General Concepts on Laboratory Accreditation

Transcription

1 IAAHS- Induction Programme for MLT General Concepts on Laboratory Accreditation Watson Wong 28 th March 2008

2 Understaffed Inadequate attention to detail Poor sample control Poor result verification Non-validated tests Think about it Why do laboratory errors occur? Inadequate Quality Control or Assessment Poor workload management and time pressure Unsatisfactory equipment performance

3 Create a workable work system is therefore important Consensus standards of national or international origin A clear declaration of policy Improved quality monitoring Improved tracking of outcomes Improved awareness of customer s satisfaction

4 Established Quality Systems for Medical Laboratories CLSI (formerly NCCLS) GP26-A2 Application of a Quality System Model for Laboratory Services; Approved Guideline Second Edition HS01-A A Quality System Model for Health Care; Approved Guideline International Organization for Standardization ISO 9001:2000 Quality Management ISO 17025:1999 General requirements for the competence of testing and calibration laboratories ISO 15189:2003 Medical laboratories -- Particular requirements for quality and competence

5 What is Laboratory accreditation? Accreditation is a procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks Accreditation can differ in process to certification and requires examination of specific scientific, technical and governance competences against an external standards. ISO is an example of an accreditation standard relevant to medical laboratories.

6 Laboratory Accreditation Scheme Both overseas and local program providers are available for application b=true&_pagelabel=accreditation as/about.htm

7 In short, it is all about quality and competence! What is ISO all about? Medical Laboratories- Particular requirements for Quality and Competence has been defined This include 15 management criteria and 8 technical criteria They are equally important and the conformance will be assessed in all aspects

8 Laboratory accreditation ISO 15189

9 HOKLAS: Process HOKLAS Accreditation Process A laboratory interested in joining the HOKLAS scheme should contact the HKAS Executive to obtain the necessary documents. The compliance of an applicant laboratory is determined through rigorous on-site assessment conducted by a team of independent specialist assessors. The assessors' findings and reports are evaluated by the Accreditation Advisory Board (AAB) which makes recommendations in respect of a laboratory's fitness to be accredited.

10 - Procedures

11 Preparation work

12 What is your role in LA? Common nonconformities The laboratory's routine practice was different from the documented procedures Some procedures are not documented Either no action to be taken or actions were not adequate to find out the root cause of nonconformities identified No record was available for some examination procedures such as identification of the operator, counterchecking person,original raw data etc. Documentation is very,very important for all polices, procedures and work instructions, no matter for pre-analytical, post-analytical and examination procedures

13 Sample of an Equipment Label Great Medical Laboratory Laboratory Equipment Identity Card Equipment name and manufacturer OHAUS Electronic Balance Serial number BJ Equipment ID EBC- 11 In service date Responsible personnel Sam Location Molecular Lab Maintenance contact no. Good Ltd Next cal. date

14 Any more? Common nonconformities Competency assessment could not confirm the competence of the staff for a particular test ( Must be well trained! Mind your proficiency testing!) Equipment used (including reagent) had not be shown to be capable of achieving the performance required ( Did you perform the maintenance as scheduled? Calibrate your instrument regularly!) Samples were accepted not following the documented criteria (Garbage in, Garbage out!) A lot of NCs raised against safe transportation of the specimen! (Must be safe to yourself and others too!) OF COURSE even more NCs raised against the examination procedures! (Why don t you do as what have written down in SOP? )

15 You may contribute more! Common nonconformities Nonconformities raised against reference ranges (Your customer s age and sex are relevant!) Nonconformities raised against quality control issues (Don t report when QC rules violated!) Nonconformities raised against EQAP issues (Will you treat it as patient samples, have you been involved in performing? ) Learn more from other s experience!

16 Finally, CQI is critically emphasized Internal Audits are therefore important Communication among staff is essential Training and sharing will promote quality improvement too Remember, to maintain the quality and competence of the laboratory is your job! Don t think it should be done by Senior!

17 References HKAS- HOKLAS websitehttp:// hkas/hoklas/directory/medical.htm ISO/DIS , International Organization for Standardization, 2002 The most common nonconformities encountered in Medical Laboratories presented by Ms Bella Ho, HKAS 2007.

18 Hey, time to wake up! Thanks for your listening!