Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at PEDIATRIC ASSOCIATES - CHAPEL TRAIL from 04/23/2026 to 05/04/2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to examine or test Proficiency Testing (PT) samples with the laboratory's regular patient workload (testing Personnel (TP)) that routinely perform the testing in the laboratory for three out of three events reviewed for Hematology and Chemistry specialty. Findings included: 1-Review of FORM CMS-209 signed and dated by the Laboratory Director (LD) on 04/23/2026 revealed the laboratory had five TP listed (TP#1, TP#2, TP#3, TP#4 and TP#5). 2-Review of the procedure manual signed by the Laboratory Director (LD) in policy titled, "LAB 410 Proficiency Testing" revealed that stated under "SCOPE" "All laboratory staff are to review and participate in the proficiency program. Any employee who is working in the lab and performing moderate complex patient testing must participate in Proficiency Testing" 3-Review of American Proficiency Institute (API) PT attestation statement records for the Hematology and Chemistry specialty for the following events 2025 (1st, 2nd and 3rd) revealed that TP#2 did not signed any of the attestations during 2025 for Hematology in 2025. The laboratory failed to have attestations signed for TP #3, TP#4 and TP#5 in Chemistry and Hematology during 2025. 4-During an interview on 05/04/2026 at 11:20 AM, the Lead Medical Assistant confirmed that TP#2 failed to participate in PT in Hematology 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 -- during 2025 and that the laboratory failed to have PT participation for TP#3, TP#4 and TP#5. D2122 HEMATOLOGY CFR(s): 493.851(b) (b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory received an unsatisfactory score for 1 out of 3 events reviewed for Hematology specialty. Findings included: 1- Review of Casper Report 96D CLIA application and Survey Summary on 04/21/2026, revealed that the laboratory received an overall score of 73% for Hematology specialty. 2-Review of American Proficiency Institute (API) proficiency testing (PT) records revealed a score of 0 % for Red Blood Cells, 60% for Hematocrit and 60% for Hemoglobin resulting in an overall score of 73 % in the second event of 2025. 3- During an interview on 04/23/2026 at 11:00 AM, the Lead Medical Assistant confirmed the proficiency testing failure. 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 record review and staff interview, the Technical Consultant (TC) failed to perform competency evaluation for three out of five Testing Personnel (TP) in 2025. Findings included: 1-Review of FORM-209 (01/2021) signed and dated by the Laboratory Director (LD) on 04/23/2026, revealed that the LD, Clinical Consultant (CC), and TC was the same person and that there were five Testing Personnel (TP) (TP#1, TP#2, TP#3, TP#4 and TP#5). 2-Review of personnel records, revealed that TP#3, TP#4 and TP#5, are not regular TP onsite and that the laboratory failed to have competency evaluation for them before they started testing patients onsite. 3-During an interview on 05/04/2026 at 11:40 AM, the Lead Medical Assistant confirmed that the TC failed to do competency evaluation for TP#3, TP#4 and TP#5 before they did patient testing. -- 2 of 2 --