Review of Plan of Correction or Allegation of Compliance by State

6134 - Review of Plan of Correction or Allegation of Compliance by State Agency (Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) The SA reviews the laboratory’s PoC or AoC and accompanying documentation for appropriateness, legibility, completeness, and timeliness. The SA verifies the evidence contains: 1. Corrective action(s) have been taken for patients found to have been affected by the deficient practice. 2. How the laboratory has identified other patients having the potential to be affected by the same deficient practice and what corrective action(s) have been taken. 3. Measures has been put into place or systemic changes have been made to ensure that the deficient practice does not recur. 4. Corrective action(s) are being monitored to ensure the deficient practice does not recur. 5. Identify the signature of the laboratory director or designee. If not properly completed or there is a question about the PoC or AoC, the SA contacts the laboratory representative to obtain clarification or appropriate modification of the plan or allegation. The SA retains a copy of the Form CMS- 2567, the laboratory’s written PoC or AoC and the laboratory’s accompanying documentation in the SA’s file with the certification packet. All records must be kept the period defined by the CMS Records Schedule at DAA-0440- 2015-0008, which is 7 years, or by State requirements, if more stringent than CMS Records Schedule.