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Medical laboratory
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.
Laboratory medicine is generally divided into two sections, each of which being subdivided into multiple units. These two sections are anatomic pathology and clinical pathology.
Distribution of clinical laboratories in health institutions varies greatly from one place to another.
The staff of medical laboratories may include:
- Pathologist
- 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.
PerkinElmer Launches Lab Venture in China
By Joseph Burns | From the Volume XXII No. 4 – March 9, 2015 Issue
CEO SUMMARY: PerkinElmer is the latest U.S. organization to open a clinical laboratory business in China. Last December, it formally opened its new Suzhou PerkinElmer Medical Laboratory. The new lab is located about 60 kilometers (37 miles) west of Shanghai. It will provide neona…
Locked Out of Payer Network, NH Hospital Opens Lab Company
By Joseph Burns | From the Volume XXII No. 4 – March 9, 2015 Issue
CEO SUMMARY: Since Anthem launched its site of service program in New Hampshire in 2010, labs in the state’s hospitals have mostly been excluded from its network and have lost market share. Recently one community hospital developed an unusual strategy to win back those patients…
Florida Docs Seek to Cut Ties with UnitedHealthcare
By Joseph Burns | From the Volume XXII No. 1 – January 5, 2015 Issue
CEO SUMMARY: Physicians in Florida continue to express significant concerns about UnitedHealthcare’s pilot program requiring pre-notification for 80 clinical laboratory tests, including many routine tests, and pre-authorization for two genetic tests. The program i…
Labs Share Successes in Delivering More Value
By Robert Michel | From the Volume XXI No.16 – November 24, 2014 Issue
CEO SUMMARY: As the number of accountable care organizations and patient-centered medical homes grows monthly, a handful of innovative labs are seizing the opportunity to develop and deliver lab testing services that add more value to physicians and patients. These early-adopter labs reco…
Alberta Picks Sonic Health for $3 Billion Lab Contract
By Robert Michel | From the Volume XXI No. 15 – November 3, 2014 Issue
CEO SUMMARY: For more than a year, Alberta’s C$3 billion RFP to develop an integrated laboratory testing service for Edmonton and surrounding regions has been the focus of intense interest. On October 17, health officials announced that Sonic Healthcare Limited was the preferred propone…
Public Comment Started on FDA LDT Regulations
By Joseph Burns | From the Volume XXI No. 15 – November 3, 2014 Issue
CEO SUMMARY: On October 3, the FDA published draft guidelines to regulate laboratory-developed tests (LDTs). Pathologists and lab executives now have 120 days to comment on the guidelines. Several prominent national lab associations have expressed concerns about this additional bureaucrat…
My Visit to Walgreens for Theranos Lab Tests
By Robert Michel | From the Volume XXI No. 11 – August 11, 2014 Issue
CEO SUMMARY: One of the biggest unknowns in the lab testing industry today is Theranos, the lab testing company based in Palo Alto, California. It says its proprietary technology is poised to transform the lab testing experience for patients and physicians. It says it can perform hundreds…
Lab Copay on the Table, But for Now, It’s Australia
By Robert Michel | From the Volume XXI No. 9 – June 30, 2014 Issue
CEO SUMMARY: Patient copayment is the idea that always appeals to government health officials who want to control healthcare costs. In Australia, Parliament has yet to vote on a bill that would, starting in July 2015, institute a patient copayment of $7.00 Australian for …
Futurist Predicts Less Margin, More Consolidation in Market
By Joseph Burns | From the Volume XXI No. 9 – June 30, 2014 Issue
CEO SUMMARY: Based on interviews with 40 CEOs of major healthcare companies, one expert says that the next three years will bring major changes to healthcare. In his presentation at the Executive War College, Ted Schwab noted that these changes include a swift adoption of budgeted care (a…
Calloway Labs Settles with Feds, West Virginia
By Robert Michel | From the Volume XXI No. 8 – June 9, 2014 Issue
CEO SUMMARY: West Virginia is the second state in recent years to settle claims of Medicare and Medicaid fraud filed against Calloway Laboratories of Woburn, Massachusetts. Last month, the pain management lab company agreed to pay $4.675 million to resolve that case, while not admitting l…
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Volume XXXII, No. 6 – April 21, 2025
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