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 the surveyor's review of the laboratory's policy and procedure, seven randomly chosen patient records, lack of personnel competency documentation, and an interview with the laboratory supervisor (LS) on July 7, 2026, as specified in the personnel requirements in subpart M, it was determined that the laboratory failed to perform the personnel competency assessment prior to patient testing. The findings include: 1. The laboratory had a written and approved policy for personnel competency assessment that stated: Competency must be assessed at the following frequency: a. During the first year of an individual's duties, competemncy must be assessed at least annually. b. After an individual has performed his/her duties for one year, competency must be assessed at least annually. 2. The surveyor reviewed seven patient records wherein the tests were performed by the multiple testing personnel (TP). The laboratory lacked competency assessment records for the year 2026 and that no