Bear Valley Community Health Care District

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 a recertification survey conducted 5/10/2023, review of CLIA database, CASPER Report 0155D and the laboratory's American Proficiency Institute (API ) proficiency testing (PT) result reports, and interview with the laboratory manager; it was determined that the laboratory failed to achieve an overall testing event score of acceptable responses for Compatibility Testing in two consecutive testing events or two out of three consecutive testing events resulting in unsuccessful performance. The findings included: a. The laboratory failed to achieve scores of 100 % of acceptable responses for Compatibility Testing in Q2 2021, and Q3 2021 API PT events which was two out of two consecutive testing events resulting in unsuccessful performance. 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 -- See D-2181 (b). b. The laboratory failed to achieve scores of 100 % of acceptable responses for Compatibility Testing in Q3 2021 and Q2 2022 API PT events which was two out of three consecutive testing events resulting in unsuccessful performance. See D-2181 (c). D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on an on-site visit 5/10/2023, review of CLIA database Casper Report 0155D and the laboratory's American Proficiency Institute (API) proficiency testing (PT) result reports, and interview with the laboratory manager; it was determined that the laboratory failed to attain an overall testing event score of at least 80 percentfor White Blood Counts (WBC) resulting in unsatisfactory performance. The findings included: a. The laboratory failed to attain an overall testing event score of at least 80 percent for WBC Differentials in Q1 2023 API PT event resulting in unsatisfactory performance. b. WBC Differentials are a part of Complete Blood Cell (CBC) count testing including, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils. c. The laboratory attained an overall testing event score of 72% for WBC Differentials in Q1 2023 API PT event which was unsatisfactory performance, as follows: . Q1 2023 API PT event Basophils 60% Eosinophils 60% Lymphocytes 100% Monocytes 80% Neutrophils 60 % d. The laboratory performed approximately 1192 patient Complete Blood Counts monthly. e. The laboratory manager affirmed (5/10/2023 @ 12: 15 PM) that the laboratory attained a score of 72% for WBC Blood Cell Differentials in Q1 2023 API PT event which was unsatisfactory performance. 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 on-site visit, 5/10/2023, review of CLIA database Casper Report 0155D and the laboratory's American Proficiency Institute (API) proficiency testing (PT) result reports, and interview with the laboratory manager; it was determined that the laboratory failed to achieve an overall testing event score of acceptable responses for two consecutive testing events or two out of three consecutive testing events was unsuccessful performance for Compatibility Testing. The findings included: a. The laboratory manager verified and confirmed by phone conversation (5/23/2023 @ 2:55 PM) that the laboratory failed to attain scores of 100% satisfactory responses for Compatibility Testing in Q2 2021, Q3 2021 and Q2 2022 for API PT events. b. The laboratory failed to achieve an overall testing event score of 100 % acceptable responses for Compatibility Testing in Q2 2021 and Q3 2021, two out of two consecutive testing events was unsuccessful performance, as follows: Year Event Score (%) 2021 Q2 80 2021 Q3 80 c. .The laboratory failed to achieve an overall testing event score of 100 % acceptable responses for Compatibility Testing in Q3 -- 2 of 4 -- 2021 and Q2 2022, two out of three consecutive testing events was unsuccessful performance, as follows:. Year Event Score (%) 2021 Q3 80 2022 Q1 100 2022 Q2 60 d. The laboratory performed compatibility testing on approximately 23 patient samples monthly. 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 on-site visit 5/10/2023, review of CLIA database Casper Report 0155D and the laboratory's American Proficiency Institute(API) proficiency testing (PT) result reports, and interview with the laboratory manager; it was determined that the laboratory director failed to ensure satisfactory performance for proficiency testing samples. The laboratory director failed to ensure the laboratory attained an overall testing event score of at least 80 percent for WBC Blood Cell Differentials in Q1 2023 API PT event resulting in unsatisfactory performance, see D-2122. 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 serverity of the deficiencies cited herin, the Condition: Laboratories performing High Complexity was not met. The laboratory director , high complexity testing fail to ensure Proficiency Testing (PT) samples were tested as required under Subpart H of this part. See D-2181 and D-6089. . 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 on-site visit 5/10/2023, review of CLIA database Casper Report 0155D and the laboratory's American Proficiency Institute(API) proficiency testing (PT) result reports, and interview with the laboratory manager; it was determined that the laboratory director failed to ensure acceptable performance for proficiency testing samples. The findings included: a. The laboratory director failed to ensure the laboratory to achieve scores of 100% acceptable responses for Compatibility Testing -- 3 of 4 -- in Q2 2021, Q3 2021 and Q2 2022 API PT events resulting in unsuccessful performance. b. The laboratory failed to achieve scores of 100 % of satisfactory responses for Compatibility Testing in Q2 2021, and Q3 2021 API PT events which was two out of two consecutive testing events constituting unsuccessful performances in the test events. See D-2181 (b). c. The laboratory failed to achieve scores of 100 % of satisfactory responses for Compatibility Testing in Q3 2021 and Q2 2022 API PT events which was two out of three consecutive testing events constituting unsuccessful performances in the test event. See D-2181 (c). -- 4 of 4 --

Summary Statement of Deficiencies D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing results reports, and interview with the laboratory staff, it was determined that the laboratory failed to attain an overall testing event score of at least 80 percent is unsatisfactory performance. The findings included: a. The laboratory perform bacteriology for, but are not limited to the followings, urine cultures, stool cultures with genus and species, and susceptibility. b. In order to ensure and verify the accuracy of their culture testing systems, the laboratory enrolled its proficiency testing (PT) programs with API (American Proficiency Institute) PT. c. The laboratory attained an overall testing event score of 69 % for its bacteriology in the 2nd 2017 PT event, which was unsatisfactory performance. d. The laboratory performed bacteriology in approximately 30 patient samples monthly. e. The laboratory staff affirmed (7/2/2018 @ 13:10) that the laboratory attained a score of 69% for the 2nd 2017 bacteriology PT event which was unsatisfactory performance. D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing results reports, and interview 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 -- with the laboratory staff, it was determined that the laboratory failed to attain an overall testing event score of at least 100 percent was unsatisfactory performance. The findings included: a. The laboratory performed compatibility testing at the facility. b. In order to ensure and verify the accuracy of their culture testing systems, the laboratory enrolled its proficiency testing (PT) programs with API (American Proficiency Institute) PT. c. The laboratory attained an overall testing event score of 80 % for compatibility testing in the 2nd 2017 PT event, which was unsatisfactory performance. d. The laboratory performed compatibility testing in approximately 6 patient samples monthly. e. The laboratory staff affirmed (7/2/2018 @ 13:15) that the laboratory attained a score of 80 % for the 2nd 2017 compatibility testing PT event which was unsatisfactory performance. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing results reports, and interview with the laboratory staff, it was determined that the laboratory director failed to ensure that laboratory personnel were performing the test methods as required for accurate and reliable results. The findings included: See D- 2020 and D- 2173 -- 2 of 2 --