C-Ton Laboratory

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: The STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's records for evaluation of proficiency testing performance from CMS, laboratory proficiency reporting from AAB (American Association of Bioanalysts) and an interview with the laboratory Technical Supervisor (TS) on 7/29/2021 between 10:00 a.m. and 12:30 p.m., it was determined that there were two unacceptable (below 80 %) proficiency testing (PT) results for Prostate Specific Antigen (PSA) for Cycles 1 and 2 in 2021. Findings include: 1. On 7/29/2021, an inspection was conducted between 10:00 a.m. and 12:30 p.m. 2. During a review of the laboratory documentation from AAB (agency providing the proficiency specimens), it was noted at approximately 11 a.m. that there were two unacceptable PT results for Cycles 1 and 2 for PSA on the 2021 proficiency reports. The laboratory utilizes the DXI instrument for chemistry testing. The TS recognized these atypical results. 3. The findings and acceptable ranges were as follows: Analyte: PSA Cycle 1 2021 Sample Actual Result Expected Result (range) 2 22.7 23.1-34.7 Cycle 2 2021 Sample Actual Result Expected Result (range) 1 20.9 22.1-33.2 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 D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on reviews of the second quarter (Q2-2018) of the American Association of Bioanalysts (AAB) proficiency testing records, random patient sampling test results, and interview with the technical supervisor, it was determined that the laboratory failed to attain an overall testing event score of at least 80 percent is unsatisfactory performance in Bacteriology. The findings included: a. Q2-2018, AAB reported an unsatisfactory score of 60% for Bacteriology. b. For two (2) out of two (2) random patient sampling test results reviewed covering period from 2/12/2018 and 1/7/2019, the laboratory analyzed and reported Bacteriology results during the approximate period that the laboratory received an unsatisfactory proficiency test results. c. The technical supervisor confirmed (4/11/2019, 1230) that the laboratory received the above unsatisfactory proficiency test score. 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 reviews of the American Association of Bioanalyts (AAB) proficiency testing records, random patient test results, interview with the technical consultant, it was determined that the laboratory failed to at least twice annually, 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 -- must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. The findings included: a. AAB reported the following unsatisfactory proficiency testing scores. Analyte: Score: Event/Year: Progesterone 50% Q1-2018 Testosterone 50% Q3-2018 b. For four 4) out of four (4) random patient test results reviewed covering period from 1/3/2017 to 10/6/2018 , the laboratory analyzed and reported Progesterone and Testosterone analytes during the period the laboratory received proficiency testing failures. c. The testing personnel confirmed (4/11/2019, 1230) that the laboratory received the above unsatisfactory proficiency testing scores. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(4)(iv) Ensure that an approved