Beverly Hills Cancer Center

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) (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 the survey on January 22, 2025, a review of the laboratory's policy and procedure, American Proficiency Institute (API) proficiency testing (PT) records, and an interview with the technical consultant (TC), it was determined that the laboratory failed to attain at least 80 percent of the acceptable score in Routine Chemistry for Albumin analyte in the second event of 2023 (Q2-2023), Ferritin analyte in the first event of 2023 (Q1-2023), and Carbon Dioxide (CO2) analyte in the first event of 2024 (Q1-2024). The findings include: 1. Based on the surveyor's review of PT records for Q2-2023 and Q1-2024, API reported an unsatisfactory score report as follows: a. Albumin PT Q2-2023 Overall score: 60% Specimen Reported Expected CHM-06 2.9 2.3 - 3.0 CHM-07 *4.6 3.6 - 4.5 CHM-08 2.2 1.8 - 2.3 CHM-09 *5.5 4.3 - 5.4 CHM- 10 4.1 3.3 - 4.1 b. Ferritin PT Q1-2023 Overall score: 50% Specimen Reported Expected IA-01 189 152 - 208 IA-02 *188 11 - 19 c. CO2 PT Q1-2024 Overall score: 40% Specimen Reported Expected CHM-06 11 10 - 21 CHM-07 *15 23 - 34 CHM-08 *16 19 - 30 CHM-09 5 4 - 15 CHM-10 *22 27 - 40 2. The TC affirmed by interview on January 22, 2025, at approximately 11:00 a.m. that the laboratory obtained the PT scores mentioned in statement #1. 3. According to the laboratory's testing declaration submitted on the day of the survey, the laboratory performed approximately 118,862 Routine Chemistry test samples, including the Albumin, Ferritin, and CO2 analytes, during the time the laboratory received unsatisfactory proficiency testing results. Thus, the accuracy and reliability of patient test reports cannot be determined. D2098 ENDOCRINOLOGY 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 -- CFR(s): 493.843(a) (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 the survey on January 22, 2025, at approximately 11:00 a.m., review of the laboratory's policy and procedure, evaluation assessment of the American Proficiency Institute (API) proficiency testing (PT) records, and an interview with the technical consultant (TC), it was determined that the laboratory failed to attain at least 80 percent of the acceptable score in Endocrinology for multiple analytes in the in different testing events for the years 2022, 2023 and 2024. The findings include: 1. Based on the surveyor's assessment of PT records for the years 2022, 2023, and 2024, API reported an unsatisfactory score report as follows: a. In the second event for 2022 (Q2-2022), Free Thyroxine (FT4) scored 40%. b. In the third event of 2022 (Q3- 2022), Free Triiodothyronine (FT3) scored 40%. c. In the first event of 2023 (Q1- 2023), Testosterone and Vitamin B12 scored 50%. d. In the third event of 2023 (Q3- 2023), Carcinoembryonic antigen (CEA) scored 0%. e. In the first event of 2024 (Q1- 2024), FT3 scored 60%. f. In the third event of 2024 (Q3-2024), CEA scored 50%. 2. The TC affirmed by interview on January 22, 2025, at approximately 11:00 a.m. that the laboratory obtained the PT scores mentioned in statement #1 covering the years 2022, 2023, and 2024. 3. According to the laboratory testing declaration submitted at the time of the survey, the laboratory performed approximately 2,217 tests in the Endocrinology subspecialty during the time the laboratory received an unsatisfactory proficiency testing results in various testing events for FT4, FT3, Testosterone, Vitamin B12, and CEA analytes. Therefore, the reliability and quality of Endocrinology patient results reported cannot be assured. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results; This STANDARD is not met as evidenced by: Based on the cited deficiencies, the Laboratory Director is herein cited for failing in the responsibility for not ensuring that the testing personnel performing patient testing, including proficiency testing, maintain accuracy and reliability as required. See D2087 and D2098. -- 2 of 2 --

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: Based on the surveyor's review of the laboratory's records for evaluation of proficiency testing performance from the CMS 96 Report, laboratory proficiency reporting from API, and an interview with the laboratory technical consultant (TC) on 11/22/2021 between 9:30 a.m. and 11:30 a.m., it was determined that there were three unacceptable (below 80 %) proficiency testing (PT) results for Chemistry in the 2020 and 2021 submission date ranges. Findings include: 1. On 11/22/2021, an inspection was conducted between 9:30 a.m. and 11:30 a.m. 2. During a review of the laboratory documentation from API (agency providing the proficiency specimens), it was noted at approximately 10 a.m. that there were three unacceptable PT results for general chemistry. The laboratory utilizes the OCD Vitros instruments for general chemistry testing. The TC recognized these atypical results. 3. The findings and acceptable ranges were as follows: Cycle 2 2020 Chemistry Analyte: TIBC (3/5 unacceptable) Sample Actual Result Expected Result (range) CH-06 317 327-502 CH-09 206 209- 292 CH-10 285 302-392 Cycle 2 2021 Chemistry Analyte: Glucose (5/5 unacceptable) Sample Actual Result Expected Result (range) CH-06 84 63-78 CH-07 131 100-123 CH-08 202 156-192 CH-09 177 137-168 CH-10 236 186-229 Cycle 3 2020 Chemistry Analyte: Ferritin (2/2 unacceptable) Sample Actual Result Expected Result (range) IA-11 78 46-59 IA-12 122 69-100 4. The TC affirmed the unacceptable results listed above. D6022 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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 -- 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)(5) Ensure that the quality control and quality assessment programs are established and maintained to identify failures in quality as they occur. This 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 the CMS 96 Report, laboratory proficiency reporting from API, and an interview with the laboratory technical consultant (TC) on 11/22/2021 between 9:30 a.m. and 11:30 a.m., it was determined that there were three unacceptable (below 80 %) proficiency testing (PT) results for Chemistry in the 2020 and 2021 submission date ranges. . The findings include: See D-2087 (3 deficiencies) listed above. -- 2 of 2 --

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 Routine Chemistry constituting unsuccessful PT performance. (See D2096) 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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, Cholesterol, HDL, as follows: 2019 Q2 2019 Q3 Cholesterol, HDL 40% 0% Q2 = Second 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, Cholesterol, HDL. 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, Cholesterol, HDL 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 D2096) -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of the laboratory test records for twelve (12) randomly selected patients' test requisitions and test results (medical records), quality control review from 09/27/2018 to 10/04/2019, proficiency testing (PT) result reports, and interview with the laboratory technical consultant (TC), it was determined that the laboratory failed to enroll and participate in a proficiency testing (PT) program that meets the criteria in subpart H of 42 CFR part 493 and is approved by HHS. The findings included: a. The laboratory performed routine chemistry and endocrinology testing which is in the list of subpart I of 42 CFR part 493 using the OCD Vitros system analyzer. b. The laboratory failed to show evidence of enroll in a PT program for routine chemistry and endocrinology testing event using a CMS approved PT program American Proficiency Institute (API) for the first event (Q-1), 2018 (which meets the criteria in subpart H of 42 CFR part 493). The laboratory analyzed and reported routine chemistry and endocrinology patient test results during the approximate time of non-enrollment in a proficiency testing (PT) program. c. The laboratory technical consultant (TC), confirmed 10/04/2018 15:30 (survey date) that patient test results were reported during the period of the PT 1st event (Q-1), 2018 for routine chemistry and endocrinology, yet the laboratory was not enrolled in an accredited PT program. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- d. The laboratory annual testing declaration (04/11/2019) estimated the routine chemistry and endocrinology, estimated the total test volume as 111,721. 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 third quarter (Q3-2017), first quarter (Q1-2018), third quarter (Q3- 2018) and second quarter (Q2-2019) of the American Proficiency Institute (API) proficiency testing records, laboratory's proficiency testing reports, random patient test records and interview with the laboratory staff, it was determined that the laboratory director failed to ensure that the laboratory successfully performed in a CMS-approved proficiency testing program. See D 2087. 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: Based on reviews of analyte performance for the third quarter (Q3-2017), first quarter (Q1-2018), second quarter (Q3-2018) and second quarter (Q3-2019) of the American Proficiency Institute (API) proficiency testing performance summary records, (12) randomly selected patients' test requisitions and test results (medical records), quality control review from 09/27/2018 to 10/04/2019, proficiency testing (PT) result reports, and interview with the laboratory technical consultant (TC), it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Sodium (NA). The findings included: a. API reported Proficiency Testing Sodium (NA) scores: Event Score % Q3 2017 60 Q1 2018 0 Q3 2018 60 Q2 2019 60 b. Patient test results reviewed covering period from 09/27/2018 to 10/04/2019, the laboratory analyzed and reported Sodium (NA) tests during the approximate time the laboratory received three (3) sequential unsatisfactory failed proficiency scores of Q3, 2017, Q1, 2018, Q3, 2018 and Q2, 2019. c. The technical consultant confirmed (10/04 -- 2 of 4 -- /2019, 15:30) that the laboratory received the above unsatisfactory proficiency testing score. d. The laboratory annual testing declaration (04/11/2019) for routine chemistry (NA included) estimated that a total test volume of 111,721. 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, D6018) 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 American Proficiency Institute (API) proficiency testing (PT) performance summaries reports for the third quarter (Q3), 2017, first quarter (Q1), 2018, third quarter (Q3), 2018 and second quarter (Q2), 2019, and an interview with the laboratory technical consultant (TC), it was determined that the laboratory director failed to be responsible for assuring compliance with the applicable CLIA regulations pertaining to successful performance of PT samples tested as required for the analyte sodium (NA) in 2017, 2018 and 2019. 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 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