Humboldt General Hospital Laboratory

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was generated as a result of the CLIA desk review of proficiency testing obtained from the national database and verified with the proficiency testing company, conducted off-site for your laboratory on August 5, 2025. 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 The findings and conclusions of any investigation by the Nevada Health Authority-Division of Healthcare Purchasing and Compliance shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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. 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 -- This CONDITION is not met as evidenced by: Based on the findings herein, the Condition: Successful Participation (in a proficiency testing program) was not met. A review of the federal database CASPER Report 0155D and the American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) evaluation forms on August 5, 2025 found that the laboratory failed to successfully participate in a proficiency testing program. Findings include: The laboratory failed to maintain successful participation with the AAB-MLE PT program shown by the unsuccessful performance for Ethanol (ETOH) in the first PT event of 2025 and second PT event of 2025. Refer to D2118. D2118 TOXICOLOGY CFR(s): 493.845(f) (f) 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 a review of the federal database CASPER Report 0155D and the American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) evaluation forms on August 5, 2025, the laboratory failed to successfully participate in a proficiency testing program. Findings include: 1. The laboratory failed to maintain successful participation with the AAB-MLE PT program shown by the unsuccessful performance for Ethanol (ETOH) in the first PT event of 2025 and second PT event 2025. 2. Both the CASPER Report 0155D and the AAB-MLE PT evaluation reported a score of 60% for the first PT event of 2025 and a score of 0% for the second PT event of 2025. 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 the findings herein, the Condition: Laboratories Performing Moderate Complexity Testing; Laboratory Director was not met. A review of the federal database CASPER Report 0155D and the American Association of Bioanalysts- Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) evaluation forms on August 5, 2025 found that the laboratory director failed to ensure successful participation in a proficiency testing program. Findings include: The laboratory director failed to ensure successful participation with the AAB-MLE PT program shown by the unsuccessful performance for Ethanol (ETOH) in the first PT event of 2025 and second PT event of 2025. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) -- 2 of 3 -- (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 a review of the federal database CASPER Report 0155D and the American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) evaluation forms on August 5, 2025, the director failed to ensure that the laboratory successfully participated in a proficiency testing program. Findings include: 1. The laboratory failed to maintain successful participation with the AAB- MLE PT program shown by the unsuccessful performance for Ethanol (ETOH) in the first PT event of 2025 and second PT event 2025. 2. Both the CASPER Report 0155D and the AAB-MLE PT evaluation reported a score of 60% for the second PT event of 2025 and a score of 0% for the second PT event of 2025. -- 3 of 3 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on December 16-17, 2024. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on a review of the laboratory's proficiency testing (PT) records, the director approved laboratory policies and procedures, and interviews with the laboratory personnel and laboratory supervisor, the laboratory failed to test PT samples in the same manner as patient specimens. Findings include: 1. A review of the laboratory's PT records from March 2023 through December 2024 found that the entire panel of chemistry tests was repeated for any PT samples that had values flagged by the chemistry analyzer. 2. The laboratory director approved "Critical Results Reporting" policy indicates that results with a "repeat and alarm value" are to be repeated and confirmed. The policy does not describe repeat testing for results that are flagged by the analyzer, but are not critical values. 3. An interview with testing personnel on Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- December 17, 2024 at approximately 4:00 PM indicated that all flagged analytes will be repeated even if they are not critical values. 4. These findings were confirmed by the laboratory supervisor in an interview at approximately 4:00 PM on December 17, 2024. The laboratory performs approximately 211,889 chemistry tests annually. 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 a review of the American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) and American Proficiency Institute (API) Proficiency Testing (PT) attestations from March 2023 through December 2024 and an interview with the laboratory supervisor, the laboratory failed to ensure that all testing personnel routinely performing patient testing were performing proficiency testing. Findings include: 1. A review of 2023 and 2024 PT attestations from AAB-MLE revealed that the proficiency testing was not rotated among the testing personnel routinely performing patient testing. a. In 2023 AAB-MLE non chem testing personnel number two on the form CMS 209 performed all three events for both blood banking and direct antiglobulin test (DAT). b. In 2024 AAB-MLE non chem testing personnel number one on the form CMS 209 performed all three events for all misc cultures, throat culture and urine culture. c. In 2023 AAB-MLE non chem testing personnel number four on the form CMS 209 performed all three events for cardiac markers. d. In 2023 AAB-MLE non chem testing personnel number nine on the form CMS 209 performed all three events for serum HCG. 2. A review of the 2023 and 2024 PT attestations from API revealed that the proficiency testing was not rotated among the testing personnel routinely performing patient testing. a. In 2023 API chem core testing personnel number two on the form CMS 209 performed all three testing events. 3. An interview with the laboratory supervisor on December 17, 2024 at approximately 2:00 PM confirmed these findings. The laboratory performs approximately 211,889 chemistry, 3,792 microbiology, five general immunology, 1,486 immunohematology and 119,616 hematology tests annually. 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 a review of the AAB-MLE and API Proficiency Testing attestations from March 2023 through December 2024 and an interview with the laboratory supervisor, the laboratory failed to ensure that the testing personnel performing the proficiency testing signed the attestation stating that the samples were performed in the same manner as patient testing. Findings include: 1. A review of API PT attestations from March 2023 through December 2024 found that in the first event in 2023 for chemistry miscellaneous the laboratory personnel performing the PT failed to sign the -- 2 of 7 -- attestations. 2. A review of the March 2023 through December 2024 AAB-MLE PT documents found that the testing personnel failed to sign the attestations as detailed below. The 2023 and 2024 Chemistry testing events included the following 16 subsections: afinion glycohemoglobin, ammonia, cardiac markers, chemistry module, fecal occult blood, high-sensitivity c-reactive protein (HS-CRP), lipid profile, neonatal /direct bilirubin, provider-performed microscopy, PSA, serum alcohol/ketones, serum HCG, therapeutic drug monitoring, urinalysis module, urine drug screen and urine sediment identification. a. Testing event M1 in 2023 had 16 out of 16 subsections were missing signatures from the testing personnel on the attestations. b. Testing event M2 in 2023 had 16 out of 16 subsections missing signatures from the testing personnel on the attestations. c. Testing event M3 in 2023 had 16 out of 16 subsections missing signatures from the testing personnel on the attestations. d. Testing event M1 in 2024 had 14 out of 16 subsections were missing signatures from the testing personnel on the attestations. e. Testing event M2 in 2024 had 16 out of 16 subsections missing signatures from the testing personnel on the attestations. f. Testing event M3 in 2024 had 15 out of 16 subsections missing signatures from the testing personnel on the attestations. 3. A review of the March 2023 through December 2024 AAB-MLE PT attestations found that the testing personnel failed to sign the attestations as detailed below. The 2023 and 2024 Nonchemistry testing events included the following 12 subsections: antimicrobial susceptibility, blood bank 2, blood cell identification, coagulation module, direct antiglobulin test (DAT), hematology with 5-part diff-abbott cell-dyn, infectious mononucleosis, rapid sedimentation rate (ESR), strep a antigen detection, throat culture, misc cultures and urine culture. a. Testing event M1 in 2023 had eight out of 11 (misc cultures was added in testing event M2) subsections missing signatures from the testing personnel on the attestations. b. Testing event M2 in 2023 had 11 out of 12 subsections missing signatures from the testing personnel on the attestations. c. Testing event M3 in 2023 had 11 out of 12 subsections missing signatures from the testing personnel on the attestations. d. Testing event M1 in 2024 had six out of 12 subsections missing signatures from the testing personnel on the attestations. e. Testing event M2 in 2024 had six out of 12 subsections missing signatures from the testing personnel on the attestations. f. Testing event M3 in 2024 had eight out of 12 subsections missing signatures from the testing personnel on the attestations. 4. An interview with the laboratory supervisor on December 17, 2024 at approximately 11:00 AM confirmed these findings. The laboratory performs approximately 211,889 chemistry, 3,792 microbiology, five general immunology, 1,486 immunohematology, 119,616 hematology and 22,085 waived tests annually. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of the laboratory's PT documentation from March 2023 through December 2024 and an interview with the laboratory supervisor, the laboratory failed to evaluate, take, and document

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on 2/07-08/2023 and a complaint investigation conducted remotely on 2/09-20/2023. The complaint submitted on 2/09 /2023 alleged that the same patient samples tested on the two blood gas analyzers in the respiratory therapy department produced significantly different results which would affect patient care. The allegation was substantiated. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) records, review of instrument print outs of patient results, review of laboratory policies and procedures, and interview with the administrative respiratory director, the laboratory failed to ensure that the PT samples were tested the same number of times that it routinely tests patient samples. Findings include: 1. Review of the instrument records for blood gas PT testing for the first event of 2023 revealed that the PT samples were tested on both Stat Profile Prime Plus analyzers. 2. Review of the instrument records for blood gas PT testing for the third event of 2022 revealed that PT samples were tested on the Rapidpoint 500 and Stat Profile Prime Plus analyzers. 3. Review of the instrument records for blood gas PT testing for the third event of 2021 revealed that PT samples were tested on both Rapidpoint 500 analyzers. 4. Review of the instrument print outs of patient results from 1/30/2023 through 2/09/2023 revealed that not all patient Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- samples were tested on both Stat Profile Prime Plus analyzers. Six of twelve patient samples were tested on both instruments. 5. The administrative respiratory director interviewed on 2/08/2023 at approximately 9:30 AM indicated that PT samples were tested on both instruments because patient samples were tested on both instruments according to the recommendation of the instrument technical representatives. However, the respiratory director indicated that not all staff members tested patient samples on both analyzers. 6. The respiratory director confirmed that there were no policies and procedures approved by the laboratory director to test patient samples on both analyzers. 7. On 2/16/2023, the respiratory director submitted a revised policy still to be approved by the laboratory director. The policy, "Reporting Blood Gas Values," states, "I. Each blood sample is to be processed through the primary machine. A. If the primary machine is not available or inoperable, samples should be run through the secondary machine." The laboratory performs approximately 1165 blood gas tests annually. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of American Association of Bioanalysts' (AAB) evaluation of proficiency testing (PT) results submitted by the laboratory from 2021 through 2022, the absence of laboratory instrument printouts of PT results, the absence of the PT program report forms and attestation statements for the first AAB PT events for 2022 (Q1 2022), and an interview with the administrative laboratory director, the laboratory failed to maintain a copy of all records, including the laboratory instrument printouts of PT results, PT program report forms used by the laboratory to record PT results and the attestation statements provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens. Findings include: 1. A review of the laboratory's PT documentation from 2021 and 2022 revealed that the only documents available for Q1 2022 were AAB's evaluations of the PT results. 2. The laboratory was unable to provide the laboratory instrument printouts of PT results, the proficiency testing program report forms used by the laboratory to record proficiency testing results, and the attestation statements provided by the PT program, signed by the analyst(s) and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens. 3. The administrative laboratory director confirmed these findings in an interview on 2/7/2023 at approximately 3:00 PM. The laboratory performs approximately 3,190 microbiology tests, 5 general immunology tests, 210,462 chemistry tests, 165,734 hematology tests, and 1,920 immunohematology tests annually. -- 2 of 13 -- D3035 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(ii) In addition, the laboratory must retain immunohematology records, blood and blood product records, and transfusion records as specified in 21 CFR 606.160(b)(3)(ii), (b) (3)(iv), (b)(3)(v), and (d). This STANDARD is not met as evidenced by: Based on review of emergency transfusion release records and an interview with the administrative laboratory director, the laboratory failed to ensure retention of immunohematology records for the emergency release of blood as required. Findings include: 1. The emergency transfusion release records for 2022 were reviewed. The laboratory was unable to locate the emergency transfusion release for patient LS from July 20, 2022. 2. The administrative laboratory director confirmed these findings in an interview on February 8, 2023 at approximately 2:30 PM. The laboratory performs approximate 1,920 immunohematology tests per year. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, review of patient test reports from the hospital medical records and analyzers, and interview with the administrative respiratory director and blood gas analyst, the laboratory failed to meet the applicable analytic systems requirements: 1. The laboratory failed to compare the results from the two blood gas analyzers in use in the respiratory department at least twice a year (refer to D5775). 2. The laboratory failed to take

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was generated as a result of the CLIA proficiency testing desk review, conducted off-site for your laboratory on 12/09/2021. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 desk review of federal database CASPER Reports 153D and 155D and the American Association of Bioanalysts (AAB) proficiency testing (PT) evaluation 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 -- forms, on 12/09/2021, the laboratory did not successfully participate in a proficiency testing program. The laboratory's failure to achieve an overall satisfactory proficiency testing event performance for two consecutive testing events for the second and third testing events of 2021 with a score of 60% and 80%, respectively, resulted in unsuccessful proficiency testing performance for compatibility testing. Findings include: The laboratory failed to maintain successful participation with the AAB PT program shown by the unsuccessful performance for compatibility testing in the second and third testing events of 2021. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory 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 desk review of federal database CASPER Reports 153D and 155D and AAB PT evaluation forms, the laboratory did not perform successfully in a proficiency testing program. Findings include: 1. The laboratory failed to maintain successful participation with the AAB PT program shown by the unsuccessful performance for compatibility testing in two consecutive testing events, the second and third testing events of 2021. 2. CASPER Report 155D and the AAB PT evaluation both reported scores of 60% for the second testing event of 2021 and a score of 80% for the third testing event of 2021. 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 desk review of federal database CASPER Reports 153D and 155D and AAB PT evaluation forms, the Condition: Laboratories Performing High Complexity Testing; Laboratory Director was not met. The laboratory director failed to provide overall management and direction in accordance with CFR 493.1445 of this subpart. Findings include: The laboratory director failed to ensure that the laboratory successfully participated in a PT program, approved by CMS; as described in subpart 1 of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on desk review of federal database CASPER Reports 153D and 155D and AAB PT evaluation forms, the laboratory did not successfully participate in a proficiency testing program. Findings include: 1. The laboratory failed to maintain successful participation with the AAB PT program shown by the unsuccessful performance for compatibility testing in the second and third testing events of 2021. 2. CASPER Report 155D and the AAB PT evaluation both reported scores of 60% for the second testing events of 2021 and 80% for the third testing event o 2021. -- 3 of 3 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on 11/10/2020. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 review of the attestation statement page for the American Proficiency Institute 2020 Chemistry-Core-First and Second Events and interview with the clinical laboratory administrative director, the laboratory director failed to ensure that the attestation form was signed by the testing personnel and the laboratory director. Findings include: Review of the American Proficiency Institute attestation statement page for 2020 Chemistry-Core-First and Second Events revealed that the testing personnel and the laboratory director did not sign the form attesting to the routine integration of the samples into the patient workload using the laboratory's routine methods to test for blood gases, pCO2, pH, pO2, and carboxyhemoglobin, hemoglobin, methhemoglobin, and oxyhemoglobin. The clinical laboratory administrative director confirmed the finding during the on-site survey on 11/10/2020 at approximately 2:00 PM. The laboratory performs approximately 149,353 chemistry tests and 57,095 hematology tests annually. D2016 SUCCESSFUL PARTICIPATION Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- 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 federal database CASPER Report 155D, American Association of Bioanalysts (AAB) proficiency testing (PT) evaluation forms, and interview with the clinical laboratory administrative director, the laboratory did not successfully participate in a proficiency testing program. The laboratory's failure to achieve an overall satisfactory proficiency testing event performance for two out of three testing events for the third testing event of 2019 and the second testing events of 2020 with a score of 0% in each event resulted in unsuccessful proficiency testing performance for Anti-HIV. Findings include: The laboratory failed to maintain successful participation with the AAB PT program shown by the unsuccessful performance for Anti-HIV for the third testing event of 2019 and the second testing events of 2020. Refer to D2084. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) 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 desk review of federal database CASPER Report 155D, American Association of Bioanalysts (AAB) proficiency testing (PT) evaluation forms, and interview with the clinical laboratory administrative director, the laboratory did not successfully participate in a proficiency testing program. The laboratory's failure to achieve an overall satisfactory proficiency testing event performance for two out of three testing events for the third testing event of 2019 and the second testing events of 2020 with a score of 0% in each event resulted in unsuccessful proficiency testing performance for Anti-HIV. Findings include: The laboratory failed to maintain successful participation with the AAB PT program shown by the unsuccessful performance for Anti-HIV in the third testing event of 2019 and the second testing events of 2020 with a score of 0% in each event.. -- 2 of 8 -- 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 review of federal database CASPER Report 155D and review of the performance summary from the American Proficiency Institute (API), the laboratory failed to attain a score of at least 80 percent of acceptable responses for blood gas pO2 for the third event of 2019. Findings include: Review of CASPER Report 155D and the performance summary from API revealed that the laboratory scored a 60% in the third event of 2019 for blood gas pO2. The laboratory performs approximately 149,353 chemistry tests annually. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on desk review of federal database CASPER Report 155D and review of the performance summary from API, the laboratory failed to take and document remedial action and maintain the documentation for two years from the date of participation in the proficiency testing event. Findings include: 1. Review of CASPER Report 155D and the performance summary from API revealed that the laboratory scored a 60% in the third event of 2019 for blood gas pO2. 2. The blood gas analysts interviewed during the on-site survey on 11/10/2020 at approximately 1:00 AM and the quality services director were unable to locate and submit documentation of the