Measles and Rubella Laboratory Check-list for Annual who accreditation



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Measles and Rubella Laboratory

Check-list for Annual WHO Accreditation

Date of Review:

/ /

On-site / by correspondence*

Accreditation for calendar year:




Laboratory:




Institute:




Address:







Country




Phone:




Email:




Website:




Head of Institute:




Head of Department:




Head of Laboratory:










Head Mea/Rub Lab:




Chief Technician:




Name of Laboratory used for Virus Isolation/Detection:

Name of Laboratory used for Virus Sequencing:

(Laboratories that act as a reference laboratory for sub-national laboratories should complete annex I to the checklist)

Reviewer(s):




Name of National Accrediting Authority (if appropriate) and current accreditation status from this authority (e.g. ISO15189 or other, provide documentation):

Part I: Summary of Review (assessor to complete)

Recommendations (check one):

 Accredit: Laboratory meets all criteria


 Provisionally accredit: Laboratory passed the most recent proficiency test, but needs to strengthen one or more of the remaining criteria
 Do not accredit: Laboratory did not pass the most recent proficiency test
Findings:

1.

Measles and rubella IgM test results are reported by the laboratory to the surveillance system within 4 days for ≥ 80% of specimens:

Measles:
Rubella:

%
%


2.

The laboratory reports to MRLDMS weekly and/or to CISID monthly

Completeness

Timeliness



%

%

3.

IgM tests are performed on at least 50 specimens annually:

Measles:
Rubella:



4.

The accuracy of IgM detection is ≥ 90% ( samples)

Measles:
Rubella:

%
%


5.

Internal quality control (QC) procedures are implemented: (Yes/No/Partially)




6.

The score on the most recent WHO proficiency test is ≥ 90%:

PT panel number: Date reported: dd/mm/yy



Measles:
Rubella:

%
%


7.

The score on the most recent WHO Molecular proficiency test (if appropriate) is ≥ 90%: Panel number: Date reported: dd/mm/yy

Measles:
Rubella:

%
%


8.

Virus genotyping (if performed) is completed AND data reported to WHO through MeaNS or RubeNS within 2 months of receipt of specimens, for ≥80% of the specimens appropriate for genetic analysis:

MeaNS:
RubeNS :

%

%

9.

The score from the on-site review of laboratory operating procedures and practices is ≥ 80%:

%




SUMMARY, Comments and recommendations:






Introduction
Accreditation of Measles Rubella Laboratory is reviewed annually (if possible) by the WHO Regional Office and based on laboratory performance during the immediately preceding 12 months. Accreditation is given for the forthcoming 12 months.
There are eight criteria for accreditation:


  1. Measles and rubella IgM test results are reported by the laboratory on at least 80% of measles and rubella IgM specimens within 4 or 7 days of receipt (according to the recommended regional reporting timeliness):

To allow an appropriate response to measles and rubella cases, test results should be reported to the EPI programme in a timely manner.


  1. IgM tests are performed on at least 50 specimens annually.

To maintain skills in performing serological assays, Virus laboratories should maintain appropriate reagents and assay kits to have capacity to test continually through the year. To maintain expertise it is required that laboratories test a minimum of 50 specimens for EIA IgM or IgG detection annually, spread across the year. Where surveillance specimens are insufficient to meet this indicator then the lab may use non-surveillance specimens for completing the minimum requirement.


  1. The accuracy of measles and rubella IgM detection is at least 90%.

Accuracy is determined by the agreement in test results on sera submitted by the (sub) National Laboratory to the supervisory laboratory (National or Regional Reference Laboratory (RRL) during the 12-month review period. The percentage of specimens sent for validation is dependent on the quality of the laboratory and could range from 10-100% with the lower proportion for a fully accredited laboratory and 100% for a laboratory that has failed accreditation. Specimens for validation should be representative of all results (positive, negative and equivocal) and outbreaks, and should be sent to the supervisory laboratory at regular intervals.


  1. Internal quality control (QC) procedures are implemented.

Appropriate QC procedures are in place and followed, including; appropriate serological and PCR controls (such as in-house positive controls and assay controls), micro-pipettor calibration and temperature recording of incubators and refrigerators/freezers. QC data sheets and summaries of corrective action are retained and available for review.


  1. The score on the most recent WHO approved serological proficiency test is at least 90%.

Proficiency test (PT) results to be reported within 14 days of panel receipt to receive full credit.


  1. The score on the most recent WHO measles/rubella molecular proficiency test panel is at least 90%.

Molecular QA/QC panel results to be reported within 2 months of panel receipt to receive full credit. This applies only to laboratories routinely performing molecular testing.


  1. Results from virus isolation/detection and genotyping (if performed) are completed within 2 months of receipt of specimen AND data reported to WHO monthly, for ≥80% of the specimens appropriate for genetic analysis.

Genotype information can assist national control programmes to determine transmission pathways and needs to be provided in a timely manner. Genetic data on appropriate specimens collected from separate chains of infection should be supplied to the national programme as soon as they become available, and to WHO through the MeaNS and RubeNS databases. Laboratories are also encouraged to submit sequence data to GenBank, once sequencing is completed, either directly or through MeaNS or RubeNS. (Note: Virus isolation/detection and genotyping performance will be assessed only on specimens meeting the recommended collection and testing strategy)


  1. The score from the on-site review of laboratory operating procedures and practices is at least 80%. For Laboratories with consistently high performance indicators, the Regional Laboratory Coordinator may waive the on-site review upon satisfactory completion of the annual checklist by the laboratory (see below).

A Laboratory that achieves less than the passing score on any one of the applicable criteria will work with the Regional Laboratory Coordinator to:



  • Identify areas where improvement is needed;

  • Develop and implement a work plan;

  • Monitor laboratory progress;

  • Provide for re-testing where required;

  • Complete steps to achieve full accreditation.

A laboratory that fails to achieve a passing score in the most recent proficiency test panel(s) (serological and molecular if appropriate) and also a repeated proficiency test panel within 3 months of the failed panel, is deemed Non-Accredited for that function (serological and/or molecular, if appropriate) and arrangements must be made for another, fully accredited, Laboratory to perform duplicate tests on all appropriate specimens. Every effort will be made to bring any non-accredited laboratory to full accreditation status as soon as possible.


The checklist consists of five parts:

Part I summarizes the findings of the review and the data on which accreditation is based and is to be filled out by the assessor;

Part II provides a worksheet to calculate and record laboratory performance for criteria 1 through 7 for the immediately preceding 12 months where data are complete. (Selection of the most recent 12-month period, rather than the most recent calendar year as a basis for calculation, provides an assessment of current performance and permits review of laboratories at any time during the calendar year. For ease of reporting, the entire previous calendar year plus the full months of the calendar year up to the date of assessment can be chosen);

Part III provides a profile of the laboratory and serves to identify resource needs;

Part IV provides a profile of the measles programme in the country the laboratory serves.;

Part V is a checklist for evaluation of laboratory operating procedures and practices for criterion 8.
All laboratories should be assessed annually but for laboratories with a consistently high accreditation score the WHO Regional Laboratory Coordinator may waive annual onsite reviews and determine accreditation status after review of criteria 1 to 7. In this situation, onsite reviews of well performing laboratories may be carried out every 2-3 accreditation cycles.
If Measles and Rubella Laboratories are separate facilities, a checklist should be completed for each of the facilities.
N.B.: This checklist does not include all laboratory activities or cover all situations. It is intended to serve as a guide. The assessor is expected to ask detailed questions and make additional suggestions as appropriate to assure high quality laboratory performance.
National Laboratories that serve Sub-national Laboratories

Countries that have established sub-national laboratories for measles and rubella surveillance should endeavour to monitor the quality and performance of these laboratories. National laboratories should consider establishing a confirmatory testing and proficiency testing programme, monitor timeliness of reporting and ensure the performance of IgM assays, in a similar process to that used for determining the quality and performance of the National and Regional measles/rubella LabNet. WHO is willing to provide technical advice to National Laboratories planning to establish a sub-national laboratory monitoring programme. A separate checklist is available for those laboratories supporting sub-national laboratories.



Part II: Laboratory Performance in Previous 12 Months


Dates from:

/

/




to

/

/







dd

mm

yyyy




dd

mm

yyyy






Percentage of measles and rubella IgM antibody test results reported within 4 days of receipt:

(Measles : 1.2/1.1 x 100, Rubella 1.4/1.3 x100)

Measles

Rubella

%

%



Number of specimens tested for measles IgM:






Number (1.1) with measles IgM antibody results reported within 4 days of receipt:




Number of specimens tested for rubella IgM:




Number (1.3) with rubella IgM antibody results reported within 4 days of receipt:

Comments and recommendations:




Total number of serological tests performed:




For measles:

IgM (same as 1.1 above):

IgG:

Special surveys (specify):






For rubella:

IgM (same as 1.3 above):

IgG:

Special surveys (specify):






For all other viruses:

IgM (specify):

IgG (specify):

Other (specify):



Comments and recommendations:





Percent accuracy of IgM detection:

Measles

%

Rubella

%



Number of IgM specimens tested:






Number and percentage forwarded to supervisory laboratory (NL/RRL):






Number confirmed accurate by supervisory laboratory (NL/RRL):






Number of times IgM specimens sent to supervisory laboratory (NL/RRL) for confirmation during review period:







Comments and recommendations:






Routine Internal Quality Control Procedures Implemented: (Yes/No/Partially)






Validated assays used for IgM detection (list kits in comments section below)






Kit validation criteria are followed






In-house positive control(s) are used for EIA






Monitoring of in-house and kit controls presented as a graphic display

Attach graphs from review period to completed checklist.








Pipette and thermometer calibration






Currently certified thermometer available

Date of certification expiry: ___/___/______








Daily monitoring of temperatures of temperature sensitive equipment, e.g. incubators, freezers & refrigerators






Appropriate controls used for each PCR run (if PCR performed)






SOPs are acceptable and readily available






A document control system is in place






Results are recorded electronically and backed up










DESCRIBE other QC Procedures IMPLEMENTED:

Summarise details of EIA kits used and controls used for EIA and PCR:

Comments and recommendations:










Result of most recent IgM Proficiency Test

Measles:

%




Rubella:

%



PT Panel Number






Date of panel receipt:

/

/






Date of test report:

/

/







NATURE OF DEFICIENCY, IF ANY, AND CORRECTIVE ACTION TAKEN:


Comments and recommendations:







Result of most recent measles/rubella molecular Proficiency Test panel
(if measles and/or rubella molecular testing is performed):







Measles:

%




Rubella:

%



Molecular PT Panel Number












Date of panel receipt:

/

/






Date of test report:

/

/







NATURE OF DEFICIENCY, IF ANY, AND CORRECTIVE ACTION TAKEN:


Comments and recommendations:





Results from virus isolation/detection and genotyping (if performed) are completed within 2 months of receipt of specimen AND data reported to WHO monthly through MeaNS or RubeNS, for ≥80% of the specimens appropriate for genetic analysis.

(Note: Virus detection and genotyping performance assessed on specimens meeting the recommended collection and testing strategy)

%

7.1

Number of specimens received for measles or rubella virus isolation/detection




7.1.1

Number of specimens with virus isolation/detection attempted:




7.1.2

Number of measles viruses confirmed:




7.1.3

Number of rubella viruses confirmed:




7.1.4

Percentage of virus isolation/detection results reported within a month of being available:




7.1.5

Number of viruses forwarded to designated sequencing laboratory:




7.2

Breakdown of methods used for measles or rubella virus isolation/detection




7.2.1

Number of measles or rubella specimens tested by virus culture methods:




7.2.2

Number of measles or rubella specimens tested by conventional PCR methods:




7.2.3

Number of measles or rubella specimens tested by real-time PCR methods:




7.3

Breakdown of number of specimens for measles genotyping received




7.3.1

Number of specimens appropriate for measles genotyping received:




7.3.2

Number of specimens genotyped:




7.3.3

Number of measles specimens genotyped within 2 months of receipt:




7.3.4

Total number of measles sequences reported to MeaNS during period of review:




7.3.5

Number of measles sequences reported to MeaNS within 2 months of receipt of specimens:




7.3.6

Percentage of measles sequence data reported to MeaNS within 2 months of receipt of specimens: (7.3.5 / 7.3.2) x 100

%

7.4

Breakdown of number of specimens for rubella genotyping received




7.4.1

Number of specimens appropriate for rubella genotyping received:




7.4.2

Number of specimens genotyped:




7.4.3

Total number of rubella sequences reported to RubeNS during period of review:




7.4.4

Total number of rubella sequences reported to RubeNS during period of review:




7.4.5

Number of rubella sequences reported to RubeNS within 2 months of receipt of specimens:




7.4.6

Percentage of rubella sequence data reported to RubeNS within 2 months of receipt of specimens: (7.4.5 / 7.4.2) x 100

%




Comments and recommendations:



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