Abstract
Laboratory tests have been a part of medical care at least as long ago as the time when Hippocrates practiced, around 300 BC. The first clinical laboratories were established late in the nineteenth century. The results of clinical laboratory tests are used to diagnose disease, determine appropriate therapies, detect toxins, monitor therapeutic drug concentrations, and assess overall health. Laboratory tests consume a very small fraction of total healthcare spending, but have great influence over medical decisions. There is little doubt that laboratory services are essential to adequate healthcare, and their role is certain to increase as clinical applications of new technologies such as proteomics and molecular diagnostics expand.
Clinical laboratory services are provided in a variety of settings: physicians’ offices, clinics, hospitals, and regional and national referral centers. Each of these settings has unique requirements for diagnostic laboratory services; therefore the design of laboratory services depends highly on the environment in which it operates. Virtually every consideration in clinical laboratory design and function—personnel, equipment, automation, consolidation, test menu, location, etc.—is influenced by the type of services the laboratory needs to provide. The greatest challenges in clinical laboratory design and function are faced by hospital laboratories because they serve the most diverse set of laboratory needs: inpatient, outpatient, critical, routine, referral, and outreach.
A well-designed laboratory service is an asset to the institution it serves, providing timely laboratory results that are used to improve patient care. In addition, prudent choices for equipment and personnel, and attention to designing efficient processes that do not waste time or resources, benefit the institution by producing an essential service at a competitive cost. In some circumstances, a greater investment results in long-term savings. Also, assigning laboratory-related services such as phlebotomy and POC testing to supervision by laboratory staff has potential benefits for both the laboratory and institution.
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Notes
- 1.
After graduating with a BS degree in chemistry from the College of Wooster in 1944, Helen Murray began working in the research department at Miles Laboratories under the direction of Dr. Alfred Free, whom she married in 1947. Helen Free is credited with the development of the dry reagent technology that was incorporated into many products marketed to clinical laboratories, including the Dextrostix, Uristix, Ketostix, Labstix, and a still-currently marketed urine dipstick product, Multistix. Helen Free was elected president of the American Association for Clinical Chemistry in 1990, and president of the American Chemical Society in 1993.
- 2.
In the pharmaceutical industry deviations from FDA-approved indications is termed “off-label,” but in laboratory practice, it generally means any modification of the manufacturer’s specifications for performing an approved test. The FDA approves laboratory tests for in vitro diagnostic use based on validation data in the manufacturer’s 510K application. The diagnostic interpretation of laboratory tests, and their appropriate use, is not restricted. Only the way the test is performed is subject to FDA restrictions. Use of non-FDA approved tests by clinical laboratories currently is a controversial issue, focusing primarily on molecular diagnostics. “Lab-Developed Tests,” or LDTs , are the focus of intense scrutiny by regulatory agencies, and a consistent set of criteria for their validation has not yet been developed.
- 3.
The ASCP is one of several organizations that certify medical laboratory professionals, but it is the oldest and most widely recognized certifying agency. The American Board of Bioanalysis (ABB) and American Medical Technologists (AMT) also certify medical technologists.
- 4.
From the Latin pro re nata, meaning “in the circumstances” or “as the circumstance arises.”
- 5.
Depreciation is an accounting mechanism for businesses to deduct the decrease in value of a capital asset from their profits, thereby recovering some of the cost of their investment. US tax laws allow this deduction to encourage businesses to invest their capital in assets that enhance productivity.
- 6.
Those in the older generation of laboratory professionals may recall when the DuPont ACA (automated clinical analyzer) was introduced and required the use of vendor-provided distilled water; use of any other purified water was not supported under the terms of the service agreement. This caused some indignation among laboratory directors, since all laboratories had a supply of distilled water, and paying for it as a reagent seemed unnecessary. It was a harbinger of things to come, however. Laboratory reagents nowadays are sold as a complete package, and modification of any component is not allowable under the terms of FDA approval.
- 7.
This is a generalization that ordinarily holds true, but exceptions exist when a test requires frequent calibration and QC because the method is unstable. Overhead can increase when the test volume increases if, for example, QC is required every few specimens to ensure analytical drift has not affected results. But that circumstance is unusual, and mostly limited to manual tests that involve errors associated with technique. An example is a chromatographic method that requires controls in parallel with every patient specimen.
- 8.
Automation of some microbiology procedures may be on the horizon. There is growing interest in using matrix-assisted laser desorption ionization/time-of-flight (MALDI-TOF) mass spectrometry to identify microbes by their protein signatures (Lay, 2001).
- 9.
The terminology for medical technology training programs is changing, and many programs now are called “Medical Laboratory Science” or “Clinical Laboratory Science” programs. The terminology used by certifying agencies also has changed. The credentials awarded by the ASCP to those who pass their medical technologist exam used to be MT(ASCP), but this was changed to MLS(ASCP) when the ASCP Board of Registry merged with the National Credentialing Agency (NCA) in 2009.
- 10.
There are several national organizations that certify phlebotomists, including the National Healthcare Association, National Center for Competency Testing, and National Phlebotomy Association.
- 11.
In reference to laboratory specimens, “mislabeled” can have several meanings, including labels that do not have sufficient information, or barcode labels that cannot be scanned because they are not properly affixed to the collection tube. In this context, however, “mislabeled” refers to a specimen labeled with information identifying a patient different than the one from whom blood was collected. A few studies have estimated the frequency of mislabeled (“wrong blood in tube” or WBIT) specimens received in hospital clinical laboratories. These studies are difficult to design and conduct because without sophisticated (and expensive) genetic analysis, it often is not possible to determine whether the blood in a collection tube belongs to the patient whose name is on the label. Studies have consistently identified specimen mislabeling as a common source of error in laboratory results, and estimate that the frequency of WBIT is between 0.05 and 0.1 % (Ansari & Szallasi, 2011; Wagar, Tamashiro, Yasin, Hilborne, & Bruckner, 2006).
- 12.
Healthcare facilities , including private physicians’ offices, are required to obtain a Certificate of Waiver from CMS before performing waived tests, but the tests are otherwise unregulated by the government. However, accrediting agencies such as The Joint Commission and CAP apply certain standards to waived tests. These accreditation standards for waived tests include specifications for training and periodic verification of competency, QC, documentation of results and reference ranges, and needs assessment.
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Bertholf, R.L. (2017). Laboratory Structure and Function. In: Molinaro, R., McCudden, C., Bonhomme, M., Saenger, A. (eds) Clinical Core Laboratory Testing. Springer, Boston, MA. https://doi.org/10.1007/978-1-4899-7794-6_1
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