Blood Regulations (SOR/2013-178)

Marginal note:Retention periods — allogeneic blood

• 119 (1) An establishment that collects allogeneic blood must keep the records set out in column 1 of the table to this section for the period set out in column 2.

• Marginal note:Calculation of record retention period

  (2) The record retention period begins on the day on which the record is created, except for the personnel records set out in item 28 of the table, in which case the period begins on the last day on which the employee was last employed by the establishment.

  Item	Column 1	Column 2
  	Records	Retention period
  1	Donor identification code	50 years
  2	Donation code	50 years
  3	Reconciliation of donation codes	10 years
  4	Donor suitability assessment	5 years
  5	Determinations of donor unsuitability — indefinite	50 years
  6	Determinations of donor unsuitability — temporary	10 years
  7	Collection — date of donation	50 years
  8	Collection — donor apheresis	5 years
  9	Collection — record of donation	5 years
  10	Lot number and name of manufacturer of container and other critical supplies for each donation	1 year
  11	Test results for transmissible disease testing, ABO group and Rh factor, and clinically significant antibody testing	50 years
  12	Blood component preparation	10 years
  13	Blood storage temperature monitoring	5 years
  14	Destruction or other disposition of blood	50 years
  15	Distribution	50 years
  16	Shipping documents	1 year
  17	Exceptional distribution	50 years
  18	Importation in urgent circumstances	50 years
  19	Post-donation information	10 years
  20	Complaints and their investigation	5 years
  21	Internal audit reports	5 years
  22	Quality control testing	5 years
  23	Maintenance, validation, qualification and calibration of critical equipment	3 years
  24	Critical supplies, including their qualification	3 years
  25	Proficiency testing	5 years
  26	Every version of the operating procedures that was implemented, other than those related to donor suitability assessments	10 years
  27	Every version of the operating procedures related to donor suitability assessments	50 years
  28	Personnel qualifications, training and competency evaluation	10 years
  29	Investigations and reports of errors and accidents	10 years
  30	Investigations and reports of adverse reactions	10 years