Checklist Phase 3 of GLI tool version 1.0

This is the checklist for assessing the progress made in phase 3 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
  Is there a current laboratory quality manual containing the quality management system’s policies and objectives that is understood and implemented by all staff?

Quality policy statement, including scope of service and
standard of service,

Objectives of the quality management system,

Management's commitment to compliance.

Reference to supporting procedures, including technical procedures.

Evidence of at least annual management review and approval.

4.2.1

4.2.2

4.2.3

4.2.4

A-1.6 N1.1
  Is there a current laboratory quality manual containing the quality management system’s procedures and organizational structure that is understood and implemented by all staff? (see ISO15189-4.2.4 for contents of a quality manual)

Description of the quality management system and the structure of its documentation.

Reference to supporting procedures, including technical procedures.

Description of the roles and responsibilities of the laboratory manager, quality manager, and other personnel to ensure compliance.

Evidence of at least annual management review and approval.

4.2.1

4.2.2

4.2.3

4.2.4

A-1.6 N1.1
  Does your laboratory collect data for monitoring performance of direct AFB-smear microscopy?

Time from receipt in laboratory to recording of result for each specimen or batch of specimens

No.of initial patient specimens tested

No.of initial patient specimens tested that were AFB-positive

No.of follow-up patient specimens tested

No.of follow-up patient specimens tested that were AFB-positive

Total No. of AFB-positive slides

Total No. of scanty+1+ positives

4.2.2, 5.6.3-5    
  Does your laboratory monitor and record quality indicators for processing specimens and inoculating and incubating cultures?

No. of specimens processed

No. of cultures inoculated

No. of cultures that contained M.tuberculosis

No. of cultures positive for any mycobacteria

No. of specimens in which all media are contaminated

No. of solid media tubes inoculated

No. of inoculated solid media tubes discarded due to contamination

No. of liquid media tubes inoculated

No. of inoculated liquid media tubes discarded due to contamination

No. of smear-positive diagnostic specimens culture

No. of smear-positive diagnostic specimens that were culture positive for M. tuberculosis

No. of patients with cultures of M.tuberculosis isolated

No. of patients with cultures of M.tuberculosis isolated of which were smear negative

Time from receipt in laboratory to recording of culture result for each specimen

4.2.2, 5.6.3-5    
  Does your laboratory monitor and evaluate quality and performance indicators for specimen acessioning?

%specimens with complete laboratory register entries

%specimens with accurate laboratory register entries

4.2.2, 5.6.3-5    
  Does your laboratory monitor and evaluate quality and performance indicators for AFB-smear microscopy?

% register entries that have complete microscopy results

% register entries that have microscopy results recorded in accord with WHO/IUALTD recommendations

No. of slides/technician/day

Average time from receipt in laboratory to recording of results

%salivary specimens

smear-positivity rate among new cases

smear-positivity rate among follow-up cases

%initial specimens tested that are AFB-positive

%follow-up specimens tested that are AFB-positive

%AFB-positive specimens that are scanty+ or 1+ AFB smear-positive specimens

%case series that are consistent

No. of days where work was delayed because of stockouts

4.2.2, 5.6.3-5    
  Does your laboratory monitor and evaluate quality and performance indicators for specimen processing and inoculating and incubating cultures?

%cultures inoculated reported as M. tuberculosis

%cultures reported as NTM

%mycobacteria cultures reported as M. tuberculosis

%specimens reported as contaminated

%inoculated solid media tubes that are contaminated

%inoculated liquid media tubes that are contaminated

%smear-positive diagnostic specimens that were culture positive

%culture-confirmed cases from smear-negative patients

%Mtb-positive culture results reported within target turnaround time for results

%register entries that have culture results recorded in accord with WHO/IUALTD recommendations

4.2.2, 5.6.3-5    
  Does your laboratory monitor and evaluate quality and performance indicators for species identification testing? 4.2.2, 5.6.3-5    
  Does your laboratory monitor and evaluate quality and performance indicators for srug susceptibility testing?

%Mtb isolates reported as drug resistant (calculate for each drug)

%Mtb isolates reported as multi-drug resistant

%tests with interpretable results

%register entries that have results recorded in accord with WHO/IUALTD recommendations

%DST results reported within target turnaround time for results

4.2.2, 5.6.3-5    
  Does any contract to provide laboratory services clearly describe, define, and document the requirements for services and that it is understood by all parties? 4.4.1    
  Does the laboratory have the capability and resources to meet the contract requirements; 4.4.1    
  Are any amendments or changes to the contract discussed, documented, and communicated to all affected parties. 4.4.2,5    
  Do the procedures and methods used by the lab meet contract requirements and clinical needs. 4.4.3    
  Are any deviations from the contract are reported to the clients? 4.4.4    
  Are referred specimens tracked properly, using a logbook or tracking form? 4.5.3 A-9.7 N8.5
  Does management review supply request forms to ensure that appropriate materials are purchased? 4.6.1 A-7.5 N7.5
  Does the laboratory management annually perform a review of all quality systems at a management review meeting? 4.12.1   N2.3
  Is the effectiveness of an improvement plan evaluated by review or audit and results submitted to management for review? 4.12.2, 4.12.3    
  Is annual review of the main elements if the QMS documented in the quality manual? 4.14.2    
  Are the findings and the actions that arise from the review documented and communicated to all laboratory staff? 4.15.4    
  Is the size of the laboratory adequate and is the layout of the laboratory, as a whole, organized so that workstations are positioned for optimal workflow? 5.2.2 A-12.1 N12.1
  Do sample collection facilities provide for the accommodation of patient disabilities, comfort and privacy? 5.2.3    
  Are the client area and the testing areas of the laboratory distinctly separate? 5.2.6 A-12.2 N12.12
  Is there adequate storage space and conditions for samples, documents, records, equipment, consumables, etc? 5.2.9    
  Are correction factors documented and up-to-date? 5.3.13    
  Are storage areas set up and monitored appropriately?

Is the storage area well organized and free of clutter?

Are there set places labeled for all inventory items?

Are hazardous chemicals stored appropriately?

Is adequate cold storage available?

Is temperature monitoring conducted according to MSDS instruction?

Is the ambient temperature monitored routinely?

Is storage in direct sunlight avoided?

Is the storage area adequately ventilated?

Is the storage area clean and free of dust and pests?

5.3.6, 5.3.12 A-7.11 N7.11
  Does management systematically reviews requests and examinations and advances in the field to decide which methods are to be used? 5.4.10    
  Are newly introduced methods validated on-site and are records documenting validation available? 5.4.2 A-5.2 N5,2
  Does your laboratory monitor and evaluate quality and performance indicators for specimen transport?

delivery time between specimen collection and its arrival at the laboratory

%of delayed shipments for which speciemns were stored at cool temperatures while awaiting transport

%specimens or shipments that are packaged in accord with procedure and regulations

%shipments with acceptable transport conditions

%apecimens accompanied by a completed request form

5.4.6 A-9.6 N11.2
  Does your laboratory review, record, and analyze:

% specimens that are accompanied by requisition forms?

% requisition forms that are complete?

% sputum containers that meet specifications and are properly labeled?

%
specimens that are saliva?

% specimens that are of adequate volume?

% specimens that are rejected and the reason for rejection?

5.4.8    
  Are only appropriate, validated methods used? 5.5.2    
  Are turnaround times monitored and recorded? 5.8.11    
  Are turnaround times monitored for biases, shifts, and trends? And are violations followed by timely troubleshooting/corrective action? 5.8.11