Quality assurance in immunohaematology

1. Quality Assurance in
Immunohematology
Laboratory
Dr. G.D.A. Samaranayaka

2. Quality
‘Degree of excellence’ and assurance as ‘positive assertion’
Quality assurance (QA) - confidence in the outcome can be
guaranteed at a pre defined level of quality.
Total quality management (TQM) in laboratory procedures and
processes stresses the importance of collecting data as a basis
for decision-making and problem solving.
Quality is everybody’s business – everyone is responsible.

3. Achieving total quality
1. Set appropriate standards.
2. Ensure good communication.
3. Full documentation and document control.
4. Traceability of all laboratory procedures, including Quality Control (QC)
results, batch numbers, expiry dates of reagents, and staff identification.
5. Training: external as appropriate; in-house, relevant, and continuous.
6. Standard operating procedures (SOPs), which must be complied with. QC
for individual procedures, which must reflect the technology used and be
appropriate.
7. External assessment by participating in QA schemes to monitor standards,
spot trends, and help to reduce errors.

4. Frequency and specificity of
control material
must be carried out for all test procedures, generally at least
daily and when new batches of reagents are introduced
Single tests (ex:- emergencies) - controls should be included at
the same time.

7. For Continues Quality Improvement
Procedures and policies
Training/education
Validation of protocols and
results
Calibration of equipment;
Document control/record
keeping
Product specifications
Suppliers
Corrective action
planning/monitoring
Error reports
Health and safety issues
(including waste management)
Audits
SOPs
Analysis of trends
problem solving
external QA results
Accreditation issues
To ensure best practice, QC, QA, and continuous quality improvement in
the laboratory include the review and approval of:

8. Quality requirements for safe
transfusion practice
The responsibilities of all personnel involved in the transfusion
process should be clear and each individual notified.
Pre-labelled tubes for patients’ samples should not be used.
Samples for pre-transfusion compatibility procedures should be
stored at 4–6°C and taken not more than 24 hours before transfusion
if a previous transfusion has been administered within the previous 3–
14 days.
A sample not older than 72 hours may be used if the last transfusion
was between 14 and 28 days previously.
Positive patient identification at sampling and at the time of
transfusion is essential for both inpatients and outpatients.

9. The request system should ensure prescription issue of
blood/components and needs to include procedures to ensure
the correct administration of the component. Written policies
for the collection of components are essential.
Emergency issue, special requirements, or telephone requests
should also be covered in the regulations.
Laboratories should have access to previous transfusion records
including historical grouping and screening results.
Transfusion committees can help to monitor the efficiency of
the procedures and recommend changes where necessary.
Multidisciplinary audits of the transfusion process on a regular
basis.
Continuous training of all staff involved in the transfusion chain
to ensure compliance with procedures.

10. Checklist of critical control points

12. QC for molecular blood group
testing
Molecular blood group testing requires controls that are included in order
to assure the integrity of the results, which are tailored to the technique(s)
being used:
• Positive and negative controls for specificity being tested.
• Negative template control (water in place of template DNA).
• Positive control for effective amplification in negative tests, preferably as
an internal control in a multiplex polymerase chain reaction (PCR). This
usually involves amplification of a non-polymorphic DNA sequence.
• Control for effective digestion when restriction enzymes are being used.
• Regular servicing of equipment being used, especially PCR machines.

13. References
Essential Guide to Blood Groups, 2nd Edition
Editor(s): Geoff Daniels PhD, FRCPath
Imelda Bromilow MSc, CBiol

14. Thank You