Efforts to achieve proper clinical test utilization have been integral to the now decades-long paradox of seeking constant improvement to laboratory service while simultaneously lowering costs. Some approaches focus on reducing overutilization or simply reducing overall test volumes and substituting cheaper tests from the charge schedule as a proxy for lowering costs. These methods tend to be reactive and do not address the real issues at hand.
An expanded viewpoint can be found in an Institute of Medicine (IOM) report advocating the need to address the “overuse, misuse, and underuse of medical procedures.”1 Furthermore, a broader IOM definition of quality can be useful when assessing laboratory utility: “The degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.”2 Given these perspectives and using the aggregate cost of patient care as a metric, it is possible to benefit both the quality and the value of laboratory services in the context of patient care.
Test Utilization Approaches
Both CLIA and The Joint Commission assign responsibility for laboratory quality assurance to the laboratory director but are silent on specifics related to test selection except for the choice of reference laboratories. Thus, many facilities’ test repertoires are assembled through the influence of various mechanisms including tradition, individual physician requests, and new technology promoted by manufacturers. Simply removing inferior tests can be a challenge without a routine protocol for justification, and the laboratory may have only anecdotal evidence of misuse through inappropriate test ordering. Similarly, test underutilization can be difficult to assess through inductive reasoning.
Taking a deductive approach, test ordering optimization processes must begin by gaining a full understanding of the clinical question. Working together with physicians to enable practice-specific test utilization is essential to gaining efficiencies. In addition, observing and incorporating certain aspects of other health care disciplines, such as pharmacy’s decisions regarding which pharmaceuticals to include in the formulary and blood bank’s appropriate use of blood products, are examples of the rigor that can be applied to the provision of clinical laboratory services.
Clinical Practice Committee
An effective approach is to convene a forum designed for enlightened discussion among principal shareholders, including laboratory managers, pathologists, laboratory scientists, and clinicians. Ideally, this would become a standing Clinical Practice Committee (CPC) composed of key laboratory leadership appointed by the laboratory director. During regularly scheduled meetings, those physicians whose practice patterns are significantly affected by the tests in question can be invited to participate ad hoc. The purpose of a CPC is as follows:
- Develop, advance, and sponsor short- and long-term goals for clinical patient care related to laboratory activities, including activities that affect an outreach practice.
- Promote and facilitate practice optimization opportunities in a fiscally responsible manner, including best practices, utilization parameters, and practice guidelines.
- Provide direction and oversight to laboratory clinical activities, including but not limited to:
a. Test utilization by ordering clinicians
b. Review before test elimination
c. Test implementation
d. Test clinical validation studies
- Work in conjunction with the laboratory director to approve clinical programs and support operational planning of laboratory departments.
- Serve as a forum for general practice discussions related to both internal practice and outreach clients.
- Formally document and communicate changes to the entire practice.
Setting the Agenda
Meetings should be regularly scheduled with sufficient time and frequency so that topics can be covered in depth. The agenda should state defined goals, objectives, and expected outcomes to ensure members are prepared and discussions are open, but focused. From these regular meetings, working groups can be formed to address specific issues that arise. For instance, a working group may be formed to gather data on current laboratory technology and clinical use together with a review of the latest literature on best practices. The recommendations of the working groups are then reviewed at meetings of the full CPC. Agendas of the CPC meetings can be set according to the following guidelines:
- Topics are derived from departmental planning objectives and are focused on issues related to clinical practice. The committee chair and secretary review the topics to determine whether the CPC is the appropriate forum for discussion.
- The proponents investigate the topics and recommendations are developed before the meeting.
- Requests to present agenda topics are submitted in advance for the CPC chair and secretary to review before granting a presentation date.
- Materials, including supporting literature, are provided to the CPC secretary no later than 7 workdays before the committee meeting so that the agenda can be prepared and sent out in advance for adequate committee review.3
Triage Your Opportunities
Topics for consideration are typically plentiful. It may be tempting to follow the money by making assumptions regarding high ticket tests and overlooking lower priced but higher volume tests of dubious value (eg, Vitamin D). Molecular tests stand out as generally high priced, but costs may be offset by avoiding far greater treatment expenses or may only need to be done once in the patient’s lifetime. Laboratory managers and scientists have an intuitive knowledge of the low hanging fruit, so considering the overuse, misuse, and underuse categories in the context of clinical utility can provide guidance.
Always Retrain Focus
A test that uses population statistics to demonstrate a shift in values between affected patients and normal individuals may have diagnostic efficacy but not be particularly useful in evaluating an individual patient using a single value. Achieving the ultimate goal of therapeutic effectiveness and changing patient outcome is usually reserved for tests that have high sensitivity and specificity. However, assessing the cost benefit of laboratory testing on the basis of analytical performance alone is not sufficient, and consideration must be given to all costs and also to disease prevalence and the clinical setting.
Chronic disease is responsible for a large portion of health care expenditures. Practice plans using the laboratory in diagnosing and treating those patients should be a high priority. Cardiologists may have a thorough understanding of the best use of the latest cardiac markers, but those protocols may need to be demystified and shared with other practitioners who are called upon to rule out myocardial infarction, for example. Analogous situations exist in diagnosing and treating diabetes, thrombosis, and infectious diseases.
Implementing the Vision
A vision without implementation is simply a hallucination. Committee decisions need not be made unanimously, but the expectation should be clear that once consensus is reached, all members will support the decision going forward. Fully vetting topics by allowing adequate time during the meeting avoids follow-up side discussions that can create hostile work scenarios. While committee meetings may appear tedious if not properly administered, they do enable implementation because objections have already been addressed and principle stakeholders have all been given a chance to air their concerns. The necessary steps to communicate changes throughout the organization to all caregivers and support staff should be systematized and executed as a matter of routine. This is another process that may require committee evaluation.
A disciplined approach to the proper use of laboratory tests can produce improved patient outcomes, contribute to physician satisfaction, and facilitate aggregate cost reduction. These are the elements of proof that give evidence of laboratory’s value to patient care. Clinical laboratory managers will continue to be challenged to produce additional laboratory cost savings in response to decreasing reimbursement, so creating a track record of contributions to organizational goals positions the laboratory as a clinical service and not a commodity. This mentality is imperative in order to change the conversation from how much needs to be cut to the importance of retaining that which is essential to produce the most cost effective patient care. The laboratory represents only 5% of costs but directly influences all of the remaining 95%.4 Clearly, the lab is becoming a key health care resource with tremendous leverage.
1. Chassin MR, Galvin RW. The Urgent Need to Improve Health Care Quality. Institute of Medicine National Roundtable on Health Care Quality. JAMA. 1998;280(11):1000-5.
2. Institute of Medicine. 2001. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: The National Academies Press. https://doi.org/10.17226/10027
3. Hernandez JS, Plapp FV, Essmyer CE, Forsman RW. Successful Models for Shaping Test Utilization Patterns in Academic and Community Hospital Settings. Clin Lab Mgmt Rev. 2009;23(1):5-11.
4. Parnham S. Communicating the laboratory’s value to health care: An interview with Rodney Forsman. Clin Lab News. 2004(30):12-13.
Rodney W. Forsman, BS, is assistant professor emeritus of laboratory medicine and pathology at the College of Medicine, Mayo Clinic in Rochester, Minnesota.
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