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.
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.
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.
WITH EACH NEW RULING about coverage for a proprietary diagnostic assay, Medicare officials send a message to the entire clinical laboratory industry that any lab company with a proprietary test needs to submit adequate clinical evidence that demonstrates two positive aspects of the test.
First, that the assay accurately measures the biomarkers that it says it
CEO SUMMARY: It’s been a common strategy among managed care payers to seek the lowest prices for clinical laboratory testing when negotiating contracts with labs. However, lower prices may become less important over time as the health system moves away from fee-for-service payment toward value-based reimbursement. Now evidence is accumulating that at least some large
EVEN AS SOME CLINICAL LABORATORY COMPANIES are closing or selling following the deep cuts in what Medicare pays for lab tests, three major lab organizations are building new, super-sized laboratory facilities.
Those three companies are ARUP Laboratories, DaVita Labs, and Quest Diagnostics Inc.
In September, DaVita Labs, a division of DaVita Kidney Care, opened a 150,000 square-foot
CEO SUMMARY: Will clinical labs heed the lessons learned from the first PAMA private payer market price reporting cycle that CMS conducted in 2017? One major difference is that the definition of applicable laboratories now includes most hospital labs. This creates the opportunity for a larger number of clinical labs to submit their price data
CEO SUMMARY: It is ironic that, after the federal Centers for Medicare and Medicaid Services (CMS) enacted the deepest price cuts to the Part B Clinical Laboratory Fee Schedule in more than 50 years, a U.S. Senator now asks CMS why it will pay billions more for lab testing. The question from Iowa Senator Chuck
By any measure, it is tougher today for clinical laboratories and anatomic pathology groups to generate the revenue needed to deliver state-of-the-art diagnostic testing services while remaining financially viable. Four recent trends prove the point.
First, every year, the Medicare program and private health insurers are cutting the prices they pay for medical laboratory tests.
CEO SUMMARY: This will be one of the most challenging years facing the clinical lab industry since the early 1990s. The CMS scheme to collect private payer lab test prices and use that data to set Medicare clinical laboratory test prices is proving to be an indiscriminate tool that is poised to undermine the financial integrity of many labs,
LAST MONTH the American Clinical Laboratory Association (ACLA) filed an appeal in its case against the federal Department of Health and Human Services (HHS). In its court filing, the ACLA said that a federal district court judge erred in her ruling against the lab association.
The district court misinterpreted the Protecting Access to Medicare Act of
NEW CLINICAL LABORATORY CONTRACTING INITIATIVES are planned at UnitedHealthcare (UHC), including the launch of a preferred laboratory network this summer.
The nation’s largest health insurer with 49 million beneficiaries, UHC announced in May that it would add Quest Diagnostics as an in-network lab provider effective Jan. 1, and retain Laboratory Corporation of America as a network