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.
Monitoring Patients on Opioids Is Opportunity for Clinical Labs
CEO SUMMARY: When developing a program to identify and treat patients who misused opioids or needed chronic opioid therapy, Community Health Network (CHN) of Indianapolis recognized that clinical lab toxicology tests were one of the few sources of objective data about patient compliance….
Lab Monitors Compliance of Chronic Opioid Patients
CEO SUMMARY: Hospitals and health systems developing programs to manage patients on chronic opioid therapy (COT) are finding that an essential element of these programs is regular toxicology testing. In its role as the toxicology test provider for a health network in Indiana, AIT Laborato…
COLA: GAO Should Address PAMA’s Effect on Patients
CEO SUMMARY: In a recent statement, COLA, an organization that accredits clinical labs, expressed strong concern about how a report from the Government Accountability Office did not address how the Protecting Access to Medicare Act of 2014 (PAMA) affects patients’ access to testing, esp…
Respected Lab Exec Found Dead in Triple Homicide
CEO SUMMARY: Police and the district attorney have released few details about the murders of well-known clinical laboratory executive Richard Nicholson, his wife, and a family friend. The crimes were committed in Nicholson’s home in Newport Beach, Calif., and 27-year old Camden Nicholso…
UnitedHealth Rumored to Be Excluding Labs from Its Network
IN RECENT DAYS, RUMORS HAVE SURFACED that UnitedHealthcare has begun to terminate the contracts it holds with a number of regional and non-national clinical laboratories. This news surfaced just as The Dark Report went to press. Given its importance to the clinical laboratory indust…
Project Santa Fe Labs Deliver Value with Tests
CEO SUMMARY: No bigger threat looms over the financial security of the nation’s clinical laboratories than healthcare’s transition from fee-for-service payment to value-based reimbursement. To navigate that transition successfully, medical labs and pathology groups will need to adopt …
Pathology Errors a Factor in 3 Deaths at VA Hospital
CEO SUMMARY: Outside pathologists are reviewing the pathology reports of almost 20,000 patients of an Arkansas Veterans Administration hospital following termination of a Chief of Pathology who was believed to have handled cases while impaired. Currently, the review identified 256 cases w…
Quest, Sonic Issue Statements about Pap Test Issues in Ireland
PROBLEMS WITH CERVICAL CANCER SCREENING IN IRELAND continue to make headlines in the Irish newspapers and roil the Irish health system. Caught up in this story are two billion-dollar lab companies that performed cervical cancer screening under contract to the Irish Health Service. T…
Why Pharma, Private Equity Want to Reshape Lab Industry
CEO SUMMARY: A disruptive force that involves precision medicine, pharmaceutical companies, and venture capital investors is poised to reshape the clinical laboratory industry. Genetic knowledge makes it possible to match cancer drugs to specific mutations. Pharma companies and professio…
SEC Charges Theranos with ‘Massive Fraud’
CEO SUMMARY: In an action against Theranos and two of its executives, the SEC said in a federal court filing this month that the company, CEO Elizabeth Holmes, and former COO Ramesh “Sunny” Balwani deceived investors into believing that the company’s portable blood analyzer could co…
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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