Overview of Proposed Regulations under the Food and Drugs Act

Safety, Quality and Efficacy of Human Blood and Blood Components for Transfusion

1. Interpretation

The Interpretation section of the regulations will provide definitions of terms used in the new Blood Regulations. Examples of terms are: donor suitability assessment and release into inventory.

2. Application

The Application section of the regulations will describe the scope of the new Blood Regulations.

• The proposed regulations will apply to human whole blood and blood components for transfusion and include recovered plasma for further manufacture and red blood cells for immunization. It is proposed that the regulations would apply to:
  
  1. collection (includes donor registration and donor suitability assessment) and testing of whole blood and blood components for transfusion or recovered plasma for further manufacturing.
  2. processing, pooling, irradiation, washing, storage, importation from other countries and distribution of whole blood and blood components for transfusion.
• The proposed regulations will cover allogeneic designated, directed and walking donor donations as well as the collection and testing of whole blood and blood components for autologous use.
• If whole blood and blood components are imported, processed, stored or distributed for further manufacturing these regulations will not apply, since blood products are covered under Division 8 of the Food and Drug Regulations.
• The regulations will not apply to stem cells and cord blood, source plasma, therapeutic apheresis, peri-operative blood collection. Stem cells will be regulated under the CTO Regulations and source plasma will be regulated under the Plasmapheresis Regulations. Therapeutic apheresis and peri-operative blood collection are considered to be practice of medicine and will, therefore, not be regulated within this framework.
• No other regulations under the Food and Drugs Act will apply to the whole blood and blood components covered by these regulations.

3. Prohibition

The Prohibition section of the regulations will describe what is not allowed unless regulatory requirements are met.

A general prohibition will prohibit the importation or sale of whole blood and blood components unless these regulations are met, and unless establishments collect (includes donor suitability assessment), test, process, pool, irradiate, wash, store or distribute whole blood or blood components in accordance with regulatory requirements.

3A. Establishments responsible for whole blood and blood components activities covered in the new Blood Regulations will be subject to regulatory requirements. The amount of regulatory oversight of establishments will be based on the risk associated with the activities that they perform.

3B. Activities will be classified based on potential risk to the safety of whole blood and blood components, the donor and the recipient. The proposed new regulatory framework defines:

• high risk activities as critical core activities with maximal impact on donor and recipient safety and the safety, quality and efficacy of allogeneic whole blood and blood components. These activities include donor suitability assessment, collection, processing, labelling, testing, release and importation of allogeneic whole blood and blood components.
• medium risk activities as
  1. additional modification activities performed on allogeneic whole blood and blood components already distributed into the general blood supply, such as washing, pooling or irradiation of allogeneic blood; and/or
  2. activities with moderate impact on donor and recipient safety and the safety, quality and efficacy of whole blood and blood components, including collection, testing, labelling and storage of autologous blood.
• low risk activities as activities with minimal impact on donor and recipient safety and the safety, quality and efficacy of whole blood and blood components. These activities include transportation or storage of allogeneic whole blood and blood components released into general inventory and transfusion-related record keeping.

4. Licensing/Registering

The Licensing/Registering section is under development and will depend on the outcome of stakeholder consultations. It will describe when and what type of regulatory obligations establishments must meet in order to carry out activities, listed in the Prohibition section, related to whole blood and blood components.

Licensing, registration and/or third party accreditation, based on the risk associated with the activities the establishment undertakes, are all considerations. Once the regulatory tools are chosen, they will be stated in the Prohibitions section as prerequisite requirements to be fulfilled before undertaking specific activities.

• Establishments undertaking high risk activities, will be required to apply for an establishment licence.
• Stakeholder input will aid in determining the regulatory approach for establishments that undertake medium risk activities.
• Whole blood or blood components imported for transfusion will be covered by these regulations. Establishments importing whole blood or blood components will require an establishment licence.

5. Donor Suitability Assessment

The Donor Suitability Assessment section will reference clauses from the National Standard, CAN/CSA-Z902-04 Blood and Blood Components, and provide requirements for allogeneic, autologous, directed, designated and walking donor donations. Requirements will include:

• informing the donor of potential risks associated with donating blood and risks to the recipient of transfusion transmission of infectious disease by blood;
• collecting donor information;
• verifying that donors are in good general health, free from evidence of diseases transmissible by blood transfusion or conditions that would adversely affect (i) the safety, quality and efficacy of blood and blood components or (ii) the health of the donor; and,
• sharing donor deferral information

The Donor Suitability Assessment section will contain donor deferral criteria in line with what is currently proposed in Amending the Food and Drug Regulations (Human Plasma Collected by Plasmapheresis) Deferral Criteria Tables 1 and 2.

6. Collection

The Collection section will reference clauses from the National Standard, CAN/CSA-Z902-04 Blood and Blood Components, and contain requirements for the collection of whole blood and blood components; including,

• methods and devices
• samples for testing
• confidential unit exclusion
• post-donation information
• autologous collection
• blood components collected by apheresis

The Maximum Volumes and Minimum Intervals section will reference clauses from the National Standard, CAN/CSA-Z902-04 Blood and Blood Components, and include requirements for:

• whole blood and blood components collected for allogeneic use

7. Testing

The Testing section will reference clauses from the National Standard, CAN/CSA-Z902-04 Blood and Blood Components, and contain requirements for allogeneic and autologous blood and blood components testing. The requirements include:

• test kits
• testing protocols
• screening tests for transmissible diseases
• ABO and RH group testing
• disposition of blood or blood components that test repeat reactive or positive
• testing for clinically significant red cell antibodies
• quality control testing
• visual inspection

8. Processing

8A. Labelling

This section will reference clauses from the National Standard, CAN/CSA-Z902-04 Blood and Blood Components, and include requirements for information to be provided on each container of blood or blood component and corresponding samples.

8B. Release into Inventory

This section will reference clauses from the National Standard, CAN/CSA-Z902-04 Blood and Blood Components, and include requirements for release of blood and blood components into general inventory.

8C. Exceptional Distribution

A blood establishment may distribute blood and blood components that have not been determined safe for transfusion, if regulatory conditions for exceptional distribution are met. In addition, a notice of exceptional distribution must be completed according to regulatory requirements and included in both the donor and recipient records. The blood establishment, following the exceptional distribution, must complete the regulatory requirements for donor assessment, any other appropriate follow-up testing and notification of the relevant transfusion establishment of the results.

8D. Walking Donor Programs

This section will reference clauses from the National Standard, CAN/CSA-Z902-04 Blood and Blood Components.

9. Storage and Storage During Transportation

This section will reference criteria listed in Table 2 'Storage requirements' from the National Standard, CAN/CSA-Z902-04 Blood and Blood Components and include requirements for:

• segregation of autologous, directed donation blood and blood components from the allogeneic blood supply
• environmental conditions for storage
• temperature requirements during transportation

10. Quality System

This section will reference the criteria set out in Table 3 'Allogeneic blood component quality control' of the blood standard and Table 4 'Record retention requirements' from the National Standard, CAN/CSA-Z902-04 Blood and Blood Components.

Establishments will be required to have a quality system in place that complies with the regulatory requirements for all activities. The purpose of the quality system is to maximize the safety, quality and efficacy of blood and blood components, or the safety of donors or recipients.

Other sections of the quality system include:

10A. Errors, Accidents and Serious Adverse Reaction Investigation and Reporting

Error and Accident (E/A) reporting will include requirements for:

• reporting of any serious E/A to Health Canada that may impact blood safety, quality or efficacy or the safety of the donor within a specific time frame
• steps to be taken following a suspected E/A
• contents of an E/A notice

Serious Adverse Reaction reporting will include requirements for:

• reporting of serious adverse reactions occurring in donors or recipients within a specific time frame
• steps to be taken following a suspected serious adverse reaction
• contents of a serious adverse reaction notice

Investigation will include a requirement for an establishment to cooperate by providing information relevant to an investigation of an E/A or a serious adverse reaction to the blood establishment conducting the investigation. The blood establishment will also be required to provide:

• a notice containing a preliminary report to Health Canada, within 24 hours after the start of the investigation
• notification of the investigation results to all implicated establishments
• a final report to Health Canada

The Lookback/Traceback section will include requirements for:

• when to conduct a lookback/traceback
• annual lookback/traceback summary reports to Health Canada
• annual written summary report of the outcomes of all closed investigations of lookbacks and tracebacks to Health Canada

10B. Records

Requirements for record-keeping include types of records, length of record retention, and record storage requirements within a records management system that achieves the following:

1. incorporates the donor identification code;
2. creates a complete and traceable history of the donation for each unit of blood or blood components, from donor registration to final disposition of blood component; and
3. is designed to allow rapid recall of blood or blood components.

11. Other

Other possible requirements may be developed for transitional provisions and quarantine.