From the Center for Clinical Standards and Quality/Quality, Safety & Oversight Group (Ref: QSO-19-17-AO/CLIA) DATE: August 20, 2019
SUBJECT: FY 2018 Report to Congress (RTC): Review of Medicare’s Program Oversight of Accrediting Organizations (AOs) and the Clinical Laboratory Improvement
Amendments of 1988 (CLIA) Validation Program
Federal Law allows for a 20% disparity rate between what CMS finds and what the Accrediting Agencies find while on survey. In the newest report – the disparity rate is still above the allowable 20%. Disparity Rate for 2015: 39%; Disparity Rate for 2016: 46%; Disparity Rate for 2017: 45% (the report was the FY 2018 report).
In order to identify where the gaps were CMS increased their Validation survey’s to 95. CMS reports the top 5 areas where disparity exits include: Physical Environment, Governing Body, Infection Control, Patient Rights, and QAPI.
What to expect in 2020: CMS will continue to increase their validation survey’s of the accrediting agencies. The Accrediting Agencies will focus more heavily in the areas identified in the disparity report and the ‘see it – cite it’ survey process will continue. We expect there will be more Condition level findings, more Preliminary Denial of Accreditation and more survey’s that include both CMS and the Accrediting agency together.