Summary:
Summary Statement of Deficiencies D0000 An initial CLIA certification survey was conducted for ConvenientMD Urgent Care - Quincy laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) review and interview with the Practice Manager on 11/18/19, the laboratory did not document and maintain a copy of all PT records as evidenced by the following: The surveyor reviewed PT records for calendar year 2019 (1 testing event). The review revealed that signed attestation statement provided by the American Proficiency Institute (API) PT program was not available for 2019 API Hematology/Coagulation 2nd Event. The Practice Manager confirmed in an interview on 11/18/19 at 1:14 PM that the attestation statement was not signed by the testing person and laboratory director. 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 --