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Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) (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 Testing Institute's proficiency testing records from 2023, 2024, and 2025, and staff interview, the laboratory failed to test proficiency testing samples the same number of times it routinely tested patient samples for 6 of 7 events. The findings included: 1. The laboratory's policy titled "Proficiency Testing" (approved 9/1/2014) stated: "PT specimens are to be treated the same as patient samples." 2. The laboratory's policy titled "Critical Values" (approved 6/15/2025) stated: "The Laboratory Personnel will repeat all CBC's outside the critical/panic value range..." The policy then defined the following ranges: White blood cell under 2.0 or over 22.0 Hemoglobin under 7.5 or over 18 Hematocrit under 24 or over 55 Platelet under 50 or over 800 3. A review of the laboratory's American Proficiency Institute's proficiency testing records from 2023 (event 3), 2024 (events 1, 2 and 3) and 2025 (events 1, 2 and 3) determined the laboratory tested proficiency samples multiple times that did not meet the defined criteria for repeat testing on 6 of 7 events. They were: a) 2023 event 3 Sample: HSY - 012 tested: 11/17/2023 @ 10:11 tested: 11/17/2023 @ 10:12 Sample: HSY-15 tested: 11/17/2023 @ 10:19 tested: 11/17/2023 @ 10:20 b) 2024 event 1 Sample: HSY - 01 tested: 03/18/2024 @ 10:44 tested: 03/18/2024 @ 10:46 c) 2024 event 2 Sample: HSY - 07 tested: 07/18/2024 @ 09:37 tested: 07/18/2024 @ 09: 38 Sample: HSY-08 tested: 07/18/2024 @ 09:40 tested: 07/18/2024 @ 09:41 d) 2024 event 3 Sample: HSY-11 tested: 11/14/2024 @ 14:09 tested: 11/14/2024 @ 14:10 Sample: HSY-13 tested: 11/14/2024 @ 14:12 tested: 11/14/2024 @ 14:15 Sample: HSY-15 tested: 11/14/2024 @ 14:21 tested: 11/14/2024 @ 14:22 e) 2025 event 1 Sample: HSY-01 tested: 03/12/2025 @ 09:42 tested: 03/12/2025 @ 09:45 Sample: 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 -- HSY-04 tested: 03/12/2025 @ 09:59 tested: 03/12/2025 @ 10:05 f) 2025 event 1 Sample: HSY-07 tested: 07/09/2025 @ 11:22 tested: 07/09/2025 @ 11:23 Sample: HSY-10 tested: 07/09/2025 @ 11:34 tested: 07/09/2025 @ 11:35 4. The technical consultant confirmed the findings in an interview conducted on 02/03/2026 at 0900 hours in exam room 4. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions for the the Sysmex XP-300 hematology analyzer, review of patient test results from January 2026, and staff interview, the laboratory failed to have documentation of following the manufacturer's instructions for the resolution of flagged differential results prior to reporting to the provider. The findings included: 1. The manufacturer's instructions for the Sysmex XP-300 hematology analyzer (Code No. AU553517, revision date: May 2014) under the section titled "Histogram flags" stated: "Various information can be obtained from the histograms. The XP-300 extracts the characteristics of the histogram and displays them as histogram flags. When the histogram flags are displayed, perform analysis again. If afterwards the flags are still displayed, the sample is considered to correspond to one of the following: WL - Probable sample cause: Incomplete lysing of red blood cells, presence of nucleated red blood cells, increase of large platelets, platelet aggregation or agglutination, precipitation of fibrin, etc. Correction: Centrifuge sample and replace the plasma with equal volume of saline or CELLPACK and repeat analysis. Check smear, etc." 2. A sampling of patient results from January 2026 identified the following patient results reported to the provider without documentation of

Summary Statement of Deficiencies 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 the laboratory's submitted Form CMS 209, review of the laboratory's American Proficiency Institute's proficiency testing records from 2022 and 2023, and staff interview, the laboratory failed to ensure 2 of 5 testing personnel participated in proficiency testing. The finding included: 1. The laboratory's submitted Form CMS 209 identified 5 testing personnel. 2. A review of the laboratory's American Proficiency Institute's proficiency testing records from 2022 (events 1, 2 and 3) and 2023 (events 1 and 2) determined testing personnel number 3 and number 5 (as listed on Form CMS 209) did not participate in proficiency testing. 3. The technical consultant confirmed the findings in an interview on 10/19/2023 at 0845 hours in the office. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) 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 reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 deficiency, 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 certification 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 at the entrance and exit conferences. The facility representative was 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 at the entrance and exit conferences. The facility representative was 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