Checklist Phase 1 of GLI tool version 1.0

This is the checklist for assessing the progress made in phase 1 and identify gaps and points for improvement. Please note that this checklist also contains more detailed technical questions specific for the TB laboratory practice.

The checklists incorporated in this tool cover the complete SLIPTA checklist (SLIPTA: Stepwise Laboratory Improvement Towards Accreditation). This means that this tool can also be used by TB laboratories enrolled in the SLIPTA programme.




Tick off Checklist question ISO 15189:2007 Old SLIPTA New SLIPTA
  Have the duties, responsibilities, and authority of a quality specialist/officer/manager been assigned to a staff member? 4.1.5 A-3.4 N3.4
  Are technical operations supervised by qualified staff (e.g., a laboratory director)? 4.1.5    
  Are daily routine work tasks established, assigned (duty roster or workstation assignments) monitored and supervised by qualified professional staff? 4.1.5 A-3.2 N3.2
  Is a trained safety officer designated to implement and monitor the laboratory safety program including training of other staff? 4.1.5 A-12.20 N12.21
  Does the laboratory identify and undertake quality improvement projects? 4.12.1 A-2.3 N2.4
  Is a workplan and budget in place for the laboratory that supports the laboratory’s testing operations and maintenance of the quality system? 4.15.1 A-2.1 N2.1
  Are quality checks and internal quality controls for AFB-smear microscopy performed daily by technicians and at random (at least weekly) by the supervisor?

Is the staining method (laboratory manual, wall chart) readily available at the workstation?

Is the staining sink level?

Does the microscopy bench and chair appear to be comfortable for the microscopist?

Is the microscope binocular, electric, and with good optics?

Are all reagent bottles labeled and show preparation and expiry dates?

Is the performance of staining reagents checked with a known positive slide at monthly intervals (or more frequently), and results entered in the register?

Are AFB-positive slides re-read by a second person, if possible?

Are 10% of AFB-negative slides re-read by a second person, if possible?

Are monthly workload statistics collected and analyzed in accord with WHO/IUALTD recommendations?

Are specimens processed within one day of receipt?

Are smears prepared on clean, unused glass slides?

Before making the smear, is the slide clearly labeled with the laboratory number ?

Is a swab-stick (or loop) used to collect a representative portion of the sample for smearing?

Is there only one smear per slide?

Is the smear approx. 2cm x 1cm and in the center of the slide?

After drying, is fixation done by gentle heating over a flame?

Does the fixed smear have the appearance of a milky white film on the slide?

Is the objective lens wiped clean after use on a positive smear?

Is the identity of the person reading the slides ientered into the register?

Are results entered directly into the laboratory register?

Are results scored in accordance with WHO recommendations?

Are all slides properly stored in sequence for re-examination by EQA?

4.2.2 etc    
  Are quality checks and internal quality controls for inoculating and incubating cultures performed daily by technicians and at random (at least weekly) by the supervisor?

The method of inoculation (laboratory manual, wall chart) is readily available at the workstation

All media and reagents pass their quality checks and are used prior to their expiration dates

Processed specimens are inoculated onto or into media as soon as possible after resuspension

The Biosafety Cabinet (BSC) is functioning properly

Liquid media is inoculated in accord with manufacturer's instructions

Only one specimen tube or slant is open at a time

A fresh pipette is used at every step to avoid transfer of bacilli from one specimen to the other

A pipette is used to inoculate each slant with 3–4 drops (about 0.1–0.15 ml) ensuring that the entire surface of the slant is inoculated

Tubes are initially incubated in a slanted position such that the surface of the solid media is horizontal and facing upwards

Tubes are incubated in a slanted position with screw-caps loose for at least 1 week

After 1 week of incubation, caps are tightened and tubes may be incubated upright

The incubator maintains a temperature of 35°C to 37°C

Tubes are checked daily for the first week and any contaminated tubes discarded

After the first week, tubes may be read once-a-week

Cultures are incubated for 6 weeks (liquid media) or 8 weeks (solid media) before being reported as negative.

Results are scored in accordance with WHO or NTP recommendations

Results are entered directly into the laboratory register

The identity of the person reading the slides is entered into the register

All isolates are properly stored in accord with WHO and NTP recommendations

Waste is properly disposed

4.2.2 etc    
  Is internal quality control (IQC) performed?,

Is the performance of staining reagents checked with a known positive slide at monthly intervals (or more frequently), and results entered in the register?

Is each new batch of media shown to be able to support the growth of mycobacteria?

Is each new batch of drug-containing media shown to support thegrowth of drug resistant strains but not of drug susceptible strains

If a device contains an internal control area, is the internal control area determined to be acceptable before interpreting the test area?

If QC is unacceptable, is there a process for repeating the the test?

4.2.2
5.6.1
A-9.11 N8.9
  Are quality checks and internal quality controls for processing samples performed daily by technicians and at random (at least weekly) by the supervisor?

The method of processing (laboratory manual, wall chart) is readily available at the workstation

All media and reagents passed their quality and sterility checks and are used prior to their expiration dates

Specimens are processed promptly after receiving and accessioning them

The Biosafety Cabinet (BSC) is functioning properly

The NaOH-NALC solution is prepared freshly each day

The sample tubes are properly labelled

The sample tubes must be capable of withstanding a force of at least 3000xg

Aliquots of buffer and decontamination solutions are used

Work is done in batches corresponding to one centrifuge load

Only one specimen tube is open at a time

A fresh pipette is used at every step to avoid transfer of bacilli from one specimen to the other

Aerosol production is minimized

The volume of the specimen is checked and two volumes of digestion-decontamination reagent is added and thoroughly mixed

The decontamination-digestion mixtures are incubated at room temperature (20°C to 25°C) for 15 minute.

Buffer is added to fill the tubes and the sample mixed

Aerosol-containment centrifuge buckets are loaded and unloaded in a BSC

A swinging bucket rotor with aerosol-containmnet buckets is used

A refrigerated centrifuge is used and the chamber is at 8-10 °C during centrifugation

Samples are centrifuged at an RCF of 3000xg for 15–20 minutes

The supernatant is decanted into a flask a tuberculocidal disinfectant

Samples are resuspended in the recommended volume of buffer

Waste is properly disposed

4.2.2, 5.6.3-5    
  Are quality checks and internal quality controls for drug-susceptibility testing performed daily by technicians and at random (at least weekly) by the supervisor?

The method of drug-susceptibility testing (lab manual, wall chart) is readily available at the workstation

All media and reagents passed their quality checks and are used prior to their expiration dates

The Biosafety Cabinet (BSC) is functioning properly

Only pure cultures (isolates) of M. tuberculosis bacteria are used (i.e., no bacterial or fungal contaminants)

All tubes and media are properly and completely labeled

Only one specimen tube is open at a time

A fresh pipette is used for each sample to avoid transfer of bacilli from one specimen to the other

Aerosol production is minimized

Solid media cultures are incubated for 3 weeks (Middlebrook agars) or 4 weeks (LJ media) before reading

Results are scored in accordance with WHO or NTP recommendations

Results are entered directly into the laboratory register

The identity of the person reading the results is entered into the register

Waste is properly disposed

4.2.2, 5.6.3-5    
  Are technical operations, including standard operating procedures for each test or procedure, documented in a manual, communicated to all relevant personnel, and readily available in the laboratory work area? 4.2.4    
  Are stock cards maintained? 4.6.3    
  Is an organizational chart of the laboratory available? 5.1.1    
  Have written job descriptions been established that define the duties and responsibilities of each staff member? 5.1.1    
  Are there written position descriptions that define the qualifications, duties, and responsibilities of each position? 5.1.1    
  Are lines of authority and responsibility clearly defined for all lab staff, including the designation of a supervisor and deputies for all key functions? 5.1.1
4.1.5
A-3.3 N3.2
  Are records of who is authorized to conduct which activities maintained and readily accessible? 5.1.12    
  Has a person been designated to have the responsibility for the services provided? 5.1.3    
  Are the roles, responsibilities, and authority of the laboratory director clearly defined in the job description? 5.1.4    
  Does the job description for the laboratory director include the duties described in ISO15189-5.1.4. 5.1.4    
  Are the qualifications, competence, and authorities of the lab director documented in their personnel file? 5.1.4    
  Are budgetary projections based on personnel, test, facility and equipment needs, and quality assurance procedures and materials? 5.1.4.i   N7.4
  Does the laboratory appear to be adequately staffed and resourced to complete the work and quality controls?

e.g., Workloads do not exceed 20 specimens per day per technician for AFB smear microscopy, smear microsopy workloads include quality control slides, etc.

5.1.5    
  Are relevant quality assurance and quality management activities included in the duties of personnel and documented in their job descriptions? 5.1.5    
  Do work schedules show task assignments and coordination of work among laboratory staff? 5.1.7 A-3.1 N3.1
  Are policies established to define who may access or alter patient records? 5.1.8    
  Is there adequate space for 1) instruments, 2) bench work, 3) materials and record storage, 4) administrative and record keeping work, and 5) staff activities? 5.2.1    
  Are ‘sharps’ handled & disposed of properly in ‘sharps’ containers that are appropriately utilized? 5.2.10 A-12.11 N12.12
  Is the work area clean, free of leakage and spills and are disinfection procedures conducted and documented? 5.2.10 A-12.7 N12.7
  Are safety inspections or audits conducted regularly and documented? 5.2.2 A-12.13 N12.14
  Is personal protective equipment (PPE) easily accessible at the workstation and utilized appropriately and consistently? 5.2.2 A-12.15 N12.16
  Is a certified and maintained biosafety cabinet (or an acceptable alternative processing procedure) in use for all specimens or organisms considered to be highly contagious by airborne routes? (Biosafety cabinet should be recertified according to national protocol). 5.2.2 A-12.8 N12.8
  Are the laboratory work areas well ventilated? 5.2.2    
  Are work stations organized such that the airflow is directed as to protect the worker? 5.2.2    
  Do the laboratory work areas meet the requirements of current recommendations for working safely with Mycobacterium tuberculosis?

Does the laboratory area where direct smear-microscopy is conducted meet the low-risk TB biosafety guidelines?

Does the laboratory area where sputum processing and inoculating cultures are done meet the moderate-risk TB biosafety guidelines?

Does the laboratory area where identification and DST are conducted meet high-risk TB biosafety guidelines?

5.2.2    
  Do employees appear to be following good laboratory practices including:

drinking and smoking, mouth pipetting is prohibited in the laboratory

lab coats or gowns are worn in the lab but are not worn outside the work area

a freshly prepared tuberculocidal disinfectant is available at all times and work surfaces are decontaminated daily?

5.2.2    
  Is standard safety equipment available and in use in the laboratory?

Biosafety cabinet(s)

Covers on centrifuge(s)

Hand-washing station

Eyewash station/bottle(s)

Spill kit(s)

First aid kit(s)

5.2.2 A-12.14 N12.15
  Is each individual workstation maintained free of clutter and set up for efficient operation?

Does the equipment placement and layout facilitate optimum workflow?

Are all needed supplies present and easily accessible?

Are the chairs/stools at the workstations appropriate for bench height and the testing operations being performed?

Is needed reference material posted, i.e., critical values and required action, population reference ranges, frequently called numbers, etc.

5.2.2 A-12.3 N12.3
  Microscopy:

Is the staining sink level?

Is the microscopy bench and chair comfortable for the microscopist?

Is the staining method (laboratory manual, wall chart) readily available at the workstation?

Is the method of smear examination (laboratory manual, wall chart) readily available at the workstation?

5.2.2    
  Do employees appear to be following good general safety practices?

wearing gloves and lab coats at appropriate times?

using only freshly prepared disinfectants

disposing of sharps in appropriate discard containers.

disposing of bio-hazardous waste in appropriate discard containers.

“clean” and “dirty” sites are appropriately labeled (biohazard labeling, etc.)?

laboratory refrigerators are labeled to designate them as either “Food Only” or “Laboratory Specimens/Reagents Only”?

Material Safety Data Sheets (MSDS) are available for review in the immediate laboratory area

hazard labels are visible in all chemicals stock bottles used in the immediate laboratory area?

proper ventilation, lighting and rodent infestation control are checked regularly

Is there evidence of at least annual review of Safety SOPs by the laboratory personnel?

5.2.2    
  Are staff aware of procedures for reporting, assessing and correcting hazardous conditions? 5.2.2    
  Is there a written emergency plan (SOPs) for spills, accidents, etc.? 5.2.2    
  Is a laboratory safety manual available, accessible, and up-to-date?

Blood and Body Fluid Precautions

Hazardous Waste Disposal

Hazardous Chemicals/Materials

MSDS Sheets

Personal protective equipment

Vaccination

Post-Exposure Prophylaxis

Fire Safety

Electrical safety

5.2.2 A-1.7 N12.15
  Is the physical work environment appropriate for testing?

Free of clutter?

Adequately ventilated?

Free of excess moisture?

Adequately lit?

Climate-controlled for optimum equipment function?

Where air-conditioning is installed, are filters checked, cleaned and/or replaced at regular intervals?

Are wires and cables properly located and protected from traffic?

Is there a functioning back up power supply (generator)?

Is critical equipment supported by uninterrupted power source (UPS) systems?

Is equipment placed appropriately, i.e. away from water hazards, out of traffic areas, etc.

Is a contingency plan in place for continued testing in the event of prolonged electricity disruption?

Are appropriate provisions made for adequate water supply, including deionized water or distilled water, if needed?

Is clerical work completed outside the testing area?

Is major safety signage posted and enforced?

5.2.5
5.2.10
A-12.4 N12.3
  Are the equipment manufacturer’s operator manuals readily available to testing staff? 5.3.5 A-5.14 N5.13
  Is there a list of who is authorized to use specified equipment? 5.3.5    
  Are logs of who uses equipment maintained? 5.3.5    
  Are SOPS available for the use of each piece of equipment. 5.3.5    
  Are SOPS available for the maintenance of each piece of equipment. 5.3.5    
  Are all methods being used in accord with NTP and international (WHO, IUATLD) policies and guidelines?

Direct AFB smear microscopy?

Concentrated AFB-microscopy?

Specimen processing?

Inoculating, incubating, and scoring cultures?

Species identification?

Drug susceptibility testing?

5.4.10    
  Is there an SOP for direct AFB-smear microscopy? 5.4.7    
  Is there an SOP for concentrated AFB-smear microscopy? 5.4.7    
  Is there an SOP for drug-susceptibility testing? 5.4.7    
  If your laboratory collects specimens:

Is the collection area well ventilated?

Is the collection container properly labeled with patient details before sample is collected?

Are specimens labeled with time, date, patient ID, and collector’s initials?

Is a laboratory number written on the side (or side and top) of the container?

Is the patient identified and matched to the request form and containers?

Are instructions provided to patient on how to produce a sputum specimen?

Is the quality of the sample checked before accepting and re-collected if necessary?

5.4.8 A-9.4 N8.1
  Are written procedures for direct AFB-smear microscopy present and easily accessible at the workbench? 5.5.3 A-9.10 N8.8
  Are written procedures for concentrated AFB-smear microscopy present and easily accessible at the workbench? 5.5.3 A-9.10 N8.8
  Are written procedures for inoculating, incubating, and scoring cultures present and easily accessible at the workbench? 5.5.3 A-9.10 N8.8
  Are written procedures for species identification testing present and easily accessible at the workbench? 5.5.3 A-9.10 N8.8
  Are written procedures for drug susceptibility testing present and easily accessible at the workbench? 5.5.3 A-9.10 N8.8
  Are procedures for each laboratory process present and easily accessible at the workbench? 5.5.3 A-9.10 N8.6
  Are job aids available next to workstation? 5.5.3-5    
  Are SOPs for each testing procedure performed (including QC guidelines, acceptability, what to do if QC out of range) complete, easily accessible and available to all relevant staff? 5.5.3-5 A-1.4 N1.5
  Are results scored and interpreted in accordance with NTP and international recommendations. 5.7.1

5.1.12

   
  Are staff aware of the symptoms of TB?      
  Are medical services for TB available to laboratory staff if needed?      
  Are quality checks and internal quality controls for species identification testing performed daily by technicians and at random (at least weekly) by the supervisor?

The method of species identification (lab manual, wall chart) is readily available at the workstation

All reagents passed their quality checks and are used prior to their expiration dates

The Biosafety Cabinet (BSC) is functioning properly

The morphology of colonies on solid medium is observed to check culture purity

Results are scored in accordance with the written procedure or manufacturer's recommendations

Results are entered directly into the laboratory register

The identity of the person reading the test results is entered into the register

Waste is properly disposed

     
  Has each staff member been provided with a written description of their duties?      
  Are occupational injuries or illnesses documented in the safety/occurrence log?   A-12.8 N12.19
  Is there an SOP for species identification testing?      
  Are drivers, couriers, and cleaners working with the laboratory trained in safety practices relevant to their jobs?   A-12.19 N12.20