Eastern Plumas Health Care

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 11/8/2024, the laboratory was found not in compliance with the following CONDITION LEVE DEFICIENCIES D2016 - C.F.R. 493.803 Conditions: Successful participation [proficiency testing] and D6000 - C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; Laboratory Director. 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 the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and American Proficiency Institute (API) proficiency testing records (2024-1 and 2024-2), the laboratory failed to successfully participate in 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 4 -- proficiency testing program approved by HHS, for each specialty, subspecialty or test which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty General Immunology for the analytes - Infectious mononucleosis (INF MONO) and Rheumatoid factor (RA/RF). Refer to D2084. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(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 the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and API proficiency testing report, the laboratory failed to achieve satisfactory performance in two out of three consecutive events for the analytes Inf Mono and RA/RF: The finding include: a. Inf Mono - 0% on the 2024 first event, Inf Mono - 0% on the 2024 second event; b. A review of the 2024 Inf Mono scores from API Proficiency Testing confirmed the above scores. c. RA/RF - 0% on the 2024 first event, RA/RF - 0% on the 2024 second event; b. A review of the 2024 RA/RF scores from API Proficiency Testing confirmed the above scores D2085 GENERAL IMMUNOLOGY CFR(s): 493.837(g) Failure to achieve an overall testing event score of satisfactory performance for 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 the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and API proficiency testing report, the laboratory failed to achieve overall testing event for two consecutuve testings or two of three consecutive testing eventss: The finding include: a. General Immunology 0% on the 2024 first event, General Immunology 0% on the 2024 second event, b. A review of the 2024 Inf Mono scores from API Proficiency Testing confirmed the above scores. D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) Failure to achieve satisfactory performance for the same analyte 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 the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and API proficiency testing report, the laboratory failed to achieve satisfactory performance in two out of three -- 2 of 4 -- consecutive events for the analytes ABO, ABO/RHO and D (RHO): The finding include: a. ABO - 0% on the 2024 first event, ABO - 0% on the 2024 second event; b. A review of the 2024 ABO scores from API Proficiency Testing confirmed the above scores; c. D (RHO) - 0% on the 2024 first event, D (RHO) - 0% on the 2024 second event; d. A review of the 2024 D (RHO) scores from API Proficiency Testing confirmed the above scores; e. ABO/RHO - 0% on the 2024 first event, ABO/RHO - 0% on the 2024 second event; f. A review of the 2024 ABO/RHO scores from API Proficiency Testing confirmed the above scores; D2172 UNEXPECTED ANTIBODY DETECTION CFR(s): 493.861(e) Failure to achieve an overall testing event score of satisfactory for 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 the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and API proficiency testing report, the laboratory failed to achieve satisfactory performance in two out of three consecutive events for the analyte Antibody Detection: The finding include: a. Antibody Detection - 0% on the 2024 first event, Antibody Detection - 0% on the 2024 second event; b. A review of the 2024 Inf Mono scores from API Proficiency Testing confirmed the above scores. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for 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 the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and API proficiency testing report, the laboratory failed to achieve satisfactory performance in two out of three consecutive events for the overall analyte Antibody Detection: The finding include: a. Antibody Detection - 0% on the 2024 first event, Antibody Detection - 0% on the 2024 second event; b. A review of the 2024 API Proficiency Testing Antibody Detection confirmed the above scores. 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 a proficiency testing desk review of the CASPER 0155D report and API -- 3 of 4 -- Proficiency Testing records for 2024-1 and 2024-2 events, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to 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 proficiency testing desk review of the CASPER 0155D report and API Proficiency Testing records for 2024-1 and 2024-2 events, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2084. -- 4 of 4 --

Summary Statement of Deficiencies D5815 TEST REPORT CFR(s): 493.1291(h) When the laboratory cannot report patient test results within its established time frames, the laboratory must determine, based on the urgency of the patient test(s) requested, the need to notify the appropriate individual(s) of the delayed testing. This STANDARD is not met as evidenced by: Based on the lack of laboratory's policies, review of patient test records randomly selected from 8/9/2022 to 5/2/2024, and interview with the technical supervisor (TS); it was determined that the laboratory failed to have a policy for turn-around time (TAT) for all tests performed in the laboratory. 1. The laboratory failed to provide TAT of testing for four (5) out of four (5) randomly chosen patients at the time of the survey (May 8, 2024). The laboratory did not provide a TAT policy which may adversely impact patient management. 2. The laboratory TS on May 8, 2024, at approximately 2:00 p.m. affirmed that the laboratory did not have a TAT policy to notify any delay on testing to the physician. 3. The laboratory's testing declaration form, signed by the laboratory director on 5/6/2024, stated that the laboratory performs 155,081 tests annually for which a TAT policy was not available. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: The laboratory director is cited herein on the lack of laboratory's written policies. Based on the surveyor's review of laboratory records and interview with 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 technical supervisor (TS); it was determined that the laboratory director failed to ensure that an approved, signed, and dates policy manual ( policies on all the phases of laboratory testing including: specimen rejection criteria, documents retention policy, panic values, labelling of reagents, proficiency testing policy, validation and verification policy, etc.) is available to all personnel responsible for any aspect of the testing process. See D5815. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of the laboratory's records of personnel training, competency evaluation, laboratory policies and procedures, random patient testing records, and interview with the laboratory 's technical supervisor (TS); the laboratory failed to provide records showing that the laboratory director (LD) has authorized, delegated, and approved lab personnel of any responsibilities and duties in writing. The findings include: 1. The laboratory did not have any records of written delegation and authorization of responsibilities and duties by the LD for the laboratory's technical supervisor/general supervisor. In addition, the responsibilities of the technical supervisor/general supervisor, and testing personnel (TP) were not specified in writing. 2. On May 8, 2024, at approximately 1:00 p.m. the TS affirmed that the LD did not assign, delegated, and authorized in writing duties and responsibilities to the laboratory personnel including the TS and TP. 3. The laboratory testing declaration form, signed by the LD on 5/6/2024 stated that the laboratory performs 155,081 tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(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 a review of the CMS Casper report 096, laboratory proficiency testing (PT) program results from API (American Proficiency Institute)and an interview with the laboratory director (LD), it was determined that the laboratory scored less than 80% for Rheumatoid Factor for Event 1, 2020. The laboratory inspection occurred on 4/8 /22 between 8:30 a.m. and 10:30 am. Findings include: 1. The Casper 096 report for the 2019-2021 was reviewed, and the RA/RF (Rheumatoid factor) result was 0 %. 2. The LP indicated that API (American Proficiency Institute) was used for proficiency testing (PT). 3. Testing results for RA/RF for Event 1 2020 included the following: Assay: RA/RF Sample Reported Expected Results Result RF-01 Positive Negative RF-02 Positive Negative RF-03 Negative Positive RF-04 Negative Positive RF-05 Negative Positive 4. At approximately 9:30 a.m. on 4/8/22, the LD affirmed the above results 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 a review of the CMS Casper report 096, laboratory proficiency testing (PT) program results from API (American Proficiency Institute)and an interview with 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 -- the laboratory director (LD), it was determined that the laboratory scored less than 80% for Lipase and Sodium (Na) for Event 2, 2021. The laboratory inspection occurred on 4/8/22 between 8:30 a.m. and 10:30 am. Findings include: 1. The Casper 096 reports and API for the 2019-2021 were reviewed, and the Lipase PT result was 40 % and Sodium result was 60 % for Event 2, 2021. 2. The LP indicated that API (American Proficiency Institute) was used for proficiency testing (PT). 3. Testing results for Lipase and Sodium included the following: Assay: Lipase Sample Reported Expected Results Result Range CH-08 144 78-139 CH-09 127 65-126 CH-10 164 95- 158 Assay: Sodium Sample Reported Expected Results Result Range CH-06 127 129- 138 CH-07 134 136-145 4. At approximately 10:00 a.m. on 4/8/22, the LD affirmed the above results. -- 2 of 2 --

Summary Statement of Deficiencies D3029 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(2) Test procedures. Retain a copy of each test procedure for at least 2 years after a procedure has been discontinued. Each test procedure must include the dates of initial use and discontinuance. This STANDARD is not met as evidenced by: Based on the laboratory failure to produce a copy of their Rubella test procedure (which they discontinued in the middle of 2018) and an interview with a technical consultant, the laboratory failed to retain a copy of a deleted test procedure for at least 2 years. Findings include: a. Upon request of the surveyor, the laboratory was unable to produce a copy of the Rubella test procedure. b. A technical consultant confirmed (June 25, 2019, 3:15 P.M.) that the laboratory did not keep their Rubella test procedure (or a copy) after they discontinued performing the test. 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 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 General Immunology constituting unsuccessful PT performance. (See D2084) 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 -- D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(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, Rubella, 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, Rubella, as follows: 2017 Q3 2018 Q2 Rubella 0% 20% Q2 = Second Testing Event Q3 = Third 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, Rubella. 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, Rubella, 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 D2084) -- 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 subspecialty of ABO Group & Rh Type constituting unsuccessful PT performance. (See D2162) 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 -- D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) Failure to achieve satisfactory performance for the same analyte 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, D (RHO), resulting in an "initial" (first) unsuccessful performance. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 100% of acceptable responses in two out of three consecutive PT events for the analyte, D (RHO), as follows: 2017 Q3 (0%) 2018 Q1 (80%) Q1 = First Testing Event Q3 = Third 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, D (RHO). D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on the severity of the deficiencies cited herein, the Condition: Laboratories Performing High Complexity Testing: Laboratory director was not met. The laboratory director, high complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See D6089) D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure 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, high complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, D (RHO), 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 D2162) -- 2 of 2 --