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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.
Helping Labs with Cash Flow, COVID-19 Response
ROUTINE SPECIMEN VOLUME REMAINS DOWN by 50% or more for clinical laboratories and anatomic pathology groups in the United States because of the pandemic. Through the end of last week, The Dark Report estimates that labs in the U.S. have lost almost $7 billion since the first week of March…
FDA Replaces March 16 Serology COVID-19 Rules
CEO SUMMARY: In the rush to allow companies and clinical laboratories to develop, validate, and bring to market serological tests for COVID-19, the federal Food and Drug Administration issued rules on March 16 that eased its requirements for these new assays. Because of the la…
Expert Offers Comments on FDA and Revised Serology Test Rules
CLINICAL LABORATORY DIRECTORS are asking what caused the federal Food and Drug Administration (FDA) to issue a highly questionable policy in March to allow serological tests for SARS-CoV-2 and then change that policy seven weeks later. Under a policy the agency issued March…
New Lab Revenue Source: COVID-19 Worker Screening
CLINICAL LABORATORIES have a new revenue-generating opportunity, as some states relax stay-at-home rules: Many employers are likely to seek COVID-19 screening tests for employees returning to work to detect the presence of the new coronavirus. This new source of lab specimens and revenue gi…
California Research Team Analyzes Performance of 12 Serology Tests
CEO SUMMARY: Researchers with the COVID-19 Testing Project used a multidisciplinary effort to analyze and compare the performance of 12 serological tests. One finding is that, 16 to 20 days or more after a confirmed infection with a molecular test, many of the 12 serological te…
MAY 11, 2020 Intelligence: Late-Breaking Lab News
Clinical laboratories in other countries have similar challenges in responding to the COVID-19 pandemic. In the United Kingdom, the Independent reported last week that “Widespread testing for coronavirus has been suspended among staff and patients at hospitals and GP practices ser…
Clinical Labs Step Up, But Serious Problems Are Ahead
ACROSS THE UNITED STATES, CLINICAL LABORATORIES ARE LIVING a good news/bad news story. The good news is that the essential role every lab plays in enabling fast, accurate diagnoses is now at the top of the news cycle. Daily, citizens of this country hear from the President and health officials th…
Lab, Path Finances Crash; Next Test Wave: Serology
CEO SUMMARY: For clinical laboratories and anatomic pathology groups, the day-by-day impact of the COVID-19 pandemic is unfolding much like Hurricane Katrina hitting New Orleans in 2005. Every 24 hours, labs get unwelcome news, along with uncertainty about whether it will …
From Mid-March, Labs Saw Big Drop in Revenue
CEO SUMMARY: In response to the coronavirus outbreak, patients stopped seeing their doctors for routine care and hospitals ceased doing elective services. With fewer test referrals, clinical labs and pathology groups were hit with a substantial decline in revenue. One of t…
Labs May Qualify for Relief Under New Federal Laws
CEO SUMMARY: After routine testing and specimen volume declined last month, so too did the associated revenue. In response, clinical laboratories and anatomic pathology groups want to bolster their finances quickly or risk incurring more financial damage to already-fragile…
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.
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