QUALITY ASSESSMENT OF LABORATORY SERVICES

Quality Assessment of Laboratory Services

Introduction of learning objectives 

Definition of terms:

·         On-site evaluation: Periodic site visits to systematic assessment of lab practices

·         Re-testing process: The process by which a random selection of specimens are collected from the routine workload at the test site and sent to the reference laboratory for validation

·         Proficiency testing: A program in which multiple samples are periodically sent to members of a group of laboratories for analysis and/or identification; whereby each laboratory’s results are compared with those of other laboratories in the group and/or with an assigned value, and reported to the participating laboratories and others.

 (Clinical and Laboratory Standards Institute (CLSI) formerly The National Committee for Clinical Laboratory Standards (NCCLS) – Definition).

·         Proficiency testing : Determination of laboratory testing performance by means of inter-laboratory comparisons.(International Standards Organisation (ISO) - Definition (guide 2:1996)

 Step 3: On-site evaluation (20 Minutes)

·         Define the standards to be used in evaluating the laboratory

·         For example: facilities, quality control, procedure manual, specimen management, and personnel)

·         Develop checklist of items to check on the evaluation and define tracer method to use

·         Third-party quality officer evaluates the laboratory and produces an evaluation report

·         Evaluated laboratory must respond with documentation to all deficiencies

·         Tanzania’s Ministry of Health and Social Welfare (MOHSW), Laboratory Department has policies and procedures that standardizes the evaluation process

·         Uses:

•      Direct observation
•      Review QC & Documentation
•      Administer individual proficiency testing
•      Collect & compare data from multiple sites
•      Opportunity for mentoring and evaluation of other programs

·         Limitations:

•     Evaluators must be trained in consistent observation
•     Checklists must be developed

·         Regulatory Bodies

•    Health Laboratory Board

§  Private Health laboratories Board (PHLB)

§  Health Laboratory Practitioners’ Council (HLPC)

·         The Health Laboratory Practitioners’ Act No. 22 of 2007

§  Medical Laboratory Scientists Association of Tanzania (MeLSAT)

•   All Laboratories subject to Law

§  Standards

§  Checklist

§  Sanctions –Withdrawal of License

 Diagram 1: On-site evaluation process

 

Source: MOHSW - Training in HIV Rapid Testing for Laboratory and Non-Laboratory Health Workers, Facilitators’ Manual, Module 13

ΠPre-Evaluation Preparation:

•         Determine site visit frequency:

o   Established sites - At least twice per year

o   New Sites - Quarterly

•         For efficiency, cluster evaluations geographically

•         Schedule in advance

o   Announced or unannounced visits

 Entrance Interview

•         The entrance interview sets the tone for the entire visit

•         Be prepared, positive and courteous

•         Introduce evaluation team - show identification

•         Provide overview of process in terms of what will be done

o   Review of facility

o   Record review

o   Observation

o   Interview with testing staff

o   Use of proficiency panel

o   Exit interview

Ž Information Gathering

•         Observe physical layout of the site

•         Evaluate testing operations

o   Specimen collection

o   Test performance with proficiency samples

o   Quality control

o   Inventory of kits

o   Record-keeping

•         Use quality systems checklist

•         Conduct in an instructional, not punitive, manner.

 Outcome Assessment

Diagram 2: Outcome assessment

  

 

Source: MOHSW - Tanzania HIV Rapid Testing Module, Facilitators’ Manual, Module 13 External Quality Assessment, January 2007

 Exit Conference

•         Review findings with supervisory and testing staff

•         Make positive statements first – acknowledge staff cooperation and support

•         Address negative findings – allow test site to discuss findings and provide additional information

•         Provide instructions and timeframe for submitting plan for correcting problem

‘ Reporting

•         Include information:

o   Site Name & Location

o   Date of Visit

o   Assessment Team Members

o   Major Findings

o   Recommendations for corrective actions

•         Submit completed checklist and report to relevant authorities

EQA Re-testing process 

Also known as Blinded or Rechecking  

Sampling of specimens for rechecking or retesting by a reference laboratory

·         Rechecking

o   Samples must be collected randomly

o   Avoid systematic sampling bias

o   Statistically significant

o   Resolve discrepancies

o   Effective feedbacko   Blinded

·         Retesting :

o   Tested by reference laboratory

o   Performed on specimen or samples not necessary blinded

o   Statistically significant

o   Primarily used to assess HIV rapid testing

·         Uses

•       Forwarding a selected sample of tests for rechecking to assess the quality of testing
•       Best utilized in high-volume settings

·         Limitations

•                Must develop a systematic sampling method to avoid bias in selecting samples for referral
•     Requires retesting to be done on a high percentage of samples
•      Practicality limited by lack of capacity at National Reference Laboratories, (NRL) / Zonal.

 EQA Proficiency testing 

Proficiency testing is organized and conducted by a reference laboratory or center. At regular intervals, a panel of specimens with known reactivity is sent to all participants who test the specimens and return results to the reference laboratory. The data is analyzed and information is provided back to the participant testing sites.

·         External proficiency testing program

• o   (e.g. National External Quality Assessment Scheme (NEQAS), East African Regional External Quality Assessment Scheme (EA-REQAS), External Quality Assessment Scheme (EQAS), South African National Accreditation Scheme (SANAS), Centre for Disease Control   and Prevention (CDC), 
• Quality Assessment and Standardization of Immunological Measure Relevant to HIV/AIDS (QUASI) Internally stabilized PT samples

   Alternative assessment mechanism – use previously analyzed specimen as blind sample or split samplenalysis

·         Proficiency Testing Process

o   Central organization sends out challenge specimens for testing

o   Laboratories analyze specimens, return results to central organization

o   Results evaluated, laboratories sent scores, performance report

o   Laboratories take appropriate corrective actions and document

·         Uses

o   Most common form of EQA

o  Development of specimen panels by the National Health Laboratory Quality Assurance and

TrainingCentre (NHLQATC)

o   Easiest type of program to implement where serum-based tests are performed

·         Limitations

o   Usually involves only a few specimens

o   Test results may not represent routine test performance

o   Preparing and distributing samples significant effort

      Describe the use of the specimen transfer form

·         Components of specimen transfer form

o   Title, name and contact of referring laboratory/site, date, name and contact of referral laboratory

o   Specimen identifiers (Specimen Tracking Number, Test Subject ID*, Final Result (Testing Site), Date Specimen Collected, Specimen Type (DBS or Serum), Collected by Referral Laboratory Request, Completed, Date to referral laboratory, Date Confirmation, Result Received, Result of Re-test)

Table 1: Example: Specimen Transfer Log for Re-testing

 Name of Referring Testing Site:

Contact Name:

Address and Phone Number

Date:_______________________

Referral Laboratory/site _________________________________

Specimen Tracking Number	Test Subject ID*	Final Result (Testing Site)	Date Specimen Collected	Specimen Type (DBS or Serum)	Collected by	Referral Laboratory Request Completed (√)	Date to referral laboratory	Date Confirmed Result Received	Result of Re-test

·         Source: Guidelines for Assuring the Accuracy and Reliability of HIV Rapid Testing: Applying a Quality System Approach, WHO/CDC 2005

      Take part in EQA (receive, perform, record, send results)

·         Before taking part in any EQA gather information on available EQA providers both at national and internal levels

·         Identify programmes that suits the level of your facility including costs involved

·         Include costs in your budget for sustainability

·         Apply for enrolment and registration

·         Document EQA distribution schedules

·         Orient and/or inform management and staff on the scheme

·         Receive distribution, register and record any discrepancies noted

·         Perform EQA in the same manner as your clinical samples

·         Interpret and record results in the same manner as your clinical samples

·         Fill in the results in the necessary documents

·         Submit report to EQA provider