ISO 15189 and The Entire Laboratory Path of Work Flow

Alicia Dimas (AD):  Can you tell us about the NHS Pathology service quality team: who are you?

Ernesto Quider (EQ): The NHS Pathology Service, from the Hull University Teaching Hospitals NHS Trust, caters the population around the Yorkshire and Humberside region. The pathology division is composed by the Blood Sciences Department, Cellular Pathology Department and the Department of Infection which includes Microbiology, Virology and Infection Prevention and Control department. Each of these departments has its own different specific discipline, so to cater different specialities such as the blood sciences, we have biochemistry, immunology and blood transfusion. Then you’ve got the specimen reception for the pre-analytic process. You’ve got haematology and coagulation and also cellular pathology, that includes our mortuary and bereavement services.

Our laboratory service has two sites, one is in Castle Hill Hospital and the other one, which is the main service centre, is based in Hull Royal Infirmary.

AD: What is your proudest achievement as a team?

EQ: I think our proudest achievement is that we are an everyday quality assurance service to the community. I know it sounds like a generic proud achievement, but working in the NHS it’s really important for us to remind ourselves that, in spite of our inadequate resourcing and all the other issues surrounding the NHS, governance and processes, I think we’re very proud to deliver quality assurance laboratory services to our service users.

And obviously on top of that, we’re so proud we received the Quality Team of the Year award. It highlights the people behind the scenes in the healthcare service delivery. Because not everybody knows a lot about pathology lab services, so it’s great to highlight the importance of the pathology service in the NHS.

AD: What are the main challenges you face?

EQ: I think working in the NHS the inadequate resourcing issues is one of the most commonly cited challenges.

From a pathology specific standpoint, the transition to a new quality accreditation programme was quite a challenge for us. It opens a new set of changes or processes that all of us should adopt, which is the ISO 15189 Medical laboratories — Requirements for quality and competence. I think it is a challenge because even though quality system, quality assurance and quality control are already established in pathology, specifically in our department, it’s about engagement with staff across all different staff groups, including the consultants and administration staff. And, as we all are aware, when we work with different staff groups, it’s not always easy to engage them in our quality management system. I think it’s a work in progress, but we’re very pleased that we’ve got them on board in our quality accreditation programme and in our quality processes.

AD: Do you feel that ISO 15189 helped you improve your quality culture and your audit results?

EQ: The good thing about ISO 15189 is that it is the official global international standard for medical laboratories, so across the globe countries are using it as their accreditation programme. It’s tailored within the Care Quality Commission (CQC) which regulates all health and social care services in England. It meets those quality management systems and governance processes, particularly for pathology which is a very highly specialised discipline.

We’re very pleased that we’re accredited against ISO 15189 because it helps us meet all the quality processes, from pre-analytic to analytic to post-analytic, which is the entire laboratory path of work flow. It’s not just a standard that covers one area of laboratory processes, it covers all the main areas of the laboratory work flow which is really good. It meets end to end processes of the quality management system.

It helps us improve staff engagement because it allows everyone to be involved in the quality management system, that’s the number one main impact to our pathology quality processes.

It also improves our quality culture. People are now aware that quality is not just about paperwork, it’s not just about documentation – it’s beyond the importance of documenting everything. It’s about embedding it into your day-to-day processes. We are starting to really see the changes in the way staff have responded to implementing quality systems.

In terms of audit results, our audit programme has really improved in a way that we are more focused on a risk based thinking. We are now thinking beyond the usual auditing process, implementing a risk base approach, implementing processes that need addressing for quality improvement. So it’s really intensifying opportunities for improvement, and I think that’s one of the most important outcomes of the ISO 15189 accreditation.

AD: How has Lean changed or improved your journey towards continuous improvement?

EQ: We implemented Lean as one of our quality management tools several years ago in one of our departments. It really helped with our continuous quality improvement and streamlining processes. It’s very effective. It helped us reduce inefficiencies – we identified some of the process steps that were not adding value to our workflow.

When we identify that duplication of efforts and inefficiencies it helps us improve our processes and staff engagement, because we are helping them to simplify things in their workflow. I think that’s very helpful for boosting staff morale, in a way that it makes them feel better in doing their day-to-day routine work. Because it’s not convoluted anymore, they feel that they have been actively involved in improving our structure and processes.

Another thing that Lean has improved, aside from the staff engagement, is our continuous quality improvement, a better awareness about quality in general. We’ve educated staff in some key topics, from what quality is, to how we are developing a quality programme.

Attribute to original publisher/ publishing organization: Ernesto Quider, CQP FCQI, Health Group Quality Systems Manager/Pathology Quality Manager at Hull University Teaching Hospitals NHS Trust, https://www.quality.org/knowledge/everyday-quality-assurance-service