The WHO measles and rubella accreditation programme was established in 2002 and consists of an assessment or external audit of laboratories within the network [6]. Accreditation provides documentation of the laboratory’s qualifications and capacity to detect, identify, and promptly report measles and/or rubella positive samples to the national surveillance programme and the regional and global WHO programmes. The accreditation process also provides a learning opportunity and serves as a mechanism to identify resource and training needs.
The WHO Regional Laboratory Coordinator (RLC) is responsible for coordinating the accreditation of National Measles and Rubella Laboratories annually and the Global Laboratory Coordinator (GLC) is responsible for coordinating the reviews of the Regional Reference and Global Specialised Laboratories. The accreditation assessment is based on laboratory’s performance with complete data during the preceding 12 months. A laboratory achieving full accreditation will maintain that status for the forthcoming calendar year. A partial accreditation, or a non-accreditation result, will set in motion a series of activities to build the capacity of the laboratory needed to reach full accreditation status as soon as possible.
Due to the considerable time and workload required for conducting on-site reviews, the on-site accreditation will be reserved for higher priority laboratories. All network laboratories will be required to complete “desk” accreditation checklists annually and submit them to the appropriate laboratory coordinator by correspondence. The checklists will be reviewed, and on-site reviews will be prioritised for laboratories that failed accreditation, have provisional accreditation status, or those laboratories requiring support to attain full functionality. The next priority for on-site visits will be given to those laboratories that have not undergone an on-site accreditation in the past 3-4 years.
Four major areas of assessment listed here are described in detail below:1. Review of the laboratory’s QA/QC programme (including the results of the WHO EQA panels)
- Review of the laboratory’s QA/QC programme (including the results of the WHO EQA panels)
- Review of laboratory environment and human resources
A. Profile of physical space
B. Biosafety in the laboratory
C. Profile of human resources - Review and verification of documented procedures, results and records of laboratory activities
Review of supervisory visits, coordination and interaction with the GMRLN
1) Review of the laboratory’s quality assurance and quality control programme
A QA/QC programme is essential to ensure accuracy and reliability of laboratory testing in the laboratory network. The laboratory should establish a quality programme that monitors the quality of all tests performed. The accreditation review requires demonstration of satisfactory performance in each laboratory’s quality assurance and quality control programmes. The QC data must be adequately recorded and maintained in an easily accessible format. The accreditation reviewer should have access to the raw data generated from testing, assay kit validation information, and evidence that proper QC procedures have been followed from any assay over at least the previous two years.
Accreditation reviewers will be expected to examine SOPs, IHC results, selected equipment maintenance records and especially check validation of equipment that can have a critical impact on results of routine testing such as daily temperature monitoring of incubators, refrigerators and freezers, and six-monthly calibration of pipettes.
2) Review of laboratory environment and human resources
A. Profile of physical space
The work space in the laboratory should be allocated to provide adequate space and separation as required for different activities performed. In addition, attention must be given to elements of the laboratory environment that can be adjusted to allow for safe performance of laboratory work and for cleaning, disinfecting and maintenance. Walls, ceilings and floors should be smooth, easy to clean, impermeable to liquids and resistant to the chemicals and disinfectants normally used in the laboratory. Bench tops should be impervious to water and resistant to disinfectants, acids, alkalis, organic solvents and moderate heat. Illumination should be adequate for all activities. Additional important aspects of laboratory design are provided in Annex 12.5.
Laboratory furniture should be sturdy and under bench storage cabinets and equipment should be accessible for cleaning. Ideally, storage space for supplies in use should be available and adequate to prevent clutter on bench tops and in aisles. Additional long-term storage space, located outside the laboratory working areas, should also be provided. There should a clear separation of infectious and clean areas with designated, separate areas for office work and eating or drinking.
Microbiological containment should be appropriate for the levels of risk of the potential pathogens in the material being worked with. Areas where the risk of contamination of microorganisms or PCR products is high should be isolated from areas that could be adversely impacted. Use of color-coded gowns, pipettes and other mobile equipment or supplies for each specialized area enhances the chances that these are not used inappropriately in clean areas. The accreditation reviewer will expect to have ready access to all areas of the laboratory and will investigate that each area of the laboratory is used appropriately and there is containment of potentially contaminating materials. The means of disinfection and sterilization prior to disposal should be adequate and performed in a safe manner.
B. Biosafety in the laboratory
The publication, WHO Laboratory Biosafety Manual Third Edition (2004) describes the essential biosafety, chemical, fire and electrical safety requirements to protect staff, the community and the environment [7]. All new staff should be made aware of the risks involved in working in a measles and rubella laboratory before starting work in the laboratory and adequate safety training should be provided. The director is responsible for implementation of and compliance with the provisions of the manual.
It is recommended that all laboratory staff receive the Hepatitis B vaccine. Measles and rubella vaccination are also strongly recommended for staff, especially in laboratories that are attempting to culture measles or rubella virus from clinical samples. Women of child-bearing age working in the measles and rubella laboratory should have demonstrable immunity to rubella.
The safe handling of blood products and precautions for opening packages of clinical samples is provided in Chapter 3. Clinical specimens for the laboratory diagnosis and molecular epidemiology of measles, rubella, and CRS, section 3.2.
C. Profile of human resources
Laboratories should develop an organogram clearly showing the names and job titles of all the staff and showing lines of responsibility and accountability and hold records of their education and training achievements. Mechanisms should be in place for regular onsite training and for regular meetings to include periodic updating of staff on technical issues. Arrangements for staff absences, either scheduled leave or due to illness, are required to ensure services are maintained. Contingency plans for increased workload, such as during outbreaks, should be developed with anticipated staff and resource needs determined and possible solutions identified. Opportunities should be provided for staff to acquire skills outside their own discipline or cross training to allow for flexibility in shifting or reassigning personnel if needed.
The profile of human resources includes a training and competency assessment. It is essential that every person working in the laboratory has undergone appropriate orientation and training in the functioning and in the operation of the laboratory. For any assay to be performed correctly, training is critical to achieve quality practices in the laboratory and in order to produce accurate, reliable and timely test results.
Training can be in several formats: one-on-one or group; hands-on or theoretical; on-site or off-site; institutional tutors or external tutors. The general topics of training should include: health and safety; SOPs and procedures and QA/QC. WHO periodically holds hands-on training workshops for the performance of specific tests and every opportunity should be taken for the persons routinely performing these tests to attend. RRLs and GSLs are also instrumental in providing on-site training and learning opportunities to the national laboratories in their constituencies.
Assessment of an employee’s performance in the laboratory should occur periodically. Refresher courses should be required to ensure technical skills, knowledge of and adherence to safety rules and policies. Positive feedback, as well as suggestions for improvement, should be provided. All identified personnel problems should be addressed with the employee when they occur, so that they can correct any issue before it can have a major impact.
3) Review and verification of documented procedures, results and records of laboratory activities
The long-standing essential indicator of quality laboratory surveillance, timeliness of reporting, requires documented totals of samples tested for both measles and rubella, as well as records of dates of sample receipt and corresponding results reported. The total number of samples tested must demonstrate that the minimum testing requirement has been met (50 serum specimens annually).
During an on-site review, the accreditation reviewer will expect to have complete and detailed documentation for all procedures and processes in the laboratory. Documents to be reviewed will be comprehensive and may include: SOPs, reagent/kit inventory lists, staff training records, safety audits, equipment logs, temperature monitoring sheets, pipette calibration details, assay details with raw data, printouts or digital records, in-house control use and graphic analysis, specimen database, confirmatory testing results and follow-up actions, minutes of regular meetings with surveillance staff, and others documents as the reviewer may think appropriate. Documents should be kept for a minimum of 10 years and the reviewer may request to review documents at least from the time of the previous on-site review.
The QA/QC system in place can illustrate the level of commitment to ensuring that all practical steps and procedures for QA have been addressed. The SOPs for laboratory tests and assays must be sufficient for detection of errors and direct the steps and documentation required for timely correction of detected errors or non-conformance to SOPs. Non-conformance (“non-conforming event report”) and the remedial and corrective action documentation is reviewed to assess adherence to established protocols and whether adequate corrective measures were implemented in time to eliminate the root cause of the errors or deficiencies.
When control samples values are outside the acceptable range, troubleshooting must be undertaken to identify the problem (Annex 12.1). In order to identify the cause of the problem all variables should be checked systematically and preferably only one remedial action at a time should be undertaken before repeating the assay. All tests with controls out of range, inconsistencies or failure of equipment should be documented, with the original problem, the problem resolution, and the remedial action clearly noted and brought to the attention of the QA manager and the Laboratory director.
4) Review of supervisory visits, coordination and interaction with the GMRLN
Due to the tiered structure of the GMRLN, some laboratories in the global network will have responsibility for monitoring the quality of other network laboratories (see Chapter 2. The Global Measles and Rubella Laboratory Network). It is important that laboratories document all interactions with other laboratories in the network and share at least a summary of the interaction with the relevant Regional Laboratory Coordinator (RLC) or Global Laboratory Coordinator (GLC), as appropriate.
It is important to communicate issues that arise to the RLC. Often, a quick resolution may be possible by an exchange of information since similar issues may have been previously encountered by other national laboratories in the region. In addition, some issues may have consequences for the entire region or even the global network. Notifications regarding important laboratory issues by e-mail with other laboratories should include a carbon copy (cc) to the appropriate RLC. The RLC will ensure that issues are brought to the attention of those RRLs or NLs that are responsible for sub-national or other non-network laboratories.
Any accreditation reviews of network laboratories carried out at the request of the RLC should follow the current checklist. The outcomes and recommendations should be reported within the prescribed timeframe. All conclusions and recommendations from the review should be presented to the relevant laboratory staff, institute director, and the Ministry of Health at the conclusion of the review in the form of a draft document which will be finalized after consultation with the RLC.