GTP Scenario

1
GTP Scenario 6

• September 17,2005

2
Scenario 6

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

3
Scenario 6

• How can the Accompanying Records of Donor
  Eligibility be prepared and transmitted?
• What options are available?

4
Accompanying Records

• Options
• Use a paper record.
• Use an electronic record.
• Use a multi-copy paper summary.
• Use a shared-computer drive.

5
Accompanying Records

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

6
Accompanying Records

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

7
Accompanying Records

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

8
Accompanying Records

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

9
Accompany the Product ?

• What does accompany the product mean?
• Where does accompany end? At the bedside? At
  the nursing station?
• Should the laboratory place donor eligibility
  records in the patients medical record?

10
Accompany the Product ?

• What does accompany the product mean?
• The FDAs 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?
• The donor records do not need to go to the
  patients 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 patients 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 recipients
  medical providers.