The Seminar named "Common Findings related to Management Requirements for Medical Testing Laboratories" was organized by the Hong Kong Accreditation Service (HKAS) on 2 Jun 2017. Ms. Bella Ho (Senior Accreditation Officer, HKAS) hold the open forum and then Dr. Alex Chan (Accreditation Officer, HKAS) was the speaker for discussing the assessment findings.
It covered two parts. The first part was open forum to discuss the issues encountered in implementation of the management requirement in ISO 15189. The second part was data analysis to show the common assessment findings on management requirement. Bella explained why we had this seminar because of many enquiries on internal auditor training. However, HKAS did not provide such training but they could share the findings for learning purpose.
A) Part 1: Open Forum
Firstly, Ms. Bella Ho briefed the overall management requirements and then pointed out the most common findings in each clause.
4.1 Organization and management responsibilityShe said most contingency plan and drill were related to safety but not the business/service viewpoint such as referral laboratory’s capability and capacity. Another common missing point was the meeting minutes to be circulated.
4.2 Quality management system
Not following documented procedures was belong to 4.2.1 (QMS applicable throughout the laboratory)
4.3 Document controlThere were 25 out of 33 (75.7%) accredited laboratories to have no external documents on their master document list and some were on the list but not all (e.g. ISO 8655 pipette standard).
4.4 Service agreements
4.5 Examination by referral laboratory
Some referral labs used did not on the updated lists.
4.6 External services and supplies
Documented procedure to select and purchase external services, equipment that should be able to provide metrological traceability.
4.7 Advisory services (Communicating with users)
4.8 Resolution of complaints (usually no complaint)
4.9 Identification and control of NCs
4.10 Corrective actionIt was found that most CARs were not monitoring their effectiveness.
4.11 Preventive action
Laboratories had done but no recorded.
4.12 Continual improvement
Improvement activities shall be directed at high risk areas. It could consider to monitoring Quality Indicator (e.g. EQA)
4.13 Control of records
Common missing records in both management records and technical records such as in-house preparation, operator traceability, reagent lot number, reference equipment ID on PM record, etc.
4.14 Evaluation and auditShe said many risk management / assessment were focused on staff. However, the laboratory shall evaluate the impact of work processes and potential failures on examination results as they affect Patient Safety.
Another common finding related to plan and conduct internal audits was confusing concept of horizontal audit (HA) and vertical audit (VA). The following diagram explained clearly the different between them.
For vertical audit report, you could find the information included sample(s), its type, test method, operator, date, etc.
For horizontal audit report, you could exam different people followed the same practice or SOPs.
Then Bella suggested how to select report for internal audit and then shared some report samples for discussion.
4.15 Management review
Most findings in management review were staff suggestions and circulation of minutes.
B) Part 2: Common assessment findings on management requirementDr. Alex Chan was held the part 2 for Data Analysis.
Firstly, he showed the summary of assessment number from Oct 2014 to May 2017. Totally, there were performed 96 assessments.
The overall NCs distribution was demonstrated in the following pie chart.
The Six most frequency findings clauses related to management requirement were (1) Document control, (2) Evaluation and audits, (3) Quality management system, (4) Control of records, (5) Organization and management responsibility and (6) Use of HKAS accreditation symbols & claims of accreditation status.
No. 1 – 4.3 Document control
Most documents were not reviewed in the past 12 months; external documents were not included in the master list. Posted instructions were not dated and signed.
No.2 – 4.14 Evaluation and audits
Internal audit no timeframe and responsible person, as well as did not give sufficient details on the auditing procedures. Recurrence of a number of NCs indicated in the last HKAS assessment. Horizontal audit report coverage was not sufficient and Vertical audit report was lack of sample ID recording. Internal audits were conducted by untrained staff. Quality indicators were no target achievement documented and no monitoring plan.
No.3 – 4.2 Quality management system
Quality manual had not been updated. No documented policies and procedures addressing several new requirements in ISO 15189:2012 (e.g. risk management, staff suggestions, and review by external organizations, etc.)
No.4 – 4.14 Control of records
The system to control records to maintain traceability required improvement. The spill kits were said to be checked every month but no record. Record of the HEPA filter leakage test of a biosafety cabinet was not retrievable during assessment.
No.5 – 4.1 Organization and management responsibility
The Code of Conduct document was not in detail. Constantly worked overtime indicated lack of staff resources seriously. Measurable quality objectives had not been documented. A Quality Policy is not evident. Quality manager did not report to the laboratory management at the level at which decisions is made on laboratory policy, objectives and resources.
No.6 – Use of HKAS accreditation symbols & claims of accreditation status.Alex shared the one and only one critical NC that non-accredited status was not indicated in the accredited test reports. Similar finding had been reported in the last assessment.
Another significant NC was that HOKLAS endorsed reports issued included results of non-accredited examination only. Some minor NC was about laboratory webpage was not updated scope of accreditation. He suggested to link with HOKLAS directory of that laboratory.
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