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.
Eastern Canada’s Latest Lab Errors Get Attention
CEO SUMMARY: Authorities for Eastern Health in Newfoundland and Labrador province in Canada are conducting a root cause analysis after finding discrepancies in breast cancer testing that affected nine patients. Health officials said these cases were discovered as a result of an improved q…
Once Again, Revenue Declines at Quest Diagnostics Incorporated
FIRST TO REPORT its fourth quarter and full year earnings for 2013 was Quest Diagnostics Incorporated. It more than other potential buyers to released its earnings report last Thursday. For fourth quarter 2013, Quest Diagnostics generated revenue of $1.76 billion, c…
LabCorp, Bio-Reference Labs, Epic, OHSU, Alberta Health
LABCORP, BRLI ISSUE REVISED GUIDANCE OF LOWER EARNINGS IN RECENT WEEKS, at least two public lab companies have issued downward earnings guidance for 2014. These changes are based, in part, on expected reimbursement reductions from the Medicare program. It was December 10 wh…
Theranos Won’t Discuss Disruptive Lab Technology
CEO SUMMARY: In a partnership with Walgreens pharmacies, Theranos Inc. announced that it will run clinical lab tests on “micro-samples” and collect these blood samples without venipuncture. Even as Theranos touts the patient-friendly benefits of its proprietary diagnostic technology, …
Alberta Lab RFP, FTC, LabMD Biodiagnostic Lab Services Guilty Pleas
ALBERTA PROVINCE MAY SOON BID $3 BILLION CLINICAL LAB CONTRACT NEWS LEAKED ON SEPTEMBER 19 that Alberta Health Services (AHS) is preparing to issue a request for proposal (RFP) to select a company to build a state-of-the clinical laboratory facility to serve…
Genesis Outreach Lab Acquired by LabCorp
CEO SUMMARY: Sources say that Genesis Clinical Laboratory of Berwyn, Illinois, owned by McNeal Hospital, is being sold to Laboratory Corporation of America. Neither party has publicly acknowledged completion of the sale. It is the latest example of consolidation within the clinical lab in…
Mass. AG Coakley Cites Two Labs in 48-Count Medicaid Kickback Case
MASSACHUSETTS ATTORNEY GENERAL Martha Coakley has cited two lab companies in a case involving kickbacks related to drugs of abuse testing. Coakley’s office made the announcement on March 8. Coakley alleges that fees were collected from patients illegally and that prescriptions for medications were…
Palmetto’s Prostate Biopsy Policy Removed after Talks with CMS
THERE IS SOME POSITIVE LAB INDUSTRY NEWS that has not been widely reported yet. It involves a decision to change an unwelcome Medicare policy that limited the number of prostate biopsy specimens per case that would be reimbursed. After discussions between lab industry groups and the federal …
Two MTs Launch New Lab In Aberdeen, North Carolina
CEO SUMMARY: Although located in the same region as two of the nation’s largest laboratory companies, newly-created Triune Laboratory, Inc., is reporting steady growth and acceptance by physicians in the community. Founded by two medical technologists and partially funded by a pathologi…
LipoScience Completes IPO, Raises $44.9 Million from Sale
IT HAS BEEN A WHILE since a laboratory company has successfully completed an initial public offering (IPO). Thus, it is notable that LipoScience Inc., of Raleigh, North Carolina, recently accomplished that feat. On January 24, 2013, Liposcience closed its IPO and raised $44.9 millio…
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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