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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.
CLIA Lab Directors Must Watch Delegated Duties
CEO SUMMARY: Laboratory accredito…
Digital Pathology Rollout Was ‘Big Bang’ at University of Louisville
CEO SUMMARY: It took less than one year to achieve full implementation of whole slide imaging and digital pathology at the University of Louisville’s Department of Pathology. One decision was to s…
Competency Assessments Prove To Be a Nagging CLIA Deficiency
CEO SUMMARY: Competency assessment problems rank high among frequently cited deficiencies during CLIA inspections. Representatives from the CAP, COLA, and The Joint Commission explain what areas to…
Dartmouth Health Lab Recruits and Trains More CLSs
CEO SUMMARY: Keeping clinical laboratories fully staffed may be the single biggest issue confronting labs today. In New Hampshire, the lab team at Dartmouth Health crafted an innovative program that pays students as they pursue their clinical laboratory scientist certification. In…
Atrium Health’s Advice on Epic Beaker Rollouts
CEO SUMMARY: Starting in 2019, Atrium Health began a years-long process to implement Epic Beaker as its laboratory information system. It was an enormous effort, involving dozens of locations across three s…
Kaiser Acquires Geisinger Health in Value-Based Deal
CEO SUMMARY: This blockbuster combination of two respected integrated delivery networks (IDNs) caught the hospital industry by surprise. Post-closing, Kaiser and Geisinger will have combined revenue…
Kaiser-Geisinger Acquisition Sets Stage for More Deals
CEO SUMMARY: Even as experts were predicting more consolidation among multi-hospital health systems at the Executive War College in New Orleans last month, acquisition of Geisinger Health by Kaiser …
Come One, Come All to the Executive War College
THIS IS FOR ALL OF YOU LONG-TIME READERS WHO EVERY SPRING SEE NEWS about the Executive War College on Diagnostics, Laboratory, and Pathology Management, tell yourself that you need to attend, but then you…
Six Important Themes to Help Labs Succeed
CEO SUMMARY: Clinical laboratories face business challenges with day-to-day operations, genetic testing, and evolving care delivery models. The 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management returns on April 25-26 in New Orleans. Participant…
Laboratories Can Find Value in Use of Leftover Samples
CEO SUMMARY: After testing on behalf of patients, there are often leftover samples. One company developed a platform to enable life science customers to access the samples and associated diagnostic data for research purposes. For clinical labs, the leftover samples provide an opport…
CURRENT ISSUE
Volume XXXI, No. 13 – September 23, 2024
The Dark Report has visited several companies in Europe to see what innovations they have developed that might be coming to laboratories and pathology groups in the U.S. Also, hospital lab outreach businesses are still valuable commodities in the eyes of the Blood Brothers. In addition, The Dark Report delivers the 2nd quarter earnings reports of the top global IVD companies.
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