Summary:
Summary Statement of Deficiencies D6112 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451 The technical supervisor is responsible for the technical and scientific oversight of the laboratory. The technical supervisor is not required to be on site at all times testing is performed; however, he or she must be available to the laboratory on an as needed basis to provide supervision as specified in (a) of this section. This STANDARD is not met as evidenced by: Based on review of Immunohematology records, and interview with the laboratory supervisor on 05/07/2019, 05/08/2019, and 05/09/2019, the laboratory failed to ensure the Technical Supervisor spent a sufficient amount of time in Blood Bank from 01/03 /2019 to 05/07/2019, to supervise the technical performance of Immunohematology procedures by the testing personnel. Findings include: 1. The technical supervisor failed to review blood bank quality control results. 2. The technical supervisor failed to review daily documentation of room temperatures, daily documentation of the blood bank refrigerator temperatures, documentation of the quarterly alarm checks on the blood bank refrigerator, daily documentation of the blood bank freezer temperatures, quarterly alarm checks on the blood bank freezer, and daily documentation of the water bath temperatures. 3. The technical supervisor failed to review maintenance documentation on the Gel System centrifuge. 4. Interview with the laboratory supervisor at 10:45 AM on 05/08/2019, revealed the laboratory failed to have a system in place to ensure Immunohematology records were reviewed by the technical supervisor in a timely manner. 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 --