Summary:
Summary Statement of Deficiencies D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on interviews with practice manager and testing personnel (TP) #1 5/18/23, the laboratory failed to employ personnel to serve in the position of laboratory director to provide overrall management and direction of the laboratory. Findings: Interview with practice manager at approximately 10:00 am confirmed the laboratory did not have a laboratory director. The practice manager stated he recently became employed on 5/14 /23 and was made aware through conversations with the testing personnel that the facility did not have a laboratory director. He stated he has been speaking with the Director of Operations to determine whom may be able to serve as the facilities laboratory director. He also stated the laboratory will cease moderate complexity testing, Complete Blood Count (CBC), until a laboratory director could be found or , if needed, they would change their certificate type. Interview with TP #1 at approximately 10:00 a.m. confirmed the laboratory did not have a laboratory director. She stated she began employment at the facility in October of 2022 to help provide guidance for the laboratory until staffing shortages could be resolved. She stated the last practice manager was trying to get help but was let go in February of 2023. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --