Starling Physicians, Pllc-Laboratory

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to self evaluate the Proficiency Testing (PT) scores graded with educational challenge as required by the College of American Pathologist (CAP) in the specialty of Hematology. Findings Include: 1. Record review on 5/16/2024 of the CAP Hematology Automated Differential Participant Summary report revealed the following: a. "Page 33: Actions Laboratories should take when a PT result is NOT GRADED." b. "Code :26: Educational Challenge, Action required: Review participant summary for comparative results and document performance accordingly." 2. Record review on 5/16/2024 of the "CAP ORIGINAL EVALUATION Hematology for Auto Differentials, FH9" reports reviewed by the laboratory director revealed the following for three of three PT events for 2023: a. " Exception reason code appearing in this evaluation: [26]= Educational Challenge." b. Test: IG % and IG Absolute sections were graded as "See Note [26]." Note: Lack of documentation of self evaluation for the tests graded with code [26] for three of three events in 2023. 4. Staff interview on 5/16/2024 at 09:35 AM with the Technical Consultant confirm the above findings. 5. The Laboratory performs 10,080 complete blood count tests annually. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to ensure all testing personnel (TP) have tested unknown samples to demonstrate competency in performing laboratory tests in the specialty of hematology. Findings Include: 1. Record review of the American Association of Bioanalysis proficiency testing (PT) attestation sheets on 8/2/21 revealed 2 of 4 TP did not examine PT materials or previously analyzed samples to accurately assess their skills and competency in 2020. 2. Record review of TP competency records on 8/2/21 revealed 2 of 4 TP were scheduled to examine PT samples but had not completed it. The laboratory did not have documentation to indicate 2 of 4 TP had analyzed previously tested specimens, internal blind samples or external proficiency testing samples to accurately assess their skills in 2020. 3. Staff interview with the point of care testing supervisor on 8/2 /21 at 12:45 PM confirmed the above TP had not examined unknown samples including PT materials to accurately assess their skills in the specialty of hematology in 2020. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --