Simplicity Health

Summary Statement of Deficiencies D0000 . The Simplicity Health laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the proficiency testing desk review survey performed on November 13, 2025. The following condition-level deficiencies were cited: 493.803 Successful Participation The following standard-level deficiencies were cited: 493.843 Endocrinology . D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: . Based on review of proficiency testing (PT) reports from the Center for Medicare and Medicaid Services (CMS) and the American Proficiency Institute (API), the 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 -- laboratory failed to successfully participate in Follicle Stimulating Hormone (FSH) PT testing under the specialty of Endocrinology in 2025. Findings are as follows: 1. The CMS CASPER Report 0155D and the API 2025 Chemistry Core - 2nd Event Performance Summary and Comparative Evaluation and the API 2025 Chemistry Core - 3rd Event Performance Summary and Comparative Evaluation were reviewed on November 13, 2025. 2. The reports indicated the laboratory failed to submit PT results to the PT program within the time frame specified by the program for one event in 2025, resulting in a score of 0 for the testing event and unsuccessful performance of the analyte (see D2104) 3.The reports indicated the laboratory failed to achieve satisfactory performance for Endocrinology Testing in two of three consecutive testing events 2025, resulting in unsuccessful performance of the analyte (see D2107) . D2104 ENDOCRINOLOGY CFR(s): 493.843(d) (d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: . Based on a review of proficiency testing (PT) reports from the American Proficiency Institute (API) provider, the laboratory failed to submit Endocrinology PT results to API prior to the submission deadline. Findings are as follows: 1. The laboratory failed to submit PT results for the Follicle Stimulating Hormone (FSH) analyte for the 2025 Chemistry Core - 2nd Event. Failure to participate in the testing event resulted in unsatisfactory performance for the analyte. 2. API PT Performance Evaluation listed the following unsatisfactory FSH score: 2025 Chemistry Core - 2nd Event Failure to Participate 0% . D2107 ENDOCRINOLOGY CFR(s): 493.843(f) (f) Failure to achieve satisfactory performance for the same analyte or test in 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 a review of Center for Medicare and Medicaid Services reports and American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to achieve successful PT performance for Follicle Stimulating Hormone (FSH). Findings are as follows: 1. The laboratory failed to attain satisfactory Testosterone PT scores in two out of three consecutive PT events. Two out of three consecutive unsatisfactory PT scores for the same analyte constituted unsuccessful performance. 2. API PT Performance Evaluation listed the following unsatisfactory FSH scores: - 2025 Chemistry Core - 2nd Event: 0% - 2025 Chemistry Core - 3rd Event: 20% . -- 2 of 2 --

Summary Statement of Deficiencies D0000 The Simplicity Health laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the proficiency testing desk review survey performed on August 11, 2025. The following condition-level deficiencies were cited: 493.803 Successful Participation The following standard-level deficiencies were cited: 493.843 Endocrinology . D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: . Based on review of proficiency testing (PT) reports from the Center for Medicare and Medicaid Services (CMS) and the American Proficiency Institute (API), the 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 -- laboratory failed to successfully participate in Testosterone Testing PT under the specialty of Endocrinology in 2025. Findings are as follows: 1. The CMS CASPER Report 0155D and the API 2025 Chemistry Core - 1st Event Performance Summary and Comparative Evaluation and the API 2025 Chemistry Core - 2nd Event Performance Summary and Comparative Evaluation were reviewed on August 11, 2025. 2. The reports indicated the laboratory failed to achieve satisfactory performance for Endocrinology Testing in two of three consecutive testing events 2025, resulting in unsuccessful performance of the analyte (see D2107). 3. The reports indicated the laboratory failed to submit PT results to the PT program within the time frame specified by the program for one event in 2025, resulting in a score of 0 for the testing event and unsuccessful performance of the analyte (see D2104) . D2104 ENDOCRINOLOGY CFR(s): 493.843(d) (d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: . Based on a review of proficiency testing (PT) reports from the American Proficiency Institute (API) provider, the laboratory failed to submit Endocrinology PT results to API prior to the submission deadline. Findings are as follows: 1. The laboratory failed to submit PT results for the Testosterone analyte for the 2025 Chemistry Core - 2nd Event. Failure to participate in the testing event resulted in unsatisfactory performance for the analyte. 2. API PT Performance Evaluation listed the following unsatisfactory Testosterone score: 2025 Chemistry Core - 2nd Event Failure to Participate 0% . D2107 ENDOCRINOLOGY CFR(s): 493.843(f) (f) Failure to achieve satisfactory performance for the same analyte or test in 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 a review of Center for Medicare and Medicaid Services reports and American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to achieve successful PT performance for Testosterone. Findings are as follows: 1. The laboratory failed to attain satisfactory Testosterone PT scores in two out of three consecutive PT events. Two out of three consecutive unsatisfactory PT scores for the same analyte constituted unsuccessful performance. 2. API PT Performance Evaluation listed the following unsatisfactory Testosterone scores: - 2025 Chemistry Core - 1st Event: 40% - 2025 Chemistry Core - 2nd Event: 0% . -- 2 of 2 --

Summary Statement of Deficiencies D0000 . A complaint investigation was completed on July 18, 2025. Immediate Jeopardy existed for the following condition level deficiencies: D5400 493.1250 Condition: Analytic Systems D6000 493.1403 Condition: Laboratory Director . D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to follow safety procedures for the disposal of biohazardous materials 2025. Findings are as follows: 1. The laboratory performed venipuncture to collect blood specimens for Chemistry testing as confirmed by Testing Personnel 3 (TP3) during a tour of the laboratory at 8:14 a.m. on 7/16/25. 2. Two large, open sharps containers were observed on the floor of the blood-drawing room next to patient chairs. The lid of one sharps container was not secured and was two-thirds full of biohazardous venipuncture materials. 3. Biohazard materials were to be "stored safely and securely" to prevent exposure and contamination as defined in the Quality Assurance Plan at Simplicity Health policy found in the Project Quality Assurance Plan binder provided by the laboratory on the date of survey. 4. In an interview at 11: 21 a.m. on 7/16/25, TP3 confirmed the above findings. . D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves 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 8 -- procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: . Based on review of laboratory policies and procedures, patient testing and quality control logs, direct observation, and interview with laboratory personnel, the laboratory failed to meet the analytic systems requirements for chemistry. Findings are as follows: 1. The laboratory failed to follow verbal manufacturer instructions for one of three chemistry analyzers prior to reporting two patient test results in February 2025. See D5411 2. The laboratory failed to complete all required performance verification (PV) activities for 24 of 24 analytes on a new chemistry analyzer prior to reporting patient test results in 2025. See D5421 3. The laboratory failed to ensure two levels of quality control material (QC) were performed and acceptable on one of three chemistry analyzers on 13 of 66 days of testing in April, May, and June 2025. See D5447 . D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to follow verbal manufacturer instructions for one of two chemistry analyzers in use prior to reporting two patient test results in February 2025. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by Testing Personnel 3 (TP3) during a tour of the laboratory at 8:14 a.m. on 07/16/25. 2. A Tosoh AIA-2000 analyzer was observed as present and available for use during the tour. The laboratory performed Vitamin D testing using this analyzer. 3. Review of the laboratory's Tosoh AIA-2000