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 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.
Add eight more laboratories to the list of lab companies whose patient data were breached when the American Medical Collection Agency was hacked. According to HealthITSecurity, in recent weeks, these labs reported breaches of their patient records:
American Esoteric Labs
South Texas Dermatopathology
Laboratory of Dermatopathology ADX
IN A SIGNIFICANT WIN for the American Clinical Laboratory Association (ACLA) and other groups suing federal Department of Health and Human Services (HHS), the U.S. Court of Appeals for the District of Columbia ruled in the ACLA’s favor on July 30.
Ruling on the appeal in the case the ACLA brought against HHS Secretary Alex Azar
CEO SUMMARY: In 2017, an auditor for CMS alleged that True Health filed fraudulent claims and the federal Medicare program cut all payments to the lab company and one month later reduced the cut to 35% of the billed amount. Two months ago, CMS ended all payments again. These facts became public on July 2
IT’S OFFICIAL! A YEAR-LONG COLLABORATION involving a health insurer, a clinical laboratory, and an analytics company showed that insurers and physicians can use clinically-actionable intelligence developed from medical lab test data to improve patient outcomes.
This important accomplishment in patient care comes with another significant milestone: The health insurer is paying the lab outside of the
CEO SUMMARY: Deep cuts in what Anthem pays pathologists for the professional component for certain AP services are having a harmful effect on the long-standing relationships that dermatologists have with dermatopathologists, some physicians say. By disrupting these relationships, Anthem is harming patient care, they add. Since late last year, in a growing number of states,
ONCE AGAIN, A HIGH-PROFILE LAB COMPANY faces allegations of fraud and abuse. This time it is True Health Diagnostics of Frisco, Texas. Details of this case were revealed last month when True Health filed a lawsuit in a federal court in Texas against the agencies running the federal Medicare program.
Another clinical laboratory company disclosed a major breach of its patients’ protected health information (PHI). On July 15, Clinical Pathology Laboratories (CPL), a division of Sonic Healthcare, issued a press release and disclosed that it estimated as many as 2.2 million of its patients may have had their data exposed in a breach at Retrieval Masters
CEO SUMMARY: At MD Anderson Cancer Center and Baylor St. Luke’s Medical Center, blood transfusion errors led to two patients’ deaths in separate incidents last fall. Then, this spring, a patient died in the emergency department of Ben Taub Hospital following “an ineffective process in patient monitoring and communication of critical lab values.” State and
CEO SUMMARY: Within five years, members of the millennial generation will make up 75% of the physician workforce in the United States, rising from about 24% in 2017. That three-fold increase represents a strong demographic trend that will require changes in the steps all clinical laboratories and pathology groups take when seeking to attract and