Aspen Mountain Medical Center

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 --