Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Director, the laboratory had not performed competency assessment on the Technical consultant for 2 out of 2 years (2017-2018) reviewed. Finding include: Record review of competency records revealed that competency evaluations had not been performed for the Technical Consultant for 2 out of 2 years (2017-2018). Interview on 01/23/2019 at 12:10 p.m., the Laboratory Director acknowledged that they had not performed competency evaluations on the Technical Consultant for 2 out of two years ( 2017-2018). 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, record review, and interview with Testing Personnel #G, the laboratory failed to ensure hematology controls (Lot#'s EX0119L, EX0119N, EX0119 H) were removed from use after the open expiration date. Findings Include: Observations on 01/23/2019 at 10:05 AM revealed hematology controls labeled with an open date of 01/03/2019 stored in the refrigerator. Record review of the package 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 -- insert showed that open hematology controls expired 16 days(01/19/2019) after opening. Patient Log revealed 1 patient was tested on 01/21/2019. Interview on 01/23 /2019 at 10:15 a.m. Testing Personnel #G stated that they did not know the hematology controls expired 16 days after opening. -- 2 of 2 --