Central Valley Diagnostic Laboratory

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 Hematology constituting unsuccessful PT performance. (See D2130) 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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, Prothrombin Time , resulting in an "initial" (first) unsuccessful performances. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analyte, Prothrombin Time, as follows: 2021 Q1 2021 Q2 Prothrombin Time 60% 60% Q1 = First Testing Event Q2 = Second Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an initial unsuccessful performance for the analyte, Prothrombin Time. 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, Prothrombin Time, 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 D2130) -- 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 review of proficiency testing reports from CMS (report 155 - Individual Laboratory Profile), API (American Proficiency Institute), and laboratory proficiency testing records, it was determined that the laboratory failed to successfully participate in a proficiency testing program for each test/analyte in which the laboratory is certified under CLIA. Findings included: 1. The laboratory failed to achieve satisfactory performance in testing for Total Bilirubin and Triglycerides for two out of three consecutive testing events. See D2096. . D2087 ROUTINE CHEMISTRY Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 2019 - 2021 Chemistry proficiency testing reports from CMS (report 155, Individual Laboratory Profile) and API (American Proficiency Institute) and laboratory proficiency testing records, and interview with laboratory personnel, it was determined the laboratory failed to attain at least 80% scores for Magnesium (Mg), Sodium (Na), Total Bilirubin, and Total Iron. Findings included: 1. Magnesium a. For 2019: Event 2, CMS and API reported a score of 0% based on the laboratory's 5 unacceptable results out of 5, demonstrating unsatisfactory testing as follows: Sample Lab result API Expected result CH-06 2.8 1.1 - 2.0 CH-07 6.4 2.5 - 4.3 CH-08 4.9 2.0 - 3.5 CH-09 5.8 2.4 - 4.2 CH-10 4.2 1.8 - 3.1 b. For 4 out of 4 test results selected at random from the timeframe May - August 2021 for this survey, the laboratory analyzed and reported results for Magnesium when test performance was unsatisfactory: Date Accession # 7/03/19 582 - 979 7/17/19 583 - 667 7/19/19 583 - 761 7/24/19 584 - 024 2. Sodium (Na) a. For 2021: Event 1, CMS and API reported a score of 60% based on the laboratory's 2 unacceptable results out of 5, demonstrating unsatisfactory testing as follows: Sample Lab result API, Mean result CH-02 122 128.7 CH-04 164 169.1 b. For 3 out of 3 test results selected at random from the timeframe January - April 2021 for this survey, the laboratory analyzed and reported results for Na when test performance was unsatisfactory: Date Accession # 3/26/21 343134 4/07/21 343509 4/20/21 343882 3. Total Bilirubin a. For 2021: Event 2, CMS and API reported a score of 0% based on the laboratory's 5 unacceptable results out of 5, demonstrating unsatisfactory testing as follows: Sample Lab result API, Mean result CH-06 2.0 0.59 CH-07 3.2 1.59 CH-08 4.9 3.35 CH-09 4.1 2.58 CH-10 5.7 4.04 b. For 3 out of 3 test results selected at random from the timeframe May - August 2021 for this survey, the laboratory analyzed and reported results for Total Bilirubin when test performance was unsatisfactory: Date Accession # 5/10/21 344439 5/13/21 344589 5/28/21 345036 4. Total Iron a. For 2021: Event 2, CMS and API reported a score of 60% based on the laboratory's 2 unacceptable results out of 5, demonstrating unsatisfactory testing as follows: Sample Lab result API, Mean result CH-07 63 86.8 CH-08 102 141.4 b. For 3 out of 3 test results selected at random from the timeframe May - August 2021 for this survey, the laboratory analyzed and reported results for Total Iron when test performance was unsatisfactory: Date Accession # 6/10/21 345385 7/01/21 345914 7/22/21 346507 5. The reliability and quality of results for Magnesium, Sodium, Total Bilirubin, and Total Iron reported during the aforementioned timeframes could not be assured. . 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 review of Chemistry proficiency testing reports (CMS report 155), API reports, and laboratory's records, it was determined that the laboratory failed to -- 2 of 6 -- achieve satisfactory performance and scores of at least 80% for two out of three consecutive testing events, constituting unsuccessful testing for Total Bilirubin and Triglycerides. Findings included: 1. Total Bilirubin (a) Records showed this was a Non-initial/ Subsequent unsuccessful performance: 2016 Q2 2016 Q3 2019 Q3 2020 Q1 60% 0% 40% 60% (b) The reliability and quality of Total Bilirubin results reported during the timeframe September 2019 - April 2020 could not be assured. For 12 out of 12 test results selected at random for this survey the laboratory tested for Total Bilirubin when test performance was unsuccessful: Date ID Barcode 12/09/2019 27 --- 12/09/2019 26 --- 12/09/2019 31 --- 01/15/2020 40 1000923 01/15/2020 48 1000922 01/27/2020 23 1001269 01/27/2020 17 1001265 02/03/2020 12 1001449 02 /03/2020 3 1001444 02/05/2020 61 1001514 02/06/2020 5 1001549 02/06/2020 6 1001547 Noted: API and laboratory reports documented testing was performed when it was at a different location: Central Valley Diagnostic Laboratory 5805 Capistrano Ave, Ste C Atascadero, CA 93422 2. Triglycerides (a) Records showed this was an initial unsuccessful performance: 2021 Q1 2021 Q2 60% 0% (b) The reliability and quality of results reported during the timeframe January - August 2021 could not be assured. For 6 out of 6 test results selected at random for this survey the laboratory tested for Triglycerides when test performance was unsuccessful: Date Accession# 03 /16/2021 342826 04/09/2021 343564 04/27/2021 344084 06/03/2021 345144 07/01 /2021 345926 07/08/2021 346221 . D2109 TOXICOLOGY CFR(s): 493.845(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 2019 Toxicology proficiency testing reports from CMS (report 155, Individual Laboratory Profile) and API (American Proficiency Institute), laboratory proficiency testing records, and patients test records, it was determined the laboratory failed to attain at least 80% score for Lithium. Findings included: 1. For 2019: Event 2, CMS and API reported a score of 40% based on the laboratory's 3 unacceptable results out of 5 for Lithium, demonstrating unsatisfactory testing as follows: Sample Lab result API, Mean result CH-07 2.4 1.71 CH-08 1.7 1.30 CH-10 1.5 1.10 2. The reliability and quality of results reported during the timeframe May - July 2019 could not be assured. For 3 out of 3 test results selected at random for this survey, the laboratory analyzed for Lithium when test performance was unsatisfactory: Date Accession # 7/05/19 583 - 102 7/10/19 583 - 342 8/01/19 584 - 416 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 reviews of 2019 Hematology proficiency testing reports from CMS (report 155, Individual Laboratory Profile) and API (American Proficiency Institute), laboratory proficiency testing records, and patients test records, it was determined the -- 3 of 6 -- laboratory failed to attain at least 80% score for Hematocrit and Prothrombin Time (ProTime). Findings included: 1. Hematocrit a. For 2019: Event 1, CMS and API reported a score of 40% based on the laboratory's 3 unacceptable results out of 5, demonstrating unsatisfactory testing as follows: Sample Lab reported API result XE- 03 16 45 - 52 XE-04 16 43 - 49 XE-05 6 18 - 21 b. The laboratory document titled, "Performance Review and

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 subspecialty 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, Glucose and BUN, resulting in an "initial" (first) unsuccessful performances. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analytes, Glucose and BUN, as follows: 2018 Q1 2018 Q2 Glucose 20% 0% BUN 40% 40% Q1 = First Testing Event Q2 = Second Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an initial unsuccessful performance for the analytes, Glucose and BUN. 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 analytes, Glucose and BUN, 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 performances. (See D2016 and D2096) -- 2 of 2 --