Summary:
Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on surveyor observation, record review and staff interview the laboratory failed to document eyewash function check at the required frequency in the subspecialty of Histopathology. Findings include: 1. Surveyor observation on 3/17/2025 at 9:45 AM of the laboratory processing room revealed a plumbed eyewash located in the sink. 2. Record review on 3/17/2025 of the "Fire extinguisher & Eye Wash Log-check weekly" logs in the "SOP Binder" revealed lack of documentation of weekly eye wash check since January 2023. 3. Staff interview on 3/17/2025 at 10:14 AM with the Histotechnician (HT) confirmed that he/she did not perform and document weekly eyewash checks. 4. The laboratory performs 528 Mohs Micrographic Surgery cases annually in the subspecialty of Histopathology. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 staff interview the laboratory failed to follow their Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- established "Quality Assurance" policy to review all the documents monthly in the subspecialty of Histopathology. Findings include: 1. Record review on 3/17/2025 of the laboratory's "Quality Assurance Policy" revealed, "Quality control assessment: Laboratory Director (LD) continually monitor quality control results by reviewing all aspects of the laboratory note book monthly and implement