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 staff interview, the laboratory failed to establish competency assessment policies and procedures to assess competency for the regulatory responsibilities for the clinical consultant (CC). Findings include: 1. Record review on 05/13/2026 of the staff training and competency files revealed lack of competency assessment policies and documented competency assessment records for the regulatory position of CC. 2. Staff interview on 05/13/2026 at 09:30 AM with the laboratory general manager confirmed the above finding. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to revise its policies and procedures and to implement appropriate