SmithKline Beecham Clinical Laboratories (SBCL) was an American-based medical laboratory company that was acquired by Quest Diagnostics in 1999 for $1.3 billion.
In 1989, SBCL had to pay a $1.5 million fine for illegal laboratory referral kickbacks. [1]
In 1997, Operation LabScam forced SBCL to agree to pay a $325 million settlement for billing Medicare and Medicaid for tests that physicians were misled into believing were free, violating the 1863 False Claims Act. [2]
In 1998, a phlebotomist at an SBCL facility in Palo Alto, California was exposed as reusing needles to save money. As a result, over 3,600 patients had to receive testing and counseling for HIV and hepatitis. The incident led to phlebotomy licensure in California. [3]
GSK plc is a British multinational pharmaceutical and biotechnology company with global headquarters in London. It was established in 2000 by a merger of Glaxo Wellcome and SmithKline Beecham, which was itself a merger of a number of pharmaceutical companies around the Smith, Kline & French firm.
Abbott Laboratories is an American multinational medical devices and health care company with headquarters in Green Oaks, Illinois, United States. The company was founded by Chicago physician Wallace Calvin Abbott in 1888 to formulate known drugs; today, it sells medical devices, diagnostics, branded generic medicines and nutritional products. It split off its research-based pharmaceuticals business into AbbVie in 2013.
Stanford University Medical Center is a medical complex which includes Stanford Health Care and Stanford Children's Health. It is consistently ranked as one of the best hospitals in the United States and serves as a teaching hospital for the Stanford University School of Medicine. In 2022–23, it was ranked by the US News as the 3rd-best hospital in California and 10th-best in the country.
The prothrombin time (PT) – along with its derived measures of prothrombin ratio (PR) and international normalized ratio (INR) – is an assay for evaluating the extrinsic pathway and common pathway of coagulation. This blood test is also called protime INR and PT/INR. They are used to determine the clotting tendency of blood, in such things as the measure of warfarin dosage, liver damage, and vitamin K status. PT measures the following coagulation factors: I (fibrinogen), II (prothrombin), V (proaccelerin), VII (proconvertin), and X.
Stark Law is a set of United States federal laws that prohibit physician self-referral, specifically a referral by a physician of a Medicare or Medicaid patient to an entity for the provision of designated health services ("DHS") if the physician has a financial relationship with that entity.
Health Net, LLC, a subsidiary of Centene Corporation, is an American health care insurance provider. Health Net and its subsidiaries provide health plans for individuals, families, businesses and people with Medicare and Medicaid, as well as commercial, small business, and affordable care insurance.
In common law, a writ of qui tam is a writ through which private individuals who assist a prosecution can receive for themselves all or part of the damages or financial penalties recovered by the government as a result of the prosecution. Its name is an abbreviation of the Latin phrase qui tam pro domino rege quam pro se ipso in hac parte sequitur, meaning "[he] who sues in this matter for the king as well as for himself."
Quest Diagnostics Incorporated is an American clinical laboratory. A Fortune 500 company, Quest operates in the United States, Puerto Rico, Mexico, and Brazil. Quest also maintains collaborative agreements with various hospitals and clinics across the globe.
The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research.
In the United States, Medicare fraud is the claiming of Medicare health care reimbursement to which the claimant is not entitled. There are many different types of Medicare fraud, all of which have the same goal: to collect money from the Medicare program illegitimately.
A medical laboratory or clinical laboratory is a laboratory where tests are conducted out on clinical specimens to obtain information about the health of a patient to aid in diagnosis, treatment, and prevention of disease. Clinical medical laboratories are an example of applied science, as opposed to research laboratories that focus on basic science, such as found in some academic institutions.
Laboratory Corporation of America Holdings, more commonly known as Labcorp, is an American healthcare company headquartered in Burlington, North Carolina. It operates one of the largest clinical laboratory networks in the world, with a United States network of 36 primary laboratories. Before a merger with National Health Laboratory in 1995, the company operated under the name Roche BioMedical. Labcorp performs its largest volume of specialty testing at its Center for Esoteric Testing in Burlington, North Carolina, where the company is headquartered. As of 2018, Labcorp processes 2.5 million lab tests weekly.
The ethics involved within pharmaceutical sales is built from the organizational ethics, which is a matter of system compliance, accountability and culture. Organizational ethics are used when developing the marketing and sales strategy to both the public and the healthcare profession of the strategy. Organizational ethics are best demonstrated through acts of fairness, compassion, integrity, honor, and responsibility.
Pharmaceutical fraud is when pharmaceutical companies engage in illegal, fraudulent activities to the detriment of patients and/or insurers. Examples include counterfeit drugs that do not contain the active ingredient, false claims in packaging and marketing, suppression of negative information regarding the efficacy or safety of the drug, and violating pricing regulations.
United States v. GlaxoSmithKline was a case before the United States District Court for the Eastern District of Pennsylvania. Robert J. Merena was one of the first who filed claims against SmithKline Beecham Clinical Laboratories on November 12, 1993. The complaints alleged that GlaxoSmithKline, which operated a system of clinical laboratories, adopted myriad complicated procedures for the purpose of defrauding state and federal healthcare programs, in particular Medicare and Medicaid. The U.S. Justice Department publicly praised Robert Merena for his "cooperation and support" in helping the government collect the largest settlement ever involving a whistle-blower lawsuit. The SmithKline settlement is considered to be one of the largest whistleblower assisted recoveries in the history of the United States.
The Health Information Technology for Economic and Clinical Health Act, abbreviated the HITECH Act, was enacted under Title XIII of the American Recovery and Reinvestment Act of 2009. Under the HITECH Act, the United States Department of Health and Human Services resolved to spend $25.9 billion to promote and expand the adoption of health information technology. The Washington Post reported the inclusion of "as much as $36.5 billion in spending to create a nationwide network of electronic health records." At the time it was enacted, it was considered "the most important piece of health care legislation to be passed in the last 20 to 30 years" and the "foundation for health care reform."
Theranos Inc. was an American privately held corporation that was touted as a breakthrough health technology company. Founded in 2003 by then 19-year-old Elizabeth Holmes, Theranos raised more than US$700 million from venture capitalists and private investors, resulting in a $10 billion valuation at its peak in 2013 and 2014. The company claimed that it had devised blood tests that required very small amounts of blood and that could be performed rapidly and accurately, all using compact automated devices that the company had developed. These claims were proven to be false.
Center for Covid Control (CCC) is a pop-up laboratory testing company based in Rolling Meadows, Illinois. It had a peak of 300 testing sites, often in storefronts or temporary buildings. In January 2022 USA Today named the entity in an article about problems with pop-up testing sites, and stated that it was under investigation by several state and federal agencies.
Phlebotomy licensure in the United States is the process by which various regulatory bodies regulate the practice of phlebotomy through licensure. There are no federal phlebotomy training or certification requirements, though several states have imposed their own requirements. In 2024, four states require licensure for phlebotomy: California, Louisiana, Nevada, and Washington.