Implementation of an electronic quality management system document management module to support reconfiguration of a district general hospital pathology department quality management system

Oluwatoyin Olamiji CSci FIBMS

A portfolio of research and development in a professional context

The thesis is submitted in partial fulfilment of the requirements for

the award of the degree of Professional Doctorate in Biomedical

Science.

School of Pharmacy and Biomedical Sciences

Faculty of Science

University of Portsmouth

February 2016

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Abstract

In order to achieve accreditation for their services, pathology departments must meet international recognised standards and comply with national guidelines, issued by accrediting bodies such as Clinical Pathology Accreditation (United Kingdom Accreditation Service), the Medicines and Healthcare products Regulatory Agency and the Human Tissue Authority in United Kingdom.

Objectives: An evaluation of existing Quality Management System (QMS) and implementation of a quality standard and a centralised electronic document management software (Q-pulse) in a pathology department of a district hospital.

Setting: The pathology department of a district general hospital. This is a rural hospital situated in the county of Hertfordshire that employs nine thousand members of staff. The trust is on two sites, Lister hospital is in Stevenage and Queen Elizabeth (ll) in Welwyn garden city. The hospital performs a wide range of general and specialist services to patients in and around the county, which includes a regional maternity, oncology, renal and out-patient treatment centre. (Surgi-centre)

Method: A service evaluation utilising an adapted version of the Context, Input, Process, and Product model, (with the addition of the implementation stage). This consisted of context evaluation (an evaluation of the departments decentralised QMS), input evaluation (an assessment of the various types of electronic document management system (EDMS), implementation (the implementation of a centralised QMS and EDMS), progress evaluation (monitoring, documentation and assessment of the progress of the QMS) and finally impact evaluation (measuring the impact of the newly implemented system). Data collection included quality audits, non-participant observation and qualitative interviews. The implementation strategies involved technical support training and feedbacks.

Results: The implementation of a continuous QMS and EDMS within the department, using the adapted CIPP model, increased the involvement of all staff in quality matters. It enabled the department to improve quality control processes, procedures and performance. Staff and quality teams now meet regularly and multidisciplinary workings groups have been put in place to continual improve the quality matters. The level of compliance and awareness to standards and guidelines has increased through education and training of staff in within the QMS, and there is an increase in top level management involvement in quality activities within the department. As a result of this evidence of compliance, the departments Quality management system, was accorded, an unconditional accreditation, by the accrediting bodies. (Clinical Pathology Accreditation (United Kingdom Accreditation Service), the Medicines and Healthcare products Regulatory Agency)

Conclusion: The quality management system is functioning in all the departments. All staff involved in the evaluation processes, judged it to be useful for them and the department. Further research is required to establish the longevity of the implemented products and other modules within Q-Pulse.

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Table of Contents

Abstract... ................................................................................................................. i

List of Tables ................................................................................................................... vii

List of Figures .................................................................................................................... x

Abbreviations .................................................................................................................... xi

Acknowledgements .......................................................................................................... xii

Declaration ...................................................................................................................... xiii

Dedication....................................................................................................................... xiv

1. Introduction .............................................................................................................. 1

1.1 Background................................................................................................................ 1

1.2 Literature review ........................................................................................................ 6

1.2.1 What is a quality management system? .................................................................... 9

1.2.2 Anticipated benefits of quality management systems .............................................. 10

1.2.3 What are the essential elements of a quality management system? ....................... 11

1.2.4 Effectiveness of quality management systems ........................................................ 13

1.2.5 Implementation of QMS .......................................................................................... 15

1.2.6 Change Management Models ................................................................................. 18

1.3 Research Design suitable for evaluating QMS ........................................................ 21

1.4 Quality models ........................................................................................................ 24

1.4.1 Plan-Do-Check-Act model ....................................................................................... 25

1.4.2 Institute for Healthcare Improvement ...................................................................... 26

1.5 Quality indicators .................................................................................................... 28

1.6 Quality management principles and clinical pathology accreditation ....................... 29

1.6.1 Clinical pathology accreditation ............................................................................... 30

1.6.2 Medicine and Healthcare Products Regulatory Agency ........................................... 32

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1.7 Aims and objectives ................................................................................................ 33

1.7.1 Aims........................................................................................................................ 33

1.7.2 Objectives ............................................................................................................... 33

2. Evaluation of the existing QMS (CONTEXT EVALUATION) ................................ 35

2.1 Introduction ............................................................................................................. 35

2.2 Evaluation of the standards related to quality management .................................... 37

2.2.1 Audit methods ......................................................................................................... 37

2.2.2 The Audit Report ..................................................................................................... 38

2.2.3 Control of clinical material, A10 ............................................................................... 39

2.2.4 User satisfaction and complaints (CPA standard, A2.2 and H2) .............................. 40

2.2.5 Document control (CPA Standard A8) ..................................................................... 41

2.2.6 Training and Education (CPA standard B9)............................................................. 42

2.2.7 Quality Assurance. (CPA standard H5) ................................................................... 43

2.2.8 Results of the evaluation of standards .................................................................... 44

2.3 Qualitative evaluation of perception and opinion of staff towards QMS ................... 47

2.3.1 Focus group method ............................................................................................... 47

2.3.2 Interviews ............................................................................................................... 48

2.3.3 The position of the researcher................................................................................. 49

2.3.4. Sample selection.................................................................................................... 51

2.4 Data analysis .......................................................................................................... 56

2.5 Results of qualitative evaluation of perception and opinion of staff towards QMS ................................................................................................................................ 59

2.5.1 Involvement ................................................................