Summary:
Summary Statement of Deficiencies D0000 An unannounced complaint survey for complaint number 2021013895, was conducted on 10/26/2021 at CSL Plasma Inc. - Tampa. The facility was not in compliance with 42 CFR 493, requirements for clinical laboratories. The following is a description of the standard level 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 observation, record review, and staff interview, the laboratory failed to ensure 2 (#B and #C) out of 4 (#A-#D) laboratory staff followed the safety procedure for hand hygiene and glove changes. Findings included: 1. Review of the laboratory's safety procedures revealed a "Daily Huddle" dated 10/28/20, titled "Hand Sanitizing or Glove Change Between Donors." The procedure stated "Glove changes or sanitizing shall be used between donors,..." and "REMINDER: Hands must be washed or sanitized between glove changes." 2. Observation of the donor reception area on 10 /26/21 at 9:45 am revealed that Testing Personnel (TP) #B performed total protein and hematocrit testing on one donor. TP #B did not change her gloves or sanitize her gloves prior to performing testing on the next donor. 3. Observation of the donor processing area on 10/26/21 at 10:00 am revealed that Phlebotomist #C was preparing a donor on the equipment to begin plasmapheresis (process for separating the plasma from the blood). During this process, another donor, who was in the process of plasma donation, called Phlebotomist #C over for assistance. Phlebotomist #C was not observed to change gloves or perform hand hygiene/glove sanitation between physical contact with both donors. 4. On 10/26/21 at 10:15 am, Phlebotomist #C confirmed he had not changed his gloves or sanitized before moving on to the next donor. 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 -- Phlebotomist #C then changed his gloves but did not wash or sanitize his hands between glove changes. 5. On 10/26/21 at 10:25 am, the Center Manager confirmed that TP #B did not change her gloves between donors. 6. On 10/26/21 at 10:45 am, the Center Manager and Assistant Manager of Quality reported that staff have to change gloves between donors or use hand sanitizer on the nitrile gloves in the screening /donor reception areas. -- 2 of 2 --