Agency for Health Care Administration

Transcription

1 Page 1 of 73 ST - B Initial Comments Title Initial Comments Type Memo Tag These guidelines are meant solely to provide guidance to surveyors in the survey process. ST - B Definitions Title Definitions FS; 59A FAC Definitions.-As used in this part, the term: (1) "Agency" means the Agency for Health Care Administration. (2) "Anatomical gift" or "gift" means a donation of all or part of a human body to take effect after the donor's death and to be used for transplantation, therapy, research, or education. (3) "Bank" or "storage facility" means a facility licensed, accredited, or approved under the laws of any state for storage of human bodies or body parts. (4) "Death" means the absence of life as determined, in accordance with currently accepted medical standards, by the irreversible cessation of all respiration and circulatory function, or as determined, in accordance with s , by the irreversible cessation of the functions of the entire brain, including the brain stem. (5) "Decedent" means a deceased individual whose body or

2 Page 2 of 73 body parts may be, or are, the source of an anatomical gift. (6) "Department" means the Department of Highway Safety and Motor Vehicles. (7) "Disinterested witness" means a witness other than a person listed in s (3) or other family member. (8) "Document of gift" means any of the documents or mechanisms used in making an anatomical gift under s (9) "Donor" means an individual who makes an anatomical gift of all or part of his or her body. (10) "Donor registry" means a database that contains records of anatomical gifts and amendments to, or revocations of, such gifts. (11) "Eye bank" means an entity that is accredited by the Eye Bank Association of America or otherwise regulated under federal or state law to engage in the retrieval, screening, testing, processing, storage, or distribution of human eye tissue. (12) "Guardian" means a person appointed pursuant to chapter 744. The term does not include a guardian ad litem. (13) "Hospital" means a hospital licensed, accredited, or approved under the laws of any state and includes a hospital operated by the United States Government or a state, or a subdivision thereof, although not required to be licensed under state laws. (14) "Identification card" means an official identification card issued by a governmental entity, state agency, or subdivision thereof. (15) "Organ procurement organization" means an entity that is designated as an organ procurement organization by the Secretary of the United States Department of Health and Human Services and that engages in the retrieval, screening, testing, processing, storage, or distribution of human organs. (16) "Part of the body" or "body part" means an organ, eye, or tissue of a human being. The term does not include the whole

3 Page 3 of 73 body. (17) "Physician" or "surgeon" means a physician or surgeon licensed to practice under chapter 458 or chapter 459 or similar laws of any state. "Surgeon" includes dental or oral surgeon. (18) "Procurement" means any retrieval, recovery, processing, storage, or distribution of human organs or tissues for transplantation, therapy, research, or education. (19) "Procurement organization" means an organ procurement organization, eye bank, or tissue bank. (20) "Reasonably available" means able to be contacted by a procurement organization in a timely manner without undue effort, and willing and able to act in a manner consistent with existing medical protocols necessary for the making of an anatomical gift. (21) "Record" means information that is inscribed on a tangible medium or that is stored in an electronic or other medium and is retrievable in perceivable form. (22) "Sign" or "signed" means, with the present intent to authenticate or adopt a record, to execute or adopt a tangible symbol, or attach to or logically associate an electronic symbol, sound, or process with the record. (23) "Tissue bank" means an entity that is accredited by the American Association of Tissue Banks or otherwise regulated under federal or state law to engage in the retrieval, screening, testing, processing, storage, or distribution of human tissue. 59A Definitions. For the purpose of this section the word, phrase, or term: (1) "Adverse reaction" means the patient's unfavorable physical response to the transplantation of an organ or tissue with regard to the transmission of infections of other diseases of potential danger. (2) "Allograft" means the transplantation of tissue or organ taken from one individual of the same species as the recipient

4 Page 4 of 73 but with different hereditary factors. (3) "Brain death" means the determination of death in accordance with Section , F.S., where there is the irreversible cessation of the functioning of the entire brain, including the brain stem. (4) "Certificate" means a license to operate as an organ procurement organization, tissue bank, or eye bank which is issued by the Agency for Health Care Administration. (5) "Clean, non-sterile" means the use of methods and techniques that reduce gross contamination. (6) "Consent" means authorization or permission to procure organ(s) or tissue(s) from a non-living donor which is obtained only under circumstances that provide the prospective donor or donor's next of kin sufficient opportunity to consider whether or not to agree to such donation and that minimize the possibility of coercion or undue influence. (7) "Container (final container)" means the immediate unit, bottle, vial, ampule, tube, or other receptacle containing grafts as distributed. (8) "Coordinators" means registered nurses, physicians' assistants, or other medically trained personnel who assist in the medical management of organ donors or in the surgical retrieval of organs. (9) "Designee" means one who has been assigned a duty or duties, and who has the necessary training and educational qualifications to act on behalf of an agency director or medical director of an agency. (10) "Distribution" means the shipment and delivery of final container grafts for recipient use. (11) "Donation" means the free and voluntary gift of one or more organs or tissues for the purpose of transplant surgery. (12) "Donor" means a medically acceptable person where appropriate permissions have been obtained to procure organ(s) and tissue(s) according to the provisions of Chapter 765, F.S., or if applicable, Chapter 406, F.S.

5 Page 5 of 73 (13) "Facilities" means any area used for retrieval, processing, testing, storage, or distribution of organs, tissues, and tissue components. (14) "Graft" means a piece of skin, bone, or other tissue to be transplanted to another place on the human body. (15) "Gross autopsy" means the anatomical examination of a body without microscopic examination. (16) "Indirect supervision" means the direction that is provided to coordinators and other staff under protocols expressly approved by the licensed physician medical director. The medical director or his physician designee shall always be available, in person or by telephone, to provide medical direction and consultation. (17) "Label" means written, printed, or graphic matter on the container or package or any such matter clearly visible through the immediate carton, receptacle, or wrapper. (18) "Next of kin" means the person or persons most closely related to a deceased individual as designated by Section , F.S. (19) "Organ" means a body part such as a heart, kidneys, pancreas, liver, lungs, that requires vascular reanastomosis. (20) "Organ Procurement and Transplantation Network (OPTN)" means the corporation under the Public Health Service Act that approves transplant programs to ensure that all organ donors meet minimum standards and requirements. (21) "Package" means the immediate carton, receptacle, or wrapper, including all labeling matter therein and thereon, and the contents of the one or more enclosed containers. (22) "Preservation" means the proper combination of conditions that serve to protect organs from decay during established periods. (23) "Procedure" means a series of activities followed in a regular and definite order. (24) "Processing" means the procedure employed after organ or tissue retrieval and before storage of the final container

6 Page 6 of 73 material; includes identification of the organ or tissue, organ or tissue treatment, preparation of components from such organ or tissue, testing, labeling, and associated record-keeping. (25) "Procure" means the removal of transplantable organs or tissues for the benefit of one or more patients. (26) "Procurement" as it applies to an OPO and eye bank means the retrieval, processing or distribution of organs and eye tissues; procurement as it applies to a tissue bank means the retrieval, processing, storage or distribution of tissues. (27) "Quality assurance" means the monitoring procedures that ensure and document that the entire agency (e.g., facilities, personnel, methods, practices, and records) conforms with these standards. (28) "Quality control" means laboratory tests and procedures for measuring or monitoring properties of organs and tissues essential to the evaluation of their safety or usefulness. (29) "Retrieval" means the excision of organs or tissues from a donor's body. (30) "Storage" means the proper combination of conditions that serve to protect tissues from decay during established periods. (31) "Tissue" means any non-visceral collection of human cells and their associated intercellular substances. (32) "Tissue bank" means a public or private entity which is involved in at least one of the following activities: a) retrieving, processing, storing, or distributing viable or nonviable human tissues to clinicians who are not involved in the procurement process; b) retrieving, processing, and storing human tissues in one institution and making these tissues available to clinicians in other institutions; or c) retrieving, processing, and storing human tissues for individual depositors and releasing these tissues to clinicians at the depositor's request. Establishments such as transplantation centers and other hospitals which store tissue only for a short

7 Page 7 of 73 term pending scheduled surgery within the same facility but do not otherwise participate in the retrieving, processing, or distribution of tissue would not be regulated under these provisions. (33) "Transplant safety" means the assurance of relative freedom from harmful effect to persons affected, directly or indirectly, by a transplant when administered, taking into consideration the character of the transplant in relation to the condition of the recipient at the time. (34) "Transplant physician" means a licensed practitioner who performs surgical repair or replacement using organs or tissues donated by a living or non-living donor. ST - B Certification Procedures Title Certification Procedures 59A FAC (1) No person shall engage in the procurement of cadaveric organs, eyes or tissues within this state without first being certified to operate by the AHCA. (2) 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. (3) All persons seeking to apply for initial or renewal certification shall submit to the AHCA a completed application, Health Care Licensing Application, Organ Procurement, Tissue Bank, Eye Bank, AHCA Form , July 2014, which is incorporated by reference. This form is available at: or and from the

8 Page 8 of 73 Agency for Health Care Administration, 2727 Mahan Drive, MS #32, Tallahassee, Florida An application for initial certification, including change of ownership, 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. Application fees shall be made payable to the AHCA and are non-refundable. (4) Upon receipt of a completed initial application, the AHCA shall conduct an inspection or review the inspection report from an approved accreditation organization as specified in subsection 59A-1.009(2), F.A.C., to determine the applicant's compliance with the standards. (5) 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 in Florida. (6) A certified OPO, tissue bank or eye bank that proposes an addition in procurement services (i.e., retrieval, processing, storage or distribution) shall notify the AHCA 60 days prior to such addition. 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 inspection or review the inspection report from an approved accreditation organization as specified in subsection 59A-1.009(2), F.A.C., to determine if the standards of this rule are met. (7) A certificate holder shall notify the AHCA of impending closure 90 days prior to such closure and shall be responsible for advising the AHCA as to the placement of inventory and disposition of records. ST - B Org Rqmts - Institutional Identity Title Org Rqmts - Institutional Identity 59A-1.005(1)(a) FAC

9 Page 9 of 73 (1) Organizational Requirements. (a) Institutional Identity. 1. The purpose of the OPO, eye bank, or tissue bank shall be clearly established and documented. 2. Documentation of institutional identity shall include whether the OPO, eye bank, or tissue bank is independent or part of another institution. 3.The OPO, eye bank, or tissue bank shall have a functional identity with a professional staff and a commitment to maintain and preserve records and operating procedures for future reference and historical continuity. 4. Policies and procedures shall be maintained for personnel and other activities. Surveyor shall review documentation for evidence that clearly states the purpose of the agency. There should be documented information regarding whether the agency is an independent operation or part of another institution. ST - B Org Rqmts - Director/Advisory Board Title Org Rqmts - Director/Advisory Board 59A-1.005(1)(b-c) FAC (1) Organizational Requirements. (b) Each OPO, eye bank, or tissue bank shall have a board of directors, an advisory board, or a designated individual to provide consultation and direction on all policy-making decisions. (c) OPO, Eye Bank, or Tissue Bank Director. Each OPO, eye bank, or tissue bank shall have a director qualified by training and experience for the scope of activities being pursued. 1. The director shall be responsible for: a. Development, implementation and maintenance of all procedures and policies, b. All administrative operations including compliance with

10 Page 10 of 73 these standards, c. The daily operation of the OPO, eye bank, or tissue bank, d. Specifying technically acceptable means for retrieving, processing, quality control, storage, and distribution, as applies to the scope of activities being pursued, e. Providing all staff members with adequate information to perform their duties safely and competently, f. Appointing technical staff with capabilities and training appropriate to their function and ensuring that competency is maintained by participation in training courses and technical meetings or other educational programs. Such training shall be recorded in the employee's personnel file, g. Establishing quality control and quality assurance programs. These programs shall include ongoing monitoring and evaluation of activities, identification of problems, and development of plans for corrective action. These procedures and records shall be reviewed at least annually; and, h. Maintaining a working relationship with medical examiner offices in the OPO, eye bank, or tissue bank's service area. 2. If the director appointed does not have medical licensure, the OPO, eye bank, or tissue bank shall have at least one physician, employed or under contract, to ensure compliance with all medical aspects and with all requirements for specialist knowledge of the particular organs and tissues processed. 3. The director is authorized to delegate his or her responsibilities to trained and competent staff. If responsibilities are delegated, the director remains responsible for ensuring that all duties are properly performed. ST - B Org Rqmts - Policies/Procedures Title Org Rqmts - Policies/Procedures 59A-1.005(1)(d-e) FAC

11 Page 11 of 73 (1) Organizational Requirements. (d) Personnel Policies and Procedures. Job descriptions, including scope of activities, specific responsibilities, and reporting relationships, for all personnel shall be established by written personnel policies and procedures. (e) Policies and Procedures. Each OPO, eye bank or tissue bank shall maintain detailed and unambiguous policies and procedures which detail all aspects of retrieval, processing, testing, storage, and distribution practices; as applicable. 1. Each of these procedures shall be reviewed and affirmed in writing annually by the director or designee. 2. Modifications of standard procedures and development of new procedures shall be approved by the director or designee prior to implementation. 3. Obsolete revised procedures shall be retained separately to maintain a historical sequence. 4. Copies of policies and procedures shall be available to the staff at all times. Technical staff shall be required to state in writing that they have read and understand the policies and procedures applicable to his or her specific responsibilities. 5. Copies of policies and procedures shall be available to surveyors for inspection upon request. ST - B Org Rqmts - Clinical Lab Testing Title Org Rqmts - Clinical Lab Testing 59A-1.005(1)(f) FAC (1) Organizational Requirements. (f) Clinical Laboratory Testing. Any clinical laboratory tests performed within an OPO, tissue bank or eye bank must

12 Page 12 of 73 comply with Chapter 483, F.S., and the Clinical Laboratories Improvement Act of 1988 (CLIA-88), as applicable. ST - B Org Rqmts - Records Title Org Rqmts - Records 59A-1.005(1)(g) FAC (1) Organizational Requirements. (g) Records. 1. Donor and recipient records shall be accurate, complete, and confidential as required by Section , F.S. Donor record confidentiality shall not preclude access by surveyors for the Agency when conducting an inspection or investigation pursuant to paragraphs 59A-1.009(1)(a), (b), (c), F.A.C., and the medical examiner for cases which fall within the medical examiner's jurisdiction, as established under Section , F.S. Donor medical records and final results of all laboratory tests shall be reviewed and affirmed by the medical director, designees, or medical contractee to ensure suitability of the donated organ(s) or tissue(s) for the intended application. 2. Documentation shall be concurrent with the performance of each activity in the retrieval, preparation, testing, storage, and distribution of organs and tissues in such a manner that all activities can be clearly traced. All records shall be legible and indelible and shall identify the person performing the procedures/tasks. The record shall include dates of entries and test results. The expiration period assigned to specific categories of processed tissues is to be recorded in the policies and procedures. 3. Records shall be as detailed as necessary for a clear understanding of each activity and shall be available for inspection by surveyors when conducting an inspection or - Surveyor shall review documentation for evidence that records identify the person performing the work, including the dates of various entries, test results, and interpretation of the results.

13 Page 13 of 73 investigation pursuant to paragraphs 59A-1.009(1)(a), (b), (c), F.A.C., upon request and within the bounds of medical-legal confidentiality, pursuant to Section , F.S. 4. Each organ donor, tissue and any components derived from tissue shall be assigned, in addition to generic designation, a unique identification number to identify the material from retrieval through distribution and utilization. 5. Records shall identify the donor, document the pathological and microbiological evaluation of the donor, verify the conditions under which the organ or tissue is retrieved, processed and stored, if applicable, and indicate disposition of the transplanted organ or tissue. Maintenance of these records shall be the responsibility of the director or designee. All records concerning donor history and processing information shall be made available to the transplant surgeon upon request, except those infringing upon donor confidentiality. 6. All records and communication between the OPO, eye bank or tissue bank and its donors, persons identified by Section (3), F.S., and patient recipients shall be regarded as confidential and privileged. Surveyors shall have access to records and communication at the time of the inspection as specified in Rule 59A-1.009, F.A.C. 7. Maintenance and certification records, if applicable, on facilities, instruments, and equipment, including their monitors, shall be maintained. These records shall indicate dates of inspection, name of facility, and performance evaluations. Each OPO, eye bank or tissue bank shall include in its procedures manual, the monitoring, inspection and cleaning procedures and schedules for each piece of equipment. Documented cleaning schedules for laboratory equipment shall be maintained. Records of function checks requiring interpretation of findings must include the interpretation. Records must include: a. Temperature of incubators when in use, b. Spore lot number and expiration date used for autoclave

14 Page 14 of 73 function check; and, c. Control and test results. 8. Each OPO, eye bank, or tissue bank shall document all aspects of its quality assurance program. 9. An adverse reactions file shall be maintained pursuant to Rule 59A-1.011, F.A.C. 10. All of these records shall be retained for seven years for OPOs and ten years for tissue banks and eye banks and be available for Agency inspection. ST - B Safety and Environmental Control Title Safety and Environmental Control 59A-1.005(2) FAC (2) Safety and environmental control. Written procedures for the operation shall be established and approved by the director. Instructions for action in case of emergency or exposure to communicable disease, chemical and biological hazard precautions shall be included. (a) Human waste items shall be disposed so as to minimize any hazard to personnel or the environment in accordance with the following rules and statutes administered by the Department of Environmental Protection and the Department of Health: Section , F.S., Chapter 403, Part IV, F.S., and Chapter 64E-16, F.A.C. (b) Dignified and proper disposal procedures shall be used to obviate recognizable human remains. (c) All organs or tissues found positive for human immunodeficiency virus shall be rendered noncommunicable or shall be destroyed, unless specifically labeled to identify the human immunodeficiency virus and: 1. Is used for research purposes, or - Surveyor shall review evidence that safety procedures and policies are posted or readily available to all personnel. - Surveyor shall review OSHA requirements, and if there appears to be non-compliance, refer immediately to OSHA.

15 Page 15 of Is used to save the life of another and is transferred with the recipient's informed consent. (d) Each OPO, eye bank or tissue bank shall comply with Occupational Safety and Health Administration (OSHA) rules 29 Code of Federal Regulations (CFR) Part , effective April 3, 2012, which are incorporated herein by reference and available at These rules establish requirements for minimizing exposure to hepatitis, HIV, and other blood-borne pathogens. ST - B Facilities and Equipment Title Facilities and Equipment 59A-1.005(3) FAC (3) Facilities and equipment. (a) Each OPO, eye bank or tissue bank shall have established procedures regarding maintenance and acceptability guidelines. (b) Facilities shall be designated for the specialized purposes for which they are to be used and shall be maintained in a clean and orderly manner. All instruments and equipment shall be subject to regularly scheduled maintenance and calibration. All temperature measuring devices must be calibrated against National Institute of Standards and Technology (NIST) certified thermometers. Refrigerators and freezers used for the storage of tissues shall have monitors. Each OPO, eye bank or tissue bank shall have established procedures to follow in the event of electrical failure. (c) Facility access shall be limited to employees of the OPO, eye bank or tissue bank, contractual employees of the OPO, eye bank or tissue bank, surveyors for an approved - Surveyor shall review for evidence of documented maintenance records.

16 Page 16 of 73 accreditation organization, and governmental surveyors as permitted by applicable laws. A security system or physical configuration shall be established to prevent entry of unauthorized persons. There shall be policies and procedures to define limited facility access. Such policies and procedures shall be made available for review by surveyors as specified in Rule 59A-1.009, F.A.C. ST - B Ethical Standards Title Ethical Standards 59A-1.005(4) FAC (4) Ethical Standards. (a) Each OPO, tissue bank, and eye bank shall have policies to avoid conflicts of interest. The policy shall ensure that no employee of the OPO, tissue bank or eye bank shall incur any obligation of any nature which is in substantial conflict with the full and competent performance of duties. (b) In the event that services are provided to the procuring OPO, eye bank or tissue bank arrangements may be made to pay expenses incurred for services rendered. Reimbursement to the individual shall not be in conflict with the personnel policies of the primary employer. ST - B Federal or Accreditation Organization Title Federal or Accreditation Organization 59A-1.005(5) FAC

17 Page 17 of 73 (5) Each OPO, eye bank or tissue bank shall provide to the Agency, upon request, a copy of any audit, review, or study performed by any federal or accreditation organization. ST - B Acquisition of Organs and Tissues Title Acquisition of Organs and Tissues 59A-1.005(6) FAC (6) Acquisition of Organs and Tissues. (a) General. 1. OPO, eye bank, or tissue bank personnel shall have written procedures to ensure that consent for donation is obtained in compliance with Chapter 765, F.S. 2. OPO, eye bank, or tissue bank personnel shall be trained regarding obtaining and documenting consent for donation. 3. Consent shall be obtained from the donor, next of kin, or other designated legal entity in order of priority and availability according to Section , F.S. 4. A copy of the signed consent form shall remain a part of the patient's hospital medical record if signed at the hospital. 5. The original signed consent form or record of telephone consent shall be retained in the OPO, eye bank, or tissue bank's donor record. (b) Informed Consent. 1. Permission to procure organs and tissues from donors which is obtained by informed consent shall be as defined in Rule 59A-1.003, F.A.C., and shall be documented in writing. The consent form shall include the organs and tissues for which permission is granted (e.g., bone from the upper or lower

18 Page 18 of 73 extremities or bone from below the waist). Information provided shall be written or spoken in language understandable to the donor or the donor's next of kin. 2. Permission to retrieve organs and tissues from non-living donors shall be sought from next of kin in order of legal precedence as required by Section , F.S. 3. In any cases falling under the provisions of Chapters 406 and 765, F.S., the permission of the medical examiner or appropriate designee shall be obtained prior to the procurement of any organ(s) and tissue(s). The donor records shall indicate the name of the contact person in the medical examiner's office, date and time of contact, and limitations, if any, imposed by those giving permission (e.g., DO NOT TOUCH CHEST). ST - B Premortem Donations Title Premortem Donations 59A-1.005(7) FAC (7) Premortem donations under the Anatomical Gift Statute. Consent expressed by a living person to donate organs and tissues under provisions of the Anatomical Gift Statute, Chapter 765, Part V, F.S., are legally valid and permits organ procurement organizations, tissue banks, and eye banks to procure organs and tissues without further authorization from next of kin.

19 Page 19 of 73 ST - B Compensation for Donors Title Compensation for Donors 59A-1.005(8) FAC (8) Compensation for Donors. Monetary compensation other than reimbursement of donation-related expenses is prohibited. ST - B Autopsy Title Autopsy 59A-1.005(9) FAC (9) Autopsy. A gross external and internal examination of any area of the donor altered by the excision of organs or tissues shall be performed and dictated or otherwise recorded by the procuring person(s) at the time of the of the surgical removal. A written report of these findings shall be immediately prepared and delivered to the person(s) responsible for the autopsy of the donor. The report shall contain itemized notation of normal conditions as well as an itemization of all abnormal findings identified during the gross examination of the donor. Whenever a full medical autopsy will not be subsequently performed by a medical examiner, the medical director or designees may elect to obtain one by other means when deemed necessary. If performed, the medical director or designees shall justify and document the need for the full

20 Page 20 of 73 autopsy in the donor's medical record and shall affix a copy of the report to the donor's record. ST - B Donor Selection Procedures Title Donor Selection Procedures 59A-1.005(10) FAC (10) Donor Selection. Each OPO,tissue bank or eye bank engaged in the retrieval or recovery of organs or tisssues, shall have written procedures regarding donor selection. (a) The medical director or designee shall be responsible for the donor selection. (b) Suitability of an individual for donation shall be based upon the medical history and clinical status of the donor and the need for particular organs and tissues. (c) Criteria for evaluating a potential donor shall include presence of infectious disease, malignant disease (with specific exceptions), neurological degenerative disease, and diseases of unknown etiology or any other diseases or conditions which may be transferred to the recipient. (d) Evaluation of the donor record shall be performed by a licensed physician or a professional familiar with the conditions for which the procured organs or tissues will be used so that organs or tissues procured shall not be the source of any toxic or harmful effects per se when transplanted to another individual. (e) Age of the donor shall be a consideration in the effective transplantation of certain organs or tissues but does not preclude an individual from donation. (f) The medical director, designee, or medical contractee shall have the responsibility to document that the donor is acceptable according to the criteria established in this rule and

21 Page 21 of 73 by the procedure established by the OPO, eye bank or tissue bank. ST - B Reconstruction Title Reconstruction 59A-1.005(11) FAC (11) Reconstruction. Each OPO, eye bank or tissue bank who is engaged in the retrieval or recovery of organs or tisssues shall have a policy for the reconstruction of the body which is integral to maintaining the dignity of the donor. ST - B Quality Assurance Title Quality Assurance 59A-1.005(12) FAC (12) Quality Assurance. The quality assurance program shall include a method for the transplanting surgeon to report adverse reactions from the transplantation of organ(s) and tissue(s) to the source OPO, tissue bank or eye bank, which in turn shall forward the adverse reaction information to the Agency as described in Rule 59A-1.011, F.A.C.

22 Page 22 of 73 ST - B Recall Procedures Title Recall Procedures 59A-1.005(13) FAC (13) Recall Procedures. A written procedure shall exist for recall of organs or tissues or notification of recipient agencies of the possibility of contamination, defects in processing, preparation or distribution, or other factors affecting suitability of the organs or tissues for their intended application. Procedures for documenting the steps in recall or notification shall be included in the policies and procedures. - Review sampling of random records to ensure that the recipient's physician and/or transplantation center are identified sufficiently to accomplish a notification or recall should such become necessary. ST - B Look Back Procedures Title Look Back Procedures 59A-1.005(14) FAC (14) Look Back Procedures. Each OPO, tissue bank, and eye bank shall have procedures for notifying the transplanting facility or physician that they may have received infected organs or tissues. Documentation of look back procedures shall be included in the policies and procedures.

23 Page 23 of 73 ST - B HIV Notification Requirements Title HIV Notification Requirements 59A-1.005(15) FAC (15) HIV Notification Requirements. Notification of HIV test results shall be given in accordance with the following statutes and rules administered by the Department of Health: Section , F.S., and Rule 64D-2.005, F.A.C. ST - B Data Collection Title Data Collection 59A-1.005(16) FAC (16) Data Collection. Each OPO, tissue bank, and eye bank shall collect, maintain, and report the following data annually to the Agency: (a) Number of donors by age and race; (b) Type of donation; (c) Cause of death for all donors; (d) Donor source (hospital, medical examiner, or funeral home); (e) Number of organs retrieved and number of tissue allografts and eyes processed; (f) Disposition of processed organs, tissues, and eyes with respect to in-state, national, or international distribution; and, (g) Revenues derived from retrieving, processing, or

24 Page 24 of 73 distributing organs and eye tissue, and revenues derived from retrieving, processing, storing or distributing tissues; (h) Expenses associated with retrieving, processing, or distributing organs and eye tissue, and expenses associated with retrieving, processing, storing or distributing tissues. ST - B Fair and Equitable System Title Fair and Equitable System 59A-1.005(17) FAC (17) Fair and Equitable System. Each OPO, eye bank, or tissue bank shall establish and document a system of distribution that is just, equitable, and fair to all patients served. Documentation of distribution (date of requests for, offer of, and delivery of organs and tissues) shall be available for examination by authorized individuals, including surveyors for the Agency. Access to organs and tissues shall be provided without regard to recipient sex, age, religion, race, creed, color or national origin. - Review records for evidence that there is a documented system of distribution that is just, equitable, and fair to all patients served by the tissue bank. Documentation of distribution shall include the date of request for, offer of, and delivery of tissues. ST - B Accreditation Organization Inspection Reports Title Accreditation Organization Inspection Reports 59A-1.009(2)(a-e) FAC (2) Acceptance of Accreditation Organization Inspection Reports. (a) For certifying organ procurement activities, each

25 Page 25 of 73 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 America (EBAA) inspection report and proof of accreditation or reaccreditation to the Agency within 30 days of receipt of such reports and accreditation or reaccreditation. (d) If the certified organization voluntarily forfeits its accreditation by AOPO, AATB or EBAA, if the accreditation 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 the 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. ST - B Annual Reporting Requirements Title Annual Reporting Requirements 59A-1.009(4-8) FAC

26 Page 26 of 73 (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 APR 2008, incorporated herein by reference and available at: /Laboratory_Licensure/organ.shtml, 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 DEC 2008, incorporated herein by reference and available at: /Laboratory_Licensure/organ.shtml, 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 DEC 2008, incorporated herein by reference and available at: /Laboratory_Licensure/organ.shtml, within 30 days after the anniversary date of certification. (8) These forms shall be available on the Agency website at: or from the Agency for Health Care Administration, Division of Health Quality Assurance, Laboratory Licensure Unit, 2727 Mahan Drive, MS #32, Tallahassee, Florida The data to be submitted to the AHCA are described in subsection 59A-1.005(17), 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.

27 Page 27 of 73 ST - B Adverse Reactions Title Adverse Reactions 59A-1.011(1) FAC (1) General. Each agency shall inform physicians and hospital personnel involved in the transplantation of organs, tissues, and eyes of policies and procedures regarding the reporting of adverse reactions to agencies. It is the responsibility of each physician and organization that utilizes organs and tissues for transplantation to notify the providing organ procurement organization, tissue bank, or eye bank in writing of any and all adverse reactions with regard to transmission of infections or other diseases. The providing organization shall notify the medical examiner if the adverse reaction involves donation from a medical examiner's case. Every reasonable effort shall be made by each providing agency to inform each receiving agency or physician of this fact and to provide a mechanism for follow-up (e.g., pre-addressed follow-up cards, a toll free number, etc.) to report such instance. ST - B Adverse Reactions - Notification Title Adverse Reactions - Notification 59A-1.011(2) FAC (2) Notification of adverse reaction. (a) In accordance with subsection 59A-1.005(14), F.A.C.,

28 Page 28 of 73 each agency shall, upon notification of an adverse reaction by a transplanting physician or hospital: 1. Immediately notify the Agency for Health Care Administration, Division of Health Quality Assurance, by telephone of a potential adverse reaction; 2. Immediately suspend distribution of grafts coming from that donor; 3. Initiate an investigation to determine whether or not the adverse reaction was due to the donor organs and tissues; and 4. Submit to the Agency for Health Care Administration, Division of Health Quality Assurance, within two working days, Part I of the AHCA's Organ and Tissue Adverse Reaction Reporting Form, AHCA Form OCT 95. This entire form 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 ST - B Adverse Reactions - Followup Procedures Title Adverse Reactions - Followup Procedures 59A-1.011(3) FAC (3) Follow-up procedures. (a) Where it is determined that the adverse reaction was due to the donor organs and tissues, each agency shall institute recall procedures in accordance with subsection 59A-1.005(15), F.A.C., and look back procedures in accordance subsection 59A-1.005(16) F.A.C. (b) Once a final determination of the cause of an adverse reaction is made, each agency shall submit Part II of the AHCA's Organ and Tissue Adverse Reaction Reporting Form, AHCA Form OCT 95, to the Division of Health

29 Page 29 of 73 Quality Assurance. ST - B Deny, Revoke, Suspend, Fine Title Deny, Revoke, Suspend, Fine 59A-1.012(1) FAC (1) Depending upon the seriousness of the violation, the AHCA shall deny, revoke, or suspend a certificate or impose an administrative fine not to exceed $500 per day per violation for any of the following actions: (a) Making false statements on an application or on any document associated with certification; (b) Advertising false services or credentials; (c) Failing to pay within 30 days of assessment, trust fund assessments in accordance with Section , F.S.; (d) Failing to comply with the provisions of Chapter 59A-1, F.A.C.; (e) Failing to correct deficiencies within the time required by the AHCA; (f) Failing to submit an annual income statement and annual data on organ and tissue procurement, revenues and expenses specified in subsection 59A-1.005(17), F.A.C.; (g) Failing to inform the AHCA of an adverse reaction or failing to comply with all provisions of Rule 59A-1.011, F.A.C.; (h) Violating or aiding and abetting in the violation of any other provision of these regulations or the rules promulgated thereunder; or (j) Violating an agency moratorium as described in Rule 59A-1.012, F.A.C.

30 Page 30 of 73 ST - B Rights and Duties at Death Title Rights and Duties at Death (2-4) FS (2) The time of death shall be determined by a physician who attends the donor at the donor's death or, if there is no such physician, the physician who certifies the death. After death, those physicians or the donor's primary care physician may participate in, but may not obstruct, the procedures to preserve the donor's organs or tissues and may not be paid or reimbursed for such participation, nor be associated with or employed by, a procurement organization. These physicians may not participate in the procedures for removing or transplanting a part. However, this subsection does not prevent a physician from serving in a voluntary capacity on the board of directors of a procurement organization or participating on any board, council, commission, or similar body related to the organ and tissue procurement system. (3) The procurement organizations, or hospital medical professionals under the direction thereof, may perform any and all tests to evaluate the deceased as a potential donor and any invasive procedures on the deceased body in order to preserve the potential donor's organs. These procedures do not include the surgical removal of an organ or penetrating any body cavity, specifically for the purpose of donation, until: (a) It has been verified that the deceased's consent to donate appears in the donor registry or a properly executed document of gift is located; or (b) If a properly executed document of gift cannot be located or the deceased's consent is not listed in the donor registry, a person specified in s (2) or (3) has been located, has

31 Page 31 of 73 been notified of the death, and has granted legal permission for the donation. (4) All reasonable additional expenses incurred in the procedures to preserve the donor's organs or tissues shall be reimbursed by the procurement organization. ST - B Duties and Liability Title Duties and Liability (1) & (7) FS (1) If, based on accepted medical standards, a hospital patient is a suitable candidate for organ or tissue donation, the hospital administrator or the hospital administrator's designee shall, at or near the time of death, notify the appropriate procurement organization, which shall access the donor registry created by s or any other donor registry to ascertain the existence of an entry in the registry which has not been revoked or a document of gift executed by the decedent. In the absence of an entry in the donor registry, a document of gift, or other properly executed document, the procurement organization shall request: (a) The patient's health care surrogate, as authorized in s (2); or (b) If the patient does not have a surrogate, or the surrogate is not reasonably available, any of the persons specified in s (3), in the order and manner listed, to consent to the anatomical gift of the decedent's body for any purpose specified in this part. Except as provided in s , in the absence of actual notice of opposition, consent need only be obtained from the person or persons in the highest priority class reasonably available.

32 Page 32 of 73 (7) The hospital administrator or a designee shall, at or near the time of death of a potential donor, directly notify the affiliated organ procurement organization of the potential organ donor. The organ procurement organization must offer any organ from such a donor first to patients on a Florida-based local or state organ sharing transplant list. For the purpose of this subsection, the term "transplant list" includes certain categories of national or regional organ sharing for patients of exceptional need or exceptional match, as approved or mandated by the Organ Procurement and Transplantation Network, or its agent. This notification may not be made to a tissue bank or eye bank in lieu of the organ procurement organization unless the tissue bank or eye bank is also designated as an organ procurement organization. ST - B Rqmts to Engage in Organ/Tissue/Eye Procureme Title Rqmts to Engage in Organ/Tissue/Eye Procureme (1-3) FS (1) The requirements of part II of chapter 408 apply to the provision of services that require licensure pursuant to ss and part II of chapter 408 and to entities licensed or certified by or applying for such licensure or certification from the agency pursuant to ss A person may not engage in the practice of organ procurement in this state without being designated as an organ procurement organization by the Secretary of the United States Department of Health and Human Services and being appropriately certified by the agency. A physician or organ procurement organization based outside this state is exempt from these certification requirements if: (a) The organs are procured for an out-of-state patient who is

33 Page 33 of 73 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 the state. (2) A person may not engage in tissue procurement in this state unless it is appropriately certified as a tissue bank by the agency. (3) A person may not engage in the practice of eye procurement in this state without being appropriately certified as an eye bank by the agency. Funeral directors or direct disposers who retrieve eye tissue for an eye bank certified under this subsection are exempt from the certification requirements under this subsection. ST - B Cadaveric Organ and Tissue Procurement Title Cadaveric Organ and Tissue Procurement FS Procurement organizations may employ coordinators who are registered nurses, physician's assistants, or other medically trained personnel who meet the relevant standards for procurement organizations adopted by the agency under s , to assist in the medical management of organ donors or in the surgical procurement of cadaveric organs, tissues, or eyes for transplantation or research. A coordinator who assists in the medical management of organ donors or in the surgical procurement of cadaveric organs, tissues, or eyes for transplantation or research must do so under the direction and supervision of a physician medical director pursuant to rules and guidelines adopted by the agency. With the exception of organ procurement surgery, this supervision may be indirect supervision. For purposes of this section, the term "indirect

34 Page 34 of 73 supervision" means that the medical director is responsible for the medical actions of the coordinator, that the coordinator is operating under protocols expressly approved by the medical director, and that the medical director or his or her physician designee is always available, in person or by telephone, to provide medical direction, consultation, and advice in cases of organ, tissue, and eye donation and procurement. Although indirect supervision is authorized under this section, direct physician supervision is to be encouraged when appropriate. ST - B Cadaveric Organs / Out-of-State Physicians Title Cadaveric Organs / Out-of-State Physicians FS Any physician currently licensed to practice medicine and surgery in the United States may surgically procure in this state cadaveric organs for transplant if: (1) The organs are being procured for an out-of-state patient who is listed on, or referred through, the United Network for Organ Sharing System; and (2) The organs are being procured through the auspices of an organ procurement organization certified in this state. ST - BE600 - Federal Compliance Title Federal Compliance 59A-1.005(45-46) FAC