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 lack of the Competency Assessment (CA) records, review of the personnel files and interview with the Testing Personnel (TP), the laboratory failed to perform a CA on one of one TP in the calendar years 2017 and 2018. The TP confirmed on 2/26 /19 at 12:00 pm that CA was not performed on TP. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observation of the Quality Control (QC) material and interview with the Testing Personnel (TP), the laboratory failed to put open and new expiration dates on Toxicology controls from 4/3/17 to the date of survey. The findings include. 1. The MPI for MAS DOA Total Liquid Assayed Drugs of Abuse Controls stated that QC material for Toxicology expired 30 days after opening if stored at 2 to 8 Celsius. a) The TP was not aware that QC material expired 30 days after opening. b) The 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 -- laboratory did not put new expiration dates on MAS DOA Total Liquid Assayed Drugs of Abuse Controls Lot # DAT19124A, DAT19053A, DAT19125A, DAT1924, and DAT19125. 2. The TP confirmed on 2/26/19 at 1:00 pm the laboratory failed to put new expiration dates on the control material. -- 2 of 2 --