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 the lack of a laboratory Safety Plan and interviews with account manager (AM); it was determined that the laboratory failed to have and follow safety procedures to ensure protection from physical and biohazardous materials. The findings include: 1. The laboratory failed to have and follow a laboratory Safety Plan (policies and procedures) based on a risk assessment to provide protection from physical and biohazardous materials as needed. 2. The AM affirmed by interview on May 20, 2026, at approximately 12:15 a.m., that the laboratory lacked a laboratory Safety Plan based on a risk assessment that is approved, signed, and dated by the laboratory director. 3. The safety of laboratory personnel cannot be assured at this time. 4. The annual testing declaration form submitted at the time of the survey stated 2,840 samples were processed and reported for Histopathology during the time when the laboratory failed to have and follow safety procedures. D3013 FACILITIES CFR(s): 493.1101(e) Records and, as applicable, slides, blocks, and tissues must be maintained and stored under conditions that ensure proper preservation. This STANDARD is not met as evidenced by: Based on the surveyor's observation during the laboratory tour on the day of the 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 -- survey May 20, 2026, and interviews with laboratory's account manager (AM); it was determined that the laboratory failed to have a policy on storage for patients' histopathology sample slides under conditions that ensure security and proper preservation. Findings included: 1. On May 20, 2026, at approximately 11:30 a.m., the AM failed to present to the surveyor a policy on storage of histopathology samples slides. 2. The AM confirmed that the laboratory did not have a written policy signed and dated by the laboratory director for storage of histopathology patients' sample slides to be maintained and stored under conditions which ensure security and proper preservation. 3. Based on the laboratory testing declaration signed and dated by the laboratory director on 5/8/2026, the laboratory stores patient sample slides from approximately 2,840 histopathology samples annually for which there is no approved storage policy. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) (e) The laboratory director must-- (e)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on the surveyor's review of laboratory's policies and procedures and interview with the Account Manager, the laboratory director is herein cited for failure to provide quality laboratory services for the preanalytic and postanalytic phases of testing. See D3011 and D3013. -- 2 of 2 --