Saddleback Medical Group Inc

Summary Statement of Deficiencies 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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Endocrinology constituting unsuccessful PT performances. (See D2016) 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 -- D2107 ENDOCRINOLOGY CFR(s): 493.843(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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Thyroid Stimulating Hormone (TSH), resulting in unsuccessful performance as follows: 2022 Q1 2022 Q3 TSH 60% 0% Q1 = First testing event Q2 = Second testing event Q3 = Third testing event Note: TSH - previously cited unsatisfactory performance: 2021 Q3 2022 Q1 TSH 0% 60% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See D6016) D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. Based on a desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, TSH, the laboratory repeatedly failed to achieve satisfactory performances for the same analyte or test in two out of three consecutive testing events, resulting in subsequent unsuccessful PT performance. (see D2016 and D2107) -- 2 of 2 --

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 the laboratory's API (American Proficiency Institute) proficiency testing (PT) result reports, and interview with the laboratory staff, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Free T4. The findings included: a. The laboratory performed endocrinology including but not limited to Free T4. b. The laboratory enrolled with API PT program to ensure the accuracy of the testing results. c. The laboratory attained a score of 0% for Free T4 in the Q3 2021 PT event was unsatisfactory analyte performance for the testing event. d. The laboratory performed in approximately 457 patient samples monthly. e. The laboratory staff affirmed (9/16/22 @ 10:55 am) that the laboratory attained a score of 0% for Free T4 in the Q3 2021 PT event was unsatisfactory analyte performance for the testing event. D2121 HEMATOLOGY CFR(s): 493.851(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 the laboratory's API (American Proficiency Institute) proficiency testing (PT) result reports, and interview with the laboratory staff, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- responses for Blood Cell Identification (Cell ID) for Q1 2022 hematology PT was unsatisfactory analyte performance for the testing event. The findings included: a. The laboratory used Coulter Act Diff2 system to perform complete blood cell counts (CBC) including but not limited to automated blood cell differentials (Cell ID) and enrolled its PT with API to verify the accuracy, reliability, and timely of the patient test results. b. The laboratory failed to attain a score of at least 80 percent of acceptable responses for Cell ID for Q1 2022 hematology PT was unsatisfactory analyte performance for the testing event. c. The laboratory performed CBC and report automated Blood Cell Identification in approximately 910 patient sample monthly. d. The laboratory staff affirmed (9/16/2022 @ 10:55am) that the laboratory failed to attain a score of 80% for automated Blood Cell ID 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 of the laboratory's API (American Proficiency Institute) proficiency testing (PT) result reports, and interview with the laboratory staff, it was determined that the laboratory, at least twice annually, the laboratory failed to verify the accuracy of any test or procedure it performed that are not included in subpart I of 42 CFR part 493. The findings included: a. The laboratory performed the following tests the following tests: CRP (hs), CRP (quant), Ferritin, PTH, Testosterone (TST) and Vitamin D, which are not listed in subpart I of 42 CFR part 493, b. The laboratory elected to enroll with API to ensure accuracy of the patient test results for evaluation of proficiency testing performance at least twice annually c. The laboratory failed to attain scores of at least 80 percent of acceptable responses for the analytes listed at (a) in various PT event as follows: Test = analyte PT Score and Event Vol = Estimated Volume Analyte Score (%) Event Vol (monthly) CRP (hs) 0 Q1 22 51 CRP (quant) 50 Q3 21 51 Ferritin 50 Q1 21 115 PTH 0 Q3 21 158 PTH 0 Q1 22 TST 50 Q1 22 16 Vit D 50 Q1 22 410 d. The laboratory staff affirmed (9/16/2022 @ 11 am) that the laboratory failed to attain a score of 80% for the analyte listed in item (c) with an estimated monthly test volumn were unsatisfactory analyte performance for those testing event. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected -- 2 of 3 -- by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review the laboratory's records, and interview with the laboratory staff, it was determined that the laboratory failed to perform and document calibration verification procedure including, but not limited to use at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system, and at least once every 6 months. The findings included: a. The laboratory used Hitachi Cobas 6000 to perform routine chemistry equipped with ISE including but not limited to the following tests: Albumin, Glucose, Calcium, Cholesterol, Triglyceride. b. The Cobas 6000 system uses one or two calibrators to perform calibration for each analyte. c. The laboratory failed to perform calibration verification for routine chemistry in 2021 and 2022. d. The laboratory staff affirmed (9/12/2022 @ 11:45 am) that the laboratory did not have documentations of calibration verification for the years of 2021 and 2022. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the laboratory's records, API (American Proficiency Institute) proficiency result reports, and interview with the laboratory staff, it was determined that the laboratory director failed to ensure that the proficiency testing samples, and evaluation of proficiency testing performance at least twice annually were tested as required. The findings included: a. The laboratory performed routine chemistry, hematology, and endocrinology. b. The laboratory enrolled with API PT programs to ensure accuracy for all the tests performed. c. The laboratory director failed to ensure that the proficiency testing samples were tested as required (see D-2098, D-2121 and D-5217). -- 3 of 3 --

Summary Statement of Deficiencies 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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Endocrinology constituting unsuccessful PT performance. (See D2107) 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 -- D2107 ENDOCRINOLOGY CFR(s): 493.843(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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Thyroid Stimulating Hormone (TSH), as follows: 2021 Q3 2022 Q1 TSH 0% 60% Q1 = First testing event Q3 = Third testing event b. Failure to achieve satisfactory performance for the same analyte or test in two of three consecutive PT resulted in an initial unsuccessful performance for the analyte, TSH.. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See D6016) D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, TSH, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (see D2016 and D2107) -- 2 of 2 --

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 of the laboratory'sAPI (American Proficiency Institute) proficiency testing (PT) results reports from the 3rd 2018 thru partial 3rd 2020 PT records, and the laboratory records, and interview with the laboratory testing personnel, it was determined that the laboratory failed to verify the accuracy of Glycated Hemoglobin (A1c), LDL (measured), CRP (quant), and Sedimentation Rate (ESR) that the laboratory performed analyte which were not included in subpart I of this part, 42 CFR part 493. The findings included: a. The laboratory performed analyte in the subspecialties of chemistry, diagnostic immunology, and hematology, including but are not limited to the followings: glycated hemoglobin (A1c), LDL (measured) (LDL), CRP (quant) (CRP), and ESR. b. In order to meet the CLIA regulations, to verify and to ensure the accuracy of any test or procedure the laboratory performed that is not included in subpart I of 42 CFR part 493. c. The laboratory elected to enroll API (American Proficiency Institute) PT programs to verify the accuracy of their testing procedures. d. On 10/23/2020 @ 11:40 AM reviewed the laboratory API PT testing results reports from the 3rd 2018 thru a partial 3rd 2020 PT result reports. e. The laboratory attended scores of 0 % and 40% for analyte of A1c and LDL for the 2nd and the 3rd 2020 PT events which were unsatisfactory test performance. f. The laboratory attended scores of 50 % the analyte of CRP for the 1st 2020 PT event which was unsatisfactory test performance. g. The laboratory attended scores of 50 % the analyte of ESR for both 3rd 2019 and the 2nd 2020 PT events which were unsatisfactory test performance. h. The laboratory performed the analyte of A1c, LDL (using HDL counts), CRP and ESR in approximately 524, 690, 45, and 73, patient samples each month, respectively. i. The laboratory personnel affirmed on 10/23/2020 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 -- @ noon that the laboratory failed to attend at least 80% of each analyte mentioned above (d) (e) and (f) in various PT events, which were unsatisfactory test performances. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) results reports from 3rd 2018 thru part 3rd 2020 PT records, and the laboratory records, and interview with the laboratory testing personnel, it was determined that the laboratory director failed to Ensure that the proficiency testing samples are tested as required under Subpart H of 42 CFR part 493. The findings included: a. The laboratory performed analyte in the subspecialties of chemistry, diagnostic immunology, and hematology, including but are not limited to the followings: glycated hemoglobin (A1c), LDL (measured) (LDL), CRP (quant) (CRP), and ESR. b. The laboratory affirmed on 10/23/2020 @ noon that the laboratory failed to attend at least 80% of the analyte of A1c, LDL, CRP, and ESR, in various API PT challenges, see D-5217, which were unsatisfactory test performances. -- 2 of 2 --