A2LA Accredits First Clinical Laboratory in US to New Version of ISO 15189
ADL Health meets requirements of ISO 15189:2022, the latest version of the standard
FREDERICK, MD, AUGUST 27, 2024—The American Association for Laboratory Accreditation (A2LA), a global accreditation body, has announced that it has accredited the first clinical laboratory in the United States to ISO 15189:2022, the fourth edition and latest version of the standard to be published. The laboratory, ADL Health, is a participant of A2LA’s Platinum Choice Accreditation Program, a program that combines the requirements of ISO 15189 and the Clinical Laboratory Improvement Amendments of 1988 into one assessment.
“A2LA extends a well-deserved congratulations to ADL Health for its ISO 15189:2022 accreditation,” said Trace McInturff, vice president of accreditation services at A2LA. “This organization exemplifies the importance of quality, accreditation, and continual improvement.”
Headquartered in San Antonio, TX, ADL Health is a molecular diagnostics group that develops and commercializes genetic products and services for reproductive health, precision medicine, and infectious diseases. Their scope of accreditation includes microbiological and chemical testing, including virology, bacteriology, mycology, parasitology, toxicology, and routine chemistry.
“Every assessment we’ve had with A2LA has been done with a culture of quality and improvement,” said Dr. Michael Pikulski, ADL Health’s chief scientific officer. “Having the assessor identify nonconformities helps us to become a more quality laboratory.”
The fourth edition of ISO 15189 was published on December 6, 2022, and included revisions that were developed over the course of four years by a team of experts.
The International Laboratory Accreditation Cooperation issued ILAC Resolution GA 26.08 providing a transition period of three years from the date of publication. This provides clinical testing laboratories with sufficient time to prepare to upgrade to the new requirements while maintaining their existing accreditation.
For clinical laboratories ready to apply for accreditation to ISO 15189:2022, contact A2LA to begin the process.
- For more information about ADL Health’s accreditation, read this A2LA case study.