ROADMAP TO ACCREDITATION. A PATHCAREKENYA EXPERIENCE By Paul Okwach Pathcare Kenya Laboratories 27 th November 2008

Background information Pathcare Kenya started operation in Nov.2002 with an aim of making a difference in laboratory diagnosis in the region. Achieved SANAS accreditation in March Fully automated laboratory with LIS interfacing the main testing centre in Parklands with its subsidiary labs/depots within Nairobi, Thika and MSA. Association with Pathcare South Africa. 100% Kenyan workforce.

Maintenance of accreditation status Initially granted for 4 years. SANAS conduct yearly audits to ensure maintenance of quality standards. In addition, Pathcare Kenya undergo yearly audits by the Division of AIDS (DAIDS) through the National Institute of Health to which it acts as a backup laboratory for its clinical trial project in Moshi (Tanzania).

Proficiency testing Pathcare Kenya conducts proficiency testing in clinical chemistry, serology / immunology, microbiology and haematology. We also participate in AFRIQAS CD4+ Lymphocytes proficiency programme run by the NHLS. In histology / cytology, we run an inter-laboratory proficiency testing ( technical & pathologist reporting) with our reference lab in CPT South Africa.

Accreditation: Defined as the formal recognition of an organization’s technical competency to perform specific tests, types of tests or calibrations. Aims to ensure laboratory test results are accurate, reliable and reproducible internationally.

Technical competence of a laboratory Management of the laboratory. Staff: recruitment, qualifications, training and experience Equipment : appropriate, properly calibrated and maintained Quality assurance: Technical processes in place Sample collection, handling and transportation practices optimal

Competence cont’d Testing procedures appropriate Traceability of measurements to international standards Recording and reporting procedures accurate Environmental appropriateness and safety Efficiency (TAT, communication)

Considerations Looked at the resources needed to support production of quality laboratory results: Infrastructural and environmental considerations. Infrastructural (physical factors): facility, equipments, layout & workspace, support services. Working environmental factors: Heat, humidity, light, vibration, noise and cleanliness. Having right staff professionally trained in laboratory sciences.

considerations cont. Use of properly validated analyzers / methodologies. Use of routinely calibrated laboratory equipments-pipettes, centrifuges, balances, timers, thermometers etc. Having an effective IQC program. Participating in an appropriate proficiency testing program.

The process Standards defined (ISO 17025/15189) Laboratory preparation. Came up with a quality manual outlining the laboratory quality policy and quality goals. Established among the staff, a health and safety committee headed by a safety officer. Engaged the services of specialist technical assessor who conducted thorough evaluation of all factors in the lab that affect the production test results.

Pre-Analytical Patient identification Patient preparation Specimen collection Specimen transport Logging in.

Analytical Developed SOP’s and ensured that they are followed. Trained staff and ensured their competence. Equipments calibrated and regularly maintained. Control materials regularly used. Documentation of all processes.

Internal QC Based on Westgard rules. No patient samples run without prior IQC. Monitor: –staff competence, –equipment and –reagents. Run IQC twice a day.

External Quality Control: All accredited tests must be enrolled for EQC. Where for some reasons a laboratory does not run EQA scheme on a test, an intra-laboratory testing on that analyte can substitute, provided the laboratory with which this is done runs a successful EQA scheme on the test. Results of such intra-laboratory QC must be analysed for acceptability and documented. For standardization purpose, we chose to enrol for Thistle EQA program-the same one used within the Pathcare group of laboratories. Offers CME for staff.

Post - Analytical Transcription errors minimized by computerization. TAT controlled. Patient results via , fax or direct delivery. Getting feedback from clients: - Questionaires. - Marketing staff.

Internal Audits & Corrective Actions To maintain recognition, laboratories are re- evaluated periodically by the accreditation body to ensure their continued compliance with requirements. - check that the standard of operation is being maintained. -Internal audits provide a mechanism of detecting operational and technical non- conformances. -Causes of these are then investigated and corrective actions done and documented.

Our experience Achieving & maintaining accreditation is an expensive but worthwhile venture. -Annual fees, Equipment maintenance, Quality control, Training. Accreditation boosts staff morale and client confidence. To maintain accreditation status is a bigger challenge than initially acquiring it. Requires a continuous effort by all laboratory personnel, to avoid a drift back to old ways

“Quality is remembered long after the price is forgotten.” Gucci Family Slogan THANK YOU FOR YOUR ATTENTION