Tag: CLIA certification

Skip to articles

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.

Sale of Tox Lab Company Attracted Multiple Buyers

CEO SUMMARY: In the midst of expanding their toxicology testing services nationally, DrugScan and DSI Medical Services (collectively Toxicology Holdings Inc.) hired a brokerage firm last year to pursue a sale of the two toxicology companies. Multiple potential buyers responded with interest. The buyer, ACM Global Laboratories—owned by a health system in Rochester, N.Y.—saw the

View Article

Allegations of Lab Test Fraud Involve Multiple Defendants

CEO SUMMARY: UnitedHealth made national news when it filed a $100 million lawsuit against Next Health and other defendants in Dallas in January 2017. The insurer alleged fraud involving clinical laboratory tests. That lawsuit is just the latest chapter in an almost decade-long string of legal proceedings involving the healthcare businesses some of the defendants have

View Article

Health Insurers Want More Data On Clinical Utility of Molecular, Genetic Tests

CEO SUMMARY: Genetic tests that lack two essentials are troublesome for the nation’s health insurers. Those essentials are clinical validity and clinical utility. During a recent webinar, two executives from major health insurers stressed the need for genetic testing labs to provide acceptable evidence that their genetic test is accurate and that it produces information

View Article

Health System Lab Is Genotyping To Identify Best Drugs for Patients

CEO SUMMARY: One essential element of precision medicine will be the regular use of pharmacogenomic testing to provide additional guidance to physicians when selecting the most appropriate therapeutics and optimal dose for each individual patient. Despite the reluctance of private payers and Medicare to reimburse for pharmacogenomic tests, Avera Institute for Human Genetics (AIHG) in

View Article

Achieving CLIA, ISO 15189 at Same Time with A2LA

CEO SUMMARY: An interesting milestone for the clinical lab industry is on the horizon. Physicians Choice Laboratory Services in South Carolina will soon become one of the first lab organizations in the United States to earn joint CLIA and ISO 15189 accreditations with the American Association of Laboratory Accreditation (A2LA). While it was undergoing ISO 15189 accreditation, the organization began to prepare for CLIA accreditation through A2LA, both for a single price.

See additional Dark Daily coverge on CLIA and A2LA certification

View Article

Labs Should Prepare for Tighter CLIA Enforcement

CEO SUMMARY: Lab directors and pathologists should take notice of disturbing new developments in enforcement of CLIA regulations. During the past year, CMS officials have revoked the CLIA certification of several hospital laboratories for what are, essentially, inadvertent violations of proficiency testing (PT) procedures. Revocation of lab’s CLIA certification lasts for one year, and also

View Article