Retention of Donor Records

Question 1

Inspection of incoming blood and components

Answer 1

10 years

Question 2

ID of individuals performing steps in collection, processing, compatibility testing, and transportation of blood and components

Answer 2

10 years

Question 3

Traceability of blood and components

Answer 3

10 years

Question 4

Source to final disposition of each unit of blood or component

Answer 4

10 years

Question 5

Unique ID of each unit

Answer 5

10 years

Question 6

Donor acknowledgement that educational materials were reviewed

Answer 6

10 years

Question 7

Parental permission for donation

Answer 7

10 years

Question 8

Consent for donors

Answer 8

10 years

Question 9

Notification to donor of abnormal findings

Answer 9

10 years

Question 10

Donors placed on permanent deferral and indefinite deferral

Answer 10

Indefinite

Question 11

Donor information, including address, PMH, PE

Answer 11

10 years

Question 12

Medical order from patient’s physician for autologous unit

Answer 12

10 years

Question 13

Platelet count for frequent plateletpheresis donors

Answer 13

10 years

Question 14

Cytapheresis record, including anticoagulant used, duration of procedure, volume of components, drugs used, lot number of disposables, and replacement fluids

Answer 14

10 years

Question 15

Maximal cumulative dose of sedimenting agents given to a donor

Answer 15

10 years

Question 16

Inspection of weld used during component preparation

Answer 16

10 years

Question 17

Verification of irradiation dose delivery

Answer 17

10 years

Question 18

Donation ID # and collecting facility for each unit in pooled components

Answer 18

10 years

Question 19

Preparation of specific components

Answer 19

10 years

Question 20

ABO group and Rh type of all collections

Answer 20

10 years

Question 21

Allogeneic donor antibody testing

Answer 21

10 years

Question 22

Control system results appropriate to method

Answer 22

10 years

Question 23

Interpretation of disease maker testing for allogeneics

Answer 23

10 years

Question 24

Distribution or issue of units before completion of tests

Answer 24

10 years

Question 25

Quarantine of units from prior collections when a repeat donor as a reactive marker

Answer 25

10 years

Question 26

Final review of records relating to testing and acceptability criteria

Answer 26

10 years

Question 27

Review of donor records to ensure any units from an ineligible donor are quarantined

Answer 27

10 years

Question 28

Serologic confirmation of donor ABO/Rh

Answer 28

10 years

Question 29

Reporting and resolution of ABO/Rh labeling discrepancies to collecting facility

Answer 29

10 years

Question 30

If a units is returned for reissue, confirmation that the tubing ID # on reattached segments is identical and confirmation that the blood or components have been inspected and are acceptable

Answer 30

10 years

Question 31

Signed statement from requesting physician indicating that the clinical situation was sufficiently urgent to require release of blood before completion of compatibility testing or ID testing

Answer 31

10 years

Question 32

Blood and components determined after release not to conform to requirements

Answer 32

10 years

Question 33

Adverse events related to donation

Answer 33

10 years

Question 34

Notification by cosign of a transfusion fatality or other serious adverse event

Answer 34

10 years

Question 35

Collection facility’s investigation of transmissible diseases

Answer 35

10 years

Question 36

Look-back investigation

Answer 36

10 years