The Seminar named
"Assessment Feedback Seminar under the HOKLAS for Medical Testing
Laboratories" was organized by the Hong Kong Accreditation Service (HKAS)
on 9 Sep 2016. Ms. Bella Ho (Senior
Accreditation Officer, HKAS) gave an introduction of the seminar. Dr. Alex Chan
(Accreditation Officer, HKAS) was the speaker for discussing the assessment
feedback.
It covered two parts. The first part was selected assessment
findings from Mar to Aug 2016. In this
period, there were 19 laboratories to be assessed. And the second part was feedback from
laboratories. The distribution of
assessment findings were summarized as following pie chart.
During this session, many
interaction discussions were raised.
A) Part 1: Selected Assessment Findings (Mar – Aug 2016)
1. Control of posted instructions
Based on HOKLAS 015 4.3H HOKLAS
Policy on Document control, posted information and instructions related to test operations shall be
considered as controlled documents. The
following table demonstrated the logic. 
2. Access control in laboratory
(HOKLAS 015 5.2.2 Laboratory and office facilities)
Porters could go directly into
the blood bank during office hours (Significant NC!) One of participants said items outside
laboratory called it specimen (could reject) and items inside laboratory called
sample after accepted.
3. Use of knife guard for
microtome
The knife of the microtome was
not covered with a knife guard when loading or unloading blocks. It was argued that the meaning of “when the
microtome is not in use”. Some participant believed to lock the moving
part is enough. 
4. Labelling of blood films
(HOKLAS SC28 9 Post-examination processes)
Laboratory number is the only
unique identifier marked on the archived abnormal peripheral blood films for
keeping at least one year.
It is NC because the lab number
is the only unique identifier marked on the stored side but it is NOT originated from the primary sample.
5. Biological reference intervals
Based on HOKLAS SC32 3-Approaches
to verify transference of reference intervals, the receiving laboratory may
transfer biological reference intervals from the donor laboratory after verification by analyzing 20 reference
individual samples.
6. Internal quality control – End
of batch and End of day QC
During the discussion, End of day
QC was considered important. It ensured result
and considering patient safety. (HOKLAS 015, 5.6.2.1)
7. Internal quality control – New
lot QC (HOKLAS 015 5.6.2 Quality control 5.6.2.1)
It considered manufacturer’s
range usually too wide and it recommended only use before 20 data were
available. After that lab established QC range from those data values. 
B) Part 2: Feedback from laboratories
1. Principle of EGFR tests (Epidermal
Growth Factor Receptor)
Should the mutation types of each
exon be specified in the SOP? Some
suggestions that mutation types were written down in SOP had benefit for clear
record and training.
2. Evaluation of Autoanalyser
(HOKLAS 015 5.3.1.2 Equipment acceptance testing)
For a new application of a
laboratory, is it necessary to perform full evaluation for an analyser used
over three years? It depended on their
equipment validation and any change during this period, as well as, its QC
result & PM record.
The HOKLAS SC38 2 stated more
details.
3. Evaluation of new lot of
reagents
HOKLAS SC28 Annex – check sensitivity
of factor VIII and IX. But lab asked
what about factor VII sensitivity. It was
depended on situation.
4. Evaluation of PT reagent
Instrument manual of coagulator
said there is no need to use 20 patient samples to determine local MNPT when
evaluating a new lot of PT reagent. During
discussion, some participants didn’t believe manufacturer’s claim. In general practical, we usually verified by ourselves
before use new reagent.
5. MU for qualitative tests?
Based on HOKLAS 015 5.5.1.4 MU of
measured quantity values, examinations included a measurement step but do not report a measured quantity value.
It had discussed in the Consensus
form Assessor Seminar 2015. For enzyme
immunoassay (EIA) (e.g. ELIZA), Microbiology quantitative assays (e.g. Real
time PCR), they also needed to verify the accuracy, precision, sensitivity,
specificity and MU at the cut-off,
etc.
6. Tests to be done by LA or PCA
Some simple preparation steps were
done by non-registered medical technologist (Lab Assistant LA or Patient Care
Assistant (PCA) considered as part of the testing procedure? Diagram had four cases.
The first 1 and 2 were arguable because
of advance equipment having error proof design.
The next 3 and 4 items were agreed to be done by registered medical
technologist. I mentioned most ISO
standard statement it shall be fulfilled legal requirement. 
7. Definitions of “Ranges”
Please clarify the definitions of
-
Measurement Range
-
Analytical Measurement Range (AMR)
-
Reportable Range
-
Clinical Reportable Range (CRR)
In JCGM 200:2012, Measurement
Range = Measuring Range = Measuring Interval
In HOKLAS 015 5.5.1.3 Validation
of examination procedures, the measuring interval using was based on your
professional judgement. 
The diagram demonstrated the
Reportable range and actual response curve.
However, the definition of AMR
and CRR was different and showed as follows.
Analytical Measurement Range (AMR) [Analytical Measuring Interval (AMI)]
-
Defined by CAP (College of American Pathologists) as the range of
numeric results a method can produce without any special specimen
pre-treatment, such as dilution, that is not part of the usual analytic
process. Same as reportable range in the
Clinical Laboratory Improvement Amendment (CLIA) terminology.
Clinical Reportable Range (CRR) [Clinical Reportable Interval (CRI)]
-
Defined by CAP as the lowest and highest numeric results that can be
reported after accounting for any specimen dilution or concentration that is
used to extend the analytical measurement range.
At the end, David described some
points to note below.
1.
Evaluation of referral labs
All referral labs
need to be evaluated before put into approved list of referral labs. A list of
tests approved is expected to be available.
2.
Turnaound time (TAT)
TAT has to be
established for all tests, not selected tests. TAT of individual test is expected
to be monitored.
3.
Correlation between manual and automated method
Correlation is always
expected between automated method and manual method even the latter is only
used as backup and is NOT routinely used.
Reference:
20150706: HKCTC & HKAS
Seminar on R&D Projects of Medical Testing - https://qualityalchemist.blogspot.hk/2015/07/hkctc-hkas-seminar-on-r-projects-of.html
20130611: HKAS First Assessment
Feedback Seminar for MedLab under ISO 15189 - https://qualityalchemist.blogspot.hk/2013/06/hkas-first-assessment-feedback-seminar.html
20130327: HKAS Seminar of the
Transition Arrangement ISO 15189_2012 - https://qualityalchemist.blogspot.hk/2013/04/hkas-seminar-of-transition-arrangement.html
20130321: Briefing on the New
Edition of ISO 15189:2012 Medical Laboratory - https://qualityalchemist.blogspot.hk/2013/03/briefing-on-new-edition-of-iso.html
20110231: Seminar - The Meaning
of Accreditation to Medical Testing - https://qualityalchemist.blogspot.hk/2011/01/seminar-meaning-of-accreditation-to.html
20101201: Medical Laboratory QM
Training - ISO 15189 - https://qualityalchemist.blogspot.hk/2010/12/medical-laboratory-qm-training-iso.html
20100727: Common nonconformities
encountered in assessments using ISO 15189 - https://qualityalchemist.blogspot.hk/2010/07/common-nonconformities-encountered-in.html
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