Blood Regulations (SOR/2013-178)

Marginal note:Results of investigation

• 114 (1) The establishment that is conducting an investigation must notify in writing every establishment and other person to which it distributed implicated blood of the results of the investigation and of any action that is required to be taken.

• Marginal note:Notice to be forwarded

  (2) An establishment that is notified under subsection (1) or under this subsection must send a copy of the notice to every establishment to which it distributed implicated blood.

Marginal note:Final report to Minister

115 On completion of the investigation, the establishment must file a final report with the Minister that contains all of the following information:

• (a) the results of the investigation;

• (b) the final disposition of the blood that was the subject of the investigation and the reasons for that disposition; and

• (c) any corrective actions taken and any other changes that are recommended to be made to relevant processes.

Marginal note:Annual report

116 At the end of each year, an establishment must prepare an annual report that summarizes all of the final reports that it filed in the year, including a concise critical analysis of the investigations that were the subjects of those reports, and must file it with the Minister on request.

Records

Marginal note:Record quality

117 Records kept by an establishment must be accurate, complete, legible, indelible and readily retrievable.

Marginal note:Donation code part of all records

118 An establishment must ensure that the donation code is a component of all of its records that relate to the processing, distribution, transformation and transfusion of blood.

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

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

Marginal note:Retention periods — transformation

• 121 (1) An establishment that transforms 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 10 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	Donation code	10 years
  2	Records of washing, pooling and irradiation of blood	10 years
  3	Lot number and name of manufacturer of critical supplies for each transformation	1 year
  4	Complaints and their investigation	5 years
  5	Internal audit reports	5 years
  6	Quality control testing	5 years
  7	Maintenance, validation, qualification and calibration of critical equipment	3 years
  8	Critical supplies, including their qualification	3 years
  9	Every version of the operating procedures that was implemented	10 years
  10	Personnel qualifications, training and competency evaluation	10 years
  11	Investigations and reports of errors and accidents	10 years
  12	Investigations and reports of adverse reactions	10 years

Marginal note:Retention periods — transfusion

• 122 (1) An establishment that transfuses 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 11 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	Donation code — allogeneic blood	50 years
  2	Donation code — autologous blood	10 years
  3	Shipping documents	1 year
  4	Blood storage temperature monitoring	5 years
  5	Distribution	50 years
  6	Exceptional distribution	50 years
  7	Record of transfusion or disposition of allogeneic blood, including identification of recipient	50 years
  8	Record of transfusion or disposition of autologous blood	10 years
  9	Complaints and their investigation	5 years
  10	Every version of the operating procedures that was implemented	10 years
  11	Personnel qualifications, training and competency evaluation	10 years
  12	Investigations and reports of errors and accidents	10 years
  13	Investigations and reports of adverse reactions	10 years