Clinical Pediatrics Associates

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on review of the laboratory's submitted CMS-209 form, review of the laboratory's policy, review of the laboratory's personnel records, and confirmed in interview, the technical consultant failed to ensure two of three testing persons had complete competency assessment to perform moderate complexity testing in 2023 and 2024. Findings include: 1. Review of the laboratory's submitted CMS-209 form determined there were three testing persons performing moderate complexity testing. 2. Review of the laboratory's policy titled "Lab personnel competency policy" stated: "The following six (6) procedures are the minimal regulatory requirements for assessment of competency for all personnel performing laboratory testing: 1. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; 2. Monitoring the recording and reporting of test results; 3. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; 4. Direct observations of performance of instrument maintenance and function checks; 5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and 6. Assessment of problem solving skills. Competency assessment, which includes the six procedures, must be performed for testing personnel ..." 3. Review 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 -- the laboratory's personnel competency records determined the technical consultant failed to evaluate the six required elements of competency for two of three testing persons in 2023 and 2024: Testing-person 2: a. Date of competency: 05/01/2023 Frequency: Annual Competency elements assessed: 5 b. Date of competency: 05/24 /2024 Frequency: Annual Competency elements assessed: 5 Testing-person 3: a. Date of competency: 05/04/2024 Frequency: 6 month review Competency elements assessed: 3 b. Date of competency: 11/24/2024 Frequency: Annual Competency elements assessed: 3 4. The technical consultant confirmed the findings during an interview on 05/30/2025 at 1120 hours in the laboratory. Key: CMS - Centers for Medicare and Medicaid Services -- 2 of 2 --

Summary Statement of Deficiencies D0000 An entrance conference was held with the laboratory representative. The survey process was discussed and survey forms were provided. An opportunity for questions and comments was given. Noted deficiencies and plans of correction were discussed with the laboratory representatives at the exit conference. The laboratory 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. 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 review of laboratory records, American Proficiency Institute (API) Proficiency Testing (PT) Hematology events for 2020 (1st and 3rd events) and 2021 (1st and 2nd event) and staff interview, the laboratory failed to have documentation of verifying the accuracy of analytes that were not graded by the proficiency testing program for 4 of 5 events in 2020 and 2021. Findings Included: 1. Review of laboratory records revealed the laboratory performed manual blood cell identification (ID) on hematology specimens if criteria were met for manual blood cell identification. 2. Review of API PT records from 2020 and 2021 revealed the following events with ungraded performance: a. Hematology 1st Event 2020 Blood Cell ID: Sample ECl-01 Reported Result: Hypochromic Red Blood Cell Expected Result: See commentary Performance: Not Graded Sample ECl-02 Reported Result: Eosinophil, all stages Expected Result: Eosinophil, all stages Performance: Not Graded Sample ECl-03 Reported Result: Lymphocyte, normal Expected Result: 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 -- Lymphocyte, normal Performance: Not Graded Sample ECl-04 Reported Result: Microcytic red blood cell Expected Result: Microcytic red blood cell Performance: Not Graded Sample ECl-05 Reported Result: Neutrophil, segmented Expected Result: Neutrophil, segmented Performance: Not Graded b. Hematology 3rd Event 2020 Blood Cell ID: Sample ECl-11 Reported Result: Nucleated Red Blood Cell Expected Result: Nucleated Red Blood Cell Performance: Not Graded Sample ECl-12 Reported Result: Lymphocyte, normal Expected Result: Lymphocyte, normal Performance: Not Graded Sample ECl-13 Reported Result: Platelets, large Expected Result: See commentary Performance: Not Graded Sample ECl-14 Reported Result: Neutrophil, segmented Expected Result: Neutrophil, segmented Performance: Not Graded Sample ECl-15 Reported Result: Platelets, clumped Expected Result: Platelets, clumped Performance: Not Graded d. Hematology 1st Event 2021 Blood Cell ID: Sample ECl- 01 Reported Result: Dacryocyte Expected Result: Dacryocyte Performance: Not Graded Sample ECl-02 Reported Result: Myelocyte Expected Result: Myelocyte Performance: Not Graded Sample ECl-03 Reported Result: Platelets, large Expected Result: Platelets, large Performance: Not Graded Sample ECl-04 Reported Result: Neutrophil, segmented Expected Result: Neutrophil, segmented Performance: Not Graded Sample ECl-05 Reported Result: Basophil Expected Result: Basophil Performance: Not Graded e. Hematology 2nd Event 2021 Blood Cell ID: Sample ECl- 06 Reported Result: Howell Jolly Body Expected Result: Howell Jolly Body Performance: Not Graded Sample ECl-07 Reported Result: Echinocyte Expected Result: See commentary Performance: Not Graded Sample ECl-08 Reported Result: Acanthocyte Expected Result: Schistocyte Performance: Not Graded Sample ECl-09 Reported Result: Macrocytic red blood cell Expected Result: Polychromatic red blood cell Performance: Not Graded Sample ECl-10 Reported Result: Ovalocyte Expected Result: Ovalocyte Performance: Not Graded 3. During an interview with the Technical Consultant on 12/08/2021 at 02:05 PM in the facility office, the consultant was asked to provide documentation of the laboratory director verifying the accuracy of analytes that were not graded by the proficiency testing program. No documentation was provided. This confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An entrance conference was held 10/30/2019 with the Technical Consultant. The survey process was discussed. An opportunity for questions and comments was given. Based upon the onsite survey conducted 10/30/2019 through 10/31/2019, this facility was found NOT to be in compliance with CLIA regulations found at 42 CFR for the specialties/subspecialties in which it was surveyed. 493.1215 Hematology; 493.1403 Laboratories performing moderate complexity testing; laboratory director; 493.1409 Laboratories performing moderate complexity testing; technical consultant An exit conference was held on 10/31/2019 with the Technical Consultant. An opportunity for questions and comments was provided. CMS form 2567 will be emailed from the Texas State Health and Human Services Commission, Health Facility Compliance Arlington Group. D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) Proficiency Testing (PT) records and staff interview the laboratory failed to test hematology PT samples in the same manner as it tests patient specimens for 3 of 3 testing events in 2018 (E-1, E-2, E-3) and 2 of 2 (E-1, E-2) testing events in 2019. Findings: 1. Review of API Attestation Statement revealed the following: "PERSON(S) PERFORMING THE Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 14 -- TEST- We certify that as closely as possible, these proficiency testing samples were tested in the same manner as possible." Further review of the attestation statement revealed the following testing persons (TP) performed testing and the corresponding PT sample: 2018 E-1: TP-1, TP-2, TP-3, TP-4, TP-5, TP-6, TP-8 all 5 hematology samples 2018 E-2: TP-2, TP-3, TP-5 hematology sample #5 TP-8 hematology sample #2 TP-4 hematology sample #3 TP-1 all 5 hematology samples 2018 E-3: TP-1 and TP-3 all 5 hematology samples and blood cell ID TP-2, TP-6, TP-7 all hematology samples TP-4 hematology sample #3 TP-8 hematology sample #3 2019 E-1 TP-1 and TP-3 all 5 hematology samples and blood cell ID TP-4 hematology sample #s 1 and 2 TP-6 hematology sample #s 3, 4 and 5 TP-7 hematology sample #s 1, 2 and 3 2019 E- 2 TP-1 and TP-3 all 5 hematology samples and blood cell ID TP-2, TP-4, TP-5, TP-6, TP-7 all 5 hematology samples The laboratory failed to test hematology PT samples in the same manner as it tests patient specimens. 3. During an interview on 10/30 /2019 at 10:51 am, the technical consultant (TC) stated that all testing persons participate in proficiency testing. He stated that was his way of assessing competency and rotating PT. The TC stated that the same PT samples were tested by different testing persons but only one result was reported. This confirmed the laboratory failed to test hematology PT samples in the same manner as it tested patient specimens. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on direct observations, review of laboratory policy, American Proficiency Institute (API) Proficiency Testing (PT) records, manufacturer's instructions, quality control (QC) records, maintenance logs,