Rocky Mountain Oncology

Summary Statement of Deficiencies D0000 The following deficiencies were a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] 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 Services Casper Report 155, review of the American Proficiency Institute evaluation reports, and staff 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 -- interview, the laboratory failed to achieve a satisfactory performance score for the analyte chloride on 2 consecutive testing events (2025 event #2, 2025 event #3). Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 Centers for Medicare and Medicaid Services (CMS) Casper Report 155, review of the API (American Proficiency Institute) evaluation reports, and staff interview, the laboratory failed to achieve a satisfactory performance score for chloride on two consecutive testing events (2025 event #2, 2025 event #3). The findings were: 1. Review of the CMS 155 report showed the laboratory failed to successfully obtain a passing score for the analyte of chloride on the following API proficiency testing events: a. 2025 event #2 showed the laboratory scored a 0%. b. 2025 event #3 showed the laboratory scored a 40%. 2. Review of the API proficiency testing evaluations confirmed the proficiency testing scores from the CMS Casper 155 were accurate. 3. Telephone interview with the technical consultant on 11/26/25 at 2: 24 PM confirmed the laboratory had failed the proficiency testing events for chloride. -- 2 of 2 --

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 the American Proficiency Institute (API) proficiency testing records, lack of documentation, and staff interview, the laboratory failed to review and evaluate proficiency testing results for 2 of 11 testing events reviewed from August 2023 through August 2025. The findings were: 1. Review of the API proficiency testing (PT) report failed to include documentation the laboratory had evaluated test scores of less than 100%. The following concerns were identified: a. Review of the 2025 API chemistry core event #1 results showed the laboratory scored an 80% on glucose and magnesium. There was no documentation the laboratory had evaluated the proficiency testing results. b. Review of the 2025 API chemistry core event #2 results showed the laboratory scored an 80% on alkaline phosphatase, iron, and magnesium. There was no documentation the laboratory had evaluated the proficiency testing results. 2. Interview with the technical consultant on 9/17/25 at 3: 07 PM confirmed the laboratory had failed to evaluate the reasons for the 80% scores. 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 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 the CMS (Centers for Medicare and Medicaid Services) 209 Laboratory Personnel Report, review of personnel records, policy and procedure review, and staff interview, the laboratory failed to ensure the technical consultant's competency assessment had been completed for 2 of 2 years reviewed (2021, 2022). The findings were: 1. Review of the CMS 209 Laboratory Personnel Report showed 1 technical consultant for the specialties of Hematology and Chemistry. 2. Review of the personnel files for the technical consultant showed no documentation a competency assessment had been completed in 2021 or 2022. 3. Review of the "Employee Competency" procedure, provided by the laboratory, failed to include a system to evaluate the duties and responsibilities of the technical consultant. 4. Interview with the technical consultant on 8/21/23 at 3:35 PM confirmed the required competency assessments had not been completed and the policy and procedure failed to include a system to evaluate the duties and responsibilities of the technical consultant. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. 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 -- This STANDARD is not met as evidenced by: Based on review of the CMS-116 form, procedure manual review, and staff interview, the current laboratory director failed to sign, and date as approved the laboratory's procedure manuals. The findings were: 1. Review of the CMS-116 form, dated 8/16 /23, showed a change of laboratory director had occurred since the last survey conducted on 9/29/21. 2. Review of the laboratory's procedure manuals failed to include the current laboratory director's signature and date of approval. 3. Interview with the technical consultant on 8/21/23 at 3:35 PM revealed the change in laboratory director occurred the first week of August 2023. The technical consultant confirmed the laboratory's policies and procedures had not been signed as approved by the current laboratory director. 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. This STANDARD is not met as evidenced by: Based on review of patient test reports, the TOSOH AIA analyzer manufacturer's instructions for use, and staff interview, the laboratory failed to follow the manufacturer's instructions to include the prostate specific antigen (PSA) test assay method used on 2 of 2 PSA patient test reports (patient #1, patient #2) reviewed. The laboratory performed approximately 730 PSA tests per year. The findings were: 1. Review of the TOSOH AIA 360 analyzer manufacturer's instructions showed "... Because of differences in reagent specificity and assay methods, the concentration of PSA in a given specimen may vary with devices from different manufacturers. Values obtained with different assay methods cannot be used interchangeably. It is mandatory that results reported by the laboratory to the physician include the identity of the assay used..." The following concerns were identified: a. Review of the PSA test report for patient #1, dated 1/18/23, and for patient #2, dated 2/9/23, failed to include the test assay method. 2. Interview with the technical consultant on 8/21/23 at 5:06 PM confirmed the patient test reports did include the test assay method. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on lack of documentation, review of the McKesson Variable Speed Centrifuge Operation Manual, and staff interview, the laboratory failed to follow the manufacturer's instructions to perform function checks every 3 months for 2 of 2 years (2021, 2022) reviewed. The findings were: 1. Review of the laboratory's documentation showed no evidence the revolutions per minute (RPM) or the timer was checked as directed. 2. Review of the McKesson Variable Speed Centrifuge -- 2 of 3 -- Operation Manual, provided by the laboratory, showed "...Calibration...The centrifuge timer should be checked for accuracy at least every 3 months. The timer is an electronic timer designed to be accurate to 5min +/- 10sec. The speed should fall within +/- 150 RPM of 3,400 RPM." 3. Interview with the technical consultant on 8/21 /23 at 3:15 PM confirmed the function checks on the centrifuge had not been performed. 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 (QC) material prior to use for 2 of 3 test systems reviewed (Horiba Pentra C400, TOSOH AIA 360). The findings were: 1. Review of the QC records for the Horiba Pentra C400 analyzer showed the normal QC lot number 21053 was put into use on 10/3/22 and the abnormal QC lot number 21052 was put into use on 11/9/22 for the testing of routine chemistry. There was no documentation the laboratory had verified the new lot numbers of quality control material prior to being used on the chemistry analyzer. 2. Review of the QC records for the TOSOH AIA 360 analyzer showed the QC lot number 40430 used for the analytes TSH, CEA, ferritin, and PSA was put into use on 3/10/23. QC lot number 74620 used for the analytes CA 125 and CA 27.29 was put into use on 1/26/23. There was no documentation the laboratory had verified the new lot numbers of quality control material prior to being used on the immunoassay analyzer. 3. Interview with the technical consultant on 8/21/23 at 3:11 PM confirmed the statistical parameters of the quality control materials had not been verified before use. -- 3 of 3 --

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 and staff interview, the laboratory failed to review and evaluate proficiency testing results for 6 of 12 testing events reviewed from January 2020 through September 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%. The following concerns were identified: a. Review of the 2020 API chemistry event #1 results showed the laboratory scored an 80% on glucose and phosphorus. b. Review of the 2020 API hematology event #2 showed the laboratory scored an 80% on eosinophils. c. Review of the 2020 API chemistry event #2 showed the laboratory scored an 80% on chloride and sodium. d. Review of the 2020 API hematology event #3 showed the laboratory scored an 80% on basophils. e. Review of the 2020 API chemistry event #3 showed the laboratory scored an 80% on calcium and chloride. f. Review of the 2021 API chemistry event #1 showed the laboratory scored an 80% on sodium and potassium. 2. Interview with the laboratory manager on 9/29/21 at 1:55 PM confirmed the laboratory had not investigated the reason for the 80% scores. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different 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 -- concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control (QC) record review, review of the patient testing logs, lack of documentation, policy and procedure review, and staff interview, the laboratory failed to perform two levels of quality control each day of testing for blood urea nitrogen (BUN), creatinine (CREA), alanine aminotransferase (ALT), and chloride (Cl) on the Pentra 400 for 4 of 4 months reviewed (May, June, July, August 2021). This failure affected the test result for BUN on 74 patient samples on 5/4 and 5/5; the test result for CREA on 31 patient samples on 6/10; the test result for ALT on 108 patient samples on 7/26, 7/27, and 7/28; and the test result for Cl on 36 patient samples on 8/10. The findings were: 1. Review of the QC records showed gaps on the Levey-Jennings charts where no data points had been recorded. The following concerns were identified: a. On 5/4/21 the high level of QC for BUN was run 6 times between 7:37 AM and 9:58 AM with no acceptable value achieved. On 5/5/21 the high level of QC was run 18 times between 7:20 AM and 2:45 PM with an acceptable value achieved at 3:04 PM. Review of the patient testing logs showed 74 patient samples had been reported on 5/4 and 5/5. b. On 6/10/21 the low level of QC for CREA was run 4 times with no acceptable value achieved. Review of the patient testing logs showed 31 patient samples had been affected. c. On 7/26, 7/27, and 7/28 the low level of QC for ALT was run with no acceptable value achieved. Review of the patient testing logs showed 108 patient samples had been reported during that timeframe. d. On 8/10/21 the low level of QC for Cl was run with no acceptable value achieved. Review of the patient testing logs showed 36 patient samples had been affected. 2. There was no documentation to show what action was taken by the laboratory to attempt to correct the failure of the quality control. 3. Review of the "Weekly QC Review" for May, June, July and August showed QC was marked as "okay" and signed by the technical consultant. 4. Interview on 9/29/21 at 3:10 PM with the technical consultant confirmed acceptable QC had not been achieved on 5/4, 5 /5, 6/10, 7/26, 7/27, 7/28, and 8/10. In addition there was no documentation to show what actions were taken by the laboratory to correct the failure. 5. Review of the Pentra 400 procedure manual showed "1.1.10 Failure to obtain proper values may indicate calibration, control or reagent deterioration, instrument malfunction, or miscalibration. If any control results are outside the acceptable ranges perform the following: re-run the control; clean the system and re-run the control; open a new vial of control; recalibrate the system." D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on review of the new instrumentation and test method verification study and staff interview, the laboratory director failed to ensure the study was completed to -- 2 of 3 -- verify the performance specification of precision and failed to sign the accuracy study for 1 of 2 test systems reviewed (ABX Pentra 60 C+) prior to patient testing. The laboratory performed approximately 74,600 hematology samples per year. The findings were: 1. Review of the new instrumentation and test method verification study, dated 10/11/19, showed studies for precision had been completed, however an analysis of the data to verify the performance specifications had not been included in the report. In addition, accuracy studies had been completed, however the laboratory director failed to sign the report as approved prior to patient testing. 2. Interview with the technical consultant on 9/29/21 at 3 PM confirmed the new instrumentation and test method verification study was incomplete. D6043 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(5) (b) The technical consultant is responsible for-- (b)(5) Resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications; This STANDARD is not met as evidenced by: Based on quality control (QC) record review, review of the patient testing logs, lack of documentation, policy and procedure review, and staff interview, the laboratory consultant failed to ensure remedial actions were taken when QC was outside of the acceptable ranges for blood urea nitrogen (BUN), creatinine (CREA), alanine aminotransferase (ALT), and chloride (Cl) on the Pentra 400 for 4 of 4 months reviewed (May, June, July, August 2021). This failure affected the test result for BUN on 74 patient samples on 5/4 and 5/5; the test result for CREA on 31 patient samples on 6/10; the test result for ALT on 108 patient samples on 7/26, 7/27, and 7/28; and the test result for Cl on 36 patient samples on 8/10. Refer to D5447. D6044 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(6) (b) The technical consultant is responsible for-- (b)(6) Ensuring that patient test results are not reported until all

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on proficiency testing records review, lack of documentation, and confirmation by the laboratory manager/technical consultant, the laboratory director failed to sign two of six testing events reviewed from October 2017 to October 2019. Findings include: 1. Proficiency testing records review failed to include the director's signature, attesting proficiency testing samples were tested in the same manner as patient specimens the first and second Chemistry Core events of 2019. 2. In an interview conducted on 10/21/2019 at approximately 4:00 P.M., the laboratory manager /technical constant confirmed the attestation statements did not include the director's signature. 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. 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 -- This STANDARD is not met as evidenced by: Based on proficiency testing records review, lack of documentation, and interview with staff, the laboratory failed to review and evaluate the results obtained in 4 of 6 American Proficiency Institute (API) Chemistry and Hematology testing events. Findings include: 1. Proficiency test records review failed to include documentation the director reviewed the test results to identify problems that may require