Impact of EQA failure on the Lab Quality Policy Tuda Otieno

At the end of the presentation? Define a Lab quality policy Review the Laboratory Quality Policy Review relationship between Competence and performance EQA and Implementation of continual improvement Challenges faced in implementation

Introduction EQA Provides a way for laboratories to ensure that data generated are timely, accurate and clinically appropriate. It operates within a peer review model. Function of Lab management is to establish the policies and processes of the quality system. Most of the Corrective action and preventive action raised, were EQA based (52.5%) and arose from failure of method to quantify or detect a new strain of microorganism. The Procedures were reviewed based on evidence gathered from validation. As a result continual improvement was realized and shown in improved EQA Performance.

What is a Policy? policy procedures Activities

What does the Lab Quality Policy state? 6.2.10 Maintain an established Internal Quality and External Quality systems in collaboration with peer Laboratories, to monitor factors affecting a test system’s performance which include elements of analytical process, operators variance, mishandling and environmental conditions. 6.2.11 The Laboratory shall carry out periodic systematic, independent and objective assessment (Internal and External Audits) to ensure that the quality is continually improved and maintained

Methodology used 30 EQA reports which scored poorly were reviewed. These were selected from clinical chemistry (n= 10), Microbiology (n=10) and hematology (n=10) respectively. Review of the Standard Operating Procedure, results record book and CAPA was used as part of ensuring GCLP compliance and identifying the root cause of the problem. Where need be, the SOP was reviewed and amended to capture the new concepts. Re-training and re-assessment on the new version of SOP was done to all technologists.  

What % is EQA failure constituted of?

What were the potential causes of EQA failure?

Staff competence vs confidence

Who participates in the UKNEQAS EQA?

Case studies In clinical chemistry, a new stable calcium methodology (cresolphtalein) replaced (Arsenazo) which was greatly interfered with by carbon dioxide from the atmosphere. In May 2014 EQA distribution, a blood culture sample was sent which had an anaerobic organism (Bacteriodes fragilis) as the significant pathogen. Using our SOP one could not be able to isolate the pathogen in question as most of the isolated pathogens from bloodstream infections are aerobic organisms. This called for the improvement of the respective SOP. Detection of inducible clindamycin resistance in staphylococcus aureus isolates is done by D-test. This involved placing a 5ug erythromycin disc closer to a 2ug clindamycin disc at a separation distance of 22 mm (Standard method). However, after reducing the separation distance to 15 mm the detection of this type of resistance was enhanced. This called for methodology improvement. In parasitology, GSK introduced an easier and more accurate parasite count method that reduced on turnaround time. This procedure called for improvement in the SOP.

Other than EQA are there other Sources?

Challenges Training and competence Interpretation and implementation of Lab quality Policy Management commitment to continual improvement Staff commitment to continual improvement

CONCLUSION The EQA Continually improved the effectiveness of the quality management system. The EQA Identified opportunities for improvement, however commitment by Laboratory management was minimal in evaluation activities, communication to staff improvement plans, quality policy and quality objectives. The AST failures were as a result of deviation of Procedure Focus was on scoring more points in EQA rather than improved Lab procedures to minimize risk to patients through better healthcare.