Blood Regulations (SOR/2013-178)

Marginal note:Retention periods — autologous blood

• 120 (1) An establishment that collects autologous 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 18 of the table, in which case the period begins on the last day on which the employee was employed by the establishment.

  Item	Column 1	Column 2
  	Records	Retention period
  1	Donor identification code	10 years
  2	Donation code	10 years
  3	Collection — donor record	5 years
  4	Lot number and name of manufacturer of container and other critical supplies for each donation	1 year
  5	Test results for transmissible disease testing, ABO group and Rh factor	10 years
  6	Blood component preparation	10 years
  7	Blood storage temperature monitoring	5 years
  8	Destruction or other disposition of blood	10 years
  9	Distribution	10 years
  10	Shipping documents	1 year
  11	Complaints and their investigation	5 years
  12	Internal audit reports	5 years
  13	Quality control testing	5 years
  14	Maintenance, validation, qualification and calibration of critical equipment	3 years
  15	Critical supplies, including their qualification	3 years
  16	Proficiency testing	5 years
  17	Every version of the operating procedures that was implemented	10 years
  18	Personnel qualifications, training and competency evaluation	10 years
  19	Investigations and reports of errors and accidents	10 years
  20	Investigations and reports of adverse reactions	10 years