Qoros Clear Lake Surgery Center, Llc

Summary Statement of Deficiencies D0000 The laboratory was found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, CLIA requirements for laboratories as a result of a recertification survey on 12/15/2025 and recertification is recommended. Standard level deficiencies were cited. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. This STANDARD is not met as evidenced by: A. Based on the review of the laboratory's aqueous/liquid QC records from January 2025 to November 2025 and confirmed in an interview, the laboratory failed to have documentation of monitoring QC values over time for 4 of 4 quantitative analytes performed on iSTAT analyzer for 11 of 11 months reviewed: pH, pCO2, pO2, and lactate. The findings were: 1. Review of the iSTAT analyzer aqueous/liquid QC records from January 2025 to November 2025 revealed the laboratory performed 4 of 4 analytes on CG4+ cartridge on iSTAT instrument (SN: 433150) with quantitative values. CG4+ cartridge analytes pH pCO2 pO2 Lactate 2. Further review of the iSTAT analyzer aqueous/liquid QC records from January 2025 to November 2025 revealed no documentation of the laboratory monitoring the QC values over time for 4 of 4 quantitative analytes performed on iSTAT analyzer for 11 of 11 months 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 -- reviewed. 3. An interview on 12/15/2025 at 2:15 pm in the break room, the testing personnel #5 (as indicated on CMS 209 form) confirmed the above findings. B. Based on the review of the laboratory's verification studies, annual test volume & proficiency testing programs worksheet, aqueous/liquid QC records from August 2025 to November 2025 and confirmed in an interview, the laboratory failed to have documentation of monitoring QC values over time for ACT quantitative analyte performed on 2 of 2 Hemochron signature Elite analyzers for 4 of 4 months reviewed. The findings were: 1. Review of the laboratory's verification studies on Hemochron Signature Elite analyers revealed the laboratory director signed in July 2025. Hemochron Signature Elite SN:SE27833 Hemochron Signature Elite SN:SE27834 2. Review of the laboratory's annual test volume & proficiency testing programs worksheet signed by the laboratory director on 12/05/2025 revealed the facility started performing ACT on Hemochron Signature Elite analyzers on 07/15/2025. 3. Review of the Hemochron analyzer aqueous/liquid QC records from August 2025 to November 2025 revealed no documentation of the laboratory monitoring the QC values over time for ACT quantitative analyte performed on Hemochron Signature Elite analyzers for 4 of 4 months reviewed. 4. An interview on 12/15/2025 at 2:15 pm in the break room, the testing personnel #5 (as indicated on CMS 209 form) confirmed the above findings. Key: QC=Quality Control ACT=Activated clotting time CMS=Center of Medicare and Medicaid Services -- 2 of 2 --

Summary Statement of Deficiencies D0000 An onsite survey conducted 04/29/2024 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. 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 the direct observation of the surveyor, the review of the laboratory's QC records from 03/13/2024 to 04/19/2024, patient results, and confirmed in an interview, the laboratory failed to perform two quantitative QC materials with different concentrations prior to patient testing for 7 of 7 patients on iSTAT MN 300 Analyzer. The findings were: 1. Direct observation of the surveyor on 04/29/2024 at 9:15 am revealed the laboratory had 1 iSTAT MN-300 Analyzer (SN: 433150) and the laboratory used ACT cartridges for ACT test and CG4+ cartridges for ABG test. 2. In an interview on 04/29/2024 at 09:25 am in the break room, the testing personnel #3 confirmed the first case date was 03/13/2024. 3. Review of the laboratory's patient results revealed the following 7 patients had testing performed on iSTAT analyzer without 2 levels of QC performed prior to the patient testing. 03/29/2024 at 11:09 am Test: ACT MRN: 924 03/29/2024 at 5:50 am and at 6:11 am Test: ACT MRN: 946 03 /29/2024 at 9:21 am and at 9:49 am Test: ACT MRN: 954 03/29/2024 at 7:53 am Test: CG4+ MRN: 960 04/25/2024 at 9:52 am Test: ACT MRN: 1052 04/25/2024 at 8: 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 -- 26 am Test: ACT MRN: 1049 04/26/2024 at 10:46 am Test: ACT MRN: 1055 3. In an interview on 4/29/2024 at 11:43 am in the break room, the admin confirmed the above findings. Key: QC=Quality Control ACT=Activated Clotting Time ABG=Arterial Blood Gas MRN=Medical Record Number D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the direct observation of the surveyor, the review of the laboratory's QC records from 03/13/2024 to 04/19/2024, patient results, and confirmed in an interview, the laboratory failed to document acceptable QC prior to reporting patient test results for 24 of 24 patients on iSTAT MN 300 Analyzer. The findings were: 1. Direct observation of the surveyor on 04/29/2024 at 9:15 am revealed the laboratory used ACT cartridges for ACT test and CG4+ cartridges for ABG test on iSTAT MN-300 Analyzer (SN: 433150). 2. In an interview on 04/29/2024 at 09:25 am in the break room, the testing personnel #3 confirmed the first case date was 03/13/2024. 3. Review of the laboratory's QC records from 03/13/2024 to 04/19/2024 revealed the laboratory used iSTAT ACT Level 1 Control Lot#: 261161 Exp.. 2024-05-31 iSTAT ACT Level 2 Control Lot#: 271161 Exp.. 2024-05-31 iSTAT TriControl Level 1 Control Lot#: 301163 iSTAT TriControl Level 3 Control Lot#: 321163 4. Further review of the laboratory's QC from 03/13/2024 to 04/19/2024 revealed the laboratory performed the following 2 levels of QC on the following dates. For ACT QC: 03/13 /2024 Level 1 at 2:39 pm Level 2 at 2:24 pm 03/14/2024 Level 1 at 1:51 pm Level 2 at 1:59 pm 03/15/2024 Level 1 at 1:39 pm Level 2 at 1:46 pm 03/19/2024 Level 1 at 10:12 am Level 2 at 10:18 am 03/21/2024 Level 1 at 12:34 pm Level 2 at 12:45 pm 03 /22/2024 Level 1 at 2:37 pm Level 2 at 3:10 pm 03/26/2024 Level 1 at 1:13 pm Level 2 at 12:59 pm 03/27/2024 Level 1 at 1:06 pm Level 2 at 1:12 pm 03/28/2024 Level 1 at 12:43 pm Level 2 at 12:54 pm 04/01/2024 Level 1 at 2:01 pm Level 2 at 2:07 pm 04 /02/2024 Level 1 at 12:58 pm Level 2 at 1:09 pm 04/03/2024 Level 1 at 12:30 pm Level 2 at 12:27 pm 04/04/2024 Level 1 at 1:38 pm Level 2 at 1:48 pm 04/05/2024 Level 1 at 1:05 pm Level 2 at 12:55 pm 04/09/2024 Level 1 at 9:43 am Level 2 at 9: 52 am 04/10/2024 Level 1 at 1:29 pm Level 2 at 1:48 pm 04/11/2024 Level 1 at 1:20 pm Level 2 at 1:26 pm 04/12/2024 Level 1 at 1:45 pm Level 2 at 1:52 pm 04/16/2024 Level 1 at 9:20 am Level 2 at 8:22 am 04/17/2024 Level 1 at 9:15 am Level 2 at 9:22 am 04/18/2024 Level 1 at 10:59 am Level 2 at 12:19 pm 04/19/2024 Level 1 at 12:51 pm Level 2 at 12:58 pm For CG4+ QC: 04/11/2024 Level 1 at 4:46 pm Level 3 at 4: 41 pm 04/12/2024 Level 1 at 1:34 pm Level 3 at 1:39 pm 04/18/2024 Level 1 at 2:09 pm Level 3 at 2:16 pm 04/19/2024 Level 1 at 2:18 pm Level 3 at 2:27 pm 5. Review of patient results for the above dates and time revealed total of 24 patients had testing performed on the iSTAT analyzer. 03/13/2024 at 8:27 am Test: ACT MRN: 917 03/14 /2024 at 10:52 am Test: ACT MRN: 919 03/15/2024 at 6:34 am Test: ACT MRN: 928 03/15/2024 at 9:59 am Test: ACT MRN: 918 03/19/2024 at 6:30 am Test: ACT MRN: 930 03/22/2024 at 10:29 am and at 11:01 am Test: ACT MRN: 944 03/22/2024 at 8: 45 am and at 9:11 am Test: ACT MRN: 945 03/22/2024 at 6:34 am Test: ACT MRN: 946 03/27/2024 at 7:53 am and at 8:12 am Test: ACT MRN: 904 03/28/2024 at 6:24 am and at 6:50 am Test: ACT MRN: 968 04/03/2024 at 6:41 am Test: ACT MRN: 993 04/04/2024 at 6:31 am Test: ACT MRN: 917 04/05/2024 at 9:59 am Test: ACT -- 2 of 3 -- MRN: 992 04/05/2024 at 11:40 am Test: ACT MRN: 944 04/11/2024 at 11:05 am Test: ACT MRN: 1004 04/11/2024 at 12:25 pm Test: ACT MRN: 1006 04/11/2024 at 09:28 am Test: ACT MRN: 945 04/11/2024 at 7:32 am Test: ACT MRN: 1007 04/12 /2024 at 7:38 am Test: ACT MRN: 984 04/12/2024 at 10:50 am Test: ACT MRN: 1003 04/12/2024 at 9:46 am and 9:52 am Test: CG4+ MRN: 965 04/17/2024 at 7:21 am Test: ACT MRN: 946 04/18/2024 at 10:01 am Test: ACT MRN: 1052 04/18/2024 at 8:34 am and 8:40 am Test: CG4+ MRN: 1024 5. In an interview on 4/29/2024 at 11: 15 am in the break room, the admin confirmed the above findings. Key: QC=Quality Control ACT=Activated Clotting Time ABG=Arterial Blood Gas MRN=Medical Record Number -- 3 of 3 --