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Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on May 15, 2025. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on direct observation, manufacturer instructions, and interview with the laboratory's technical consultant (TC), the laboratory failed to follow manufacturer's instructions of adhering to the stability of the Consult Liquid Urine Quality Controls (QC) to the expiration date on the label. Findings Included: 1. During a tour of the laboratory on 5/15/2025 at 11:51 AM one box of the urine QC material was observed available for testing. 2. Review of the manufacturer's package insert reveals the QC is stable to the date on the label if stored between 2 - 8 degrees celcius. The lot # UCL3030019 expired 3/15/25. There was not another lot # available to use. 3. During an interview in the laboratory on 5/15/2025 at 11:51 am, the laboratory's technical consultant (CMS 209) confirmed the finding that the QC was expired. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. 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 review of the WSLH proficiency testing (PT) evaluation reports and an interview with technical consultant (TC), the laboratory director (LD) failed to sign the attestation statements for 2024 events #1 and #3. Findings: 1. Review of the WSLH PT 2024 events #1 & #3 revealed the LD did not attest to the PT samples being handled and ran like patient samples. 2. Interview with the TC (CMS 209 form) in the break room area at 12:15 pm on 5/15/25 confirmed the finding above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was performed on April 25, 2023 An entrance conference was held with the laboratory representatives. The survey process was discussed, along with review of the survey forms that was sent to the facility, previous to the survey. 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 deficencies, but none were provided. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 laboratory policy and procedure manual (SOP) review and testing personnel (TP) interview, the laboratory failed to establish and follow a policy and procedure to assess (TP) competency as required. Findings include: 1. SOP review revealed there was no policy and procedure to assess (TP) competency available at the time of survey. 2. Lack of TP competency documents revealed there was no initial, semiannual, or annual competencies performed for the 8 of 8 TP (refer to CMS 209). 3. Interview with TP #1 (CMS 209) on 4/25/23 at 10:27 a.m. confirmed the lack of a TP competency policy and procedure at the time of survey. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of laboratory records, policies and procedures, and testing personnel (TP) interview, the laboratory failed to have general laboratory system Quality Assessment (QA) written policies and procedures for the speciality of hematology. Findings : 1. Review of the laboratory's records and the policies and procedures revealed the laboratory failed to define or provide documentation of errors, how the laboratory identifies a potential problem, how the laboratory resolves a problem or error relating to: Patient confidentiality, Specimen identification and integrity, Complaint investigations, Communications, Personnel competency, and Proficiency testing performance. 2. Interview with testing personnel # 1 [see Laboratory Personnel Report (CMS 209)] on April 25, 2023 at 11:00 am, in the providers area, confirmed the laboratory has no documentation of Quality Assessment (QA). D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of laboratory records, policy and procedures, and a testing personnel (TP) interview, the laboratory failed to define Quality Assessment (QA) activities, review the effectiveness of

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on June 29, 2021. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on February 20, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 review of patient reports and interview with the office manager, the laboratory failed to include all required components on the facility's result reports. Findings include: 1. Review of patient reports (performed at the on site laboratory) revealed the units of measure were not included on the report. 2. Interview with the office manager at approximately 12 noon on 2/20/19 in the back office area, confirmed the reports did not contain the units of measurement. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform 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 -- 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of testing personnel(TP) documents and an interview with the office manager, the lab director failed to ensure proper documented training was given to all new testing personnel. Findings include: 1. Review of personnel documents revealed the lab director failed to ensure proper training was documented/given to 3 of 3 new testing personnel (TP#5, 6, & 7 CMS 209 form). 2. Interview with the office manager at approximately 11:15 AM on 2/20/19 in her office area, confirmed the aforementioned training documents were not available. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of testing personnel(TP) documents and an interview with the office manager, the technical consultant (TC)(lab director) failed to perform semiannual competency on all testing personnel. Findings include: 1. Review of competency documents revealed the TC (lab director) failed to perform 6 month competencies on 5 of 5 testing personnel (TP#1,2,3,4,5 CMS 209 form) in 2018. 2. Interview with the office manager at approximately 11:15 AM on 2/20/19 in her office area, confirmed the 2018 semiannual competencies were not available. -- 2 of 2 --