The Laboratory’s Role in Patient Safety

Michael Schubert interviews Gareth McKeeman

What is your role in the lab?
I’m a consultant clinical scientist specializing in clinical biochemistry. I work at a National Health Service (NHS) hospital laboratory within the Belfast Health and Social Care Trust, where I provide consultant oversight of the General Chemistry (Automation Laboratory) across three separate hospital sites within the Trust, and also the Regional Immunoprotein Laboratory. My main roles are to provide clinical and scientific leadership in the areas in which I work – much of which involves oversight of quality management processes, procurement and implementation of equipment, verification and validation of new tests, oversight and review of assay performance across the various sites, and attending laboratory quality and governance/management meetings. Another significant aspect of my role involves assisting with the interpretation of clinical biochemistry test results, providing clinical advice, and adding appropriate interpretive comments to reports issued by the laboratory. I am also involved with teaching and training staff for clinical validation of results, delivering lectures and seminars to undergraduate students and laboratory staff, supervising research projects, investigation of incidents, developing policies and standards for the department and wider Trust, and quality improvement.

What does “patient safety” mean to you?
Patient safety is an integral component of my job. Many of the strands of my work are linked to ensuring the ongoing provision of accurate patient test results, which are used to assess their general health, diagnose any disease or condition, and guide treatments. But I believe that there is much more to patient safety than oversight of the internal lab processes around sample analysis and producing results. As a laboratory pathologist, when I think about patient safety, I think of the total testing pathway – that is, the complete sample journey from the patient’s first appointment with the doctor to the final test result and its impact on treatment decisions. The lab has a role to play in every aspect of this pathway. It’s up to us to ensure that all the steps in the sample journey are carried out correctly and in line with proper standards and guidelines. Each process carries a risk of error, so a key aspect of patient safety is continually reviewing and monitoring, and then taking steps to reduce risk and errors that would negatively affect the patient.

 

I feel that patient safety is also linked to patient experience. It’s about making the patient feel that they have had a positive and effective experience – and increasing awareness of what goes on in pathology labs is part of that. I think a part of our role as pathologists is to consider what information we could provide to particular groups of patients to improve transparency and provide them with more ownership over the processes surrounding sample collection and result reporting, perhaps including the timelines involved. I believe that, when service users feel calm and content with laboratory testing, we are enhancing patient safety.

How do you contribute to patient safety?
Much of the work we do in the lab has an important impact on the patient. I am proud to work in a laboratory where many staff are engaged in safety and quality, and working to deliver an effective laboratory service. We senior lab professionals have to be willing to take responsibility for every result that is produced and reported. We must do everything we can to ensure that the result we report is accurate and reflects the clinical state of the patient at that time. My work contributes to patient safety on a daily basis. I provide oversight and leadership of the quality management processes within my work areas, which includes ensuring that we have appropriate policies and procedures – built on evidence-based standards – in place to support staff and provide guidance on all areas associated with the analysis and reporting of accurate test results. To maintain high levels of safe working practice, we make sure procedures are followed, reviewed, and updated on a regular basis as we evaluate the service and receive feedback. We also ensure that we have an accurate audit trail surrounding analysis and reporting of results. Ultimately, these practices are in place to promote safe working practices and to protect our patients. 

Our laboratory is currently accredited under ISO15189 standards, many of which impact patient safety; part of my role is to review ongoing compliance. We have quality indicators that we set and review regularly, which include monitoring the time it takes us to report results for urgent medical tests and ensuring such results are reported within stated timeframes. We also have a systematic approach to reporting performance issues; we record them as occurrences (a failure to fulfil a requirement that has not led to a system failure) or as incidents (any event or circumstance that could have or did lead to harm, loss, or damage to people, property, environment, or reputation). Recently, our quality team and I have developed an improved system for logging and coding occurrences to allow for more robust tracking and root cause analysis. We’ve introduced new codes to capture data across the total testing process and empowered all staff to log occurrences and incidents. We review these regularly and have now started to trend them as involving human, mechanical, or external factors and discuss them at risk management meetings, where there is oversight from the senior lab and governance team. All of these endeavors allow our lab to proactively reduce risk by implementing appropriate corrective and preventative actions, making a significant contribution to patient safety overall. Ongoing staff training and engagement is a key element, so we’re continuing to work on it by providing regular training and promoting open discussions about overall improvement.

I also liaise with clinical colleagues to provide guidance on test results; for example, assisting with the clinical interpretation of tests results by advising on what might cause a result to change, when this is significant, advice on further testing, and possible treatment. This layer of communication is particularly important when a new test is introduced, because my role involves developing relevant user information and ensuring all staff and clinical users have access to it so that they can accurately interpret results and follow up with patients. An important aspect of this liaison is meeting service users to review current services and to see where improvements can be made. Recently, we have piloted a small sample reception area within our emergency department (ED) where one of our medical laboratory scientists (MLSes) centrifuges and processes samples before sending them to the laboratory. The reception allows urgent samples to bypass the lab’s busy sample acceptance area and go straight to analysis. We showed some improvements in result turnaround time but, more significantly, a reduction in the number of samples rejected due to preanalytical problems (such as hemolysis). I have also worked with a consultant cardiologist, ED consultant, and specialist chest nurses to develop and implement a new one-hour chest pain pathway to improve triage of patients with suspected acute coronary syndrome, leading to faster discharge or referral. 

One of our recent projects has been a safety campaign promoting full labeling of patient and sample details. When all Blood Sciences samples have all the essential information, it allows escalation of critical results to the correct person or team and to ensure sample integrity and accuracy of reported results. Here, the onus is on the clinical staff taking the sample to get it right first time to avoid inappropriate sample rejection. Such improvements have a significant impact on patient safety. Overall, other senior lab professionals and I constantly review and monitor the services we provide within our governance and management structures, which all work together to enhance patient safety.

Do you interact with patients?
As part of Patient Safety Week 2020, I was privileged to be involved in developing a podcast that features a conversation between a laboratory pathologist (me) and a patient. We discuss what blood testing means for a patient in treatment for cancer, explore their thoughts around laboratory medicine, and discuss pathology services to highlight the crucial role they play in the patient journey. It has been interesting to hear what really matters to a patient when it comes to blood testing – it’s not all about the speed of result reporting, like I had assumed. The main message that came from this conversation is the need for more patient information about what happens to their samples, the lab processes that lead to a result, and some of the common errors. For example, the patient I spoke to had never realized that a hemolyzed sample could result from sample collection or preanalytical handling errors. They had wrongly assumed that it was something to do with them – something they had done or something wrong with them – and this caused anxiety when they were asked to return for a repeat blood sample. And that’s an important message for those of us who work in pathology labs. How may our lab reports be interpreted in the absence of appropriate explanations?

I believe we have an important role in providing useful information to patient groups to increase knowledge about the processes within the sample journey and what can affect the results to reduce anxiety. This conversation has also highlighted how much our work means to a patient whose results are used to guide treatment. It was fascinating to hear that some patients focus a lot on numbers and, when a result for an important test (such as a tumor marker) changes, it can cause a lot of stress even if it never leaves the reference range. In the laboratory, we may not pay attention to small variations in results, because we know that there is a level of uncertainty associated with all of our tests. However, it is important for us to realize that a patient may not have this same level of insight. The key message I have taken from this discussion is that we laboratory professionals have a role to play in reducing some stresses and fears about changing numbers – perhaps by providing better information about expected levels of variation in test results.

I believe it is important for laboratories to increase their visibility and transparency to improve the links between the lab and the patient. We need to raise awareness of laboratory pathology and promote our role in the patient journey – and that means we need to understand what matters to the patient. Our local Trust now emphasizes Personal and Public Involvement (PPI) initiatives in which service users, caregivers, and the general public get involved in service design and development. For instance, some colleagues and I have invited patients from a cancer services PPI group to visit the labs and work with us on developing an information sheet for cancer patients that will provide useful information on blood sampling and testing. I would recommend other labs develop links with patients and use them to promote pathology, improve the patient experience, and enhance patient safety.

It’s important for labs to improve visibility to clinical users and colleagues as well. We have held lab open days for doctors and nurses in the past, and these have been successful in building links, sharing experiences, and coming up with ideas for improvement. To affect patient safety, we need to meet other teams and seek feedback from our users. A key part of this is ensuring that the laboratory is considered in changes to patient services and represented during investigations into incidents and serious events. Too often, we are only included at the final stages – if at all – despite the fact that seeking our feedback can have an important impact on improvements to patient safety. Our pathology labs have a good safety culture and our staff feel able to report errors without blame. This openness needs to be continually encouraged as part of daily practice – and especially when staff change over time.

One final important element is to talk to all staff in pathology labs who handle samples and encourage them to consider the patient at the end of the sample. We have a dedicated team of MLSes in our Blood Sciences sample reception who work hard receipting and processing samples for analysis. Within Clinical Biochemistry, we have a number of logic rules set up to hold or release results once they have been analyzed and evaluated. The majority of these results are within normal reference limits and are released automatically or auto-validated to allow quick lookup by clinicians. And so for a significant number of samples, our MLSes are the only people interacting (indirectly) with the patient and assisting them on their journey. It is important for staff to hear this. They are in a privileged position and, hopefully, by telling all staff what happens to the results once they have completed their work, we can remind them how important their job is and how essential it is to follow all procedures and policies.

What advice do you have on improving patient safety?
Go out and meet clinicians and service users (and patient groups, if possible) and learn from each other. My involvement in quality improvement work has been a useful way to network with other colleagues in the hospitals where our labs are based, and has led to projects with an emphasis on patient safety. We have also given lab tours to staff from the emergency department and the neonatal unit and, in turn, toured their areas. Such networking has improved the link between lab and patient by allowing us all to see the challenges at both ends of the sample journey. It’s important to see how our processes impact patients, especially if we want to make service changes.

It’s also good to see what other hospital sites and labs are doing around patient safety by attending relevant meetings. I also invite external speakers to provide talks on interesting cases, improvement work, and lessons learned from past incidents.

Developing effective networks and teams is vital. It’s also important to consider the total testing pathway – especially preanalytical processes. We know that errors in these processes can significantly impact the quality of the reported result and, ultimately, patient safety. It is very difficult for us to make and enforce changes to the processes before a sample reaches us. We must find local champions working at the frontline who can implement and continually promote improvement initiatives to their colleagues. This point was particularly apparent during the implementation of our new chest pain pathway; the specialist chest pain nursing team played an instrumental role in training and updating ED staff to ensure that everyone was aware of – and used – the pathway.

Overall, remember that knowledge is paramount. Providing a little information to patients about what happens to their samples – and what goes on behind the lab doors while they are sitting in the ED or clinic waiting for important test results to come back – can have a huge positive impact on their experience and can reduce their fears. It’s within our power to improve not only patient safety, but also the patient experience – and I believe it’s our duty to do everything we can.

Gareth McKeeman is a Consultant Clinical Scientist at Belfast Health and Social Care Trust, Belfast, UK