Children's Medical Associates

Summary Statement of Deficiencies D0000 A proficiency testing desk review of Children's Medical Associates, PC laboratory, was conducted pursuant to 42 CFR Part 493 of the Clinical Laboratory Improvement Amendments (CLIA) of 1988. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on record review of the Proficiency Testing (PT) data Casper Report 155D from Center for Medicaid and Medicare and graded results from the American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE), the laboratory failed to obtain a satisfactory score for 2 out of 3 events for the regulated analyte Hematocrit (HCT) in the specialty of Hematology. Refer to D2130 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on record review of the Proficiency Testing (PT) data Report 155D from Center for Medicaid and Medicare and graded results from the American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE), the laboratory failed to obtain a satisfactory score for 2 out of 3 events in the analyte HCT in the specialty of Hematology. Findings include: 1. Record review on 11/10/2025 of the Centers for Medicare and Medicaid Services (CMS) Casper 155D Report revealed the laboratory failed to obtain a score of at least 80% leading to unsatisfactory scores for 2 out of 3 Proficiency Testing (PT) events as follows: a. 2025 Event 1, analyte HCT Score 40%. b. 2025 Event 3, analyte HCT Score 20%. 2. Record review on 11/10/2025 of the PT results from the American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE), 2025 event 1 revealed the following: a. Sample 1: analyte HCT 17.7%, Grading range 17.9%-19.4%. b. Sample 3: analyte HCT 40.2%, Grading range 40.5% -43.8%. c. Sample 5: analyte HCT 18.0%, Grading range 18.1%-19.6%. 3. Record review on 11/10/2025 of the PT results from the American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) 2025 event 3, revealed the following: a. Sample 12: analyte HCT 19.1%, Grading range 17.3%-18.7%. b. Sample 13: analyte HCT 42.8%, Grading range 39.2%-42.4%. c. Sample 14: analyte HCT 57.3%, Grading range 52.2%-56.6%. d Sample 15: analyte HCT 19.4%, Grading range 17.4% -18.8%. 4. A telephone interview with the Laboratory Director (LD) on 11/10/2024 at 03:00 PM confirmed the findings listed above. The LD further commented he/she was unaware of 2025 PT Event 3 failure. 5. The laboratory performs 2,490 tests annually in the specialty of Hematology. D9999 An off-site proficiency testing desk review (PTDR) revisit was conducted on January 14, 2026, and found that Children's Medical Associates, PC laboratory had corrected all previous deficiencies cited on 11/20/2025, with no new noncompliance found. The facility is in compliance with all applicable parts of 42 CFR, Part 493; The Clinical Laboratory Improvement Amendments. -- 2 of 2 --

Summary Statement of Deficiencies 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) 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 D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to return Proficiency Testing (PT) results to the proficiency testing program within the allotted timeframe. Findings include: 1. Record review of the CMS CASPER 155D report on 7/14/21 revealed scores of 0% for Event 3 2019 and Event 3 2020 for Analyte #s: 0760 Hematology; 0765 Cell I.D. or WBC Diff; 0775 RBC; 0785 HCT (non-waived); 0795 HGB (non-waived); 0805 WBC and 0815 Platelets. 2. Record review on 7/14/21 of the American Association of Bioanalysts (AAB) records revealed the following submission deadline dates: a. Event 3 2019: deadline 9/25/19 b. Event 3 2020: deadline 9/30/20 3. Record review on 7/14/21 of the laboratory PT runs revealed the following: a. Event 3 2019 PT specimens were tested on 9/23/19. b. Event 3 2020 PT specimens were tested on 10/5/20. 4. Staff interview with testing personnel #1 (TP#1) on 7/14/21 at 11:40 AM confirmed the 0% scores for the above 2 events and further stated the following: a. Event 3 2019 specimens were tested and results mailed to AAB but were postmarked and arrived after the deadline date and were not evaluated by AAB. b. Event 3 2020 specimens were tested after the deadline date and were mailed and not evaluated by AAB. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time 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 4 -- collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on surveyor observation, record review and staff interview, the laboratory failed to ensure positive identification of a patient's specimen from the time of collection through completion of testing in the specialty of hematology. Findings include: 1. Surveyor observation on 7/14/21 at 11:15 AM of the laboratory work area revealed the following: a. 4 of 4 completed patient Complete Blood Count (CBC) collection test tubes in corrugated trays with the trays containing headers 'DOB and Init'. b. 3 of 4 of the above corrugated trays did not contain the patient identifiers of 'DOB and Init'. c. 4 of 4 patient test vials contained no patient identification. d. The laboratory did not contain an approved laboratory procedure manual available at the immedicate work bench. 2. Record review on 7/14/21 of the laboratory procedure manual revealed the laboratory did not have a procedure for proper labeling of patient test specimens. 3. Staff interview on 7/14/21 at 11:15 AM with the testing personnel #1 (TP#1) confirmed: a. The laboratory process is to collect the sample in the exam room, label the tray with the patient's date of birth and patient initials and bring the specimen to the laboratory for testing. b. Test vials are not labeled directly due to the small size of the vials. c. The above corrugated trays were not labeled according to the laboratory procedure. d. TP#1 was unaware of the location of the approved laboratory manual other than the Cell-Dyn operator's manual. 4. The laboratory performs 3,165 CBCs annually in the specialty of hematology. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to evaluate proficiency testing (PT) results when results were not evaluated and scored by the American Association of Bioanalysts (AAB) due to late submission. Findings include: 1. Record review of the CMS CASPER 155D report on 7/14/21 revealed scores of 0% for Event 3 2019 and Event 3 2020 for Analyte #s: 0760 Hematology; 0765 Cell I.D. or WBC Diff; 0775 RBC; 0785 HCT (non-waived); 0795 HGB (non-waived); 0805 WBC and 0815 Platelets. 2. Record review on 7/14/21 of PT records for Event 3 2019 and Event 3 2020 revealed: a. The laboratory results were received after the deadline date and therefore not evaluated by the AAB resulting in scores of 0% for both events. b. The laboratory did not have documentation of self evaluation and review to assess the accuracy of the laboratory's PT results versus the PT provider results for these events. 3. Staff interview with testing personnel #1 (TP#1) on 7/14/21 at 11:40 AM confirmed the above. TP#1 stated he/she was unaware PT results not evaluated by the PT program require self evaluation. 4. The laboratory performs 3,165 CBCs annually in the specialty of hematology. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) -- 2 of 4 -- The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to review and verify the accuracy of proficiency testing (PT) results and take

Summary Statement of Deficiencies D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on record review and staff interview, testing personnel had not tested unknown samples to assess their knowledge and skills to maintain their competency in the specialty of hematology. Findings include: 1. Record review of the American Association of Bioanalysts (AAB) attestation sheets on 5/16/18 revealed 7 of 9 testing personnel (TP) did not examine proficiency testing (PT) material to accurately assess their knowledge and skills in 2016 and 6 of 9 in 2017. 2. Record review of TP competency records on 5/16/18 revealed previously analyzed samples were not available for 7 of 9 TP in 2016 and 6 of 9 TP in 2017. 3. Staff interview with the testing personnel #1 on 5/16/18 at 11:00 AM confirmed the above. 4. Laboratory performs approximately 3,921 complete blood counts tests annually. 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 --