Duly Health And Care - Lisle Lab

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 review of American Proficiency Institute (API) Proficiency testing (PT) records, laboratory procedure, and interviews with technical supervisor (TS) #1 and testing personnel (TP) #6, the laboratory failed to evaluate unacceptable PT scores in 5 of 24 events reviewed from 2022 to the date of survey, 10-02-2024. Findings include: 1. Review of API PT records identified an unacceptable grade for the following samples: 1. CH-10 - CO2 -2024 Chemistry - 2nd event 2. BCI- 14 - Blood cell identification - 2023 Hematology - 3rd event 3. XE-15 - RDW-SD - 2023 Hematology - 3rd event 4. XE-10 - RDW-SD - 2023 Hematology - 2nd event 5. CH- 01 - Albumin - 2023 Chemistry - 1st event 6. NB-03 - Bilirubin, Direct (Neonatal) - 2023 Chemistry - 1st event 2. Review of laboratory procedure titled, "QMS.06: Quality Assurance", stated under "survey evaluation": "If the evaluation report contains one or more unacceptable results: Challenges that were not graded because of lack of consensus, because the laboratory submitted its results after the cut-off date, failed to submit results, or made an error in completing the result form, a proficiency testing deviation form is completed for each unacceptable result.

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 review of laboratory records and interview with the technical supervisor (TS); the laboratory failed to verify the accuracy of ungraded proficiency testing (PT) analyte performance for the second PT event of 2018. Findings Include: 1. Review of American Proficiency Institute (API) Hematology/Coagulation PT documentation for event 2 of 2018 found that the laboratory's performance was not graded for the following analytes: Erythrocyte Count, Hematocrit, Hemoglobin, IG absolute, IG percent, Immature Platelet Fraction, INR, IRF, Leukocyte Count, MCH, MCHC, MCV, MPV, Nucleated RBCs, Partial Thromb. Time, Platelet Count, Prothrombin Time, RDW-CV, RDW-SD, Reticulocyte Count, Reticulocyte Hgb, Sedimentation Rate, White Blood Cell Differential. 2. Review of the laboratory's PT policy, "Proficiency Testing", stated on page 3 the following: "5. Evaluate all ungraded responses and perform a self-evaluation to verify the accuracy of analytes that are not graded". 3. Review of PT