• the geographic location of the patient-donor in relation to a CBS collection site is not convenient.
• patients often travel to urban areas for their surgical procedures and want to donate autologous blood closer to home.
• some high risk patients are not accepted by CBS programs and are therefore accommodated at the hospital where the surgery is anticipated. For example, some hospitals have autologous programs for open heart surgery patients.

For these reasons, hospital-based autologous blood programs have evolved. When hospital personnel perform these procedures, the hospital is considered a manufacturer of blood. With this responsibility come strict standards. The following information is provided for guidance and includes but is not limited to requirements specific to autologous blood collection programs outlined in the Canadian Standards Association, Standard CAN/CSA-Z902-04, Blood and Blood Components.

Note: With the permission of Canadian Standards Association, material is reproduced from CSA Standard CAN/CSA-Z902-04, Blood and Blood Components which is copyrighted by Canadian Standards Association, 178 Rexdale Blvd., Toronto, Ontario, M9W 1R3. While use of this material has been authorized, CSA shall not be responsible for the manner in which the information is presented, nor for any interpretations thereof. For more information on CSA or to purchase standards, please visit their website at www.shopcsa.ca or call 1-800-463-6727.
These references only provide basic guidance; users should refer to the standard for the full requirements of autologous donation.

General Requirements

1. There must be a medical director responsible for the collection program who authorizes each collection series.
2. A hospital that collects autologous blood for transfusion must have operating procedures in place that govern all activities for this program.
3. Any deviations from existing procedures must be justified by the medical director in consultation with the patient's physician.
4. The patient's physician must prescribe the autologous blood collection.
5. Informed consent must be obtained by authorized individuals.
6. Autologous blood must be used solely for that purpose and not be crossed over into the allogeneic blood supply.

Donation Criteria

1. There are no age limits for autologous collection, unless specified by the medical director responsible for the autologous program.
2. A donor questionnaire must be developed by each facility. Many facilities base their questionnaire on the Record of Donation used by CBS
3. Guidelines must be established by the medical director and documented in operating procedures. These must include but are not limited to the following requirements:
   - Collection should not take place within 72 hours of the planned surgery or transfusion unless collected in peri-operative situations.
   - Collection should not be done when the patient has been diagnosed or is receiving treatment for bacteremia or has a conspicuous bacterial infection that may be associated with bacteremia.
   - The skin at the phlebotomy site must appear normal.
   - The volume of blood collected in relation to the weight of the patient must be considered.
   Frequency of phlebotomy must be established in consultation with the patient's physician.

Collection and Labelling

1. Operating procedures must include the following critical elements:
   essential equipment and supplies.
   signs, symptoms and management of donor adverse events and steps to minimize their incidence.
   provision of medical care in situations where adverse events occur.
   Collections under 300 mL that have not been collected in a reduced amount of anticoagulant must not be transfused.
   Inspection of the blood bag prior to use for defects, damage and contamination. Defects must be reported to the manufacturer.
   Time of collection, all records, blood bags and samples are properly identified and linked to the donor.
2. Blood bags and other equipment or devices used for the collection must be approved by Health Canada and must not be used if defective, damaged or contaminated.
3. Blood must be continually mixed during collection and carefully weighed to avoid overcollection. If the blood collected is greater than the maximum capacity specified by the bag manufacturer, the bag must be discarded.
4. At the time of collection, additional specimens in tubes must be collected for testing. These must be properly identified at the time of collection.
5. The bag and samples must be labelled at the point of donation, before leaving the patient bedside. The unit must be segregated.
6. A green label or tag must be attached to each unit and include the following information:
   - For autologous use only"
   - Patient (donor) full name
   - Name of the hospital where the transfusion is intended to take place
   - A unique identifying number such as the date of birth, health number or comparable unique identifier
   - A biohazard label until samples collected at the time of collection are tested and found to be negative for transmissible diseases. If testing will not take place on this collected unit, as defined in the operating procedures, the unit must be labelled as "untested"

Testing

1. The ABO and Rh of the autologous donation must be done at the collecting facility.
2. Transmissible disease testing must be performed on the donor, on the first unit collected and within each 42-day period. If the autologous donation is found to be positive for any required transfusion-transmitted disease marker testing and this unit must be shipped to another hospital for transfusion, the shipping facility must notify the receiving facility of the reactive tests regardless of the results of confirmatory testing.
3. The patient's physician must be notified of any abnormal results found during testing.

Administration

There must be procedures in place that ensure the issue and transfusion of autologous units before the release of allogeneic units for the patient.