Quality Assurance in

Hematology Laboratory

By

Mohammed Abdalla Elhassan , M.Sc,SH(ASCPI)

CM

What is Quality assurance ?

• Simply it is all about those activities and measures through which the

laboratory can make sure that all generated results are reliable i.e Accurate

& Precise .

• it is comprehensive that covers all aspects of laboratory i.e Pre analytical

, Analytical and Post analytical phase of Testing

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

What is Precisions

• Closeness of measured value to each others(Reproducibility or

Repeatability)

Any noticeable deviation is attributed to random errors and it can easily be

observed by checking SD and or CV%

Who is Responsible ?

• QA is responsibility of Everyone in Clinical

Laboratory

What is outcome of Compliance to QA

• Enhancement of patient Safety

• Trustfulness of 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

Components of QA in Hematology lab

• Pre Analytical Stage

• Analytical Stage

• Post Analytical

Pre Analytical Stage

• Mainly Concerned with 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 EDTA for → FBC ,CBC, Hb electrophoresis , Citrated for ESR and Tri

Sodium Citrate for → Coagulation Tests

Order of draw (Coagulation first )

Stability of blood must be ensured which is 4 hours for Coagulation at RT, here we are concerned with Add on tests since many times our phlebotomist are requesting us to do D-Dimer from coagulation tube and vice versa so pay attention to this. Specimens of Special Coagulation should be separated, double centrifugation and frozen.

Pre Analytical Stage-Continue

Specimens for Hematology Tests must be free from Clots , properly filled

and correctly labeled.

Lipemic samples of CBC will result in erroneous readings namely a high

Hb ,MCV ,MCH therefore it must be pretreated to obtain a correct

result. a simple way to do so is to centrifuge it , remove the plasma and

replace the same volume you extract with isotone , do this for 2-3

times and re run the sample.

Pre Analytical Stage-Continue

Proper Mixing on rotator is crucial for reliable FBC test , improper one will result in false flags namely MO blast , Basophilia or any others and eventually unnecessary Hold of deferential counts.

Diluted Specimens must be suspected if not visually from CBC report , do proper correlation through Delta check and match with Biochemistry.

Cold Agglutination must be suspected from CBC report , obviously it will result in

Hb/RBCs matching 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 manual mode since it is faster than Automatic .

Lastly remember as good is your specimens integrity as reliable is your Final Report.

EDTA effect

Analytical Phase in Hematology Lab

• Composed of

Internal Quality Control

External Quality Assessment or Proficiency Testing

Internal Quality Control in Hematology Lab

• The purpose of running IQA is to :

Check the accuracy of tests system by comparing the daily run to the assigned

Mean Value.

Assess the precision of test system through cumulative run comparison CV%

Predict and or to detect the potential errors and fluctuations in test system before

it could affect the Patients Results.

Assure the stability of analytical runs by running control every 8 hours.

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 failure please 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.

IQC in Hematology-Latron Beads

• Purpose of Lateron control for hematology analyzer

The main reason behind running latron is optimization assessment of

VCS Technology, so make sure that your daily run is passed otherwise rerun

if again failed call the BC engineer and follow up.

IQA in Hematology-Latron Beads

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 tips in 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 quantity of vial ,Exp date , 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.

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 approach your shift Supervisor and or Line Manager.

Remember QC review is crucial to gauge the acceptance of run, so please do view the graph for all concerned QC .

Be mindful for Shift & or Drift alert your supervisor if any is/are observed

Apply west Guard rules all the time.

For Retics the Steps are Same

10X Rules violation

10X Rules violation, Corrective Action

• In Regards to previous image the acceptable corrective action will be a

modification of Cal factor followed by consecutive monitoring of

subsequent runs of concerned Control for 2 weeks. this to be done by unit

Supervisor. The equation to do so is

New cal factor=𝑇𝑎𝑟𝑔𝑒𝑡 𝑀𝑒𝑎𝑛 𝑉𝑎𝑙𝑢𝑒

𝑂𝑏𝑠𝑒𝑟𝑣𝑒𝑑 𝑚𝑒𝑎𝑛 𝑣𝑎𝑙𝑢𝑒∗ 𝐶𝑢𝑟𝑟𝑒𝑛𝑡 𝑐𝑎𝑙 𝑓𝑎𝑐𝑡𝑜𝑟

Remember to documents all corrective actions you have done.

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 (Cumulative or monthly).

Remember to review the Graph not single run to discover any Shift ,drift or violations of

Westguard Rules.

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 patients by developing and maintaining a system that enable us to discover the potential errors before it affect the patients management.

It is comprehensive that covers all aspects of Pre analytical ,Analytical and post analytical stages of laboratory tests.

Represent our Compliance to P&P for 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.

Maintenance as part of QA

• Aimed to maintain our instruments Optimized all the time.

Daily ,weekly, monthly.

Follow the log file Step by step Module.

Document all the time.

Carry Over DXH800

• Why ? And How to perform it

To check the accuracy of aspiration

To predict any possible pneumatic, leaks or vacuum issues

To assure the accuracy of the device .

Choose the function from menu and place one tube filled with blood in

position 1 followed by 3 tubes filled with Isotone in positions 2,3 and 4.

review the carry over acceptance and documents.

Reproducibility (Repeatability)

• Why? And How to perform it

To test the precision of instruments (Repeatability)

Choose the function from list menu and fill one tube with blood place it in

position 1 and select 10th frequency of aspiration , review the acceptance

and documents properly.

Calibration DXH 800

• What is calibration ?

It is a relationship between Concentration and Measurement which

supposed to be Linear.

Calibration DXH 800

• Why it is required

☺To adjust the instrument functionality and to correct any observed

deviations or else as part of accreditations requirements.

Calibration DXH 800

• How to perform it

♥ Use the manufacturer recommended calibrator or else use any normal

sample just run it 10th time through reproducibility procedure, take the

average readings , enter it as described and run the same sample as

calibrator , once finished do review the acceptance criteria and documents.

this procedures must be done under supervision of Shift Supervisor or

Quality officer.

Calibration DXH 800

When to Calibrate

♠ After major repair.

♠ Instrument mis functionality.

♠ Lot number changes.

♠ As indicated by QC runs.

♠ Every 6 months as required by Accreditation body.

Calibration DXH 800

• Beyond Calibration

☺QC runs should be monitored for at least 20 days to make sure that

calibration success.

EQA or Proficiency Testing

• Why

♥ To gauge or assess long term Accuracy .

♥ Identify the necessity for corrective action

♥ As part of accreditation requirements

EQA or Proficiency Testing

• How does it works ?

♠ Three level of control from CAP to be runs twice a year.

♠ Results of runs are submitted online

♠ Lab received the obtained Score from CAP , lab is requested to calculate

SDI.

♠ Corrective action and documentation is required when the lab failed to

obtain acceptable score.

Post Analytical Stage

• Some Facts

♥ As per IOM 75% of Critical decisions in patients management depends on

Lab Results.

♥ Greater percentage of Errors occur in post analytical stage

♥ Proper communication, consultation, and collaboration put you and your

patients in safe side.

Post Analytical Stage

• Components

☺Verifications or correctness of concerned tests results base on optimization of tests necessities e.g. Specimens integrity, stability of AMR …etc

☺Proper correlation of Lab findings with Clinical remarks.

☺Proper communications with concerned care giver e.g. Dr, or Nurses.

☺Notifications of Critical results for concerned Staff, apply read back policy and documents

☺Minimized unnecessary recollection.

☺Approach your Senior or line Manager for any doubts.

QA in Coagulation

• All previously mentioned details are applicable to coagulation tests , but I’ll add some few points

◊ PT and APTT calculation module occur electromagnetically i.e they aren’t affected if specimens are hemolyzed . But match the result to delta check.

◊ D-Dimer test calculation module done by optical detection i.e hemolyzed samples aren’t acceptable.

◊ In DIC all 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.

QA in Coagulation

♣ In more than Max result in any test do check specimens integrity as a first step.

♣ In APTT tests 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.

♣ TT test is done for many reasons not only ruling out heparin 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.

Conclusion

Behind each single tube you load on your analyzer is Human lives.

Thousands of times you comply with all guidance's will passed un noticed ,instead one time you done a mistake it come out.

Lastly remember as proper you communicate as more lives are you save.

Consultation is required all the time

Thank you for your attention and patience.

Mohammed Abdalla