Examining The Impact Of ISO 15189 2012 Accreditation In An NHS Specialist Pathology Laboratory. A Single Centre Longitudinal Study

Johnson, Julie

Abstract

Introduction:
Quality and particularly the assurance of quality for service users has become a significant part of healthcare over the years. In an attempt to drive quality, quality improvement strategies such as accreditation have been introduced. Accreditation is a procedure by which an authoritative body gives formal recognition that a laboratory is competent to carry out specific procedures according to specified standards. NHS medical laboratories have been encouraged to implement ISO 15189:2012 accreditation as a tool with which to demonstrate an acceptable level of service quality. However, there is little evidence to substantiate the impact of ISO accreditation on laboratory quality, efficiency, or whether it is cost effective. Current evidence highlights a paucity of quality empirical data examining the effect of the implementation of ISO accreditation, especially in the field of Laboratory Medicine in the UK.
Method:
This is a single-centre study of the impact of laboratory accreditation employing performance measures to generate an evidence base for ISO 15189:2012 accreditation in an NHS speciality pathology Histocompatibility and Immunogenetics (H&I) Laboratory. Utilizing a convergent mixed method approach longitudinal data was collected measuring quality (repeat and error rates), efficiency (TATs), and cost effectiveness to evaluate the impact of ISO accreditation. The experiences and perceptions of laboratory personnel were captured using a questionnaire and focus group discussions. Data was integrated to establish the overall effects of ISO 15189:2012 accreditation.
Results:
• There is increasing financial impact of ISO accreditation, especially when changes to the scope of practice are required with the average percentage of laboratory budget spent at 0.56% over the last seven years.
• There is no significant correlation between ISO Accreditation and laboratory quality (P=0.95), but a significant correlation was observed for efficiency where the TATs were monitored –
o Deceased Donor HLA typing (P=0.0001).
o Deceased Donor Crossmatching (P=0.05)
• Accreditation was not considered value for money (86%), viewed as expensive (93%) by the study group, whilst seen as a useful management tool it had a significant impact on staff workload.
Conclusion:
The findings of this study enhance the evidence-base surrounding the impact of accreditation in healthcare, generating new knowledge from the perspective of a specialist NHS laboratory. It provides valuable understanding on the impact of accreditation on both laboratory process and personnel, establishing a framework of measurements for other laboratories to employ. Evidence is generated for policy makers and managers to understand the impact of UK accreditation and recommendations of potential change, to enhance laboratory accreditation.

• Thesis Type: Thesis
• Deposit Date: May 30, 2024
• Publicly Available Date: Jul 1, 2024
• Award Date: May 31, 2024