1. GTP Scenario # 6 September 17,2005

2. Scenario # 6 The Institute of America collects, processes and transplants PBPC. The Institute of America collects, processes and transplants PBPC. Donor evaluations are performed by the Oncology Department. Donor evaluations are performed by the Oncology Department. Donor’s Medical Record contains dictated notes and laboratory results. Donor’s Medical Record contains dictated notes and laboratory results. IDM results are in the hospital computer system. IDM results are in the hospital computer system. Products are collected by Apheresis and delivered to the Processing Lab within the same hospital. Products are collected by Apheresis and delivered to the Processing Lab within the same hospital. After processing, the product is delivered to the patient’s room. After processing, the product is delivered to the patient’s room.

3. Scenario # 6 How can the “Accompanying Records” of Donor Eligibility be prepared and transmitted? How can the “Accompanying Records” of Donor Eligibility be prepared and transmitted? What options are available? What options are available?

4. Accompanying Records Options: Options: Use a paper record. Use a paper record. Use an electronic record. Use an electronic record. Use a multi-copy paper summary. Use a multi-copy paper summary. Use a shared-computer drive. Use a shared-computer drive.

5. Accompanying Records Paper Accompanying Record Paper Accompanying Record Needs to move from collection to processing to transplant areas. Needs to move from collection to processing to transplant areas. Needs to have documentation of the eligibility determination. Needs to have documentation of the eligibility determination. High risk of being ‘misplaced’. High risk of being ‘misplaced’. Not very practical. Not very practical.

6. Accompanying Records Electronic Accompanying Record. Electronic Accompanying Record. Need to add CLIA statement to IDM results. Need to add CLIA statement to IDM results. Need to make eligibility determination part of the electronic record. Need to make eligibility determination part of the electronic record. All appropriate personnel must have access. All appropriate personnel must have access.

7. Accompanying Records Multi-Copy Paper Summary Multi-Copy Paper Summary Would summarize all records used in the eligibility determination. Would summarize all records used in the eligibility determination. Would contain required statements. Would contain required statements. A copy could be maintained by each group (Collection, Processing Lab, Transplant Unit {patient chart}). A copy could be maintained by each group (Collection, Processing Lab, Transplant Unit {patient chart}).

8. Accompanying Records Shared-Computer Drive Shared-Computer Drive Create an electronic summary similar to paper summary. Create an electronic summary similar to paper summary. Must have secured access for entering information. Must have secured access for entering information. Must be easily accessible. Must be easily accessible.

9. Accompany the Product ? What does ‘accompany the product’ mean? What does ‘accompany the product’ mean? Where does ‘accompany’ end? At the bedside? At the nursing station? Where does ‘accompany’ end? At the bedside? At the nursing station? Should the laboratory place donor eligibility records in the patient’s medical record? Should the laboratory place donor eligibility records in the patient’s medical record?

10. Accompany the Product ? What does ‘accompany the product’ mean? What does ‘accompany the product’ mean? The FDA’s expectation is that the donor records will accompany the product to the transplant facility. The FDA’s expectation is that the donor records will accompany the product to the transplant facility. Where does ‘accompany’ end? At the bedside? At the nursing station? Where does ‘accompany’ end? At the bedside? At the nursing station? The donor records do not need to go to the patient’s bedside or to the nursing station, they need to be stored within the transplant facility and be available for review by any medical personnel needing access to these records in order to provide patient care. The donor records do not need to go to the patient’s bedside or to the nursing station, they need to be stored within the transplant facility and be available for review by any medical personnel needing access to these records in order to provide patient care.

11. Accompany the Product ? Should the laboratory place donor eligibility records in the patient’s medical record? Should the laboratory place donor eligibility records in the patient’s medical record? If the information is available within the transplant facility this is not required, but it may be done to ensure ‘quick access’ to donor eligibility information for the recipient’s medical providers. If the information is available within the transplant facility this is not required, but it may be done to ensure ‘quick access’ to donor eligibility information for the recipient’s medical providers.