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.
Clinical laboratories are at the forefront of the personalized medicine trend. However, they are also targets for cost-cutting measures by payers, and increased regulation by CMS and FDA, making the industry a challenging one in which to succeed.
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. Under their respective approaches to laboratory licensure and accreditation, many countries have legal requirements that medical laboratories must be accredited to ISO 15189. This is not true in the United States.
In the United States, there are federal and state laws that address the licensure and accreditation of medical laboratories. 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.
NorDx Lab Started to Prepare for COVID-19 Testing in 2019
CEO SUMMARY: In a remarkable example of prescience, informed by decades-long experience in clinical lab testing and past epidemics, the president of NorDx Laboratories in Maine saw the December news accounts of a widespread outbreak of a new respiratory disease in China. He warned h…
Pooled COVID Testing a Success for New York Hospital Lab
This is an excerpt of a 1,552-word article in the November 16, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Pooled COVID testing helps the clinical lab staff at the hospital in Saratoga Springs, N.Y., do …
California Builds Its Own COVID Lab: $25 Million or $1.7 Billion?
CEO SUMMARY: California dropped a bomb on the state’s existing network of hospital labs and independent clinical labs when, on Oct. 30, it announced it had built and opened a new laboratory facility in Valencia designed to perform 150,000 COVID-19 tests per day. Now, existing labs…
NY Hospital Lab Succeeds with Pooled COVID-19 Testing
CEO SUMMARY: Pooled testing helps the clinical lab staff at the hospital in Saratoga Springs, N.Y., do more COVID-19 tests when supplies might otherwise run short. Lab managers estimate this method has saved 5,000 test cartridges since May. Pooled testing also helps the physician st…
Palmetto GBA Tells Consultant to Take Down Test Price Data
CEO SUMMARY: Lawyers for Medicare contractor Palmetto GBA sent a cease and desist letter in September to a respected lab consultant, telling him to delete from his health policy blog a document containing Medicare genetic test price and coding data. In the letter, Quinn was directed…
$481 Mil Federal COVID Contract Awarded to Young IVD Company
IN THEIR FIGHT AGAINST THE PANDEMIC, federal officials are boosting the fortunes of some little-known or emerging in vitro diagnostics (IVD) companies. One example is the recent award of a $481 million COVID-19 test contract to Cue Health Inc., of San Diego. Earlie…
Texas Company Operates 400 COVID-Collection Sites
CEO SUMMARY: In April, the federal Department of Health and Human Services contracted with eTrueNorth to operate COVID drive-through specimen-collection sites under the Community-Based Testing Sites program. The drive-through sites are an extension of non-COVID testing the company has …
Wisconsin Lab Network Feeds Valuable Data to State Health Lab
CEO SUMMARY: From the earliest days of the COVID-19 pandemic, the 138-member Wisconsin Clinical Laboratory Network has reported to the state health lab the number of COVID-19 tests, the number of positive results, as well as other data that includes data on lab testing supplies and ca…
COVID-19 Pooled Testing: Good for Labs? Not IVDs?
CEO SUMMARY: Pooled testing for COVID-19 could be a double-edged sword for clinical labs and in vitro diagnostics companies. Offering the advantage of reducing the number of standard tests for SARS-CoV-2, this testing method would cut lab spending on tests and testing supplie…
Officials Differ on Value of COVID-19 Pooled Testing
CEO SUMMARY: Some experts on testing strategies support pooled testing because this method may support reopening by schools and businesses and thus bring the economy back. But other experts have raised questions about this strategy. Rules from the federal Centers for Medicare …
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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