Tri-Parish Pediatrics

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Tri-Parish Pediatrics, CLIA ID 19D1032343, on April 30, 2025. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of expiration check logs, and interview with personnel, the laboratory failed to ensure one (1) of three (3) Uricult test kits had not exceeded its expiration date. Findings: 1. Observation by surveyor during the laboratory tour on April 30, 2025 revealed the following expired Uricult test kit: Aidian CLED EMB Uricult, lot 1922282, expiration date: 2025-03-21, Quantity: five (5) vials 2. Review of the laboratory's "Expired Product Check Log" revealed the laboratory performed checks for expired items on the following dates without identification of the expired test kit: March 22, 2025 March 29, 2025 April 5, 2025 April 12, 2025 April 19, 2025 April 26, 2025 3. In interview on April 30, 2025 at 1:18 pm, Testing Personnel 1 confirmed the identified Uricult test kit was expired. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results; 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 -- This STANDARD is not met as evidenced by: Based on observation by surveyor, record review, and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Refer to D5417. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Recertification survey was performed on December 20, 2021 at Tri-Parish Pediatrics, CLIA ID # 19D1032343. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, proficiency test records, and interview with personnel, the laboratory failed to ensure the Laboratory Director reviewed the proficiency testing performance evaluation results for two (2) of five (5) events reviewed. Findings: 1. Review of the laboratory's "Evaluation Proficiency Testing Performance" policy revealed "Employees and the laboratory director review and evaluate the results from the proficiency testing. If all results are acceptable, the laboratory director will then sign off on the results." 2. Review of the American Proficiency Institute (API) proficiency testing records for 2020 and 2021 revealed the laboratory did not have documentation of review of their results by the Laboratory Director for the following events: 2020 Microbiology 2nd Event: Date not documented by Laboratory Director 2020 Microbiology 3rd Event: no signature and date by Laboratory Director 3. In interview on December 20, 2021 at 9:52 am, Testing Personnel 1 stated the Laboratory Director reviewed the proficiency testing results. Testing Personnel 1 further stated the Laboratory Director did not sign/date the identified proficiency testing results. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) 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 -- All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records, policies, and interview with personnel, the laboratory failed to establish and document proficiency testing assessment activities for one (1) of five (5) events reviewed. Findings: 1. Review of the laboratory's "Evaluation Proficiency Testing Performance" policy revealed "If any results are acceptable, we will perform

Summary Statement of Deficiencies D0000 A PT Desk Review was performed on June 17, 2020. Tri-Parish Pediatrics, CLIA ID 19D1032343, was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 42 CFR 493.1403 CONDITION: Laboratories Performing Moderate Complexity Testing; Laboratory Director 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 review of proficiency testing (PT) results from the CASPER 155D report, the laboratory failed to successfully participate in proficiency testing for Hematology. Findings: 1. The laboratory failed to participate in Event 3 of 2019 for 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 3 -- Hematology specialty resulting in an unsatisfactory performance and score of zero for the following analytes: White Blood Cell Differential (WBC Diff), Hematocrit (HCT), Hemoglobin (HGB), White Blood Cell (WBC), and Platelets. Refer to D2123. 2. The laboratory failed to achieve a score of at least 80% for White Blood Cells (WBC) in two consecutive events, resulting in an initial unsuccessful performance. Refer to D2130. D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) results from the CASPER 155D report, the laboratory failed to participate in Event 3 of 2019 for the Hematology specialty resulting in an unsatisfactory performance and score of zero for the following analytes: White Blood Cell Differential (WBC Diff), Hematocrit (HCT), Hemoglobin (HGB), White Blood Cell (WBC), and Platelets. Findings: 1. Review of the CASPER 155D report for proficiency testing results revealed the laboratory received the following unsatisfactory scores for Event 3 of 2019 for Hematology: WBC Diff: 0% HCT: 0% HGB: 0% WBC: 0% Platelets: 0% D2130 HEMATOLOGY CFR(s): 493.851(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 review of proficiency testing (PT) results from the CASPER 155D report, the laboratory failed to achieve a score of at least 80% for White Blood Cells (WBC) in two consecutive events, resulting in an initial unsuccessful performance. Findings: 1. Review of the CASPER 155D report for PT results revealed the laboratory received the following scores for WBC resulting in an initial unsuccessful performance: a) 2019 Event 2: 60% b) 2019 Event 3: 0% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. -- 2 of 3 -- This CONDITION is not met as evidenced by: Based on record review, the Laboratory Director failed to provide overall management and direction for the laboratory. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on record review, the Laboratory Director failed to ensure that proficiency testing results are satisfactory as required. Findings: 1. The laboratory failed to participate in Event 3 of 2019 for the Hematology specialty resulting in an unsatisfactory performance and score of zero for the following analytes: White Blood Cell Differential (WBC Diff), Hematocrit (HCT), Hemoglobin (HGB), White Blood Cell (WBC), and Platelets. Refer to D2123. 2. The laboratory failed to achieve a score of at least 80% for White Blood Cells (WBC) in two consecutive events, resulting in an initial unsuccessful performance. Refer to D2130. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Certification Survey was performed on June 28, 2019 at Tri-Parish Pediatrics, CLIA ID # 19D1032343. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to retain all proficiency testing records for at least two years for one (1) of five (5) events reviewed. Findings: 1. Review of the laboratory's Hematology American Proficiency Institute (API) proficiency testing (PT) records for 2017 (3rd event), 2018 (all three events), and 2019 (1st event) revealed the laboratory did not maintain the following records: a) 2018 2nd Event remedial action records for API reported "unacceptable" result for WBC sample 10: score 80% b) 2018 2nd Event instrument printouts 2. Review of the laboratory's "Proficiency Testing" policy revealed "