Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Mahesh Patel MD PA on 10/15/20. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing and interview with Testing Person #B, the laboratory failed to have a signed attestation statement for 1 (3rd testing event in 2019) out of 8 (2nd, and 3rd testing events in 2018, 1st, 2nd, and 3rd testing events in 2019, and 1st, 2nd, and 3rd testing events in 2020) testing events reviewed. Findings Included: Review of API proficiency testing revealed the attestation statement for Chemistry Core in the 3rd testing event in 2019 had not been signed by the laboratory director or the testing personnel. Interview on 10 /15/20 at 11:00 AM with Testing Person #B confirmed that the API Chemistry Core 3rd testing event in 2019 attestation sheet had not been signed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --