Blood Bank Procedure H83 - HCV, HIV, and Other Look-back Notifications

Transfusion Medicine Services

HCV,  HIV AND OTHER LOOK-BACK NOTIFICATIONS

 

Purpose: To define the process for identification and notification of recipients of blood components from prior donations of persons who now test positive for HCV, HIV-1 and/or HIV-2; and also, when deemed indicated, for other post-donation information.

Procedure:

A.        Investigate disposition of product(s):

1.       When a blood collection agency identifies a donor whose blood demonstrates possible infection with the viral agent(s) for HCV, HIV-1 and/or HIV-2, and in certain other instances, written notice is sent to the Medical Director of the Blood Bank and Transfusion Service (BBTS) to which blood components of previous donations by that donor were shipped. Such notices typically contain the following information:

a.      type of component shipped

b.      ABO/Rh type of component

c.      date shipped

d.      product expiration

2.      When such notification is received, the BBTS Medical Director provides the information to the Blood Bank Manager, who is responsible for completing a search of Blood Bank records to identify the disposition of each component specified in the notification. See procedure H80, “Blood Product Recipient Look-back Data Retrieval”, for help in finding data.

3.      Record requested information on the form provided by the blood supplier.

a.      If component was not transfused and is no longer in inventory record final disposition on supplier form, retain a copy for Blood Bank records. Return original form to the blood supplier; faxing form is acceptable. Attach Print Screen from ‘Final Disposition’ to our copy.

b.      If component is still in inventory, quarantine immediately, return to blood supplier and record final disposition on the form provided by the supplier. Retain a copy for Blood Bank records and return original form to the blood supplier with component(s).

c.      If component was transfused, record donor and patient information on BB:14, "TTD Look-Back" form.

B.        Completion of BB:14:

1.      Complete parts 1-5 of the form using the information supplied either from the blood supplier notification form or directly from the blood supplier.

2.      Record patient information obtained from Blood Bank records on the first line of part 6. The information required to complete sections 7 and 8 will be obtained by the Blood Bank and Transfusion Medicine Resident and/or Fellow.

3.      Part 9, 1 and 2 will be completed by the Blood Bank and Transfusion Resident and/or Fellow.

C.                Notification, counseling and testing:

1.      HIV1/2:

a.      When the supplemental test for HIV is positive, a recipient’s attending physician of record will be notified of the need for HIV testing and counseling.  If the attending physician of record is no longer employed at the University of Virginia, that physician’s division chief or department chair will be notified.  The physician will be informed in accord with Federal Regulation 21CFR 610.46:

                                                  i.      Reasonable attempts to notify the recipient should be completed within 8 weeks after receiving the supplemental test results.

                                                ii.      A legal representative or relative of the recipient should be notified if the recipient is a minor, deceased, or adjudged incompetent by a state court.

                                              iii.      If the recipient is competent, but state law permits a legal representative or relative to receive information on behalf of the recipient, such notification is also permissible.

                                               iv.      At least 3 separate attempts to notify the recipient must be made.

b.      Record of notification or failure to notify will become part of the patient’s medical record.

c.      Record of notification and results of testing, if applicable, will be maintained in recipient’s record in the Blood Bank.

d.      The Blood Bank Manager will complete any additional forms supplied by the blood supplier, and return them to the supplier in accord with the instructions provided by the supplier.

e.      Copies of all forms related to this event will be retained permanently in the Blood Bank.

f.        The BBTS Medical Director has final responsibility for assuring that this procedure is followed.

2.      HCV:

a.      When the supplemental test for HCV is positive, a recipient’s attending physician of record will be notified of the need for HCV testing and counseling.  If the attending physician of record is no longer employed at the University of Virginia, that physician’s division chief or department chair will be notified.  The physician will be informed in accord with Federal Regulation 21CFR 610.47:

                                                  i.      Reasonable attempts to notify the recipient should be completed within 12 weeks after receiving the supplemental test results.

                                                ii.      A legal representative or relative of the recipient should be notified if the recipient is a minor or adjudged incompetent by a state court.

                                              iii.      If the recipient is competent, but state law permits a legal representative or relative to receive information on behalf of the recipient, such notification is also permissible.

                                               iv.      At least 3 separate attempts to notify the recipient must be made.

b.      Record of notification or failure to notify will become part of the patient’s medical record.

c.      Record of notification and results of testing, if applicable, will be maintained in recipient’s record in the Blood Bank.

d.      The Blood Bank Manager will complete any additional forms supplied by the blood supplier, and return them to the supplier in accord with the instructions provided by the supplier.

e.      Copies of all forms related to this event will be retained permanently in the Blood Bank.

f.        The BBTS Medical Director has final responsibility for assuring that this procedure is followed.

3.      Other:

a.      At the discretion of a Blood Bank and Transfusion Medicine attending physician, recipient look-back may be conducted for other notifications.

b.      If such a process is undertaken, the procedure utilized for HCV look-back will be followed.

 

References:

AABB Standards for Blood Bank and Transfusion Services, 26th edition, p 81, Standard 7.4.6..

21 CFR 610.46, 610.47, Food and Drug Administration, 2010.

UVa Medical Center Policy No. 0019, “Alerts and Recalls of Products, Tissues, Devices, and Drugs.”  April 1, 2003.

42 CFR 482.27, Joint Commission PC 05.01.09