Tag: CLIA certification

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CLIA certification is the requirement under the Clinical Laboratory Improvement Amendments of 1988 that all entities that perform even one test, including waived tests, on … “materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings” meet certain Federal requirements. If an entity performs tests for these purposes, it is considered under CLIA to be a laboratory and must register with the CLIA program.

The CLIA certification application collects information about a medical laboratory’s operation, which is necessary to determine the type of certificate to be issued and the fees to be assessed.

All types of CLIA certifications are effective for two years, and the different types of certificates are:

  • Certificate of Waiver – Issued to a laboratory that performs only CLIA waived tests
  • Certificate for Provider Performed Microscopy (PPM) procedures – Issued to a laboratory in which a physician, midlevel practitioner or dentist performs specific microscopy procedures during the course of a patient’s visit. A limited list of microscopy procedures is included under this certificate type and these are categorized as moderate complexity.
  • Certificate of Registration – Issued to a laboratory to allow the laboratory to conduct nonwaived (moderate and/or high complexity) testing until the laboratory is surveyed (inspected) to determine its compliance with the CLIA regulations. Only laboratories applying for a certificate of compliance or a certificate of accreditation will receive a certificate of registration.
  • Certificate of Compliance – Issued to a laboratory after an inspection by the state Department of Health that finds the laboratory to be in compliance with all applicable CLIA requirements
  • Certificate of Accreditation – Issued to a laboratory on the basis of the laboratory’s accreditation by an accreditation organization approved by CMS. This type of certificate is issued to a laboratory that performs nonwaived (moderate and/or high complexity) testing.

There are six CMS-approved accreditation or organizations:

  • AABB
  • American Osteopathic Association
  • American Society of Histocompatibility and Immunogenetics
  • COLA
  • College of American Pathologists (CAP)
  • Joint Commission on Accreditation of Healthcare Organizations

Laboratories that apply for accreditation by one of the CMS-approved accreditation organizations must also apply to CMS for a COA at the same time. Laboratories must apply for the highest-level CLIA certification that covers the tests they perform.
Any laboratory located in a state that has a CMS-approved laboratory program is exempt from CLIA certification. Currently, there are two states with approved programs: Washington and New York (partial exemption).

If CMS or the State Agency receives a complaint against a laboratory, the laboratory may receive an unannounced on site survey, even though it only perform waived tests or PPM procedures.

The following exceptions to CLIA certification apply regardless of a laboratory’s location:

  • Any laboratory that only performs testing for forensic purposes
  • Research laboratories that test human specimens but do not report patient-specific results for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, individual patients
  • Laboratories certified by the Substance Abuse and Mental Health Services Administration (SAMHSA), in which drug testing is performed that meets SAMHSA guidelines and regulations. However, a CLIA certification is needed for all other testing conducted by a SAMHSA-certified laboratory.

Pathologist Builds General Path Business From Office Lab

CEO SUMMARY: Doctors Pathology Services in Delaware is successful for two reasons. First it runs the largest pathology lab in the state. But more important, it runs one of the few successful mobile pathology services anywhere. The Mobile Intraoperative Consultation Service(MICS)allows the pathologist to do pathology work on site at ambulatory surgery centers, physicians’ offices,

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Docs’ In-Office Testing Showing Mixed Trends

CEO SUMMARY: Despite the burdens of CLIA certification and reduced reimbursement for lab tests, many medical practice experts are advising doctors to expand in-office testing. However, diagnostic technologies for near-patient testing are still not robust enough to support this trend. Early attempts to expand testing in physicians’ office laboratories show the technology is still not

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Two New Public Labs Launch Operations in FL

CEO SUMMARY: In 49 states, independent commercial laboratory companies are disappearing. But that’s not the case in Florida. In recent months, two new public laboratory companies completed organizational steps and now offer diagnostic testing services. Both companies are starting small, but each is optimistic that the healthcare market will support steady growth in specimen volumes

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