Quality Assurance in Hematology laboratory

Quality Assurance in Hematology.This lecture best fitting those whom using instruments from Beckman Coulter and Stago

1. Quality Assurance in
Hematology Laboratory
By
Mohammed Abdalla Elhassan , M.Sc,SH(ASCP
I
)
CM

2. What is Quality assurance ?
•Simply it is all about those activitiesand measuresthrough which the
laboratory can make surethat all generated results are reliablei.e Accurate
& Precise.
•it is comprehensivethat covers all aspects of laboratory i.e Pre analytical
, Analyticaland Post analytical phase of Testing

3. What is Accuracy ?
•Closeness of Measured value to assigned Target value. Any deviation in
readings is attributed to systematic errors. It can easily be assessed by
comparing the current findings to the Mean of True Value

4. What is Precisions
•Closeness of measured value to each others(Reproducibility or
Repeatability)
Any noticeable deviationis attributed to random errorsand it can easily be
observed by checking SDand or CV%

5. Who is Responsible ?
•QA is responsibility of Everyone in Clinical
Laboratory

6. What is outcome of Compliance to QA
•Enhancement of patient Safety
•Trustfulnessof Laboratory results
•Customer Satisfaction, our customers may be physicians , others clinical
departments and the main customer is our patients.
•Fulfilling the organization goals
•Reaching excellency

7. Components of QA in Hematology lab
•PreAnalytical Stage
•Analytical Stage
•PostAnalytical

8. Pre Analytical Stage
•Mainly Concernedwith Specimens Integrity. as per IOM Survey, most of laboratory errors occur in pre
analytical stage followed by post analytical , simply because of great human interventions at this phases. Pre
analytical issues may involve : -
Anticoagulants must be EDTAfor →FBC ,CBC, Hb electrophoresis , Citrated for ESRand Tri
Sodium Citrate for →Coagulation Tests
Order of draw (Coagulation first )
Stabilityof blood must be ensured which is 4 hours for Coagulationat RT, here we are concerned with
Add on tests since many times our phlebotomistare requesting us to do D-Dimerfrom coagulation tube
and vice versa so pay attention to this. Specimens of Special Coagulation should be separated, double
centrifugationand frozen.

9. Pre Analytical Stage-Continue
Specimens for Hematology Tests must be free from Clots , properly filled
and correctly labeled.
Lipemicsamples of CBC will result in erroneousreadings namely a high
Hb,MCV,MCHtherefore it must be pretreatedto obtain a correct
result. a simple way to do so is to centrifuge it , remove the plasmaand
replace the same volume you extract with isotone, do this for 2-3
times and re runthe sample.

10. Pre Analytical Stage-Continue
Proper Mixingon rotator is crucial for reliableFBC test , improper one will result in false
flags namely MO blast , Basophiliaor any others and eventually unnecessary Hold of
deferential counts.
Diluted Specimens must be suspected if not visually from CBC report , do proper
correlationthrough Delta check and match with Biochemistry.
Cold Agglutination must be suspected from CBC report , obviously it will result in
Hb/RBCsmatching failure (Role of 3 ) in addition to High MCH, MCV. So sample
should be incubated for 30 to 60 minutes before testing as well it is recommended to run it
on manualmode since it is faster than Automatic .
Lastly remember as good is your specimens integrity as reliable is your Final Report.

11. EDTA effect

12. Analytical Phase in Hematology Lab
•Composed of
Internal Quality Control
External Quality Assessment or Proficiency Testing

13. Internal Quality Control in Hematology Lab
•The purpose of running IQAis to :
Check the accuracyof tests system by comparing the daily run to the assigned
Mean Value.
Assess the precisionof test system through cumulative run comparison CV%
Predictand or to detectthe potential errors and fluctuations in test system before
it could affect the Patients Results.
Assure the stabilityof analytical runs by running control every 8 hours.

14. IQC in Hematology Lab-DXH800 Daily check
•Reason behind doing this is
to make sure that your instrument in optimal condition , in case of daily
checks failureplease do mind for which part does it fail ? , if it is in
measurement side there might be some sort of dirtiness just do one more
cycle of shut down for 30 minutes and re do the daily checks.

15. IQC in Hematology-Latron Beads
•Purpose of Lateron control for hematology analyzer
The main reason behind running latron is optimizationassessment of
VCSTechnology, so make sure that your daily run is passed otherwise rerun
if again failed call the BC engineer and follow up.

16. IQA in Hematology-LatronBeads

17. IQC in Hematology , 6 C & Retics
•6 C & Retics control is to be run in morning shift as part of daily ,weekly and monthly
maintenance of hematology analyzer, here am gonna mention few tipsin regards to it
•As per CLSI 3 levels of control must be run and evaluated at least one a day.
In case of out of limit control check which parameter is involved and which level of
control? Thereafter check the quantityof vial ,Expdate , Lot Number and follow the
prescribed corrective action steps
If the failure is in CBC part then direct your focus towards Isotone& DXH lyse ,check
their opening date and quantity, if look good then do Flush flow cells and appreature
maintenance (Unlock) and make sure your daily check & latron pass.

18. Continue
If the failure is in Diff Part then mind DXH diff pack do same steps prescribed
earlier and follow the written step by steps corrective actions instructions.in all
cases make sure to approachyour shift Supervisor and or Line Manager.
Remember QC review is crucial to gaugethe acceptance of run, so please do view
the graph for all concerned QC.
Be mindful for Shift& or Driftalert your supervisor if any is/are observed
Apply west Guard rules all the time.
For Reticsthe Steps are Same

19. 10X Rules violation

20. 10X Rules violation, Corrective Action
•In Regards to previous image the acceptable corrective action will be a
modification of Cal factor followed by consecutive monitoringof
subsequent runs of concerned Control for 2 weeks. this to be done by unit
Supervisor. The equationto do so is
New cal factor=
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Remember to documentsall corrective actions you have done.

21. Evaluation of QC Run
•Objectives
To Compare the current run to the mean Target value (Daily Run evaluations) it shouldn’t
exceed +-2SD.
To obtain acceptable CV%value for overall assessment (Cumulativeor monthly).
Remember to review the Graphnot single run to discover any Shift ,driftor violations of
Westguard Rules.

22. Risk Assessment in Hematology Lab
•New concepts in QA is RA. when it is applied in a proper way it will pose a greater impact on
positive patients safety .
•Aimed to minimize harms to our patientsby developing and maintaining a system that enable
us to discoverthe potential errors before it affect the patientsmanagement.
It is comprehensive that covers all aspects of Pre analytical ,Analytical and post analytical
stages of laboratory tests.
Represent our Complianceto P&Pfor Specimens Criteria ,Reagents storage, opening dates,
EXP dates, Lot number validation, Instruments calibration & maintenance, and Staff
competency.
Essentials components of RA are Mindfulness , Reluctant to simplify , Consultation of Senior
Staff. Remember Second opinion is always matter.

23. Maintenance as part of QA
•Aimedto maintain our instruments Optimizedall the time.
Daily ,weekly, monthly.
Follow the log file Step by step Module.
Documentall the time.

24. Carry Over DXH800
•Why? And Howto perform it
To checkthe accuracyof aspiration
To predictany possible pneumatic, leaks or vacuum issues
To assure the accuracyof the device .
Choose the function from menu and placeone tube filled with bloodin
position 1 followed by 3 tubes filled with Isotonein positions 2,3 and 4.
review the carry over acceptance and documents.

25. Reproducibility (Repeatability)
•Why?And How to perform it
To testthe precisionof instruments (Repeatability)
Choose the function from list menu and fill one tube with blood place it in
position 1 and select 10
th
frequency of aspiration , reviewthe acceptance
and documentsproperly.

26. Calibration DXH 800
•What is calibration ?
It is a relationshipbetween Concentrationand Measurementwhich
supposed to be Linear.

27. Calibration DXH 800
•Why it is required
☺To adjustthe instrument functionalityand to correctany observed
deviationsor else as part of accreditationsrequirements.

28. Calibration DXH 800
•How to perform it
♥Use the manufacturer recommendedcalibrator or else use any normal
sample just run it 10
th
time through reproducibilityprocedure, take the
average readings , enter it as described and run the same sampleas
calibrator , once finished do reviewthe acceptance criteriaand documents.
this procedures must be doneunder supervisionof Shift Supervisor or
Quality officer.

29. Calibration DXH 800
When to Calibrate
♠After major repair.
♠Instrument misfunctionality.
♠Lot number changes.
♠As indicated by QC runs.
♠Every 6 months as required by Accreditation body.

30. Calibration DXH 800
•Beyond Calibration
☺QC runsshould be monitored for at least 20 days to make sure that
calibration success.

31. EQA or Proficiency Testing
•Why
♥Togauge or assess long term Accuracy.
♥Identifythe necessity for correctiveaction
♥As part of accreditationrequirements

32. EQA or Proficiency Testing
•How does it works ?
♠Three level of control from CAPto be runs twice a year.
♠Results of runs are submittedonline
♠Lab received the obtained Score from CAP , lab is requested to calculate
SDI.
♠Corrective action and documentation is required when the lab failedto
obtain acceptablescore.

33. Post Analytical Stage
•Some Facts
♥As per IOM75% of Critical decisions in patients management depends on
LabResults.
♥Greater percentage of Errorsoccur in post analytical stage
♥Proper communication, consultation, and collaborationput you and your
patientsin safe side.

34. Post Analytical Stage
•Components
☺Verifications or correctnessof concerned tests results base on optimization of tests
necessitiese.g. Specimens integrity, stability of AMR …etc
☺Proper correlation of Lab findings with Clinical remarks.
☺Proper communicationswith concerned care giver e.g. Dr, or Nurses.
☺Notifications of Critical results for concerned Staff, apply read back policy and
documents
☺Minimized unnecessaryrecollection.
☺Approach your Senioror line Manager for any doubts.

35. QA in Coagulation
•All previously mentioned details are applicableto coagulation tests , but I’ll add some few points
◊PTand APTTcalculation module occur electromagneticallyi.e they aren’t affected if
specimens are hemolyzed. But match the result to delta check.
◊D-Dimertest calculation module done by optical detection i.e hemolyzed samples aren’t
acceptable.
◊In DICall coagulations tests will be prolonged except fibrinogen will be very low and it is very
critical, do report immediately and notify the concerned care giver.
◊In Regard to QC do review the graph all the time and mind the potential existence of Shift and
/or Drift.
◊Change the Ca++ chloride if its opening dates exceed 3 days.

36. QA in Coagulation
♣In more than Maxresult in any test do check specimens integrity as a first step.
♣In APTTtests partial clot will result in short result while full clot will result in
prolongation of both PT and APTT due to full consumption of coagulation
factors.
♣TTtest is done for many reasons not only ruling outheparin contamination,
Prolongation of the thrombin time (TT) is consistent with the presence of heparin-
like anticoagulants, Hypofibrinogenamia, dysfibrinogenemia, fibrin
degradation products, and antibody inhibitors of thrombin. An immeasurably
prolonged TT is usually the result of heparin in the specimen or, rarely, the
presence of thrombin antibodies or afibrinogenemia.

37. Conclusion
Behind each single tube you load on your analyzer is Human lives.
Thousands of times you complywith all guidance'swill passed un noticed
,instead one time you done a mistake it come out.
Lastly remember as proper you communicate as more livesare you save.
Consultationis required all the time
Thank you for your attention and patience.
Mohammed Abdalla