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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.

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.

AG Jerry Brown Settles With Westcliff Med Labs

CEO SUMMARY: In California, Attorney General Jerry Brown is making progress in the whistleblower lawsuit alleging that seven lab companies in California violated state law by not giving Medi-Cal, the state’s Medicaid program, the same lowest lab test prices they extend to physi…

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Did Wrong Strategy Sink Westcliff Medical Labs?

CEO SUMMARY: All sorts of people will argue all sorts of opinions about the financial demise of BioLabs, Inc., and its subsidiary, Westcliff Medical Laboratories, Inc., and why it ended up in a California bankruptcy court. Documents filed in the case indicate that, from the birth…

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ISO 15189 Accreditation Requires Specific Steps For Global Recognition

CEO SUMMARY: This intelligence briefing is the third in an ongoing series about quality management systems (QMS) and their role in advancing the performance of clinical laboratories and improving the quality of the testing services they provide. ISO 15189 is a set of standards for medical…

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Preparing for New Lab Role In Personalized Medicine

CEO SUMMARY: Laboratory medicine is about to find itself between the two jaws of a powerful vise. One jaw is pending major legislative overhaul of the entire healthcare system, along with dwindling reimbursement as Medicare and Medicaid runs out of money. The other jaw is personalized med…

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Ireland Is Restructuring National Lab Test System

CEO SUMMARY: Working from a consultant’s report and recommendations based on studies dating back to 2006 and 2007, Ireland’s Health Service Executive is moving forward to effect a comprehensive reconfiguration of clinical laboratory testing across the nation. This ma…

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January 25, 2010 “Intelligence: Late Breaking Lab News”

Probably few pathologists know that a musical group in San Diego, California, is performing under the name “Pathology.†It is classified as an American death metal band. Alert readers will notice a theme in this band’s output. In 2006, it released its debut album, called “Surgically Hacked, 

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New Clinical Lab Trends To Shape Events in 2010

CEO SUMMARY: In presenting this list of macro trends for clinical laboratories, several themes are in play. They range from a continued emphasis on improving lab operations to the need to acquire and deploy sophisticated information technology. During the next few years, the long…

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December 14, 2009 “Intelligence: Late Breaking Lab News”

In Nigeria, there is an aggressive effort underway to raise the quality of medical laboratory testing. One major element involves inspection of clinical laboratories throughout the nation by teams of laboratory professionals working with the Medical Laboratory Science Council of Nigeria …

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Explaining Certification Versus Accreditation

CEO SUMMARY: Early signs are that the quality management systems (QMS) most likely to find favor with hospitals and clinical laboratories in the United States will be those that meet standards developed by the International Organization for Standardization (ISO). Many hospitals and clinic…

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Auckland Health Boards Give DML Some Testing

CEO SUMMARY: Auckland’s chaotic lab testing situation just became more complicated. Today the Auckland District Health Boards announced a four-year contract to allow Diagnostic Medlab to perform 10% of the area’s test volume, primarily for private hospitals and private specialists. It…

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