Martin Garza Md Pa

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, review of patient test records from April 2025 to July 2025, and staff interview, the laboratory failed to follow it's policies for: A) repeat testing of samples, B) addressing flags, and C) the notification of panic values. The findings included: A) Repeat of samples 1. A review of the laboratory's policy titled "Repeat Criteria for CBC's with Critical Values (approved September 2023) determined the laboratory defined criteria for the repeat testing of complete blood counts. They were: WBC: less than 2 or greater than 20 HGB: less than 8 or greater than 18 HCT: less than 24 or greater than 55 PLT: less than 80 or greater than 500 2. A review of patient test records from April 2025 to July 2025 identified the following patient samples which met the laboratory's criteria repeat testing however repeat testing was not performed: a) Date: 05/22/2025 ID: 02192024 Result: PLT - 508 b) Date: 06/16/2025 ID: 12032013 Result: WBC - 24.1 c) Date: 07/17/2025 ID: 03162021 HGB - 5.4 HCT - 14.9 3. The technical consultant confirmed the findings after her review of the records on 07/22/2025 at 1100 hours in the break room. B) Addressing flags 1. A review of the laboratory's policy titled "Policy for Handling Flagged CBC's" (approved 2/17/2022) determined: "It will be the policy of this laboratory to rerun flagged CBC results. If the second run still shows flags, then the lab will evaluated flagged differentials according to procedures in the unit's operators manual. Lab procedures must ensure sample requirements are met, that the unit is in good condition order, and that the testing procedure is correctly followed. Sometimes the flags will disappear when the sample is allowed to equilibrate at room temperature 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 -- for 15 to 20 minutes, or by recollecting the sample. If the flags disappear, then report that result. If the flags persist, then the laboratory will confirm abnormal differential by sending out to a reference laboratory or crossing out the flagged values. Crossing out of the flagged parameters has to occur prior to handing the results to the provider. These results cannot be used to diagnose the condition of the patient. Flagged results will not be reported at any time." 2. A review of patient test records from April 2025 to July 2025 identified the following flagged patient results which were reported to the provider: a) Date: 05/07/2025 ID: 04152024 Flag: OM - not repeated - flagged results reported to provider b) Date: 05/27/2025 ID: 08202024 Flag: BD - not repeated - flagged results not crossed out c) Date: 06/04/2025 ID: 08292024 Flag: OM - not repeated - flagged results reported to provider 3. The technical consultant confirmed the findings after her review of the records on 07/22/2025 at 1100 hours in the break room. C) Notification of critical values 1. A review of the laboratory's policy titled "Repeat Criteria for CBC's with Critical Values (approved September 2023) determined the laboratory defined criteria for the identification of critical values. They were: WBC: less than 2 or greater than 20 HBG: less than 8 or greater than 18 HCT: less than 24 or greater than 55 PLT: less than 80 or greater than 500 2. A review of the laboratory's policy titled "Reporting Panic Values" (no approval date) determined: "It is the policy of this laboratory to document the reporting of panic values. Document: - who was notified - when was the person notified - by whom was the person notified 3. A review of patient test records from April 2025 to July 2025 identified the following patient samples which met the laboratory's critical values however the laboratory's policies were not followed: a) Date: 05/01/2025 ID: 05122023 WBC: 20.1 - notification time not documented b) Date: 05/22/2025 ID: 02192024 PLT: 506 - not repeated - notification time not documented c) Date: 05/27 /2025 ID: 08202024 PLT: 522 - not repeated - notification time not documented d) Date: 06/16/2025 ID: 12032013 WBC: 24.1 - not repeated - notification time not documented e) Date: 07/17/2025 ID: 3162021 HGB: 5.4 HCT: 14.9 - not repeated - notification time not documented 4. The technical consultant confirmed the findings after her review of the records on 07/22/2025 at 1100 hours in the break room. Key WBC - white blood cell HGB - hemoglobin HCT - hematocrit PLT - platelet -- 2 of 2 --

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. 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. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedures, review of patient test records from May 1, 2023 to June 20, 2023, and staff interview, it was revealed the laboratory failed to have documentation of following its policy for repeat testing of patient samples. The findings include: 1. A review of the laboratory's policy titled "Policy for Repeating CBC Tests" (approved on 03/13/2012) revealed: In an effort to ensure accuracy in patient CBC testing, it is the policy of this laboratory to repeat tests when patient results are outside the following range: RBC less than 4.00 or greater than 6.00 million WBC less than 2.5 or greater than 20 thousand HCT less than 24 or greater than 45% HGB less than 8 or greater than 15 mg% PLT less than 80 or greater than 450 thousand" 2. A review of patient test records from May 1, 2023 to June 20, 2023 identified the following 6 patients which met the laboratory's criteria for repeat testing, however the laboratory failed to have documentation of repeat testing. They were: Date: 05/08 ID: 01102017 Test: HCT 15.3 Date: 05/08 ID: 03152020 Test: PLT 78 Date: 05/15 ID: 02122023 Test: RBC 3.42 Date: 05/23 ID: 05182022 Test: RBC 3.96 Date: 06/05 ID: 08122022 Test: RBC 3.95 Date: 6/06 ID: 03282022 Test: RBC 3.73 3. The laboratory was asked to provide documentation of repeating the identified tests as required by its policy. No documentation was provided. 4. An interview with 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 technical consultant on 06/22//2023 at 0930 hours in the laboratory - after her review of the records- confirmed the findings. Key CBC - complete blood count WBC - white blood cell RBC - red blood cell HCT - hematocrit HGB - hemoglobin PLT - platelet -- 2 of 2 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representatives at the entrance and exit conferences. The facility 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 D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) 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