Microbiologists working in front-line clinical laboratories need to adapt to using new analytic tools and techniques
Judith L. Isaac-Renton
➤ Clinical microbiologists are being asked to diagnose infectious diseases in human populations with new dynamics while adapting to using new analytic tools.
➤ Changes in health care systems as well as advances in medical science involving microbiology and microbiomes face patients and clinical microbiologists with challenges; huge amounts of information must be assimilated and difficult decisions made.
➤ The Quality Management System approach is one way of helping clinical microbiology laboratories to better meet client needs, while introducing improvements across all phases of laboratory medical practice.
➤ Those managing clinical microbiology labs need to keep forging new partnerships, better focus on personnel, and continue to make better use of automated technologies.
Health care professionals, microbiologists, and public health workers are increasingly networked, and their networks are being linked more with one another and with health information systems in other sectors. Meanwhile, the patients with whom microbiologists are dealing are moving pretty freely from acute care hospitals into their communities and then back to health care facilities. In those communities, healthy people are in near-constant motion, traveling across jurisdictional and geographical boundaries in unprecedented numbers. Health care networks and systems are being forced to deal with these mobile patients and to anticipate the health needs of others belonging to very different population groups who move in and out of their jurisdictions. What are some of the tools that help clinical microbiologists adapt to this changing scene?
The discipline of medical microbiology is also in flux, leading clinical microbiologists to use a variety of faster, more sensitive molecular tools, including the polymerase chain reaction (PCR), genomics, metagenomics, bioinformatics, and information management systems. No area in clinical microbiology can afford to ignore these scientifıc trends. Front-line laboratories, including community microbiology laboratories, acute care hospital laboratories, and specialized reference labs in diagnostic or public health networks, must adapt and learn how to use these new analytic tools.
Diagnostic Laboratories Shoulder Ever-Broader Responsibilities
Diagnostic laboratories continue to be used in more than 70% of medical decisions. Physicians require answers to many diagnostic challenges that existed decades ago, although, as yet, no radical new clinical questions are coming directly from the metagenomic paradigm shift emerging from front-line research laboratories. For example, no health care workers are currently considering whether particular patients might be overweight because of an unhealthy microbiome. Nor are physicians directing the microbiology laboratory to characterize their patients’ microbiomes as part of a routine clinical assessment—at least not yet.
What happens in front-line laboratories affects both patients and health populations, and their members should at least anticipate some of the effects of these new ways of practicing medicine and analyzing medical conditions. If nothing else, these changes will confront patients, their families, and policy makers with large amounts of technical information along with new costs to be managed.
Moreover, changes in the health care system are creating pressures of their own. As medical knowledge grows more complex amid fıscal stress to manage increasing medical costs, some political leaders focus their search for cost savings on what some consider “back-offıce functions.” Some administrators may think that this source for cost savings should focus on diagnostic laboratories. While we clinical microbiologists refute the notion of being a “back-offıce function,” we do embrace the need to continually improve. Front-line laboratories need to adjust to change coming from developments in health care and in basic science. The health care industry continues to ask them to do more with less, while science provides them with tools to develop better, faster diagnostic answers (at a cost).
On top of these sometimes conflicting forces, clinical microbiologists also need to maintain their focus on quality, for the greater good of patient safety as well as to meet formal requirements stipulated by regulatory bodies and accreditation programs. How then does a front-line laboratory, with its critical mandate for patient health and societal well-being, continue to increase its effectiveness and effıciencies, while developing its capability to conduct novel testing procedures?
In terms of societal well-being, how do these challenges apply to that strange hybrid of specialized diagnostic teams, the regional public health laboratory? Surely, such laboratories must be part of meeting this challenge. As rapid and frequent travel makes the spread of microbiological threats from novel pathogens easier, networked as well as timely and accurate testing is needed. Hence, public health laboratory accreditation in a Quality Management System (QMS) is now occurring here along with labs engaged at the front lines. Whether environmental samples are being tested or patient samples are being assayed, I believe that quality testing done with appropriate and timely information sharing provides a good return on investment; prevention saves money downstream in health care.
Many front-line clinical laboratories are under continuing pressure to integrate further. One reason behind this pressure is the idea that integration may help address a shortage of equipment by sharing capital investments; this may be true where there are rapidly changing, costly technologies. Another stated reason is the ongoing need for an increasingly rare resource: highly trained members of health care teams, namely specialized laboratory experts. And, it is partly driven by the concept—often untrue in practice—that savings simply arise from mergers. For these and other reasons, a hub-and-spoke model with links to regional public health reference laboratories is a good one. The isolated, independent frontline lab of the past is a rare entity today.
Useful Tools To Help Labs in Coping with These Forces: QMS
Here are some suggestions for coping with these forces. They are meant to enhance the efforts of clinical laboratories to adapt to current changes, to foster their technical capabilities, and to promote their build-up of capacity. None of these suggestions is esoteric or diffıcult to implement, but each requires adherence to the principles, well known inQMScircles, of management commitment, ongoing discipline, and strategic investment to manage change. All require support of decision makers.
Setting aside time for planning is an overarching strategy for any laboratory. Change will not stop; neither should one stop planning how to respond to change. One key framework for any front-line laboratory is use of the QMS, tailored to different laboratory settings. Its structure provides a roadmap for integrating efforts to address population needs as well as improved patient safety, making internal as well as external accreditation assessments a success, and prioritizing, planning, and implementing improvements across all parts of the laboratory.
In our yearly QMS review, we use the recommended plan-do-check-act (PDCA) approach as we review policies, processes, and procedures while setting priorities and goals for the next year. Most fuel this cycle by regular self-assessments (some groups do internal quality assessments led by their own staff) or by using preparation for on-site inspections with external audits. Another tool for adapting to change is called “Lean,” a way of planning and acting to eliminate waste from a specifıc process or procedure. When using Lean, one can ask: What is the client willing to support in terms of value added? If some steps in a laboratory procedure provide no added value, can they be eliminated? This helps medical, technical, and administrative decision makers to focus on what is needed and what might be eliminated to produce a particular end result—for instance, in the clinical lab, an accurate, timely report.
The Lean approach, with its analytic toolkit, is already used extensively in the manufacturing arena but, more recently, is being applied to health care systems. By applying Lean tools within a QMS and PDCA cycle review, laboratory administrators can identify and implement changes that they want their experienced frontline staff to implement, thereby identifying and eliminating wasteful procedures while freeing up resources for reinvestment in new technologies and better training of staff.
Another management tool, Value Streams (VS), provides an overview of work flows based on questions asked of the diagnostic laboratory. For example, the lab may be asked: Does this patient have HIV? Or, what is the cause of a food poisoning outbreak? Responses are mapped to capture all the components of how the questions are addressed through a laboratory’s testing process. Points of possible waste in the VS map are noted and, based on what analysts fınd, improvements are suggested and then implemented to reduce waste (all changes are monitored carefully). Although Lean projects are led by trained staff in an interdisciplinary team, front-line technical, medical, administrative, and support staff conduct the VS analysis and identify improvements.
Using these tools within one’s QMS is essential. For example, training leaders in the principles of Lean and empowering them to lead VS and to implement subsequent improvements might be built into the PDCA cycle. In our experience at the British Columbia Public Health Microbiology & Reference Laboratory (BCPHMRL), having staff trained in Lean allowed a rapid response to the surge of samples we were asked to analyze during the 2009 influenza pandemic. A Lean team that included management, technical, medical, and support staff was assembled on an emergency basis within a few days of the identifıcation of the novel respiratory virus. Its members met in the virology laboratory to apply Lean principles. Their work made efforts to adapt to this surge possible.
Another example of the importance of regular assessment and forward planning, particularly in the context of globalization, is business continuity planning (BCP). While Lean events and QMS-based planning efforts focus on improving internal processes, continuity planning requires external work, scanning of local, regional, and national networks as well as recognizing current scientifıc knowledge (genomics for novel or engineered pathogens) and best laboratory practices. BCP looks at processes within the lab and then at systems and networks outside it. The analysis makes provisions for any needed redundancies in equipment, supplies, and staff. BCP links frontline laboratory personnel with external partners to provide mutual support in times of stress or threat.
Useful Tools To Help Labs in Coping with These Forces: Partnerships
No front-line laboratory works in isolation. Most are either networked as part of a hub-and-spoke reference testing system or are part of a loosely organized consortium. In British Columbia (BC), Canada, for example, microbiology laboratories work in a network with the public health laboratory acting as the regional reference team. Membership in the Canadian Public Health Laboratory Network (CPHLN), which includes all of Canada’s public health laboratories, links the BC network to the national and international labs network.
Some networks work together, setting forth terms in contracts, service-level agreements, or memoranda of agreement for mutual aid. Many state or provincial public health laboratories, with their mandate for protecting community well-being as well as for diagnosing patients, scientifıc and teaching expertise, and monitoring the environment, may act as regional (state or provincial) microbiology reference hubs. When this public health lab network was seen to be in trouble some years ago, experts recommended steps to correct the flaws in the lab system. They identifıed core functions that are applicable to all public health laboratories, including the Association of Public Health Laboratories (APHL) and the Canadian Public Health Laboratory Network (CPHLN), that link them with community and acute care laboratories in jurisdictional networks. These networks alert one another about new infectious agents such as SARS—in part, by systematically collecting and analyzing surveillance data and having the capability and capacity to create a response based on new science.
Through such efforts, public health offıcials maintain their ability along with the labs system to respond rapidly to emerging pathogens, to outbreaks of foodborne illnesses, and to other microbiologically based threats. Other partnerships involve front-line laboratories joining global laboratory networks, again helping to speed up responses to emerging threats. Examples of such partnerships include the sentinel networks for monitoring influenza.
Before the 2010 Winter Olympics in British Columbia, representatives from public health laboratories in Washington State and British Columbia met to set terms for cooperating in case of an emergency. Additionally, experts from the BC public health laboratory met with their counterparts from local acute care and community microbiology laboratories to establish a lab-based surveillance system that monitors test order volumes for particular results indicating unusual activity (enteric and respiratory illnesses). Although there were no unusual health-related incidents during the 2010 Winter Olympics, these partnerships fostered good relationships and the regional networking continues.
Useful Tools To Help Labs in Coping with These Forces: People
Laboratory workers are key to making these systems operate properly. Not only do they keep up with their daily duties, but they are also involved in planning and partnerships by building relationships. Their knowledge of microbiology and their experience in using it are another form of capital investment. Because few technical training schools are keeping pace with changes within molecular microbiology, microbial genomics, parasitology, and bio-informatics, the scarcity of broadly trained laboratory experts is a growing concern.
Some local networks are trying to meet this training challenge in medical microbiology, offering courses to staff in specifıed areas. For example, the BCPHMRL led a two-year public health microbiology course for its staff and other laboratories. Unfortunately, however, this volunteer- taught course could not be sustained and no funding was available. The need for adequately trained people is unmet; how this shortage will be corrected remains unknown.
Useful Tools To Help Labs in Coping with These Forces: Parts
Finally, we need to deal with the trend to automate microbiological testing. In the British Columbia Public Health Microbiology Reference Laboratories, robotic equipment at a centralized site is being used for automated screening of thousands of serum samples daily. The process is managed by a single technical lead, a “Line Master.” Elsewhere, manual methods to detect bacterial pathogens with cultures have been replaced with the use (by highly trained lab workers) of robotic plating followed by proteomic isolate characterization. These ongoing trends affect planning, partnerships, and laboratory staff. We note from the Lean perspective that the standard practice of routine test automation should improve quality and allow more time for the experts to deal with complex issues, including system analyses in their PDCA.
Planning, partnerships, people, and parts are interconnected elements of forward-thinking laboratory teams. Front-line laboratories that carry out regular planning in the context of a Quality Management System, that build networks with partners, that consider and plan for their staff, and that remain cognizant of trends in microbiology science and technology will have a strategic advantage in today’s competitive landscape.
Judith L. Isaac-Renton is Professor of Medical Microbiology, Department of Pathology and Laboratory Medicine, Faculty of Medicine, University of British Columbia and Medical Director, British Columbia Public Health Microbiology Reference Laboratories.