Summary:
Summary Statement of Deficiencies D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based on facility observation, a review of refractometer correlation studies, a review of testing personnel (TP) competency assessment records, and staff interviews, the laboratory failed to maintain complete quality assessment records for a period of two years when ownership changed on 07/01/24. The findings include: 1. Facility observation on 09/19/24 at 9:45 a.m. revealed the laboratory performed serum total protein using the Reichert TS Meter-DSP to determine donor eligibility for plasmapheresis. 2. A review of the "Refractometer Correlation Study" document dated 9/25/23 revealed "FAIL" for refractometer "Equipment ID # R7." The