Mountain After Hours Clinic

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The laboratory 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] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 proficiency testing desk review of the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER)-0155 and American Proficiency Institute (API) 2023 records (2nd and 3rd events), the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Hematology for the Platelets analyte. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER-0155 and API records 2023 (2nd and 3rd events), the laboratory failed to achieve satisfactory performance (80% or greater) for two consecutive testing events in the specialty of Hematology for the Platelets analyte. 1. A Review of the CASPER-0155 report revealed the following: Hematology 2023- 2nd Event The Laboratory received an unsatisfactory score of 60% for the Platelets analyte. Hematology 2023- 3rd Event The Laboratory received an unsatisfactory score of 0% for the Platelets analyte. 2. A review of proficiency testing records from API 2023 confirmed the above findings. 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 a proficiency testing desk review of the CASPER-0155 Individual Laboratory Report and API 2023 records (2nd and 3rd events), the laboratory director failed to provide overall management and direction of the laboratory services. (Refer to D6016) D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER-0155 and API 2023 records (2nd and 3rd events), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. (Refer to 2130) -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 03/09/2023 and the laboratory was found not to be in substantial compliance with the laboratory requirements at 42 CFR Part 493, with deficiencies cited. 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 record review and interview, it was determined the laboratory failed to review and evaluate the results of the American Proficiency Institute (API) proficiency test (PT) in the specialty of Hematology/Coagulation for two (2) of three (3) events in 2022. The findings include: A review of PT records for the specialty of Hematology/Coagulation included attestation statements dated 07/27/2021 for Event Two (2) and 03/21/2022 for Event One (1). The attestation forms did not indicate a signature of the Laboratory Director (LD) or designee to indicate the PT samples were tested in the same manner as the patient specimens. During an interview on 03/09 /2023 at 3:33 PM, Testing Personnel (TP) #1 stated the LD failed to review and sign the PT attestation statements for the specialty of Hematology/Coagulation for the 2021, Event Two (2), and the 2022, Event One (1). D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. 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 record review and interview, it was determined the Technical Consultant (TC) failed to assess the competency of the Testing Personnel (TP) for the specialty of Hematology for 2021 and 2022. The findings include: A review of the TP records revealed competency assessments for the Abbot Cell Dyn Emerald analyzer was performed on TP #1 and TP #2 in 03/2021, 06/2021, 09/2021, and 12/2021. The competency assessments for TP #1 dated 03/2021, 06/2021, 09/2021, and 12/2021, did not include the signature of the TC. The competency assessments for TP #2 dated 03/2021, 06/2021, 09/2021, and 12/2021, did not include the signature of the TC. A review of Competancy assessments completed by TP for 2022 did not include a signature of the TC. During an interview on 03/09/2023 at 2:30 PM, TP #1 stated annual competencies were not reviewed and signed by the TC for the specialty of Hematology for 2021 and 2022. -- 2 of 2 --

Summary Statement of Deficiencies 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)

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on staff interview and record review, the Technical Consultant failed to perform Quality Assurance from September 17, 2016 through September 26, 2018. Findings include: Record Review on 09/27/18, revealed no documented evidence Quality Assurance was performed from September 17, 2016 through September 26, 2018. The staff acknowledged in an interview on 09/27/18 at 3:42 PM, they did not have a system in place to document Quality Assurance on a quarterly basis. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on staff interview and record review, the laboratory failed to monitor and 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 -- document the humidity of the laboratory where the testing was performed. Humidity was not recorded from September 17, 2016 through September 26, 2018. Findings include: The Manufacturer's Operations Manual for the Cell-Dyn Analyzer lists an operating range for humidity for the Analyzer between zero percent (0%) and eighty percent (80%). Review of the Maintenance Log, on 09/27/18, revealed no documented evidence the humidity had been monitored from September 17, 2016 through September 26, 2018. Testing personnel acknowledged in an interview on 09/27/18 at 2:30 PM, the laboratory failed to have a system in place to ensure the humidity was monitored and documented daily. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on staff interview and record review, the Technical Consultant failed to perform and document Annual Competency using the six (6) mandated competency assessment requirements for testing personal. Competency assessment was performed using one (1) of six (6) methods of assessment for two (2) out of two (2) employees from September 17, 2016 through September 26, 2018. Findings include: Record review on 09/27/18, revealed there was no documented evidence of competency assessments between September 17, 2016 and September 26, 2018, for two (2) employees that included the following: direct observation of routine patient test performance; direct observation of performance of instrument maintenance function checks and calibration; monitoring the recording and reporting of test results; review of worksheets; review of quality control records; review of proficiency test results; review of maintenance records; assessment of testing external proficiency testing samples; and problem solving skills. An interview with the staff on 09/27/18 at 2:42 PM, revealed the facility failed to have a system in place between September 17, 2016 and September 26, 2018 to ensure competency was performed using all six (6) mandated competency assessment requirements. -- 2 of 2 --