Summary:
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 the laboratory's American Proficiency Institute (API) proficiency testing (PT) records, and interview with Testing Personnel (TP) #1 (CMS 209 personnel #8), the laboratory failed to document the evaluation and verification activities performed for 1 of 1 API Chemistry Core PT testing events in 2024. Findings include: 1. The API PT Performance Evaluation Form states, "Laboratories should review the Performance Summary and Comparative Evaluation thoroughly for failures or ' not graded' analytes." 2. On the day of the survey, 01/22/2025 at 11:00 am, review of API PT records revealed the laboratory director/designee failed to document the evaluation and verification activities performed for the API Chemistry Core PT 3rd Event performed in 2024. 3. TP #1 confirmed the findings above on 12/10 /2024 at 11:22 am. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. 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 -- This STANDARD is not met as evidenced by: Based on lack of documentation and interview with Testing Personnel (TP) #1 (CMS 209 personnel #8), the laboratory failed to verify the performance specifications for hematology and chemistry tests analyzed on 1 of 1 Abott i-STAT prior to reporting patient test results from 10/24/2024 to the date of the survey. 1. On the day of the survey, 01/22/2025 at 10:33 am, the laboratory failed to provide documentation for the verification of performance specifications for precision, accuracy, reportable range, and reference intervals/range for the following analytes tested on 1of 1 Abott i- STAT before reporting patient results from 10/24/2024 to 01/22/2025: - Activated Clotting Time (ACT) - pH - Partial Pressure Carbon dioxide (PCO2) - Partial Pressure of Oxygen (PO2) - Potassium - Sodium - Ionized Calcium (iCa) - Hematocrit (Hct) - Hemoglobin (Hb) - Bicarbonate (HCO3) - Total Carbon Dioxide (TCO2) - Oxygen Saturation (sO2) - Base Excess (BE) 2. The laboratory could not provide a procedure of new instruments, analytes, or methodology. 3. The laboratory performed 150 Chemistry tests and 108 hematology tests in 2024 (CMS 116 annual volume) 4. TP#1 confirmed the findings above on 01/22/2025 at 11:22 am. -- 2 of 2 --