Summary:
Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of proficiency test (PT) performance evaluation records from American Proficiency Institute (API) and interview on 9/13/2022 at 12:30 p.m. with general supervisor #1 (GS#1), the laboratory failed to self-evaluate 5 not graded results from 5 of 28 events from 11/13/2020 to 9/13/2022. Findings: 1. 2021 Hematology/Coagulation 2nd Event not graded results: a. Blood Cell Indentification, BCI-01 b. No evidence of self-evaluation was available at the time of survey. 2. 2021 Hematology/Coagulation 3rd Event not graded results: a. Vaginal Wet Preparation (KOH), VKP-03 b. No evidence of self-evaluation was available at the time of survey. 3. 2021 Microbiology 2nd Event not graded results: a. Influenza A, RSP-08 b. No evidence of self-evaluation was available at the time of survey. 4. 2022 Immunology /Immunohematology 1st Event not graded results: a. Compatibility, SER-05 b. No evidence of self-evaluation was available at the time of survey. 5. 2022 Immunology /Immunohematology 2nd Event not graded results: a. Compatibility, SER-06 b. No evidence of self-evaluation was available at the time of survey. 6. Interview with GS#1 9/13/2022 at 12:30 p.m. confirmed, the laboratory failed to self-evaluate 5 not graded results from 5 of 28 events from 11/13/2020 to 9/13/2022. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of proficiency test (PT) performance evaluation records from American Proficiency Institute (API) and interview on 9/13/2022 at 12:30 p.m. with general supervisor #1 (GS#1), the laboratory failed to evaluate 4 unacceptable results from 4 of 28 events from 11/13/2020 to 9/13/2022. Findings: 1. 2021 Chemistry Core 1st Event unacceptable results: a. ALT, CH-02 b. No documentation of evaluation, investigation or