Achieving accreditation requires submission of documentation demonstrating substantial compliance to the Standards. Though the accreditation application provides only a “snapshot” of laboratory functions and quality, it has always been expected that accredited laboratories continuously adhere to and uphold the Standards on a daily basis, throughout their three-year accreditation cycles. In the legal accreditation agreement submitted by all applicant laboratories, it is stated that once granted accreditation, “the laboratory bears the burden of showing and maintaining compliance during the application review period and for the duration of accreditation.”

In an effort to further substantiate continued compliance by accredited laboratories and in response to the requirements sanctioned by the Centers for Medicare & Medicaid Services (CMS) for CMS appointed Accreditation Organizations as part of the Medicare Improvements for Patients and Providers Act (MIPPA), the IAC has implemented a policy requiring all accredited laboratories to undergo an audit or site visit at some time during their three-year accreditation period.

Laboratories are randomly selected and assigned a date to receive an audit or site visit, by a computer program. Once selected, the laboratory is notified via e-mail and provided with instructions for either submitting the required audit materials or notification that a site visit will be performed. No additional fees are assessed to the laboratory as a result of these processes.

Random Site Visit

As mandated by CMS, random site visits will be performed on an undisclosed date. However, the IAC is able to provide laboratories with a two to three month timeframe during which to anticipate the site visit. One week after the notification has been sent, an IAC staff member will contact the laboratory to confirm that the notification was received. At this time, the appropriate laboratory contact person is established and any questions regarding selection for the site visit are addressed and clarified.

Random Audit

Accredited laboratories selected to participate in the audit program will be provided a 30-day timeframe by which the audit information must be submitted. Failure to submit the information will result in suspension of the laboratory’s accreditation and potential revocation of the accreditation which would necessitate the laboratory resubmitting an entire application for accreditation.

Any of the following items may be requested as part of the laboratory audit:

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