Quality assurance in laboratories Quality Control Quality assurance in laboratories May 2007

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

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

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

Quality ? Consistency Right result Accuracy Precision First time Every time

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

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

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

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)

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

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

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

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

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

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

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.

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

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?

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

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

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

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

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

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)

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

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.

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

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;

2.1 Example of EQA organizer: CMPT, Canada

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)

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 …)

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

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

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

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

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