In the beginning, Ms. Ho introduced the milestones of HKAS medical programme that launched on 16 February 2004. Up to 1 May 2010, there were 26 accreditations granted for ISO 15189:2007 (Medical Laboratories – Particular requirements for quality and competence).
The following slide showed the management and technical requirement of ISO 15189.
The summary of NCs distribution against management and technical requirements in 2009 were discussed.
Most common NCs management requirement:
4.2 Quality management system
4.13 Quality and technical records
4.6 External services and supplies
4.3 Document Control
Most common NCs technical requirement:
5.5 Examination procedures
5.6 Assuring the quality of examination
5.3 Laboratory equipment
Some observations were shared below:
Management Requirement -
In clause 4.2:
i) Actual practice was different form the documented procedures.
ii) Procedures practiced were not document (Staff did not follow the same protocol.)
In clause 4.3.1:
i) Instructions to patients were not controlled
ii) Kit inserts were not controlled
In clause 4.3.2:
i) Quality documents were not reviewed regularly (It should be review annually in ISO 15189 under HOKLAS policy)
ii) Document reviewed but obvious errors
In clause 4.6:
i) Specification of regents used not defined
ii) No verification protocol for new lot of reagents
iii) No acceptance criteria and no proper evaluation
In clause 4.13:
i) No original observation record (Interpreted results recorded instead of raw data)
ii) Operator identification was not traceable
Technical Requirement -
In clause 5.3.2:
i) No follow up on outranged temperature and wrong temperature recorded
ii) Equipment bias was not properly investigated and followed up
iii) Correction factor was not properly incorporated
In clause 5.3.3:
i) Reagent bottles were not labeled with person preparing the reagent, preparation and expiry date
ii) Equipment place in stat lab / collection centres / Operation Theater (OT) had no unique equipment ID
In clause 5.5.1:
i) For Rh(D) negative antenatal case, result was not confirmed with another brand of anti-D
ii) Effect of haemolysis on potassium measurement was not properly monitored
In clause 5.5.2:
i) No evaluation protocol
ii) No acceptance criteria of each study
iii) No conclusion regarding the evaluation
In clause 5.6.1:
i) No action was taken when long-term bias observed
ii) QC material used was not at a concentration at clinical decision level
iii) Use of Westgard rules were not well documented
iv) No proper positive and negative controls incorporated
In clause 5.6.4:
i) EQAP unsatisfactory results were not investigated and the only action taken was to repeat testing of the sample
In clause 5.6.6:
i) Interinstrument comparison was not done for units performing the same test
ii) No acceptance criteria established for analyzing comparison results
For more details, please visit
http://www.itc.gov.hk/en/quality/hkas/seminar.htm#ref_materials
5.5 Examination procedures
5.6 Assuring the quality of examination
5.3 Laboratory equipment
Some observations were shared below:
Management Requirement -
In clause 4.2:
i) Actual practice was different form the documented procedures.
ii) Procedures practiced were not document (Staff did not follow the same protocol.)
In clause 4.3.1:
i) Instructions to patients were not controlled
ii) Kit inserts were not controlled
In clause 4.3.2:
i) Quality documents were not reviewed regularly (It should be review annually in ISO 15189 under HOKLAS policy)
ii) Document reviewed but obvious errors
In clause 4.6:
i) Specification of regents used not defined
ii) No verification protocol for new lot of reagents
iii) No acceptance criteria and no proper evaluation
In clause 4.13:
i) No original observation record (Interpreted results recorded instead of raw data)
ii) Operator identification was not traceable
Technical Requirement -
In clause 5.3.2:
i) No follow up on outranged temperature and wrong temperature recorded
ii) Equipment bias was not properly investigated and followed up
iii) Correction factor was not properly incorporated
In clause 5.3.3:
i) Reagent bottles were not labeled with person preparing the reagent, preparation and expiry date
ii) Equipment place in stat lab / collection centres / Operation Theater (OT) had no unique equipment ID
In clause 5.5.1:
i) For Rh(D) negative antenatal case, result was not confirmed with another brand of anti-D
ii) Effect of haemolysis on potassium measurement was not properly monitored
In clause 5.5.2:
i) No evaluation protocol
ii) No acceptance criteria of each study
iii) No conclusion regarding the evaluation
In clause 5.6.1:
i) No action was taken when long-term bias observed
ii) QC material used was not at a concentration at clinical decision level
iii) Use of Westgard rules were not well documented
iv) No proper positive and negative controls incorporated
In clause 5.6.4:
i) EQAP unsatisfactory results were not investigated and the only action taken was to repeat testing of the sample
In clause 5.6.6:
i) Interinstrument comparison was not done for units performing the same test
ii) No acceptance criteria established for analyzing comparison results
For more details, please visit
http://www.itc.gov.hk/en/quality/hkas/seminar.htm#ref_materials
沒有留言:
發佈留言