Measles and Rubella Laboratory Check-list for Annual who accreditation

Part III: Laboratory Profile

	Staff
	Number of scientific and technical staff assigned to measles and/or rubella laboratory: Please list according to function, indicating years of measles and/or rubella laboratory experience and proportion of current working time spent on measles and rubella related activities.

Names of staff	Position Title or Duties	Full-time or Part-time (in Institute)	% of time spent working on measles or rubella	Years of experience in Measles or Rubella Lab	Undergone WHO measles/ rubella training

COMMENTS AND RECOMMENDATIONS:

	Space (provide floor plan or sketch of laboratories if possible)
	Total m^2 available:
	Number of rooms:
	Separate cell culture room (if virus isolation facilities available):
	Physically separate areas for nucleic acid amplification (if PCR procedures performed)
1	Dedicated clean area for the preparation of reagents (including dispensing of master mix):
2	Area for extraction of nucleic acids and for the addition of sample DNA to master mix prior to amplification:
3	Dedicated contained area for amplification and product detection:

COMMENTS AND RECOMMENDATIONS:

	Specimen IgM test results performed by the Measles Rubella laboratory for the review period:
Dates		from	/	/		to	/	/

Measles IgM
	Total	Pos	Pos %	Equiv	Equiv %	Neg	Neg %	Not tested
All specimens tested			%		%		%
Specimens from surveillance program / suspected cases			%		%		%

Rubella IgM
	Total	Pos	Pos %	Equiv	Equiv %	Neg	Neg %	Not tested
All specimens tested			%		%		%
Specimens from surveillance program / suspected cases			%		%		%

COMMENTS AND RECOMMENDATIONS:
Part IV: National surveillance data

1. 
   Country-specific data
   

Reporting year
Total Population
Vaccine coverage
	Measles	Rubella
Total number of suspected cases reported
Reporting rate (per 100,000)
Number of clinically confirmed cases
Number of laboratory confirmed cases
Number of epidemiologically linked cases
Incidence of all confirmed cases (per million)^a
Incidence of all lab confirmed and epi-linked cases (per million)^b

2. 
   Laboratory reporting
   

Percentage of adequate specimens tested in lab^c	Number of days required to report lab results	Lab reporting timeliness (%) within the required days
%		%

1. 
   Incidence per million population of ALL confirmed (laboratory, epi-linked and clinically confirmed) measles cases regardless of the source (endemic, imported, import- related or unknown)
   
2. 
   Incidence per million population of measles cases that are either laboratory confirmed or confirmed by epidemiological linkage regardless of the source (endemic, imported, import- related or unknown). This incidence measure should exclude any clinically confirmed cases
   
3. 
   Specimens adequate for detecting measles or rubella IgM should be collected from at least 80% of suspected measles or rubella cases and tested in a proficient laboratory. Any cases that are epidemiologically linked to a laboratory-confirmed case of measles, rubella or other communicable disease should be excluded from the denominator
   

Part V: Laboratory Operating Procedures and Work Practices

	Space (4 points)	Score:
	Space is used efficiently with appropriate equipment placement:
	Space configuration is adequate and consistent with good laboratory practices:
	Space is clean and well kept
COMMENTS AND RECOMMENDATIONS:

	Staff (4 points)	Score:
	Staff are effectively assigned:
	Staff have appropriate training for the activities they perform:
	The number of trained staff are adequate to handle the workload:
COMMENTS AND RECOMMENDATIONS:

	Management and supervision (9 points)	Score:
	The lines of supervision and accountability are clear to all staff:
	Supervisor or another senior staff member critically reviews test worksheets and results for accuracy and completeness and indicate the need for any follow up actions:
	Arrangements are in place for qualified back-up staff to maintain services during scheduled staff absences (e.g. during vacation, study, maternity or paternity leave):
	Periodic meetings are held with staff to review and improve laboratory performance:
	Standard Operating Procedures have been developed and arrangements are in place for periodic review, update and evaluation of compliance:
	Mechanisms are in place for on-site staff training or periodic updating of staff on technical issues:
COMMENTS AND RECOMMENDATIONS:

	Specimens (5 points)	Score:
	Specimens are processed in accordance with WHO protocols:
	Specimens for serological testing are appropriately labelled and stored at –20^oC for at least 12 months
	Specimens for virus isolation/detection are stored at –70^oC if not tested within a day of receipt or if -70°C capacity is not available, shipped to the designated virus identification laboratory within 3 days of receipt with appropriate cold chain
	All potentially infectious clinical materials are processed in a certified biological safety cabinet:
	Specimens for isolation, all virus isolates, and other potentially infectious materials are stored separately from non-infectious materials in designated freezers and refrigerators:
	Specimens for virus isolation/detection (if not performed) are dispatched to the designated laboratory at regular intervals under appropriate conditions:
COMMENTS AND RECOMMENDATIONS:

	Serological testing (IgM) (16 points)	Score:
	Appropriate written SOPs are available and used:
	Records are maintained on all IgM assays performed, including:
	a. Kit manufacturer and batch number
	b. Reagent expiry dates
	c. Positive and negative controls
	d. OD values and calculation details of all specimens tested
	e. Assay validation using in-house controls
	Specimens giving equivocal/indeterminate results are retested and appropriate action taken if still equivocal/indeterminate.
	Positive specimens are stored for at least 12 months and only discarded after discussion with WHO. (Positive specimens of > 0.5 ml can be used for QA purposes)
COMMENTS AND RECOMMENDATIONS:

	Cell Lines (if virus isolation performed) (6 points)	Score:
	Appropriate SOPs are available and used for:
	a. Freezing and recovery of cells:
	b. Routine passage of cells:
	c. Inoculation of cells
	d. Harvest and storage of viral isolates
	Vero/hSLAM cells are available for measles, or Vero (or Vero/hSLAM) for rubella virus culture:
	Cells are obtained from approved WHO stocks:
	Geneticin (G418) is used in the media for preparation of frozen cell stocks:
	Foetal calf serum is derived from certified, disease–free sources
	Low passage cell stocks are labelled appropriately and stored in liquid nitrogen:
	Cells are routinely replaced at least after 3 months or 15 passages:
	Cells remain healthy and adherent for at least 5 days:
	Cells are passaged and maintained in space separate from that used for specimen processing and virus inoculation:
	Media and cells are prepared at separate times and sterility checks performed for media prepared in-house:
	Permanent records are maintained on cell passage and storage histories:
	Reagents and stock solutions are labelled appropriately, including dates of preparation and expiration, and stored at indicated temperatures:
	Cells are routinely tested for the presence of mycoplasma
COMMENTS AND RECOMMENDATIONS:

	Virus Isolation (if performed) (6 points)	Score:
	Appropriate SOPs are available and used:
	Extracts are inoculated on Vero/hSLAM cells for measles or rubella:
	Records are maintained on daily observations of inoculated cells:
	Two sequential passages of 4-5 days are performed before recorded as negative (minimum time in culture is 8 days):
	Isolates are confirmed with IFA, ICA, RT-PCR, real-time PCR or other recommended method:
	Isolates are sequenced or transported to designated sequencing laboratory within 2 months of receipt of the specimen.
	Aliquots of isolates are stored appropriately at –70^oC or lower for at least 12 months:
	Storage vials are clearly and permanently labelled:
	Permanent records are maintained on the identity and location of all isolates:
COMMENTS AND RECOMMENDATIONS:

	Molecular Techniques (if performed) (8 points)	Score:
	Appropriate SOPs are available and used:
	Records are maintained on all procedures:
	Source of molecular protocols are known: (Record details in comments section)
	Source of primers, probes and control RNA are known: (Record details in comments section)
	In-house and external controls are used with each PCR and sequencing run:
	Appropriate physical separation of PCR preparation and testing procedures are established:
	Staff have received specific training in DNA sequencing editing and database interpretation:
	Adequate biosafety measures are in place for RNA extraction methods
	Thermocyclers and real-time instruments have been calibrated and properly maintained
	Staff have access to, and regular submit data to the WHO sequence databases, MeaNS and RubeNS
	PCR results are documented adequately
	Original specimens are stored appropriately at –70^oC or lower for at least 12 months:
	Storage vials are clearly and permanently labelled:
	Permanent records are maintained on the identity and location of all specimens:
	Sequence chromatogram files are stored properly
	Software for sequence alignment and phylogenetic analysis is adequate
	The most recent versions of WHO virus reference strains are used
COMMENTS AND RECOMMENDATIONS:

	Biosafety (10 points)	Score:
	Employees have been instructed in biosafety:
	Appropriate SOPs are available to all employees:
	Biosafety practices are enforced, including:
	a. Hand washing:
	b. Pipetting with aid of mechanical device:
	c. Routine use of gloves and laboratory coats:
	d. No eating, drinking, smoking, or storage of food in laboratory:
	e. Decontaminating all infectious or clinical waste before discarding:
	f. Decontaminating lab work surfaces:
	g. Immunizing staff against measles and rubella:
	h. Immunizing staff against hepatitis B:
	Class II Biosafety cabinets are used for materials which are potentially infectious through an aerosol route:
	Biosafety cabinets are assessed at least annually and dates recorded:
	Chemical safety plan is in use (e.g. for ethidium bromide):
	Eye protection is available for labs using UV transilluminators for Agarose gels:
COMMENTS AND RECOMMENDATIONS:

	Equipment (8 points)	Score:
	Equipment is functioning and in good condition:
	Equipment is maintained periodically as recommended and dates recorded:
	Equipment location is conducive to optimal performance:
	Records are kept on daily temperature readings of incubators, refrigerators, and freezers:
COMMENTS AND RECOMMENDATIONS:

	Supplies (6 points)	Score:
	Current inventories are maintained:
	Adequate time is allowed for replenishing supplies:
	No interruption to testing due to shortage of supplies has occurred:
COMMENTS AND RECOMMENDATIONS:

	Cooperation with EPI and field Staff (10 points)	Score:
	Laboratory and EPI staff communicate/meet at least monthly: (8 points)
	EPI staff are contacted if specimens arrive without adequate information or EPID numbers: (1 point)
	Laboratory staff are familiar with protocols for collecting and transporting specimens and are able to advise field staff: (1 point)
COMMENTS AND RECOMMENDATIONS: