Summary:
Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the ConvenientMD Urgent Care Weymouth laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: . Based on record review and interview with the Director of Operations on 5/26/21, the laboratory failed to authorize the proficiency testing (PT) program to release all data to Health and Human Services (HHS) as evidenced by the following: The surveyor reviewed the CMS CLIA Application and Summary report prior to the survey which revealed no proficiency testing results for Hematology testing. The surveyor reviewed PT records for calendar years 2019, 2020, and 2021 on 5/26/21. The review revealed that the laboratory's CLIA number was not listed on the American Proficiency Institute (API) PT reports. The Director of Operations confirmed through interview on 5/26/21 at 2:30 PM that the API PT reports did not contain the laboratory's CLIA number therefore Hematology PT results were not released to HHS. The laboratory performs approximately 450 Hematology tests annually. D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on record review and interview with the Director of Operations on 5/26/21, the laboratory failed to participate in the first Proficiency Testing (PT) event of 2020 as evidenced by the following: The surveyor reviewed PT records for calendar years 2019, 2020, and 2021 on 5/26/21. The review revealed a 0% score for the first event in 2020 for the Hematology specialty. The Director of Operations interviewed on 5/26 /21 at 2:30 PM confirmed that the laboratory failed to participate in PT for the first event in 2020 because the practice manager at the time was not aware of PT. -- 2 of 2 --