Cpn, Inc Dba Atrium Health Urgent Care

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with the TC (technical consultant) and TP (testing personnel) #2 on 5/16/23, the laboratory failed to discard urine collection devices that exceeded their expiration dates. Findings: During a tour of the laboratory approximately 12:10 p.m. - 12:30 p.m., the surveyor observed the following expired supplies in a bin in a cabinet, available for use: 1. 1 BD Vacutainer urinalysis transfer kit, lot # 1190376 with expiration date 12/2022; 2. 2 Cobas PCR urine sample packs, lot # H05302 with expiration date 3/31/2023. During an interview at approximately 12: 20 p.m., the TC and TP #2 confirmed the tubes were expired. 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) 11/12/19, the TC failed to ensure TP competency evaluations included a yearly 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 TP 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 #1 began testing in 2017 and had participated in PT on 10/17/17, but had not been assessed in 2018 and 2019. 2. TP #2 began testing in 2017 and had not been assessed in 2017, 2018 and 2019. 3. TP #3 began testing in 2016 and had participated in PT event FH2-B in 2017, but had not been assessed in 2018 and 2019. 4. TP #4 began testing in 2018 and had not been assessed in 2018 and 2019. 5. TP #5 began testing in 2016 and had not been assessed in 2017, 2018 and 2019. 6. TP #7 began testing in 2016 and had participated in PT in 2016, but had not been assessed in 2017, 2018, and 2019. Interview with TC at approximately 11:50 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 --