Med 360 Urgent Care

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) proficiency test records and an interview with Testing Personnel #6, the Laboratory failed to implement a mechanism to verify the accuracy of the mecA gene, a non-regulated test in the specialty of Microbiology. This was noted for three of three Microbiology events reviewed in 2021 and 2022. The findings include: 1. A review of the API proficiency records revealed the laboratory scored zero percent due to "Failure to participate" on the following events: a) 2021 Microbiology Other 3rd Event. b) 2022 Microbiology Other 1st and 2nd Event. 2. During an interview on October 26, 2022, at 1:20 PM, when asked why the laboratory had not submitted results for three consecutive surveys, Testing Personnel #6 explained the laboratory only performed testing for the presence of the mecA gene. Testing Personnel #6 further stated the laboratory had called API about why the mecA gene was only reported. The results that were submitted stated "see data summary" but there was no evidence the laboratory had reviewed the data. The surveyor asked if the laboratory had implemented another mechanism to verify the accuracy of the mecA gene at least semi-annually; Testing Personnel #6 stated she was not aware this was required. 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 --

Summary Statement of Deficiencies D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on a review of the installation and validation documentation for the Horiba ABX Micros ES Hematology analyzer and interviews with Testing Personnel #2 and the General Supervisor, the surveyor determined the Laboratory Director failed to document (as indicated by signature and date) his review and approval of the initial validation procedures for precision, accuracy and reportable ranges, as verifying the manufacturer's performance specifications for the analyzer, before patient testing began. The findings include: 1. A review of the installation and validation records for the Horiba ABX Micros ES Hematology analyzer revealed no documentation of review and approval by the Laboratory Director (as indicated by a signature and date) on the initial verification procedures for precision and reportable ranges performed on 10/7/2019, and the correlation studies for accuracy performed in November 2019. (These studies were printed by the General Supervisor on the day of the survey.) 2. A review of Hematology records revealed patient CBC (Complete Blood Count) testing on the analyzer began 10/21/2019. 3. During an interview and review of these records on 9/16/2020 at 11:10 AM, Testing Personnel #2 and the General Supervisor confirmed the previous Laboratory Director had failed to document his review before the analyzer was utilized for patient CBC testing. SURVEYOR ID#32558 Licensure and Certification Surveyor 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 --