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 procedure review, record review, and interview with testing personnel #5 (TP5), the laboratory failed to ensure competency policies were followed for one (#2) of five TP performing the mycology and parasitology testing. Findings include: 1. Procedure review of the "CLIA Statement Book" under the "Personnel Review Information" section revealed the competency is to assessed every six months. 2. Record review of the TP competency assessments revealed their was no documentation to show the 2nd six month of 2017 and the 2018 assessments were performed and documented for TP2. 3. During the interview on March 14, 2019 at 2: 08 PM, TP5 acknowledged the competency policy had not been followed for TP2 in 2017 and 2018. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: . Based on record review and interview with testing personnel #5 (TP5), 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 3 -- laboratory failed to perform and document the refrigerator and dermatophyte testing media (DTM) incubation drawer temperature for 37 (November 7-30 and December 3- 31) of 41 days of operation in 2018 for the storage and incubation of the DTM media. Findings include: 1. Record review of the "Daily DTM Temperature" log for the incubation drawer and the "Daily DTM Temperature" log for the refrigerator showed the laboratory did not document the temperatures for 37 days of operation in 2018 as follows: a. November 7-9, 12-16, 19-21, 23, and 26-30 b. December 3-7, 10-14, 17 - 21, 24, 26-28, and 31. 2. During the interview on March 14, 2019 at approximately 12: 38 PM, TP5 confirmed no temperatures were taken and recorded prior to testing patients. D5781