TAG:
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.
Economic, Tech Changes Drive Lab Concerns
By Robert Michel | From the Volume XXXII, No. 7 – May 12, 2025 Issue
CEO SUMMARY: Uncertainty around tariffs, future regulations, and artificial intelligence (AI) defined the mood at the 2025 Executive War College, where nearly 1,000 lab leaders gathered. Speakers warned of how stagnant healthcare spending could trickle down to labs. Meanwh…
LDT Oversight May Fall to Congress, CLIA
By Robert Michel | From the Volume XXXII, No. 7 – May 12, 2025 Issue
CEO SUMMARY: After a federal court struck down the FDA’s final rule on laboratory developed tests, attention has shifted to Congress and CLIA as likely paths forward for oversight. A lack of bipartisan momentum makes new legislation unlikely in the near term. Experts sug…
How Labs, Pathologists Should Prepare for Payer Audits
By Robert Michel | From the Volume XXXII, No. 7 – May 12, 2025 Issue
PAYER AUDITS ARE ON THE RISE, AND CLINICAL LABORATORIES AND PATHOLOGY PRACTICES THAT ARE NOT ADEQUATELY PREPARED could face millions of dollars in unexpected recoupment demands. That’s the word from Jane Pine Wood, JD, a healthcare attorney with McDonald Hop…
CLIA Lab Directors Must Watch Delegated Duties
By Robert Michel | From the Volume XXX, Number 17 – December 4, 2023 Issue
CEO SUMMARY: Laboratory accredito…
Digital Pathology Rollout Was ‘Big Bang’ at University of Louisville
By Scott Wallask | From the Volume XXX, No. 11 – July 31, 2023 Issue
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
By Scott Wallask | From the Volume XXX, No. 11 – July 31, 2023 Issue
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
By Scott Wallask | From the Volume XXX, No. 10 – July 10, 2023 Issue
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
By Scott Wallask | From the Volume XXX, No. 9 – June 19, 2023 Issue
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
By Robert Michel | From the Volume XXX, No. 7 – May 8, 2023 Issue
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
By Robert Michel | From the Volume XXX, No. 7 – May 8, 2023 Issue
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 …
CURRENT ISSUE

Volume XXXII, No. 7 – May 12, 2025
Economic, Tech changes drive lab concerns, The Dark Report provides insights from the Executive War College speakers about how clinical labs can use business strategies and tactics to handle the new tariffs, future regulations, and artificial intelligence (AI). Also, this issue provides guidance on how labs and pathologists should prepare for payer audits.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!
Sign up for TDR Insider
Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.
Topics
- Anatomic Pathology
- Clinical Chemistry
- Clinical Laboratory
- Clinical Laboratory Trends
- Digital Pathology
- Genetic Testing
- In Vitro Diagnostics
- IVD/Lab Informatics
- Lab Intelligence
- Lab Marketplace
- Lab Risk & Compliance
- Laboratory Automation
- Laboratory Billing
- Laboratory Compliance
- Laboratory Equipment
- Laboratory Information Systems
- Laboratory Management
- Lean Six Sigma
- Managed Care Contracts
- Molecular Diagnostics
- Pathology Trends
- People
- Uncategorized
The Dark Report
1000 N West Street, Suite 1200 Wilmington, Delaware, United States, 19801
Phone: 512-264-7103
Email: info@darkreport.com
© 2025 The Dark Report. All rights reserved. Part of the LabX Media Group