Mary Greeley Medical Center

Summary Statement of Deficiencies D0000 A routine recertification survey was completed on April 29, 2025. The laboratory was found to be out of compliance with the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R 493.803 Condition: Successful Participation D6076 - 42 C.F.R 493.1441 Condition: Laboratory Director, high complexity 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 College of American Pathologists (CAP) proficiency testing records and confirmed by interview with the general supervisor identifier #1 (GS #1) at 9:14 am on 4/29/2025 the laboratory failed to successfully participate in two out of three consecutive testing events for the analyte quantitative human chorionic 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 -- gonadotropin testing. The laboratory had unsatisfactory scores for 2024 testing event 1 and 2024 testing event 3. Refer to D2097. D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) (g) Failure to achieve an overall testing event score of satisfactory performance for 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 College of American Pathologists (CAP) proficiency testing records and confirmed by interview with the general supervisor identifier #1 (GS #1) at 9:14 am on 4/29/2025 the laboratory failed to successfully participate in two out of three consecutive testing events for the analyte quantitative human chorionic gonadotropin testing. The findings include: 1. For 2024 event 1, the laboratory received an unsatisfactory score of zero for the analyte, quantitative human chorionic gonadotropin testing. 2. For 2024 event 3, the laboratory receive an unsatisfactory score of 60% for the analyte, quantitative human chorionic gonadotropin testing. 3. GS #1 confirmed the above unsatisfactory proficiency testing scores. 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 review of College of American Pathologists (CAP) proficiency testing records (2024 event 1 and 2024 event 3) and confirmed by interview with the general supervisor identifier #1 (GS #1) at 9:14 am on 4/29/2025 the laboratory director failed to provide overall management and direction of laboratory services. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; This STANDARD is not met as evidenced by: Based on review of College of American Pathologists (CAP) proficiency testing records and confirmed by interview with the general supervisor identifier #1 (GS #1) at 9:14 am on 4/29/2025 the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2028. -- 2 of 2 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory test list, proficiency testing (PT) records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 10:45 am on 9/21/21, the laboratory failed to verify the accuracy twice annually for the analyte, Clostridium difficile (C. diff) - method Cepheid GeneXpert for two of of three time periods from 1/1/2020 - 9/21/2021. The findings include: 1. The laboratory test list indicated the laboratory performed C. diff testing using the Alere QuickChek Complete and the Cepheid GeneXpert. 2. Laboratory personnel identifier #2 indicated the laboratory used the Alere QuickChek Complete as the primary method for performing C. diff testing. 3. The laboratory enrolled in PT for the primary method of C. diff testing - Alere QuickChek Complete for 2020 and 2021. 4. The laboratory performed verification of accuracy for C. diff between the Alere QuickChek Complete and the Cepheid GeneXpert in November 2020. 5. At the time of the survey, the laboratory did not have any additional records verifying the accuracy of the analyte C. diff - method Cepheid GeneXpert. 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 coagulation reagent studies, the STA Compact Max - PT Assay, and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 3:15 pm on 9/21/2021, the laboratory failed to program the correct patient geometric mean into the Stago coagulation analyzer 6907 for one out of one lot number of coagulation reagent (lot number 256797, expiration date 1/31 /2022.) The findings include: 1. The laboratory had two Stago coagulation analyzers in use, analyzer 6096 and analyzer 6097. 2. The STA Compact Max - PT Assay procedure stated, "When PT-INR is reported, both the ISI and the geometric mean must be entered into the instrument for the INR calculation. With each new lot number of PT reagent (rollover), the geometric mean must be manually entered into the analyzer in order for the correct calculation of the INR." 3. The coagulation reagent studies for analyzer 6096 indicated the geometric mean as 13.5 for lot number 256797, expiration date 1/31/2022 of reagent. 4. The coagulation reagent studies for analyzer 6097 indicated the mean geometric mean as 13.4 for lot number 256797, expiration date 1/31/2022 of reagent. 5. At the time of the survey, the laboratory had the incorrect geometric mean of 13.5 programmed into analyzer 6097. -- 2 of 2 --