Castle Rock 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 personnel files, review of the CMS (Centers for Medicare and Medicaid Services) 209 Laboratory Personnel Report, policy and procedure review, and staff interview, the laboratory failed to ensure an annual competency assessment had been completed for 1 of 3 testing personnel (LD/TC/TP #1) for 2 of 2 years (2022, 2023) reviewed. The findings were: 1. Review of the CMS 209 Laboratory Personnel Report showed LD/TC/TP #1 performed the duties of the laboratory director (LD), the technical consultant (TC), and testing personnel (TP). Review of the personnel file for LD/TC/TP #1 showed no competency assessments had been completed to evaluate her testing personnel responsibilities in 2022 or 2023. 2. Interview with LD/TC/TP #1 on 11/5/24 at 12 PM confirmed the competency assessments for her testing personnel responsibilities had not been completed. 3. Review of the "Policy and Procedure for Laboratory Staff Competency Assessment", last revised 6/19/24, showed "Every lab employee shall regularly be assessed for competency for the tasks defined by their position's job description..." The policy stated a competency assessment would be conducted upon hire, at 6-months, and annually thereafter. 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 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 -- 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 VITROS XT 7600 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 on 1 of 1 PSA patient test reports (patient #1) reviewed. The laboratory performs approximately 527 patient PSA tests annually. The findings were: 1. Review of the VITROS XT 7600 analyzer manufacturer's instructions stated "Different test methods cannot be used interchangeably. PSA results in a given patient sample determined with different tests and from different manufacturers can vary due to differences in test methods and reagent specificity. A change to a different method during serial monitoring of a patient should be accompanied by additional sequential testing to confirm baseline values. The results reported by the laboratory to the physician must include the identity of the PSA test used." Review of the VITROS XT 7600 new instrument verification study showed the study was approved by the laboratory director on 4/28/23. The following concerns were identified: a. Review of the PSA test report for patient #1, dated 10/30/24, failed to include the test method used. 2. Interview with the laboratory director on 11/5/24 at 4:30 PM confirmed the PSA test method was not included on the patient test reports. -- 2 of 2 --

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 Centers for Medicare and Medicaid Services Casper Report 155, review of the American Proficiency Institute and the American Association of Bioanalysts-Medical Laboratory Evaluation reports, and staff interview, the laboratory failed to sucessfully participate in two consecutive testing events for the automated white blood cell differential challenge (2023 event #3, 2024 event #1). Refer to D2121. D2121 HEMATOLOGY CFR(s): 493.851(a) 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 -- Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services (CMS) Casper 155 report, review of the American Proficiency Institute (API) and AAB-MLE (American Association of Bioanalysts-Medical Laboratory Evaluation) reports, and staff interview, the laboratory failed to successfully participate in two consecutive API and AAB-MLE non-chemistry testing events for the automated white blood cell (WBC) differential challenge (2023 event #3, 2024 event #1). The findings were: 1. Review of the CMS Casper 155 report showed the laboratory failed to successfully obtain a passing score for the automated WBC differential for the following proficiency testing events: a. The 2023 AAB-MLE event #3 showed the laboratory scored a 0%. b. The 2024 API event #1 showed the laboratory scored a 28%. 2. Interview on 4/26/24 at 9:30 AM with the laboratory director confirmed the laboratory scored a 0% on the 2023 event #3 due to failing to submit the results prior to the deadline and the failure of the 2024 event #1 was due to the testing personnel failing to follow the instructions as outlined by the proficiency testing program. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on proficiency testing record review and staff interview, the laboratory failed to ensure all of the proficiency testing specimens within a specialty or subspecialty received in a "quarter" were analyzed by one analyst for 4 of 14 College of American Pathologist (CAP) and American Association of Bioanalysts (AAB) testing events reviewed from November 2020 to November 2022. The findings were: 1. Review of the CAP and AAB attestation statements showed the following concerns: a. Review of the 2021 first quarter AAB chemistry proficiency testing event showed basic chemistry samples #1 and #2 were performed by testing personnel (TP) #1 and samples #3, #4, and #5 were performed by TP #2. Special chemistry and bilirubin sample #1 was performed by TP #2 and sample #2 was performed by TP #1. b. Review of the 2021 first quarter CAP Chlamydia/Neisseria gonorrhoeae proficiency testing event showed the samples were split between TP #1 and TP #2. c. Review of the 2021 second quarter AAB special chemistry proficiency testing event showed the samples were split between TP #3 and TP #4. d. Review of the 2022 second quarter AAB chemistry proficiency testing event showed the bilirubin, microalbumin, lipids, basic chemistry, and immunochemistry samples were split between TP #1 and TP #2. In addition, non-chemistry proficiency testing samples for infectious mononucleosis, Cryptosporidium/Giardia, and Clostridium difficile testing samples were split between TP #2 and TP #5. 2. Interview with the laboratory director on 11/15/22 at 3 PM revealed she was unaware of the regulation and split the proficiency samples between testing personnel to evaluate competency. 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 -- D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on observation and staff interview, the laboratory failed to report 586 SARS- CoV-2 negative test results from 5/1/22 through 11/16/22. The findings were: 1. Observation of the laboratory showed testing for SARS-CoV-2 was performed using a molecular platform on the Cepheid Gene Xpert Xpress and the Abbott ID Now test systems 2. Interview with the laboratory director on 11/16/22 at 10:39 AM revealed the laboratory had reported 257 positive SARS-Co-V-2 test results to the State Public Health Laboratory, however the laboratory had not reported the 586 negative test results. Further, the laboratory director stated she was unaware of the regulation. 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). This STANDARD is not met as evidenced by: Based on review of proficiency testing records, lack of documentation, and staff interview, the laboratory failed to have a system in place for reviewing proficiency test results that received an artificial score of 100% due to lack of peer group data for 2 of 6 American Association of Bioanalysts (AAB) proficiency testing events reviewed from November 2020 to November 2022. The laboratory performed approximately 378 prostate specific antigen (PSA) tests annually. The findings were: 1. Review of the AAB proficiency testing evaluation forms showed the laboratory received an artificial score of 100% on the analyte of PSA on the first and second events of 2022 due to lack of peer group data. There was no documentation the results of the proficiency testing events had been evaluated for accuracy. 2. Interview with the laboratory director on 11/15/22 at 4:47 PM confirmed an evaluation of the proficiency testing results had not been evaluated for accuracy. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks -- 2 of 3 -- may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the CMS (Centers for Medicare and Medicaid Services) 116 form, lack of documentation, and staff interview, the laboratory failed to have a written procedure for reporting SARS-CoV-2 test results to the appropriate agencies. The findings were: 1. Review of the CMS-116 form showed the laboratory performed SARS-Co-V-2 testing using the Abbott ID Now and the Cepheid Gene Xpert Xpress test systems. 2. Review of the laboratory's procedure manuals showed no evidence the laboratory had developed a policy and procedure for reporting SARS-Co-V-2 test results to the appropriate agencies. 3. Interview with the laboratory director on 11/16 /22 at 10:39 AM confirmed the laboratory did not have a written procedure for reporting SARS-Co-V-2 patient test results. 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 review of the laboratory's environmental records, review of manufacturer's instructions, and staff interview, the laboratory failed to monitor humidity in the testing and reagent storage areas. The laboratory performed approximately 70,000 patient tests annually. The findings were: 1. Review of the daily environmental log sheets showed the humidity level in the laboratory was not monitored. 2. Review of the manufacturer's instructions for the Sysmex SN-L 430 hematology instrument showed the relative humidity must be maintained between 10 and 95%. The Diagnostica Stago Start 4 instrument required the relative humidity to be maintained between 20 and 80%. 3. Interview with the laboratory director on 11/16/22 at 10:32 AM confirmed the humidity of the laboratory had not been monitored. -- 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 proficiency testing records review, lack of documentation, and interview with staff, the laboratory failed to review and evaluate proficiency test results for 8 of 18 American Association of Biocatalysts (AAB) and College of American Pathologists (CAP) proficiency testing events reviewed for testing performed from November 4, 2018 to November 4, 2020. Findings include: 1. Proficiency testing records review failed to include documentation of review of proficiency test results for: AAB Proficiency Agency Score/Analyte Event 2nd Chemistry 2019 80%/Carbon Dioxide 80%/ Iron 2nd Non-Chemistry 2019 100% 3rd Chemistry 2019 100% 3rd Non-Chemistry 2019 80% Cell ID Basophilic Stippling reported Acceptable = Giant Platelet 1st Chemistry 2020 80% Albumin 80% Cholesterol 80% Alanine Transaminase 1st Non-chem 2020 80% Influenza B 2nd Non-Chem 2020 100% CAP 3rd 2018 Hematology 80% Protime 2. In an interview conducted on 11/04/2020 at approximately 6:15 PM, the director confirmed the proficiency tests listed lacked documentation results were reviewed to identify problems that may need

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: . Based on calibration records review, lack of documentation, and interview with staff, the laboratory failed to verify the reportable range at least once every six months using testing materials with values at the zero or minimal level, at the mid-level, and at the upper level of the reportable range for 10 of 10 tests reported from the Vitros 350 instrument, Alkaline Phosphatase, Alanine Transaminase, Amylase, Aspartate Transaminase, Potassium, Chloride, Uric Acid, Triglycerides, Phosphorous, 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 -- Magnesium tests reviewed from October 2016 to October 2018. The laboratory performed approximately 12,000 of these tests per year. Findings include: 1. Calibration records review failed to include documentation the laboratory verified calibration at least once every six months in 2017 and 2018 for Alkaline Phosphatase, Amylase, Potassium, Chloride, Uric Acid, Triglycerides, Phosphorous, and Magnesium. 2. Calibration records review failed to include documentation they used a material with a zero or minimal value, midlevel value, and a value at the upper level of the reportable range for Potassium, Sodium, and Chloride once every six months of testing for 3 of 4 six month periods between October 2016 and October 2018. 3. In an interview conducted on 10/25/2018 at approximately 5:30 P.M., the laboratory technical consultant stated the laboratory did not have a process to verify the reportable range at least once every six months using at least 3 levels of assayed materials at the low, mid, and upper level of the testing reportable range. This is a repeat deficiency. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on Individualized Quality Control Plan (IQCP) review, lack of documentation, and interview with staff, the laboratory failed to include a risk assessment and a quality assessment plan for the IQCP for 6 of 6 tests performed using the Cepheid Gene Expert molecular detection system for Group A Strep, Flu A and B, Neisseria Gonorrhea, Chlamydia, and Respiratory Syncytial Virus. Findings include: 1. The IQCP failed to include a risk assessment and quality assessment plan for reducing the frequency of quality control to two levels of control for each new lot number of test kits from the standard frequency of two levels of controls each day of testing. 2. In an interview conducted on 10/25/2018 at approximately 3:45 P.M., the laboratory technical supervisor stated the approved laboratory IQCP failed to include the required risk assessment and quality assessment plan needed to monitor the reduction in quality control frequency. -- 2 of 2 --