Constructing A Lab Formulary


Vol. 19 • Issue 20 • Page 24

Given healthcare’s increasing emphasis on cost control and quality measurement, laboratorians need to reconsider their roles within healthcare organizations. A lab that provides what appears to be a commodity service may be at risk of being marginalized at best or outsourced at worst. But a laboratory that plays a highly visible role in promoting high-quality clinical care can strengthen its status within a hospital or healthcare system. One approach worth considering is to think of the laboratory test menu as a “laboratory formulary” analogous to the drug formulary maintained by a hospital pharmacy.

table

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The Pharmacy Model

Despite what outsiders might think, the role of the hospital pharmacy goes far beyond simply stocking drugs and fulfilling orders. For one thing, it is not feasible to stock every drug in every formulation that a physician might order. For another, it would not be in patients’ best interests for pharmacists to fulfill blindly all orders they receive. Pharmacists routinely assist physicians in correcting dosages and suggesting alternative therapies. Finally, pharmacies play an important cost control role, e.g., by substituting generics where appropriate.

The Proactive Laboratory Role

Likewise, the appropriate role of the laboratory professional goes far beyond simply maintaining analytic quality and fulfilling laboratory orders. It includes determining what test methodologies will be offered and in what forms, specifically point of care, in-house laboratory and referral laboratory. It also includes redirecting physicians when they order tests that the laboratory knows to be suboptimal.

The first task in constructing a laboratory formulary is determining the methods to be offered in house. The following are examples of questions that must be answered before setting up a new test:

• What is the rationale behind using this new test in house? In other words, why should we consider this move? Is a literature search required? Is this the lab’s idea, a clinician’s idea or both?

• What are the laboratory costs of the new test? Several parameters must be considered, e.g. new instrument, reagents, validation. The cost to the clinician also must be considered-fewer scans or examples may be needed if the new test is implemented, it may be less costly overall even if it increases the laboratory costs, etc.

• What are the benefits of having this test in house (e.g., financial, turnaround time, physician and patient satisfaction)? It’s critical to contrast in-house testing to a send out to determine if, for example, bringing an analyzer in house to do one specialized test such as rapid PTH testing for intraoperative determinations is cost effective.

• How and by whom is the decision to be made?

• How does the laboratory validate the new method? How do we compare statistics from old and new? Here, descriptive data such as means, inferential data, t-test, r, R2, scatter and difference plot, ROC curves, precision, etc. are crucial.

• If the new method is adopted, education will be needed for the clinical staff and the lab. How will this be done? Should a lab staff member be appointed to call with questions? Or, is a seminar for the clinical staff necessary? Other educational sources to consider may be a simple newsletter or two emailed to the staff, a single information sheet put in the staff dining room or a seminar on how the test is performed and what precautions are needed for the sample.

Additionally, there will need to be a lead time to transition to the new method and/or overlap time of a finite duration between the old and new method (e.g., switching PSA manufacturers).

Setting Policies

The second task in setting up a lab formulary-and one that may be less comfortable to many lab managers-is to set policies around what tests clinicians can order and when. Given the thousands of lab tests available, it is not realistic to expect physicians to stay up to date on the most current recommended ordering practices. Observational data shows that suboptimal ordering is common. Because diagnostic processes are upstream processes, inefficient and/or inaccurate diagnostic practices may have big implications for cost and quality of care as manifested through therapeutics, procedures, office visits and admissions.

Examples of suboptimal diagnostics are:

• ordering an old test when a newer, better test (with respect to cost and/or accuracy) is available (i.e., T3 uptake instead of Free T4),

• adding a new, improved test to a “panel” without replacing the existing test (i.e., ordering total CK, CK-MB, cardiac Troponin [cTn] and myoglobin instead of troponin alone), or

• ordering a new test that may be of value in research settings but has not had extensive clinical validation and/or has not been demonstrated to improve diagnosis versus existing tests (i.e., use of one of the newer cholesterol subfractionation panels for cardiac preventive care versus total cholesterol).

Educating, Influencing Physicians

Technologists and pathologists often ask the question, “How do we convince doctors to change their ordering practices?” One common reaction is to say that the doctors are in control, and the lab can’t change what the doctors order. But just as pharmacists influence physicians’ drug ordering, the lab can make a huge difference in test ordering.

One of the main tools available to a hospital pharmacist is the Pharmacy and Therapeutics (P&T) Committee. This committee oversees what drugs the pharmacy should stock, when it is permissible to substitute generics, and whether any of the drugs have special rules associated with ordering. An example of the latter might be an expensive antibiotic that might be orderable, but only with the permission of the Infectious Disease service.

Membership on the committee includes pharmacists and clinical staff. The committee provides the authority and political cover for the pharmacists to assert their expertise in the interest of patient care.

Although lab “formulary” or utilization committees are not yet widespread, they may become so. Forward-thinking lab professionals and management would do well to discuss this issue with hospital administration and physician staff leadership. To start, the authors have identified markers of interest that could be discussed by this committee (Table). Some of these are not new but come under the heading not of adding a test, but “de-selecting” or subtracting a test. Both questions are similar and can be approached with many of the same questions from above.

Defying Stereotypes

The stereotype of a lab professional, whether technologist, clinical lab scientist or pathologist, is one of an introvert who likes to hide away in the lab. This is probably unfair, and many lab professionals are truly “people people.” But the stereotype still risks being self-fulfilling. Again, though, consider the pharmacy analogy. The father of one of the authors was a hospital pharmacist in the days when the pharmacy was treated as a back office function-just supply the drugs and give the doctors what they want, which is not unlike how many labs are perceived today. Pharmacists have grown substantially in their professional status as they’ve taken on a greater role in clinical care. Pharmacists play a leadership role on P&T committees, they provide extensive prescribing education to their medical staffs, and in some cases go on ICU rounds with the critical care doctors to help calculate doses and adjust regiments. As lab professionals find creative ways (such as the committee) to share diagnostic testing expertise with medical staffs, we, too, will see an increase in professional status. And more importantly, patients will benefit through more efficient and accurate diagnostic testing.

David Plaut is a chemist and statistician in Plano, TX. Dr. Jackson is medical director of Informatics at ARUP Laboratories and assistant professor of Pathology (Clinical) at the University of Utah.

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