Checklist Phase 2 of GLI tool version 1.0

This is the checklist for assessing the progress made in phase 2 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
  Has the lab been established as a legal entity in accord with local or national regulations? 4.1.1    
  Do the laboratory services meet the needs of the patients, clinicians, TB control program? 4.1.2    
  Do the laboratory interpretation and advisory services meet the needs of the patients, clinicians, TB control program? 4.1.2    
  Are policies and procedures in place to avoid conflicts of interest and commercial, financial, political or other pressures that might affect the quality and integrity of operations? 4.1.4

4.1.5

A-1.3 N1.4
  Do personnel appear to have the authority and resources to carry out their duties? 4.1.5    
  Are the duties of the quality officer/manager described in their job description? 4.1.5    
  Are the qualifications, competence, and authorities of the quality manager documented in their personnel file? 4.1.5    
  Is there documentation that all staff have read and understood the policies and SOPs that relate to their responsibilities in the laboratory? 4.1.6

5.2.8

A-1.5 N1.6
  Are staff meetings held regularly?

Are problems and complaints discussed?

Are SOPs routinely reviewed?

Are systemic and or recurrent problems and issues addressed including actions to prevent recurrence?

Are results reviewed of prior corrective actions?

Are improvement topics/projects discussed and evaluated?

Are employees recognized for exemplary performance (i.e., employee of the month, letter of commendation, etc.)?

Are reports and updates relayed from lab attendance at meetings with clinicians regarding the use of lab services and/or attendance at clinical rounds?

Are meeting notes recorded and monitored for progress on issues?

4.1.6

5.2.8

A-3.8 N3.8
  Do the environmental checks / temperature logs document action taken on unacceptable results? 4.10.1 A-10.1 N8.12
  Are quality indicators, performance indicators, and EQA results selected, tracked, and reviewed regularly to monitor laboratory performance and identify potential quality improvement activities? 4.12.4

5.8.11

A-11.2 N11.2
  Are results and technical and quality records archived in accordance with national guidelines? 4.13.1-3 A-1.10 N1.9
  Does the laboratory communicate with upper management regularly regarding personnel, facility, and operational needs? 4.14.3 A-2.4 N2.5
  Does the laboratory supervisor routinely perform a documented review of all quality records?

Follow-up of action items from previous management reviews

Changes in volume, type of work the laboratory undertakes, suitability of reference intervals and client handbook

Environmental monitoring logsheets

Specimen rejection logbook

Equipment calibration and maintenance records

IQC records across all test areas

EQA results

Turnaround Time

Quality indicators and internal audit results

Results of assessment(s) by external bodies

Customer Complaints and Feedback

Reports from managerial and supervisory personnel

Occurrence/incidence logs and corrective action reports

Results of improvement projects

Operational procedures (for potential sources of non-conformance and opportunities for
improvement)

Evaluation of referral laboratories

Evaluation of suppliers

Quality Management System (at least once a year)

Documentation of review and action planning with staff for resolution and follow-up review

4.15

4.15.1

4.15.2

4.15.3

4.15.4

A-2.2 N2.2
  Are internal quality control (IQC) procedures performed and results recorded on the laboratory register? 4.2.2

5.6.1

   
  Is internal quality control (IQC) performed, documented, and reviewed prior to release of patient results?

Are QC results documented in register and signed by authorized, competent reviewer?

Does QC for qualitative testing include a positive and negative control and is appropriate follow-up taken on indeterminate results?

If QC is unacceptable, is there a process for investigation and corrective action?

4.2.2

5.6.1

A-9.11 N8.9
  Are internal quality control (IQC) procedures performed, documented, and reviewed prior to release of patient results?

If IQC is unacceptable, is there a process for investigation and corrective action?

4.2.2

5.6.1

A-9.11 N8.10
  Does the laboratory participate in an External Quality Assessment (EQA) scheme (e.g., blinded rechecking), proficiency testing, or inter-laboratory comparison for determining the acceptability of procedures?

Do the EQA samples come from approved providers, e.g., WHO or CAP?

Are EQA specimens handled and tested in the same fashion as patient testing?

4.2.2

5.6.4

5.6.5

5.6.7

A-9.18 N8.13
  For poor EQA results, does the laboratory perform a root cause analysis and implement and document corrective actions? 4.2.2

5.6.4

5.6.5

5.6.7

A-9.18 N8.13
  Does the laboratory monitor and evaluate the results of External Quality Assessment (EQA) ? 4.2.2

5.6.4-7

A-9.18 N8.13
  Does your laboratory monitor and record quality indicators of AFB-smear microscopy?

Total No. of specimens received for microscopy

No. of specimens tested by microscopy

No. of specimens with microscopy results entered in the laboratory register

No. of specimens with complete microscopy results entered in the laboratory register

No. of register entries that have results recorded in accord with WHO/IUALTD recommendations

Total No. of slides examined

No. of staff days spent on AFB-smear microscopy

No. of slides stored

No. of slides submitted for blinded rechecking

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 species identification testing? 4.2.2, 5.6.3-5    
  Does your laboratory monitor and record quality indicators for drug susceptibility testing?

Total No. of specimens received for DST

No. of specimens tested for drug suceptibility

No. of specimens tested with interpretable DST results

No. of isolates reported as drug resistant (calculate for each drug)

No. of register entries that have results recorded in accord with WHO/IUALTD recommendation

No. of specimens tested with complete laboratory register entries

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

4.2.2, 5.6.3-5    
  Are performance indicators of AFB-smear micrscopy results monitored for nonconformance, biases, shifts, and trends? And are violations followed by timely troubleshooting/corrective action? 4.2.2, 5.6.3-5 A-9.13 N11.1&2
  Are performance indicators of specimen processing and inoculating and incubating cultures results monitored for nonconformance, biases, shifts, and trends? And are violations followed by timely troubleshooting/corrective action? 4.2.2, 5.6.3-5 A-9.13 N11.1&2
  Are performance indicators of species identification testing cultures results monitored for nonconformance, biases, shifts, and trends? And are violations followed by timely troubleshooting/corrective action? 4.2.2, 5.6.3-5 A-9.13 N11.1&2
  Are performance indicators of drug susceptibility testing cultures results monitored for nonconformance, biases, shifts, and trends? And are violations followed by timely troubleshooting/corrective action? 4.2.2, 5.6.3-5 A-9.13 N11.1&2
  For direct AFB-smear Microscopy, does the laboratory participate in blinded rechecking; on-site evaluations; panel testing; or exchange slides with another laboratory? 4.2.2, 5.6.4-5    
  For species identification testing, does the laboratory participate in panel proficiency testing or exchange isolates with another laboratory? 4.2.2, 5.6.4-5    
  For drug susceptibility testing, does the laboratory participate in panel proficiency testing or exchange isolates with another laboratory? 4.2.2, 5.6.4-5    
  Are policies and standard operating procedures (SOPs) for laboratory functions current and available for each testing procedure performed (including QC guidelines, acceptability, what to do if QC out of range) 4.2.4 A-1.3 N1.4
  Are microscopes serviced as recommended by the manufacturer, and service records kept in the laboratory? 4.2.5    
  Is routine preventive maintenance performed on all equipment and recorded according to SOPs? 4.2.5

5.3.2

A-5.7 N5.7
  Is equipment routinely serviced according to schedule and documented in appropriate logs? 4.2.5

5.3.2

A-5.8 N5.8
  Is routine calibration of laboratory equipment – including pipettes, centrifuges, balances, and thermometers – scheduled, indicated on the equipment, and verified? 4.2.5

5.3.2

5.3.9

A-5.6 N5.6
  Are all documents and records properly maintained and easily accessible? 4.3.1 A-1.2 N1.3
  Is there a system or procedure for document and record control and retention? 4.3.1 A-1.1 N1.2
  Are procedures dated when put into use and when discontinued? 4.3.1

4.3.2

A-1.8 N1.7
  Are invalid or discontinued policies and procedures removed from use and retained according to schedule? 4.3.1

4.3.2

A-1.9 N1.8
  Are all documents reviewed and approved by authorized personnel prior to issue? 4.3.2    
  Is a list or document control log that identifies the current valid documents and their distribution maintained? 4.3.2 A-1.2 N1.3
  Is there evidence of at least annual review and approval of documents by authorized personnel? 4.3.2    
  Are changes documented and communicated to staff immediately? 4.3.2    
  Are procedures in place to remove and account for all copies of invalid documents from points of use; e.g. workstations? 4.3.2    
  Are documents uniquely identified? Indentification includes:

title; edition or current revision date or revision number; number of pages; authority for issue; source identification

4.3.3    
  Is timely written notification provided to clients when the laboratory finds it necessary to change the examination procedures? 4.4.4 A-4.3 N4.3
  Are duplicates of the laboratory report retained in both the patient record and in the permanent file of the laboratory? 4.5.3    
  Have criteria been established for accepting or rejecting materials? 4.6.1    
  Does the equipment meet the quality requirements of the laboratory and applicable regulations? 4.6.1    
  Are equipment specifications and maintenance needs routinely communicated to upper management? 4.6.1 A-5.15 N5.14
  Are all orders tracked until delivery and inspected, receipted, and labeled with date of receipt when checked in? 4.6.1 A-7.6 N7.6
  Are procedures in place for inspecting, accepting or rejecting, and storing purchased equipment? 4.6.1    
  Are procedures in place for inspecting, accepting or rejecting, and storing purchased materials? 4.6.1    
  Are supply and reagent suppliers periodically reviewed and approved suppliers identified? 4.6.1 A-7.2 N7.2
  Are supply and reagent specifications periodically reviewed and approved materials identified? 4.6.1 A-7.2 N7.2
  Is an inventory control system in place?

Acceptance and rejection of consumables

Recording of lot number, date of receipt, and date placed into service

Storage of consumables

4.6.1

4.6.3

A-7.7 N7.7
  Is the quality and performance of each new batch of materials (e.g., stains) checked prior to use? 4.6.2    
  Is each new lot number or new shipment of microbiology media checked for sterility and its ability to support growth before being incorporated into patient testing? 4.6.2 A-9.9 N8.8
  Is there a reagent logbook for lot number and dates of opening that reflects verification of new lots? 4.6.2

5.5.3

A-9.8 N8.7
  Is First-Expiry-First-Out (FEFO) practiced? 4.6.3 A-7.12 N7.12
  Has the laboratory provided uninterrupted testing services, with no disruptions due to stock outs in the last year (or since the last assessment). 4.6.3 A-7.15 N7.15
  Are stock counts routinely performed? 4.6.3 A-7.10 N7,10
  Are expired products disposed of properly? 4.6.3 A-7.13 N7.13
  Are all reagents/test kits in use (and in stock) currently within the manufacturer-assigned expiry dates. 4.6.3 A-7.14 N7.14
  Are inventory records complete and accurate, with minimum and maximum stock levels denoted? 4.6.3 A-7.8 N7.8
  Is the consumption rate monitored? 4.6.3 A-7.9 N7.9
  Do laboratory staff take responsibility for ensuring there are adequate stocks of stains, slides, etc? 4.6.3    
  Are there buffer supplies of materials available to allow for interruptions in supply, where practicable? 4.6.3    
  Is a list available with complete contact information for approved manufacturers/suppliers? 4.6.4 A-7.3 N7.3
  Have suppliers been evaluated and records of evaluations and lists of those approved maintained? 4.6.4    
  Is there a laboratory handbook for clinicians’ use that includes information on agreed turnaround times? 4.7

4.12.5

5.5.6

A-4.2 N4.2
  Is there a laboratory handbook for clinicians’ use that includes information on services offered, how to order tests, specimen requirements, testing methods, testing algorithms, quality assurance, laboratory operations, and sample collection and transport, agreed turnaround times, etc.? 4.7

4.12.5

5.5.6

A-4.2 N4.2
  Are clients provided training regarding required types of samples, choice of examinations, repeat frequency, and interpretation of results? 4.7.1

4.12.5

A-4.1 N4.1
  Are there policies and criteria established for hiring and retaining qualified staff? 5.1.1    
  Is the confidentiality of patient information maintained by all personnel? 5.1.13    
  Is there a system for competency assessment of staff (both new hires and existing staff) and does it include planning and documentation of retraining and reassessment, when indicated? 5.1.2 A-3.6 N3.6
  Does each staff member have a current training record? 5.1.2    
  Is the technical knowledge and skills of each staff member evaluated at least annually by direct observation of the supervisor and competencies recorded in their personnel file? 5.1.2

5.1.11

   
  Are Personnel Files present?

Employee Orientation

Education & Training (e.g., degrees/certificates)

Written job description, with documentation that staff member received a copy of their job description

Letter of employment or appointment

Review of job-relevant SOPs

Documented review of safety manual, evidence of safety training

Review of procedure for employees to communicate concerns about test quality and laboratory safety

Registration with professional board

Training record documenting trainings received, including vendor training received on-site, on-the-job training

Periodic Performance Review –
including Observation, Competency Assessment, Coaching, Feedback

Documentation of employee recognition (i.e., employee of the month, letter of commendation, etc.)

Human Resource (HR) Data – (vaccination status, injuries, accident history, etc.)

5.1.2

5.1.11

A-3.5 N3.5
  Is the laboratory directed by a person or persons who has the authority and responsibility for the services provided? 5.1.3    
  Is the laboratory directed by a person having executive responsibility and the competence to assume responsibility for the services provided? 5.1.3    
  Do staff have adequate time and resources for EQA activities such as blinded rechecking or proficiency testing? 5.1.5    
  Do staff have adequate time and resources to complete the work and carry out the functions of the QMS? 5.1.5    
  Is training in quality assurance and QMS that is specific to the duties and responsibilities of each position documented in personnel records?. 5.1.6    
  Are the specific duties of each staff member documented in their personnel files? 5.1.7    
  Are patient records and laboratory registers accessible only to authorized persons? 5.1.8    
  Are patient records and laboratory registers stored in a secure location and under appropriate environmental conditions? 5.1.8

5.1.13

   
  Are laboratory registers stored in a secure location and protected from adverse environmental conditions? 5.1.8

5.1.13

   
  Is training and refresher training provided to maintain and improve skills? 5.1.9    
  Is sufficient waste disposal available and is waste separated into infectious & non-infectious waste, with infectious waste autoclaved, incinerated, or buried? 5.2.10 A-12.9 N12.10
  Are instructions to be provided to patients (visual aids) for producing a sputum specimen readily available? 5.2.3    
  Are environmental conditions, such as temperature or electrical supply, that might affect the quality of the results monitored, recorded, analyzed and controlled and corrective action taken and documented as needed? 5.2.5    
  Is work involving hazards (e.g., infectious agents, radioactivity, hazardous chemicals) appropriately separated from other sections of the laboratory and are measures to prevent cross-contamination of work spaces in place? 5.2.6 A-12.2 12.2P
  Are patient samples stored separately from reagents and blood products in laboratory refrigerators and freezers? 5.2.6 A-12.6 N12.6
  Is the laboratory properly secured from unauthorized access with appropriate signage? 5.2.7 A-12.5 N12.5
  Is the lab locked outside of working hours or resources are otherwise safeguarded (e.g. locked cabinets)? 5.2.7    
  Within the laboratory facilities, is there a way to communicate and transfer messages efficiently with staff working in all areas of the laboratory? 5.2.8    
  Can staff communicate effectively with one another in the laboratory? For highly restricted areas or laboratories with many rooms, this may require an intercom or public address system. 5.2.8    
  Are specimens stored appropriately prior to, during, and following testing and disposed of in a safe manner? 5.2.9, 5.7.3, 5.4.14 A-9.5 N9.5
  Has the laboratory provided uninterrupted testing services, with no disruptions due to equipment failure or lack of equipment in the last year (or since the last assessment)? 5.3.1 A-5.16 N5.15
  Are repair orders monitored to determine if the service is completed? 5.3.10 A-5.11 N5.11
  Is all equipment checked and documented as properly functioning before being put back into use after being out of control of the laboratory? 5.3.10 A-5.13 N5.11
  Is patient information stored in secure locations? 5.3.11    
  Are microscopes are cleaned after use (daily) and stored in a dry environment when not in use? 5.3.12    
  Is equipment adequately secured and protected when not in use? 5.3.14    
  Is access to equipment controls and computers restricted to authorized users? 5.3.14    
  Is equipment installed and placed as specified in the operators’ manuals and uniquely labeled or marked? 5.3.3 A-5.1 N5.14
  Are all materials uniquely labeled labeled including the status and date of verification or calibration? 5.3.3, 5.3.9    
  Is current equipment inventory data available on all equipment in the laboratory?

Name of equipment

Manufacturer

Condition received (new, used, reconditioned)

Serial number

Date of purchase

Date of entry into service

5.3.4 A-5.3 N5.3
  Is relevant equipment service information readily available in the laboratory?

Service contract information

Contact details for service provider

Performance and maintenance records

Last date of service

Next date of service

Current location

5.3.4 A-5.4 N5.4
  Is training in the use of specific pieces of equipment documented in personnel files? 5.3.5    
  Is authorization to use specified equipment recorded in personnel files? 5.3.5    
  Are logs of who uses equipment reviewed to ensure that only authorized persons use the equipment? 5.3.5    
  Is each piece of equipment in good working condition and properly stored when not in use? 5.3.6, 5.3.12    
  Is defective equipment clearly labeled as defective? 5.3.7    
  Is equipment malfunction resolved by cause analysis and performing corrective action or issuing a repair order? 5.3.7

4.9

A-5.10 N5.10
  Is non-functioning equipment appropriately decontaminated and removed from the laboratory and storage area? 5.3.7

5.3.8

A-5.5 N5.5
  Have users been instructed as how to order tests in writing and verbally (if aplicable)? 5.4    
  Have users been instructed on how to complete the test requisition form? 5.4    
  Have written instructions been provided to users as how to order tests in writing, electronically, and verbally (if aplicable)? 5.4    
  Is space provided on the test requsition form for:

Patient identification information (e.g., name or unique specimen code)?

Patient gender?

Patient date of birth or age?

Identity of person collecting the specimen

Name and contact information of to whom to report the result?

Tests to be performed?

Source of the specimen (e.g., sputum, biopsy, etc)?

Type of specimen (e.g., initial diagnostic, follow-up)?

Date and time of collection?

5.4.1    
  Is a test requisition form used that meets user and laboratory needs (e.g., the WHO/IUATLD AFB-smear microscopy form)? 5.4.1    
  Is space provided on the test requsition form for:

Patient identification information (e.g., name or unique specimen code)?

Patient gender?

Patient date of birth or age?

Identity of person collecting the specimen

Location of collection, identity of laboratory or health care facility

Name and address or other unique identifier of the authorized person ordering the test?

Name and contact information of to whom to report the result?

Tests to be performed?

Source of the specimen (e.g., sputum, biopsy, etc), when appropriate?

Type of specimen (e.g., initial diagnostic, follow-up)?

Date and time of collection?

Clinical information when appropriate?

Method and conditions of transport of samples?

Date and time of receipt of the samples by the laboratory?

5.4.1 Modified PH-4  
  Is there an SOP for evaluating completeness of a submitted request form and obtaining missing data? 5.4.1    
  Is there an SOP for accepting or rejecting, receiving, labeling, testing, and reporting of samples marked as urgent? 5.4.11 A-9.4 N8.2
  Have users been instructed as how to mark samples whose testing is urgent, if applicable? 5.4.11    
  Is there a written policy and SOP for accepting or rejecting, receiving, labeling, testing, and reporting of samples marked as urgent? 5.4.11 A-9.4 N8.2
  If samples are divided, are all portions labeled such that they can be traced to the original sample? 5.4.12 A-9.4 N8.2
  Are all derivatives of samples (e.g. processed sputum sediments, DNA preparations, cultures, subcultures) labeled such that they can be traced to the original sample? 5.4.12    
  Is there an SOP for accepting, rejecting, and processing verbal requests for examinations? 5.4.13 A-9.4 N8.2
  Is there a written policy and SOP for accepting, rejecting, and processing verbal requests for examinations? 5.4.13    
  Are samples properly stored in accord with local and National requirements? 5.4.14    
  Are written instructions provided for the volume and type of specimen required, specimen collection (including client safety, labeling, storage, and transport that are easily understood by the person collecting the patient specimen? 5.4.2 A-9.3 N8.1
  Are written instructions provided to the provider for packaging the specimen for transport? 5.4.2 PH-7  
  Has a procedure for transport of samples been established and communicated to users?

Are samples forwarded to the laboratory by a secure process as soon after collection as practical?

When delays are unavoidable, are specimens stored at cool temperatures?

Are samples protected from extreme environmental conditions (e.g., heat) during transport?

Are samples delivered to a designated location in the laboratory?

Is the security of samples is maintained at all times?

5.4.2    
  Does your laboratory provide written instructions or training the SOP that are easily understood by the person collecting the patient specimen? 5.4.2    
  Is there an SOP for sample collection and labeling of samples? 5.4.2    
  Is there an SOP for sample packaging and transport? 5.4.2    
  Are instructions for sample packaging and transport provided to specimen collectors? 5.4.2    
  Does the laboratory communicate regularly with users to ensure that adequate specimens are obtained and to promote an understanding of quality parameters? 5.4.2    
  Has a sample collection manual been distributed and does it contain

A list of available laboratory examinations and information on the selection of tests?

Copies of required forms (request forms, consent forms, transport forms, etc)?

Instructions for completing the forms?

Instructions for verbal requests or requests for urgent tests, if applicable?

Instructions to be provided to patients?

SOP for sample collection including

type and labeling of specimen containers?

positive identification of the patient?

method and timing (e.g., early morning) of collection?

type and amount of specimen?

recording the identity of the person collecting the specimen?

safe disposal of materials used in the collection?

SOP for specimen handling and transport including

storage of specimen (e.g., refrigeration) prior to transport?

packaging and transport?

SOPs for post-collection activities including

storage of examined samples?

requesting additional examinations and reflex testing?

repeat testing or collection of additional specimens if test failed?

5.4.3    
  Is the sample collection manual included in the document control system? 5.4.4    
  Does the request form contain the information necessary to trace the sample to an individual? 5.4.5    
  Is there a written policy for rejecting or accepting primary samples lacking proper identification to trace to an individual? 5.4.5    
  Does your laboratory monitor and record the following indicators of transport quaility:

Total No. of specimen shipments

Time for transport of each shipment

No. of shipments with acceptable transport conditions

No. of specimens or shipments that are packaged in accord with procedure and regulations

No. of shipments that were delayed prior to transport

No of delayed shipments for which speciemns were stored at cool temperatures while awaiting transport

No. of specimens or shipments packaged in accord with procedure and regulations?

No. of specimens accompanied by a completed request form?

5.4.6    
  Are the following transport parameters recorded in the register:

the date and time of the collection of the of samples?

the date and time of the receipt of samples?

the identity of the person receiving the sample?

any unusual variation in transport time or condition?

5.4.6    
  Are the following recorded in the register:

the date and time of the receipt of samples?

the identity of the person receiving the sample?

any unusual variation in transport time or condition?

whether the specimen is a diagnostic sample or a follow-up sample?

results of a visual assessment of the specimen quality?

5.4.6    
  Does your laboratory monitor and record quality indicators of specimen accessioning?

Total No. of specimens received

No. of specimens entered in the laboratory register

No. of specimens with complete laboratory register entries

Completeness of the laboratory register (percentage of complete entries)

No. of accurate entries in the laboratory register (compare entries to requisition forms)?

5.4.6    
  Are all received samples recorded in a laboratory register that meets national (NTP) and international standards (WHO, IUATLD)?

Are details of submitted samples entered into the lab register before tests are carried out?

Is whether the specimen is a diagnostic sample or a follow-up sample entered in the register?

Is a visual assessment of the specimen quality entered into the laboratory register?

5.4.7    
  Are adequate specimen receiving procedures in place (in addition to level 1)?

If not a 24 hour lab, is there an SOP for handling of specimens received after hours?

Are all samples received or referred to a higher level laboratory accompanied by a sample delivery checklist or transmittal sheet?

If a two-identifier system is in use and is each sample assigned a unique identifying number?

Are specimens delivered to the correct workstations in a timely manner?

5.4.7 A-9.4 N8.2
  Is there an SOP for specimen accessioning? 5.4.7    
  Are there SOPs for specimen processing and inoculating and incubating cultures? 5.4.7    
  Are adequate specimen receiving procedures in place?

Are all test requests accompanied by an acceptable and approved test requisition form?

Are specimens logged appropriately upon receipt in the laboratory (including date, time, and name of receiving officer)?

Are patient details matched with information on the specimen container before registration?

5.4.7, 5.4.1 A-9.4 N8.2
  Are specimens that do not comply with quality guidelines rejected and rejection reported immediately to the health care provider for collection of another sample? 5.4.8 A-9.4 N8.2
  Does your laboratory furnish the healthcare provider with a copy of the criteria for rejecting specimens? 5.4.8    
  Does your laboratory monitor and record quality indicators of sample collection and labeling?

Total No. specimens collected

No. of specimens submitted

No. of specimens that are accompanied by requisition forms?

No. of requisition forms that are complete?

No. of sputum containers that meet specifications and are properly labeled?

No. of sputum specimens that are saliva?

No. of specimens that are of adequate volume?

No.
specimens that are rejected and the reason for rejection?

5.4.8    
  Is there an SOP for the acceptance or rejection of samples based on the quality or quantity of the sample? 5.4.8    
  If noncompliant specimens are accepted for testing, has an SOP been established for testing of potentially inadequate or compromised specimens and reporting results including describing the nature of the noncompliance and potential impact on test interpretation on the final report? 5.4.8    
  Does your laboratory monitor and document quality indicators of sputum collection:

if instruction is provided to patient on how to produce a sputum specimen?

if service users have been trained or instructed on how to collect samples?

if sample collectors identify the patient and match the patient to the request form and containers?

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

if collection takes place in a ventilated area?

if the quality of the sample is checked before accepting and forwarding to the laboratory and re-collected if necessary?

5.4.8    
  Are sample volume requirements reviewed periodically and whenever there is a change in testing procedures? 5.4.9    
  Are procedures establised for collecting and labeling sputum specimens that are in accord with NTP, WHO or IUATLD guidelines, meet the needs of the service users, and are appropriate for the testing? 5.5.1    
  Are relevant policies and procedures written, easily accessible and available to all staff? 5.5.3 A-1.4 N1.5
  Are written procedures for specimen processing present and easily accessible at the workbench? 5.5.3 A-9.10 N8.8
  Are SOPs for each laboratory process present and easily accessible at the workbench? 5.5.3 A-9.10 N8.6
  Are policies and standard operating procedures (SOPs) for laboratory functions current, available and approved by an authorized person?

Writing SOPs for laboratory procedures

Laboratory Safety (including biohazard waste, chemical storage & handling & spills, blood borne pathogens, accidental exposure/needle sticks, fire)

Method / Equipment Validation

Equipment Maintenance

Document & Record Control

Specimen Collection & Processing

Specimen pre- and post-test Storage

Inventory Control & Procurement

Communication of Test Results, including confidentiality

Evaluating, selecting, and monitoring the performance of referral laboratories and consultants

Quality Assurance, including collection and keeping of quality records

Resolution of complaints and other feedback from clinicians, patients, and other parties

Policies and procedures to avoid conflicts of interest and commercial, financial, political or other pressures that might affect the quality and integrity of operations.

Employee communication of concerns about test quality and laboratory safety

Are SOPs reviewed and updated at least once a year?

Are SOP changes documented and communicated to staff immediately?

5.5.3 4.1.6

4.2.1

4.3.2

4.8

4.12

4.12.1

5.4.4

A-1.3 N1.4
  Are all necessary SOPs established and complete?

e.g., preparation of stains and staining reagents, smears, stained AFB smear; examination of smears, etc.

5.5.3-5    
  Is there a master SOP on writing SOPS and does it describe all the required elements of an SOP? 5.5.3-5    
  Have service users been informed verbally or in writing of the laboratory testing that you perform? 5.5.6    
  Has a list of available services and tests been distributed to users? 5.5.6    
  Is timely written notification provided to clients when the laboratory finds it necessary to change the examination procedures? 5.5.7 A-4.3 N4.3
  Have alert values been defined? (e.g., an AFB-positive result from a new patient)? 5.5.8    
  Do the alert values meet the needs of service users and are in accord with NTP guidelines? 5.5.8    
  Are quality control results are reviewed by individuals with sufficient knowledge and competence to determine the acceptance or rejection of the quality control results. 5.6.1    
  Are QC systems implemented to address mistakes that might occur during pre-examination, examination, post-examination processes? 5.6.1    
  Are discordant results tracked and appropriate corrective action taken? 5.6.1 A-10.4 N10.4
  Are test results reported by authorized personnel? 5.7.1 A-9.14 N9.9
  Are results reported as soon as practicable? 5.7.1    
  Are test requests crosschecked with test results thereby assuring completion of all tests? 5.7.1 A-9.15 N8.14
  Does each relevant SOP have a section on evaluating and interpreting test results (e.g., assessing controls)? 5.7.1

5.1.12

   
  Are test results validated and interpreted by appropriately authorized personnel? 5.7.1

5.8.13

A-9.14 N9.9
  Are test results reveiwed and released by appropriately authorized personnel? 5.7.1

5.8.13

A-9.14 N9.9
  Have SOPs been established for the storage and retrieval of laboratory samples? 5.7.2, 5.4.14    
  Are quality indicators of sample transport monitored for biases, shifts, and trends, i.e. Levy-Jennings charts? And are violations followed by timely troubleshooting/corrective action? 5.8 A-9.13 N11.1&2
  Are quality indicators of sample receipt, processing, and accessioning monitored for biases, shifts, and trends, i.e. Levy-Jennings charts? And are violations followed by timely troubleshooting/corrective action? 5.8 A-9.13 N11.1&3
  Are IQC results documented and monitored for biases, shifts, and trends, i.e. Levy-Jennings charts? And are violations followed by timely troubleshooting or corrective action? 5.8 A-9.13 N8.10
  Is the laboratory result report in a standard form meeting NTP and international standards?

Is the laboratory issuing the report clearly identified?

Does the report contain patient or specimen identifier?

Is the name of the person to receive the report indicated on the report?

Is the type of sample received and the test requested included in the report?

Are the date and time for specimen collection, receipt of specimen, and release of report indicated?

Does the result contain the name of the person accepting responsibility for its content?

5.8.1 A-9.12 N9.8
  Is the laboratory result report in a standard form meeting NTP and international standards?

(in addition to level 1)

Does the report contain the patient’s name, address, and the hospital/destination of the report?

Is the name of the person requesting the test indicated on the report?

Does the report indicate reference ranges for each test?

Is the result reported in SI units, when applicable?

Is there space for interpretation of results?

Does the report contain information on the quality of the primary sample and its potential impact on the test results or interpretation?

Does the result contain the name of the person releasing the report and the signature of the person accepting responsibility for its content?

5.8.1 A-9.12 N9.8
  Are actions taken in response to alert values documented in the laboratory register and patient record? 5.8.10    
  Is there an SOP established for notifying the requester when an examination is delayed and the delay could compromise patient care? 5.8.11 A-9.16 N4.3
  Are expected turnaround times for each test established in consultation with requestors? 5.8.11    
  Is there an SOP for verifying the correctness of all transcriptions of results received from referral laboratories? 5.8.12    
  Is there a written policy for verifying the correctness of all transcriptions of results received from referral laboratories? 5.8.12    
  Is there a written policy for the release of test results including details of to whom results can be released? 5.8.13    
  Is there a written policy and SOP for ensuring that results distributed by telephone or other electronic means reach only authorized receivers and that results sent verbally are followed by a properly recorded report? 5.8.14 A-9.16 N1.4
  Is there a written policy and SOP for the alteration or amendment of report and for notifying clinicians of an altered report? 5.8.15 A-9.16 N1.2
  Are all reported laboratory results (original and altered) maintained in the patient record and clearly identified in the record as original or altered? 5.8.16    
  Is there an SOP for reporting or releasing results to authorized recipients? 5.8.2, 5.8.13, 5.8.14    
  Is there a procedure in place for confirming that the test results were received by the apppropriate person? 5.8.2, 5.8.13-14    
  Are test results legible, technically verified, and confirmed against patient identity? 5.8.3 A-8.1 N9.1
  Is there a system for reviewing for clerical errors? 5.8.3 A-8.5 N9.5
  Is reporting language used that is in accord with recommendations of the World Health Organization or other relevant international organizations? 5.8.4 A-9.16 t-n
  Are results and reports properly labeled and stored in a secure location, protected form adverse environmental conditions, and accessible only to authorized personnel? 5.8.6 A-8.6 N9.8
  Are archived results properly labeled and stored in a secure location accessible only to authorized personnel? 5.8.6 A-8.6 N9.6
  Are there documented procedures for the prevention of the loss of test result data in the event of hardware/software failure or theft? 5.8.6 A-8.7 N9.7
  Are archived records and results retrievable in a timely fashion? 5.8.6 A-1.11 N1.10
  Are AFB-positive or culture-positive results from new patients reported immediately? 5.8.7    
  Is an SOP established for immediately notifying clinicians of alert results? 5.8.7 A-9.16 N1.4
  Is a process in place to ensure that any preliminary or interim report is followed by a final report? 5.8.9    
  Are hazardous chemicals/materials handled properly?

Are hazardous chemicals properly labeled?

Are hazardous chemicals properlystored?

Are hazardous chemicals properly utilized?

Are hazardous chemicals properly disposed?

  A-12.10 N12.11
  Is fire safety attended to as part of the laboratory’s overall
safety program?

Are all electrical cords, plugs, and receptacles used appropriately and in good repair?

Is an appropriate fire extinguisher available, in working condition, and routinely inspected?

Is an operational fire alarm system in place in the laboratory with periodic fire drills?

Are all electrical cords, plugs, and receptacles used appropriately and in good repair?

Is an appropriate fire extinguisher available, in working condition, and routinely inspected?

Is an operational fire alarm system in place in the laboratory with periodic fire drills?

  A-12.12 N12.13
  Are there back-up procedures for equipment failure (including SOPs for handling specimens during these times, identification of a back-up lab for testing, and referral procedures)?   A-5.12 N5.12
  Are testing personnel identified on the requisition and record?   A-8.2 N9.2
  Are test results recorded in a logbook or electronic record in a timely fashion?   A-8.3 N9.3
  Are test results traceable to the equipment used for testing?   A-8.4 N9.4
  Does a completed requisition form accompany the specimens during transport to the laboratory?      
  Do the purchased or received materials meet the quality requirements and specifications for materials used in a tuberculosis laboratory.      
  Is there a quality officer/manager with delegated responsibility to oversee compliance with the quality management system?   A-3.4 N3.4
  Is a stock of expendable parts present on site?   A-5.9 N5.9
  Are environmental checks and temperature logs complete, accurate, and regularly reviewed

E.g., temperatures of the room, freezers, refrigerators, incubators, water baths, etc.

  A-9.1 N8.11
  Have acceptable ranges been defined for all temperature dependent equipment with procedures that detail what to do when temperatures are out of range?     N8.12
  Are specimens packaged appropriately according to local and or international regulations and transported to referral laboratories within acceptable timeframes?     N8.4
  Is there a system for accurately forecasting needs for supplies and reagents?   A-7.1 N7.1
  Is the lab overall path of workflow and each of the individual processes documented?      
  Are any changes in sample volume requirements documented in SOPs and communicated to users?      
  Does your laboratory have an up-to-date reference manual for your providers that describes available services, test indications, specimen requirements, testing methods, and result interpretation?      
  Are the qualifications and competence of each staff to perform their duties assessed at least annually by observation, competency assessment or proficiency testing and documented in their personnel record.      
  Do archived records document the history of changes and revisions to controlled documents?