International Journal of Health Care Quality Assurance Medical laboratory quality systems – a management review Dimitris Theodorou Padelis Giannelos

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Medical laboratory quality systems – a management review Dimitris Theodorou and Padelis Giannelos Priority Quality Consultants, Athens, Greece

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Abstract

Medical laboratory quality systems 267 Received 6 April 2014

Revised 22 October 2014 Purpose – The purpose of this paper is to highlight changes in ISO 15189:2012 and ISO 15189:2007 Accepted 3 November 2014 concerning management review requirements and to present a management review checklist, which includes all the revised ISO 15189’s requirements. Design/methodology/approach – The recent revised and updated ISO 15189:2012 standard recommends a management review using a process approach and includes some additional topics. Findings – The management review is a key element in many quality management systems, including medical laboratory management systems in accordance with ISO 15189. The process approach enables laboratory top managers and personnel to achieve all the quality management system’s important inputs and outputs. Originality/value – As laboratory staff often encounter difficulties fully exploiting the management review process, this checklist helps laboratory staff carry out an effective management review covering all the quality management system’s important aspects. Keywords Management review, Checklist, ISO 15189:2012, Medical laboratory Paper type Viewpoint

Introduction The medical laboratory accreditation standard ISO 15189 (International Organization for Standardization, 2012), aligned with most management systems standards, includes a requirement to implement a management review, which is considered a vital management-system element, ensuring its continuing suitability and effectiveness. The recent revised and updated ISO 15189 recommends a management review using the process approach and requires that it shall review certain inputs, perform some value added activities and produce outputs. According to ISO 9000 (International Organization for Standardization, 2005, p. 11), a process is defined as a “set of interrelated or interacting activities, which transforms inputs into outputs” and that “Processes in an organization are generally planned and carried out under controlled conditions to add value.” The process approach in a management review context has been discussed in detail by Islin and Andersen (2008), who highlight that using a process approach in the management review ensures that the quality system continually improves. The managerial requirement significance, like a management review, is often underestimated by laboratory staff aiming at accreditation, who put most effort into meeting the accreditation standard’s technical requirements (training, calibration, method validation, etc.). In newly established quality systems, an additional factor is that personnel do not have the experience to evaluate management review process necessity and to implement it in a way that will have a positive outcome and add value. They find it difficult to transform the ISO 15189 requirements concerning management review into comprehensive discussion topics. Therefore, developing a management review checklist helps laboratory staff to fully exploit and use the management review process advantageously. The proforma we present updates the Theodorou and Anastasakis (2009) checklist. Our approach has been revised to cover medical laboratories specifically and meet the new ISO 15189’s requirements.

International Journal of Health Care Quality Assurance Vol. 28 No. 3, 2015 pp. 267-273 © Emerald Group Publishing Limited 0952-6862 DOI 10.1108/IJHCQA-04-2014-0039

IJHCQA 28,3

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268

Some topics not required by ISO 15189, but important medical laboratory quality management system elements, have been included in the checklist. The recent revised and updated ISO 15189:2012 introduces some changes, which should be recognized when planning and conducting a management review. The differences between ISO 15189:2012 and ISO 15189:2007 are summarized in Table I. ISO 15189 management review requirements According to ISO 15189:2012 (clause 4.15), laboratory managers are responsible for reviewing the quality management system at planned intervals; typically yearly or more frequently especially for newly established systems. The quality manager is responsible for ensuring that the management review is conducted in a systematic manner according to an established (and optionally documented) procedure and that the results (actions, decisions, findings) are recorded. The quality manager should also be responsible for preparing and distributing an agenda with topics that meet ISO 15189:2012 requirements and for ensuring that any action identified and recorded during the review meeting is implemented within an agreed time limit. Topics that should be discussed are presented in Table II, where their correspondence with relevant ISO 15189:2012 clauses is shown. We add two more inputs: first, quality and appropriateness of the laboratory’s contribution to patient care and second, quality control activities. These elements comprise important medical laboratory quality management system elements (Parsley and Corrigan, 1999; Levett and ISO 15189:2012 clause no. 4.15

Table I. Differences between ISO 15189:2012 and ISO 15189:2007 concerning the management review requirements

Corresponding ISO 15189:2007 clause no. 4.15

4.15.2

4.15.2

4.15.3

4.15.1, 4.15.3

4.15.4

4.15.4

Differences The whole management review clause is reworded and in order to be treated using the process approach has been divided into three distinct stages: review input (4.15.2); review activities (4.15.3); and review outputs (4.15.4) Period for conducting management review has been moved to a note below clause 4.15.4 Inputs into management review have been expanded to include the following Section 4 (management requirements) activities: periodically reviewing procedure suitability and sample requirements; staff suggestions; and risk management Management review must analyze the input information for non-conformity causes, trends and patterns that indicate process inadequacies. Opportunities for improving and need for changes to the quality management system shall be assessed Management review records shall include any decisions and actions taken related to: improving the quality management system and its processes; improving services to users; and resource needs

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Management review point

ISO 15189:2012 clause no

Medical laboratory quality systems

a. Periodically reviewing requests, procedures and sample requirements 4.14.2 b. Assessing user feedback 4.14.3 a c. Staff suggestions – recommendations for improvement 4.14.4, 4.12 d. Internal audits 4.14.5 269 e. Risk management 4.14.6 f. Using quality indicators 4.14.7 g. Reviews by external staff 4.14.8 h. Participation in inter-laboratory comparison programs (external quality 5.6.3 assessments/proficiency testing) i. Monitoring and resolution of complaints 4.8 j. Supplier performance, including subcontractors and referral laboratoriesb 4.5, 4.6 k. Identifying and controlling non-conformities 4.9 l. Continual improvement – corrective and preventive actions 4.10, 4.11, 4.12 m. Follow-up actions from previous management reviews 4.15.4 n. Changes in work volume, scope, personnel and premises 4.1.2.4, 5.1, 5.2, 5.5 o. Laboratory staff’s contribution to patient care quality and appropriatenessc 4.14.7 p. Quality control activitiesc 5.6.2 Table II. Notes: aStaff suggestions and recommendations for improvement are treated as separate inputs by Management review ISO 15189:2012; bthis point has been slightly modified compared to the title referred in ISO 15189:2012 inputs corresponding to make sure that subcontractors and referral laboratories are discussed; cinputs not required by ISO to ISO 15189:2012 15189:2012 clause

Burney, 2011) and should have a place in the management review meeting. Moreover, staff suggestions and recommendations for improvement, which are treated as separate inputs by ISO 15189:2012, have been merged. Finally, the point concerning supplier performance has been slightly modified compared to the ISO 15189:2012 title to make sure that subcontractor performance and referral laboratories are discussed. The review meeting should be attended by top managers, including the person under whose authority the quality policy and possibly the quality manual have been issued. In the laboratory, which is part of a larger organization (e.g. hospital), this person is probably not laboratory personnel. Moreover, it is essential that at least the laboratory director, technical and quality manager and other key managerial and technical personnel are present. In a small laboratory, one person may be fulfilling more than one role. Other staff may also participate or at least be informed about the outcome and action plan. For the participants to contribute to the management review, preparation is important. Participants should be informed about the management review meeting, gather data they regard most important, prepare a presentation and be ready to propose changes to improve the quality system. Management review checklist Table III presents a management review checklist that analyzes the input points required by ISO 15189:2012 into simpler questions. This document can serve as a useful tool for quality system managers and the other participants, helping them to prepare an agenda, collect data (management review inputs), keep records and actions agreed or distributing minutes. As laboratory needs vary, it is advisable to use the checklist dynamically, modifying it, if necessary, depending on the findings. The way the checklist is used depends on laboratory size and discipline.

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Action arising Management review point

270

Due Finding Description Responsible time

a. Reviewing requests, procedures and sample requirements Are the examinations provided by the laboratory appropriate for the requests received? Is there a need for sample review requirements (volume, collection, preservation) because method and equipment has changed? Is the laboratory personnel aware of the quality policy? Do management system procedures meet laboratory needs? Is there a need for review (changes) in the management system procedures? Do the request forms satisfy laboratory users’ needs?

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b. Assessing user feedback What were the results of the recent customer satisfaction survey? Were the results evaluated? Were non-satisfactory results from customer satisfaction surveys investigated? What was the outcome? c. Staff suggestions – recommendations for improvement Are there recommendations for improvement from the personnel? Were staff suggestions evaluated? How many were implemented? Did the staff get feedback? d. Internal audits How many non-conformities occurred during the internal audits? What did they concern? Was their significance evaluated? Have these non-conformities re-occurred? Are they related to non-conformities from previous year(s)? Did laboratory staff take all required corrections? Did the audit schedule include both horizontal audits (evaluating quality system elements) and vertical audits (evaluating complete processes)? Who were the auditors? Were they independent? e. Risk management Has the laboratory identified the risks associated with potential failures on examination results? Were these risks evaluated taking into account the potential severity and likely recurrence in pre-examination, examination and post-examination phases? Were appropriate control measures taken to reduce risks to acceptable levels?

Table III. ISO 15189:2012 management review checklist

f. Use of quality indicators Do the quality indicators monitored meet laboratory staff needs? Were the previous quality objectives achieved? If no, what was the reason? Have new quality objectives been set?

(continued )

Action arising Management review point

Due Finding Description Responsible time

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g. Reviews by external organizations When was the last assessment by the Accreditation Body? How many non-conformities occurred? What was the non-conformities’ nature (grading)? What did they concern? Have these non-conformities re-occurred? Are they related to non-conformities in previous year(s)? Which corrective actions were taken to eliminate non-conformities? Are they over?

Medical laboratory quality systems 271

h. Participation in inter-laboratory comparison programs (external quality assessments/proficiency testing) In which external quality assessment schemes (proficiency testing schemes, inter-laboratory comparisons) do laboratory staff participate? How often? Is the participation frequency satisfactory? Were the results from these schemes satisfactory? Were non-satisfactory results further investigated? What were the outcomes? Are there any cases of non-availability of proficiency testing schemes? If yes, what steps did laboratory staff take toward satisfying the requirement for external quality control (e.g. exchanging samples with other laboratories)? i. Monitoring and resolving complaints How many complaints were recorded? What did they concern? Were there any complaints that resulted from laboratory mistakes, bad practises or omissions? How did the laboratory staff investigate them? What was the outcome? j. Suppliers, subcontractors and referral laboratories What outcomes followed supplier evaluation? Was any non-conforming work resulting from purchased service or supply? What was the correction/corrective action? What outcomes emerged from subcontractor or referral laboratory evaluations? Has any cooperation with a subcontractor or a referral laboratory resulted in non-conforming work? k. Identifying and controlling non-conformities How many non-conformities occurred since the last management review? What did they concern? Was their significance evaluated? Did laboratory staff take all the required corrections to eliminate non-conformities? l. Continual improvement – corrective and preventive actions How many corrective and preventive actions are in progress? What do they concern?

(continued )

Table III.

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Action arising Management review point

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Due Finding Description Responsible time

How many corrective and preventive actions were recorded and implemented since previous management review? What did they concern? Are the corrective and preventive actions implemented within the agreed timescale? Have the laboratory staff implemented any action plans for improving areas associated with potential failures? Were the actions taken evaluated? Which were the most significant improvements in laboratory processes since the last management review?

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m. Follow-up actions from previous management reviews Were the previous management review actions carried out effectively and efficiently? If no, what was the reason? n. Changes in work volume, scope, personnel and premises Are there any planned changes in the equipment, personnel and premises or in the examination methods used? Are they going to affect the quality management system? Is there any plan to extend the accreditation scope? If yes, are the resources (personnel, equipment, supplies and other financial resources) adequate for the planned extension? Is any change expected in work volume? If yes then is it going to affect the quality management system? o. Laboratory contribution to patient care – quality and appropriateness Have the laboratory staff objectively evaluated their contribution to patient care? In which way? Has the laboratory staff established a turnaround time for all examinations? Does this turnaround time reflect clinical needs? Does turnaround time need to improve? If yes, what actions are required?

Table III.

p. Quality control activities Is internal quality control (type and frequency) satisfactory? How many “out of control” situations occurred? Were they investigated? What were the corrective actions? Were any customers’ results affected by these situations?

Conclusions The management review process is integral to the medical laboratory quality management system and a major opportunity for senior managers to reaffirm their commitment to the management system and to continually improve its effectiveness. Management review is a process in which all laboratory staff are involved. They can collect data and should be informed about the outcome and action plan. Medical laboratory staffs often do not get the most out of a management review and fail to realize that an ineffective and inefficient management review process may lead to an ineffective and inefficient quality management system. Targeted management review checklists provide assurance that all the important quality management system

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aspects are analyzed and discussed, serving as step by step guide. This can help staff to improve the management review and make sure that the quality management system supports the laboratory’s objectives and quality vision. References International Organization for Standardization (2005), ISO 9000: Quality Management Systems – Fundamentals and Vocabulary, International Organization for Standardization, Geneva. International Organization for Standardization (2012), ISO 15189: Medical Laboratories – Requirements for Quality and Competence, International Organization for Standardization, Geneva. Islin, H. and Andersen, T. (2008), “The process of management review”, Accreditation and Quality Assurance Journal, Vol. 13 No. 3, pp. 157-160. Levett, J.M. and Burney, R.J. (2011), Using ISO 9001 in Healthcare: Applications for Quality Systems, Performance Improvement, Clinical Integration, and Accreditation, ASQ Quality Press, Milwaukee, WI. Parsley, K. and Corrigan, P. (1999), Quality Improvement in Healthcare: Putting Evidence into Practice, Nelson Thornes, Cheltenham. Theodorou, D. and Anastasakis, P. (2009), “Management review checklist for ISO/IEC 17025 and ISO 15189 quality-management systems”, Accreditation and Quality Assurance Journal, Vol. 14 No. 2, pp. 107-110.

Corresponding author Padelis Giannelos can be contacted at: [email protected]

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Medical laboratory quality systems 273

Medical laboratory quality systems - a management review.

The purpose of this paper is to highlight changes in ISO 15189:2012 and ISO 15189:2007 concerning management review requirements and to present a mana...
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