Westlake Complete Care Llc

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. Standard level deficiencies were cited. D6047 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b(8)(i) (b)(8)(i) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure, competency evaluations, and interview, the technical consultant failed to assess test performance through direct observation of routine patient test performance including specimen collection through testing for 13 out of 18 testing personnel competencies reviewed for moderately complex testing. Findings follow. A. Review of the laboratory's policy and procedure titled Laboratory Procedure Competency and Skills Checks for Technical Personnel, revised 08/31/2023, under Competency and Skills Checks at 2. Procedure stated, "c. The Technical Consultant will also use the following methods of validating competency... Direct observation of routine test performance." B. Review of the competency evaluations from 2023, 2024, and only 6-month evaluations from 2025, showed the following testing personnel were missing test performance through direct observation of routine patient test performance including specimen collection through testing for: 1. Testing personnel #1 (TP#1) (as listed on the CMS Form 209) from 05 /2024 for CBC on the Sysmex, Met12 on the Piccolo and Troponin I and D-Dimer on the Triage. 2. TP#2 from 1st 6-month evaluation in 04/2024 for Met12 on the Piccolo, and Troponin I and D-Dimer on the Triage. 3. TP#2 2nd 6-month evaluation from 01 /2025 for Met12 on the Piccolo, and Troponin I and D-Dimer on the Triage. 4. TP#4 from 12/2023 for CBC on the Sysmex, Met12 on the Piccolo, and Troponin I and D- Dimer on the Triage. 5. TP#4 from 04/2024 for CBC on the Sysmex, Met12 on the 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 -- Piccolo, and Troponin I and D-Dimer on the Triage. 6. TP#5 from 1st 6-month evaluation from 01/2025 for Troponin I and D-Dimer on the Triage. 7. TP#5 from 2nd 6-month evaluation from 04/2025 for Met12 on the Piccolo. 8. TP#6 from 06/2023 for CBC on the Sysmex, Met12 on the Piccolo and Troponin I and D-Dimer on the Triage. 9. TP#6 from 10/2024 for CBC on the Sysmex. 10. TP#7 from 1st 6-month evaluation from 12/2023 for Met12 on the Piccolo and Troponin I and D-Dimer on the Triage. 11. TP#7 from 2nd 6-month evaluation from 05/2024 for Troponin I and D-Dimer on the Triage. 12. TP#8 from 05/2024 for Met12 on the Piccolo. 13. TP#9 from 05/2024 for Troponin I and D-Dimer on the Triage and on 07/2024 for CBC on the Sysmex C. Interview with the Technical Consultant (as listed on the CMS Form 209) on July 16, 2025 at 1130 hours in the office confirmed test performance through direct observation of routine patient test performance including specimen collection through testing was not done for all testing personnel for each competency evaluation. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) (b)(8)(v) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure, competency evaluations, and interview, the technical consultant failed to assess test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples for 10 out of 18 testing personnel competencies reviewed for moderately complex testing. Findings follow. A. Review of the laboratory's policy and procedure titled Laboratory Procedure Competency and Skills Checks for Technical Personnel, revised 08/31/2023, under Competency and Skills Checks at 2. Procedure stated, "c. The Technical Consultant will also use the following methods of validating competency... Testing of previously analyzed specimens or Proficiency Samples." B. Review of the competency evaluations from 2023, 2024, and only 6- month evaluations from 2025, showed the following testing personnel were missing test performance through previously analyzed specimens, internal blind testing samples, or external proficiency testing samples: 1. Testing personnel #2 (TP#2) (as listed on the CMS Form 209) from 1st 6-month evaluation in 04/2024 was missing Met12 testing on the Piccolo. 2. TP#2 2nd 6-month evaluation from 01/2025 was missing the Met12 testing on the Piccolo, and Troponin I and D-Dimer on the Triage. 3. TP#3 from 04/2023 was missing CBC on the Sysmex. 4. TP#3 from 06/2024 was missing the Met12 on the Piccolo and Troponin I and D-Dimer on the Triage. 5. TP#4 from 12/2023 was missing the Met12 on the Piccolo and Troponin I and D-Dimer on the Triage. 6. TP#4 from 04/2024 was missing the Met12 on the Piccolo and Troponin I and D-Dimer on the Triage. 7. TP#5 from 2nd 6-month evaluation from 04/2025 was missing the CBC on the Sysmex. 8. TP#6 from 06/2023 was missing the CBC on the Sysmex, Met12 on the Piccolo and Troponin I and D-Dimer on the Triage. 9. TP#7 from 1st 6-month evaluation from 12/2023 was missing the Met12 on the Piccolo and Troponin I and D-Dimer on the Triage. 10. TP#7 from 2nd 6-month evaluation from 04/2024 was missing the CBC on the Sysmex. C. Interview with the Technical Consultant (as listed on the CMS Form 209) on July 16, 2025 at 1130 hours in the office confirmed test performance through previously analyzed specimens, internal blind testing samples, or external proficiency testing was not done for all testing personnel for each competency evaluation. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. 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 review of the laboratory's policies and procedures, calibration verifications and interview, the laboratory failed to perform calibration verification every six 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 -- months for Troponin I and D-Dimer performed on the Alere Triage for three of four events reviewed. Findings follow. A. Review of the laboratory's policy and procedure titled Triage Cardiac Panel, effective 10/25/2019, under Verification of Linearity and Precision stated, "Verification of the analyzer's linearity range for the instrument ensures that accurate results are being produced by the instrument. This range is determined by analyzing a set of standards, plotting the observed value against the concentration of the sample and then visually inspecting the graph to estimate the analytical range of the assay..." And, under Verification Frequency stated, "The verification of linearity and precision of the analyzer should be performed When a new analyzer is put into use and every 6 months after this date." B. Review of calibration verifications showed one performed on 07/13/2023. Additional calibration verifications were requested on July 13, 2023 1655 hours but not provided. C. Interview with the Technical Consultant on July 13, 2023 at 1655 hours in the break room confirmed they just performed their first calibration verification on the day of the survey. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure, competency evaluations, pre-survey paperwork, training records, and interview, the technical consultant failed to document the performance of individuals performing moderately complex testing at least semiannually during the first year the individual tested patient specimens for five out of eight testing personnel reviewed for 2 of 2 years. Findings follow. A. Review of the laboratory's policy and procedure titled Competency and Skills Checks for Technical Personnel, approved 01/15/2019, under Competency and Skills Check at Frequency stated, "All employees are evaluated at least twice during the first year of employment for all tests they perform and annually each year thereafter. Annually is defined as a calendar year." B. Review of competency evaluations from 2021 and 2022 showed none for testing personnel #19, 20, 21, 22, and 23. C. Review of the pre- survey paperwork titled Laboratory Personnel showed the following testing personnel with their hire dates: Testing personnel # Hire date missing Competency Evaluations 1. 19 12/26/2022 6 month 2. 20 unknown 6 month, 12 month 3. 21 unknown 6 month, 12 month 4. 22 see below 6 month 5. 23 unknown 6 month, 12 month D. Review of documentation of training showed testing personnel #22 was trained on 08/06/2022. The other training documents for testing personnel #20, 21, and 23 did not have dates of training. E. Interview with the Nurse Manager/testing personnel #2 on July 13, 2023 at 1135 hours in the break room confirmed competency evaluations were not performed, and most of the testing personnel were PRN employees. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure, competency evaluations, pre-survey paperwork, training records, and interview, the technical consultant failed to document the performance of individuals performing moderately complex testing at least annually after the first year the individual tested patient specimens for seven out of 12 testing personnel reviewed for 2 of 2 years. Findings follow. A. Review of the laboratory's policy and procedure titled Competency and Skills Checks for Technical Personnel, approved 01/15/2019, under Competency and Skills Check at Frequency stated, "All employees are evaluated at least twice during the first year of employment for all tests they perform and annually each year thereafter. Annually is defined as a calendar year." B. Review of competency evaluations from 2021 and 2022 showed none for testing personnel #10, 11, 12, 13, 15, 17, 18, and 23. C. Review of the pre- survey paperwork titled Laboratory Personnel showed the following testing personnel with their start dates: Testing personnel # Hire date missing Competency Evaluations 1. 10 unknown, see below 2022 2. 11 08/02/2019 2021, 2022 3. 12 09/13/2016 2021 3. 13 unknown 2021, 2022 4. 15 unknown 2021, 2022 5. 17 05/21/2018 2021, 2022 6. 18 unknown 2021, 2022 7. 23 unknown 2022 D. Review of documentation of training for testing personnel #10 showed she was trained on 10/22/20. The other training documents for testing personnel #13, 15, 18, and 23 did not have dates of training. E. Interview with the Nurse Manager/testing personnel #2 on July 13, 2023 at 1135 hours in the break room confirmed competency evaluations were not performed, and most of the testing personnel were PRN employees, -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey was performed on December 29, 2021. The laboratory was found out of compliance with the CLIA regulations. The conditions not met were: D2000 - 42 C.F.R. 493.801 Enrollment And Testing Of Samples 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 patient testing records, proficiency testing (PT) records and interview, the laboratory failed to enroll in proficiency testing for the Gastrointestinal Panel tested on the Biofire Film Array for five of five months reviewed. Findings follow. A. Testing records showed the laboratory started reporting patient testing for the Gastrointestinal Panel on the Biofire on July 24, 2021. B. Review of the American Pathology Institute PT records from the 3rd event of 2021 for Microbiology from October 2021, showed the Biofire Gastrointestinal Panel under the specialty of Microbiology was not enrolled. The Gastrointestinal Panel included the bacteria: Campylobacter, Clostridium difficile toxin A/B, Plesiomonas shigelloides, Salmonella, Vibrio, Vibrio Cholerae, Yersinia enterocolitica, Enteroaggregative E. coli, Enteropathogenic E. coli, Enterotoxigenic E. coli, Shiga-like toxin-producing E. coli, E. coli O157; parasites: Cryptosporidium, Cyclospora cayetanensis, Entamoeba histolytica, Giardia lamblia; viruses: Adenovirus F 40/41, Astrovirus, Norovirus GI Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- /GII, Rotavirus A, Sapovirus. C. Interview with the Technical Consultant on December 29, 2021 at 1200 in the office acknowledged they should have started PT and confirmed they were not enrolled. D. Review of patient testing records showed 39 patients were tested for the Gastrointestinal Panel between 07/24/2021 to 12/29/2021. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of patient testing records, maintenance logs and interview, the laboratory failed to document the periodic maintenance on the Biofire Film Array used to test the Gastrointestinal Panel and Respiratory Panel for 13 of 13 months reviewed. Findings follow. A. Patient testing for the Respiratory Panel started November 2, 2020 and patient testing for the Gastrointestinal Panel started July 24, 2021. B. Review of maintenance logs from 11/02/2020 - 12/29/2021 showed the Biofire Periodic Maintenance Logs were not being utilized by the laboratory, and the laboratory was not documenting the exterior cleaning, pouch loading station decontamination, module decontamination, weekly shutdown and restart, and the monthly archive of results to a flash drive. C. Interview with the Technical Consultant on December 29, 2021 at 1545 hours in the office confirmed the log was not being utilized by the laboratory and the maintenance on the Biofire was not documented. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control records, patient testing records, and interview, the laboratory failed to run controls every day of patient testing for the Complete Blood Count (CBC) tested using the Sysmex XP-300 for one out of 58 days reviewed. Findings follow. A. Review of quality control records from 10/19/2021 - 12/16/2021 showed there was no QC run on 11/18/2021. B. Review of testing records showed 3 patients were tested on 11/18/2021 for the CBC. C. Interview with the Technical Consultant on December 29, 2021 at 1530 hours in the office confirmed the findings. 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) -- 2 of 5 -- The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control records, patient testing records, and interview, the laboratory failed to include a negative and positive control each day of patient testing (or perform a IQCP study) for the Respiratory Panel tested on the Biofire Film Array for seven out of 13 months reviewed. Findings follow. A. Review of quality control records from 11/02/2020 - 06/30/2021 showed QC was performed on the following date: 1. 11/02/2020. An IQCP study was then performed from 07/01/2021 - 07/26 /2021. B. Review of patient testing records showed the laboratory started reporting patient testing for the Respiratory Panel using the Biofire on 11/02/2020. From 11/3 /2020 - 06/30/2021 213 patient testing were reported: 1. 11/03/2020: 8 patients 2. 11 /04/2020: 3 patients 3. 11/05/2020: 2 patients 4. 11/06/2020: 3 patients 5. 11/07/2020: 2 patients 6. 11/08/2020: 2 patients 7. 11/09/2020: 1 patient 8. 11/10/2020: 9 patients 9. 11/12/2020: 2 patients 10. 11/13/2020: 4 patients 11. 11/14/2020: 3 patients 12. 11 /16/2020: 4 patients 13. 11/17/2020: 7 patients 14. 11/18/2020: 8 patients 15. 11/19 /2020: 2 patients 16. 11/20/2020: 4 patients 17. 11/21/2020: 1 patient 18. 11/24/2020: 5 patients 19. 11/25/2020: 5 patients 20. 11/28/2020: 1 patient 21. 11/30/2020: 1 patient 22. 12/01/2020: 5 patients 23. 12/02/2020: 1 patient 24. 12/02/2020: 1 patient 25. 12/04/2020: 1 patient 26. 12/06/2020: 1 patient 27. 12/07/2020: 1 patient 28. 12/09 /2020: 2 patients 29. 12/13/2020: 1 patient 30. 12/14/2020: 2 patients 31. 12/15/202: 2 patients 32. 12/16/2020: 1 patient 33. 12/20/2020: 1 patient 34. 12/22/2020: 1 patient 35. 12/23/2020: 1 patient 36. 12/26/2020: 1 patient 37. 12/29/2020: 4 patients 38. 12 /30/2020: 1 patient 39. 12/31/2020: 2 patients 40. 01/01/2021: 1 patient 41. 01/02 /2021: 1 patient 42. 01/04/2021 2 patients 43. 01/05/2021: 3 patients 44. 01/08/2021: 1 patient 45. 01/15/2021: 1 patient 46. 01/19/2021: 3 patients 47. 01/21/2021: 1 patient 48. 01/23/2021: 1 patient 49. 01/26/2021: 2 patients 50. 01/29/2021: 1 patient 51. 01/30/2021: 1 patient 52. 02/02/2021: 2 patients 53. 02/03/2021: 1 patient 54. 02 /07/2021: 1 patient 55. 02/09/2021 2 patients 56. 02/18/2021: 1 patient 57. 02/20 /2021: 1 patient 58. 02/23/2021: 1 patient 59. 03/08/2021: 1 patient 60. 03/11/2021: 1 patient 61. 03/13/2021: 1 patient 62. 03/17/2021: 2 patients 63. 03/22/2021: 2 patients 64. 03/23/2021: 1 patient 65. 03/26/2021: 2 patients 66. 04/01/2021: 1 patient 67. 04 /04/2021: 2 patients 68. 04/06/2021: 1 patient 69. 04/07/2021: 1 patient 70. 04/10 /2021: 1 patient 71. 04/11/2021: 2 patients 72. 04/13/2021: 1 patient 73. 04/14/2021: 1 patient 74. 04/15/0221: 2 patients 75. 04/19/2021: 2 patients 76. 04/21/2021: 1 patient 77. 04/22/2021: 1 patient 78. 04/23/2021: 1 patient 79. 04/26/2021: 1 patient 80. 04/27 /2021: 1 patient 81. 04/28/2021: 1 patient 82. 04/29/2021: 1 patient 83. 04/30/2021: 1 patient 84. 05/01/2021: 1 patient 85. 05/04/2021: 1 patient 86. 05/05/2021: 1 patient 87. 05/15/2021: 1 patient 88. 05/18/0221: 1 patient 89. 05/19/2021: 1 patient 90. 05/20 /2021: 1 patient 91. 05/22/2021: 1 patient 92. 05/27/2021: 1 patient 93. 05/29/2021: 1 patient 94. 05/30/2021: 1 patient 95. 06/01/2021: 1 patient 96. 06/03/2021: 6 patients 97. 06/04/2021: 2 patients 98. 06/05/2021: 1 patient 99. 06/06/2021: 3 patients 100. 06 /07/2021: 3 patients 101. 06/09/2021: 1 patient 102. 06/12/2021: 1 patient 103. 06/13 /2021: 2 patients 104. 06/14/2021: 3 patients 105. 06/15/2021: 4 patients 106. 06/18 /2021: 2 patients 107. 06/19/2021: 2 patients 108. 06/22/2021: 2 patients 109. 06/28 /2021: 1 patient 110. 06/29/2021: 1 patient 111. 06/30/2021: 1 patient C. Interview with the Technical Consultant on December 29, 2021 at 1400 hours in the laboratory confirmed the findings. D6041 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(3) -- 3 of 5 -- (b) The technical consultant is responsible for-- (b)(3) Enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered; This STANDARD is not met as evidenced by: Based on review of patient testing records, proficiency testing (PT) records and interview, the technical consultant failed to ensure the laboratory was enrolled in proficiency testing for the Gastrointestinal Panel tested on the Biofire Film Array (see D2000). D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on review of quality control records, patient testing records, and interview, the technical consultant failed to ensure a quality control program was appropriate for the testing performed for the Respiratory Panel tested on the Biofire Film Array (see D5449). D6047 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. This STANDARD is not met as evidenced by: Based on review of the competency evaluations and interview, the laboratory consultant failed to incorporate the direct observation of routine patient test performance for four of four test systems in the laboratory for six of six testing personnel for two of two years reviewed. Findings follow. A. Review of the 2020 and 2021 competency evaluations for testing personnel #one through six, on the CMS form 209, showed for the Complete Blood Count (CBC) performed on the Sysmex XP-300, Metlac 12 on the Piccolo, Cardiac Markers and D-Dimer on the Alere Triage, and the Respiratory and Gastrointestinal panels on the Biofire Film Array, the skill of "testing performed in accordance with manufacturer's instructions and lab policy" were accomplished by "B" and "C". B was defined as "Monitoring the recording and reporting of results" and C was defined as the "Review of records, Worksheets Maintenance records Proficiency results and QC records". "A," not included in the verification method for the test performance was defined as the "Direct observation of test performance". B. Interview with the Technical Consultant on December 29, 2021 at 1040 hours in the office acknowledged she watched some, but not everyone who performed testing. -- 4 of 5 -- D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. This STANDARD is not met as evidenced by: Based on review of training records, patient testing records, and interview, the laboratory failed to have documentation of training for four of four testing personnel using the Biofire Film Array for the Respiratory and Gastrointestinal Panels performed. Findings follow. A. Training records for the Biofire were requested on December 29, 2021 at 1040 hours but not provided. B. Patient testing for the Respiratory Panel started November 2, 2020 and patient testing for the Gastrointestinal Panel started July 24, 2021. C. Interview with the Technical Consultant on December 29, 2021 at 1040 hours in the office confirmed she was not able to locate any training records for the Biofire for any testing personnel. NOTE: The technical consultant replaced the previous Technical Consultant in July 2021. -- 5 of 5 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780: 493. 1403 Condition: Laboratories Performing Moderate Complexity Testing; Laboratory Director 493. 1421 Condition: Laboratories Performing Moderate Complexity Testing; Testing Personnel 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 review of laboratory policies and procedures, quality control records, patient test records, and confirmed in interview with laboratory staff, the Laboratory Director failed to provide overall management and direction to the laboratory. 6. The laboratory Director failed to ensure that Testing personnel had received the appropriate education and training prior to performing non waived testing. ( See D 6028 and D6029) D6028 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(10) 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)(10) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate 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 -- consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart; This STANDARD is not met as evidenced by: Review of personnel files, laboratory test records, patient test records and interview of facility personnel found that the laboratory director failed to ensure thattwo of 15 testing personnel performing non waived testing had the appropriate education and training for performing non waived procedures. (see D 6065 and D6066) D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Review of the CMS Report 209 Laboratory Personnel Report, personnel records and interview of facility personnel found that two of 15 testing personnel failed to meet the minimum requirements for performing moderate complexity testing. (See D6065, D6066) D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Review of the CMS 209 Laboratory Personnel Report, Personnel records, patient test records and interview of facility personnel found that the laboratory failed to ensure that one of 15 testing personnel listed on the CMS Report 209 performing moderately complex testing held the minimum education requirements of a high school diploma or general education diploma (GED). Findings included: 1. Review of personnel records found testing person 15 (hired February 2018) had no foreign equivalency evaluation for education received in Canada available for review 2. review of patient test records between February 9, 2018 and February 4, 2020 found testing person 15 had tested: 19 patient samples for Complete Blood counts (CBC) using the Horiba micros 60 5 patient samples using the Met Lac 12 panel on the Abaxis Piccolo 2 patient samples using the Cardiac Marker panel of the Alere Triage meter 2 patient samples using the D dimer on the Alere triage meter. 3. Interview of technical -- 2 of 3 -- consultant 2 listed on the CMS Report 209 Laboratory Personnel report conducted on February 4, 2020 at 10:45 AM confirmed that education records had not been evaluated by the world credentialing evaluations services. She went on to say that testing person 15 tested patient specimens until she discovered the high school diploma was from a a High school in Canada. D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. This STANDARD is not met as evidenced by: Review of the CMS 209 Laboratory Personnel Report, Personnel records, patient test records and interview of facility personnel found that the laboratory failed to ensure that one of 15 testing personnel listed on the CMS Report 209 performing moderately complex testing had received training for moderately complex testing at this facility before testing patient specimens . Findings included: 1. Review of personnel records found testing person 12 (hired August 2019) had no documentation of training at this laboratory available for review. 2. review of patient test records between August 2019 and February 5 2020 found testing person 2 had not tested any patient specimens for moderately complex procedures. 3. Interview of technical consultant 2 listed on the CMS Report 209 Laboratory Personnel report conducted on February 4, 2020 at 10:45 AM confirmed that training records offered for review were from another laboratory in San Antonio. -- 3 of 3 --

Summary Statement of Deficiencies D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on review of the CMS 155D proficiency testing report, review of the laboratory's American Proficiency Institute's (API) proficiency testing records from 2017, and staff interview, the laboratory failed to ensure proficiency testing data was released to HHS for 3 of 3 events in 2017. The findings were: 1. Based on a review of the laboratory's CMS 155 proficiency testing report, proficiency testing data was not being sent to HHS for the following regulated analytes found in 42 CFR part 493 subpart I: Albumin Blood urea nitrogen Calcium Chloride Creatinine Glucose Potassium Magnesium Sodium 2. At 11:09 hours on 2/14/2018, the surveyor called the Abaxis technical support number listed on the MetLac 12 Panel instructions for use (part number 400-7192-1, Rev. G). The Abaxis technical representative provided two documents from Abaxis that list the MetLac 12 Panel reagent cartridge as moderate complexity (product information sheets 888-3210 and piccolo 888-3010). 3. Based on a review of the laboratory's American Proficiency Institute's proficiency testing records from 2017 (events 1, 2, and 3), the proficiency testing agency was not sending data to HHS. The laboratory was enrolled in proficiency testing for the regulated analytes listed above; however, the laboratory had previously reported the analytes as waived complexity. Based on a review of the American Proficiency Institute's proficiency testing instructions, under "Reporting Instructions:", number 8 states "Abaxis Piccolo or Alere Cholestech users need to choose either waived reagent or moderately complex reagent. If you are using serum to perform patient testing, your method is considered moderately complex. You must test five samples in order 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 -- to be in compliance with CLIA, and your proficiency results will be sent to CMS. If you are using whole blood to perform testing, your method is considered waived. Your proficiency scores will not be sent to CMS." 4. In an interview at 11:15 hours on 2/14/2018, the Technical Consultant stated the laboratory routinely tests whole blood specimens and had followed the American Proficiency Institute's proficiency testing instructions for reporting proficiency results. 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 proficiency testing records and interview with facility personnel, the laboratory failed to assess the accuracy twice annually (2 of 2) for the analytes Lactate and Phosphorus for the year 2017. The findings included: 1. Based on review of Food and Drug Administration (FDA) decision summary K130113, the analyte Lactate is moderate complexity on the reagent cartridge MetLac 12 for the Abaxis Piccolo xpress chemistry analyzer. The Lactate analyte is not a regulated analyte found in 42 CFR part 493 subpart I and is subject to twice annual accuracy verification. At 11:09 hours on 2/14/2018, the surveyor called the Abaxis technical support number listed on the MetLac 12 Panel instructions for use (part number 400- 7192-1, Rev. G). The Abaxis technical representative provided two documents from Abaxis that list the MetLac 12 Panel reagent cartridge as moderate complexity (product information sheets 888-3210 and piccolo 888-3010). The analyte Phosphorus is not a regulated analyte found in 42 CFR part 493 subpart I and is subject to twice annual accuracy verification. 2. Based on review of American Proficiency Institute (API) proficiency testing records, the laboratory did not submit Lactate or Phosphorus results on proficiency testing challenges to be graded. The laboratory did not perform another method of accuracy assessment for the analytes Lactate and Phosphorus at least twice annually for 2017. 3. In an interview at 11:42 hours in the breakroom, the Technical Consultant stated the laboratory had tested Lactate and Phosphorus on the proficiency testing samples but did not submit the scores for evaluation or perform another means of accuracy assessment. 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 review of the laboratory's Individualized Quality Control Plan (IQCP) procedure and interview with facility personnel, the laboratory failed to identify the -- 2 of 3 -- frequency and potential impact for each potential source of error identified in the laboratory's Risk Assessment (RA) for the Abaxis Piccolo xpress chemistry analyzer. The findings included: 1. Based on review of Food and Drug Administration (FDA) decision summary K130113, the analyte Lactate is moderate complexity on the reagent cartridge MetLac 12 for the Abaxis Piccolo xpress chemistry analyzer. 2. Review of the Risk Assessment portion of the IQCP for the Abaxis Piccolo xpress chemistry analyzer test system, signed by the laboratory director on 10/19/2016, included potential sources of error for the following categories: Specimen, Reagent, Test System, Environment, and Testing Personnel. The Risk Assessment DID NOT include the frequency with which the laboratory defined potential sources of error had occurred or were likely to occur. As a potential risk, the laboratory identified "incorrect results due to operation the measuring system outside of the manufacturer's environmental specifications." The lab did not define how often (frequency) the risk was likely to occur or the impact (risk to the patient) if the instrument were operated outside of the defined requirements. 3. The Risk Assessment DID NOT include an assessment of the potential impact on patient results for each laboratory defined potential source of error. The lab defined "Incorrect results due to low-volume sample" as a potential risk of error. The laboratory did not define how often (frequency) that specimens were rejected due to not meeting the volume requirements for testing or the impact (risk to patient) if low-volume specimens were tested, instead. 4. In an interview at 13:25 hours on 02/14/2018 in the breakroom, the Technical Consultant stated that the laboratory monitored potential sources of error through quality assurance activities but had not defined the frequency and impact of each source of error as part of the IQCP risk assessment. -- 3 of 3 --