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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.
CAP Loses CLIA Accreditation Clients to Joint Commission
This is an excerpt of a 1,790-word article in the January 19, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Over the past 18 months, several prominent national health systems decided to shift their CLIA …
2021 Opens with a Major Story … and It’s Not COVID!
On the pages that follow, you will learn about a major story in the clinical laboratory…
CAP Loses Accreditation Clients to Joint Commission
CEO SUMMARY: Over the past 18 months, several prominent national health systems decided to shift their CLIA laboratory accreditation services away from the College of American Pathologists and to The Joint Commission. These shifts from one accrediting body to another will involve hu…
Why Are Health Systems Changing CLIA Accreditors?
CEO SUMMARY: It is uncommon for a major health system to switch its CLIA lab accreditation business from one accrediting body to another. Yet, just in the past 18 months, that decision was made by the Veterans Administration, Ascension Health, and Providence Health. This is an impor…
Understanding Differences Between 2 CLIA Accreditors
MAJOR CHANGES ARE HAPPENING IN THE COMPETITIVE MARKET for CLIA accreditation of hospital laboratories. Some health systems representing hundreds of hospitals have shifted from using the College of American Pathologists (CAP) to using The Joint Commission (TJC) to meet the accreditation …
Two-Drop ‘Digital CBC’ Enters U.S. Market with FDA Clearance
“We believe the ability to work with just two drops of blood, plus the…
January 19, 2021 Intelligence: Late-Breaking Lab News
Just days ago, the federal Food and Drug Administration (FDA) issued updated information about the COVID-19 tests it has authorized since early in the pandemic. As of Jan. 15, 2021, the agency had authorized a total of 317 tests for the SARS-CoV-2 coronavirus. Included in this total are 236 mo…
Top 10 2020 Lab Stories Are about More than Just COVID-19
This is an excerpt of a 3,689-word article in the December 28, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: There are several surprises in The Dark R…
2020’s Top 10 Lab Stories Are Without Precedent!
CEO SUMMARY: There are several surprises in The Dark Report’s list of the Top 10 Lab Stories for 2020. Despite the SARS-CoV-2 pandemic dominating every aspect of clinical care, social…
OIG Says Medicare Spending On Testing Increased in 2019
CEO SUMMARY: Newly-released data indicates that Medicare officials are falling far short of their goal to decrease the total amount of money spent annually on Part B clinical laboratory tests. That is one finding by the federal Office of the Inspector General in its report of Medica…
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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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