Lander Medical Clinic

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 during an event were analyzed by one analyst for 10 of 20 proficiency testing events (Chemistry, Microbiology) reviewed from April 2022 to April 2024. In addition, the laboratory failed to rotate testing personnel for 3 of 3 Miscellaneous Chemistry testing events reviewed. The findings were: 1. Review of the 2022 American Proficiency Institute (API) attestation statements for Chemistry and Microbiology Event #2 and Event #3 were signed as tested by both the technical consultant (TC) and TP (testing personnel) #1. 2. Review of the 2023 API attestation statements for Chemistry Event #1, #2, and #3 and Microbiology Event #3 were signed as tested by both the TC and TP #1. 3. Review of the 2024 API attestation statements for Chemistry Event #1 and Microbiology Event #1 were signed as tested by both the TC and TP #1. 4. Review of the API 2022 Miscellaneous Chemistry Event #2 and the 2023 Miscellaneous Chemistry Event #1 and #2 showed no evidence TP #1 had participated in the testing event. 5. Interview with the TC on 4/10/24 at 1:38 PM confirmed the proficiency testing specimens were not assigned to one testing personnel per event and not rotated as required. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 review of proficiency testing records and staff interview, the laboratory failed to maintain a copy of the American Proficiency Institute (API) proficiency testing data submission forms for 18 out of 20 testing events reviewed from April 2022 to April 2024. The findings were: 1. Review of the laboratory's proficiency testing records from April 2022 to April 2024 showed 18 out of the 20 events failed to include the data submission forms. 2. Interview with the technical consultant on 4/10 /24 at 1:30 PM confirmed the proficiency testing records failed to include a copy of the data submission forms. 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 the CMS (Centers for Medicare and Medicaid) 209 Laboratory Personnel Report, review of personnel records and staff interview, the laboratory failed to ensure the technical consultant's competency assessment had been completed for 2 of 2 years reviewed (2022, 2023). The findings were: 1. Review of the CMS 209 Laboratory Personnel Report showed 1 technical consultant (TC) was listed for the specialties of microbiology, hematology, and chemistry. 2. Review of the personnel files for the TC showed no documentation a competency assessment had been completed in 2022 or 2023. 3. The laboratory was unable to locate a competency assessment policy and procedure. 4. Interview with the TC on 4/10/24 at 1:38 PM confirmed the required competency assessments had not been completed. 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, staff interview, and policy and procedure review, the laboratory failed to review and evaluate proficiency testing (PT) results for 8 of 20 proficiency testing events reviewed between April 2022 and April 2024. The findings were: 1. Review of the American -- 2 of 6 -- Proficiency Institute (API) 2022 Chemistry Event #2 PT records showed the laboratory scored an 80% on measured LDL (low density lipoprotein). There was no documentation the laboratory had evaluated the proficiency testing results. 2. Review of the API 2022 Hematology Event #2 PT records showed the laboratory scored an 80% on the eosinophil count. There was no documentation the laboratory had evaluated the proficiency testing results. 3. Review of the API 2022 Hematology Event #3 PT records showed the laboratory scored an 80% on the lymphocyte count. There was no documentation the laboratory had evaluated the proficiency testing results. 4. Review of the API 2023 Chemistry Event #1 PT records showed the laboratory scored an 80% on albumin. There was no documentation the laboratory had evaluated the proficiency testing results. 5. Review of the API 2023 Chemistry Event #2 PT records showed the laboratory scored an 80% on measured LDL. There was no documentation the laboratory had evaluated the proficiency testing results. 6. Review of the API 2023 Hematology Event #1 PT records showed the laboratory scored an 80% on hematocrit and the blood cell identification. There was no documentation the laboratory had evaluated the proficiency testing results. 7. Review of the API 2023 Hematology Event #2 PT records showed the laboratory scored an 80% on blood cell identification. There was no documentation the laboratory had evaluated the proficiency testing results. 8. Review of the 2024 API Chemistry Event #1 PT records showed the laboratory scored an 80% on phosphorus. There was no documentation the laboratory had evaluated the proficiency testing results. 9. Interview with the technical consultant on 4/10/24 at 1:38 PM confirmed an evaluation of the proficiency testing results had not been evaluated. 10. Review of the "Proficiency Testing Guidelines" policy, last reviewed May 2022, showed "Survey performance resulting in a score of less than 100% will require further investigation and correction...Any analyte that fails evaluation against graded criteria should be re-evaluated to identify the reason for the failure and

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: . Based on review of the new test verification documentation for the Cepheid Gene Xpert respiratory panel which included RSV (respiratory syncytial virus), influenza A and influenza B, review of the laboratory's annual workload worksheet, lack of documentation, and staff interview, the laboratory failed to enroll in an approved proficiency testing program for the regulated virology test system for 1 of 2 years of patient testing (2021). The laboratory performed approximately 1,077 respiratory panels in 2021. The findings were: 1. Review of the laboratory's annual workload worksheet showed 1,077 respiratory panels had been performed from 1/1/21 to 12/31 /21. Review of the laboratory's documentation showed no evidence the laboratory was enrolled in proficiency testing. 2. Interview with the laboratory manager on 4/27/22 at 1:27 PM confirmed the laboratory had not enrolled in a proficiency testing program for the virology panel. . D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the 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 -- 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 review of the laboratory's "Billing Summary Report", review of reporting documentation, and staff interview, the laboratory failed to report 904 SARS-CoV-2 negative test results from 11/27/20 through 4/27/22. The findings were: 1. Observation of the laboratory on 4/27/22 at 12:30 PM showed testing for SARS-CoV- 2 was performed using a molecular platform on the Cepheid Gene Xpert. 2. Review of the "Billing Summary Report" from 11/27/20 through 4/27/22 showed the laboratory had performed 1,304 SARS-CoV-2 tests. 3. Interview and review of the reporting documentation with the laboratory manager on 4/27/22 at 4 PM revealed the laboratory had reported 400 positive SARS-Co-V-2 to the State Public Health Laboratory, however the laboratory had not reported 904 negative test results. Further the laboratory manager stated he was not aware of the regulation until recently, and confirmed the negative test results had not been reported to the State Public Health Laboratory. . D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: . Based on review of the new test verification documentation for the Cepheid Gene Xpert respiratory panel which included SARS-CoV-2, review of the laboratory's annual workload worksheet, lack of documentation, and staff interview, the laboratory failed to at least twice annually verify the accuracy of the SARS-CoV-2 test for 1 of 2 years of patient testing (2021). The laboratory performed approximately 1,500 SARS- CoV-2 tests in 2021. The findings were: 1. Review of the laboratory's annual workload worksheet showed approximately 1,500 SARS-Co-V-2 tests had been performed from 1/1/21 to 12/31/21. Review of the laboratory's documentation showed no evidence the laboratory had verified the accuracy of the test. 2. Interview with the laboratory manager on 4/27/22 at 1:27 PM confirmed the laboratory had not verified the accuracy of the SARS-CoV-2 test in 2021. . 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 may supplement but not replace the laboratory's written procedures for testing or examining specimens. -- 2 of 4 -- This STANDARD is not met as evidenced by: . Based on lack of documentation and staff interview, the laboratory failed to have a written procedure for reporting SARS-CoV-2 positive and negative test results. The findings were: 1. Review of the laboratory's procedure manuals showed no evidence a policy and procedure had been developed in regard to reporting SARS-CoV-2 positive and negative test results to the appropriate agencies. 2. Interview with the laboratory manager on 4/27/22 at 4 PM confirmed the laboratory did not have a written procedure for reporting SARS-CoV-2 test results. . 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 lack of documentation and staff interview, the laboratory failed to verify the reportable range at least every 6 months using testing materials with values at the zero or minimal level, the mid-level, and the upper-level of the reportable range for free thyroxine, ferritin, testosterone, prostate specific antigen, thyroid stimulating hormone, and human chorionic gonadotropin hormone analyzed on the Roche Cobas e411 instrument for 2 of 2 years reviewed (2020, 2021). The laboratory performed approximately 1,670 immunoassay tests per year. The findings were: 1. Review of the laboratory's records showed a calibration verification had been performed on 1/24/20, 4/7/21, and 3/7/22. 2. Interview with the laboratory manager on 4/27/22 at 2:38 PM confirmed the calibration verification had not been performed every 6 months as required. . 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 -- 3 of 4 -- 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 the quality control (QC) records, review of the laboratory's individualized quality control plan (IQCP), lack of documentation, review of the "Billing Summary Report", staff interview, and review of the manufacturer's instructions, the laboratory failed to perform two levels of quality control each day of patient testing for 46 days of patient testing reviewed (12/22/20 through 2/6/21) for the Cepheid Gene Xpert molecular respiratory panel (SARS-CoV-2, respiratory syncytial virus (RSV), influenza A, and influenza B). The laboratory performed 121 respiratory panels during this timeframe. The findings were: 1. Review of the QC records showed the laboratory performed a positive and a negative control on the Cepheid Gene Xpert analyzer for the respiratory panel on 12/21/20 and again on 2/18 /21. Review of the "Billing Summary Report" showed 121 respiratory panels had been performed between 12/22/20 and 2/6/21. 2. Further review of the QC records showed a positive and negative control was performed on 3/15/21, 1/26/21, 9/26/21, 10/25/21, 12/6/21, 12/22/21, 2/15/22, and 4/11/22. 2. Review of the IQCP, last reviewed 12/6 /19, for the Cepheid Xpert instrument showed the tests of Chlamydia/Neisseria gonorrhoeae (CT/NG), Group B Streptococcus (GBS), and Clostridium difficile (C- diff) were included in the quality control plan. There was no evidence the IQCP had been updated to include the respiratory panel. 3. Interview with the laboratory manager on 4/27/22 at 3:22 PM revealed the laboratory had included the respiratory viruses performed on the Cepheid Xpert in the IQCP which included the tests of CT /NG, GBS, and C-diff. The laboratory manager confirmed the laboratory had not updated the IQCP and had not performed positive and negative control materials each day of testing for the respiratory viruses. 4. Review of the Cepheid Xpert manufacturer's instructions for use showed "The ultimate responsibility for determining the type and frequency of testing controls remains with the laboratory director. Laboratories should follow all applicable federal and local regulations." . D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: . Based on review of the new test verification documentation for the Cepheid Gene Xpert respiratory panel which included RSV (respiratory syncytial virus), influenza A and influenza B, review of the laboratory's annual workload worksheet, lack of documentation, and staff interview, the laboratory director failed to ensure the laboratory was enrolled in an approved proficiency testing program for the regulated virology test system for 1 of 2 years of patient testing (2021). The laboratory performed approximately 1,077 respiratory panels in 2021. Refer to D2000. -- 4 of 4 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: . Based on review of the new test verification documentation for the Cepheid Gene Xpert respiratory panel which included RSV (respiratory syncytial virus), influenza A and influenza B, review of the laboratory's annual workload worksheet, lack of documentation, and staff interview, the laboratory failed to enroll in an approved proficiency testing program for the regulated virology test system for 1 of 2 years of patient testing (2021). The laboratory performed approximately 1,077 respiratory panels in 2021. The findings were: 1. Review of the laboratory's annual workload worksheet showed 1,077 respiratory panels had been performed from 1/1/21 to 12/31 /21. Review of the laboratory's documentation showed no evidence the laboratory was enrolled in proficiency testing. 2. Interview with the laboratory manager on 4/27/22 at 1:27 PM confirmed the laboratory had not enrolled in a proficiency testing program for the virology panel. . D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the 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 -- 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 review of the laboratory's "Billing Summary Report", review of reporting documentation, and staff interview, the laboratory failed to report 904 SARS-CoV-2 negative test results from 11/27/20 through 4/27/22. The findings were: 1. Observation of the laboratory on 4/27/22 at 12:30 PM showed testing for SARS-CoV- 2 was performed using a molecular platform on the Cepheid Gene Xpert. 2. Review of the "Billing Summary Report" from 11/27/20 through 4/27/22 showed the laboratory had performed 1,304 SARS-CoV-2 tests. 3. Interview and review of the reporting documentation with the laboratory manager on 4/27/22 at 4 PM revealed the laboratory had reported 400 positive SARS-Co-V-2 to the State Public Health Laboratory, however the laboratory had not reported 904 negative test results. Further the laboratory manager stated he was not aware of the regulation until recently, and confirmed the negative test results had not been reported to the State Public Health Laboratory. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: . Based on review of the new test verification documentation for the Cepheid Gene Xpert respiratory panel which included SARS-CoV-2, review of the laboratory's annual workload worksheet, lack of documentation, and staff interview, the laboratory failed to at least twice annually verify the accuracy of the SARS-CoV-2 test for 1 of 2 years of patient testing (2021). The laboratory performed approximately 1,500 SARS- CoV-2 tests in 2021. The findings were: 1. Review of the laboratory's annual workload worksheet showed approximately 1,500 SARS-Co-V-2 tests had been performed from 1/1/21 to 12/31/21. Review of the laboratory's documentation showed no evidence the laboratory had verified the accuracy of the test. 2. Interview with the laboratory manager on 4/27/22 at 1:27 PM confirmed the laboratory had not verified the accuracy of the SARS-CoV-2 test in 2021. . 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 may supplement but not replace the laboratory's written procedures for testing or examining specimens. -- 2 of 4 -- This STANDARD is not met as evidenced by: . Based on lack of documentation and staff interview, the laboratory failed to have a written procedure for reporting SARS-CoV-2 positive and negative test results. The findings were: 1. Review of the laboratory's procedure manuals showed no evidence a policy and procedure had been developed in regard to reporting SARS-CoV-2 positive and negative test results to the appropriate agencies. 2. Interview with the laboratory manager on 4/27/22 at 4 PM confirmed the laboratory did not have a written procedure for reporting SARS-CoV-2 test results. . 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 lack of documentation and staff interview, the laboratory failed to verify the reportable range at least every 6 months using testing materials with values at the zero or minimal level, the mid-level, and the upper-level of the reportable range for free thyroxine, ferritin, testosterone, prostate specific antigen, thyroid stimulating hormone, and human chorionic gonadotropin hormone analyzed on the Roche Cobas e411 instrument for 2 of 2 years reviewed (2020, 2021). The laboratory performed approximately 1,670 immunoassay tests per year. The findings were: 1. Review of the laboratory's records showed a calibration verification had been performed on 1/24/20, 4/7/21, and 3/7/22. 2. Interview with the laboratory manager on 4/27/22 at 2:38 PM confirmed the calibration verification had not been performed every 6 months as required. . 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 -- 3 of 4 -- 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 the quality control (QC) records, review of the laboratory's individualized quality control plan (IQCP), lack of documentation, review of the "Billing Summary Report", staff interview, and review of the manufacturer's instructions, the laboratory failed to perform two levels of quality control each day of patient testing for 46 days of patient testing reviewed (12/22/20 through 2/6/21) for the Cepheid Gene Xpert molecular respiratory panel (SARS-CoV-2, respiratory syncytial virus (RSV), influenza A, and influenza B). The laboratory performed 121 respiratory panels during this timeframe. The findings were: 1. Review of the QC records showed the laboratory performed a positive and a negative control on the Cepheid Gene Xpert analyzer for the respiratory panel on 12/21/20 and again on 2/18 /21. Review of the "Billing Summary Report" showed 121 respiratory panels had been performed between 12/22/20 and 2/6/21. 2. Further review of the QC records showed a positive and negative control was performed on 3/15/21, 1/26/21, 9/26/21, 10/25/21, 12/6/21, 12/22/21, 2/15/22, and 4/11/22. 2. Review of the IQCP, last reviewed 12/6 /19, for the Cepheid Xpert instrument showed the tests of Chlamydia/Neisseria gonorrhoeae (CT/NG), Group B Streptococcus (GBS), and Clostridium difficile (C- diff) were included in the quality control plan. There was no evidence the IQCP had been updated to include the respiratory panel. 3. Interview with the laboratory manager on 4/27/22 at 3:22 PM revealed the laboratory had included the respiratory viruses performed on the Cepheid Xpert in the IQCP which included the tests of CT /NG, GBS, and C-diff. The laboratory manager confirmed the laboratory had not updated the IQCP and had not performed positive and negative control materials each day of testing for the respiratory viruses. 4. Review of the Cepheid Xpert manufacturer's instructions for use showed "The ultimate responsibility for determining the type and frequency of testing controls remains with the laboratory director. Laboratories should follow all applicable federal and local regulations." . D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: . Based on review of the new test verification documentation for the Cepheid Gene Xpert respiratory panel which included RSV (respiratory syncytial virus), influenza A and influenza B, review of the laboratory's annual workload worksheet, lack of documentation, and staff interview, the laboratory director failed to ensure the laboratory was enrolled in an approved proficiency testing program for the regulated virology test system for 1 of 2 years of patient testing (2021). The laboratory performed approximately 1,077 respiratory panels in 2021. Refer to D2000. -- 4 of 4 --

Summary Statement of Deficiencies D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on procedure manuals review, lack of documentation, and interview with staff, the laboratory failed to include in the manufacturer's operator's manuals the laboratory specific procedures for 4 of 4 test systems reviewed. The laboratory performed approximately 130,000 tests per year using the 4 test systems. Findings include: 1. Procedure manuals reviewed for Roche Cobas Integra 400 and E411 analyzers, Beckman Coulter DxH cell counter, and Cepheid molecular test system for microbiology and virology testing failed to include laboratory specific instructions for documentation 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 American Proficiency Institute (API) report review, Centers for Medicare and Medicaid Services (CMS) Casper 155 report review, and E-Mail interview conducted on 10/07/2019, and telephone interview on 10/15/2019, the laboratory failed to successfully participate in proficiency testing for Chloride (CL) in two consecutive testing events (the 2nd and the 3rd events of 2019). (See 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 American Proficiency 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 Chloride, (CL) (API events 2 and 3 of 2019). Findings include: 1. API summary evaluation reports review for the second and third Chemistry events of 2018 included summary scores of 0% Chloride scores for the for the 2nd and 3rd American Proficiency testing agency events of 2019. 2. Casper reports for 2 out of 3 events reviewed included Chloride scores of 0% for the 2nd and 3rd events of 2019. 3. In an E-mail interview on 10/07/2019 the laboratory technical consultant stated the laboratory failed the 2nd and 3rd 2019 events making 2 consecutive Chloride failures. -- 2 of 2 --

Summary Statement of Deficiencies 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 and interview with staff, the laboratory failed to perform a risk assessment for 4 of 4 tests reviewed, (Group B Strep. Nisseria gonorrhea, Chlamydia trachomatis, and Clostridium difficile) testing performed on the Cepheid Gene X pert test system. The laboratory performed approximately 10 to 15 tests per week. Findings include: 1. The IQCP failed to include a risk assessment for each test performed using the Cepheid Gene X pert test system. The laboratory failed to include the sources of error and mitigating processes the laboratory performed to ensure the risk of testing errors was minimal for reducing the frequency of quality control performance to each new lot number of test kits for Group B Strep, Chlamydia, Nisseria gonorrhea, and C. difficile testing. 2. In an interview conducted on 04/05/2018 at approximately 12:30 P.M., staff confirmed the IQCP did not include a risk assessment for determination the reduced frequency for quality control performance would not be likely to miss testing errors that quality control would detect for Gene Xpert testing. D5787 TEST RECORDS CFR(s): 493.1283(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 -- The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on patient test reports review and interview with staff, the laboratory record system failed to include the identity of the personnel who performed 13 of 34 test reports reviewed. Findings include: 1. Patient test reports review included the initials of the personnel who performed the tests or an "[A]". 2. Test reports review included documentation of the [A] for specimens numbers: 6428, 12309, 12422, 31368, 13121, 3556, 10721, 27790, 4123, 9313, 34372, 2272, and 1062 3. In an interview conducted on 04/05/2018 at approximately 11:30 A.M. staff stated the tests reported with [A] were auto approved by the laboratory information system and did not have a person associated with the results. Staff stated the laboratory did not have a mechanism to record the person responsible for test performance and reporting for each of tests reported that were auto approved. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on patient test report review, test reagent package review, and interview with staff, the laboratory failed to monitor routine chemistry test reports to identify errors in test reports for 2 of 2 Phosphorus test reports reported as phosphate. Findings include: 1. Patient test reports for patient's specimens #10721 and #12422 included the Analyte phosphate on the test report. The laboratory actually tested and reported phosphorus. 2. The test system reagent package label review was worded as Phosphorus. 3. In an interview, on 04/05/2018 at approximately 3:00 P.M., staff confirmed the test Analyte was incorrect on the test report and that post analytic test review did not identify the problem. -- 2 of 2 --