EmailHospital Circular 4/1995
NB - This circular is replaced by Circular 32/2008
Date
Issued:
23 January 1995
Publication: 4/1995
Contact : Regional Office or Public Health Branch (Tel (03) 616
8055)
Distribution:
Public Hospitals
Private Hospitals
Private Pathology Laboratories
Subject: Traceability of
transfused blood and blood products
Purpose:To provide guidelines
fo r the retention of patient records in the hospital and records maintained
by hospital blood banks and by laboratories.
1. TRACEABILITY
In the interests of patient care it is essential that blood and blood products (including those produced by CSL) 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 and platelets, and CSL pooled products at laboratory and patient levels, are adequately recorded to enable product recall in cases of:
- blood presumed infected by HIV, HEP B and C, HTLV1 and HTLV2;
- presumed contamination occurring during manufacture;
- labelling or testing errors; and
- other events which compromise the quality of the product and 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 bank and of CSL.
CSL and the supplying blood banks will also retain records to allow the tracing of any given product to the donor and from any donor to the destination of any issued product.
3. GUIDELINES
Since it may be necessary to trace 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 Disposal Schedule for Patient Information Records* for public hospitals
- 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 Printing and Publishing Services Victoria, PO Box 292 South Melbourne 3205. Tel: 03/242 4600).
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:
| Category A Fresh blood Products
|
Pooled Products
|
For each of the blood products in Category A, 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 pooled products in category A.
Category B. Pooled Products |
For the blood products in category B, a record must be kept of:
- date of receipt;
- quantity and batch identification; and
- quantities issued and date of issue to the ward.
Records related to all products under categories A and B must be retained for at least twenty years.
DR C W BROOK
DIRECTOR PUBLIC HEALTH
DR MICHAEL WALSH
DIRECTOR ACUTE HEALTH SERVICES
