NEQAS Mock Autumn 2022 Answers

Question 1

a) What is the result of this EQA exercise?

This EQA exercise returned with a result of outwith concensus and the clinical advice given
for this resulted in a dose of warfarin which was inappropriately high.

b) What might be the clinical impact of this error?

This EQA exercise assessed the capillary INR test used in an anticoagulation clinic setting.
Had this been a clinical sample, this result suggest our laboratory might have overdosed
patients with warfarin increasing the risk of out of range INRs and bleeding complications.

c) How would you investigate and resolve this?

I would recommend retesting the original NEQAS material if still available and asking NEQAS
for a repeat/new sample. I recommend reviewing staff training in the use of the laboratory
technique. We should review the standard operating procedure and manufacturers
reccomendations for the technique. We should review pre-analytical, analytical and post-
analytical variables. If this fails to determine the cause for the discrepancy we should ask a
different laboratory (or use an alternative technique such as venous INR) to process paired
samples until such time as we can be confident in the results of the assay. We would need to
review the causative factors to determine if there may have been any clinical impact.

d) What might be the outcome if your laboratory continues to receive similar results?
If the laboratory continues to receive similar results, we may receive a result in the survey of
Persistently Outwith Concensus which would result in a letter from the scheme director
offering assistance. If we fail to return accurate NEQAS results this may impact the
laboratories UKAS accreditation for this test.

Question 2

a) What is your laboratories current performance?

The result from this NEQAS return is Outwith Concensus for Factor XI assay test results.

b) What is the impact of another E grade report?

Another E grade would change the current performance to Persistently Outwith
Performance and trigger correspondence from the Scheme Director to offer guidance for
the laboratory on correcting the issues.

c) How would you investigate and manage this?

I would recommend retesting the original NEQAS material if still available and asking NEQAS
for a repeat/new sample. I recommend reviewing staff training in the use of the laboratory
technique. We should review the standard operating procedure and manufacturers
reccomendations for the technique. We should review pre-analytical, analytical and post-
analytical variables. If this fails to determine the cause for the discrepancy we should ask a
 different laboratory to process paired samples until such time as we can be confident in the
results of the assay.

d) What would be the result if you fail to correct the errors?

If the errors persist and we fail to gain result within concensus, the laboratory performance
will downgrade to Persistently Outwith Concensus. If we fail to resolve these errors then
UKAS may withdraw accreditation for the laboratory to perform the tests.

Question 3

a) What is this NEQAS exercise assessing and how did your laboratory perform?
This exercise is an ABO grouping/crossmatching assessment. This EQA exercise ensures that
the laboratory is able to establish a patients ABO group correctly and match selected units
appropriately. In this exercise, our laboratory returned an unsatisfactory performance with a
score of 150.

b) What do you need to do to investigate this?

(NB this is a cut and paste answer! make sure you can recite it in the exam)
I would recommend retesting the original NEQAS material if still available and asking NEQAS
for a repeat/new sample. I recommend reviewing staff training in the use of the laboratory
technique. We should review the standard operating procedure and manufacturers
reccomendations for the technique. We should review pre-analytical, analytical and post-
analytical variables. If this fails to determine the cause for the discrepancy we should ask a
different laboratory to process paired samples until such time as we can be confident in the
ability of the laboratory to ABO group and crossmatch.

c) You continue to issue similar results. What will you need to consider?
In this scenario, the most concerning consequence of these results is that we may issue ABO
incompatible blood to a patient. If we are not confident that these errors are related to a
NEQAS specific failure (such as data entry or sample handling) then we must immediately
cease processing ABO grouping/crossmatching on site and arrange for this to be done in a
different laboratory.
We must also retrospectively review the ABO/crossmatch requests taken since the last
acceptable NEQAS performance to determine if there may have been any clinical harm from
this. Where appropriate, each patient who may have been affected must be reported to
SHOT and investigated internally as a potential SI. Duty of candour must be completed
where a patient has, or may have, come to harm.

Question 4

a) What is the principle of the acid elution test?

The acid elution (or Kleihauer) test is performed to quantify potential feto-maternal
haemorrhage. The principle of the test is that fetal haemoglobin is resistant to denaturation
in acidic solutions. Fixed slides of maternal blood are placed in an acidic solution where
 normal adult haemoglobin denatures but fetal haemoglobin remains. This slide is then
stained routinely and the quantity of any FMH estimated by the number of fetal cells visible
in a measured area.

b) Calculate the deviation index (%deviation) and state which category this falls into.
(Not a fair question!)

Deviation index = result median / SD = 1-9/2 = -4

This result is < -3 so falls under the category Requiring Investigation see slide of the
Lab Transfusion talk for more details)

In this case we have also issued incorrect advice which would have resulted in an insufficient
dose of Anti-D and we would not have triggered quantification.

We therefore meet the definitions of Unsatisfactory Performance (slide 45 in the Lab

Transfusion talk) on both counts DI < -2 and incorrect advice.

The DI threshold of < -3 is categorised as Requiring Investigation, however anything < -2 is an

unsatisfactory performance separate classifications, best to mention both here.

c) What would have been the clinical significance of acting on this result?
In this scenario, the patient would have received an insufficient dose of Anti-D and the
sample would not have been sent for quantification as our result was significantly out of
range. We would need to review the cause of this and may need to perform a clinical review
of all FMH screens performed by the laboratory between this exercise and our previous
acceptable EQA submission.

d) What corrective measures should be undertaken to address the error?

I would recommend retesting the original NEQAS material if still available and asking NEQAS
for a repeat/new sample. I recommend reviewing staff training in the use of the laboratory
technique. We should review the standard operating procedure and manufacturers
reccomendations for the technique. We should review pre-analytical, analytical and post-
analytical variables. If this fails to determine the cause for the discrepancy we should ask a
different laboratory to process paired samples until such time as we can be confident in the
ability of the laboratory to perform the assay. If we cannot isolate the cause of this error as
being confined to EQA samples, we would need to perform a clinical review of all FMH
screens performed by the laboratory between this exercise and our previous acceptable EQA
submission.

Question 5

a) What result has your laboratory been issued?

The laboratory has been issued with a Persistent Outwith Concensus report for this
performance
 NB: This is a real EQA exercise from the lab this is often recorded in the
notes accompanying section so don’t be confused by the performance of Outwith
Concensus for the assay result.

b) What will happen as a consequence and how will this impact on your service?
The laboratory will receive a letter from the scheme director offering assistance in
investigating and resolving the poor EQA performance.
This will not have any impact on our service.

c) How would you investigate and manage this?

I would recommend retesting the original NEQAS material if still available and asking NEQAS
for a repeat/new sample. I recommend reviewing staff training in the use of the laboratory
technique. We should review the standard operating procedure and manufacturers
reccomendations for the technique. We should review pre-analytical, analytical and post-
analytical variables. If this fails to determine the cause for the discrepancy we should ask a
different laboratory to process paired samples until such time as we can be confident in the
ability of the laboratory to perform the assay.

Question 6

(Every now and then you get a NEQAS question which isn’t centered around a result the
clue here is that you get given something that makes no sense to you at all!)

a) What is the NEQAS scheme?

NEQAS stands for National External Quality Assurance Scheme and is designed to offer
assurance to laboratories that the results they are publishing match the results published by
other laboratories using similar assays and reference ranges.

b) Why should your laboratory take part in NEQAS?

Laboratories should take part in an EQA scheme as a routine part of good practice. The
NEQAS scheme is also essential for a laboratory to receive UKAS accreditation both as a
whole and for individual tests.

c) What parts of laboratory practice are covered by NEQAS?

The remit of NEQAS includes all analytical tests where patient samples are analysed and
results issued. Not all tests a laboratory performs have a NEQAS scheme available, but
where NEQAS is available, participation is essential for a laboratory to be UKAS accredited
for the testing.

d) What happens if you fail to submit NEQAS results or perform poorly?

Initially, failed submissions or poor performance will be recorded as an Outwith
Concensus/Unsatisfactory performance result. If this progresses to a Persistently Outwith
Concensus/Unsatisfactory Performance report then the laboratory will receive a letter from
the scheme organiser offering assistance. Two or more PUPs within a 12 months period
would prompt further intervention from the scheme organiser. If the laboratory fails to
engage with NEQAS exercises or the advice from the scheme organiser then UKAS will
withdraw accreditation for the tests and may withdraw the accreditation from the
laboratory as a whole.
Question 7

a) What result has your laboratory received?

The laboratory result is Outwith Concensus

b) How has this happened?

The laboratory here has received an F grade as they have not submitted a sample for testing
in this round. A-E and a-e grades are issued for samples based on whether they conform to
the median result. F grades are treated as equivalent to E grades (i.e. poor performance)

c) What would be the result of another E or F grade result?

Another F or E grade results would escalate the status to Persistently Outwith Concensus.

d) Your chromogenic FVIII NEQAS result was within concensus. What is the different between
a chromogenic and a 1-stage Factor VIII assay?
A 1-stage Factor VIII assay is an APTT and clot based assay which determines the ability of
the patient serum to correct the APTT abnormalities in a factor VIII deficient serum sample
at serial dilutions.
A chromogenic Factor VIII assay uses a chromogenic substrate to Factor VIIIa added to
patient serum after other coagulation factors have been removed. This is a two stage assay
as there is an incubation step to allow Factor VIII to activate and then a determination step
to measure this activity.

e) How would you resolve the issues in the return?

The laboratory must ensure that NEQAS returns are made to prevent a further F grade being
issued.

Question 8

a) What result has your laboratory been given?

The laboratory has returned a result which is Outwith Concensus (D).

b) Your interpretation is specificed as adequate. What interpretation is this referring to?

Some NEQAS assays include an assessment of the efficacy of the intervention or
recommended treatment such as anti-Xa, INR or FMH estimation. These interpretations
offer a number of suggested standard interventions/comments by the scheme and the
laboratory must choose the most appropriate.

c) What is the consequence of providing inadequate interpretation in a NEQAS assay?

If this interpretation is inadequate (missing) or not clinically safe this will generally result in a
return of Unsatisfactory Performance.

d) How would you monitor and correct the issues in your laboratory?
I would recommend retesting the original NEQAS material if still available and asking NEQAS
for a repeat/new sample. I recommend reviewing staff training in the use of the laboratory
technique. We should review the standard operating procedure and manufacturers
reccomendations for the technique. We should review pre-analytical, analytical and post-
analytical variables. If this fails to determine the cause for the discrepancy we should ask a
different laboratory to process paired samples until such time as we can be confident in the
ability of the laboratory to perform the assay.