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Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and interview with Testing Personnel (TP) #1 (CMS 209 personnel #3), the laboratory failed to verify the accuracy of the PT results obtained for 1 of 3 API Chemistry core testing events performed in 2024. Findings Include: 1. On the day of survey, 12/10/2024 at 09:45 am., review of the laboratory's API PT records revealed the laboratory failed to verify the accuracy for the following analyte that was not scored by the PT agency in 2024: - API 2024 Chemistry-core 1st event: Bilirubin, Total (CH-02, CH-03, CH-05), not graded (result variance). 2. The API Proficiency Testing performance Evaluation form states " Laboratories are responsible for documenting and performing

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 the CASPER 155 report and graded results from the American Proficiency Institute (API) proficiency testing (PT) organization, the laboratory failed to successfully participate in proficiency testing for the analyte Chloride. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- 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 CASPER 155 report and graded results from the American Proficiency Institute (API) proficiency testing (PT) organization, the laboratory failed to successfully participate in proficiency testing for the analyte: Chloride, which is in the subspecialty of Routine Chemistry. The laboratory had unsatisfactory scores for the 1st event of 2023, and the 2nd event of 2023. Findings include: Analyte Year Event Score Chloride 2023 1 60%. Chloride 2023 2 60%. -- 2 of 2 --

Summary Statement of Deficiencies D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with testing personnel #1 (TP), the laboratory failed to evaluate twice a year the relationship between test results for 2 of 2 Cell-Dyn Emerald hematology analyzers from 01/14/2021 to the day of the survey. Findings include: 1. On the day of the survey, 03/22/2023 at 11:00 am, the laboratory could not provide documentation of the biannual comparison of test results between 2 of 2 Cell-Dyn Emerald hematology analyzers for the complete blood count (CBC) differentials performed from 01/14/2021 to 03/22/2023. 2. The laboratory performed 79,320 hematology tests in 2022 (annual volume listed on CMS-116). 3. TP #1 confirmed the finding above on 03/22/2023 at 2:00 pm. 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 a review of the CASPER Report 155 report and graded results from the proficiency testing organization American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for the analyte Chloride. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER 155 report and graded results from the proficiency testing organization American Proficiency Institute (API), the laboratory failed to successfully participate in a proficiency testing for the analyte: Chloride, which is in the subspecialty of Routine Chemistry. The laboratory had unsatisfactory scores for the 1st event of 2021 and the 3rd event of 2021. Findings include: Analyte Year Event Score Chloride 2021 1 40%. Chloride 2021 3 20%. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing (PT) records and interview with the Testing personnel (TP) #1, the Laboratory Director and TP failed to sign the API PT attestation statement documents for 1 of 3 Hematology events in 2019 and 1 of 3 Chemistry events 2020. Findings include: 1. On the day of survey, 01/14/2021, review of API PT records revealed, the following API PT attestation statement documents were not signed by the LD and TP examining the API PT samples: - 2019, Event #3, Hematology. - 2020, Event #1. Core Chemistry. 2. TP #1 confirmed the findings above on 01/14/2021 at 9:55 am. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of competency assessment records and interview with testing personnel (TP) #1, the Laboratory failed to assess the competency of 3 of 14 TP (on the CMS-209 form listed as TP # 1, #6 and #14) who performed tests in the specialities of Hematology and Chemistry in 2020. Findings include: 1. On the day of 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 -- survey, 01/14/2021, TP#1 could not provide competency assessment records for 3 of 14 TP for the following testing specialities: - TP# 1 for Hematology and Chemistry in 2020. - TP# 6 and TP# 14 for Hematology in 2020. 2. TP#1 confirmed the findings above on 01/14/2021 at 9:15 am. -- 2 of 2 --