Minimum Standards for Laboratories in SADC Regions · Using the PDCA Model in the Audit Process ... MINIMUM STANDARDS FOR LABORATORIES IN SADC REGIONS ... the Facilitator can ask

Minimum Standards for Laboratories in

SADC Regions

Facilitator Guide

Day 5 Assessments and External

Quality Assurance

MINIMUM STANDARDS FOR LABORATORIES IN SADC REGIONS

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Table of Contents 1. Learner Information .................................................................................................... 4

2. About this Course ...................................................................................................... 5

3. Learning Styles .......................................................................................................... 6

4. Keys to Icons ............................................................................................................. 8

5. Course Agenda .......................................................................................................... 9

6. Course Agenda .......................................................... Error! Bookmark not defined. 7. Assessments and External Quality Assurance ........................................................ 10

Module Objectives ............................................................................................................................ 10 Activity .............................................................................................................................................. 11 High Level Overview ........................................................................................................................ 13 What is an Assessment? .................................................................................................................. 14 Why Perform an Assessment / Audit? ............................................................................................. 15 Types of Assessments ..................................................................................................................... 16 Path of Workflow .............................................................................................................................. 17 What Information to gather during Audits ......................................................................................... 18 Internal Audits & Benefits ................................................................................................................. 19 Responsibilities of Laboratory Director & Quality Manager ............................................................. 20 ISO Standards and Requirements ................................................................................................... 22 Using the PDCA Model in the Audit Process ................................................................................... 23 Critical Skills for Auditors.................................................................................................................. 26 Audits lead to Actions ....................................................................................................................... 27 Problem-solving ................................................................................................................................ 28 Continuous Improvement ................................................................................................................. 30

8. External quality assurance/assessment ................................................................... 32 Objectives ......................................................................................................................................... 32 What is EQA? ................................................................................................................................... 33 Why is there a need for EQA? ......................................................................................................... 34 Types of EQA ................................................................................................................................... 35 What should you look at when choosing EQA? ............................................................................... 36 EQA samples ................................................................................................................................... 38


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Advantages and Disadvantages ...................................................................................................... 39 Choosing an EQA program .............................................................................................................. 40 EQA Management Process .............................................................................................................. 41 Managing EQA: Handling Samples .................................................................................................. 43 Managing EQA: Assign Testing Responsibilities ............................................................................. 44 Managing EQA: Multiple Datasets ................................................................................................... 45 Managing EQA: Acting on Results ................................................................................................... 46 EQA Performance Problems ............................................................................................................ 47 Data Analysis: EQA Reports ............................................................................................................ 48 Data Analysis: Root Cause Analysis ................................................................................................ 49 Data Analysis: Common Problems .................................................................................................. 50 Data Analysis: Action vs Reaction ................................................................................................... 51 Activity .............................................................................................................................................. 52 Activity .............................................................................................................................................. 53

9. Summary ................................................................................................................. 54

10. References and Links .............................................................................................. 55

11. Daily Wrap Up .......................................................................................................... 56


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Learner Information

Details Please Complete details Name of Learner

Participant’s Country

Job Title

Facilitators: Quality Management – Assessment and EQA Quality Management - Importance of Management Review Quality Management - Importance of Process Management and Control

Mahlatse Maleka Henry Julius / Patience Dabula Henry Julius


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About this Course

The National Health Laboratory Services welcomes you to the Minimum Standards for National Reference Laboratories in SADC Regions course. In this course the participant will learn about the different Learning Styles, understand the Key Icons used in the manual and will be taken through the training material developed for Day 6 of this course on Minimum Standards required to run an effective National Reference Laboratory. The Course includes discussions, activities and workshop sessions. At the end of the course, participants are required to write a Summative Assessment. The Modules covered in Day 6 are as follows:

1. Quality Management – Assessment and EQA 2. Quality Management - Importance of Management Review 3. Quality Management - Importance of Process Management and Control

This guide covers Assessments and External Quality Assurance


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Learning Styles

What are learning styles?

Learning styles are simply different approaches or ways of learning.

The different types of learning styles are as follows:

Visual Learners: learn through seeing...

These learners need to see the teacher's body language and facial expression to fully understand the content of a lesson. They tend to prefer sitting at the front of the classroom to avoid visual obstructions (e.g. people's heads). They may think in pictures and learn best from visual displays including: diagrams, illustrated text books, overhead transparencies, videos, flipcharts and hand-outs. During a lecture or classroom discussion, visual learners often prefer to take detailed notes to absorb the information. Auditory Learners: learn through listening...

They learn best through verbal lectures, discussions, talking things through and listening to what others have to say. Auditory learners interpret the underlying meanings of speech through listening to tone of voice, pitch, speed and other nuances. Written information may have little meaning until it is heard. These learners often benefit from reading text aloud and using a tape recorder.


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Tactile/Kinesthetic Learners: learn through moving, doing and touching...

Tactile/Kinesthetic persons learn best through a hands-on approach, actively exploring the physical world around them. They may find it hard to sit still for long periods and may become distracted by their need for activity and exploration.

Read / Write Learners: learn through reading and writing...

Read / Write persons prefer to learn and memorize through reading and writing things down.


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Keys to Icons

The following icons are used throughout the study guide to indicate specific functions:

ACTIVITY

Written activities to be completed

DISCUSSION

Take part in the discussion

IMPORTANT / TAKE NOTE

This icon indicates information of particular importance

Notes

The participant should write notes, should he/she wish to do so


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Course Agenda

Day 5

Quality Management – Assessment and EQA Quality Management - Importance of Management Review Quality Management - Importance of Process Management and Control

Times Topic Duration Presenter 08:00 Registration 15 minutes 08:15 Day 4 Questions 15 minutes 08:30 Introduction to Human Resource

Management Principles 2 hours Mmalefu Manoto

10:30 Tea 15 minutes 10:45 Introduction to Human Resource

Management Principles (continued) 1 hour 30 minutes Mmalefu Manoto

12:00 Lunch 1 hour 12:45 Quality Management - Overview to a

Laboratory Quality Management System 2 hour 30 minutes

15:15 Tea 15 minutes 15:30 - Final Wrap Up

- Complete Evaluation Forms - The way forward - Handing out Certificates of Attendance

1 hour 30 minutes Thinyane Molelle

17:00 Course Ended


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Assessments and External Quality Assurance Module Objectives

Facilitator to go through the objectives for this module

At the end of this module, participants will be able to:

Develop a process to prepare your laboratory staff for an external audit; Plan and manage an internal audit; Discuss how to use results from a laboratory audit; Advocate for the importance of taking corrective actions. Explain the purpose of External Quality Assurance (EQA); Describe what an EQA panel is; Discuss the advantages and disadvantages of EQA Discuss Data analysis; Discuss how daily operating procedures provide quality service; Identify any changes needed to maintain quality service; Describe how to adjust quality system in response to external and internal

influences


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Activity

Facilitator to explain what the activity is about and then go through the scenario and lead the discussion.

Purpose: The purpose of this activity is to discuss the main elements of organizing an audit based on the experience of the participants

Suggested Time: 10 minutes

Instructions: Read the scenario below and then as a class group discussion, answer the question below.

Scenario:

“You are the quality manager in your laboratory and you want to organize an internal audit.”

What steps will you take?

Suggested answers to conduct an internal audit could include:

Develop a plan; Prepare checklist based on selected guidelines or standards; Meet with all staff and explain the audit process; Select staff to serve as auditors; Collect and analyze information; Share results with staff; Prepare a report; Present the report to management; Retain the report as a permanent laboratory record.

Ensure that there is an established Quality Management system in place that conforms to an international standard.


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Develop an internal audit schedule/plan – to enable the laboratory and auditor/assessor to prepare for the audit in advance

Assign responsibilities to an audit team, and ensure that they have been trained and are familiar with relevant disciplines

Prepare audit documents e.g checklists, non-conformance sheets.


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High Level Overview

The Facilitator should go through the high level overview. Assessments, Management Review and Process Improvement are critical components to ensure quality management in a laboratory. The goal of a QMS is to ensure quality in all aspects of laboratory services on an ongoing basis. Assessment is determining the effectiveness of a laboratory’s quality

management system through internal and external audits, and evaluation of performance in an external quality assessment (EQA) program.

“Laboratory Management shall review the quality Management system at planned

intervals to ensure its continuing suitability, adequacy and effectiveness and support of patient care” – ISO15189:2012

Process Improvement institutes a program for helping to guarantee continual

improvement in the laboratory quality over time.


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What is an Assessment?

The Facilitator should go through what an assessment is.

An assessment, known as “audit”, according to ISO standards, is described as the logical and methodical way of examining some part (or sometimes all) of the quality management system. This is done to show to all concerned that the laboratory is meeting regulatory, accreditation, and customer requirements. Recognised standards, policies and procedures are the foundation for laboratory audits. When audits are carried out, either internally or externally, questions are asked, such as: Are there written policies and procedures in place in the laboratory? Do the current procedures and processes comply with written policies and

procedures? What procedures and processes are being followed in the laboratory; what is

being done? Do written policies and procedures comply with standards, regulations, and

requirements?


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Why Perform an Assessment / Audit?

Instructions for Facilitator

Before showing slide, the Facilitator can ask the participants why an assessment / audit should be performed. Then Facilitator to go through the slide.

Audits enable the laboratory to identify how well it is performing when measured against a benchmark or standard. Audits will also show up any gaps or nonconformities in performance thus allowing management to understand if the policies and procedures that were created require revision or are not being followed. A laboratory needs this information about its performance for: Planning and implementing the quality system;

Examining the effectiveness of the quality system;

Amending any faults that are identified;

Working toward continuous improvement.


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Types of Assessments

Facilitator to explain the types of assessments.

There are two types of assessments:

1. Internal Audit 2. External Audit

Internal Audit: Performed in-house. Staff working on one area conduct assessments on another area in the same laboratory. Easily assists to understand how the laboratory is performing and how well staff comply with policy requirements. External Audit: Agencies or group from outside the laboratory come to the facility and conduct the assessments. These audits may also be used for the purpose of accreditation, certification, or licensure.

Internal and External audits are key to continuous improvement and customer satisfaction


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Path of Workflow

When performing audits, the whole testing process should be assessed, that is the phases of pre-examination, examination and post-examination.


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What Information to gather during Audits


Before showing slide, the Facilitator can ask the participants if they can tell you what information should be gathered during audits. Then Facilitator to go through the slide.

Information that is collected and reviewed during audits is as follows: Processes and operating procedures Staff competence and training Equipment Environment Handling of samples Quality control and verification of results Recording and reporting practices.

All findings from the audits need to be compared with the laboratory’s internal policies and to a standard or external benchmark. Audits will identify deviances from procedures, as well as any breakdown in the system.


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Internal Audits & Benefits


Before showing slide, the Facilitator can ask the participants if they can tell you what some of the benefits are for performing an audit. Then Facilitator to go through the slide.

Performing an internal audit allows the laboratory to look at its own processes and action audits as often as required. Internal audits cost less and are required by ISO standards. An internal audit can help the laboratory to: Prepare for an external audit; Increase staff awareness of quality system requirements; Identify the gaps or nonconformities that need to be corrected; Understand where preventive or corrective action is needed; Identify areas where education or training needs to occur; Determine if the laboratory is meeting its own quality standards.


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Responsibilities of Laboratory Director & Quality Manager

Facilitator to go through the responsibilities of the Laboratory Director and Quality Manager.


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Overall policies for the internal audit program are the responsibility of the Laboratory Director and he/she must assign a person, usually the Quality Manager, to run the audit program. The Laboratory Director also needs to give full support to Quality Manager and staff who will implement all corrective action measures that may arise from the audit.


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ISO Standards and Requirements

Facilitator to explain the ISO standards and requirements.


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Using the PDCA Model in the Audit Process

Facilitator to go through the PDCA model in the audit process. A simple approach to developing an audit system for the laboratory is to use the Plan-Do-Check- Act (PDCA) model to clarify the steps which must be taken to ensure a thorough process is followed.


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Keep the internal audit process as simple as possible. Focus on defined areas of the laboratory activities, identified by issues such as customer complaints or quality control problems. In the policies developed, specified intervals as to when audits should be performed. In general, audit regularly and consider three to six month intervals between audits. If any specific problems are identified from the audits, it may be necessary to include more frequent audits. Develop checklists and forms: Take into account any established national policies

and standards; Ensure checklists are easy to use and include

areas for recording information; Focus on specific tests or processes; address all

areas of the quality system; consider personnel competency or equipment maintenance, sample handling, and quality control associated with these tests.

Create forms to record corrective actions and to make reports.

Select auditors Auditors need to be selected and when doing so it is important that auditors are independent of the area audited.


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Some things to consider are: The availability of staffing, and level of technical expertise; Whether to hire a consultant—this could still be conducted as an internal audit:

the Audit is planned by the laboratory itself, without any external constraints, but Consultants or peers recruited by the laboratory for this specific audit will help the Laboratory staff to conduct it.

Notes:

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Critical Skills for Auditors


Before showing slide, the Facilitator can ask the participants if they can tell you what some of the critical skills auditors should have. Then Facilitator to go through the slide.

The selection of auditors is important and they need to be selected carefully. A good auditor will: Pay attention to details, for example, open and inspect refrigerators and storage

areas; check expiry dates, Be able to communicate effectively, but also diplomatically; careful not to imply

criticism during an audit process. Have the technical skills needed to evaluate the area being audited, Have a good understanding of the laboratory’s quality management system.

If auditors are poorly chosen, the audits will be much less effectual.


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Audits lead to Actions

Facilitator to go through the points explaining how audits should lead to actions being taken.

The reason for audits is to advance the process of continual improvement in the Laboratory by identifying opportunities for improvement (OFI).

Audits must lead to actions.

Preventive and corrective actions are steps taken to improve a process or to correct a problem and need to be carried out within an agreed time.

Keep a record of OFIs as well as all actions that are taken.

The Quality Manager is responsible for starting actions.


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Problem-solving

Facilitator to explain how problem solving is used in audits.

If at any time, the cause of the problem is not easily identified, a team to perform problem-solving should be formed and the following should be done:

Look for root causes; Recommend the appropriate corrective action; Execute the actions decided upon; Check to see if the corrective actions are effectual; Monitor the procedures over time.

By recording all actions and findings during the monitoring phase, the laboratory will be able to learn from these activities.


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Example of a form for recording OFIs and the corrective action taken.


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Continuous Improvement

Facilitator to explain what continuous improvement in a laboratory entails.

Continuous monitoring is the key element to success in the quality system.


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SPECIALIST TALK


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External quality assurance/assessment

Instructions to Facilitator

Facilitator to go through the slides and expand on points mentioned

Objectives

Definition and Purpose of EQA

Why is there a need for EQA

What is an EQA panel

Advantages and disadvantages

EQA in the lab

Data analysis


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What is EQA?

The term external quality assessment (EQA) is defined as a system for objectively checking the laboratory’s performance using an external agency or facility. The term EQA is sometimes used interchangeably with proficiency testing It is a technique to challenge a laboratory’s routine methods and procedures. EQA programs provide samples of known unknown composition, with the expectation that they will be able to generate a proper laboratory report.

Notes:

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Why is there a need for EQA?

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Types of EQA

There are different EQA methods or processes. These include: Proficiency testing: An external provider sends unknown samples for testing to a

agreed on laboratories, and the results of all laboratories are analysed, compared, and reported to the laboratories.

Rechecking or retesting: Slides that have been read are rechecked by a reference laboratory; samples that have been analyzed are retested, allowing for inter-laboratory comparison.

On-site evaluation: This is usually performed when it is difficult to conduct traditional proficiency testing or to use the rechecking/retesting method.

Notes:

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What should you look at when choosing EQA?

What is an EQA panel?

Notes:

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What is an EQA panel?

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EQA samples

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Advantages and Disadvantages

Notes:

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Choosing an EQA program

Notes:

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EQA Management Process

All laboratories should take part in EQA challenges, and this should include EQA for all testing procedures performed in the laboratory, if possible. EQA provides the only means available to a laboratory to ensure that its performance is similar and equal to that of other laboratories. When taking part in EQA programs, the laboratory must have a process for the management of the process in place. A primary objective is to assure that all EQA samples are treated in the same manner as other samples tested. Procedures should be developed for the following: Handling of samples: These will need to be logged, processed properly, and

stored as needed for future use. Analyses of samples: Consider whether EQA samples can be tested so that

staff do not recognize them as different from patient samples–blinded testing. Appropriate record keeping: Records of all EQA testing reporting should be

kept over a period of time, so that performance improvement can be measured. Investigation of any deficiencies: For any challenges where performance is not

acceptable. Taking corrective action when performance is not acceptable: The purpose of

EQA is to allow for detection of problems in the laboratory, and as a result, offer an opportunity for improvement.


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Communication: Communication of outcomes to all laboratory staff and to management.

Notes:

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Managing EQA: Handling Samples

Notes:

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Managing EQA: Assign Testing Responsibilities

Notes:

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Managing EQA: Multiple Datasets

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Managing EQA: Acting on Results

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EQA Performance Problems

If the laboratory performs poorly on EQA, the problems may lie anywhere along the path of workflow. All aspects of the process will need to be checked. Some examples of problems that may be identified include the following.

Pre-examination The sample may have been compromised during preparation, shipping, or after

receipt in the laboratory by improper storage or handling. The sample may have been processed or labeled improperly in the laboratory.

Examination The EQA challenge materials may exhibit a matrix effect in the examination

system used by the participating laboratory. Possible sources of analytical problems include reagents, instruments, test

methods, calibrations, and calculations. Analytical problems should be investigated to determine whether error is random or systemic.

Competency of staff will need to be considered and evaluated.

Post-examination The report format can be confusing. Interpretation of results can be incorrect. Clerical or transcription errors can be sources of error.

Incorrect data captured by the EQA provider is another possible source of error.


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Data Analysis: EQA Reports

Notes:

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Data Analysis: Root Cause Analysis

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Data Analysis: Common Problems

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Data Analysis: Action vs Reaction

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Activity

Suggested Time: 10 minutes (3 minutes for answers & 7 minutes discussion)

Instructions: Read the scenario and then jot down some answers to the question.

Scenario:

The lab participated in a Bacteriology EQA.

Out of 4 samples received, one was reported as no growth.

In the final report, it’s noted that the no growth was supposed to be reported as Bacteroides fragilis.

According to the commentary, 86% of participants recorded an acceptable result for this sample, and 14% recorded an unacceptable response

What should the lab do about the two samples they missed?

Suggested answers

Each samples comes with a clinical scenario to give guidance with regard to testing procedures, if the person doing the test doesn’t follow standard procedures, they are bound to get wrong results

The samples could have been incubated at the wrong temperature, different organisms require specific temperatures to grow adequately.

Wrong media could have been used for sample inoculation resulting in growth inhibition.

The B.Fragilis needs specific incubation conditions i.e would not grow in aerobic conditions.

Ideally, the replacement samples could be requested for corrective action.


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Activity

Suggested Time: 10 minutes (3 minutes for answers & 7 minutes discussion)

Instructions: Read the scenario and then jot down some answers to the question.

Scenario:

The lab tested a panel of 10 serum samples for HIV Serology.

Out of 10 samples, they had 9 positive and 1 negative results.

Upon inspection, it’s found that one of the positive results is incorrect and is in fact negative.

The lab therefore had a false positive result.

What should the lab do about the false positive result?

Possible Answers

Possible causes could be:

Transcription error Samples mixed during testing Contamination during testing Reagents Instrumentation Operator error Repeat testing should be done on the sample to rule out cross-contamination Trouble shooting Check pre-analytical processes e.g labelling Check sample handling prior to testing e.g preparation, storage Check reagents for testing e.g expiration date Check equipment for testing e.g maintenance and service records Verification of correct testing procedures and processes Training and competency of staff conducting the testing QC, test verification and validation Sample reporting e.g transcription errors Request a replacement sample from the EQA provider.


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Summary

Facilitator to go through the points on the summary slides – indicated below.

Let us sum up what has been covered in the module Assessments and External Quality Assurance

Assessment is important in monitoring the effectiveness of the laboratory quality management system.

Both external and internal audits yield useful information.

An outcome of assessment is finding root causes of problems and taking corrective actions.

All laboratories should establish an internal audit program. Conducted on a regular basis, it will provide information for continual improvement.

Problems become opportunities for improvement.

EQA should be a point of pride for laboratories;

It is an opportunity to empower staff;

Provides a platform on which performance can be measured internationally;

EQA is not there to “catch out” laboratories;

EQA participation instills confidence in the operation of a lab and the results it produces;

Also empowers staff and gives them a measurable way of testing their individual proficiency.


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References and Links

REFERENCES

WHO: Quality Management Toolkit

ISO 15189:2007: Quality management in the clinical laboratory

Guidance for Laboratory Quality Manuals (Ontario Laboratory Accreditation Division)

Exploring the Medical Laboratory Quality Toolbox-A by Michael Noble


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Daily Wrap Up

The Facilitator must go through the objectives and confirm that the participants have understood everything and are able to do the objectives below.

This is the end of module Assessments and External Quality Assurance

Participants should now be able to:

Develop a process to prepare your laboratory staff for an external audit;

Plan and manage an internal audit;

Discuss how to use results from a laboratory audit;

Advocate for the importance of taking corrective actions.

Explain the purpose of External Quality Assurance (EQA);

Describe what an EQA panel is;

Discuss the advantages and disadvantages of EQA:

Discuss Data analysis;

Discuss how daily operating procedures provide quality service

Identify any changes needed to maintain quality service

Describe how to adjust quality system in response to external and internal influences

Are there any questions?

The Facilitator to ask if there are any further questions.

Documents

Minimum Standards for Laboratories in SADC Regions · Using the PDCA Model in the Audit Process ... MINIMUM STANDARDS FOR LABORATORIES IN SADC REGIONS ... the Facilitator can ask