Essential Criteria for Quality Control Systems for Medical Laboratories

Table of Contents

1. Introduction and scope
2. General information
3. Quality policy and strategy
4. Organization and management
5. Personnel
6. Premises and environment
7. Equipment, materials and reagents
8. Pre-analytical phase
9. Analytical phase
10. Post-analytical phase
11. Evaluation of the quality system

Eur J Clin Chem Clin Biochem 1997; 35(2): 123-132 © 1997 by Walter de Gruyter Berlin New York

European Community Confederation of Clinical Chemistry (EC4) Working Group on harmonisation of quality systems and accreditation

Address for correspondence:

Summary

The introduction of total quality systems in medical and clinical laboratories and accreditation of these laboratories is gaining more and more interest. In several countries laboratories have set up quality systems, and accreditation schemes are also operating. The standards of these schemes have much in common although several differences exist. There exists uncertainty in several countries on the choice of a system. Laboratory specialists are confronted with a new way of thinking concerning the management and daily practice of their laboratories. It is not clear, which standards should be used as a basis, and certainly not how to interpret such standards. Particularly in the European Union, harmonisation of criteria for quality systems is desirable. In the present paper, the document "Essential Criteria for Quality Systems in Medical Laboratories" is presented. The document has been accepted in the General Assembly of the European Communities Confederation of Clinical Chemistry and Laboratory Medicine (EC4) and by the working group on Good Laboratory Services of the European Council on Laboratory Medicine (ECLM). The criteria in the document are focussed on the particular situation of medical laboratories, including pre- and post-analytical aspects. Reference is made, were applicable, to EN 45001, ISO 9001 and ISO guide 25 draft 3.

Introduction to the document

The introduction of total quality systems in medical and clinical laboratories and accreditation of these laboratories is gaining more and more interest. In several countries laboratories have set up quality systems, and accreditation schemes are also operating. Examples are Clinical Pathology Accreditation (CPA) in the UK (1), Foundation for Accreditation of Laboratories in Health Care (CCKLtest) (2) in The Netherlands and the Belgian Accrediting and Recognizing System (BELTEST)/Belgian government using Coordinating Committee for the Promotion of Quality Control of Laboratory Investigation in Health Care (CCKL) standards in Belgium. The standards of these schemes have much in common although several differences exist. Some schemes (CCKLtest, BELTEST) are partially based on EN45001 and ISO9001 standards, but in all schemes additional norms for the particular situation of medical laboratories have been introduced.

There exists uncertainty in several countries on the choice of a system. Laboratory specialists are confronted with a new way of thinking concerning the management and daily practice of their laboratories. It is not clear, which standards should be used as a basis, and certainly not how to interpret such standards (3). Particularly in the European Union, harmonisation of criteria for quality systems is desirable. Therefore an enquiry into the existing ideas of member societies of the European Communities Confederation of Clinical Chemistry and Laboratory Medicine (EC4) has been organised by the EC4 Working Group on harmonisation of quality systems and accreditation.

The results of this enquiry have been published (4). The main conclusions were:

• the willingness of EC4 member societies harmonize and to cooperate
• the recognition of the limitations of EN45001 and ISO9001 as standards for medical laboratories
• the necessity for additional requirements covering pre- and post-analytical aspects
• the requirement that the head of the laboratory should be a laboratory specialist
• the continuing need for external quality assessment schemes.

The next step in the strategic plan of the Working Group is the publication of essential criteria, that are focussed on and designed for quality systems of clinical and medical laboratories. The present article reports the Essential Criteria for Quality Systems of Medical laboratories, as formulated by the EC4 working group.
Major aspects of the document are:

• the cross referencing to the existing standards EN45001, ISO9001 and the preliminary draft ISO guide 25 draft 3;
• the appearance of separate sections on pre-analytical, analytical and post-analytical issues;
• requirements for head and professional staff;
• requirements for consultation on efficacy of tests (the right test at the right time);
• requirements for patient facilities.

The document has been unanimously accepted at the EC4 General Assembly, 7th July, Wembley London, which was attended by delegates of the large majority of member societies.

The European Council on Laboratory Medicine (ECLM), in which all disciplines in laboratory medicine cooperate, has installed a working group on Good Laboratory Services (chairman Prof. Dr. R. Haeckel, Germany). This working group has accepted the present EC4 document as a main source of information on what is needed to provide good service to patients and physicians, to be used by all disciplines in laboratory medicine.

If a quality system based on the present Essential Criteria is introduced in a laboratory, that laboratory will be prepared for accreditation according to any of the existing profession related schemes, like CPA, CCKLtest and BELTEST. Accreditation according to EN45001, or certification of those items of ISO9001 which pertain to the medical laboratory, are also feasible.

To set up a quality system in a laboratory requires the introduction and maintenance of a quality handbook, containing in annexes all documents and procedures operating in that laboratory. Model quality handbooks are an important aid to starting this process. The NVKC Model Quality Manual (5) is an example of such a handbook. The EC4 Working Group is preparing a Model Handbook based on the present Essential Criteria and on the NVKC Manual.

Next steps of the working group will be to produce a checklist of practical items, to give guidelines for inspections and to further promote the cooperation between disciplines in this important field.

References

1. Introduction and Scope

There is increasing awareness in medical laboratories for the need of total quality management. After a long history of the use of internal quality control and external quality assessment schemes, there is now the requirement for control of the complete laboratory process. An important tool to achieve such control is a total quality management system. Medical laboratories are in need of international criteria for such quality systems.

There exist International Standards for certification (ISO9001) and for accreditation (EN45001 and ISO guide 25). However these standards are either very general (ISO9001), or are developed for testing and calibration laboratories (EN45001, ISO guide 25), and therefore do not address specific aspects of the work of medical laboratories. The scope of medical and clinical laboratories is different from these laboratories and needs additional criteria.

The Working Group on Harmonisation of Quality and Accreditation Systems of The European Communities Confederation of Clinical Chemistry and Laboratory Medicine (EC4) has prepared the present document in order to clarify the specific needs. This document provides guidelines for implementation of total quality systems in medical laboratories. Although written for discipline of clinical biochemistry, the document is generally applicable to multidisciplinary and other types of medical laboratories. The quality systems of medical laboratories should reflect the special tasks of such laboratories. Therefore the emphasis of the document is not only on analytical and observational aspects, but also on the pre-analytical and post-analytical phases, on consultation and on efficacy and efficiency of requested investigations.

Where possible, reference is given to EN45001, ISO guide 25 (Draft 3) and ISO9001 standards. Several criteria are not addressed in these standards. In particular, the criteria in Sections 7 and 9 of this document concerning the pre- and post-analytical phases, as well as criteria in other sections concerning patient preparation, clinical advise, efficacy and teaching, represent additions to the ISO guide 25 and the EN45001 standards.

Some requirements of the EN45001 standard and ISO guide 25 seem less relevant for medical laboratories. Requirements regarding calibration are formulated differently in the present document. This also pertains to the reference methods and materials requirements, which in many cases are not available for medical laboratory tests, particularly the observational tests. The use of subcontractors for specialized or infrequently requested assays is daily practice for medical laboratories, in contrast to the requirements for testing laboratories.

Any medical laboratory that has implemented a quality system according to the criteria described in the present document, fulfils ISO9001, EN45001 and ISO guide 25 standards that are relevant to medical laboratories, and is prepared for accreditation or certification by all relevant schemes. Particularly schemes originating in, though operating independently of the professions, like the Belgian system, Foundation for Accreditation of Laboratories in Health Care (CCKLtest) in the Netherlands, Clinical Pathology Accreditation (CPA) in the United Kingdom, and the French Guide de Bonne Execution des Analyses Biologie Médicale (GBEA) system, are suited for such accreditation. Guidelines published by these organisations are in agreement with the present international document and the Handbooks and Model Quality Manuals based on the guidelines and issued in these countries are of use for laboratories wishing to implement a quality system based on the present document.

2. General Information

2.1 Introduction

There should be a description of the scope of the quality system, the use of the quality manual and the relationship to the quality system of the parent organization if applicable. (addressed in ISO9001 1)

2.2 Definitions and abbreviations

Used terms should be defined (addressed in EN45001 2; ISO guide 25 3; ISO9001 3). Abbreviations should be avoided, and if used, be explained (addressed in EN45001 2; ISO guide 25 3; ISO9001 3).

2.3 Legal identity

The legal identity (type, name, address) of the laboratory should be stated (addressed in EN45001 3; ISO guide 25 4.1; ISO9001 4.1). Name and title of the director of the laboratory should be stated (addressed in ISO guide 25 4.2). The position of the laboratory within the parent organization should be clarified, e.g. in an organizational diagram.

2.4 Clinical advisory service based on analytical facilities

There should be a list of activities of the laboratory with respect to the fields covered and clinical advice provided. There should be a list of the general methodologies and techniques used. A list should be available of the repertoire in regular and out of hour service. The types of requesting physicians and if applicable other service users should be stated.

2.5 Research and development

The laboratory is recommended to take part regularly in projects of research concerning development or evaluation of new methods and methodologies. Larger laboratories should be involved in research. If applicable the hospital laboratory should give support to clinical research. The laboratory should give analytical and consulting support to clinical trials.

2.6 Teaching

The laboratory should take part in teaching of medical students, nurses, technologists and trainees if applicable.

2.7 Subcontractors

There should be a list of activities performed by subcontractors, that is laboratories to which specialized or infrequently requested assays are sent. Subcontractors should be known, recognized or accredited institutes or laboratories.

3. Quality policy and strategy

3.1 Quality policy of the parent organization

There should be a list of references to quality documents of the parent organization, if applicable.

3.2 Quality policy of the laboratory

The general policy of the laboratory with regard to quality issues should include services, health, safety, welfare and environment, with due regard to legal requirements (addressed in EN45001 5.4.2; ISO guide 25 5.2; ISO9001 2.1.1). The laboratory should use materials and reagents that, where possible, should be safe for personnel and the environment. If the use of hazardous materials (toxic, mutagenic, radioactive) or procedures is unavoidable, appropriate measures should be taken to protect personnel and environment.

3.3 Quality strategy of the laboratory

The quality system of the laboratory should be described in a quality manual (addressed in EN45001 5.4.2;ISO guide 25 5.1; ISO9001 4.2). There should be a list of specific quality goals of the laboratory (addressed in ISO9001 4.2). The general structure of documents should be defined. The general format of procedures should include:

• Subject
• Purpose and scope
• Responsibility
• Definitions
• Action and methods
• References
• Documentation

There should be a system for document control defining the responsibilities for writing, evaluation, authorisation and distribution of quality system documents (addressed in ISO9001 4.4.1). Information appearing on each page of any document should include title, version number, page number of total number of pages, and document identification code. Only valid versions of procedures should be used, dated and signed by the responsible staff officer. The quality manual should be accessible for all personnel (addressed in EN45001 5.4.2; ISO guide 25 5.2). Personnel should be actively involved in writing and changing of procedures and they should take notice of such changes. All procedures should be evaluated at least once a year (addressed in EN45001 5.4.2).

3.4 Confidentiality

Information about patients should be treated confidentially and measures to ensure this should be defined (addressed in EN45001 5.4.6; ISO guide 25 5.2).

3.5 Improper influence

Measures taken to protect against improper influence (corruption) should be defined (addressed in EN45001 4; ISO guide 25 4.2).

4. Organization and Management

4.1 External relationship

There should be a description of the position of the laboratory within the parent organization, if applicable, illustrated by e.g. a diagram (addressed in ISO guide 25 5.2).

4 .2 Internal organizational structure

There should be a description of the organizational structure of the laboratory illustrated by a management diagram (addressed in EN45001 5.1, 5.4.2; ISO guide 25 4.2; ISO9001 4.1.2.1). There should be a list of all functions and their tasks, responsibilities and competencies (addressed in EN45001 5.1; ISO9001 4.1.2.1).

4.3 Budget management

There should be a yearly report of the strategy, achievements and production figures of the laboratory. There should be a budgetting and debiting system specifying salaries, investments, other working expences. Responsibilities for budgets and efficiency should be clearly stated.

4.4 Head of the laboratory

The head of the laboratory should be a laboratory specialist (e.g. clinical pathologist, clinical biochemist, biologist clinique) recognized at national and/or international level (e.g. registered in the EC4 Euro Register). The head of the laboratory should be responsible for management and scientific direction and should be individually responsible for giving clinical advice.

4.5 Professional staff and other staffing

The professional staff should include appropriate numbers of recognized laboratory specialists, registered at national and European level (e.g. the EC4 Euro Register). The staff should have defined individual responsibility for consultation, choice of methodology and quality aspects of assays. There should be a quality officer (e.g. chief-technician) responsible for the maintenance of the quality system and manual, reporting directly to the head of the department (addressed in EN45001 5.4.2; ISO guide 25 4.2). There should be a safety advisor. There should be appropriate members of staff with the required training to insure a satisfactory operation of service (addressed in EN45001 5.1; ISO9001 4.1.2.2). Regular staff meetings should be held to review the organization of services. All staff of varying levels should be involved. Records should be kept and actions audited. Regular staff meetings should be held to review technical and research aspects. Records should be kept and actions audited.

5. Personnel

5.1 Job descriptions, duties and responsibilities

There should be job descriptions for different grades of staff and these should be consistent with the management diagram (addressed in EN45001 5.2; ISO guide 25 4.2; ISO9001 4.1.2.1). All staff should have an up-to-date copy of these job descriptions (addressed in EN45001 5.2). The duties and responsibilities of all staff should be specified in the job descriptions (addressed in EN45001 5.2; ISO guide 25 4.2; ISO9001 4.1.2.1).

5.2 Service and leave planning; sickness substitution

There should be an adequate system of time scheduling of working hours and of leave planning and sickness substitution.

5.3 Education, training and development of staff

There should be a continuing education program for all staff. Records should be kept (addressed in EN45001 5.2; ISO guide 25 6.2; ISO9001 4.1.2.2, 4.18). Professional staff take part in appropriate post graduate education, symposia and congresses. Sufficient handbooks and scientific literature should be available. If it is advantageous for a limited range of tests and procedures to be performed outside the laboratory (e.g. point of care or near patient testing) non-pathology staff should be properly trained and supervised by laboratory staff.

5.4 Staff appraisal system

Personal records should be kept to ensure that there is evidence that each member of staff is regularly appraised, with clear statements of objectives.

6. Premises and Environment

6.1 Laboratory space

There should be adequate bench space, in accordance with national legislation (addressed in EN45001 5.3.2; ISO guide 25 7.1). There should be adequate space according to each specialisation of the laboratory (addressed in ISO guide 25 7.4). There should be adequate space to enable personnel to perform the required functions (addressed in EN45001 5.3.2). There should be space for equipment in accordance with the manufacturers recommendation. There should be adequate circulation space. There should be adequate space for sample reception and handling. There should be separate and adequate (according to legislation) areas for radioactive isotope work and high risk work (addressed in ISO guide 25 7.4). Access to the laboratories should be regulated (addressed in EN45001 5.3.2; ISO guide 25 7.5). All areas should be tidy and properly clean
(addressed in EN45001 5.3.2; ISO guide 25 7.6).

6.2 Office space

There should be separate office space for the head of the laboratory, the professional staff and for administration. There should be adequate space for computer equipment.

6.3 Facilities for personnel

There should be adequate staff facilities for relaxation. There should be sufficient locker space. There should be sufficient toilet accommodation.

6.4 Facilities for patients

There should be an adequate reception area with suitable access also for disabled. There should be adequate waiting space. There should be phlebotomy rooms which afford sufficient privacy. There should be rooms for collection of special samples from patients, where appropriate. There should be room for performance of dynamic function tests, where appropriate. There should be adequate sanitary facilities for urine collection as well as hand-washing.

6.5 Safety facilities

There should be sufficient emergency exit facilities. There should be fire protection facilities. There should be protection against etching fluids and other high risk materials. There should be safety boxes for high risk reagents. There should be protection against hazards of biological materials.

6.6 Provisions for working environment

There should be adequate provisions for temperature control, power supply and lighting (with back-up facilities in case of power failure), ventilation, water and gases (addressed in EN45001 5.3.2; ISO guide 25 7.3).

6.7 Storage facilities

There should be adequate and secure refrigerators and freezers, and for storage of critical material these should be connected to a recording and alarm system (addressed in ISO9001 4.15.3). There should be adequate storage facilities for glassware, supplies, reagents, specimens and other materials (addressed in ISO9001 4.15.3).

7. Equipment, Materials and Reagents

7.1 Administration of equipment

There should be a list of the major equipment including identification, date received, manufacturer, price, maintenance service (addressed in EN45001 5.3.3; ISO guide 25 8.4; ISO9001 4.6.3). Equipment out of order should be properly indicated (addressed in EN45001 5.3.3; ISO guide 25 8.2).

7.2 Purchasing of equipment

There should be a procedure for specification of requirements (addressed in ISO9001 4.6.3). There should be a procedure for validation of performance against specified requirements (addressed in ISO9001 4.6.4). There should be a procedure for assessment of suppliers (ISO certificate) including training, documentation and service (addressed in ISO9001 4.6.2). The criteria for selection of equipment should be established by the head of the laboratory.

7.3 Calibration

There should be calibration procedures for basic equipment like pipettes, balances, microscopes and centrifuges (addressed in EN45001 5.3.3; ISO guide 25 9.1; ISO9001 4.11). There should be procedures for calibration of major equipment. Where possible and feasible reference materials should be used for calibration. The traceability of the used calibration materials should be stated (addressed in EN45001 5.3.3; ISO guide 25 9.2-3; ISO9001 4.11).

7.4 Instructions for use and maintenance

There should be procedures describing the use and operation of instruments (addressed in EN45001 5.3.3; ISO guide 25 10.1; ISO9001 4.11). There should be procedures for periodic maintenance (addressed in EN45001 5.3.3; ISO guide 25 8.2; ISO9001 4.11). There should be logbooks for all major equipment in which maintenance and trouble shooting should be recorded (addressed in EN45001 5.3.3; ISO guide 25 8.2; ISO9001 4.11). Diagnostic testing equipment outside the laboratory (e.g. near patient or point of care testing) should be ordered, operated, maintained and controlled according to procedures from the laboratory.

7.5 Computerfacilities

There should be documentation of all hardware and software including operating instructions (addressed in ISO guide 25 10.7). Computer systems must be reliable and back-up facilities guaranteed (addressed in EN45001 5.4.1; ISO guide 25 10.7). Systems should be validated for required functions (addressed in ISO guide 25 10.7). There should be adequate facilities for the storage of software back-ups and databases (addressed in ISO guide 25 10.7). Access to databases should be protected from non-authorised persons (addressed in ISO guide 25 10.7). There should be defined access to different authorisation levels.

7.6 Administration of materials and reagents

There should be procedures for selecting reagents and materials (addressed in ISO9001 4.6.1). There should be procedures for purchasing and ordering of reagents and materials (addressed in ISO guide 25 10.8; ISO9001 4.6.3). The criteria of these should be established by the head of the laboratory. There should be a procedure for assessment of suppliers (ISO certificate)
(addressed in ISO9001 4.6.2). There should be procedures to ensure that reagents and materials are checked for condition upon delivery, that they are stored correctly (temperature and other conditions) and that they are used only before the expiry date (addressed in ISO9001 4.6.4). There should be procedures to control inventory (minimum/maximum stock). Reagents and materials should be correctly identified and dated, including name of responsible organization or person, name, concentration, date of first use, date of expiry, danger/safety indication (addressed in ISO9001 4.6.3).

7.7 Safety and environment

There should be appropriate danger indications on all reagents and materials if toxic, radioactive, carcinogenic or mutagenic. There should be procedures for separate collection of different types of waste, including reagents, wash-waste, needles and infectious materials, and these procedures should be monitored (addressed in ISO guide 25 11.4).

8. Pre-analytical Phase

8.1 User information

There should be a user information system (e.g. handbook) which will contain appropriate information from the succeeding paragraphs.

8.2 Consultation and efficacy

Consultation concerning efficacy of tests, repeat frequency and required type of sample should be available at all times. There should be regular meetings of professional staff with the clinical staff regarding the use of the laboratory, and for the purpose of consultation on scientific matters. The professional staff should participate in clinical rounds, enabling consultation on efficacy in individual cases as well as in general. The consultation function should be part of medical audit.

8.3 Repertoire

There should be a list of the stat and 24 hours repertoire. There should be a list of the repertoire of all available tests, including required specimen and sample volume, special precautions, normal turn-around time, and reference ranges. There should be a defined role for the laboratory in the validation, assessment and quality control of near patient and point of care testing. The repertoires should be adjusted regularly and be part of the medical audit.

8.4 Request procedures

There should be procedures for urgent and routine requests. The request form should be designed with a view to obtaining necessary information for identification of the patient, the requesting physician, requested tests and clinical information. The request form should facilitate efficacy by its lay-out (e.g. disease oriented). In the request form specific required conditions for the patient for individual tests (e.g. fasting) should be indicated.

8.5 Information and preparation of patients

There should be information available for patients regarding special diets or other preparatory measures. There should be information available for patients concerning collection of urine, faeces, semen. There should be information for patients concerning opening hours and location of the laboratory. Waiting time for the patients should meet defined criteria.

8.6 Sample collection

There should be a procedure describing all aspects of blood and other specimen collection including patient identification, patient position, sampling technique, and biological safety aspects. There should be a procedure for unique identification of samples and subdivided samples including labelling and date and time registration of sample and requests (addressed in EN45001 5.4.5; ISO guide 25 11.1). There should be a list containing for each test information about the type of specimen, the type of tube and anticoagulant, collecting temperature, and the amount of sample needed (addressed in EN45001 5.4.5; ISO guide 25 10.5).

8.7 Sample transport and handling

There should be procedures for transport and handling of samples including required temperature, protection from light, stoppering precautions, allowable time lag before pre-treatment (e.g. centrifugation, deproteinisation) or assay and storage conditions (addressed in EN45001 5.4.5; ISO guide 25 11.3). There should be procedures to minimize the risk of interchange of samples and subdivided samples (addressed in EN45001 5.4.5; ISO guide 25 11.3). There should be procedures for sending samples to other laboratories, including required pre-treatment and precautions, urgency of transport, required forms and arrangements (addressed in EN45001 5.4.7; ISO guide 25 14.1). If a sample is assayed elsewhere, enough information should be given and the mutual responsibilities should be defined (addressed in EN45001 5.4.7; ISO guide 25 14.2).

8.8 Experimental testing

Procedures should be laid down for experimental testing, including the regulations regarding informed consent and involvement of the medical ethical committee. Testing should be performed according to strict protocols. If conditions differ from those of routine laboratory procedures, they should be made explicit.

8.9 Confidentiality and safety

Regulations to guarantee biological safety of patients, phlebotomists and technicians should be present, known and audited. Confidentiality of patients should be guaranteed (addressed in EN45001 5.4.6; ISO guide 25 5.2). All accidents with respect to sampling, transportation and handling of samples should be documented (addressed in EN45001 5.4.5; ISO guide 25 11.2).

9. Analytical Phase

9.1 Validation

On introduction of a new analytical procedure the performance should be validated against specified requirements (addressed in EN45001 5.4.1; ISO guide 25 10.2; ISO9001 4.9.1). Such validation should include, where possible, determination of systematic bias against reference materials or otherwise stated values, limit of detection, limits of determination, within- and between-run reproducibility, interfering substances, robustness (addressed in ISO guide 25 10.2). Limitations of applicability for different materials should be stated (addressed in ISO guide 25 10.1). Equipment should be validated by the manufacturer with respect to basic functions such as temperature control, wavelength characteristics and pipetting performance. The validation summary should be available upon request (addressed in EN45001 5.3.3; ISO guide 25 9.1).

9.2 Calibration and traceability of methods

Calibration frequency and calibration method should be stated e.g. in the working procedure (addressed in EN45001 5.3.3; ISO guide 25 9.1; ISO9001 11). Calibration materials and their traceability should be stated (addressed in EN45001 5.3.3; ISO guide 25 9.2; ISO9001 11). Origin of absorption coefficients, factors and their traceability should be documented (addressed in EN45001 5.3.3; ISO guide 25 9.2).

9.3 Working procedures

Working procedures for all assays should be available in written form (addressed in EN45001 5.4.1; ISO guide 25 10.1; ISO9001 9.1). Working procedures should be available at the bench (addressed in EN45001 5.4.1; ISO guide 25 10.1). There should be working procedures for logistic procedures, analytical procedures including measurement and observation techniques, and instrument procedures (addressed in EN45001 5.4.1; ISO guide 25 10.1; ISO9001 9.1). Working procedures should comprise, if applicable:

• Title
• Subject
• Purpose and scope
• Responsibilities
• Definitions
• Actions and methods
• Clinical relevance
• Reaction principle
• Safety and environment aspects
• Reagents, calibrants and control materials
• Equipment and means
• Sample taking, specimen requirements, identification
• Instructions including start-up, precautions, pretreatment, analysis, detection limit, lower and higher limit,disposal of waste, remarks and errorcodes, trouble shooting
• Results, units, registration, calculations, particularities
• Reporting, report values, emergency limits, reference limits
• Quality control and assessment: intra-laboratory control (materials, acceptance limits), external quality assessment
• Validation: referal to documents stating within-run and between-run variation, accuracy, detection limit, linearity, interfering substances
• Remarks
• References
• Documentation

9.4 Quality control and assessment

There should be a system of internal quality control (addressed in EN45001 5.4.2; ISO guide 25 5.6; ISO9001 10.2). Criteria against which analytical processes (measurement and also observation) are judged should be stated, for example, in the working procedures. Such criteria should preferably be based on biological variance. Internal quality control results should be checked and kept at the bench where the working procedures are performed (addressed in ISO guide 25 5.6; ISO9001 10.2). The laboratory should take part in valid external quality assessment schemes (EQAS), preferably those organized by the profession, and covering the repertoire (addressed in EN45001 5.4.2; ISO guide 25 5.6). Internal quality control results, also from near patient or point of care testing equipment, and EQAS results should be regularly evaluated in technical staff meetings and actions taken should be documented (addressed in ISO guide 25 5.6).

9.5 Authorisation

Measurements and observations should be verified by competent technical staff, taking into account internal quality control results, instrument flags, linearity, limits of determination. Initial authorisation should be the responsibility of senior staff. Professional staff should authorize final reports (addressed in EN45001 5.4.3; ISO guide 25 13.2).

9.6 Archiving

Outdated procedures should be archived for at least two years. Request forms should be archived for at least three months. Worklists containing intermediate results and observations should be archived for at least three months (addressed in EN45001 5.4.4; ISO guide 25 12.1; ISO9001 4.16). Results should be archived for a period of twice the medically informative period, with a minimum of one year and an advised maximum of ten years. Archives should be organized to ensure patient confidentiality (addressed in EN45001 5.4.4; ISO guide 25 12.2). Internal quality control results should be archived for at least one year. External quality assessment results should be archived for at least five years. Destruction of archives should ensure confidentiality.

9.7 Disposal of samples

Patient material should be considered and treated as potentially infectious. Specimens, needles and blood-contaminated disposables should be disposed of in special containers and be treated as infectious waste (addressed in EN45001 5.4.5; ISO guide 25 11.4).

10. Post-analytical Phase

10.1 Reporting procedures

There should be procedures for reporting of results. Report items should include:

• Laboratory name
• Patient name and address
• Requesting person
• Test description
• Sample kind
• Sampling date and time
• Result(s)
• Interpretational comments if necessary
• Signature of professional

(addressed in EN45001 5.4.3; ISO guide 25 13.2). Reporting of results should be definitive only after the complete analytical authorization procedure, including authorization by professional staff (addressed in EN45001 5.4.3; ISO guide 25 13.2). Stat results, results obtained in out of hours service and results outside alarm limits should be reported as soon as possible, but only after verification by a competent technician. Reporting of results by telephone should be limited and followed by written, printed or electronic reporting as soon as possible.

10.2 Correction procedures

Reported results should only be corrected by authorized professionals (addressed in EN45001 5.4.3; ISO guide 25 13.5). Correction of the results should be reported as soon as possible to the requesting physician (addressed in ISO guide 25 13.6). Corrected results should be clearly indicated as such in the report (addressed in EN45001 5.4.3; ISO guide 25 13.5). In case of a wrong result there should always be a procedure to investigate the underlying cause (addressed in ISO9001 4.14).

10.3 Turn-around time

The requesting physician should be familiar with the normal reporting time for assays. Turn-around times for stat and routine tests should be audited regularly. The turn-around time for assays sent to other laboratories should be known and checked. Turn-around times should be part of medical audit. 10.4 Reference values

Reference values should be available for all assays, where relevant. The reference values should be checked by the laboratory.

10.5 Interpretation and consultation

Consultation concerning interpretation of results and advice on further investigation should be available at all times. There should be regular meetings of professional staff with the clinical staff regarding use of the laboratory and interpretation of results. The professional staff should participate in clinical rounds for consultation on the interpretation in individual cases. Professional staff should participate in the medical and clinical audit. Professional staff should add interpretational remarks to reported results if necessary, e.g. warnings should be added to the report when pathological pitfalls or interfering substances are suspected.

10.6 Archiving

Results should be archived for a period of twice the medically informative period, with a minimum of one year and an advised maximum of ten years (addressed in EN45001 5.4.4; ISO guide 25 12.1). Archives should be organized to ensure patient confidentiality (addressed in EN45001 5.4.6; ISO guide 25 12.2). There should be adequate back-up procedures for electronic archives. The archive should be protected against damage (addressed in EN45001 5.4.4; ISO guide 25 12.2).
10.7 Confidentiality

There should be a procedure regarding confidentiality of results (addressed in EN45001 5.4.6; ISO guide 25 12.2).

11. Evaluation of the Quality System

11.1 Internal audit

There should be a system of planned internal audits (addressed in EN45001 5.4.2; ISO guide 25 5.3; ISO9001 4.17). Results of internal audits should be documented and responsible staff should be informed (addressed in ISO9001 4.17). Actions in response to the results of internal audits should be documented (addressed in EN45001 5.4.2; ISO guide 25 5.3; ISO9001 4.17). There should be procedures for corrective actions and assessment of their effectiveness. All procedures should be checked at least once a year (addressed in ISO guide 25 5.4). There should be a checklist of all items and aims described in the handbook and this should be checked once a year.

11.2 Internal and external complaints

There should be a low threshold system for reporting internal (from within the laboratory) (near) accidents, complaints and ideas. Internal (near) accidents, complaints and ideas should be registered (addressed in ISO guide 25 16.1). External (from outside the laboratory) accidents, near accidents and complaints should be registered (addressed in ISO guide 25 16.1). Internal and external complaints and ideas should be discussed in staff meetings and actions taken documented (addressed in EN45001 5.4.2; ISO guide 25 16.1). Professional staff should decide whether reported (near) accidents should lead to the immediate introduction of new measures in the laboratory organization or the consultation procedure.

11.3 External audit

Professional staff should take part in the medical audit. The laboratory should strive for inspection and accreditation according to EC4 approved criteria (addressed in EN45001 6.2). Professional staff should be prepared to function as auditor(s) in the external accreditation system, and be able to claim expenses for this service.