Summary:
Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 09/29/2026. The laboratory was found in substantial compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. STANDARD LEVEL DEFICIENCIES were cited. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory's submitted Laboratory Personnel Report Form CMS 209, policies/procedures, personnel records and staff interview the laboratory failed to document technical supervisor (TS) and/or general supervisor (GS) competency assessment for one of one TS/GS employed by the facility. Findings included: 1. Review of laboratory's submitted Laboratory Personnel Report Form CMS 209 revealed the laboratory employed one TS/GS. 2. Review of laboratory's policies /procedures revealed the documents did not include requirements for TS/GS competency assessments. 3. Review of laboratory's personnel records for facility's TS /GS revealed there was no documentation of competency assessments based on the roles' responsibilities for the TS/GS employed by the facility. 4. In an interview on 09 /29/2026 at 1600 hours in the laboratory, the facility's Laboratory Manager (as indicated on submitted Entrance/Exit Conference document) confirmed the findings. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by 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 -- 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 review of laboratory's policies/procedures, patient test records and staff interview, the laboratory failed to follow its own policies and document the time of formalin fixation for one of one test performed by the facility, Tissue Grossing for histopathology exam. Findings included: 1. Review of laboratory's "Formalin Fixation" policy/procedure (effective 10/20/2025) revealed: "The time of fixation must be documented for each specimen, and the technician must verify that the tissue has been adequately fixed before moving to further processing stages." 2. Review of laboratory's test records revealed the laboratory did not have documentation of the time of fixation for the received tissue samples. 3. Review of laboratory's submitted test volumes revealed the laboratory estimated 3500 tissue grossing procedures annually. 4. In an interview on 09/29/2026 at 1550 hours in the laboratory, the facility's Laboratory Manager (as indicated on submitted Entrance/Exit Conference document) confirmed the findings. -- 2 of 2 --