has:
1. A direct or indirect ownership interest (or any combination thereof) of 5 percent or more in the entity;
2. Is the owner of a whole or part interest in any mortgage, deed of trust, note or other obligation secured (in whole or in part) by the entity or any of the property or assets thereof, in which whole or part interest is equal to or exceeds 5 percent of the total property and assets of the entity;
3. Is an officer or director of the entity, if the entity is organized as a corporation;
4. Is a partner in the entity, if the entity is organized as a partnership;
5. Is an agent of the entity; or
6. Is a managing employee, i.e., an individual (including a general manager, business manager, administrator or director) who exercises operational or managerial control over the entity or part thereof, or directly or indirectly conducts the day-to-day operations of the entity or part thereof.
(d) For the purposes of this section, the term:
1. Indirect ownership interest includes an ownership interest through any other entities that ultimately have an ownership interest in the entity in issue. (For example, an individual has a 10 percent ownership interest in the entity at issue if he or she has a 20 percent ownership interest in a corporation that wholly owns a subsidiary that is a 50 percent owner of the entity in issue.)
2. Ownership interest means an interest in:
a. The capital, the stock or the profits of the entity; or
b. Any mortgage, deed, trust or note, or other obligation secured in whole or in part by the property or assets of the entity.
(13) A limited certificate may be issued to a tissue bank or eye bank certifying only those components of procurement which the bank has chosen to perform. A limited certificate shall be requested at the time that application is made as specified in paragraph 59A-35.060(1)(cc), F.A.C. on AHCA Form 3140-2001-OCT 95, which is incorporated herein by reference.
(14) Expiration. A certificate, 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 assessment fee prescribed by these rules, provided that the applicant and agency meet the requirements established under this rule as determined by an on-site inspection in accordance with subsection 59A-1.004(6), F.A.C. Application for renewal of a certificate shall be made not less than 60 days prior to the expiration of a certificate as specified in paragraph 59A-35.060(1)(cc), F.A.C. on AHCA Form 3140-2001-OCT 95.
(15) Revocation of certification. An OPO, tissue bank or eye bank that submits or causes to be submitted an enrollment application that contains materially false or incorrect information shall have its certificate revoked.
(16) Each agency for which a certificate is requested shall be designated by a distinctive name, and the name shall not be changed without first notifying the AHCA in writing and receiving approval in writing. Duplication of existing agency names is prohibited.
(17) Each certificate shall be valid only for the person to whom it is issued and shall not be subject to sale, assignment, or other transfer, voluntary or involuntary, nor shall a certificate be valid for any premises other than that for which it was originally issued.
(18) A certified OPO, tissue bank or eye bank that proposes a change in procurement services (i.e., retrieval, processing, storage or distribution) shall notify the AHCA 30 days prior to that change in service. This notification shall include an explanation in the change of any aspect of the procurement process and how this change affects the agency’s operations. Prior to the addition of services, the AHCA shall conduct an on-site visit to determine if the standards of this rule are met.
(19) An application for a certificate is required when the ownership of a certified agency has been transferred or assigned or when a lessee agrees to undertake or provide services to the extent that legal liability for operation of the agency rests with the lessee. The application for a certificate reflecting such change shall be made at least 60 days prior to the date of the sale, transfer, assignment, or lease.
(20) Each certificate shall be returned to the AHCA by the agency immediately upon change in ownership or classification, suspension, revocation or voluntary cessation of operations.
(21) A certificate holder shall notify the AHCA of impending closure of an agency 90 days prior to such closure. The agency shall be responsible for advising the AHCA as to the placement of inventory and disposition of records.
Rulemaking Authority 765.541(2), 408.819 FS. Law Implemented 765.541, 765.542, 765.544, 873.01, 408.806 FS. History–New 11-26-92, Amended 8-20-96, 6-19-08,________.