Cpn Inc Dba Atrium Health Levine Children's

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of performance verification records, review of laboratory procedure and interview with technical consultant (TC) 11/22/24, the laboratory failed to verify the reportable range for hemoglobin (HGB) on the Beckman Coulter DXH 520 hematology analyzer. No patients were reported for Hgb above the verified range of 19.49 grams per deciliter (g/dL) from August of 2022 until time of survey November 22, 2024. Findings: Review of performance verification records for the Beckman Coulter DXH 520 hematology analyzer revealed the analyzer was put into use and the performance was verified in August of 2022. Review of performance verification records for the Beckman Coulter DXH 520 hematology analyzer revealed the highest reportable range verified for HGB is 19.49 g/dL. Review of laboratory procedure "Beckman Coulter DXH 520" revealed the highest reportable range for HGB as 25.0 g /dL. Interview with TC at approximately 11:00 a.m. confirmed the HGB on the Beckman Coulter DXH 520 analyzer has a reportable range up to 25.0 g/dL. She also confirmed the performance verification records verified a reportable range for HGB up to 19.49 g/dL and there were no patient test results released with a HGB greater than the 19.49 g/dL from August of 2022 until time of survey 11/22/24. 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 review of laboratory competency assessment policy, review of 2017, 2018 and 2019 testing personnel (TP) competency assessments, and interview with technical consultant (TC) 11/14/19, the TC failed to ensure assessment of TP test performance through the testing of previously analyzed specimens, internal blind testing samples or external proficiency testing (PT) samples for all TP. Findings: Review of competency assessment policy "MOD/High Competency Personnel Competency" revealed "12. Successfully participates in Proficiency Testing. Date of latest participation:" Review of 2017, 2018 and 2019 competency assessments revealed TP competency evaluations had not included a yearly assessment of TP test performance through the testing of previously analyzed specimens, internal blind testing samples or external PT samples for all TP. For example: 1. TP #3 participated in PT in 2017, but had not been assessed in 2018 and 2019. 2. TP #5 participated in PT in 2017, but had not been assessed in 2018 and 2019. 3. TP #6 participated in PT in 2017, but had not been assessed in 2018; competency was not yet completed for 2019. Interview with TC at approximately 10:00 a.m. confirmed that all TP had not been assessed yearly as required through the testing of previously analyzed specimens, internal blind testing samples or external PT samples. 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 --