Aspen Mountain Medical Center

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, lack of documentation, review of policy and procedures, and staff interview, the laboratory failed to ensure the competency of the staff member holding the position of general supervisor was assessed for 2 of 2 years reviewed (2024, 2025). The findings were: 1. Review of the CMS 209 Laboratory Personnel Report showed the laboratory listed one staff member as the general supervisor. 2. Review of the personnel records for the general supervisor showed no evidence a competency assessment had been completed in 2024 or 2025. 3. Review of the "Employee Competency Evaluation" policy, last revised 6 /2025, failed to include a procedure to assess the duties of the general supervisor. 4. Interview with the general supervisor on 3/31/26 at 11 AM confirmed no further documentation was available and the policy did not include a procedure for assessing the competency of the general supervisor. 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). 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 proficiency testing records, lack of documentation, staff interview, and review of policy and procedure, the laboratory failed to review proficiency test results that received an artificial score of 100% due to result variance for 1 of 24 American Proficiency Institute (API) proficiency testing events reviewed from January 2024 through December 2025. The findings were: 1. Review of the 2025 API Chemistry Event #3 proficiency testing comparative evaluation form showed the laboratory received an artificial score of 100% for the analyte of total bilirubin. There was no documentation the laboratory had performed a self-evaluation. 2. Interview with the general supervisor on 3/31/26 at 10:30 AM confirmed an evaluation of the proficiency testing results had not been evaluated for accuracy. 3. Review of the "PROFICIENCY TESTING" policy, last revised 6/2025, showed "...If PT [proficiency testing] challenges were not graded because of 1) lack of consensus, Scientific Decision, or Educational challenge...the laboratory will compare and evaluate each result with the PT booklet and findings are documented. For other exception reason codes that signify the proficiency testing (PT) for an analyte has not been graded. The exception reason code is located on the evaluation report in brackets to the right of the results. Therefore the laboratory must identify all of the analytes with exception reason code with the same rigor as if it were an unacceptable performance..." D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on new instrument and new test method verification study review, lack of documentation, review of policy and procedure, review of patient testing logs, and staff interview, the laboratory failed to verify the reportable range and confirm the manufacturer's normal values were appropriate for the laboratory's patient population prior to patient testing for 1 of 1 (Alcor miniiSED) verification studies reviewed. The laboratory performed seven erythrocyte sedimentation rate (ESR) patient tests from 2 /2/26 through 3/30/26. The findings were: 1. Review of the new instrument and new test method verification study failed to show documentation the laboratory had verified the reportable range and had confirmed the reference intervals used for the test system were appropriate for the laboratory's population. The laboratory director approved the verification study on 2/15/26. 2. Review of the patient testing log showed ESR testing on the Alcor miniiSED commenced on 2/2/26. 3. Review of the "ESR-ALCOR Mini-i-Sed" policy and procedure showed it was approved by the laboratory director in March of 2026. 4. Interview with the general supervisor on 3/31 /26 at 11:58 AM confirmed no further documentation was available. 5. Review of the "VERIFICATION OF PERFORMANCE SPECIFICATIONS AND NOTIFICATION OF CURRENT LABORATORY METHODS" policy and procedure, last revised 6 -- 2 of 3 -- /2025, showed "Verification of Performance Specifications are required prior to reporting patient test results on any unmodified, FDA-cleared or approved non- waived test system (i.e., moderate and high complexity) introduced into the laboratory...the laboratory is required to verify the following: 1. Accuracy 2. Precision 3. Reportable range of patient test results (comparable to the manufacturer's) 4. Reference intervals/range (normal values) for the Laboratory's patient population..." D6080 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(c) (c) The laboratory director must: (c)(1) Be onsite at least once every 6 months, with at least 4 months between the minimum two on-site visits. Laboratory directors may elect to be on-site more frequently and must continue to be accessible to the laboratory to provide telephone or electronic consultation as needed; and (c)(2) Provide documentation of these visits, including evidence of performing activities that are part of the laboratory director responsibilities. This STANDARD is not met as evidenced by: Based on review of laboratory records and staff interview, the laboratory director failed to conduct at least two onsite visits to the laboratory for 1 of 1 year reviewed (2025). The findings were: 1. Review of the laboratory's records showed no evidence the laboratory director had made an onsite visit to the laboratory in 2025. Interview with the general supervisor on 3/31/26 at 8:30 AM confirmed the laboratory director had not been onsite and revealed she was unaware of the regulation. -- 3 of 3 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation, review of the laboratory's coagulation records, and staff interview, the laboratory failed to ensure the coagulation reagent was not used beyond its expiration date for 1 of 2 coagulation procedures (Prothrombin time) reviewed. The laboratory performed 21 Prothrombin time tests between 2/15/23 and 11/15/23. The findings were: 1. Review of the CA660 Innovin Protime Mean Normal Patient study for lot #549795 showed it was accepted and implemented on 2/15/23. 2. Observation on 11/15/23 at 10:41 AM showed the Siemens Dade Innovin reagent lot #549795, with an expiration date of 10/5/24, was entered into the Sysmex CA660 coagulation analyzer; however, the vial in use on the instrument was lot #549771 with an expiration date of 2/25/23. Observation of the reagent stored in the refrigerator showed the expired reagent was the only reagent available. Interview with the laboratory manager at that time revealed she had no idea what had happened as she had a system in place to monitor the expiration dates of reagents. The laboratory manager discarded the reagent and educated staff to send any Prothrombin time tests to the reference laboratory. 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 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 sodium, potassium, and chloride (2021 event #2, 2021 event #3). 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 4 -- 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 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 sodium, potassium, and chloride (2021 event #2, 2021 event #3). The findings were: 1. Review of the API chemistry core PT evaluations showed the laboratory failed to successfully obtain a passing score for the analyte of sodium on the following API testing events: a. 2021 event #2 showed 3 of the 5 specimens tested were not graded due to a "lab reported test problem". b. 2021 event #3 showed 4 of the 5 specimens tested were not graded due to a "lab reported test problem". 2. Review of the API chemistry core PT evaluations showed the laboratory failed to successfully obtain a passing score for the analyte of potassium on the following API testing events: a. 2021 event #2 showed 3 of the 5 specimens tested were not graded due to a "lab reported test problem". b. 2021 event #3 showed 3 of the 5 specimens tested were not graded due to a "lab reported test problem". 3. Review of 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 3 of the 5 specimens tested were not graded due to a "lab reported test problem". b. 2021 event #3 showed 4 of the 5 specimens tested were not graded due to a "lab reported test problem". 4. Review of the PT

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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 qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the laboratory manager, the laboratory failed to ensure availability of photographs or charts of all possible urine sediment components to meet the control requirements for approximately 4 microscopic urinalysis tests performed annually. Findings include: 1. The laboratory lacked photographs or charts for all possible urine sediment components to use as microscopic urinalysis controls. 2. In an interview conducted on 10/23/2019 at approximately 4:30 P.M., the laboratory manager confirmed the laboratory did not have photographs or charts with all the possible microscopic urine sediment components. 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 D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on patient test records review, education documentation reviewed, and interview with the laboratory manager, 1 of 3 testing personnel (test person B) failed to qualify to be a high complexity testing person performing compatibility testing. (See D6065.) D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: 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 -- Based on education records review, patient test records review, and interview with the laboratory manager, 1 of 3 testing personnel failed to qualify as a high complexity testing person performing compatibility testing for July 1 to August 2, 2019. Findings include: 1. Personnel education qualification records review lacked documentation test person B held an Associates, Bachelors, Masters or Doctorate degree in a chemical, physical, or biological science or medical laboratory technology, or was licensed as a physician, or had 50 weeks of military training as a Medical Laboratory Specialist. 2. A. Patient test records review included documentation test person B performed ABO group, Rh type, antibody screen and compatibility testing on 08/02 /2019 for patient #25361; 08/01/2019 for patient #24283; and on 07/24/2019 for patient #24438. B. Patient test records review included documentation test person B performed ABO Group, Rh type, and antibody screen as a precaution for patients that were scheduled for surgery. Test person B performed ABO, Rh and Antibody screens for patient specimens pending a compatibility test request prior to surgical procedures on 07/24/2019 for one patient's sample, 07/18/2019 for four patient's samples, 07/17 /2019 for three patients samples, 07/10/2019 for one for one patient's sample, and 07 /08/2019 for one patient's sample. 3. In an interview conducted on 08/02/2019 at approximately 11:00 A.M., the laboratory manager confirmed test person B performed the pre-transfusion ABO, Rh, and Antibody screening. 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 an on-site survey, the director failed to ensure 1 of 3 testing personnel (test person B) qualified to be a high complexity testing person performing compatibility testing. (See D6102.) D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on personnel education records review, lack of documentation, patient testing records review, and interview with staff, the director failed to ensure all personnel had the appropriate education and experience prior to testing compatibility test results for 1 of 3 testing personnel (test person B) for one month of test records reviewed, (July 2019). Findings include: 1. Personnel records review failed to include documentation test person B held, at a minimum, an associate's degree in a chemical, physical, biological science or medical laboratory technology to qualify as a high complexity testing person. 2. A. Patient test records review included documentation test person B performed high complexity ABO, Rh, Antibody screens, and blood compatibility -- 2 of 3 -- testing on 08/02/2019, 08/01/2019, and 07/24/2019. B. Test person B performed ABO, Rh and Antibody screens for patient specimens pending a compatibility test request prior to surgical procedures on 07/24/2019 for one patient's sample, 07/18 /2019 for four patient's samples, 07/17/2019 for three patient's samples, 07/10/2019 for one for one patient's sample, and 07/08/2019 for one patient's sample. 3. In an interview conducted on 08/02/2019 at approximately 11:00 A.M., staff confirmed test person B performed ABO, Rh, Antibody Screens, and compatibility testing without having the required education documentation. -- 3 of 3 --