1. Quality assurance in laboratories
Quality Control
Quality assurance in laboratories
May 2007

2. Learning objectives
At the end of the presentation, participants should
Understand the principles of Quality control
Understand the importance for internal and external quality control schemes

3. Quality is....
invisible when GOOD
impossible to ignore when BAD

4. Quality ?
= sum-total of all the characteristics of a product/service that has a bearing upon the utilization of the product/service to the entire satisfaction of the consumer 1

5. Quality ? Consistency Right result Accuracy Precision First time
Every time

6. Objectives of quality in lab
Support provision of high quality health-care
Reduce morbidity
Reduce mortality
Reduce economic loss
Ensure credibility of lab
Generate confidence in lab results 24

7. Consequences of poor quality
Inappropriate action
Over-investigation
Over-treatment
Mistreatment
Inappropriate inaction
Lack of investigation
No treatment
Delayed action
Loss of credibility of laboratory
Legal action

8. Quality assurance = Internal quality control + External quality assessment
Continuously and concurrently assessing lab work
Retrospectif and periodic

9. Assessment of Quality System
Man-driven
Material-driven
Audit, On-site inspection
Internal
External
Accreditation
Quality Assessment
Internal
External
Schematic way: External Quality Assessment Scheme (EQAS)

10. 1 - Internal quality control in laboratory
= set of procedures undertaken by the staff to ensure quality of reports
Total process beginning with sample collection up to final reporting

11. Quality in labs is mutual responsibility of…..
Laboratory specialists
Clinicians
Public health physicians 2

12. Factors influencing internal quality
Sample
Transport
Sample
handling
Sample
receiving
Sample
Collection
Analysis
Patient
preparation
Outside laboratory
Within laboratory
Various factors influence the quality of the laboratory results. These could be pre-analytic, analytic or post-analytic. Naturally, some of these factors are not within the scope of the laboratory. The cycle begins with the initiation of the request by the doctor for laboratory investigation (right or wrong choice of test), selection of proper test as related to the timing of the illness, proper completion of requisition form, adequate preparation of the patient for collecting representative clinical sample and proper collection, handling and transport of the sample to the laboratory. The analytical factors include quality of laboratory materials, equipment and performance of laboratory personnel. Post-analytical factors include transcriptional errors, incomplete reports and subjective interpretation.
Requisition
Results
Patient
Reports
Doctor 2

13. 1.1 - Factors influencing quality: Pre-analytical
Investigation
Ex: blood culture in the first week of enteric fever and not Widal
Specimen
Ex: No stool in SARS
Collection technique
Ex: Stool from bedpan→ collect stool in a clean container
Storage and transportation
Ex: Not kept in cold chain- overgrowth of other bacteria
Quantity
Ex: Not enough serum for serology
Labeling
Ex: Mismatch of sample
Laboratory
Ex: Not necessary test capacity
Right

14. 1.2 - Factors influencing quality: Analytical
PROFICIENCY OF PERSONNEL:
Education, Training, Aptitude, Competence, Commitment, Adequate number, CME, Supervision, Motivation
REAGENTS STABILITY, INTEGRITY AND EFFICIENCY:
Stable, Efficient, Desired quality, Continuously available, Validated
EQUIPMENT RELIABILITY:
Meet technical needs, Compatible, User & maintenance friendly, Cost effective, Validated
SPECIFICITY & SENSITIVITY OF SELECTED TEST:
Adequate ST, Sufficient SP, cost effective, compatible with, available infrastructure and expertise, interpretable, meets the needs/ objectives, validated
USE OF APPROPRIATE CONTROLS:
Internal: Labs, Calibrated against national
External: Supplied by manufacturer, National, International
ANALYTICAL FACTORS
Procedural reliability using Standard Operating Procedures
DOCUMENTATION:
All the written policies, plans, procedures, instructions and records, quality control procedures and recorded test results involved in providing a service or the manufacture of a product
Assessment

15. Documentation If you have not documented it, you have NOT done it …
it is a RUMOUR !!! 5

16. Value of Documentation
Ensures processes and outcomes are traceable
Processes can be audited, thus external assessments can take place
Tool for training
Reminds you what to do next
Documentation is valuable in that:
Records ensures processes and outcomes are traceable.e.g process may refer to the addition of raw materials to make a final product and outcome refer to the product meeting product specifications.
Documents can prove that the job was done according to known industry standards, this documentation helps external assessors measure the organizations compliance to the said industry standard.
Documentation is a tool for training.
Easier to train staff to approved procedures than to ad hoc information.
Documentation in the form of approved SOPs reminds one what to do next.
e.g A cake recipe, or a complicated test method.

17. Standard Operating Procedures (SOP)
= comprehensively written document that describes the laboratory procedure and all other related issues
Essential for ensuring uniformity in laboratory procedures
SOP for Gram Staining

18. Validation
= is about determining whether something does what it is supposed to do
validation can be simple or complicated, it is up to you
the best systems are always the simplest
keep the simple question in everyone’s mind - does this thing (equipment/process/software - whatever it is) do what it is supposed to do?

19. Importance of validation
Validation - before you introduce something
Re-validation
after you have changed/modified
periodic
Validation is applied to:
SOP
reagents
equipment
software
keep everything simple
validation and re-validation are to do with the same thing, but performed at different times and for different reasons

20. 1.3 - Factors influencing quality: Post-analytical
Right recording and reporting
Right interpretation
Range of normal values
Right turnaround time
Report to right user 23

21. KISS ! (Keep it short and simple)
Reporting
Unequivocal message
Numerical value with units as and when required
KISS ! (Keep it short and simple) 6

22. Bottom-line €
Quality costs ,
but poor quality costs more … € 21

23. Training
The quality system is only as good as the staff who actually work with it
No matter how good the quality system is on paper, quality cannot be achieved if the theory cannot be translated into practice
Training policy and plan
Training must include an understanding of why quality is important
Training should be need based, for all staff and reviewed
Qualifications must be appropriate for the job being performed.
Identify the minimum qualifications necessary for the job. Include these minimum qualifications as a pre requisite for recruitment and selection.E.g. Use a microbiologist to do microbiology.
Supervision is necessary.
Supervisors can determine the competence and knowledge of a staff member and provide additional training.
This increases the quality of a product or service.
E.g. Staff member who performs a crossmatch inappropriately may interpret the results incorrectly and issue incompatible blood. Adequate supervision should prevent this from happening.
Training is a key element of the quality system. In order to provide a high quality product or service, staff have to be trained to perform the work in a competent manner
Staff awareness of the outcome of both good and bad quality can assist in implementing a quality system. 17

24. 2 - External Quality Assessment
3 types, mainly 2:
An EQA organizer provides surveys in which identical material will be tested by all participating laboratories
 ex: WHO/NHLS programme in Africa
Participating laboratories send specimens to EQA organizer for Rechecking
 ex: Tuberculosis bacilloscopy quality control in Morocco
On-site visits with physical assessment)

25. EQA
According to the ISO definition, EQA (also known as ‘proficiency testing’ (PT) or ‘EQ Control = EQC’) refers to:
a system of objectively checking laboratory results by means of an external agency
including comparison of a laboratory's result at intervals with those of other laboratories
the main objective being the establishment of trueness

26. What makes microbiology different to other EQA schemes?
Microbiology samples are fundamentally non-uniform.
Microbiological taxonomy is fundamentally imprecise.
Microbiological samples are changing.
Traditional microbiological analysis depends upon behavior, not constitution.
Microbiology has many “right” answers.

27. Objectives of EQA schemes for laboratories
Laboratory oriented objectives:
1. Identifying possible deficiencies in laboratory practice, and guiding participants in any corrective actions to be taken for improvement;
2. Identifying the reliability characteristics of particular methods, materials and equipment under routine conditions and suggest corrective actions as appropriate;
3. Assessing and monitoring the impact of training; help for the preparation of future trainings

28. Objectives of EQA schemes for laboratories
Public health oriented objectives:
4. Providing the basis for the comparability of results during epidemiological surveillance and disease control
5. Collecting information on laboratory measurements ( intra- and inter-laboratory) to alert professionals and/or government bodies about problems related to traceability and harmonization of results, and establish limits of acceptability of results as appropriate for a given purpose;
6. Collecting information for the purpose of licensing or accreditation of laboratories;

29. 2.1 Example of EQA organizer: CMPT, Canada

30. 2-2 Rechecking (RC)
Participating laboratories send specimen to be rechecked on a regular basis to the EQA body
Targeted specimens and/or randomized specimens
Usually blind, can be single or multiple
Example of tuberculosis bacilloscopy in Morocco:
180 centres in the country
All positives smears (targeted)
10% of all negative smears (randomized)

31. 2.3 On-site visits Laboratory assessment
Laboratory licensing and/or accreditation
Combined with the other types of EQA
After repeated problems (corrective action)
During on-site supervision (routine checking)
After training session (practical implementation of the training )
 In addition to the assessment of the existing conditions, QC material can also be provided (slides, strain, sera, specimen for rapid tests …)

32. The ideal situation: 2 types together and very targeted on-site visits
Expensive, heavy
Only for one laboratory
Very much time consuming
Very effective if motivated staff
Very complementary to all other schemes especially rechecking
On-site visits should be used with « extreme » situations
« Initial » situation: laboratory assessment, licensing
« Bad » situation: repeated problems, failures in training
« Good » situation: accreditation

33. 3- Accreditation
= process of inspection of laboratories and their licensing by a third party to ensure conformity to pre-defined criteria
Very very long task (As example, around 20% of French laboratories are accredited by COFRAC, it takes around 2-3 years to follow the roadmap)
Last step of the entire process
Quality assurance (procedures, way of working)
IQC
EQC
Networking of the laboratories
… and then only accreditation if 1-4 completed

34. Carry home messages……..
Quality assurance measures what a lab can do to improve reliability
As an epidemiologist, you may engage the laboratory in a dialogue and tactfully ask about QA measures in place
BE CAREFUL ! An epidemiologist is NOT in a position to assess the reliability of the lab or to evaluate its QA procedures as this requires a specific expertise

35. To summarize
The determinants that ensure the quality of the laboratory & therefore the specimen results are:
Pre-analytical
Analytical
Post-analytical
INTERNAL QUALITY CONTROL:
Set of procedures undertaken by the staff to ensure quality of reports
Investigation
Specimen
Collection technique
Storage and transportation
Quantity
Labeling
Laboratory
Proficiency of personnel
Reagents stability, integrity and efficiency
Equipment reliability
Specificity & sensitivity of selected test
Procedural reliability using standard operating procedures
Use of appropriate controls
Documentation
Assessment
Recording and reporting
Interpretation
Turnaround time
EXTERNAL QUALITY ASSESSMENT:
a system of objectively checking laboratory results by means of an external agency
External quality assessment scheme
Rechecking
On-site visits
Combination of any two or more of the above
ACCREDITATION: Process of inspection of laboratories and their licensing by a third party to ensure conformity to pre-defined criteria
Laboratory license

36. Quality Control
Developed by: The Department of Epidemic and Pandemic Alert and Response of the World Health Organization with the assistance of: European Program for Field Epidemiology Training Canadian Field Epidemiology Programme Thailand Ministry of Health Institut Pasteur