Summary:
Summary Statement of Deficiencies D5661 CYTOLOGY CFR(s): 493.1274(f)(2)(3) (f) Record and slide retention. (f)(2) Slides may be loaned to proficiency testing programs in lieu of maintaining them for the required time period, provided the laboratory receives written acknowledgment of the receipt of slides by the proficiency testing program and maintains the acknowledgment to document the loan of these slides. (f)(3) Documentation of slides loaned or referred for purposes other than proficiency testing must be maintained. This STANDARD is not met as evidenced by: Based on a review of cytology records, policy and procedures, and an interview with Technical Supervisor (TS) #1, the laboratory failed to establish and maintain a method for tracking slides shipped from and to their facility from January 1, 2021 to January 3, 2023. Findings: 1. A review of Retention of Cytology Materials and Records CYTO-079 revealed the laboratory failed to document slides sent to an outside consult as stated, "D ...written in the "send out" logbook located in the pathology secretary:" 2. The laboratory failed to have a logbook for tracking slides received or sent to another location. 3. Interview with TS #1 on January 03, 2023, at 12:15 PM, confirmed the laboratory failed to establish and document a process to track slides sent or received by the laboratory. 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 --