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.
Translating Genomic Testing to the Clinic
CEO SUMMARY: An entrepreneur in the liquid biopsy sector outlines a series of questions to answer if a diagnostic innovation is to ever succeed in the commercial marketplace. Scientists and businesspeople will want to ask about a potential product’s significance, uniquen…
Bringing Lab Testing to Hybrid Care Locations
CEO SUMMARY: Clinical laboratory testing plays an important role in individual urgent care and emergency sites, but when such services are offered under one roof, planning for lab tests, related equipment, and CLIA provisions becomes more complicated. TriCore shares its ex…
Quest, Labcorp Tout Their Alzheimer’s Tests and Use of AI
Executives at Quest Diagnostics and Labcorp cheered strong revenue growth in the third quarter. Both companies noted excellent recent launches of Alzheimer’s disease tests. In addition, both companies reported they are leaning heavily into artificial intelligen…
From the Bench to Capitol Hill: Advocating for Laboratories
Many of us think our work ends at the clinical lab bench, but it doesn’t. Science extends into policy, advocacy, and the communities we serve. On October 21, I joined fellow members of the American Society of Clinical Laboratory Science (ASCLS) on Capitol Hill …
Quest, Labcorp Discuss PAMA and M&A with Investors
WHILE LAUDING EXCELLENT GROWTH FOR THE SECOND QUARTER, executives at Labcorp and Quest Diagnostics also expressed concern over the Protecting Access to Medicare Act (PAMA), which was passed by Congress in 2014 and which continues to cause uncertainty as full implementation is repeatedly…
My Green Lab Prepares Full-Scale Entry into Diagnostics
AGAINST THE BACKDROP OF REDUCED SUSTAINABILITY INITIATIVES IN THE CORPORATE AND POLITICAL WORLDS, environmental stewardship remained a topic of discussion  at the Association for Diagnostics and Laboratory Medicine’s (ADLM) 2025 conference. Among the more interesting announcements wa…
Elizabeth Holmes’ Partner Sought Campaign to Get Her Out of Jail
IN A BRIEF MENTION THAT WENT LARGELY UNNOTICED,  a well-known marketing professor said he declined a request by Billy Evans—the partner of disgraced Theranos founder Elizabeth Holmes—to help organize an effort to get Holmes out of prison. “[Evans] reached out t…
Quest, Labcorp CEOs Discuss Tariff Strategies with Investors
Leaders at Labcorp and Quest Diagnostics indicated that they are prepared to weather at least the early months of the unfolding tariff war that is upending the global economy. “There will be some impact from …
Clinical Lab Test Jargon Could Spur Mistrust among Patients
LITTLE DETAILS CAN MAKE A BIG DIFFERENCE in not only how customers view a clinical laboratory, but also in ensur…
Some Health Plans Drop Deductibles as Response to New Consumerism
It may surprise many pathologists and clinical laboratory administrators to learn that one major health insurer’s best-selling plan has only copays and no deductible, no coinsurance, and no cost-shifting! That plan is Surest, a group plan offered by UnitedHealthcare in recent ye…
CURRENT ISSUE
Volume XXXIII, No. 2 – February 9, 2026
Congress has once again delayed cuts to test reimbursement rates under PAMA, this time until Jan. 1, 2027. Laboratory professionals are urged to lobby Congress to pass the RESULTS act to solve the PAMA cuts problem permanently. Also, patient-driven testing is spurring new opportunities.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!
Sign up for TDR Insider
Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.