In the interests of patient care it is essential that blood and blood products (including plasma products from CSL, Baxter, Wyeth, Novo Nordisk and Octapharma) used by hospitals should always be traceable from donor to recipient and from recipient to donor. Hospitals which fail to keep adequate records run greater legal risks should tracing be necessary.
It is imperative that all issues of blood and blood products, including whole blood, red blood cells, fresh frozen plasma, platelets, and plasma derived products at laboratory and patient levels, are adequately recorded to enable product recall in cases of:
- blood presumed infected by HIV, HEP B, HEP C, HTLV1 and HTLV2;
- presumed contamination occurring during manufacture;
- labelling or testing errors; and
- other events which compromise the quality of the product and have the potential to put the recipient at risk.
Hospitals are responsible for recording all blood and blood products received and dispatched. Adequate arrangements must be made to record the receipt and issue of blood and blood products so that any individual product or batch (in the case of pooled products) can be traced to the individual recipient.
2. RECORDS SYSTEMS
An effective traceability system involves both keeping a register of blood products issued in the hospital, and recording transfused product details on the patient's file.
This system must also enable tracing back from the recipient to the donation or batch number and thus back to the laboratory. Laboratory records must therefore be compatible with records of the supplying blood service (ARCBS), CSL and plasma product manufacturers.
Plasma fractionators and the supplying blood service will also retain records to allow the tracing of any given product or component to the donor and from any donor to the destination of any issued product.
Since it may be necessary to trace the path between donor and recipient many years after the transfusion, the following guidelines are provided for the retention of hospital patient records, and records maintained by hospital blood banks and by laboratories.
3.1 Transfusion Details in Patient Records
Donation numbers and batch numbers of all products transfused must be recorded in the patient's record. The patient record must be retained for the periods specified in:
- The General Retention and Disposal Authority for Public Health Services Patient Information Records*
- The current Regulations covering private hospitals.
It is recommended, however, that any patient history extracted and used for a transfusion associated disease investigation should be retained for a further maximum time period as specified in the above Schedule and Regulations. Wherever possible, this procedure should also be applied retrospectively to the current stock of histories.
(* Copies are available from the Public Records Office website.
3.2 Register of Transfused Products
Hospitals and laboratories must ensure that all transfused products are registered according to the following guidelines. Wherever hospital blood banks, laboratories or pharmacies do not exist to perform this task, the hospital must ensure that other arrangements are in place:
For each of the blood products, a record must be maintained detailing:
- date of receipt;
- identification number of donation or batch(s), including the batch quantity;
- date of transfusion;
- identification of recipient (name and unit record number); and
- blood group of the product if applicable.
A single product register could contain information on both fresh blood and plasma derived products.
Records related to all products must be retained for at least twenty (20) years.
DR C W BROOK
EXECUTIVE DIRECTOR, RURAL AND REGIONAL HEALTH AND AGED CARE SERVICES
EXECUTIVE DIRECTOR, METROPOLITAL HEALTH AND AGED CARE SERVICES