Checklist Phase 4 of GLI tool version 1.0

This is the checklist for assessing the progress made in phase 4 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
  If work is conducted at more than one site, does the work at all sites meet the same standards as the permanent site? 4.1.3    
  Are internal audits addressing areas important to patient care routinely conducted at the intervals defined in the quality manual?

Are internal audits conducted by the head of lab, quality officer, or designated qualified personnel?

Are the personnel who conduct internal audits trained and competent in auditing?

Is care taken to ensure that auditing staff do not audit their own activities?

Is cause analysis performed for non conformities/noted deficiencies?

Are internal audit findings documented and presented to the laboratory team.

Are blinded characterized samples routinely distributed for testing to determine accuracy?

Are recommendations and/or corrective actions prescribed and an action plan developed with clear timelines?

Is there documented follow-up of recommendations/corrective actions?

4.2.4

4.10.3

4.14

A-6.1 N6.1 AND 6.2
  Are the qualifications of the referral laboratory reviewed (initially & periodically), monitored and documented?

Are criteria and procedures in place to evaluate referral laboratories?

Are the qualifications of the referral laboratories documented?

4.5.1

4.5.2

   
  Is an up-to-date register of referral laboratories available? 4.5.3    
  Does the referring laboratory and not the referral laboratory report the results and findings of the referral laboratory to the person making the request? 4.5.4    
  Are newly introduced equipment validated on-site and are records documenting validation available? 4.6.2

5.3.2

A-5.2 N5.2
  Do staff with appropriate professional qualifications provide clients with advice and/or 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
  Is there a tool for regularly evaluating client satisfaction and is feedback utilized to improve services? 4.8

4.15.2

A-4.5 N4.4
  Are laboratory occurrence reports completed, cause analysis performed, and corrective and preventive actions defined and taken on all reports to avoid recurrence? 4.9 A-11.1 N10.1
  Is corrective action taken on out-of-control runs documented in the occurrence log, with results withheld, if indicated by the level of control violated? 4.9.1

5.6.7

A-10.3 N10.3
  Have procedures been established for the release of examination results in the case of nonconformities, including the review of such results? 4.9.3    
  Are out-of-control runs reviewed and submitted to troubleshooting and cause analysis? 4.10

5.6.7

A-10.2 N10.2
  Are any changes to operational procedures resulting from corrective or preventive actions documented and communicated to staff and service users? 4.10.2    
  Are the results of any preventive actions monitored and evaluated to determine if they have been effective? 4.10.3, 4.11.2    
  Are the results of any corrective actions monitored and evaluated to determine if they have been effective? 4.10.3, 4.11.2    
  Are graphical tools (charts and graphs) used to communicate quality findings and identify trends? 4.11.1 A-9.17 N11.1
  Does the laboratory have adequate training policies, procedures, and/or training plan, including cross training within the laboratory team, one-on-one mentoring, and/or off-site external training? 4.12.5

5.1.6

5.1.9

A-3.7 N3.7
  Are staff provided continuing education including cross training within the laboratory team, one-on-one mentoring, and/or off-site external training? 4.12.5

5.1.6

5.1.9

A-3.7 N3.7
  Are internal audits conducted by the quality manager of all elements of the system? 4.14.1    
  Are appropriate corrective or preventive actions taken, documented, and carried out promptly. 4.14.3    
  Is training in preventing or containing adverse events that is specific to the duties and responsibilities of each position provided anddocumented in personnel records? 5.1.10    
  Are biologic reference intervals reviewed periodically and when there is a change in a method? 5.5.5    
  Is the comparability of results for examinations performed at different sites or with different procedures or instruments verified?

e.g., A random selection of slides is exchanged between two sites, reread,
and the results compared.

The results using solid media are compared to results using liquid media

5.6.6    
  Are corrective actions promptly initiated and documented? 5.6.7    
  Are referral laboratory results reported by the referring laboratory to the test requester? 5.8.1    
  Does the laboratory appear to be adequately staffed and resourced to complete the work, quality controls, and EQA?      
  Is a list of service users maintained that contains:

name and address of the requestor?

name and contact information of person to whom results are reported?

documentation that the user has received a copy of the laboratory services handbook?