Children's Medical Group

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