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.
CEO SUMMARY: Some lab companies may be prepared to challenge in court the methodology CMS used in setting the requirements of the Protecting Access to Medicare Act of 2014 to conduct a study of private payer market prices for lab tests and use that data to propose new prices for the Part B Clinical Laboratory
ALL LABORATORY PROFESSIONALS AND pathologists are encouraged to submit comments to CMS before the Oct. 23, as well as send letters to their elected officials in Congress to urge both to delay and to fix the market price study and revise the proposed Clinical Laboratory Fee Schedule for 2018.
Beneficiaries Will Lose Out
Among the most important
FOR THE LAB INDUSTRY, THE FEE CUTS proposed in the 2018 Clinical Laboratory Fee Schedule would be even more aggressive than what the federal Centers for Medicare and Medicaid Services had earlier predicted for Medicare Part B.
In the days following the Sept. 22 publication of the proposed fee schedule, major lab industry associations issued statements
CLINICAL LABORATORIES WITH A HIGH percentage of Medicare Part B lab test reimbursement are expected to suffer the most under the Part B Clinical Laboratory Fee Schedule (CLFS) cuts that the Centers for Medicare and Medicaid Services proposed Sept. 22.
With the proposed rates scheduled to go into effect on Jan. 1, that leaves just 12
CEO SUMMARY: If the draft lab rates that CMS published Sept. 22 for the Clinical Laboratory Fee Schedule for 2018 go into effect Jan. 1 as proposed, then clinical labs will see a cut of 28% in what they get paid for the top 20 most common tests, according to a recent analysis. The rates
ON SEPT. 22, MEDICARE OFFICIALS RELEASED THE DRAFT PRICES for the 2018 Clinical Laboratory Fee Schedule. The bad news for the lab industry is that the fee cuts are deeper than the federal Centers for Medicare and Medicaid Services had predicted earlier.
The price cuts to clinical laboratory test fees will total $670 million in 2018.
CEO SUMMARY: In what may be a first for the clinical lab industry, the American Medical Association and the American Hospital Association joined with 20 other healthcare associations to ask CMS Administrator Seema Verma to address the problems with the CMS proposal involving Medicare Part B fees. Specifically, the associations asked Verma to delay implementing
AT THIS MOMENT, THE ENTIRE CLINICAL LABORATORY INDUSTRY STANDS on the precipice of the most financially disruptive development in the past three decades. On Jan. 1, the federal Centers for Medicare and Medicaid Services will implement deep cuts to the Medicare Part B Clinical Laboratory Fee Schedule.
There is additional unwelcome news. CMS now says that,