Additional Essential Criteria for Quality Systems of Medical Laboratories

Table of Contents

1. General Information
2. Quality Policy and Strategy
3. Organisation and Management
4. Personnel
5. Premises and Environment
6. Equipment, Materials and Reagents
7. Pre-Analytical Phase
8. Analytical Phase
9. Post-Analytical Phase
10. Evaluation of the Quality System

(Clin. Chem. Lab. Med. 1998; 36: 249-252, © W. de Gruyter, Berlin)

Summary

Essential Criteria for Quality Systems of Medical Laboratories have been published recently by the European Community Confederation of Clinical Chemistry (EC4) Working Group on Harmonisation of Quality Systems and Accreditation. The Essential Criteria address the majority of critical aspects of quality management in the medical laboratory. They have been accepted by the EC4 General Assembly and are endorsed by the Forum of European Societies for Clinical Chemistry (FESCC). However, a supplement to the Essential Criteria was necessary, addressing two aspects, which are only partly covered by the Essential Criteria: the management of resources and point of care testing.

Thus, the EC4 Working Group on Harmonisation of Quality Systems and Accreditation has decided to formulate Additional Essential Criteria for Quality Systems of Medical Laboratories, directed at the issues of management of resources and point of care testing. Criteria on management of resources address financial aspects, information, logistics and acceptance by clients. Criteria on point of care testing address responsibilities, education of non-laboratory staff and operational aspects. The Additional Criteria are supplementary to the previously published Essential Criteria and should be read as an integral part of these.

Introduction to the Document

Essential Criteria for Quality Systems of Medical Laboratories have been published recently by the European Community Confederation of Clinical Chemistry (EC4) Working Group on Harmonisation of Quality Systems and Accreditation (1). The Essential Criteria have been accepted by the EC4 General Assembly and are endorsed by the Forum of European Societies for Clinical Chemistry (FESCC). The Essential Criteria address the majority of critical aspects of quality management in the medical laboratory. Where applicable reference is given to important international documents such as the ISO 9000 and EN 45000 series and ISO guide 25. However, from recent documents and developments it appears that a supplement to the Essential Criteria stressing two aspects, which are only partly addressed in the Essential Criteria, is necessary: the management of resources and point of care testing.

The Guideline on the total quality management published by the European Foundation on Quality Management (EFQM) (2) and also a publication of an European Confederation of Laboratory Medicine (ECLM) group (3) stress the importance of criteria on management of resources. Such criteria should address financial aspects, information, logistics and acceptance by clients. In the EC4 Essential Criteria, and also in the ISO and EN documents, limited attention is paid to these aspects. The issue of point of care testing is gaining more and more interest. Particularly in the UK (4-7) documents have been prepared for national use to give guidance. Again, the EC4 Essential Criteria pay only limited attention to this important aspect. Therefore the EC4 Working Group on Harmonisation of Quality Systems and Accreditation has decided to formulate Additional Essential Criteria for Quality Systems of Medical Laboratories, directed to the issues of management of resources and point of care testing.

The Additional Criteria are supplementary to the previously published Essential Criteria and should be read as an integral part of these. The Additional Essential Criteria follow the numeration of the Essential Criteria and should be added at the indicated paragraphs.

References

Received 4 February 1998; accepted 26 March 1998.

Additional Essential Criteria for Quality Systems of Medical Laboratories

Prepared by the Working Group on Harmonisation of Quality Systems and Accreditation

Additional Criteria on Management of Resources

The criteria formulated below are additional to the EC4 Essential Criteria for Quality Systems of Medical Laboratories that have been published in Eur J Clin Chem Clin Biochem 1997; 35:123-132 and should be read as an integral part of these.

1. General Information
(See Essential Criteria)

2. Quality Policy and Strategy
(See Essential Criteria)

3. Organisation und Managment

3.1 Budget management.

The head of the laboratory should be responsible for budget and cost control. The overall investment in the laboratory should be matched with aims of the parent organisation. There should be a management information system and it should be used as a steering tool. There should be documentation on number of tests performed per period (month, quarter of a year, year), number of emergency tests (stats), and on turnaround times. ´

4. Personnel

4.1 Job descriptions, duties and responsibilities.

There should be information on the liability of professional staff and personnel. There should be a procedure to check satisfaction of personnel regularly.

5. Premises and Environment
(See Essential Criteria)

6. Equipment, Materials and Reagents

6.2 Purchasing of equipment.

The criteria for selection of equipment should include cost per test, the effect on personnel, the effect on provisions and facilities, the effect on environment, and the effect of possible outsourcing to a referral laboratory. There should be a system for evaluation of capital expenditure including direct and indirect (staffing) costs.

6.6 Administration of materials and reagents

There should be regularly updated information on costs per work station and/or per test, including use of reagents.

7. Pre-Analytical Phase

7.1 Consultation and efficacy

There should be documentation on active participation of professional staff in the effective use of laboratory services, including optimisation of frequency and timing of tests (right test at the right time). There should be consultation with clinicians on new developments, new services, and time needed to introduce these. There should be consultation with clinicians on obsolete tests, changing services and adequate communication concerning necessary changing of reference values.

8. Analytical Phase
(See Essential Criteria)

9. Post-Analytical Phase

9.1 Turn-around time.

There should be procedures to communicate the efficiency of turn-around times in terms of medical need and costs.

10. Evaluation of the Quality System

10.1 Internal audit

There should be an estimate of costs of the quality system, including costs of duplicates, control samples and also costs of overhead, and effects on costs of failures and corrective actions.

10.2 External audit

In clinical audit, services should be checked for clinical effectiveness and cost efficiency.