Pediatric Healthcare Associates

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to obtain a proficiency testing (PT) score of at least 80 percent for White Blood Cell (WBC) differential testing for Event 2 of 2025 in the specialty of Hematology. Findings include: 1. Record review on 7/23/2025 of the Center of Medicare and Medicaid Services (CMS), generated "Casper Report 0155D" revealed the laboratory obtained an unsatisfactory PT score of 40% for WBC Differential analyte, Event 2, 2025. 2. Record review on 7/23/2025 of the College of American Pathologist (CAP), "Original Evaluation" report for "FH16-B 2025 Hematology Auto Differentials, FH-16" revealed following unacceptable results for the WBC Differentials: a."Test: Neut /Gran % : Specimens FH16-06, FH16-07, FH16-09, and FH16-10." b. "Test: Neut /Gran Absolute: Specimens FH16-06, FH16-07, FH16-08, FH16-09, and FH16-10." c. "Test: Lymphs %: Specimens FH16-06, FH16-07, and FH16-10." d. "Test: Lymphs Absolute: Specimens FH16-07." e. "CMS performance Summary for Analytes Regulated Under the Clinical Laboratory Improvement Amendments of 1998" revealed the following: i. "Regulated Analyte: WBC Differential" ii. "Proficiency Event: 2, 2025" iii. "Test Event: FH16-B" iv. "Score: 2/5; 40 %" v. "Performance Interpretation: Unsatisfactory" 3. Staff interview on 7/23/2025 at 11:20 AM with the Technical Consultant (TC) confirmed the above findings. The TC further stated that the laboratory performed the PT using the "QC mode" as advised by the Beckman coulter technical services and obtained an unsatisfactory score. He/she further 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 -- commented that the laboratory has stopped reporting the WBC differentials on patient samples as of 06/02/2025. 4. The laboratory performs 4150 complete blood counts annually in the specialty of Hematology. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to establish competency assessment policies and procedures to assess competency for the regulatory responsibility of the technical consultant (TC). Findings include: 1. Record review on 07/20/2023 of the CMS 209 Laboratory Personnel Report, revealed 1 of 1 TC. 2. Record review on 07/20/2023 of the staff training and competency files revealed lack of competency assessment documentation for the regulatory position of TC. 3. Staff interview on 07/20/2023 at 9:45 AM with the TC confirmed the above findings. The TC further commented that he/she was unaware that a TC competency assessment is a regulatory requirement. 4. The laboratory performs 6,211 complete blood counts annually in the specialty of hematology and one test annually in the subspecialty of general immunology. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to ensure the accuracy of the cold agglutinin test system twice annually in the subspecialty of 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 -- general immunology. Findings Include: 1. Record review on 07/20/2023 of the 'Cold Agglutinin Biannual Assessment Log Sheet' revealed the following: a. One assessment completed on 06/29/2022. b. Lack of documentation of biannual assessment of the cold agglutinin test in 2022. 2. Record review on 07/20/2023 of the 'Rapid Cold Agglutinin Test Procedure' revealed the following: a. 'Lab evaluation: performance of biannual testing for verification of test results'. b. 'For one positive and one negative blood cold agglutinin test results in the Stratford lab, a whole blood specimen will be obtained and sent to Quest for hemagglutination (HA), every six months'. 3. Staff interview on 07/20/2023 at 10:09 AM with the technical consultant confirmed the above findings. 4. The laboratory performs one cold agglutinin test annually in the subspecialty of general immunology. -- 2 of 2 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to verify the accuracy bi-annually for the cold agglutinin screen in the subspecialty of general immunology. Findings include: 1. Record review of the laboratory's 2017 and 2018 proficiency testing results on 2/27/19 revealed documentation of biannual verification for accuracy of the cold agglutinin screen was not available. 2. Staff interview with testing personnel #1 on 2/27/19 at 10:00 AM confirmed the above findings. 3. The laboratory performs 95 cold agglutinin tests annually. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to ensure an 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 -- appropriate test record in the subspecialty of general immunology. Findings include: 1. Record review on 2/27/19 of patient #1 encounter record for 12/26/18 revealed the following test result: "A serum cold agglutinins for Mycoplasma pneumoniae was positive." 2. Record review of the 'Rapid Cold Agglutinin Test (Garrow)' procedure on 2/27/19 revealed the following: a. Specimen type is whole blood. b. Results are reported as positive (presence) or negative (no agglutination). 3. Record review on 2 /27/19 of an article, 'A Rapid Test for the Presence of Increased Cold Agglutinins', Garrow, British Medical Journal: July 26,1958 revealed: a. The article was used as the reference for the above procedure. b. The rapid test is for the presence of increased cold agglutinins. c. Mycoplasma pneumoniae is not specifically mentioned in the article. 4. Staff interview with testing personnel #2 on 2/27/19 at 10:10 AM confirmed the above findings. 5. The laboratory performs 95 cold agglutinin tests annually. -- 2 of 2 --