NATIONAL PATHOLOGY ACCREDITATION ADVISORY COUNCIL

REQUIREMENTS FOR PATHOLOGY LABORATORIES (2007 Edition)

ISBN: 1 74186 162 4 Online ISBN: 1 74186 163 2 Publications Approval Number: 3960 © Commonwealth of Australia 2007 This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the Commonwealth available from the Department of Communications, Information Technology and the Arts. Requests and inquiries concerning reproduction and rights should be addressed to the Commonwealth Copyright Administration, Copyright Law Branch, Attorney-General’s Department, Robert Garran Offices, National Circuit, Baron ACT 2600 or posted at http://www.ag.gov.au/cca

First published 1987 Second edition 1998 Third edition 2002 Fourth edition 2007

reprinted with minor revisons reprinted with minor revisions reprinted with revisions and name change from Standards for Pathology Laboratories

Publications Production Unit Australian Government Department of Health and Ageing

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Requirements for Pathology Laboratories

Contents Introduction...................................................................................................................1 NPAAC hierarchical document structure........................................................................3 Standard 1 – Laboratory ethics.......................................................................................4 Standard 2 – Quality systems..........................................................................................5 Standard 3 – Staffing, supervision and consultation.......................................................6 Standard 4 – Facilities....................................................................................................7 Standard 5 – Pre-analytical phase...................................................................................8 Standard 6 – Analytical phase........................................................................................9 Standard 7 – Post-analytical phase...............................................................................11 Standard 8 – Audit and assessment...............................................................................12 Bibliography.................................................................................................................13

Requirements for Pathology Laboratories

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National Pathology Accreditation Advisory Council 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. An ongoing function of NPAAC is to formulate standards and initiate and promote guidelines and 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.

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Requirements for Pathology Laboratories

Introduction Requirements for Pathology Laboratories is the primary National Pathology Accreditation Advisory Council (NPAAC) document that sets the minimum standards acceptable for good pathology laboratory practice in Australia. NPAAC Requirements apply to all pathology laboratories seeking accreditation. • Laboratories must be able to demonstrate continued compliance with NPAAC Requirements in their assessment history • Failure to meet these minimum standards may pose a risk to public health and patient safety These Requirements are written in broad principles. Other NPAAC documents are based on the principles established in this document. A general overview is shown in the flowchart titled ‘NPAAC hierarchical document structure’. The use of the word ‘must’ in each standard within this document indicates a mandatory requirement for pathology practice; ‘should’ is used to indicate guidelines or recommendations where compliance would be expected for good laboratory practice. Notes and commentaries provide guidance on the document, and examples are intended to illustrate the text and provide guidance on interpretation. • A standard is the minimum requirement for a procedure, method, staffing resource or laboratory 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). • A guideline is a consensus recommendation for best practice and should be used if a higher standard of practice is appropriate, particularly when setting up or modifying a laboratory test, or when contamination problems have occurred – guidelines are prefaced with a ‘G’ (e.g. G2.2) and are numbered to correspond with their associated standard. • A commentary is provided to give clarification to the standards and guidelines, which may include examples, references and guidance for interpretation. The particular requirements for the quality and competence of medical testing laboratories are described in AS 4633:2004 Medical Laboratories - Particular Requirements for Quality and Competence. As this standard, issued by Standards Australia, has been reproduced from, and is identical to, ISO 15189, the two standards will be collectively referred to hereafter as ISO 15189.

Requirements for Pathology Laboratories



More detailed requirements, guidelines and information are contained in other NPAAC publications, publications of the National Association of Testing Authorities, Australia (NATA) and other statutory authorities, state and territory health authorities, the Royal College of Pathologists of Australasia (RCPA), specialist medical and scientific societies, the National Health and Medical Research Council (NHMRC), Standards Australia, and other accrediting organisations and authorities. The bibliography lists the publications used in the preparation of these Standards. While this document is for use in the accreditation process, any comment from users would be appreciated and can be directed to: The Secretary NPAAC Department of Health and Ageing MDP 107 GPO Box 9848 CANBERRA ACT 2601



Requirements for Pathology Laboratories

Phone: +61 2 6289 4017 Fax: +61 2 6289 8509 Email: [email protected]

NPAAC hierarchical document structure Requirements for Pathology Laboratories Requirements for Quality Management in Medical Laboratories

Requirements for the Supervision of Pathology Laboratories

Specific documents can be accessed from the NPAAC website: http://www.health.gov.au/internet/wcms/Publishing.nsf/Content/health-npaac-publication.htm

Requirements for Pathology Laboratories



Standard 1 - Laboratory ethics S1.1

The wellbeing of patients and confidentiality of patient information must be primary considerations in the operation of a pathology service.

S1.2

The laboratory must have policies and procedures for ensuring the protection of confidential information.

S1.3

The laboratory must have policies and procedures to ensure that staff treat human samples, tissues or remains with due respect.

Commentary

C1.1

No person, by virtue of his/her office or employment within the pathology service, should disclose information about patients or the results of investigations thereon, except in the normal and approved performance of his/her duties.

C1.2

Results of investigations are normally provided in confidence to the requesting medical practitioner. However, records may be made available to another medical practitioner or other healthcare provider linked to the same patient and having regard for prevailing privacy legislation and associated guidelines (refer to http://www.privacy.gov.au/act/index.html#health).

C1.3

The patient should be encouraged to obtain all reports from his/her requesting medical practitioner. However, laboratories are required to have a policy for release of reports directly to a patient.



(a) There should be regard to the duty of care that is owed to the patient.



(b) If the disclosure is authorised or permitted by privacy legislation (See C1.4) the report should be made available to the patient by an appropriate member of the staff.



(c) The requesting practitioner should be notified that the patient has requested the results directly and, where practicable, be provided with the same information as that which was provided to the patient.

C1.4

Under some circumstances, legal requirements override privacy issues.

C1.5

The laboratory is to ensure that any improper internal or external commercial, financial or other pressure does not affect the quality of work performed by the laboratory.



Requirements for Pathology Laboratories

Standard 2 - Quality systems S2.1

The organisation must employ a quality system to ensure that the services provided meet required standards for good medical laboratory practice.

S2.2

The quality system must embody the requirements of International Organization for Standardization (ISO) 15189:2003.

Commentary

C2.1

It would be expected that the quality system would be appropriate to the size of the laboratory and the complexity and the nature of the diagnostic work it undertakes.

C2.2

It is the responsibility of management to set the objectives of the quality system and to provide sufficient resources for those objectives to be achieved. This would include ensuring that all staff participate in quality improvement activities and understand the organisation’s objectives for, and commitment to, good medical laboratory practice as a means of fulfilling the needs and requirements of users of the laboratory’s services. The NPAAC document Requirements for Quality Management in Medical Laboratories provides information on the establishment and maintenance of a quality system.

Requirements for Pathology Laboratories



Standard 3 - Staffing, supervision and consultation S3.1

There must be sufficient pathology, scientific, technical and support staff who have appropriate qualifications, training and experience relevant to the scope of the testing performed.

S3.2

Pathologists, scientists and other appropriate staff must participate in continuing professional development.

Commentary

C3.1

It is a requirement that the person(s) providing supervision and direction:



(a) takes responsibility for the professional, scientific, consultative, organisational, administrative and educational requirements of the laboratory and



(b) has the authority to implement and maintain the standards required of pathology laboratories.

C3.2

Elements of these responsibilities may be delegated to appropriately qualified and experienced pathologists or scientists.

C3.3

Documentation demonstrating that the education, training and experience of individual staff members are appropriate and adequate for the procedures used and the tests performed is required, as well as documentation of staff participation in continuing professional development.



Requirements for Pathology Laboratories

Standard 4 - Facilities S4.1

The laboratory must have sufficient space and appropriate facilities for the satisfactory provision of the laboratory service.

Commentary

C4.1

Aspects to be considered are:



(a) handling of specimens



(b) handling of hazardous substances



(c) performance of laboratory testing



(d) functioning and maintenance of equipment



(e) storage of reagents



(f ) storage of blood and blood products where required



(g) storage of specimens and records



(h) undertaking of administrative duties.

C4.2

The laboratory is expected to comply with the appropriate guideline or Australian Standard pertinent to the facilities listed below:



(a) Ventilation and lighting should be appropriate and adequate for the safe functioning of the laboratory.



(b) Emergency power should be available for essential functions.



(c) Communication facilities within the laboratory and with clients should be adequate for proper consultation and reporting.



(d) The level of physical security should be in accordance with the function of the laboratory.

C4.3

Effective separation is required between laboratory sections in which there are incompatible activities. Measures to prevent cross-contamination are required.

C4.4

Occupational health and safety is not an explicit part of this standard as it is covered by relevant jurisdictional legislation.

Requirements for Pathology Laboratories



Standard 5 - Pre-analytical phase S5.1

The laboratory service must ensure that there is information available for requesting practitioners and patients on the services that are available.

S5.2 Services provided must be in response to a documented request identifying the patient, the requesting practitioner, the tests requested and appropriate clinical information. S5.3

Collection of specimens must be performed in appropriate facilities and under appropriate conditions using protocols that ensure accurate identification of the patient and labelling of samples.

S5.4

The laboratory must ensure the integrity of the specimen appropriate to the proposed testing.

Commentary

C5.1

Access to protocols for specimen collection, processing and storage is required.

C5.2

Recording of relevant information regarding the specimen is required, for example:



(a) date and time of collection



(b) anatomical site of the specimen



(c) person performing the collection



(d) physiological and/or clinical status



(e) drug or other therapy taken by the patient



(f ) specimen characteristics that may provide relevant information to the interpretation of results (e.g. haemolysis).

C5.3

Retention of the original request for testing or examination is required, in a readily accessible form in compliance with legislative and accreditation requirements.

C5.4

Where a specimen is referred to another laboratory, the sample should conform to the requirements of the referral laboratory.



Requirements for Pathology Laboratories

Standard 6 - Analytical phase S6.1

The procedures and the analytical performance must be appropriate for the clinical application of the results.

Commentary

This Standard requires that: C6.1

only validated and/or recognised procedures are used

C6.2

appropriate validation records be available

C6.3

as part of the quality system, all test procedures be documented in sufficient detail to enable the test to be properly performed. Documentation outlining the procedures authorised for use are required to be available in the appropriate work area. Periodic documentation review should be conducted as part of the audit process

C6.4

the documentation of tests or procedures includes the source or reference for the procedure or method, the date the procedure was last reviewed, the calibration standards and controls required, and instructions for handling specimens and reporting results. The manufacturer’s package insert may be included in the documentation

C6.5

reference intervals and their source be readily available as part of the quality system documentation. (Refer to NPAAC’s Requirements for Quality Management in Medical Laboratories)

C6.6

the laboratory monitor the validity of testing by employing internal quality control procedures using control materials appropriate to the methods and materials used in sample analysis. The frequency of control testing gives assurance that the method is in control at the time of testing

C6.7

criteria be documented for the acceptance of quality control results as well as the action to be taken when control results are unacceptable

Requirements for Pathology Laboratories



C6.8

equipment records include:



(a) the overall history of each item of equipment



(b) its date of acquisition



(c) commencement of operation within the laboratory



(d) initial acceptance and validation testing



(e) maintenance



(f ) service and repair



(g) cleaning and decontamination



(h) on-going conformity testing.

C6.9

the identity of the staff performing the procedures is recorded.

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Requirements for Pathology Laboratories

Standard 7 - Post-analytical phase S7.1

Reports commensurate with good medical laboratory practice and patient care must be provided to the requesting practitioner.

Commentary

C7.1

Reports may be written or electronic, provided they have been appropriately authorised/validated. A telephone or verbal report is always to be followed by an authorised written or electronic report. A record of any telephone or verbal communication is required, which includes:



(a) reasons for reporting (such as urgent request, critical values)



(b) recipient



(c) staff member



(d) date and time of call.

C7.2

Interpretive comments and appropriate additional information may be added to reports at the discretion of the person responsible for the issued report.

C7.3

Retention of patient data, specimens, test procedures and equipment records is required to be in compliance with good medical laboratory practice, and statutory and accreditation requirements. Appropriate storage to ensure their preservation and to facilitate retrieval is necessary.

Requirements for Pathology Laboratories

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Standard 8 - Audit and assessment S8.1

A pathology service must audit its operations as part of the quality system in order to determine compliance of the service with current regulatory and accreditation requirements.

S8.2

Laboratories must be continuously enrolled, participate and perform to an acceptable standard in external proficiency testing programs that cover all test methods performed in the laboratory where such programs are available.

S8.3

The laboratory must be able to track the specimen and procedures performed at all times.

Commentary

C8.1

Procedures are required for:



(a)



(b) monitoring the validity of test results



(c) performing corrective actions after the detection of testing failures, departures from documented procedures or any other incident with the potential to adversely affect patient care



(d) reviewing the quality system



(e) keeping the results of corrective action(s) taken as a consequence of deviation in quality control or proficiency testing data



(f ) assessing user satisfaction and complaint handling.

C8.2

Where external proficiency programs do not exist for a test method, demonstration of the validity of test results by inter-laboratory comparisons and/or the analysis of appropriate reference and control materials is required.

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the auditing of the organisation’s procedures, facilities, records and documents, methods, instruments, calibrations, staff training and competency and quality control at appropriate intervals according to a predetermined schedule

Requirements for Pathology Laboratories

Bibliography AS (Australian Standard) (2004), Medical Laboratories – Particular Requirements for Quality and Competencies (AS 4633, ISO 15189:2003), Standards Australia, Homebush, New South Wales. AS/NZS (Australian and New Zealand Standard) (2006), Safety in Laboratories (AS/NZS 2243 Set), Standards Australia, Homebush, New South Wales. Clinical Pathology Accreditation (UK) Ltd (2000), Standards for the Medical Laboratory, http://www.cpa-uk.co.uk NATA (National Association of Testing Authorities), Australia (2006), Application Document: Supplementary Requirements for Accreditation in the Field of Medical Testing (AS 4633, ISO 15189), NATA, Rhodes, New South Wales.

Requirements for Pathology Laboratories

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