Rocky Mountain Oncology Lander

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records, the CMS (Centers for Medicare and Medicaid Services) 209 Laboratory Personnel Report, and staff interview, the laboratory failed to rotate the testing personnel performing 12 out of 12 API (American Proficiency Institute) chemistry core and hematology PT events reviewed from October 2022 through September 2024. The findings were: 1. Review of the CMS 209 Laboratory Personnel Report, dated 10/4/24, showed 5 testing personnel (TP #1, TP #2, TP #3, TP #4, TP #5) were listed as performing moderate complexity testing. 2. Review of the laboratory's PT records from October 2022 through September 2024 showed each of the 12 PT events were performed by TP #1. 3. Interview with the technical consultant on 10/7/24 at 1:33 PM confirmed the PT events had not been rotated between testing personnel. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of proficiency testing records, lack of documentation, and staff interview, the laboratory failed to evaluate proficiency testing (PT) results for 2 of 12 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 -- PT events reviewed from October 2022 through September 2024. The findings were: 1. Review of the American Proficiency Institute (API) 2023 Chemistry Core Event #3 proficiency testing evaluation showed the laboratory scored a 40% on glucose. Review of the

Summary Statement of Deficiencies 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 personnel files, review of the CMS (Centers for Medicare and Medicaid Services) 209 Laboratory Personnel Report, lack documentation, and staff interview, the technical consultant (TC) failed to complete a 6-month competency assessment for 1 of 3 (TP #3) testing personnel. In addition, an annual competency assessment had not been completed for the TC for 1 of 2 years reviewed (2021). The findings were: 1. Review of the personnel file for TP #3 showed an initial competency assessment had been completed on 4/7/21 and an annual competency assessment was completed on 2/2/22. There was no evidence the 6-month competency assessment had been completed. 2. Review of the personnel file for the TC showed no evidence a competency assessment had been completed in 2021. 3. Interview with the TC on 11 /14/22 at 2:10 PM confirmed the 6-month competency assessment for TP #3 had not been completed and was unable to locate his 2021 competency assessment. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. 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 -- This STANDARD is not met as evidenced by: Based on review of the ABX Pentra 60 C+ manufacturer's instructions for use (IFU), review of patient testing records, staff interview, and policy and procedure review, the laboratory failed to follow the manufacturer's instructions and review and resolve any instrument flags prior to reporting patient results for 7 of 21 (#1, #2, #3, #4, #6, #10, #21) patient test reports with flagged analytes reviewed. The findings were: 1. Review of the instrument printouts of patient testing showed the following concerns: a. Review of patient #1, dated 8/26/21, showed an exclamation point next to the white blood cell, neutrophil, lymphocyte, monocyte, eosinophil, and basophil counts. b. Review of patient #2, dated 8/26/21, showed an exclamation point next to the neutrophil, lymphocyte, monocyte, eosinophil, and basophil counts. c. Review of patient #3, dated 8/26/21, showed an exclamation point next to the neutrophil and lymphocytes counts. d. Review of patient #4, dated 8/26/21, showed an exclamation point next to the white blood cell, neutrophil, lymphocyte, monocyte, eosinophil, and basophil counts. e. Review of patient #6, dated 8/26/21, showed an exclamation point next to the neutrophil and lymphocyte counts. f. Review of patient #10, dated 6/24/21, showed the red blood cell and platelet counts were flagged with an exclamation mark. g. Review of patient #21, dated 3/11/22, showed an exclamation point next to the neutrophil and lymphocyte counts. 2. Interview with testing personnel #1 on 11/14/22 at 4:20 PM revealed she did not repeat patient samples when an exclamation point appeared on the instrument printout. 3. Review of the ABX Pentra 60 C+ policy and procedure, signed by the laboratory director on 9/28/20, failed to include a procedure for resolving the exclamation point flag prior to releasing patient results. 4. Review of the ABX Pentra 60 C+ IFU showed "6. Results Interpretation...6.1.2 Suspicion... A suspicion on a parameter is shown by "!". The sample must be rerun." D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of documentation and staff interview, the laboratory failed to verify the statistical parameters of quality control material prior to use for 2 of 2 test systems reviewed (hematology, chemistry). The findings were: 1. There was no documentation the laboratory had verified new lot numbers of quality control material prior to being used on the hematology and chemistry analyzers. 2. Interview with the technical consultant on 11/14/22 at 3 PM confirmed the statistical parameters of the quality control materials had not been verified before use. -- 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 the Centers for Medicare and Medicaid Casper Report 155, review of the American Proficiency Institute (API) evaluation reports, and staff interview, the laboratory failed to participate in two out of three API Hematology proficiency testing events for the regulated analytes; erythrocytes, hematocrit, hemoglobin, leukocytes, and the white blood cell differential (2021 Event #2, 2022 Event #1). Refer to D2121. . D2121 HEMATOLOGY CFR(s): 493.851(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 3 -- 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 review of the Centers for Medicare and Medicaid (CMS) Report Casper 155, review of the American Proficiency Institute (API) evaluation reports, and staff interview, the laboratory failed to participate in 2 out of 3 API Hematology proficiency testing (PT) events for the regulated analytes; erythrocytes, hematocrit, hemoglobin, leukocytes, and the white blood cell differential (2021 Event #2, 2022 Event #1). The findings were: 1. Review of the CMS Casper Report 155 and the API Hematology PT evaluations showed the laboratory failed to participate in the API Hematology 2021 Event #2 and the API Hematology 2022 Event #1. The laboratory received a score of 0% for each PT event. 2. Telephone interview on 5/19/22 at 9:04 AM with the technical consultant revealed he was unaware of the reason the API Hematology 2021 Event #2 was not completed and confirmed the API Hematology Event #1 was not completed due to an "oversight". . 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 review of the Centers for Medicare and Medicaid Casper Report 155, review of the American Proficiency Institute (API) evaluation reports, and staff interview, the laboratory director failed to ensure proficiency testing events were returned within the specified timeframe established by the proficiency testing program (D6017). . D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) 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)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: . Based on review of the CMS (Centers of Medicaid and Medicare) CASPER Report 155D and staff interview, the laboratory director failed to ensure the results of 2 of 3 API (American Proficiency Institute) proficiency testing events (API Hematology 2021 Event #2, API Hematology 2022 Event #1) were returned within the specified timeframe established by the proficiency testing program. The findings were: 1. Review of CMS Casper Report 155D showed the laboratory scored a 0% on the API 2021 Hematology Event #2 and the API 2022 Hematology Event #1 for lack of -- 2 of 3 -- participation. 2. Telephone interview on 5/19/22 at 9:04 AM with the technical consultant revealed he was unaware of the reason the API Hematology 2021 Event #2 was not completed and confirmed the API Hematology Event #1 was not completed due to an "oversight". -- 3 of 3 --

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 Centers for Medicare and Medicaid Casper 155 report, review of the American Proficiency Institute (API) evaluation reports, and staff interview, the laboratory failed to successfully participate in two consecutive API chemistry core proficiency testing events for chloride (2021 event #2, 2021 event #3). Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 Centers for Medicare and Medicaid (CMS) Casper 155 report, review of the American Proficiency Institute (API) evaluation reports, and staff interview, the laboratory failed to successfully participate in two consecutive API chemistry core proficiency testing (PT) events for chloride (2021 event #2, 2021 event #3). The findings were: 1. Review of the CMS Casper 155 report and the API chemistry core PT evaluations showed the laboratory failed to successfully obtain a passing score for the analyte of chloride on the following API testing events: a. 2021 event #2 showed the laboratory scored a 40%. b. 2021 event #3 showed the laboratory scored a 20%. 2. Telephone interview on 11/22/21 at 3:28 PM with the technical consultant verified the laboratory had failed to achieve a passing score for chloride on the API 2021 PT event #2 and event #3. 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 review of the Centers for Medicare and Medicaid Casper 155 report, review of the American Proficiency Institute (API) evaluation reports, and staff interview, the laboratory director failed to ensure an effective

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of proficiency testing records, lack of documentation, and staff interview, the laboratory failed to review and evaluate proficiency testing results for 1 of 2 testing events reviewed from November 2020 to May 2021. The findings were: 1. Review of the American Proficiency Institute (API) proficiency testing (PT) report failed to include documentation the laboratory had evaluated test scores of less than 100% for 2021 Event 1. Results showed the laboratory scored an 80% for chloride. There was no documentation the laboratory had evaluated the test result. 2. Interview with the technical consultant on 5/5/21 at 10:54 AM revealed he was unaware of the requirement. D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. 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 -- (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on review of patient test records, lack of documentation, and staff interview, the laboratory failed to include gender in the test requisition information to ensure the correct normal range was used for 10 of 10 test requisitions reviewed (#1, #2, #3, #4, #5, #6, #7, #8, #9, #10). The lab performed approximately 7 CBCs (complete blood counts) per day. The findings were: 1. Review of patient test requisitions from 11/5/20 through 3/4/21 showed the test requisition failed to include the patient's gender. 2. Review of patient test records included different normal ranges for female and male patients. 3. Interview with the technical consultant on 5/5/21 at 11:10 AM confirmed gender had not been included on the test requisition. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)