Requirements for Enrolment and Participation in External Quality Assessment

NATIONAL PATHOLOGY ACCREDITATION ADVISORY COUNCIL

REQUIREMENTS FOR ENROLMENT AND PARTICIPATION IN EXTERNAL QUALITY ASSESSMENT

(Fifth Edition 2013)

NPAAC Tier 3B Document

Print ISBN: 978-1-74241-946-6

Online ISBN: 978-1-74241-947-3

Publications approval number: 10207

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First published 1995
Second edition 1999

Third edition 2004

Fourth edition 2009 (formerly titled: Standards for Pathology Laboratory Participation in
External Proficiency Testing Programs)

Fifth edition 2013 reprinted and reformatted to be read in conjunction with the Requirements for Medical Pathology Services

Australian Government Department of Health

Contents

Scope v

Abbreviations vi

Definitions vii

Introduction 1

1. Selection of external quality assessment programs 3

2. Enrolment and participation in external quality assessment programs 5

3. Pre-analytical quality assessment 6

4. Analytical Quality Assessment 7

Bibliography 8

Further information 9

The National Pathology Accreditation Advisory Council (NPAAC) was established in 1979 to consider and make recommendations to the Australian, state and territory governments on matters related to the accreditation of pathology laboratories and the introduction and maintenance of uniform standards of practice in pathology laboratories throughout Australia. A function of NPAAC is to formulate Standards and initiate and promote education programs about pathology tests.

Publications produced by NPAAC are issued as accreditation material to provide guidance to laboratories and accrediting agencies about minimum Standards considered acceptable for good laboratory practice.

Failure to meet these minimum Standards may pose a risk to public health and patient safety.

Scope

The Requirements for Enrolment and Participation in External Quality Assessment is a Tier 3B NPAAC document and must be read in conjunction with the Tier 2 document Requirements for Medical Pathology Services. The latter is the overarching document broadly outlining standards for good medical pathology practice where the primary consideration is patient welfare, and where the needs and expectations of patients, Laboratory staff and referrers (both for pathology requests and inter-Laboratory referrals) are safely and satisfactorily met in a timely manner.

Whilst there must be adherence to all the Requirements in the Tier 2 document, reference to specific Standards in that document are provided for assistance under the headings in this document.

Participation in external quality assessment is a mandatory requirement for meeting acceptable performance standards and extends beyond the analytical aspects of pathology testing into all areas of Laboratory function.

The Requirements for Enrolment and Participation in External Quality Assessment outlines the general features that an external quality assessment program must have in order to provide an effective monitoring strategy for the various pathology disciplines. It is important for a Laboratory to be able to select a quality assessment program which is compatible with the Medical Pathology Services being provided by that Laboratory.

Pathology Laboratories and suppliers of external quality assessment programs alike are required to have established and to maintain a quality system appropriate to the functions of their respective organisations.

Abbreviations

AS / Australian Standard
CLSI / Clinical Laboratory and Standards Institute
EQA / External Quality Assessment
IEC / International Electrotechnical Commission
ILAC / International Laboratory Accreditation Cooperation
ISO / International Organization for Standardization
KPI / Key Performance Indicators
NPAAC / National Pathology Accreditation Advisory Council
OECD / Organisation for Economic Cooperation and Development
QC / Quality Control

Definitions

Quality can be defined as the ‘the totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs’. An entity in this definition may be an organisation or a set of procedures, instruments or assays in the case of pathology. The application of the term quality to the many aspects of Laboratory practice may differ between pathology organisations and/or between the various disciplines of pathology. The common references to quality in Laboratory practice include quality systems, quality control, and external quality assessment.

The definition of terms used to describe the components of quality control and external proficiency testing programs have been provided on numerous occasions by internationally recognised professional groups, authors of text books and professional papers. Even though the descriptive words may be different, the concepts inherent in the definition for a given item are essentially equivalent. Definitions in this document have been sourced from the CLSI Harmonized Terminology Database1 and the Health Insurance Act 1973.2

Accuracy
(of measurement) / means closeness of the agreement between the result of a measurement and a true value of the measurand.
Bias / means systematic error of the indication of a measuring instrument.
Control Material / means a device, solution, or lyophilized preparation intended for use in the quality control process to monitor the reliability of a test system and to maintain its performance within established limits,
or
means a material to be used for the assessment of the performance of an analytical procedure or part thereof.
Error / means result of a measurement minus a true value of the measurand.
External Quality Assessment / means a program in which multiple Specimens are periodically sent to Laboratories for analysis and/or identification, in which each Laboratory’s results are compared with those of other Laboratories in the group and/or with an assigned value, and reported to the participating Laboratory and others.
Such a program may also compare an individual’s results with their peer group.
Imprecision / means the random dispersion of a set of replicate measurements in the same Specimen under specified conditions and/or values expressed quantitatively by a statistic, such as standard deviation or coefficient of variation.
Inaccuracy / means numerical difference between a value and the true value.
Internal Quality Control / means operational techniques and activities at the point of use that are used to fulfil requirements for quality of Medical Pathology Services.
Interpretative Tests / means tests where the result is based on pattern recognition utilising the interpretative expertise of an appropriately qualified and experienced scientist or pathologist (for example, most histopathology and cytology tests, many microbiology tests and morphological haematology).
Precision / means closeness of agreement between independent test results from the same Specimen obtained under stipulated conditions.
Proficiency Testing / See External Quality Assessment
Qualitative Tests / means tests where there may only be two outcomes (positive/negative; detected/not detected) or where the degree of change in the test procedure is ranked on a relative or semi-quantitative scale (for example, 1+, 2+, 3+ - urine drugs of abuse screening, pregnancy tests).
Quality / means the totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs
Quality Assessment / means a measurement and monitoring function of quality assurance for determining how well health care is delivered in comparison with applicable standards or acceptable bounds of care.
Quality Assurance / means part of quality management focused on providing confidence that quality requirements will be fulfilled.
Quality Control / means operational techniques and activities that are used to fulfil requirements for quality.
Quantitative tests / means tests whose output can be measured on a metrical scale (for example, most clinical biochemistry tests and many haematological measurements).
Requirements for Medical Pathology Services (RMPS) / means the overarching document broadly outlining standards for good medical pathology practice where the primary consideration is patient welfare, and where the needs and expectations of patients, Laboratory staff and referrers (both for pathology requests and inter-Laboratory referrals) are safely and satisfactorily met in a timely manner.
The standard headings are set out below –
Standard 1 – Ethical Practice
Standard 2 – Governance
Standard 3 – Quality Management
Standard 4 – Personnel
Standard 5 – Facilities and Equipment
A – Premises
B – Equipment
Standard 6 – Request-Test-Report Cycle
A – Pre-Analytical
B – Analytical
C – Post-Analytical
Standard 7 – Quality Assurance
Uncertainty / means parameter, associated with the result of a measurement that characterizes the dispersion of the values that could reasonably be attributed to the measurand.

Introduction

This document is issued by the National Pathology Accreditation Advisory Council (NPAAC) for the guidance of Laboratories in Australia in providing the minimum standards considered acceptable for assessing the participation of pathology Laboratories in external quality assessment programs. It provides a description of minimum acceptable Standards based on the application of the Requirements for Medical Pathology Services and with reference to AS ISO 15189 Medical laboratories – Requirements for quality and competence.

Satisfactory participation in external quality assessment is a requirement for all pathology Laboratories seeking accreditation. NPAAC considers it important that criteria for the assessment of external quality assessment testing programs be available in order to establish standards of acceptability. External quality assessment programs can be used in all disciplines and for all categories of pathology tests to assess performances and are most effective when the assessments can be compared with peers. External quality assessment schemes compare testing outcomes between Laboratories to set target or consensus values by assessing the relationships between the results.

External quality assessment is usually conducted by an external agency and is primarily designed to determine the performance of the Laboratory for specific tests or test procedures, and to monitor a Laboratory’s continuing performance. In addition, quality assessment results provide an objective means of assessing the reliability and comparative accuracy of the data through inter-Laboratory comparisons. Internal quality control is also part of the overall quality assurance systems process as it allows real time assessment and control of assay performance.

These Requirements are intended to serve as minimum Standards in the accreditation process and have been developed with reference to current and proposed Australian regulations and other standards from the International Organization for Standardization including:

AS ISO 15189 Medical laboratories – Requirements for quality and competence

These Requirements should be read within the national pathology accreditation framework including the current versions of the following NPAAC documents:

Tier 2 Document

·  Requirements for Medical Pathology Services

Tier 3B Document

·  Requirements for the Estimation of Measurement Uncertainty

In addition to these Standards, Laboratories must comply with all relevant state and territory legislation (including any reporting requirements).

The relevant policies for participation in external quality assessment programs by both Laboratory and the program supplier should include:

·  the aims, range of services and criteria for program selection

·  documented procedures for participation in the selected program

·  reporting procedures, suitability of data analysis and interpretation of results

·  review mechanisms.

In each section of this document, points deemed important for practice are identified as either ‘Standards’ or ‘Commentaries’.

·  A Standard is the minimum requirement for a procedure, method, staffing resource or facility that is required before a Laboratory can attain accreditation – Standards are printed in bold type and prefaced with an ‘S’ (e.g. S2.2). The use of the word ‘must’ in each Standard within this document indicates a mandatory requirement for pathology practice.

·  A Commentary is provided to give clarification to the Standards as well as to provide examples and guidance on interpretation. Commentaries are prefaced with a ‘C’ (e.g. C1.2) and are placed where they add the most value. Commentaries may be normative or informative depending on both the content and the context of whether they are associated with a Standard or not. Note that when comments are expanding on a Standard or referring to other legislation, they assume the same status and importance as the Standards to which they are attached. Where a Commentary contains the word ‘must’ then that commentary is considered to be normative.

In 2002, the former Australian Government Department of Health and Ageing commissioned an Evaluation of the Australian Pathology Laboratory Accreditation Arrangements. One of the report’s recommendations was that the criteria for selection of external quality assessment programs include mechanisms to detect and deter falsification and collusion by irresponsible participants.

Please note that all NPAAC documents can be accessed at NPAAC Website

While this document is for use in the accreditation process, comments from users would be appreciated and can be directed to:

The Secretary
NPAAC Secretariat
Department of Health
GPO Box 9848 (MDP 951)

CANBERRA ACT 2601

Phone: +61 2 6289 4017
Fax: +61 2 6289 4028
Email: NPAAC Email Address
Website: NPAAC Website