Clinical Laboratory
A clinical laboratory is a laboratory where tests are done on clinical specimens in order to get information about the health of a patient as pertaining to the diagnosis, treatment, and prevention of disease.
Clinical laboratories are at the forefront of the personalized medicine trend. However, they are also targets for cost-cutting measures by payers, and increased regulation by CMS and FDA, making the industry a challenging one in which to succeed.
Laboratory medicine is generally divided into two sections, each of which being subdivided into multiple units. These two sections are:
- Anatomic pathology: Units included here are histopathology, cytopathology, and electron microscopy. Other disciplines pertaining to this section include anatomy, physiology, histology, pathology, and pathophysiology.
- Clinical pathology, which includes:
- Clinical Microbiology: This encompasses five different sciences. These include bacteriology, virology, parasitology, immunology, and mycology.
- Clinical Chemistry: Units under this section include instrumental analysis of blood components, enzymology, toxicology and endocrinology.
- Hematology: This section consists of automated and manual analysis of blood cells.
- Genetics is also studied along with a subspecialty known as cytogenetics.
- Reproductive biology: Semen analysis, Sperm bank and assisted reproductive technology.
Credibility of medical laboratories is paramount to the health and safety of the patients relying on the testing services provided by these labs. The international standard in use today for the accreditation of medical laboratories is ISO 15189. Under their respective approaches to laboratory licensure and accreditation, many countries have legal requirements that medical laboratories must be accredited to ISO 15189. This is not true in the United States.
In the United States, there are federal and state laws that address the licensure and accreditation of medical laboratories. Accreditation is done by the Joint Commission, College of American Pathologists, AAB (American Association of Bioanalysts), and other state and federal agencies. CLIA 88, the Clinical Laboratory Improvement Amendments, also dictate testing and personnel.
In addition, many clinical laboratories have adopted quality management programs such as Six Sigma and Lean quality to improve clinical quality, reduce turnaround time, cut costs, and boost productivity. Lean and Six Sigma are both process improvement methodologies. At a very basic level, Lean is about speed and efficiency, while Six Sigma is about precision and accuracy, leading to data-driven decisions. Lean and Six Sigma methods are finding numerous applications in anatomic pathology laboratories and pathology group practices.
Why Small Labs and Even Hospitals Are at Risk from PAMA Cuts
CEO SUMMARY: Clinical lab executives and experts who have studied the final rule for PAMA lab test market price reporting are seriously concerned that the design of this rule may put many of the nation’s smallest, but still essential, clinical labs at great risk of financial distress, i…
Will Coming Medicare Fee Cuts Reduce Access to Laboratory Tests?
SEVERAL IMPORTANT clinical laboratory associations are concerned that the lab test price reporting under the Patient Access to Medicare Act of 2014 will have a negative effect on diagnostic innovation and on Medicare beneficiaries’ access to lab testing services. The American Clinical Laboratory A…
Theranos Ends Patient Testing, Sued for Deceiving Investors
IN THE EARLY 1960S, the great bluesman Albert King wrote, “Born Under a Bad Sign,” which contained the unforgettable lyric, “If it wasn’t for bad luck, I wouldn’t have no luck at all.” That lyric almost describes what’s happened to Theranos Inc. since October 2015. Al…
Attorney Jane Pine Wood to Be Chief Legal Counsel at Bio-Reference
One of the most widely-respected and trusted attorneys serving the clinical laboratory industry and anatomic pathology profession is leaving private practice to join the corporate world. …
Patient Safety Expert Says: ‘Tell Patients About Errors’
CEO SUMMARY: As described in a civil lawsuit filed by a whistleblower pathologist in Kansas in July, a chair of pathology allegedly misdiagnosed cancer and the patient’s healthy pancreas was surgically removed. Court documents say that the pathologist then altered records to cover up th…
Elizabeth Holmes of Theranos Speaks at AACC To Skeptical PhDs, Pathologists, and Press
CEO SUMMARY: Elizabeth Holmes, Founder and CEO of Theranos, Inc., was given the ideal platform by AACC to show the science behind her lab company’s much-touted diagnostic technologies. But in a surprise to the assembled audience, Holmes, accompanied by three PhDs on her team, chose to d…
Theranos Now Scrambling To Save What It Can
CEO SUMMARY: On July 7, CMS imposed severe sanctions on Theranos for CLIA violations. Included is a two-year ban on owning and operating a clinical laboratory for Theranos, CEO Elizabeth Holmes, the former COO, and the former medical director. Theranos appears to be pivoting away from a c…
Years of Biobank Experience Pay Off for Mayo Clinic Lab
THANKS TO 10 YEARS OF EXPERIENCE, an existing infrastructure for banking patient specimens, and the unique capabilities of its clinical laboratory organization, Mayo Clinic has been awarded a five-year, $142 million grant from the National Institutes of Health. Last…
Is Theranos Kowtowing To CMS over Pending CLIA Sanctions?
CEO SUMMARY: Having ignored the profession of laboratory medicine for nearly all of its 13-year corporate life, Theranos suddenly began engaging with expert laboratorians last month. The timing of this new outreach coincides with public disclosure that CMS proposed the severest sanctions …
Lab, Emergency Department at Cleveland Clinic Collaborate to Reduce Hemolysis Rates
CEO SUMMARY: Two years ago, the rate of hemolysis in blood drawn in the Cleveland Clinic’s Emergency Department was about nine times higher than the ASCP recommended rate of 2%. With a two-year cooperative agreement and funding from the federal Centers for Disease Control and Prevention…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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