CEO SUMMARY: In a tale of two fraudsters, the Department of Justice has filed a warning shot to all technology startups: Criminal indictments against Elizabeth Holmes and Ramesh “Sunny” Balwani could mean prison time and massive fines. In this latest Theranos news, The DOJ cited harm to investors, doctors and patients by the two company
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A medical laboratory or 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.
Distribution of clinical laboratories in health institutions varies greatly from one place to another.
The staff of medical laboratories may include:
- Clinical biochemist
- Pathologist’s assistant (PA)
- Medical laboratory scientist (MT, MLS or CLS)
- Medical laboratory technician (MLT)
- Medical laboratory assistant (MLA)
- Phlebotomist (PBT)
In many countries, there are two main types of labs that process the majority of medical specimens. Hospital laboratories are attached to a hospital, and perform tests on patients. Private (or community) laboratories receive samples from general practitioners, insurance companies, clinical research sites and other health clinics for analysis.
These can also be called reference laboratories where more unusual and obscure tests are performed. These include Mayo Medical Laboratories, ARUP Laboratories, Quest Diagnostics and LabCorp. For extremely specialized tests, samples may go to a research laboratory. Many samples are sent between different labs for uncommon tests. It is more cost effective if a particular laboratory specializes in a rare test, receiving specimens (and money) from other labs, while sending away tests it cannot perform.
Laboratories today are held together by a system of software programs and computers that exchange data about patients, test requests, and test results known as a laboratory information system or LIS. The LIS is interfaced with the hospital information system.
This system enables hospitals and labs to order the correct test requests for each patient, keep track of individual patient or specimen histories, and help guarantee a better quality of results as well as printing hard copies of the results for patient charts and doctors to check.
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. In the United States, under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), accreditation of medical laboratories is done by the Joint Commission, College of American Pathologists, AAB (American Association of Bioanalysts), and other state and federal agencies. CLIA 88 or the Clinical Laboratory Improvement Amendments also dictate testing and personnel.
CEO SUMMARY: Federal criminal indictments were unsealed last Friday in San Francisco against Elizabeth Holmes and Ramesh “Sunny” Balwani for their actions as executives at Theranos, Inc., the once high-flying lab test company. Officials at the Department of Justice said the counts against Holmes and Balwani are based on the alleged actions of each to
CEO SUMMARY: Several developments have moved the case forward since December when the American Clinical Laboratory Association filed suit in federal court against the Department of Health and Human Services. Inrecent weeks, ACLA filed for summary judgment; HHS responded with its own request for summary judgment; and most recently ACLA filed its rebuttal to the
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 conduct comprehensive blood tests from drops of blood collected via
THERE IS ALREADY A SHORTAGE of competent professionals available to sign off on medical laboratory reports in India. Now a recent Supreme Court decision may exacerbate this problem.
On Jan. 11, the Hindu Business Line, a newspaper, reported that medical labs across India could face a significant shortage of competent professionals to sign lab reports after
Sept. 22 was the day that an agreement to sell Miraca Life Sciences (MLS) of Irving, Texas, was announced. Miraca Holdings will sell the anatomic pathology lab company to Avista Capital Partners. As part of the transaction, a new holding company, called Symphony Buyer, will be formed and will own MLS. Miraca Holdings will be
ON SEPT. 22, MEDICARE OFFICIALS RELEASED THE DRAFT PRICES for the 2018 Clinical Laboratory Fee Schedule. The bad news for the lab industry is that the fee cuts are deeper than the federal Centers for Medicare and Medicaid Services had predicted earlier.
The price cuts to clinical laboratory test fees will total $670 million in 2018.
Last week, 23andMe raised $250 million in a financing round led by Sequoia Capital. The company has an estimated value of $1.75 billion and has attracted $491 million in capital since its founding. In 2015, 23andMe formed a therapeutics division. This business unit is partnering with several major players in the pharmaceutical industry to use
CEO SUMMARY: NYU Langone Health recognized the clinical and financial advantages of providing competitive lab outreach testing services to its employed physicians. The laboratory joint venture with Sonic Healthcare USA will allow NYU Langone to increase use of its hospital labs and will facilitate standardizing its testing methods, results, and reference ranges. The first phase
PAML of Spokane, Washington, was the subject of an unusual public disclosure recently made by Laboratory Corporation of America. The lab company sent a statement to the Spokane Journal of Business stating its plans to make PAML “its primary lab site in the western U.S. for workplace and toxicology testing.” The statement was made to the