Central Coast Multispecialty

Summary Statement of Deficiencies D2098 ENDOCRINOLOGY CFR(s): 493.843(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: Based on interview with Laboratory Director (LD) and review of Proficiency Testing (PT) evaluation records on November 21, 2024, it was determined that the Laboratory failed to attain a score of at least 80% of acceptable responses for Thyroid- stimulating Hormone (TSH) in the third events of 2022 and 2023, which were unsatisfactory analyte performance for the testing events. The findings include: 1. The laboratory enrolled in the American Association of Bioanalysts (AAB) proficiency testing program for TSH testing using Tosoh AIA 900 instrument in 2022, 2023 and 2024. According to the AAB evaluation, the laboratory attained a score of 40% in the third event of 2022 and 60 % in the third event of 2023 for TSH: Event Analyte Sample Repor. Value Exp. Results Q3 2022 TSH 11 6.7 4.1 - 6.7 Q3 2022 TSH 12 3.1 1.9 - 2.8 Q3 2022 TSH 13 5.7 3.5 - 5.4 Q3 2022 TSH 14 9.9 4.2 -11.5 Q3 2022 TSH 15 7.9 4.7-7.8 Q3 2023 TSH 11 9.6 6.1 - 9.7 Q3 2023 TSH 12 3.0 1.9 - 3.1 Q3 2023 TSH 13 8.1 5.4 - 7.5 Q3 2023 TSH 14 6.8 4.5 -6.6 Q3 2023 TSH 15 5.7 3.5 -5.8 2. On November 21, 2024, at approximately 10:00 am the laboratory director affirmed that the laboratory received the above unsatisfactory proficiency scores. 3. The laboratory's testing declaration form, signed by the laboratory director on October 28, 2024, stated that the laboratory performed approximately 280 endocrinology tests annually. 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 D2098 ENDOCRINOLOGY CFR(s): 493.843(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: Based on reviews of analyte performance of the American Association of Bioanalysts (AAB) proficiency testing performance summary records, six (6) randomly selected patients' test requisitions from 02/27/2020 to 10/04/2021 and test results (medical records), quality control reviewed, proficiency testing (PT) result reports and interview with the laboratory director on 10/06/2121 at 10:30 a.m., it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for 3rd quarter (Q3) proficiency event of 2020 for thyroid stimulating hormone (TSH). The findings included: 1. AAB Q3 2020 reported Proficiency Testing Event score of 0% for TSH: Event Analyte Sample Results Exp. Results Q3 2020 TSH 11 4.5 5.7-7.6 Q3 2020 TSH 12 1.7 2.1-2.9 Q3 2020 TSH 13 1.1 1.3-1.9 Q3 2020 TSH 14 5.1 5.7-8 Q3 2020 TSH 15 3.6 4.1-5.9 2. Patient test results reviewed covering the period of Q3, 2020, the laboratory analyzed and reported TSH tests during this time. 3. The laboratory director confirmed 10/06/2021, 11:30 a.m. (survey date) that the laboratory received the above unsatisfactory proficiency testing score. 4. The laboratory annual testing declaration (09/30/2021) for Endocrinology (TSH included) estimated that a total test volume of 400. 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 D2098 ENDOCRINOLOGY CFR(s): 493.843(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: Based on review of 2017: Event 3 proficiency testing reports from CMS (Report 155D, Individual Laboratory Profile) and AAB (American Association of Bioanalysts), laboratory proficiency testing records, and patients test records; and interview with the Laboratory Director (Testing person), it was revealed that the laboratory failed to attain a score of at least 80% for TSH (Thyroid Stimulating Hormone). Findings included: a. CMS and API reported a score of 0% based on the laboratory's 5 unacceptable results out of 5. b. The Laboratory Director (Testing person) affirmed (4/25/19 at 5:30pm) the aforementioned score; and thus unsatisfactory testing for TSH. c. The reliability and quality of results reported for TSH could not be assured when testing was unsatisfactory. Based on review of patients tests records, the laboratory reported no TSH results in September 2017 and fewer than 2 during the timeframe October - December 2017. 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 --