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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.

Expert Says Time is Now For Labs to Adopt QMS

CEO SUMMARY: Laboratories in the United States are knowledgeable about the use of quality control (QC) and quality assurance (QA) programs. But QC and QA represent only two small parts of a comprehensive quality management system (QMS), says Lucia Berte, an expert in lab quality. One bene…

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Irish Labs Appeal to Keep Pap Smear Expertise

CEO SUMMARY: In Ireland, pathologists are asking the government to return enough Pap tests back to the country to support and sustain medical training programs in gynecologic cytology. It was 2008 when the Irish government outsourced all Pap testing to a U.S. lab company. That forced Irel…

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June 29, 2009 “Intelligence: Late Breaking Lab News”

In recent weeks, the laboratory at Blanchard Valley Hospital in Findlay, Ohio, received its accreditation for ISO 15189: Medical Laboratories. With this achievement, Blanchard Valley becomes only the third lab in the United States to become ISO 15189-accredited. Blanchard Valley’s …

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Attorney General Brown Sues Seven California Labs

CEO SUMMARY: California Attorney General Jerry Brown made a big splash last month by accusing seven lab firms of committing “massive fraud and kickbacks” under state Medicaid laws. However, he is relying on a legal theory that has not prevailed in some prior court cases invol…

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Got a Lab Test Question? Call an ASCLS Lab Guru!

CEO SUMMARY: Each year since its launch in 2001, the ASCLS Consumer Response Team serves increasing numbers of patients and physicians. Clinical Laboratory Scientist volunteers from the American Society for Clinical Laboratory Science provide answers and help patients understand …

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Staunch Laboratory Advocate Retires After 31 Years of Service

LAST MONTH, THE LABORATORY INDUSTRY lost one its most dedicated, full-time advocates. With his retirement in January, Joe Boone, Ph.D., ended a 31-year career with the Centers for Disease Control and Prevention (CDC). Boone started with the CDC in 1977. In 1992, he …

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Inaccurate Results + Quest Dominates News Cycle

CEO SUMMARY: Most laboratory professionals don’t know it yet, but significant changes occurred to the entire lab industry last week. After Quest Diagnostics Incorporated acknowledged that it was retesting tens of thousands of patients because 7% of the Vitamin D results it repo…

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2008’s Top Ten Lab Stories Lacked Disruptive Impact

CEO SUMMARY: For the first time in recent memory, a year has passed without major tumult or disruptive change in the laboratory industry. Our list of the Top Ten Most Important Stories of 2008 reflects a rather quiet year when compared to most years of this decade. Howeve…

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Two U.S. Labs Pursuing ISO 15189 Accreditation

CEO SUMMARY: In their first public interviews, the nation’s only two laboratories to seek ISO 15189:2007 accreditation share insights about the process, along with its challenges and benefits. Both laboratories are in the final stages of implementation and expect to earn accreditation b…

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Piedmont Med Lab Mixes ISO with Lean & Six Sigma

CEO SUMMARY: Piedmont Medical Laboratory (PML) could be the only clinical laboratory ever to pursue three quality improvement initiatives simultaneously. Even as it was in the early stages of implementing both Lean and Six Sigma methods, PML also decided to seek ISO 15189:2007 accreditati…

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