2016年9月9日星期五

HOKLAS Assessment Feedback Seminar for Medical Testing Laboratory 2016

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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