Agency for Health Care Administration

Transcription

1 Page 1 of 43 ST - O Initial Comments Title Initial Comments Type Memo Tag ST - O Eligibility Title Eligibility The agency is in substantial compliance with the requirements established in Chapter 381, F.S., and 59A-1, F.A.C., for an OPO certification. ST - O Eligibility Title Eligibility The OPO certificate is posted in a conspicuous place. Ch.59A-1.004(7), F.A.C. Surveyor shall verify that the current certificate is posted/hung in an area accessible to the public (bulletin board, wall, etc.). Access can be limited to a reception area, waiting room or offices as long as the public can access the area. Access is to be allowed at least during normal awake/business hours, 9-5, seven days a week. Framing, laminating the license is optional, as long as the printed information is visible and shows no signs of alteration.

2 Page 2 of 43 ST - O Eligibility Title Eligibility The agency has clearly defined its purpose. Ch.59A-1.005(1)(a), F.A.C. 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 - O Organizational Standards Title Organizational Standards Each OPO shall comply with 42 CFR Part 485, 1994, and make the records relating to the federal standards available upon request to surveyors for the AHCA. Ch.59A-1.005(20), F.A.C. ST - O Organizational Standards Title Organizational Standards Each OPO shall comply with existing federal laws and guidelines in its fiscal and accounting procedures.

3 Page 3 of 43 Ch.59A-1.005(21), F.A.C. ST - O Organizational Standards Title Organizational Standards There is an agency policy indicating a provision for access by the medical examiner for cases which fall within the medical examiner's jurisdiction. Surveyor shall review written documentation of agreement with medical examiner's office. The agreement may differ with each service area. Ch.59A-1.005(1)(a)4., F.A.C ST - O Agency Staffing Title Agency Staffing The agency director's job description clearly indicates that he is responsible for: 1. all procedures and policies which are developed and maintained under his/her supervision. Ch. 59A-1.005(1)(a)2., F.A.C. 1. Surveyor shall review documentation for evidence that the agency director reviews procedures and policies. 2. all administrative operations including, but not limited to, compliance with these standards. Ch. 59A-1.005(1)(a)2.a., F.A.C. 3. coordination of daily operations of the agency. Ch. 59A-1.005(1)(a)2.b., F.A.C.

4 Page 4 of implementing the policies of the board of directors or advisory board. Ch. 59A-1.005(1)(a)2.b., F.A.C. 5. prescribing technically acceptable means for procuring, processing, quality control, storage, and distribution of tissue. Ch. 59A-1.005(1)(a)2.b., F.A.C. 6. ensuring that technical staff maintain competency through training courses and technical meetings or other educational programs. Ch. 59A-1.005(1)(a)2.d., F.A.C. 6. Surveyor shall review records for evidence that the employee is qualified by training and experience for the scope of activities being pursued, e.g., physician, cryobiologist, geneticist or scientists in a medical discipline. 7. appointing technical staff with capabilities and training appropriate to their function. Ch.59A-1.005(1)(a)2.g., F.A.C. ST - O Agency Staffing Title Agency Staffing The OPO has a licensed physician medical director, licensed to practice medicine and surgery in the state in which the agency is incorporated, the medical director provides supervision to coordinators and all other staff who assist in the medical management of donors. Florida-based agencies must have a medical director licensed to practice medicine and surgery in Florida. Surveyor shall review the records for documentation that the medical director or designee is always available in person or by telephone to provide medical direction or consultation. Ch.59A-1.005(1)(a)3., F.A.C. ST - O Agency Staffing

5 Page 5 of 43 Title Agency Staffing The OPO shall have policies and procedures to facilitate and coordinate the procurement of donated organs by trained and qualified personnel. Ch.59A-1.005(26), F.A.C. ST - O Agency Staffing Title Agency Staffing Each employee is assigned duties which are consistent with his job description and with his level of education, preparation, and experience. Ch. 59A-1.005(1)(a)2.g., F.A.C., and Ch.59A-1.005(1) (a)5., F.A.C. Surveyor shall review documentation for evidence that employment applications, continuing education, certificates, and copies of licenses are on file to ensure that personnel are qualified for designated positions under Chapter 483, Part IV, F.S. ST - O Agency Policies Title Agency Policies The agency maintains a personnel policies manual. Ch.59A-1.005(1)(a)4., F.A.C. Surveyor shall verify that OPO personnel policies manual exists and is available to employees. Surveyor shall review documentation for copies of activities, specific responsibilities and reporting

6 Page 6 of 43 relationships that are established by written personnel policies approved by the director or designee. ST - O Agency Policies Title Agency Policies The agency has job descriptions for each employee and position. Surveyor shall review employee's file for completeness. Ch.59A-1.005(1)(a)5., F.A.C. ST - O Agency Policies Title Agency Policies Each agency shall maintain policies and procedure which detail all aspects for the procurement, processing, storage, and distribution practices. Ch. 59A-1.005(1)(a)6., F.A.C. 1. Each of these procedures is reviewed and affirmed in writing annually by the agency director or designee. Modifications of standard procedures and development of new procedures have been approved by the agency director or designee. Ch. 59A-1.005(1)(a)6.a., F.A.C. 2. Obsolete revised procedures are retained separately to maintain a historical sequence. Ch. 59A-1.005(1)(a)6.b., F.A.C.

7 Page 7 of Copies of the procedure and/or policies and procedures manual are available to the staff at all times. Staff are required to affirm/attest in writing in the manual to signify that they have read and understand the manual. Ch. 59A-1.005(1)(a)6.c., F.A.C. 4. Copies of procedures from published literature cited by reference shall be attached in an appendix to the procedures manual. Ch. 59A-1.005(1)(a)6.d., F.A.C. 5. Copies of the policies and procedures manual shall be available to surveyors for the AHCA for inspection upon request. Ch. 59A-1.005(1)(a)6.e., F.A.C. 6. Procedures shall be sufficiently detailed and unambiguous. Ch.59A-1.005(1)(a)6.f., F.A.C. ST - O Records Title Records The OPO maintains records in a format that can be readily used by a successor OPO. Uninterrupted service shall be maintained. Ch.59A-1.006(3)(a), F.A.C. ST - O Records

8 Page 8 of 43 Title Records Records shall be as detailed as necessary for a clear understanding of each activity and shall be available for inspection by surveyors for the AHCA. Ch.59A-1.005(1)(b)3., F.A.C. ST - O Records Title Records 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. Ch.59A-1.005(1)(b)2., F.A.C. ST - O Records Title Records All records shall be legible and indelible and shall identify the person performing the procedures/tasks.

9 Page 9 of 43 The record shall include dates of entries and test results. 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. Ch.59A-1.005(1)(b)2., F.A.C. ST - O Records Title Records There is an agency policy which indicates a provision for access by the medical examiner for cases which fall within the ME's jurisdiction. Ch.59A-1.005(1)(a)4., F.A.C. ST - O Records Title Records Donor medical records and results of all laboratory tests indicate that they were reviewed by the medical director, designees, or medical contractee. Ch.59A-1.005(1)(b)1., F.A.C. Surveyor shall review documentation for evidence that records and results of all laboratory tests are reviewed by medical director or designee prior to transplantation. ST - O Records Title Records

10 Page 10 of 43 Maintenance and certification records on facilities, instruments, and equipment, including monitors are maintained. Ch.59A-1.005(1)(b)7., F.A.C. ST - O Records Title Records Records shall be as detailed as necessary for a clear understanding of each activity and shall be available for inspection by surveyors for the AHCA when conducting an inspection or investigation pursuant to Ch. 59A-1.009(1)(a), (b), (c), F.A.C., upon request and within the bounds of medical-legal confidentiality, pursuant to s , F.S. Ch.59A-1.005(1)(b)3., F.A.C. ST - O Records Title Records All of these records are retained for seven years after distribution of organ(s).

11 Page 11 of 43 Ch.59A-1.005(1)(b)9., F.A.C. ST - O Community Involvement & Education Title Community Involvement & Education The OPO documents assistance to hospitals in developing protocols for making routine inquiries about organ and tissue donations by potential donors. Ch.59A-1.006(5)(a), F.A.C. ST - O Community Involvement & Education Title Community Involvement & Education The OPO documents that educational programs concerning organ procurement and donation for professional and lay people have been conducted. Ch.59A-1.005(5)(b), F.A.C. ST - O Community Involvement & Education Title Community Involvement & Education

12 Page 12 of 43 The agency produces and/or has available literature and media items that provide education for donation of organs, tissues, and/or eyes. Ch.59A-1.005(5)(d), F.A.C. ST - O Safety & Environmental Control Title Safety & Environmental Control The agency director shall establish written procedures and instructions for action in case of emergency or exposure to communicable disease, chemical and biological hazard. Surveyor shall review evidence that safety procedures and policies are posted or readily available to all personnel. Ch.59A-1.005(2), F.A.C. ST - O Safety & Environmental Control Title Safety & Environmental Control Human waste items are disposed so as to minimize any hazard to personnel or the environment. Dignified and proper disposal procedures are used to obviate recognizable human remains. Any organs or tissues from a donor whose blood test for HIV or hepatitis, pursuant to s , F.S., that are confirmed as positive by confirmatory testing shall be destroyed,

13 Page 13 of 43 treated, or disposed, in accordance with s , F.S., Chapter 403 Part IV, F.S., and 10D-104, F.A.C. Ch.59A-1.005(2)(a), F.A.C. ST - O Safety & Environmental Control Title Safety & Environmental Control The OPO complies with Occupational Safety and Health Administration (OSHA) rules 29 CFR Part , These rules establish requirements for minimizing exposure to Hepatitis, HIV, and other blood-borne pathogens. Surveyor shall review OSHA requirements, and if there appears to be non-compliance, refer immediately to OSHA. Ch.59A-1.005(2)(b), F.A.C. ST - O Facilities & Equipment Title Facilities & Equipment Facilities are designated for the specialized purposes for which they are to be used. There appears to be sufficient space, equipment, and supplies. Ch.59A-1.005(3)(a), F.A.C. ST - O Facilities & Equipment Title Facilities & Equipment

14 Page 14 of 43 All instruments and equipment are subjected to regularly scheduled maintenance and calibration. Ch.59A-1.005(3)(a), F.A.C. Surveyor shall review for evidence of documented maintenance records. ST - O Facilities & Equipment Title Facilities & Equipment Refrigerators and freezers used for the storage of tissues shall have monitors. Each agency shall have established procedures to follow in the event of electrical failure. Ch.59A-1.005(3)(a), F.A.C. ST - O Facilities And Equipment Title Facilities And Equipment An security system or physical configuration is provided to prevent entry of unauthorized persons. Ch.59A-1.005(3)(b), F.A.C.

15 Page 15 of 43 ST - O Ethical Standards Title Ethical Standards The OPO has written policies to avoid conflicts of interest. Ch.59A-1.005(4)(a), F.A.C. ST - O Ethical Standards Title Ethical Standards In the event that services other than obtaining referral or consent are provided to the procuring agency, that procuring agency may make arrangements to pay expenses incurred for services rendered. Reimbursement to the individual shall not be in conflict with the personnel policies of the primary employer. Ch.59A-1.005(4)(b), F.A.C. ST - O Quality Assurance Title Quality Assurance

16 Page 16 of 43 The QA program shall include ongoing monitoring and evaluation of its activities, identification of problems, and plans for corrective action. Ch.59A-1.005(1)(a)2.f., F.A.C. ST - O Quality Assurance Title Quality Assurance Tests and procedures are available for measuring, assaying, or monitoring properties of tissue essential to the evaluation of their safety and usefulness, e.g., hepatitis B surface antigen (HBsAG), human immunodeficiency virus HIV-1 and HIV-2 antibodies, and hepatitis C virus (HCV) antibody. Ch.59A-1.005(1)(a)2.e., F.A.C. ST - O Quality Assurance Title Quality Assurance The agency's quality assurance program shall include a method for the transplanting surgeon to report adverse reactions from the transplantation of organ(s) and tissues(s) to the source OPO, tissue bank or eye bank, which in turn shall forward the adverse reaction

17 Page 17 of 43 information to the AHCA. Ch.59A-1.005(13), F.A.C. ST - O Qualty Assurance Title Qualty Assurance The QA procedures and records shall be reviewed at least annually and shall provide the basis for the development of the QA program. Ch.59A-1.005(1)(a)2.f., F.A.C. Surveyor shall review documentation for: 1. evidence of signed reviews by the agency director; and 2. evidence the modifications of standard procedures and development of new procedures are approved and signed by the director or designee. ST - O Informed Consent Title Informed Consent Personnel records indicate that agency personnel are trained in obtaining and documenting consent for donation. Ch.59A-1.005(7)(a)2., F.A.C. ST - O Informed Consent Title Informed Consent

18 Page 18 of 43 The agency documents consent has been obtained from each donor, next of kin, or other designated legal entity in order of priority and availability according to , F.S. Ch.59A-1.005(7)(a)3., F.A.C. ST - O Informed Consent Title Informed Consent A copy of the original signed consent form is retained in the agency's donor record. Ch.59A-1.005(7)(a)4., F.A.C. Surveyor shall review documentation for evidence that the consent form was written or spoken in language understandable to the donor or the donor's next of kin. Ch.59A-1.005(7)(b)(1), F.A.C. ST - O Informed Consent Title Informed Consent 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 s , F.S. In any cases falling under the provisions of

19 Page 19 of 43 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). Ch.59A-1.005(7)2., F.A.C. ST - O Donor Compensation Title Donor Compensation Monitory compensation other than reimbursement of donor-related expenses is prohibited. Ch.59A-1.005(9), F.A.C. ST - O Sale of Anatomical Matter Title Sale of Anatomical Matter There is a policy in the agency's procedure manual which states that sale of tissue by a living donor for financial compensation is illegal under Public Law , s. 301; 42 United States Code s. 274e; and Chapter 873, F.S.

20 Page 20 of 43 Ch.59A-1.005(10), F.A.C. ST - O Potential Cadaveric Donor Evaluation Title Potential Cadaveric Donor Evaluation The OPO shall ensure that donor death has been determined in accordance with s , F.S., and has documented such in the organ donor's medical record. Ch.59A-1.005(22), F.A.C. ST - O Potential Cadaveric Donor Evaluation Title Potential Cadaveric Donor Evaluation A gross external and internal examination of any area of the donor altered by the excision shall be performed and dictated or otherwise recorded by the excising surgeon(s) at the time of the surgical removal of organs from the cadaveric donor. Ch.59A-1.005(23), F.A.C. ST - O Potential Cadaveric Donor Evaluation Title Potential Cadaveric Donor Evaluation

21 Page 21 of 43 A written report of these findings shall be immediately prepared and delivered to the person(s) responsible for the autopsy of the donor. 1. This report contains an itemization of all normal conditions noted as well as all abnormal pathological findings found during the gross internal examination of the donor. 2. Whenever a full medical autopsy of the donor will not subsequently be performed by the medical examiner, the OPO shall attempt to obtain a full medical autopsy by other means. 3. Upon request, the OPO shall make a copy of the autopsy report available to all recipient transplant programs that were in receipt of the donor's organs and will affix a copy of the report to the donor record. Ch.59A-1.005(23), F.A.C. ST - O Potential Cadaveric Donor Evaluation Title Potential Cadaveric Donor Evaluation 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.

22 Page 22 of 43 Ch.59A-1.005(24), F.A.C. ST - O Potential Cadaveric Donor Evaluation Title Potential Cadaveric Donor Evaluation The OPO's organ donor evaluation and management procedures shall be approved by the OPO medical director. These procedures are to be undertaken with medical supervision and support. Ch.59A-1.005(24)(a), F.A.C. ST - O Potential Cadaveric Donor Evaluation Title Potential Cadaveric Donor Evaluation 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. Ch.59A-1.005(24)(b), F.A.C. ST - O Potential Cadaveric Donor Evaluation

23 Page 23 of 43 Title Potential Cadaveric Donor Evaluation The evaluation of the donor shall conclude: 1. an attempt to acquire a social history; 2. a physical examination; 3. documentation of the donor's ABO group, donor's weight and height; 4. a review of the current inpatient medical record; and 5. documentation of significant events in the donor's clinical course. Ch.59A-1.005(24)(c), F.A.C. ST - O Potential Cadaveric Donor Evaluation Title Potential Cadaveric Donor Evaluation In the brain dead donor, the OPO shall ensure that adequate respiratory, hemodynamic and electrolyte management of the donor is provided. Ch.59A-1.005(24)(d), F.A.C. ST - O Potential Cadaveric Donor Evaluation

24 Page 24 of 43 Title Potential Cadaveric Donor Evaluation The OPO shall ensure that the donor receives appropriate antibiotic coverage, if a need is indicated. Ch.59A-1.005(24)(e), F.A.C. ST - O Potential Cadaveric Donor Evaluation Title Potential Cadaveric Donor Evaluation 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: Surveyor shall refer to Chapter 483, Part I, F.S., for licensure requirements for laboratory testing. 1. hepatitis testing according to OPTN policies and/or procedures; 2. FDA-licensed HTLV test; 3. appropriate FDA licensed HIV-1 and HIV-2 screens; 4. serologic test for syphilis (STS); 5. blood and urine cultures; 6. cultures of preservation solutions; 7. CMV; and

25 Page 25 of CBC. Ch.59A-1.005(24)(f)1.-8., F.A.C. ST - O Allocation Of Donated Organs Title Allocation Of Donated Organs Each OPO shall have a policy to ensure that donated organs are allocated according to the standards of the OPTN and in keeping with OPTN-approved local variances. Organs that are allocated outside of the sequence of patients, as determined by the OPTN, shall have documentation explaining the reason for the variance. Ch.59A-1.005(25)(a), F.A.C. ST - O Allocation Of Donated Organs Title Allocation Of Donated Organs 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. Ch.59A-1.005(25)(b), F.A.C. ST - O Allocation Of Donated Organs

26 Page 26 of 43 Title Allocation Of Donated Organs Organs shall be allocated by the OPO utilizing the sequence of patients as determined by OPTN computer or by an approved OPTN variance. Ch.59A-1.005(25)(c), F.A.C. ST - O Allocation Of Donated Organs Title Allocation Of Donated Organs Any variation from the OPTN donor/recipient match routine shall be documented and made a permanent part of the donor record. Ch.59A-1.005(25)(d), F.A.C. ST - O Allocation Of Donated Organs Title Allocation Of Donated Organs Documentation of actual allocation of each organ procured shall be filed in accordance with OPTN

27 Page 27 of 43 guidelines as specified in Ch. 59A-1.005(24). Ch.59A-1.005(25)(e), F.A.C. ST - O Organ Procurement Procedures Title Organ Procurement Procedures The OPO has policies and procedures to facilitate and coordinate the procurement of donated organs by trained and qualified personnel. Ch.59A-1.005(26), F.A.C. ST - O Organ Procurement Procedures Title Organ Procurement Procedures 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 medical director. Ch.59A-1.005(26)(a), F.A.C. ST - O Organ Procurement Procedures Title Organ Procurement Procedures

28 Page 28 of 43 The medical director of the OPO shall be responsible for the surgical standards and technical quality of services provided by their consulting surgeons. Ch.59A-1.005(26)(b), F.A.C. ST - O Organ Procurement Precedures Title Organ Procurement Precedures In the brain dead donor, 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. The goal of this intra-operative support includes: Surveyor shall review documentation for evidence of information/guidelines for the administration of anesthesia for the intra-operative procedure. 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. Ch. 59A-1.005(26)(c)1.-4., F.A.C.

29 Page 29 of 43 ST - O Organ Procurement Procedures Title Organ Procurement Procedures 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. Ch.59A-1.005(26)(d), F.A.C. ST - O Organ Procurement Procedures Title Organ Procurement Procedures The OPO has responsibility for packaging and labeling organs, tissue typing material and blood, according to OPTN policy 5.0. Ch.59A-1.005(26)(e), F.A.C. ST - O Organ Procurement Procedures Title Organ Procurement Procedures

30 Page 30 of 43 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. Ch.59A-1.005(26)(f)4.a., F.A.C. ST - O Organ Procurement Procedures Title Organ Procurement Procedures The OPO has a policy for the reconstruction of the body which is integral to maintaining the dignity of the donor. Ch.59A-1.005(14), F.A.C. ST - O Donor Information Documentation

31 Page 31 of 43 Title Donor Information Documentation The OPO has a standardized method of recording the following information on each donor: 1. name; 2. age, sex, race; 3. cause of death; 4. time and date of hospital admission; 5. time and date of pronouncement of death; 6. UNOS identification number; and 7. OPO identification number. Ch.59A-1.006(26)(f)4.b.(I-VII), F.A.C. ST - O Donor Information Documentation Title Donor Information Documentation The OPO documents the following information for purposes of follow-up: 1. name and address of the legal next of kin;

32 Page 32 of record of the organs donated; 3. name of attending and consulting doctor; 4. medical examiner or coroner, as applicable; 5. copy of signed consent form; and 6. copy of declaration of death note. Ch.59A-1.005(26)(f)4.c.(I-VI), F.A.C. ST - O Donor Information Documentation Title Donor Information Documentation The OPO obtains a medical and social history of each potential donor in an attempt to determine whether the potential donor is in a "high risk" group as described in 59A-1.005(11)(a), F.A.C. That history shall be communicated in writing to the physician responsible for the care of the recipient. Ch.59A-1.005(26)(f),4.d., F.A.C. ST - O Donor Information Documentation Title Donor Information Documentation The documented past medical history shall, when

33 Page 33 of 43 available, include significant episodes of the following: 1. any previous hospitalization; 2. any prior surgery; 3. history of a chronic illness, e.g., diabetes, hypertension, cardiovascular disease, etc.; 4. history of communicable disease, e.g., hepatitis; and 5. history of disease specific to transplantable organs and treatment of same. Ch.59A-1.005(26)(f)4.e.(I - V), F.A.C. ST - O Donor Information Documentation Title Donor Information Documentation The current hospital history is the most vital and shall include: 1. description of injuries and treatments (e.g., surgeries); 2. account of significant febrile episodes - duration, treatment, and response; 3. account of cardiac and pulmonary arrests -- type, duration, and treatment required to restore function (particularly closed chest massage); and 4. record of blood transfusions -- type and amount. Ch.59A-1.005(26)(f)4.f.(I - IV), F.A.C.

34 Page 34 of 43 ST - O Donor Information Documentation Title Donor Information Documentation It is essential that the OPO document a detailed picture of the donor's hemodynamic status from admission through organ procurement in a standardized, easy to interpret manner. Ch.59A-1.005(26)(f)4.g., F.A.C. ST - O Donor Information Documentation Title Donor Information Documentation Documentation of blood pressures shall include: 1. average pressure; 2. any hypotensive periods, -- noting lowest pressure and duration; 3. use of vasopressors -- type, amount, duration, and response; 4. any periods of prolonged hypertension -- highest pressure, duration, and treatment instituted; 5. any abnormal heart rhythm and treatment; and

35 Page 35 of Swan Ganz and central venous pressure readings and which shall be correlated with blood pressure, when available. Ch.59A-1.005(26)(f)4.h.(I - VI), F.A.C. ST - O Donor Information Documentation Title Donor Information Documentation All potential donors are to be tested for HIV-1 and HIV-2 antibodies, pursuant to 10D , F.A.C., and for the HTLV antibodies for which FDA-licensed test systems are available. Ch.59A-1.005(26)(f)4.i.(I), F.A.C. ST - O Donor Information Documentation Title Donor Information Documentation Organs from donors with repeatedly reactive screening tests for HIV-1 and HIV-2 antibodies and HTLV antibodies are not suitable for transplantation unless subsequent confirmation testing unequivocally indicates that the original test result was unconfirmed. Ch.59A-1.005(26)(f)4.i.(I), F.A.C.

36 Page 36 of 43 ST - O Organ Specific Lab Results Title Organ Specific Lab Results The OPO shall document the following available lab results: (a) for ALL donors: 1. CBC; 2. Electrolytes; 3. ABO typing; 4. Blood and urine cultures; 5. Serological testing in accordance with OPTN guidelines; 6. Appropriate FDA-licensed HIV-1 and HIV-2 screens, FDA-licensed HTLV test. 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, urinary, and perfusion fluid, when appropriate, 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.

37 Page 37 of 43 (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: 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;

38 Page 38 of Serum lipase; and 3. Glucose. (f) LUNG evaluation: 1. Blood gases; 2. Chest X-ray; and 3. Sputum gram stain and culture. Ch.59A-1.005(27)(a)-(f), F.A.C. ST - O Volume Status Documentation Title Volume Status Documentation The OPO shall document detailed information on volume intake and urine output in order to assess and maintain donor stability. Ch.59A-1.005(28), F.A.C. ST - O Volume Status Documentation Title Volume Status Documentation The OPO shall document volume intake type (crystalloid vs. colloid) and amount for a minimum of 8 hours prior

39 Page 39 of 43 to organ procurement and for the duration of the operative procedure. The use of any blood or blood products shall be noted. Ch59A-1.005(28)(a), F.A.C. ST - O Volume Status Documentation Title Volume Status Documentation The OPO documents 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. Ch.59A-1.005(28)(b), F.A.C. ST - O Procurement Procedure Documentation Title Procurement Procedure Documentation The OPO is responsible for proper documentation of the events surrounding the surgical removal of all organs for transplantation. Ch.59A-1.005(29)(a), F.A.C. ST - O Procurement Procedure Documentation

40 Page 40 of 43 Title Procurement Procedure Documentation On ALL donors, the OPO documents the following intra-operative information: 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. If the organs are not used for transplantation or

41 Page 41 of 43 research, a written note regarding discard shall be documented in the OPO's donor records. Ch.59A-1.005(29), F.A.C. ST - O Transplant Recipient Documentation Title Transplant Recipient Documentation The following information shall be documented on each recipient: 1. name; Surveyor shall review records for documentation that the information is available on each recipient. 2. UNOS recipient identification number; 3. recipient center; 4. age, sex, and race. Ch.59A1.005(30), F.A.C. ST - O OPTN Forms Submission Title OPTN Forms Submission Each OPO shall routinely submit documentation describing donor activity to the OPTN, as required by 42 CFR Part 485, 1994.

42 Page 42 of 43 Ch. 59A-1.005(31), F.A.C. ST - O Adverse Reaction Policy Title Adverse Reaction Policy The agency has an adverse reaction policy. Ch.59A-1.011(1), F.A.C. ST - O Recall Procedure Title Recall Procedure A written procedure exists for the recall of organs or tissue or notification of recipient agencies of the possibility of contamination, defects in processing, preparation or distribution, or other factors affecting suitability of the tissue for their intended application. Ch.59A-1.005(14), F.A.C. ST - O Look Back Procedure Title Look Back Procedure

43 Page 43 of 43 The agency has procedures for notifying the transplanting agency or physician that they may have received infected organs or tissues. Ch.59A-1.005(15), F.A.C. ST - O HIV Testing & Notification Title HIV Testing & Notification The agency describes procedures for HIV testing and notification pursuant to s , F.S., and 10D , F.A.C. Ch.59A-1.005(16), F.A.C. ST - O Final Observations Title Final Observations Type Memo Tag