Comanche County Medical Center Company

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of laboratory policy, American Proficiency Institute (API) proficiency testing (PT) records, review of the laboratory's CMS-209 form, and confirmed in interview, the laboratory failed to ensure qualified personnel participated in proficiency testing for one of three events in 2023 and one of two events in 2024 (cross refer to D6046). Findings include: 1. Review of the laboratory's policy titled "SUBJECT: PROFICIENCY TESTING" determined: "Testing Proficiency Samples Samples are to be tested by personnel who normally perform laboratory testing." 2. Review of API PT records revealed the following PT samples were tested for blood gas: 2023: a. Date/Time: 01/11/2023 09:36 Sample: BLX-01 b. Date/Time: 01/11 /2023 09:39 Sample: BLX-02 c. Date/Time: 01/11/2023 09:42 Sample: BLX-03 d. Date/Time: 01/11/2023 09:46 Sample: BLX-04 e. Date/Time: 01/11/2023 09:49 Sample: BLX-05 2024: a. Date/Time: 05/27/2023 08:43 Sample: BG-06 b. Date /Time: 05/27/2023 08:46 Sample: BG-07 c. Date/Time: 05/27/2023 08:49 Sample: BG-08 d. Date/Time: 05/27/2023 08:52 Sample: BG-09 e. Date/Time: 05/27/2023 08: 55 Sample: BG-10 3. Review of the laboratory's CMS-209 form determined the operator performing the proficiency testing samples was not listed as a testing person. 4. Testing Person-16 (TP-16), as listed on the CMS-209 form confirmed the findings during an interview conducted on 12/03/2024 at 1150 hours in the conference room. 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 -- 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 laboratory policy, review of American Proficiency Institute (API) proficiency testing (PT) attestation forms, and confirmed in interview, the laboratory failed to attest the routine integration of PT samples for six of nine events in 2024. Findings include: 1. Review of the laboratory's policy titled "SUBJECT: PROFICIENCY TESTING" determined: "Testing Proficiency Samples Print attestation statement. This must be signed by all personnel participating in the survey and by either the medical director or designated representative." 2. Review of PT attestation forms determined the following attestation forms were not signed by the laboratory director or designated representative in 2024: a. Hematology / Coagulation 1st Event b. Hematology / Coagulation 2nd Event c. Immunology / Immunohematology 2nd Event d. Microbiology 2nd Event e. Chemistry Core 2nd Event f. Chemistry Core Verification 2nd Event 3. The Technical Consultant (TC-1), as listed on the CMS-209 form confirmed the findings during an interview on 12/03 /2024 at 1140 hours in the conference room. Key: CMS - Centers for Medicare and Medicaid Services D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: I. Based on review of patient final reports, and confirmed in interview, the laboratory failed to provide normal reference ranges on patient final reports for four of four Wet Prep tests performed in 2024. Findings included: 1. Review of Wet Prep patient final reports in 2024, revealed the laboratory failed to provide normal patient reference ranges on the four of four patient final reports in 2024. Patients reviewed: (See Patient Alias List) 1. Patient 1 2. Patient 2 3. Patient 3 4. Patient 4 The laboratory was asked to provide documentation of normal patient reference ranges for Wet Prep testing provided to physicians, and none were provided. 2. In an interview with the Technical Consultant (TC-1) on 12/04/2024, at 12:25 PM, TC-1 confirmed the laboratory failed to provide normal reference ranges on patient final reports for four of four Wet Prep tests performed in 2024. This confirmed the above findings. 49553 II. Based on review of manufacturer's instruction for use (IFU), review of patient final reports, and confirmed in interview, the laboratory failed to provide normal reference ranges on patient final reports for MRSA Screen tests for five of five patients in 2024 (random review). Findings include: 1. Review of the manufacturer's IFU titled "remel Spectra (Trademark) MRSA," IFU 1821, Revised April 16, 2013 determined: "INTERPRETATION OF THE TEST After 24 hours incubation, MRSA will appear as small to medium denim blue colonies against a white background .... Other organisms (non-MRSA) will exhibit marked inhibition or produce white colonies. If -- 2 of 4 -- after 24 hours no denim blue colonies are observed, the specimen is considered negative and plates should be discarded." 2. Review of MRSA Screen patient final reports determined the laboratory failed to provide normal patient reference ranges for five of five patient final reports in 2024 (random review): Patients reviewed: (See Patient Alias List) 1. Patient 1 2. Patient 2 3. Patient 3 4. Patient 4 5. Patient 5 The laboratory was asked to provide documentation of normal patient reference ranges for MRSA Screen tests provided to physicians, and none were provided. 3. The Technical Consultant (TC-1) confirmed the findings during an interview conducted on 12/04 /2024 at 0930 hours in the conference room. Key: MRSA - methicillin-resistant Staphylococcus aureus D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing (PT) records, review of the laboratory's CMS-209 form, and confirmed in interview, the technical consultant failed to evaluate the competency of personnel performing PT for blood gas for one of three events in 2023 and one of two events in 2024. Refer to D2007. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of moderate complexity testing person competency assessment, and confirmed in interview, the technical consultant failed to include the review of proficiency testing in competency assessments for four of four moderate complexity testing persons in 2024. Findings included: 1. Review of competency assessments for moderate complexity blood gas testing on the RapidPoint 500 Blood gas system, revealed the technical consultant failed to include documentation of proficiency testing review in the competency assessment for the following four of four testing persons: Testing Person 16 (TP16): Competency performed on 01/05/2024 Testing Person 17 (TP17): Competency performed on 01/05/2024 Testing Person 18 (TP18): Competency performed on 02/21/2024 Testing Person 19 (TP19): Competency performed on 03/07/2024 The laboratory was asked to provide documentation of proficiency testing review as part of the competency assessment for the above testing persons. No documentation was provided. 2. In an interview with Technical Consultant 2 (TC-2) in the conference room on 12/03/2024 at 3:20 PM, TC-2 confirmed the technical consultant failed to include the review of proficiency testing in competency assessments for four of four moderate complexity testing persons in 2024. This confirmed the above findings. -- 3 of 4 -- D6052 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(vi) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of problem solving skills. This STANDARD is not met as evidenced by: Based on review of moderate complexity testing person competency assessment, and confirmed in interview, the technical consultant failed to include the assessment of problem-solving skills in competency assessments for four of four moderate complexity testing persons in 2024. Findings included: 1. Review of competency assessments for moderate complexity blood gas testing on the RapidPoint 500 Blood gas system, revealed the technical consultant failed to include problem solving skills in the competency assessment for the following four of four testing persons: Testing Person 16 (TP16): Competency performed on 01/05/2024 Testing Person 17 (TP17): Competency performed on 01/05/2024 Testing Person 18 (TP18): Competency performed on 02/21/2024 Testing Person 19 (TP19): Competency performed on 03/07 /2024 The laboratory was asked to provide documentation of problem-solving skills as part of the competency assessment for the above testing persons. No documentation was provided. 2. In an interview with Technical Consultant 2 (TC-2) in the conference room on 12/03/2024 at 3:21 PM, TC-2 confirmed the technical consultant failed to include the assessment of problem-solving skills in competency assessments for four of four moderate complexity testing persons in 2024. This confirmed the above findings. -- 4 of 4 --

Summary Statement of Deficiencies D0000 Laboratory representatives were present at the entrance conference. The survey process was discussed. An opportunity for questions and comments was given. The exit conference was held with the laboratory representatives. The laboratory was found to be in substantial compliance for the specialties/subspecialties for which it was surveyed. The standard level deficiencies cited were discussed. The process for submitting the corrections was explained. CMS form 2567 will be emailed from the Texas Health and Human Services Commission, Health Facility Compliance Arlington Group. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 An entrance conference was held with the laboratory representatives. The survey process was discussed and survey forms were provided. An opportunity for questions and comments was given. Noted deficiencies and plans of correction were discussed with the laboratory representatives at the exit conference. The laboratory representatives were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in COMPLIANCE with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, 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 preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: No deficiency details available. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: No deficiency details available. D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: ************************** Revisit conducted 09/23/2020 -- 09/24/2020 This is a NEW finding. Based on review of specimen receipt logs, patient reports, and in interview with staff, the laboratory failed to enter an accurate received and/or collection time for specimens received from outside clients in their Laboratory Information System (LIS) for 5 of 5 patients (random sampling from May - September 2020). Findings included: 1. A review of the laboratory Specimen Receipt Logs from May - September 2020 revealed the following information was documented on the log: "Patient Name and Date of Birth Today's Date and Tests Ordered Time Paperwork Dropped off at Administration Time Specimen(s) Dropped Off at Lab Collection Time and Name of Collector Home Health Number and Fax Number Number to Call a Critical" 2. A random review of test reports from patients listed on the laboratory specimen receipt logs revealed the following: Date 07/15/2020 Patient M000045353 Date/ Time Received documented on Log = 07/15/2020 1120 hours Date/Time Received in LIS = 07/15/2020 1139 hours Date 07/22/2020 Patient M000017368 Date/ Time Received documented on Log = 07/22/2020 1148 hours Date /Time Received in LIS = 07/22/2020 1158 hours Date 08/21/2020 Patient M000000625 Date/ Time Received documented on Log = 08/21/2020 1718 hours Date /Time Collected documented on Log = 08/21/2020 1240 hours Date/Time Received in LIS = 08/21/2020 1738 hours Date/Time Collected in LIS = 08/21/2020 1700 hours Date 09/02/2020 Patient M000000842 Date/ Time Received documented on Log = 09 /02/2020 1555hours Date/Time Collected documented on Log = 09/02/2020 1530 hours Date/Time Received in LIS = 09/02/2020 1856 hours Date/Time Collected in LIS = 09/02/2020 1455 hours Date 09/07/2020 Patient M000008340 Date/ Time Received documented on Log = 09/07/2020 0830 hours Date/Time Received in LIS = 09/07/2020 1010 hours 3. In an interview on 09/24/2020 at 1000 hours in the conference room, the laboratory manager confirmed the above findings. ************************ D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: *********************** Revisit Conducted 09/23/2020 -09/24/2020 This is a NEW finding. Based on review of the laboratory's defined analytical ranges, review of the laboratory's verification studies performed on the Siemens RAPIDPoint 500 (Serial Number 46068) blood gas analyzer, and staff interview, it was revealed the laboratory failed to have documentation of studies to support the analytical ranges currently in use. Findings included: 1. 1. A review of the laboratory's defined analytical ranges revealed the laboratory utilized the following ranges to aid in the assessment of patient test results: Test Hemoglobin; Analytical Range: 2.0 - 25.0 g/dl -- 2 of 3 -- pO2; Analytical Range: 10.0 - 700.0 mmHg pCO2; Analytical Range: 5.0 - 200.0 mmHg pH; Analytical Range: 6.500 - 7.800 2. A review of the laboratory's verification studies performed on the Siemens RAPIDPoint 500 (Serial Number 46068) blood gas analyzer on 01/13/2020 through 01/15/2020 revealed the laboratory was able to prove the following analytical ranges: Test Hemoglobin; Analytical Range: 4.83 - 21.10 g/dl pO2; Analytical Range: 51.07 - 519.53 mmHg pCO2; Analytical Range: 15.60 - 173.40 mmHg pH; Analytical Range: 6.7020 - 7.6987 3. The laboratory was asked to provide documentation of performing studies to support the reportable ranges currently in use. No documentation was provided. 4. In an interview on 09/23/2020 at 1332 hours in the conference room, the respiratory therapy manager confirmed the above findings. ************************* -- 3 of 3 --