Ms. Bella Ho (Senior Accreditation Officer, HKAS) gave an introduction of the seminar. She said the seminar was focused on the NC statement on ISO 15189 new requirement, feedback from laboratories and assessors, and continuous improvement. The NC harmonization seminar would be arranged at the end of 2013.
The speaker was Dr. Alex Chan (Accreditation Officer, HKAS) and his topic entitled "Discussion on feedback & Presentation on previous assessment findings".
It covered the findings from the assessments since 1 Jan 2013. The following topics would be discussed:
1. Overview of assessment findings reported;
2. Selected observations for discussion or clarification;
3. Requirements that laboraties may not be fully aware of.
The overall of assessments was shown in the following diagram.
A) Feedback from Labs and Assessors:
Case 1: Two identical blood grouping auto-analysers gave a final blood group and antibody screen positive or negative. Do it need additional correlation studies of the digitised parameters? During the discussion, it agreed that no need to make correlation of qualitative results by using digitised parameters (except quantitative results).
Case 2: Lab required to quote the source of the acceptable limits of performance for method comparison (e.g. The Royal College of Pathologists of Australasia (RCPA)). The acceptable limits of performance was discussed to be set based on your laboratory situation.
Case 3: Assessor would like to have a collective understanding on the acceptance criteria for the method validation or verification, review correlation study, IQC and EQAP, etc. It would be discussed in the next harmonisation workshop.
Case 4: An autoanalyser with two detection channels (i.e. Can detect signals from two different reaction cells simultaneously). Do it need to perform correlation study between these two detection channels for the same assay?
During the discussion, both need and no need opinions were obtained. It needed to considered (1) fix for the purpose and (2) continuous improvement. It was also instrument dependence. If two detection channels were not separated, only using IQC and EQAP were enough. If two detection channels were separated, it needed to perform correlation study based on sensitivity concern.
Case 5: The use of stem cell. HKAS replied that the accreditation service had not expanded to stem cell yet.
B) Observations from previous assessments
1. Storage of items in refrigerators - Clinical sample vs reagent
HOKLAS 015 (4th Edition) 5.2.6 Accommodation and environmental conditions (Key words: Incompatible activities; to prevent cross-contamination);
HOKLAS 015 (5th Edition) 5.2.6 Facility maintenance and environment conditions (Key words: Incompatible activities; to prevent cross-contamination); 5.2.3 Storage facilities (Key words: Clinical samples and materials; to prevent cross-contamination)
Note: Eventhough blood sample is clean and reagent is clean, it could be cross-contaminated if they mixed.
2. Storage of items in refrigerators - Blood Product vs Drugs/reagents
HOKLAS 015 (4th Edition) 5.2.6 Accommodation and environmental conditions (Key words: Incompatible activities; to prevent cross-contamination);
HOKLAS 015 (5th Edition) 5.2.6 Facility maintenance and environment conditions (Key words: Incompatible activities; to prevent cross-contamination)
Note: The concept of effective separation to prevent cross-contamination such as separate refrigerators, items well labelled and compartmentalised.
3. Guidelines for statistical analyses
Precision, Linearity, method comparison and inter-instrument comparison were recommended to analyse and interpret the data with appropriate sources of reference.
Note: Laboratory could set criteria and document the justification of such statistical analyses using lab professional judgement.
4. Blood returning record
HOKLAS 015 (4th Edition) 5.3.12 (Key words: safe handing, transport, storage and use of equipment; prevent its contamination or deterioration);
HOKLAS 015 (5th Edition) 5.3.13 (Key words: safe handing, transport, storage and use of equipment; prevent its contamination or deterioration)
Note: Suitability of the returned blood products for transfusion is an important issue (e.g. Within 30min). It should be Major NC if not fulfilled the requirement.
5. Decontamination of biosafety cabinets (BSCs)
A disinfectant cleaner and 75% alcohol were used to decontaminated the BSCs once per month or on the day just after PM.
HOKLAS 015 (4th Edition) 5.3.7 (Key words: to decontaminate equipment prior to service, repair or decommissioning);
HOKLAS 015 (5th Edition) 5.3.1.5 Equipment Maintenance and Repair (Key words: to decontaminate equipment prior to service, repair or decommissioning; provide suitable space for repairs and appropriate PPE)
During the discussion, some lab decontaminate the BSCs per 3 month and before PM. The frequency of PM depended on the usage. The decontamination (e.g. Fumigation) should be performed prior to every PM (e.g. Access to potentially contaminated parts, carrying out filter penetration tests, after a spillage where inaccessible surfaces, etc.) (Reference: BS 5726:Part 4:1992 - 4.2 Fumigation).
Note: Adequately protected from biohazards; Justification and proof on the effectiveness of the decontamination procedures should be kept.
6. Functional check of autopipettes
HOKLAS Supplementary Criteria No. 2 recommended to verify autopipettes once every three months.
HOKLAS 015 (4th Edition) 5.3.2 (Key words: Equipment shall be shown to be capable of achieving the performance required);
HOKLAS 015 (5th Edition) 5.3.1.2 (Key words: capable of achieving the necessary performance)
According to Harmonisation Workshop for Microbiology on 1 Nov 2012, justification and objective evidence were needed to prove the performance of the autopipettes were satisfactory. For less frequent verification because of its infrequent use, lab should provide evidence. However, the extension was restricted to the same brand/model of pipette with similar routine frequency of use shown by the evidence.
Note: Key point was without justification.
7. Calibration labels on autopipettes
HOKLAS 015 (4th Edition) 5.3.2 (Key words: Equipment shall be shown to be capable of achieving the performance required);
HOKLAS 015 (5th Edition) 5.3.1.2 (Key words: capable of achieving the necessary performance)
Note: If calibration or performance verification is done and the problem is just out-dated label, this would only be a "Recommendation".
8. Evaluation of Euroimmune Analyser I
HOKLAS 015 (4th Edition) 5.5.2 (Key words: Only validate procedures for confirming the examination procedures are suitable for the intended use; The validations shall be as extensive as are necessary);
HOKLAS 015 (5th Edition) 5.5.1.2 (Key words: performance claims for the examination procedure have been met; relevant to the intended use of the examination results)
Note: If the test is qualitative in nature, and there are a sufficient number of positive/negative/borderline samples covered in the evaluation, the LOD determination may not be necessary depending on the intended use of the test.
9. Quality Control for coagulation
QC materials frozen which is against manufacturer's recommendation such as 2C to 8C.
HOKLAS 015 (4th Edition) 5.3.2 (Key words: capable of achieving the performance required);
HOKLAS 015 (5th Edition) 5.3.2.2 (Key words: store received reagents and consumables according to manufacturer's specifications.)
Note: Lab needs to provide evaluation data to support the rationale of freezing the aliquots.
10. Quality Control of Hematoxylin and Eosin staining (H&E staining)
HOKLAS 015 (4th Edition) 5.6.1 (Key words: verify the attainment of the intended quality of results);
HOKLAS 015 (5th Edition) 5.6.2.1 (Key words: verify the attainment of the intended quality of results)
Note: Daily QC of H&E staining is suboptimal. Alternative reference material showing different cellular staining pattens.
11. Sterilisation of Container
HOKLAS 015 (4th Edition) 5.3.2 (Key words: Equipment shall be shown to be capable of achieving the performance required);
HOKLAS 015 (5th Edition) 5.3.1.2 (Key words: capable of achieving the necessary performance)
Note: The media will be subjected to sterilisation after being made up. Therefore, a clean container, not necessarily sterilised should be used for media preparation.
12. Use of accreditation symbol
The new symbols have to be used for all new documents starting from 1 November 2010.
13. Fumigation Frequency
The fumigation of BSCs in the TB laboratory was found to be performed every three monts.
Note: No international standard or consensus on fumigation frequency was found. It depended on actual workload and examination procedures undertaken by the laboratory. For safety, the level of formalin shall be monitored after fumigation (ceiling limit of 0.3ppm recommended by the Labour Department).
14. Internal Audits
It was found the IA did not cover any new tests.
HKAS SC No.5 - Internal Audit and Management Reviews - 5.8 when organization seek extension of accreditation, the management should ensure audits are carried out and corrective actions are taken before the HKAS on-site assessment.
15. Elements covered in Code of Conduct document
HKAS SC No.6 - Code of Conduct 2.2(k) should be considered
2.2(k) - Procedures for reporting suspected violation and established mechanism for the prompt and fair adjudication of alleged violations
16. Records of the ingredients of in-house media
In-house media means media to be made up by weighing each specified component in the formula.
HOKLAS SC No.27 5.5.6 - Records shall be kept of the preparation details for all types of media including: (f) Media ingredients, manufacturer, manufacturer's batch number and quantity of each component
Note: No need to record provided that (i) the media are made in accordance with the formula give in the SOP; and (ii) Both positive and negative controls available to evaluate the performance of the in-house media after it's been made.
HOKLAS 015 (5th Edition) 5.3.2.3 Reagents and consumables - Acceptance testing (Key words: Consumables that can affect the quality of examinations shall be verified)
Note: Culture media are considered as consumables.
17. Source of Eggs for Lowenstein-Jensen Medium Preparation
It used for culture of mycobacteria such as Mycobacterium tuberculosis.
Note: a known source allowed traceability in case the eggs appeared to have problems. It belongs to supplier management.
Reference:
HKAS - http://www.itc.gov.hk/en/quality/hkas/about.htm
The fumigation of BSCs in the TB laboratory was found to be performed every three monts.
Note: No international standard or consensus on fumigation frequency was found. It depended on actual workload and examination procedures undertaken by the laboratory. For safety, the level of formalin shall be monitored after fumigation (ceiling limit of 0.3ppm recommended by the Labour Department).
14. Internal Audits
It was found the IA did not cover any new tests.
HKAS SC No.5 - Internal Audit and Management Reviews - 5.8 when organization seek extension of accreditation, the management should ensure audits are carried out and corrective actions are taken before the HKAS on-site assessment.
15. Elements covered in Code of Conduct document
HKAS SC No.6 - Code of Conduct 2.2(k) should be considered
2.2(k) - Procedures for reporting suspected violation and established mechanism for the prompt and fair adjudication of alleged violations
16. Records of the ingredients of in-house media
In-house media means media to be made up by weighing each specified component in the formula.
HOKLAS SC No.27 5.5.6 - Records shall be kept of the preparation details for all types of media including: (f) Media ingredients, manufacturer, manufacturer's batch number and quantity of each component
Note: No need to record provided that (i) the media are made in accordance with the formula give in the SOP; and (ii) Both positive and negative controls available to evaluate the performance of the in-house media after it's been made.
HOKLAS 015 (5th Edition) 5.3.2.3 Reagents and consumables - Acceptance testing (Key words: Consumables that can affect the quality of examinations shall be verified)
Note: Culture media are considered as consumables.
17. Source of Eggs for Lowenstein-Jensen Medium Preparation
It used for culture of mycobacteria such as Mycobacterium tuberculosis.
Note: a known source allowed traceability in case the eggs appeared to have problems. It belongs to supplier management.
Reference:
HKAS - http://www.itc.gov.hk/en/quality/hkas/about.htm
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