The Agency is proposing to amend the rules governing organ, eye and tissue procurement organizations to include the current industry standards, to remove outdated requirements and to incorporate recommendations of the Organ and Tissue Procurement ...

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Health Facility and Agency Licensing

RULE NO.:RULE TITLE:

59A-1.005Standards for OPOs, Tissue Banks and Eye Banks

PURPOSE AND EFFECT: The Agency is proposing to amend the rules governing organ, eye and tissue procurement organizations to include the current industry standards, to remove outdated requirements and to incorporate recommendations of the Organ and Tissue Procurement and Transplantation Advisory Board established by Section 765.543, F.S.

SUMMARY: The rule details the regulatory standards for organ procurement organizations, tissue banks and eye banks. The proposed rule seeks to update the regulation to align with current industry practices.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: A SERC has not been prepared by the agency. For rules listed where no SERC was prepared, the Agency prepared a checklist for each rule to determine the necessity for a SERC. Based on this information at the time of the analysis and pursuant to section 120.541, Florida Statutes, the rule will not require legislative ratification. 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.

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.

RULEMAKING AUTHORITY: 408.819, 765.541(2), FS.

LAW IMPLEMENTED: 381.0041, 382.009, 406.11, 408.805, 765.512, 765.541, 765.542, 765.543, 765.545, 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 (IF NOT REQUESTED, THIS HEARING WILL NOT BE HELD):

DATE AND TIME: July 25, 2017, 3:00 p.m. to 5:00 p.m. ET.

PLACE: Agency for Health Care Administration, 2727 Mahan Drive, Building #3, Conference Room C, Tallahassee, FL 32308. Interested parties that would like to participate by phone can do so by using a call-in number and passcode: Call-in Number: 1(888)670-3525, Participant Passcode: 6396795315#

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Zachary Masters at [phone] or email at: [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

(Substantial rewording of Rule 59A-1.005 follows.  See Florida Administrative Code for present text.)

59A-1.005 Standards for OPOs, Tissue Banks and Eye Banks.

(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.

(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 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 employees 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 under contract to ensure compliance with all medical-legal 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.  

(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.

(f) Clinical Laboratory Testing. Any clinical laboratory tests performed within an OPO, tissue bank or eye bank must comply with Chapter 483, F.S., and the Clinical Laboratories Improvement Act of 1988 (CLIA-88), as applicable.

(g) Records.

1. Donor and recipient records shall be accurate, complete, and confidential as required by Section 456.057, 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 406.05, 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 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 456.057, 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 765.512(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 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.

(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 as required by Section 381.0098, 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

2. 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 1910.1030, effective April 3, 2012, which are incorporated herein by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX. These rules establish requirements for minimizing exposure to hepatitis, HIV, and other blood-borne pathogens.

(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 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.

(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 other than obtaining referral or consent 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.

(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.

(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 765.512, 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 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 765.512, 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).

(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 X, 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.

(8) Compensation for Donors. Monetary compensation other than reimbursement of donation-related expenses is prohibited.

(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 autopsy in the donor’s medical record and shall affix a copy of the report to the donor’s record. 

(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 by the procedure established by the OPO, eye bank or tissue bank.

(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.

(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.

(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 shall be included in the policies and procedures.

(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.

(15) HIV Notification Requirements. Notification of HIV test results shall be given as required by Section 381.0041, F.S. and Rule 64D-2.005, F.A.C.

(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 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.

(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.

(18) Each OPO shall comply with 42 CFR Parts 413, 441, 486, and 498, effective May 31, 2006, incorporated herein by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX.  Records relating to the federal standards must be made available upon request.

(19) Each OPO shall be a member in good standing of the Organ Procurement Transplantation Network (OPTN) created by 42 CFR Part 121.

(20) Each OPO shall employ or have under contract a physician medical director who:

(a) Is licensed to practice medicine in the state of Florida;

(b) Is board certified in a specialty recognized by the American Board of Medical Specialties (ABMS); and

(c) Has a minimum of two (2) years affiliation with an OPO, transplant program or tertiary care hospital associated with a transplant program.

(21) The Medical Director of an OPO shall provide direction and supervision to coordinators and all other staff who assist in the procurement of organs for transplantation.  With the exception of organ recovery surgery, this may be indirect supervision.

(22) Financial Policies and Procedures. Each OPO shall comply with existing federal laws and guidelines in its fiscal and accounting procedures.

(a) The OPO shall have accounting and other fiscal procedures necessary to ensure the fiscal stability of the organization, including procedures to obtain payment for kidneys and non-renal organs provided to transplant centers.

1. There shall be an annual budget approved by the board of directors or advisory board.

2. Unless otherwise provided by law, there shall be an annual audit conducted by an independent public accountant. In the case of hospital OPOs, the hospital must undergo an annual financial audit.

3. There shall be adequately trained staff or qualified contractors to ensure the establishment and maintenance of internal controls and general accounting functions. The general accounting functions shall include management of accounts receivable, management of accounts payable and other disbursements, and the handling of cash. An OPO shall maintain the ability to generate periodic statements of the status of the assets, liabilities and fund balance, and statements of its periodic revenues and expenses. Hospital OPOs shall be exempt from this requirement to the extent that these functions are performed by hospital staff.

(b) The OPO shall have policies and procedures established for the documentation of all direct and indirect costs. These costs shall be used as the basis for the establishment of organ and tissue procurement charges.

(c) An OPO shall establish accounting policies and procedures to permit allocation of all its direct and indirect costs to the organ and tissue cost centers maintained. Hospital OPOs shall adhere to an appropriate hospital authority for established accounting policies and procedures.

(d) The accounting records of the OPO shall include documentation of allocations made to organ and tissue cost centers, as applicable, for each direct expense incurred by the OPO. Allocations shall be made insofar as they are related to the procurement of the particular organ. For example, records documenting the payment of a donor hospital bill shall identify the procured organs of the particular case and shall document the equal allocation of the costs to each organ type. The same procedure shall apply to other direct expenses related to the procurement, such as tissue typing or transportation. When these expenses are for the purpose of procurement of a particular organ(s), the cost shall be allocated only to that organ(s).

(e) The accounting records of the OPO shall permit the expensing of indirect costs, (e.g., office rent, utilities, administrative salaries and salary related costs) so that they may be allocated in compliance with Medicare rules and guidelines.

1. The OPO’s costs shall be charged as expenses and allocated in accordance with the appropriate guidance provided by the Medicare program or by the appropriate hospital authority for hospital OPOs and by established agreements with other agencies, companies, providers or vendors.

2. The costs paid by the OPO for services used in the procurement of organs (for example, surgeon’s fees, donor evaluation fees, laboratory, transportation, etc.) shall be based on reasonable and customary fees within the service area as determined by the OPO. The OPO may refer to limitations on the reimbursement of such costs as specified by the Medicare program.

(f) The OPO shall maintain the ability to develop and utilize average procurement costs as a basis for establishment of its organ and tissue acquisition charges. The acquisition charges are to be established in accordance with the OPO’s board of directors or advisory board and with reference to prevailing Medicare program rules and regulations. These charges shall be reviewed at least semi-annually and appropriate adjustments made unless otherwise proscribed.

(23) Verification of Death. The OPO shall ensure that death has been determined in accordance with traditional cardiopulmonary criteria or as required by Section 382.009, F.S., and documented in the organ donor’s medical record.

(24) An OPO’s policies and procedures for the evaluation and management of a potential organ donor shall be in writing. Evaluation and management of donors is mandatory for organs which may be allocated to and received by the Organ Procurement and Transplantation Network (OPTN)-approved transplant programs to ensure that all organ donors meet the minimum standards and the requirements established by the OPTN policies, effective April 6, 2017, incorporated herein by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX.

(a) The OPO’s organ donor evaluation and management procedures shall be approved by the OPO’s medical director.

(b) Once the patient has been declared dead or death is imminent and consent for donation has been obtained from the next of kin and from the medical examiner, if the death meets the requirements for referral to the medical examiner as specified in Chapter 406, F.S., the OPO shall implement the guidelines for the evaluation and management of the potential organ donor.

(c) The evaluation of the donor shall include:

1. An attempt to acquire a social history which may be obtained from individuals not limited to the person giving consent;

2. A physical examination of the donor;

3. Documentation of the donor’s ABO group, donor’s weight and height;

4. A review of the donor’s current inpatient medical record; and

5. Documentation of significant events in the donor’s clinical course.

(d) In the brain dead donor, the OPO shall ensure that adequate respiratory, hemodynamic and electrolyte management of the donor is provided.

(e) The OPO shall ensure that the donor receives appropriate antibiotic coverage, if a need is indicated.

(f) The OPO shall evaluate the infectious disease status of the potential donor. All serological testing shall be noted to be either pre- or post-transfusion. Such evaluation shall include:

1. Hepatitis testing according to OPTN policies and procedures;

2. Appropriate FDA-licensed HIV-1/HIV-2 screens;

3. Serologic test for syphilis (STS);

4. Blood and urine cultures;

5. Cytomegalovirus (CMV); and

6. Complete blood count (CBC).

(25) Allocation of Donated Organs.

(a) Each OPO shall have a policy to ensure that donated organs are allocated according to OPTN policies, effective April 6, 2017.

(b) The OPO shall document that the OPTN computer was accessed and reason for selection of a donor/recipient match and the placement allocation of the donor organ.

(c) Organs shall be allocated by the OPO utilizing the sequence of patients as determined by OPTN computer or by an approved OPTN variance.

(d) Documentation of actual allocation of each organ procured shall be filed in accordance with OPTN policies, effective April 6, 2017.

(26) Procurement Procedures. The OPO shall have written policies and procedures to facilitate and coordinate the recovery of donated organs by trained and qualified personnel.

(a) A certified HHS OPO shall ensure that any surgeons (i.e., surgeons whose fees are paid by the OPO) working as consultants to the OPO for the surgical recovery of donated organs meet qualifications and standards as set by the OPO’s medical director.

(b) The medical director of the OPO shall be responsible for the surgical standards.

(c) The OPO is responsible for coordinating anesthesia support for the organ procurement process. The OPO shall provide protocols to the anesthesia support service for the intra-operative procedure which address:

1. Maintaining an adequate blood pressure, fluid volume, organ perfusion and function;

2. Adequate oxygenation and oxygen transport to the organs being procured;

3. Replacement of excessive volume loss; and

4. Administration of required and desirable medications to facilitate organ procurement and function.

(d) If the anesthesia records are not included in the donor’s chart, records reflecting documentation of anesthesia protocol used by the OPO shall be available for inspection.

(e) In all organ donors, the OPO is responsible for packaging and labeling organs, tissue typing material and blood, according to OPTN policies, effective April 6, 2017.

(f) In all organ donors, the OPO is responsible for distributing the following documentation to each transplant center receiving an organ from an individual donor:

1. Verification of donor ABO type;

2. Copy of death determination from the donor’s medical record;

3. Copy of consent for organ procurement from the donor’s medical record; and

4. Copy of the following OPO donor information:

a. The OPO shall be responsible for documentation of demographic information relative to the donor so that pertinent information is available for centers considering organs for transplant. The OPO shall document information that will enable follow-up with the next of kin and donor hospital personnel.

b. The OPO shall have a standardized method of recording the following information on each donor:

(I) Name;

(II) Age, sex, race;

(III) Cause of death;

(IV) Time and date of hospital admission;

(V) Time and date of pronouncement of death;

(VI) United Network for Organ Sharing (UNOS) identification number; and

(VII) OPO identification number.

c. The OPO shall document the following information for purposes of follow-up:

(I) Name and address of the legal next of kin;

(II) Record of the organs donated;

(III) Name of attending and consulting doctor;

(IV) Medical examiner or coroner, as applicable;

(V) Copy of signed consent form; and

(VI) Copy of declaration of death note.

d. Documentation of donor history. The OPO shall obtain a medical and social history of each potential donor in an attempt to determine whether the potential donor is at increased risk as described in “PHS Guideline for Reducing Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus Transmission Through Organ Transplantation”, as published in Public Health Reports/July-August 2013/Volume 128, incorporated herein by reference and available online at: http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX. That history shall be communicated to the physician responsible for the care of the recipient.

e. The documented past medical history shall, when available, include significant episodes of the following:

(I) Any previous hospitalization;

(II) Any prior surgery;

(III) History of a chronic illness, e.g., diabetes, hypertension, cardiovascular disease, etc.;

(IV) History of communicable disease, e.g., hepatitis; and

(V) History of disease specific to transplantable organs and treatment of same.

f. The current hospital history is the most vital and shall include:

(I) Description of injuries and treatments (e.g., surgeries);

(II) Account of significant febrile episodes – duration, treatment, and response;

(III) Account of cardiac and pulmonary arrests – type, duration, and all treatment required to restore function (particularly closed chest massage); and

(IV) Record of blood transfusions – type and amount.

g. Documentation of donor hemodynamics.

h. Documentation of blood pressures shall include:

(I) Average pressure;

(II) Any hypotensive periods – noting lowest pressure and duration;

(III) Use of vasopressors – type, amount, duration, and response;

(IV) Any periods of prolonged hypertension – highest pressure, duration, and treatment instituted;

(V) Any abnormal heart rhythm and treatment; and

(VI) Swan Ganz and central venous pressure readings and which shall be correlated with blood pressure, when available.

i. Transfused donor.  All potential donors are to be tested for HIV-1/HIV-2 antibodies, pursuant to Rule 64D-2.005, F.A.C. If the donor’s pre-transfusion test is antibody negative and subsequent transfusions are pre-tested, retesting for HIV-1/HIV-2 antibodies is not necessary. If no pre-transfusion blood sample is available, the donor institution must provide, along with the screening test results, a complete history of all transfusions received by the donor during the ten (10) day period immediately prior to removal of the organs. Except as provided in Section 59A-1.005(2)(c), F.A.C., organs from donors with repeatedly reactive screening tests for HIV-1/HIV-2 antibodies are not suitable for transplantation unless subsequent confirmation testing unequivocally indicates that the original test result was unconfirmed. If additional tests related to HIV-1/HIV-2 antibodies are performed, the results of all tests must be communicated immediately to the recipient’s institution.

(27) Documentation of Organ-Specific Test Results. Requirements for organ specific testing shall be in writing. The OPO shall provide the transplanting physician with certain test results for the evaluation of organ function. These results shall be documented in a standardized manner.

(a) The OPO shall, at minimum, document the following available lab results for ALL donors:

1. CBC;

2. Electrolytes;

3. ABO typing;

4. Blood and urine cultures;

5. Serological testing in accordance with OPTN policies, effective April 6, 2017;

6. Appropriate FDA-licensed HIV-1/HIV-2 screens. If blood products have been given, a pre-transfused sample shall be obtained. If unavailable, explanation shall be documented in the donor’s medical record;

7. Cultures, including blood, and urine, which allow for interpretation of laboratory results. Each OPO must define procedures for the type, source and indication for obtaining these cultures;

8. CMV antibody.

(b) Kidney evaluation:

1. Urinalysis;

2. Creatinine; and

3. Blood urea nitrogen (BUN).

(c) Liver evaluation:

1. Liver enzymes;

2. Total bilirubin;

3. Direct bilirubin; and

4. Prothrombin time/partial thromboplastin time (PT/PTT).

(d) Heart evaluation:

1. 12 lead EKG;

2. Cardiology consult;

3. Chest X-ray;

4. Blood gases;

5. Echocardiogram or cardiac cath (optional); and

6. Creatine phosphokinase including MB fraction.

(e) Pancreas evaluation:

1. Serum amylase;

2. Serum lipase; and

3. Glucose.

(f) Lung evaluation:

1. Blood gases;

2. Chest X-ray; and

3. Sputum gram stain and culture.

(g) The OPO shall utilize an internal standard format or form to document all of the above-mentioned information.

(28) The OPO shall document detailed information on volume intake and urine output in order to assess and maintain donor stability.

(a) The OPO shall document volume intake type (crystalloid vs. colloid) and amount for a minimum of 8 hours prior to organ procurement and for the duration of the operative procedure. The use of any blood or blood products shall be noted.

(b) The OPO shall document urine output for a minimum of 8 hours prior, if possible, to organ retrieval and for the duration of the operative procedure. Any periods of oliguria, anuria, or the occurrence of diabetes insipidus and its treatment shall be documented.

(29) Documentation of Organ Retrieval Procedure.

(a) The OPO is responsible for proper documentation of intraoperative information and all information related to the surgical recovery of all organs for transplantation.

(b) Documentation shall include:

1. Blood pressures, urine output, and fluids administered;

2. Medications administered;

3. Blood products administered;

4. Type and amount of perfusion solution and flush characteristics;

5. Type of storage solution;

6. Type of procurement procedure (i.e., enbloc, in-situ perfusion);

7. Aortic cross-clamp time and date;

8. Description of typing material available;

9. Warm ischemia time;

10. Anatomical description:

a. Kidneys – include number of vessels and approximate length and diameter of each;

b. Extra renal – include description and any injuries or abnormalities; and

11. Organs recovered and not utilized. If the organs are not used for transplantation or research, a written note regarding disposition shall be documented in the OPO’s donor records.

(30) Documentation of Organ Recipient Information.

(a) The OPO shall document specific information on the recipients of recovered organs.

(b) The following information shall be documented on each recipient:

1. Name;

2. A recipient identification number;

3. Recipient center; and

4. Age, sex, and race.

(31) Each tissue bank shall comply with 21 CFR Part 1270, 2010 Edition, which is incorporated herein by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX and 21 CFR Part 1271, 2012 Edition which is incorporated herein by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX and make the records demonstrating compliance with the federal standards available to surveyors for the Agency.

(32) Each tissue bank shall be registered  as a tissue establishment with the U.S. Food and Drug Administration (FDA) as required by 21 CFR Part 1271.21. 

(33) Tissue Bank Organizational Staff Requirements.

(a) Each tissue bank shall employ or have under contract a physician medical director who maintains a valid state license from any state within the United States.

(b) Medical directors for tissue banks are limited to performing their responsibilities for multiple banks under the following criteria:

1. Medical directors for tissue banks where at least one of the tissue banks is performing Recovery, Processing and Distribution are not permitted to act as Medical Director for more than five (5) tissue banks at one time;

2. Medical directors for tissue banks which perform any one of the following (but no single tissue bank performing all three activities): Recovery, Processing or Distribution are not permitted to act as Medical Director for more than ten (10) tissue banks at one time;

(c) Medical directors are required to assure that no actual or potential conflict of interest occurs when acting as Medical Director for multiple tissue banks.

(d) Qualifications of technical personnel vary by nature of responsibility. Qualifications may be demonstrated by certification by examination administered by the American Association of Tissue Banks.

(e) All supervisory or senior technical personnel responsible for performing retrieval or processing activities shall be certified in tissue banking by the American Association of Tissue Banks within 18 months of employment with a licensed tissue bank.

(34) Tissue Donor Selection.

(a) The eligibility of each donor must be determined by a licensed Medical Director using all available relevant information.  Such determination shall be documented.

(b) A medical history shall be examined, if available. If scant medical history is available, as in the case of a sudden death, a documented attempt shall be made to acquire information beyond what is available before these tissues can be released. In the event that additional information or records cannot be found, the medical director shall determine if these tissues are suitable for release for transplantation and document the release in the donor’s medical record.

(c)  HIV infections. HIV testing is required under Rule 64D-2.005, F.A.C.

(d) Tissues with evidence of infectious diseases are conditions which shall preclude distribution for transplantation. The following is a list of examples of commonly encountered conditions which preclude donation of tissues:

1. Infectious diseases such as:

a. Septicemia (demonstrable) at time of death;

b. Systemic mycoses;

c. Meningitis or encephalitis;

d. Active systemic viral disease or past history of chronic viral disease;

e. Active tuberculosis;

f. Active hepatitis; and

g. Active syphilis or anatomically demonstrable syphilitic lesions.

2. Bacterial infections such as:

a. Pyelonephritis;

b. Peritonitis;

c. Pneumonia (other than non-confluent bronchopneumonia);

d. Bacterial endocarditis;

e. Osteomyelitis; and

f. Other potentially transmittable bacterial diseases.

3. Malignancies. Individuals with malignancies arising anywhere in the body shall be excluded from the donor pool. Any exceptions shall be approved by the medical director.

4. Collagen and immune complex diseases such as:

a. Rheumatoid arthritis;

b. Systemic lupus erythematosus;

c. Polyarteritis nodsa;

d. Sarcoidosis;

e. Myasthenia gravis; and

f. Acute rheumatic fever.

5. Transfused Donor.  Tissues from a donor who has been transfused shall comply with the FDA Guidance for Industry “Eligibilty Determination for Donors of Human Cells, Tissues and Cellular and Tissue-based Products (HCT/Ps)”, August 2007, incorporated herein by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX.

6. Recipients of organ transplants. Recipients or organ transplants shall not be automatically eliminted because of the transplant.

7. Other. Toxic exposure sufficient to affect tissue procured and an unknown but suspicious medical history shall constitute a reason for rejecting a donor.

(35) Required studies of the tissue donor in addition to FDA requirements specified in Rule 59A-1.005, F.A.C.

(a) Serologies:

1. HBcAb;

2. FDA-licensed HTLV test for viable, leukocyte rich cells or tissues only;

3. Serologic test for syphilis (STS) – confirmed. Tissues from donors with positive (confirmed) tests shall not be used for transplantation; and

4. Rh determination shall be provided cautioning about the possibility of sensitization.

(b) Evaluation of the donor. Prior to transplantation, the medical director, designees, or medical contractee shall state in writing that the current medical history, postmortem examination and laboratory test results, together with the available previous medical history, are sufficient to indicate that the donor is acceptable for tissue donation.

(36) Microbiological Examination. Each tissue bank shall have written microbiological laboratory policies and procedures which, at minimum, ensure allograft safety. Documentation of adherence to these policies and procedures is required.

(37) Tissue Bank Records.

(a) Responses from transplant centers which identify adverse reactions attributable to allografts shall be maintained. The records of the tissue bank shall be open to inspection by the Agency at a mutually convenient time.

(b) Records shall show the expiration date assigned to specific processed tissues as defined in the policies and procedures.

(c) To ensure suitability of donated tissues for transplantation, records shall be made concurrently with the performance of each step of processing of tissue allografts. Distribution records shall be available but these may be collected and stored separately. All records shall be legible and indelible, shall identify the person or persons performing the procedures, and shall include the dates of written entry. All records shall be made available to that surgeon on request. The only exception is information infringing upon donor confidentiality. All records shall be maintained for a minimum of ten years.

(d) A tissue bank, when sending tissue to a hospital or surgeon, must request in writing that the transplanting surgeon report allograft-related complications to the tissue bank’s medical director. Records of adverse reactions and all related follow-up documentation shall be maintained for a period of ten years.

(e) Inventory. A record of all unprocessed, processed, and distributed tissues shall be maintained.

(38) Documentation of Tissue Donor Information. The records shall include all information on the donor including laboratory reports, autopsy reports, a clinical history, a tissue procurement record, donor eligibility and related material. The records of the consent to procure the tissue are kept at least ten (10) years after the date of its administration, or if the date of its administration is not known, at least ten (10) years after the date of distribution, disposition, or expiration, whichever is later.

(39) Timely Procurement. The tissue bank shall have written procedures that specify the time limits for the recovery of tissue consistent with tissue-specific standards, where applicable.

(40) Tissue Bank Facilities and Equipment. Environmental monitoring procedures shall be established in writing as part of the quality assurance program, when applicable. Monitoring procedures, at minimum, shall include equipment and personnel monitoring where tissue contact occurs, work-surface cultures, and, where appropriate, static and dynamic air particulate air sampling.

(41) Tissue Retrieval and Processing Procedures.

(a) Tissues shall be retrieved using either aseptic or clean, nonsterile techniques. If tissues are retrieved using aseptic techniques, methods shall be consistent with standard operating room practice. Aseptic technique does not necessarily preclude the need for subsequent tissue sterilization. Allografts procured using aseptic or clean, nonsterile techniques are suitable for transplantation if adequate precautions are taken to identify and eliminate microorganisms.

(b) Tissue banks employing ethylene oxide (ETO) for sterilization of tissues, chambers of freeze-dryers, instruments or equipment must monitor occupational exposure to ethylene oxide. Semi-annual reports of ETO monitoring must be kept for 30 years. Specifically the following requirements must be met and documented:

1. Air change rate – minimum rate for rooms where ethylene oxide is used is 10 air changes per hour.

2. Review of gas circuits. The following must be checked for leaks:

a. Gas tank valves;

b. Gas tank manifolds including filter cartridges;

c. Sterilizer and other equipment door seals;

d. Pressure relief valves;

e. Gas-steam mixing chambers;

f. All elbows, compression fittings, gauges, valves, etc. along the gas circuit;

g. Gas inlet into chamber; and

h. Chamber air intake filter.

3. ETO alarm must be installed near equipment where ETO spill may be possible.

4. Automatic aeration after sterilization without having to open sterilizer door must be provided.

5. Periodic personnel exposure monitoring must be conducted.

6. A canister type respirator (NIOSH approved and rated for 5,000 ppm ETO) and gloves must be kept in the gas sterilization area in case of an emergency.

7. Safety data sheets must be kept in the tissue bank and the location of these sheets and content must be known to the employee.

8. An emergency evacuation plan must be posted for all employees to see.

9. Personnel must be trained regarding the safe use of ETO and records retained in the file.

10. All exhaust systems must be non-circulating.

(c) Tissues shall be processed into specimens appropriate for clinical use. The specific methods employed may vary with each type of tissue and with the manner in which it has been procured. Each type of tissue shall be processed according to written tissue bank procedures.

(d) Bone and tissue allografts shall be packaged in an environment specified in written procedures.

(42) Tissue Labeling.

(a) Container label. Containers shall be labeled so as to identify the following:

1. Name of the product;

2. Name and address of the tissue bank;

3. Tissue identification number; and

4. Expiration date, if applicable.

(b) Shipping label. Packages shall be labeled so as to identify the following:

1. Identification of human tissue;

2. Name and address of tissue bank;

3. Name of facility to which tissue is being shipped;

4. Recommended storage temperature; and

5. Special instructions indicated by the particular product, e.g., DO NOT FREEZE.

(43) Tissue Shipping.

(a) Each tissue bank shall have written procedures for shipping.

(b) Packaging shall be designed to ensure tissue quality and prevent contamination of the contents of the final container(s).

(c) All tissues shall be accompanied by a package insert which contains instructions for proper storage and reconstituting when appropriate. Specific instructions shall be enclosed with tissues requiring special handling. Such instructions shall include:

1. Presence of known sensitizing substances;

2. Type of antibiotics present, if applicable;

3. A statement that it has undergone infectious disease testing;

4. Sterilization procedure, if utilized; and

5. Concentration of preservative(s) and/or cryoprotectant(s) in final package solution, if applicable

(44) Tissue Tracking.

(a) Each tissue bank shall have written procedures for tissue tracking.

(b) Each tissue and any components derived therefrom shall be assigned, in addition to generic designation, one unique tissue identification number which shall identify the material during all steps from retrieval through distribution and utilization.

(45) Each eye bank shall comply with 21 CFR Part 1270, 2010 Edition, and 21 CFR Part 1271, 2012 Edition.

(46) Each eye bank shall be registered  as a tissue establishment with the U.S. Food and Drug Administration (FDA) as required by 21 CFR Part 1271.21. 

(47) Eye Bank Organization Staff Requirements.

(a) The medical director shall have served a corneal fellowship, and shall be certified by the American Board of Ophthalmology.

(b) Eye Bank technical personnel.

1. A supervisory eye bank technician shall be the individual responsible for the daily operation of the eye bank laboratory. The supervisory eye bank technician shall ensure compliance with these standards for the eye bank laboratory. Each eye bank processing laboratory must have at least one certified technician in a supervisory role.

2. An eye bank technician shall be trained in acquisition, evaluation, processing, storage and distribution of eye tissue for transplantation.

3. A procurement technician shall be proficient in screening and retrieval of the eye tissue.

(48) Training, Certification, and Continuing Education.

(a) An eye bank shall provide an orientation program for each new technician and the employee’s participation shall be documented.

(b) An eye bank shall provide educational opportunities such as in-service training programs, attendance at meetings, seminars, and workshops for all technical personnel, including laboratory supervisors, at a frequency that is defined and reasonable for the size and needs of the technical staff.

(c) To function as the supervisory technician in the eye bank processing laboratory, the technician must pass the Eye Bank Association of America’s (EBAA) Technician Certification examination or an approved examination administered by a medical school’s Department of Ophthalmology approved for residency training in ophthalmology.

(49) Performance Standards.

(a) Each eye bank shall demonstrate proficiency in all aspects of eye banking by annually retrieving, processing, or distributing at least 100 corneas for penetrating keratoplasty and provide the Agency with documentation of its performance upon request.

(b) Each eye bank shall have a consistent policy for the physical inspection of the donor and examination and documentation of the prospective donor’s available medical record or death investigation.

(c) Review of all available records on each eye donor shall be performed by an individual who is qualified by profession, education and training to do so, and who is familiar with the intended use of the tissue.

(50) Eye Donor Selection.

(a) Eye tissue from donors with the following shall not be used for penetrating keratoplasty, lamellar keratoplasty, patch grafts, epikeratoplasty or any other type of surgery:

1. Death of unknown cause;

2. Death from central nervous system diseases of unknown etiology;

3. Creutzfeldt-Jakob disease;

4. Subacute sclerosing panencephalitis;

5. Progressive multifocal leukoencephalopathy;

6. Congenital rubella;

7. Reye’s syndrome;

8. Active viral encephalitis of unknown origin;

9. Active septicemia (bacteremia, fungemia, viremia);

10. Active bacterial or fungal endocarditis;

11. Active viral hepatitis;

12. Rabies;

13. Intrinsic eye disease:

a. Retinoblastoma;

b. Malignant tumors of the anterior ocular segment;

c. Active ocular or intraocular inflammation: conjunctivitis, scleritis, iritis, uveitis, vitreitis, choroiditis, retinitis;

d. Congenital or acquired disorders of the eye which would preclude a successful outcome for the intended use, e.g., a central donor corneal scar for an intended penetrating keratoplasty, keratoconus, and keratoglobus; and

e. Pterygia or other superficial disorders of the conjunctiva or corneal surface involving the central optical area of the corneal button.

f. Exceptions are that tissue with local eye disease affecting the corneal endothelium may be used for epikeratoplasty, patch grafts, and scleral transplant surgery, and tissue with local eye disease affecting the corneal endothelium or previous ocular surgery that does not compromise the corneal stroma may be used for lamellar keratoplasty or patch grafts.

14. Prior intraocular or anterior segment surgery:

a. Refractive corneal procedures, e.g., radial keratotomy, lamellar inserts, etc.;

b. Laser photoablation surgery;

c. If corneas are used from donors who have had prior anterior segment surgery (e.g., cataract, intraocular lens, glaucoma filtration), the corneas shall be screened by specular microscopy and meet the eye bank’s endothelial standards as determined by the medical director; and

d. Laser surgical procedures such as argon laser trabeculoplasty, retinal and panretinal photocoagulation do not necessarily preclude use for penetrating keratoplasty but shall be cleared by the medical director.

15. Active leukemia;

16. Active disseminated lymphomas;

17. Hepatitis B surface antigen positive donors;

18. Recipients of human pituitary-derived growth hormone (pit-hGH) during the years from 1963-1985;

19. HIV seropositive donors;

20. Acquired immunodeficiency syndrome (AIDS);

21. Children (under 13 years old) and infants of mothers with AIDS or at high risk of HIV infection;

22. High risk for HIV infection based on the FDA Guidance Concerning Application of Testing and High Risk Criteria for HIV and Hepatitis for Banked Human Tissue, incorporated herein by reference.

23. HTLV infection except in the case of viable, leukocyte cell or tissue donors;

24. Active syphilis; and

25. Hepatitis C seropositive donors.

(b) Tissue from donors meeting the criteria in paragraph 59A-1.005(50)(a), F.A.C., above shall not be used for epikeratoplasty or other surgery with the exception that tissue with local eye disease affecting the corneal endothelium (e.g., aphakia, iritis) is acceptable for use. Interval of time from donor’s death to preservation of eye tissue may be extended.

(51) Eye Donor Testing.

(a) Microbiologic Culturing. Culturing of eye bank donor eyes is recommended. However, the responsibility for determining the need for culturing shall reside with the transplanting surgeon.

1. Presurgical Cultures. Eye banks may elect to perform corneal-scleral rim cultures at the time of corneal preservation in tissue culture medium. Positive culture reports shall be reported to the receiving surgeon or recipient eye bank.

2. Surgical Culturing. Each eye bank shall recommend culturing of the corneal-scleral rim for corneal transplantation, or a piece of sclera for scleral implantation at the time of surgery. Positive culture results in cases of postoperative infection shall be reported to the eye bank that processed the tissue.

(b) HIV Screening.

1. Each eye bank shall have an HIV screening program using FDA-approved tests, pursuant to Rule 64D-2.005, F.A.C., for all donors of surgically designated tissue. A negative screening test shall be documented prior to release of tissue for transplantation.

2. Eye tissue from a donor who has been transfused shall comply with the FDA Guidance for Industry “Eligibilty Determination for Donors of Human Cells, Tissues and Cellular and Tissue-based Products (HCT/Ps)”, August 2007.

(c) Hepatitis B Screening. Each eye bank shall have a hepatitis B screening program using an FDA-approved test for hepatitis B surface antigen for all donors of surgically designated tissue. A negative screening test or neutralization or confirmatory test must be documented prior to release of tissue for transplantation.

(d) Hepatitis C Screening. Each eye bank shall have a hepatitis C screening program using an FDA-approved test for hepatitis C surface antigen for all donors of surgically designated tissue. A negative screening test or neutralization or confirmatory test must be documented prior to release of tissue for transplantation.

(e) HTLV Screening. HTLV screening is required of viable, leukocyte rich cells or tissues only. If donor screening for HTLV has been performed, a negative screening test shall be obtained and documented prior to release of tissue for transplantation.

(f) Syphilis Screening. If the screening test is performed and is positive, a negative confirmatory test shall be obtained and documented prior to release of tissue for transplantation.

(52) Documentation of Eye Donor Information.

(a) Donor screening forms and copies of medical charts, medical examiner, or coroner review forms and gross autopsy results, if performed, shall be completed and retained on all donated eye tissue as part of the donor record. Until the final written autopsy report becomes available, documentation of verbal reports of autopsy findings are acceptable.

(b) Donor information forms shall contain information regarding the circumstances surrounding the death of the donor and medical history so that the suitability of the tissue for transplantation may be evaluated.

(c) Minimum information to be retained. A report form for retaining donor and recipient information shall be established for permanent record and shall be readily accessible for inspection by authorized individuals, including surveyors for the Agency. The record shall include the following minimum information:

1. Eye bank identification number unique to each tissue graft;

2. Name of eye bank;

3. Location of eye bank;

4. Phone number;

5. Type of preservation;

6. Age of donor;

7. Cause of death;

8. Death date and time;

9. Enucleation or in-situ retrieval date and time;

10. Preservation date and time;

11. Slit lamp report;

12. Specular microscopy, if performed;

13. Name of enucleator/evaluator/technician;

14. Name of surgeon receiving tissue;

15. Recipient identification;

16. Utilization of non-transplantable tissue;

17. All serological or microbiological tests performed; and,

18. Adverse reactions, when reported.

(d) Length of storage. All records shall be maintained for a minimum of ten years from the date of transplantation/ implantation.

(53) Eye Bank Facilities and Equipment.

(a) Each eye bank shall have sufficient space, equipment and supplies to perform the volume of laboratory services with optimal accuracy, efficiency, sterility, timeliness and safety.

(b) Each eye bank shall have an adequate stable electrical source and a sufficient number of grounded electrical outlets for operating laboratory equipment. Laminar flow hoods or similar piece of equipment shall be available for sterile processing.

(c) Each eye bank shall have a refrigerator with a device for recording temperature variations. Temperature variations shall be recorded daily and remain within the range of 2 degrees to 6 degrees C. These records shall be kept for a minimum of ten years. The refrigerator shall be maintained for the exclusive use of donor related material and shall contain clearly defined and labeled areas for all tissue stored, i.e., quarantined tissue, surgical tissue awaiting distribution, and research tissue.

(d) In the event of a power failure, there shall be established policies and procedures for action to be taken, which may include an emergency power supply to maintain essential refrigeration.

(e) No sterilized instruments, supplies, and reagents, such as corneal preservation medium for surgical tissues, shall be used beyond the expiration date for surgical tissues.

(54) Satellite Eye Banks.  Satellite eye banks that retrieve, process, and distribute tissue shall have a technician and be supervised by and have access to a qualified medical director or designee. Such satellite eye bank shall be inspected by surveyors for the Agency as part of the certification process for the parent eye bank.

(55) Eye Bank Retrieval and Processing Procedures.

(a) Enucleation procedure. Ultimate responsibility for personnel who perform enucleation rests with the director and the medical director.

(b) In-situ and facility-based removal of the corneal-scleral rim. Removal of the corneal-scleral rim shall be performed using sterile technique by individuals specifically trained in in-situ retrieval and facility-based removal of the corneal-scleral segment.

(c) Use of preservation medium. Eye banks shall use a corneal storage medium which has been used and stored according to the manufacturer’s recommendations. The manufacturer’s recommendations must be retained and made available for inspection by surveyors for the Agency.

(d) Long-term preservation. Eye banks employing long-term preservation of corneal tissue, such as organ culturing, shall carefully document the procedure in their procedures manual, and adhere to strict aseptic technique.

(e) Whole globe preservation. Eye banks that store whole eyes for lamellar or refractive keratoplasty shall employ aseptic practices using one of the preservation methods given in the eye bank’s procedures manual. The selected preservation method shall be documented in the eye bank’s own procedure manual.

(f) Scleral Preservation.

1. If the eye bank preserves scleral tissue, the selected preservation method shall be documented in the eye bank’s own procedures manual.

2. An expiration date for use of tissue shall be indicated based on the container capability and factors documented or recommended by the eye bank.

(g) Interval between death, enucleation, procurement, and preservation. Acceptable time intervals from death, enucleation, or procurement to preservation of eye tissue may vary according to the circumstances of death and interim means of storage of the body. Corneal preservation shall occur as soon as possible after death and within the time frame determined by the medical director as defined by the policies and procedures. All time intervals (i.e., time of death to the time of enucleation and preservation) shall be recorded for each donor.

(h) Eye maintenance prior to enucleation. The prospective donor’s corneal integrity shall be maintained. Procedures for eye maintenance shall be described in the eye bank’s policies and procedures. Each individual eye bank’s procedure is left to the discretion of the medical director and shall be clearly documented and adhered to.

(i) Review of donor medical history. Prior to distribution of tissue for transplantation, the medical director or designee shall review and document the medical and laboratory information in accordance with criteria established in this rule.

(j) Non-surgical donor tissue. If donor tissue is provided for purposes other than surgery, e.g., research, practice surgery, etc., and if that donor tissue is not screened for HIV, hepatitis, or syphilis, a label stating that screening for HIV-antibody, hepatitis B, hepatitis C, or syphilis has not been carried out or stating “Potentially Hazardous Biological Material” shall be attached to the container used for the donor tissue storage and transport.

(56) Eye Tissue Evaluation. The transplanting surgeon has ultimate responsibility for determining the suitability of the tissue for transplantation.

(a) Gross examination. The corneal-scleral segment shall be initially examined grossly for clarity, epithelial defects, foreign objects, contamination, and scleral color (e.g., jaundice).

(b) Slit lamp examination. The cornea shall be examined for epithelial and stromal pathology and in particular endothelial disease. Enucleated whole globes shall be examined in the laboratory prior to distribution and corneal retrieval. After corneal retrieval, the corneal-scleral rim shall be evaluated by slit lamp biomicroscopy, even if the donor eye has been examined with the slit lamp prior to retrieval of the corneal-scleral rim, to ensure that damage to the corneal endothelium or surgical detachment of Descemet’s membrane did not occur.

(57) Eye Tissue Storage.

(a) All surgical tissue shall be stored in quarantine until negative serology results have been documented, pursuant to Rule 64D-2.005, F.A.C.

(b) All tissue shall be stored at a temperature appropriate to the method of preservation used.

(c) Each eye bank shall precisely document its procedures for storage.

(58) Corneal or Scleral Tissue Labeling.

(a) Visual inspection. A sufficient area of the container shall remain unobstructed to permit inspection of the contents.

(b) Each corneal or scleral tissue shall be clearly and indelibly labeled to include, at least, the following:

1. Name of source eye bank;

2. Tissue identification number;

3. Type of tissue;

4. Date and time of donor’s death;

5. Date and time of corneal-scleral preservation;

6. Expiration date for scleral tissue; and

7. A statement shall accompany the tissue stating that:

a. The tissue is intended for single patient application only and that it is not to be considered sterile and that the FDA therefore recommends culturing or reculturing; and,

b. The tissue has undergone infectious disease testing.

(59) Eye Tissue Packaging.

(a) Each tissue shall be individually packaged and sealed with a shrink wrap.

(b) The tissue shall be packed in a water proof container with wet ice, so as to maintain the temperature of the tissue at an acceptable level. Packing shall be done so that the package insert and tissue label do not become wet. Special instructions shall be included on the package insert.

(c) Package insert. A package insert form shall accompany the tissue for transplantation. This form shall include the following:

1. Recommended storage temperature with specific emphasis on Do Not Freeze;

2. That the surgeon shall check for integrity of the seal and immediately report to the eye bank any evidence of possible tampering;

3. That color change per the manufacturer’s guidelines may indicate a change in pH, in which case the tissue shall not be used and a report made immediately to the eye bank;

4. Whether pre-surgical microbiological cultures were performed by the eye bank, including the advisement that culture of the donor rim and sclera shall be performed at the time of surgery; and,

5. The form shall also advise the receiving surgeon that the tissues are delivered with no warranty as to merchantability or fitness for a particular purpose, and that the receiving surgeon is ultimately responsible for judging if the tissue is suitable for use.

Rulemaking Authority 408.819, 765.541(2) FS. Law Implemented, 765.541, 765.542, 765.543, 765.545 FS. History–New 11-26-92, Amended 8-20-96, ________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Zachary Masters

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Justin M. Senior

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: 06/16/2017

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: 06/01/2016