Summary:
Summary Statement of Deficiencies D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to document the time patient specimens from other locations were received into the laboratory. Findings are as follows: 1. The laboratory performed Dermatopathology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:05 a.m. on 02/24/20. 2. Requirements for patient specimen (tissue) receipt time documentation for cases received from other locations were not established in the Procedure Manual - Histology. 3. Tissue receipt time was not documented in laboratory records for Dermatopathology cases received from other locations. 4. In an interview at 11:45 a.m. on 02/24/20, TP1 confirmed the above finding. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: . Based on observation, document review and interview with laboratory personnel, the laboratory failed to ensure laboratory policies, procedures, and performance verifications were approved, signed, and dated by the laboratory director prior to use. Findings are as follows: 1. The laboratory performed Dermatopathology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:05 a.m. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- on 02/24/20. 2. The Procedure Manual - Histology present on date of survey included laboratory policies, procedures, and testing performance verification documents. 3. The laboratory Director did not approve, sign, or date the the laboratory policies and procedures prior to testing implementation. The laboratory director did not approve, sign, or date 8 of 10 performance verification documents prior to testing implementation. 5. In an interview at 12:10 p.m. on 02/24/20, TP1 confirmed the above finding. -- 2 of 2 --