Children's Medical Group

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on June 2, 2026. 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: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation during the laboratory tour, review of the Standard Operating Procedures, and interview with the Clinical Team Lead, the laboratory director failed to ensure that safety procedures were established, accessible, and followed. Findings: 1. A review of the Standard Operating Procedures revealed there was no written laboratory safety policy. 2. Observation during the laboratory tour, revealed TP #4 (CMS-209) handling a capillary tube, containing blood, without wearing gloves or a laboratory coat. 3. Observation during the laboratory tour revealed the eyewash station was located on a dirty sink that contained current patient urine specimens. 4. An interview with the Clinical Team Lead, in the conference room, on June 2, 2026, at 12:00 p.m., confirmed that a written safety policy was not included in the Standard Operating Procedures. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify 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 -- failures in quality as they occur; This STANDARD is not met as evidenced by: Based on review of quality assessment, quality control records and interview with the Clinical Team Lead, the Laboratory Director failed to ensure quality assessment and quality control programs were maintained. Findings: 1.A review of Quality Assessment records revealed there was no documented quality assessment log completed for 2025 and 2026. 2. A review of Quality Control records revealed daily quality control was performed for all chemistry and complete blood count testing; however, there was no documentation of monthly review of the quality control records by the Laboratory Director. 3. An interview with the Clinical Team Lead, in the conference room, on June 2, 2026, at 12:00 p.m., confirmed that quality assessment logs had not been completed and also the failure of a monthly review of quality control records by the Laboratory Director. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) (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 personnel records and interview with the Clinical Team Lead, the Laboratory Director failed to ensure initial competency assessments were documented for all Testing Personnel (TP). Findings: 1. A review of Testing Personnel records revealed that 2 of 4 testing personnel, TP #3 (CMS-209) and TP #4 (CMS-209), did not have documented initial competency assessments. Specifically, TP #3 did not have a documented 2025 initial competency assessment, and TP #4 did not have a documented 2026 initial competency assessment. 2. Interview with the Clinical Team Lead in the conference room on June 2, 2026, at 12:00 p.m., confirmed that the initial competency assessments were not performed for TP #3 (2025) and TP #4 (2026). D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) (e)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; and This STANDARD is not met as evidenced by: Based on review of the Standard Operating Procedures and interview with the Clinical Team Lead, the laboratory director failed to ensure that approved procedures were signed and dated. Findings: 1. A review of the Standard Operating Procedures revealed that the laboratory director had not signed or dated the procedure manual prior to placing in use, March 14, 2024. 2. Interview with the Clinical Team Lead in the conference room on June 2, 2026, at 11:30 a.m., confirmed the laboratory director had not reviewed, signed, and dated the procedure manual since March 14, 2024. D6032 LABORATORY DIRECTOR RESPONSIBILITIES -- 2 of 4 -- CFR(s): 493.1407(e)(14) (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of the Standard Operating Procedures and interview with the Clinical Team Lead, the laboratory director failed to specify, in writing, the duties and responsibilities for all laboratory personnel. Findings include: 1. Review of the Standard Operating Procedures revealed that duties and responsibilities were documented for the Laboratory Director and Testing Personnel positions; however, the Technical Consultant and Clinical Consultant positions did not have documented duties and responsibilities. 2. Interview with the Clinical Team Lead in the conference room, on June 2, 2026, at 12:00 p.m., confirmed the Standard Operating Procedures did not include documented duties and responsibilities for the Technical Consultant and Clinical Consultant positions. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) 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 personnel records and interview with the Clinical Team Lead, the Laboratory Director failed to ensure semiannual competency assessments were documented for all Testing Personnel (TP). Findings: 1. Review of Testing Personnel records revealed that 1 of 4 testing personnel, TP #3 (CMS-209), did not have a documented 2025 semiannual competency assessment. 2. Interview with the Clinical Team Lead in the conference room on June 2, 2026, at 12:00 p.m., confirmed that the 2025 semiannual competency assessment had not performed for TP #3 (CMS-209). D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on review of personnel records and interview with the Clinical Team Lead, the Laboratory Director failed to ensure annual competency assessments were documented for all Testing Personnel (TP). Findings: 1. Review of Testing Personnel records revealed that 2 of 4 testing personnel did not have documented annual competency assessments completed for 2025 and 2026 to date. 2. Interview with the -- 3 of 4 -- Clinical Team Lead in the conference room on June 2, 2026, at 12:00 p.m., confirmed annual competency assessments for TP 1 (CMS-209) and TP 2 (CMS-209) were not performed during the aforementioned years. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A recertification survey was performed on , May 29, 2024. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. 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 review of the College of American Pathologist (CAP) Proficiency Testing Provider (PT) and staff interview, the laboratory failed to verify the accuracy of testing for the Specialty Chemistry- Subspeciality ( Routine) -Analyte ( Direct Bilirubin(DBili). In the year 2022, events A,B, and C, for the year 2023, events A, B, C. Findings: 1, Review of the CAP, PT documents for DBili (2022 events A,B,C) and (2023 events A,B,C) the laboratory received a score of NOT GRADED for insufficient peer group data. The laboratory failed to verify the accuracy of the analyte (DBili.) 2. Interview with the supervisor, on 05/29/2024, at approximately 1 pm in the doctor's office, confirmed the statement above. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance 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 -- characteristics of the method; This STANDARD is not met as evidenced by: Based on review of the College of American Pathologist (CAP) Proficiency Testing (PT) provider and staff interview the Laboratory Director(LD) failed to ensure that Specialty- Chemistry, Subspecialy (General), Analyte( Direct Bilirubin (DBILI)) was verfied twice a year after receiving NOT GRADED results for 2022 events A,B,C, and 2023 events A,B,C. Findings: 1, Review of the CAP, PT documents for DBili (2022 events A,B,C) and (2023 events A,B,C) the laboratory received a score of NOT GRADED for the insufficient peer group data. The LD failed to monitor and verify the accuracy of the analyte - DBili. 2. Interview with the supervisor, on 05/29/2024, at approximately 1 pm, in the doctor's office, confirmed the statement above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on July 28, 2022. 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: D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on review of the laboratory policy and procedure manual and interview with Testing Personnel. The Laboratory failed to have a policy and procedure in place for complaint investigations. The Finding include: 1. SOP document review revealed that the laboratory did not have a policy and procedure for complaint investigations, during the time of the survey. 2. During an interview with Testing Personnel#1(CMS- 209) on July 28, 2022 at approximately 3:25 PM, in the front conference room, confirmed that the laboratory did not have a SOP in place for complaint investigations. 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. 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 -- This STANDARD is not met as evidenced by: Based on the review of the Standard Operating Procedure (SOP) records review and staff interview. The laboratory failed to establish a competency policy and procedure. The Findings include: 1. The laboratory failed to establish a written policy and procedure to assess competency based on the position responsibilites on an initial, semi-annual, and annual bases. 2. An annual competency assessment was not performed for the following staff: Testing Personnel#1(CMS-209) and Testing Personnel#3(CMS-209). 3. An annual competency assessment was performed for the following staff, but the evaluation was not signed by the Laboratory Director or the Testing Personnel: Testing Personnel#3(CMS-209)- Initial competency for 2022, Testing Personnel#5(CMS-209)-Initial competency for 2022. 4. During an interview on July 28, 2022 with Testing Personnel#1(CMS-209) at approximately 2:25 PM, confirmed the failure to establish a competency policy and procedure. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on the review of a laboratory policy and procedure manual (SOP) and staff interview. The laboratory failed to have a policy and procedure for complaint investigations. Findings include: 1. SOP document review revealed there was no complaint investigations policy and procedure, available at the time of survey on July 28, 2022. 2. During an interview on July 28, 2022 with Testing Personnel#1(CMS- 209) in the conference room at approximately 2:30 PM, confirmed the lack of a complaint investigations policy and procedure for the laboratory. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of