Michael B Scott Md Inc

Summary Statement of Deficiencies D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) laboratory proficiency testing results and interview with the laboratory testing personnel (TP); it was determined that the laboratory failed to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events which is unsuccessful performance. The findings included: 1. The laboratory attained scores of 0 % for the subspecialty of Bacteriology on the analyte "Urine Colony Count" for the second PT event on 2018 (Q2/2018) and 40% for the third PT event on 2018 (Q3/2018) respectively. 2. Based on the laboratory's annual testing declaration submitted on the day of the survey February 26, 2021, the laboratory performed and reported approximately 660 patient samples in the Bacteriology section which accuracy of the urine colony counts cannot be assured. 3. Testing Personnel confirmed on 02/26/2020 at approximately 12:00 p.m. that the laboratory received the above unsuccessful performance proficiency testing scores. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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 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 -- director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

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 review for third quarter (Q3-2016) score of 60%, third quarter (Q3-2017) score of 60% of the American Proficiency Institute (API) proficiency testing records, interview with the laboratory staff, and random patient test results, it was determined that the laboratory failed to at least twice annually, the laboratory must verify the accuracy of any test or procedure it performs. The findings included: a. Q3-2016 and Q3-2017, the laboratory received unsatisfactory results for the Uricult colony count test of 60 % scores respectively. b. For eight (8) out of eight (8) random patient test results reviewed covering period from 2/22/2016 to 2/8/2018, the laboratory analyzed and reported colony count during the time that the laboratory received the unsatisfactory proficiency testing scores. c. The laboratory staff affirmed (3/8/2018, 12N), that the laboratory received the above unsatisfactory proficiency testing scores. 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 --