TAG:
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.
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.
33 Groups Cooperated to Get PAMA-Related LAB Act Passed
>CEO SUMMARY: At the end of 2019, the Laboratory Access for Beneficiaries (LAB) Act became law and addressed two of the three most onerous requirements in the Protecting Access to Medicare Act (PAMA) of 2014. It delays the data-reporting requirements under PAMA, an…
Any Hope for Relief from PAMA Medicare Price Cuts?
It is a notable and rare success for the clinical laboratory profession to convince the House and Senate to pass a law that is favorable to the interests of patients and the clinical laboratories that serve them. Yet that is what happened when Congress passed the Laboratory Access for Beneficiarie…
Is Health Price Transparency at Its Tipping Point?
Is it a coincidence that a number of uninsured consumers filed separate lawsuits in federal courts against Laboratory Corporation of America and Quest Diagnostics—alleging, in both cases, that they were overcharged for clinical…
November 25 2019 intelligence late breaking lab news
Medicare lab test price cuts mandated by the Protecting Access to Medicare Act (PAMA) are eroding the finances of urology groups that do in-office clinical laboratory testing. In the November issue of Urology Times, urologist Robert A. Dowling, MD, wrote a news story that identified the cut…
Veritas Genetics to Close Its Testing Operations in U.S.
MAYBE CHARGING CONSUMERS THE LOW PRICE of $599 for a whole human genome sequence is not a winning financial strategy. That’s one possible reason why closely-watched Veritas Genetics of Cambridge, Mass., will stop operations in the United States. It was in July that Veritas annou…
How Northwell’s Lab Team Demonstrated Value Over 10 Years
CEO SUMMARY: Among hospital administrators, the popular wisdom is that their clinical lab is a cost center. This thinking leads them to consider drastic cost-management strategies that include partnering with commercial labs to manage in-hospital lab testing and the outright sale of lab o…
Labs May Be Excluded from Revised Stark, AKS Rules
CEO SUMMARY: When CMS and the OIG issued proposed rules last fall to make it easier for providers to participate in value-based and coordinated care arrangements, they considered excluding clinical labs, pharma companies, and DME firms because of concerns that the proposed rules could pro…
Labs May Be Excluded from Revised Stark Law, AKS Rules
This is an excerpt of a 1,460-word article in the Jan. 6, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Here are early insights about a federal compliance reform that has not gotten much attention among clinical la…
December 16, 2019 Intelligence: Late Breaking Lab News
John M. Mattsen, III, MD, one of the founders of ARUP Laboratories of Salt Lake City, died on November 9, at the age of 86. As a pathologist and an executive leader, he was at the forefront of laboratory medicine for many decades. A graduate of Brigham Young University…
Judge Issues Split Ruling on Quest’s Motion to Dismiss
CEO SUMMARY: There have been significant developments in the case against Quest Diagnostics for allegedly overcharging uninsured patients for clinical laboratory tests. This second section covers the federal judge’s most recent decisions, along with an assessment of how the plaintiffs a…
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.
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.