Cpn, Inc Dba Atrium Health Primary 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 (TC) technical consultant 9/26/22, the laboratory failed to discard supplies that exceeded their expiration date. During a tour of the laboratory 9/26/22 at approximately 12:10 p.m., the surveyor observed 1 box of Hemoccult ICT controls with an expiration date of 7/31/22 in a cabinet in the laboratory, available for use. The box contained: 2 bottles of positive control, lot #M101127; 2 bottles of negative control, lot #M101009. During interview at approximately 1:15 p.m., the TC stated she thought the laboratory had checked for expired supplies prior to the survey. 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 D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of personnel records and interview with the TC (technical consultant) 1/10/19, the TC failed to perform and document competency evaluations for 4 of 4 providers (TP #3, #4, #5, #7) who perform wet prep and KOH (potassium hydroxide) tests. Review of personnel records for 4 of 4 providers (TP #3, #4, #5, #7) who perform wet prep and KOH (potassium hydroxide) tests revealed there was no documentation of competency evaluations performed during 2017 or 2018. During interview at approximately 2:30 p.m., the TC confirmed that he did not perform competency evaluations for the providers during 2017 or 2018. 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 --