Star Valley Medical Center

Summary Statement of Deficiencies D0000 The following deficiencies were a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility 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] 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 and review of the American Proficiency Institute evaluation reports the 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 2 -- failed to achieve a satisfactory performance score for compatibility testing on 2 out of 3 testing events (2024 event #2, 2025 event #1). Refer to D2173. D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) (a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services (CMS) Casper Report 155 and review of the API (American Proficiency Institute) evaluation reports, and staff interview, the laboratory failed to achieve a satisfactory performance score for compatibility testing on 2 out of 3 testing events. The findings were: 1. Review of the CMS Casper 155 report showed the laboratory failed to successfully obtain a passing score for compatibility testing on the following API proficiency testing events: a. 2024 event #2 showed the laboratory scored an 80%. b. 2025 event #1 showed the laboratory scored an 80%. 2. Review of the API proficiency testing evaluations confirmed the laboratory had scored an 80% for compatibility testing on the 2024 event #2 and the 2025 event #1 testing events. 3. Telephone interview with the laboratory manager on 6/18/25 at 2:37 PM confirmed the laboratory had failed 2 out of 3 compatibility proficiency testing events. -- 2 of 2 --

Summary Statement of Deficiencies D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the Centers for Medicare and Medicare 209 Laboratory Personnel Report, review of policy and procedures, lack of documentation, review of proficiency testing records, and staff interview, the laboratory failed to complete 6-month and annual competency assessments in a timely manner (D5209) and failed to ensure proficiency testing results with an artificial score of 100% were evaluated (D5215) for 2 survey cycles (2022, 2024). 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 Centers for Medicare and Medicaid Services 209 Laboratory Personnel Report, lack of documentation, review of policy and procedure, and staff interview, the general supervisor failed to complete 6-month 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 -- and annual competency assessments for 5 of 5 respiratory therapists (RT #1, RT #2, RT #3, RT #4, RT #5) as required for 2 of 2 years reviewed (2023, 2024). The findings were: 1. Review of the personnel file for RT #1, RT #2, RT #3, RT #4, and RT #5 showed an initial competency assessment had been completed in January of 2023. There was no evidence the laboratory had completed a 6-month competency assessment (due in July of 2023) or an annual competency assessment (due in January of 2024). The personnel files showed an annual assessment had been completed in September of 2024. 2. Interview with the general supervisor on 9/17/24 at 1:45 PM revealed the competency assessments had not been completed due to an oversight by the laboratory. 3. Review of the "Clinical Laboratory Staff Training and Competency" policy, effective 9/2022, showed "...Initial training is performed and documented for each staff member based on assigned duties...Competency is assessed and documented 6-months following initial training...Competency is assessed and documented annually thereafter. 4. Review of the "Laboratory Director Delegation of Responsibilities" policy, last revised 10/2023, showed the laboratory director had delegated the responsibility of performing the competency assessments to the general supervisor. THIS IS A REPEAT DEFICIENCY, last cited on 9/14/22. 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 testing results that received an artificial score of 100% for 13 out of 34 American Proficiency Institute (API) and College of American Pathologists (CAP) proficiency testing events reviewed from September 2022 through August 2024. The findings were: 1. Review of the 2022 API Immunology/Immunohematology Event #3 proficiency testing evaluation showed the laboratory scored an artificial score of 100% on samples RUB-11, RUB-12, RUB-13, RUB-14, and RUB-15 (quantitative Rubella) due to a peer group of less than 10 participants. There was no documentation a self-evaluation of the results had been completed. 2. Review of the 2022 API Hematology/Coagulation Event #3 proficiency testing evaluation showed the laboratory scored an artificial score of 100% on sample BCI-14 (blood cell identification) due to a lack of consensus. There was no documentation a self- evaluation of sample BCI-14 had been completed. 3. Review of the 2022 API Microbiology Event #3 proficiency testing evaluation showed the laboratory scored an artificial score of 100% on sample ES-03 (beta-lactamase). There was no documentation a self-evaluation of sample ES-03 had been completed. 4. Review of the 2023 API Hematology/Coagulation Event #1 proficiency testing evaluation showed the laboratory scored an artificial score of 100% on sample BFM-02 (body fluid microscopy) and GOB-02 (gastric pH) due to a lack of consensus. There was no documentation a self-evaluation of sample BFM-02 or GOB-02 had been completed. 5. Review of the 2023 API Hematology/Coagulation Event #3 proficiency testing evaluation showed the laboratory scored an artificial score of 100% on sample VA-03 (vaginal wet-prep) due to a lack of consensus. There was no documentation a self- -- 2 of 4 -- evaluation of sample VA-03 had been completed. 6. Review of the 2023 API Microbiology Event #1 proficiency testing evaluation showed the laboratory scored an artificial score of 100% on sample UR-01 (antibiotic susceptibility testing for aztreonam and ceftazidime) due to a lack of consensus. There was no documentation a self-evaluation of sample UR-01 had been completed. 7. Review of the 2023 API Microbiology Event #2 proficiency testing evaluation showed the laboratory scored an artificial score of 100% on sample UR-06 (antibiotic susceptibility testing for cefepime and cefotaxime) due to less than 5 participants. There was no documentation a self-evaluation of sample UR-06 had been completed. 8. Review of the 2023 API Immunology/Immunohematology Event #2 proficiency testing evaluation showed the laboratory scored an artificial score of 100% on samples RUB-06, RUB-07, RUB-08, RUB-09, and RUB-10 (quantitative Rubella) due to a peer group of less than 10 participants. There was no documentation a self-evaluation of the results had been completed. 9. Review of the 2023 API Immunology/Immunohematology Event #3 proficiency testing evaluation showed the laboratory scored an artificial score of 100% on samples RUB-11, RUB-12, RUB-13, RUB-14, and RUB-15 (quantitative Rubella) due to a peer group of less than 10 participants. In addition, sample SER-13 (compatibility testing) was not graded due to no consensus. There was no documentation a self-evaluation of the results had been completed. 10. Review of the 2024 API Hematology/Coagulation Event #1 proficiency testing evaluation showed the laboratory scored an artificial score of 100% on sample COU-02 (nucleated red blood cells) and the laboratory was directed to review the data summary. There was no documentation the laboratory had reviewed the results. 11. Review of the 2024 API Microbiology Event #1 proficiency testing evaluation showed the laboratory scored an artificial score of 100% on SF-01 (cerebrospinal fluid culture antibiotic susceptibility) and GS-02 (gram stain morphology) and the laboratory was directed to review the data summary. Other concerns identified included the BioFire Film Array molecular assay for detecting joint-wound resistant genes (7 total assays); RSP-01, RSP-02, RSP-03 (molecular respiratory virology); and UR-01 (urine culture susceptibility testing). There was no documentation the laboratory had reviewed the results. 12. Review of the 2024 Microbiology Event #2 proficiency testing evaluation showed the laboratory scored an artificial score of 100% on GS-08 (gram stain) and UR-06 (urine culture antibiotic susceptibility) due to a lack of consensus. There was no documentation the laboratory had reviewed the results. 13. Review of the 2024 CAP Chemistry Event #1 proficiency testing evaluation showed the laboratory scored an artificial score of 100% on CHM-04 (quantitative serum pregnancy, free T3, digoxin, transferrin) and the laboratory was directed to review note 22 and note 30. There was no documentation the laboratory had reviewed the results. 14. Interview with the general supervisor on 9/17/24 at 1 PM confirmed a self-evaluation of the non- graded test results had not been conducted. 15. Review of the "Proficiency Testing for Non-Waived Testing" policy, last revised 8/2024, showed "...Evaluation of Ungraded Proficiency Testing...The General Supervisor shall routinely review the laboratory's proficiency testing results when a formal evaluation has not been provided by the testing agency under the following conditions: The PT program assigned an artificial score of 100% (i.e., results not evaluated or scored)..." THIS IS A REPEAT DEFICIENCY, last cited on 9/14/22. 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 -- 3 of 4 -- 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 had performed approximately 490 patient PSA tests since the VITROS XT 7600 was approved for use in April of 2024. 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 3/12 /24. The following concerns were identified: a. Review of the PSA test report for patient #1, dated 9/9/24, failed to include the test method used. 2. Interview with the general supervisor on 9/18/24 at 10:08 AM confirmed the PSA test method was not included on the patient test reports. 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 review of quality control (QC) records, patient testing logs, the laboratory's Individual Quality Control Plans (IQCP), policy and procedure review, and staff interview, the laboratory failed to perform a positive and negative control each day of patient testing from 4/5/24 through 9/15/24 for the SURE-VUE qualitative serum pregnancy test. This failure affected 60 patient samples. The findings were: 1. Review of the QC logsheet showed a positive and negative control were performed on 4/2/24, 5/7/24, 6/5/24, 7/2/24, 8/5/24, and 9/10/24. Review of the patient testing log showed 60 patient tests were performed on days in which QC was not performed. 2. Review of the "SURE-VUE Serum/Urine hCG Test" procedure, last revised 11/2022, showed "Quality Control...2. External Quality Control...a. Serum: Test external controls monthly, with each new lot, with each new shipment received..." 3. Review of the laboratory's IQCPs showed no evidence an IQCP had been developed for the SURE- VUE qualitative serum pregnancy test. 4. Interview with the general supervisor on 9 /18/24 at 9:40 AM confirmed an IQCP had not been developed for the qualitative serum pregnancy test and QC was not being performed as required. -- 4 of 4 --

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 (API) evaluation reports, and staff interview, the laboratory failed to achieve satisfactory performance scores on the analyte of partial pressure of oxygen for 3 consecutive events (2023 event #2, 2023 event #3, 2024 event #1). Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 achieve satisfactory performance for the same analyte or test in 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 the Centers for Medicare and Medicaid Services Casper (CMS) Report 155, review of the American Proficiency Institute (API) evaluation reports, and staff interview, the laboratory failed to achieve satisfactory performance scores on the analyte of partial pressure of oxygen (PO2) for 3 consecutive events (2023 event #2, 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 analyte of PO2 for the following API proficiency testing events: a. 2023 event #2 showed the laboratory scored a 60%. b. 2023 event #3 showed the laboratory scored a 0%. c. 2024 event #1 showed the laboratory scored a 60%. 2. Telephone interview on 4/23/24 at 3:15 PM with the technical supervisor confirmed the laboratory had failed to submit the 2023 event #3 and the failures of 2023 event #2 and 2024 event #1 were due to the testing personnel failing to follow the instructions as outlined by the proficiency testing program. 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 the Centers for Medicare and Medicaid Services Casper 155 report and staff interview, the laboratory director failed to ensure an effective

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of proficiency testing records, review of the CMS (Center for Medicare and Medicaid Services) 209 Laboratory Personnel Report, and staff interview, the laboratory failed to include the respiratory therapists in the rotation of personnel performing blood gas (pH, partial pressure of oxygen, partial pressure of carbon dioxide) testing for 6 of 6 proficiency testing events reviewed from September 2021 through September 2022. The laboratory performed approximately 150 blood gases per year. The findings were: 1. Review of the CMS 209 Laboratory Personnel Report dated 9/8/22 showed 5 respiratory therapists were listed as testing personnel performing moderate complexity testing. 2. Review of 6 American Proficiency Institute Chemistry Core Proficiency testing events from September 2021 through September 2022 showed the blood gas section of the events was performed by laboratory personnel which did not include the respiratory therapists. 3. Interview with testing personnel #1 on 9/14/22 at 9 AM revealed blood gas testing was shared between the respiratory therapists and the laboratory staff. 4. Interview with the general supervisor on 9/14/22 at 11 AM confirmed the respiratory therapists had not participated in the proficiency testing events. 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, 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 -- consultant competency. This STANDARD is not met as evidenced by: Based on review of personnel files, review of the CMS (Center for Medicare and Medicaid Services) 209 Laboratory Personnel Report, lack of documentation, review of policy and procedure, and staff interview, the general supervisor failed to complete competency assessments for 5 of 5 respiratory therapists (RT #1, RT #2, RT #3, RT #4, RT #5) as required for 2 of 2 years reviewed (2020, 2021). The findings were: 1. Review of the laboratory's personnel files showed the following concerns: a. Review of the personnel file for RT #1 showed he was hired in February of 2022. There was no evidence the general supervisor had completed an initial or 6 month competency assessment. b. Review of the personnel file for RT #2 showed she was hired in June of 2017. There was no evidence the general supervisor had completed the annual competency assessment in 2020 or 2021. c. Review of the personnel file for RT #3 showed he was hired in May of 2014. There was no evidence the general supervisor had completed the annual competency assessments in 2020 or 2021. d. Review of the personnel file for RT #4 showed she was hired in March of 2021. There was no evidence the general supervisor had completed the initial competency assessments or any required assessment thereafter. e. Review of the personnel file for RT #5 showed he was hired in February of 2020. There was no evidence the general supervisor had completed the initial competency assessments or any required assessment thereafter. 2. Interview with the general supervisor on 9/14/22 at 11:50 AM confirmed the competency assessments had not been completed. 3. Review of the policy and procedure titled "Clinical Laboratory Staff Training and Competency" dated 10/2021 showed "...Initial training is performed and documented for each staff member based on assigned duties. Competency is assessed and documented 6-months following initial training. Competency is assessed and documented annual (sic) thereafter." 4. Review of the policy and procedure titled "Laboratory Director Delegation of Responsibilities" dated 7/2022 showed the laboratory director had delegated the responsibility of performing the competency assessments to the general supervisor. 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 review of proficiency testing records, lack of documentation, and staff interview, the laboratory failed to review and evaluate proficiency testing results for 6 of 37 proficiency testing events reviewed from September 2020 through August 2022. The findings were: 1. Review of the American Proficiency Institute (API) proficiency testing (PT) reports failed to include documentation the laboratory had evaluated test scores of less than 100%. The following concerns were identified: a. Review of the 2020 API Chemistry Core Event #3 showed the laboratory scored an 80% on sodium. There was no documentation the laboratory had evaluated the test results. b. Review of the 2021 API Chemistry Core Event #1 showed the laboratory scored an 80% on creatinine. There was no documentation the laboratory had evaluated the test results. c. Review of the 2021 Chemistry Core Event #2 showed the laboratory scored an 80% on triglyceride. There was no documentation the laboratory had evaluated the test results. d. Review of the 2021 Hematology Event #3 showed the laboratory scored an -- 2 of 4 -- 80% on eosinophils. There was no documentation the laboratory had evaluated the test results. e. Review of the 2021 Microbiology Event #1 showed the laboratory scored an 80% on the detection of Group A Streptococcus using the Quidel Solana test method. There was no documentation the laboratory had evaluated the test results. f. Review of the 2021 Microbiology Event #2 showed the laboratory scored an 80% on the detection of Mycoplasma pneumoniae using the BioFire test method. There was no documentation the laboratory had evaluated the test results. 2. Interview with the general supervisor on 9/14/22 at 11:50 AM confirmed the PT scores of less than 100% had not been investigated. 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 5 of 6 College of American Pathologists (CAP) proficiency testing events reviewed from September 2020 to September 2021. The laboratory performed approximately 64 pancreatic amylase patient tests annually. The findings were: 1. Review of the CAP proficiency testing evaluation forms showed the laboratory received an artificial score of 100% on the analyte of pancreatic amylase on the third event of 2020, the second and third events of 2021, and the first and second events of 2022. There was no documentation the results of the proficiency testing events had been evaluated for accuracy. 2. Interview with the general supervisor on 9/13/22 at 9:36 AM confirmed an evaluation of the proficiency testing results had not been evaluated for accuracy. 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 190,000 patient tests annually. The findings were: 1. Review of the daily environmental log showed the humidity level in the laboratory was not monitored. 2. Review of the manufacturer's instructions for the Beckman Coulter DxH 690 and the DxH -- 3 of 4 -- Slidemaker Stainer II hematology instruments showed the relative humidity must be maintained at less than 85% when the temperature of the laboratory was between 60 and 84 degrees Fahrenheit. The DxH Slidemaker Stainer II required the relative humidity to be maintained at less than 70% then the temperature of the laboratory was between 68 and 80 degrees Fahrenheit. 3. Review of the manufacturer's instructions for the Beckman Coulter AU 480 chemistry analyzer showed the relative humidity must be maintained between 15% and 90%. 4. Interview with the general supervisor on 9/14/22 at 11:50 AM confirmed the humidity of the laboratory had not been monitored. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of documentation and staff interview, the laboratory failed to verify the statistical parameters of quality control material prior to use for 2 of 3 test systems reviewed (hematology, coagulation). The findings were: 1. There was no documentation the laboratory had verified new lot numbers of quality control material prior to being used on the hematology and coagulation analyzers. 2. Interview with the general supervisor on 9/14/22 at 9:57 AM confirmed the statistical parameters of the quality control materials had not been verified before use. -- 4 of 4 --

Summary Statement of Deficiencies D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

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 proficiency testing reports review and confirmation by the laboratory manager, the laboratory failed to achieve successful participation for partial Carbon Dioxide (pCO2) in 2 consecutive proficiency testing events (the 1st and 2nd American Proficiency Institute (API) testing events of 2018). Findings include: 1. The laboratory failed to attain a pCO2 score of at least 80% for the 1st and 2nd API events of 2018. (See D2087.) 2. In an interview with the laboratory manager on 08/28/2018 via email the laboratory manager confirmed they received scores of less than 80% for the 1st and 2nd API events of 2018. 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 -- D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) 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 proficiency testing reports review and interview with staff, the laboratory failed to attain a score of at least 80% for partial pressure Carbon Dioxide (pCO2) for the 1st and 2nd American Proficiency Institute (API) 2018 testing events. Findings include: 1. API proficiency testing reports reviewed included documentation the laboratory scored 40% for pCO2 the first event of 2018 failing results for specimens: a. BG-01 t:he lab reported 42mmHg. The acceptable range was 47-58. b. BG-02 the lab reported 65mmHg. The acceptable range was 74-88. c. BG-04 the lab reported 25mmHg. The acceptable range was 29-39. 2. API proficiency testing reports reviewed included documentation the laboratory scored 60% for pCO2 the Second event of 2018 failing results for specimens: a. BG-09 t:he lab reported 31mmHg. The acceptable range was 40-51. b. BG-0 the lab reported 20mmHg. The acceptable range was 23-33. 3. In an interview with the laboratory manager via email on 08/28/2018, the laboratory manager confirmed the laboratory failed to achieve successful participation for 2 consecutive proficiency testing events for pCO2 test results. D5809 TEST REPORT CFR(s): 493.1291(e) The laboratory must, upon request, make available to clients a list of test methods employed by the laboratory and, as applicable, the performance specifications established or verified as specified in 493.1253. In addition, information that may affect the interpretation of test results, for example test interferences, must be provided upon request. Pertinent updates on testing information must be provided to clients whenever changes occur that affect the test results or interpretation of test results. This STANDARD is not met as evidenced by: Based on new instrument verification records review, lack of documentation and interview with staff, the laboratory failed to provide pertinent updates to clients when test method changes occurred that affected test results for 10 of 31 tests verified for the new Architect immunoassay instrument. Findings include: 1. The laboratory verification records reviewed for the new Architect instrument included documentation the laboratory compared the new test method to the previous test method via correlation studies. Correlation studies of patient samples compared using the previous and new methods for B-type natriuretic Peptide (BNP), Carcinoembryonic Antigen (CEA), Dehydroepiandrosterone (DHEA), Estradiol, Ferritin, Follicle Stimulating Hormone (FSH), Insulin, Lutenizing hormone, Progesterone, and Testosterone included bias percentages of greater than 20% from the previous test method. BNP bias 37.8% FSH bias 21.18% CEA bias 29.7% Insulin bias 52.44% DHEA bias 32% LH bias 32.47% Estradiol bias 30.8% Prolactin bias 27% Ferritin bias 23.0% Testosterone bias 157% 2. In an interview conduced on 08/23 /2018 at approximately 6:00 P.M. staff confirmed the laboratory did not provide updates to clients that advised them of the changes in the new method's normal ranges. -- 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 American Proficiency Institute (API) report review, Centers for Medicare and Medicaid Services, (CMS) Casper 155 report review, and E-Mail interview conducted on 04/29/2018, the failed to successfully participate in proficiency testing for the endocrinology analyte Free Thyroxine (FT4) in two consecutive testing events (the 3rd event of 2017 and the 1st event of 2018). See D2017. D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) 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 -- (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based onAmerican Proficinecy Institute (API) report review, CMS CASPER 153 and 155 reports review, and E-mail confirmation of test results, the laboratory failed to successfully participate in 2 consecutive proficiency testing events for Free Thyroxine (Free T4) (API event 1 of 2018 and event 2 of 2017). Findings include: 1. API summary evaluation reports review for the first Chemistry and Endocrinology even of 2018 and second Endocrinology proficiency testing event of 2017 included summary scores of 60% for score for the Free T4 analyte for the 3rd American Proficiency testing agency event of 2017. 2. Casper reports for 2 out of 3 events reviewed included Endocrinology scores of 0% for the 1st and 2nd events of 2017 . 3. In an E- mail interview conducted on 04/ 18/2018 the laboratory technical supervisor stated they had failed 2 events in a row. -- 2 of 2 --