Alice Pediatric Clinic

Summary Statement of Deficiencies D6055 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of the laboratory's instrumentation, review of the laboratory's personnel records, and staff interview, the laboratory failed to have documentation of competencies being perform prior to testing on the new Medonic M-series hematology analyzer for 6 of 6 testing personnel requiring them. The findings included: 1. A review of the laboratory's instrumentation determined the laboratory installed a new hematology analyzer - a Medonic M-series (serial number 62408) in January 2025. 2. A review of the laboratory's personnel records determined the facility failed to have documentation of competency assessments being performed on 6 of 6 testing personnel prior to reporting patient results on the new analyzer. They were (as listed on Form CMS 209): Testing personnel number 2 Testing personnel number 3 Testing personnel number 4 Testing personnel number 5 Testing personnel number 6 Testing personnel number 7 3. The technical consultant confirmed the findings in an interview on 08/14/2025 at 909 hours in the break 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 1 --

Summary Statement of Deficiencies D0000 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. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, review of the laboratory's American Proficiency Institute's proficiency testing records from 2022 and 2023, and staff interview, it was revealed the laboratory failed to have documentation of testing proficiency testing samples the same number of times as patient samples for 4 of 4 events. The findings include: 1. A review of the laboratory's policy titled "Policy for Handling Flagged CBC Differentials" (approved 6/1/2017) revealed: "It will be the policy of this laboratory to rerun flagged CBC results." 2. A review of the laboratory's American Proficiency Institute's proficiency testing records from 2022 (Events 1, 2 and 3) and 2023 (event 1) revealed the laboratory failed to have documentation of rerunning proficiency testing samples with flagged CBC results. The samples which had flagged results were: a) 2022 Event 1 Sample 1 Sample 2 Sample 3 Sample 4 Sample 5 b) 2022 Event 2 Sample 6 Sample 7 Sample 8 Sample 9 Sample 10 c) 2022 Event 3 Sample 11 Sample 12 Sample 13 Sample 14 Sample 15 d) 2023 Event 1 Sample 1 Sample 2 Sample 3 Sample 4 Sample 5 3. The laboratory was asked to provide documentation of rerunning the samples as required by its policy. No documentation was provided. 4. An interview with the technical consultant on 07/11 /2023 at 1340 hours in the break room - after is review of the records- confirmed the findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the conditions of participation found in the CLIA regulations at 42 CFR 493 and recertification is recommended. 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: Based on review of the laboratory's verification studies, review of patient test records and staff interview, it was revealed the laboratory failed to have documentation of verifying patient normal ranges for 3 of 3 patient normal range used for testing CBCs (complete blood count). The findings included: 1. A review of the laboratory's verification studies revealed the laboratory failed to have documentation of verifying patient normal ranges for the following three patient CBC normal ranges: Age 1: WBC 6 - 14 RBC 3.8 - 6 HGB 10.5 - 14 HCT 26 - 60 MCV 72 - 88 MCH 24 - 30 MCHC 32 - 36 RDW 11.5 - 14.5 PLT 150 - 440 MPV 0 - 99.8 LYM % 24 - 72 LYM# 0.6 - 4.9 MON% 0.1 - 24 MON# 0 - 1.8 GRA% 37 - 92 GRA# 1.5 - 7.5 Age 14 Female: WBC 4 - 10 RBC 3.8 - 6 HGB 12.5 - 18 HCT 36.1 -51 MCV 78 - 97 MCH 27 - 31 MCHC 32 - 36 RDW 11.5 -14.5 PLT 150 - 440 MPV 0 - 99.8 LYM % 10 - 58.5 LYM# 0.6 - 4.9 MON% 0.1 - 24 MON# 0 - 1.8 GRA% 37 - 92 GRA# 1.5 - 8 Age 19 Male: WBC 3.5 - 10 RBC 3.8 - 5.8 HGB 11 - 16.5 HCT 35 - 50 MCV 80 - 97 MCH 26.5 - 33.5 MCHC 31.5 -35 RDW 10 - 15 PLT 150 - 450 MPV 6.5 - 11 LYM 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 -- % 17 - 48 LYM# 1.2 - 3.2 MON% 4 - 10 MON# 0.3 - 0.8 GRA% 43 - 76 GRA# 1.5 - 8 2. Review of patient records revealed the listed CBC ranges were in use for patient testing. 3. The laboratory was asked to provide documentation of verifying the patient normal ranges currently in use. No documentation was provided. 4. An interview with the technical consultant on 09/27/2021 at 11:00 hours in the break room - after his review of the records- confirmed the findings. -- 2 of 2 --