Analytical Science and Patient Safety

Michael Schubert, Editor of The Pathologist, 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. As a Clinical Scientist, I’m responsible for providing clinical and scientific leadership and oversight across different areas of clinical biochemistry, including the General Chemistry (Automation Laboratory) and Regional Immunoproteins lab. Clinical biochemistry is one of many disciplines within pathology, and incorporates a number of specialist areas, such as toxicology, pediatric metabolics and screening, endocrinology, and trace elements, as well as the two areas mentioned above.

There are three hospitals incorporated within my Trust. We have a general biochemistry (automated) lab across each of the three sites, set up as a hub-and-spoke model, with two smaller “hot” labs and a main site where regional services are based. We handle approximately 130,000 samples per month in our clinical biochemistry lab, and approximately 5,000 samples on a normal working day in the general biochemistry (automated) section.

We use variations of spectrophotometric analysis (endpoint and rate assays), electrochemistry (using ion-specific electrodes), immunoturbidimetry, and immunoassays (competitive and sandwich), as well as osmometry, electrophoresis, high-performance LC- and GC-MS, and inductively coupled plasma-tandem MS, to report on samples across primary and secondary care. One of my main roles is to ensure that appropriate methods are used, and that they are performed to the standards required for patient management. I must maintain insight into the common problems that can occur with such analyses to provide appropriate guidance to both laboratory staff and service users.

Many of the tasks we perform in the hospital laboratory focus on quality management and service monitoring and review. Daily internal quality control (IQC) monitoring is key, and we have different IQC regimes for different tests. In fact, our general automation lab produces up to 2,500 IQC data points per day – a significant amount of information for review. Development and implementation of software to assist with the collation and review of IQC data has significantly improved the process, allowing us to track and trend analyzer performance across all three lab sites.

Important components of this work include regular monitoring of potential differences in results for the same test across the lab network, assessing measurement uncertainty, and using a scientific approach to develop goals for acceptable performance for many of our quantitative tests (taking into account analytical performance, biological variation, and clinical need). We can also use the data we obtain to develop and review appropriate Westgard rules for IQC acceptance and rejection using sigma metrics methodology.

The validation and verification of new tests or equipment is another important task that requires assessment of assay precision, bias, and linearity to ensure tests meet performance targets. Once methods have been developed and introduced, we initiate appropriate quality assurance procedures, incorporating IQC and external monitoring. We also set key performance and assurance indicators, monitor them frequently, and perform regular audits to assess ongoing compliance against set standards.

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 medicine professional, 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 laboratory medicine professionals 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.
 

How can other analytical scientists contribute to patient safety, and to patient care in general?

We must ensure that all analyses undertaken in the hospital laboratory are performed to a high standard, taking into account the clinical need for each result and how it is used to guide the patient’s journey. Having a robust quality management system in which all staff are engaged is important in any lab, but especially in the case of patient care.

Research and development are also linked to improving patient safety. The development of new and improved markers for assessing different biochemical functions and translating those markers into laboratory tests is important. We can also have a positive impact by developing improved analytical methods for current tests, or by automating them to enhance capability and throughput. That way, we contribute to service improvements that can expedite the clinical decision-making process.

There have been significant developments in MS technologies in recent years, including the ability to automate different aspects of sample processing, allowing the introduction of improved methods for biochemistry tests (for instance, hormone or vitamin D tests) into the routine clinical laboratory. It is important that analytical methods continue to evolve – especially for tests that currently use only spectrophotometric methods, which are affected by known interferences (for instance, by certain medications). As new drugs and compounds proliferate, studying potential interferences with existing assays is a key aspect of ensuring patient safety; analytical research and development must continually evolve to improve medical testing.

How do you see the interaction between analytical and medical sciences going forward?

It is important that we continue to maintain close links and learn together. Clinical labs need to continually review their test repertoire and the services they provide in line with new evidence-based guidelines. They must also increase their visibility to both medical colleagues and other service users to highlight the services they can provide – for instance, information on analytical platforms and laboratory methods and experience with specific methodologies. Laboratory professionals should be included in clinical discussions and reviews of patient care pathways that involve laboratory testing, so that they can provide scientific input into the best available test methods and how to most efficiently implement them.

There is now an increasing focus on “big data” and how we can better use the information we generate to improve healthcare. To transform patient services, clinical and scientific leadership is vital – and a key aspect is linking laboratory data and test results to patient outcomes.

Clinical hospital laboratories must also provide feedback to assay manufacturers about test performance and identify tests that need improvement – particularly with respect to assay sensitivity and interference. We must foster research and development opportunities with industry to improve point-of-care and remote testing technologies that can safely enhance patient care. This is where senior laboratory leaders must be involved. And we must nurture interactions between analytical and medical sciences. The next few years are likely to bring many challenges, particularly with respect to COVID-19 testing, tracking, and monitoring, and it has never been more important to establish connections between our disciplines as we work together to improve patient care.

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 laboratorian (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 the laboratory 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. The Pathologist (www.thepathologist.com) is a sister magazine of The Analytical Scientist.