Summary:
Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review and an interview with the laboratory manager; the laboratory failed to follow written quality control procedures for the Histopathology slide interpretations performed. Findings include: 1. The laboratory procedures manual and the Hematoxylin and Eosin (H&E) stain quality control (QC) logs from January through April of 2019 were reviewed. 2. The procedure manual require the testing personnel (TP) to document the date and quality of all H&E-QC slides received with patient slides from the tissue processing laboratory. 3. The H&E-QC logs revealed the following: *TP1 and TP2 failed to record the day and date H&E-QC slides were read from January to April of 2019. *TP1 and TP2 recorded the QC results from other stains on the H&E-QC log and failed to record the day and date of these stains, also. *TP1 and TP2 failed to follow instructions when completing the H&E-QC log, leaving required information blank or unanswered. 4. On a Recertification survey conducted on 04/30/2019 at 12:30 PM, the laboratory manager confirmed the above findings. 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 --