Summary:
Summary Statement of Deficiencies D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) (d)(3)(i) Each quantitative procedure, include two control materials of different concentrations; This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, lack of documentation, and interview with the laboratory representative; the laboratory failed to ensure two levels of quality control (QC) materials were ran each day of testing for one of six patient testing dates reviewed for Total Protein (TP) testing in the subspecialty of routine chemistry from 2024 through the date of survey, 04/09/2026. Findings include: 1. Review of laboratory policies and procedures revealed the procedure titled "Control Verification of Refractometer", which stated, under "Controls Used", "Low & High (white & black caps)" and under "Frequency", "Daily before refractometer is used". 2. Review of laboratory records revealed two levels of QC materials were not performed/documented each day of patient testing for one of six patient testing dates reviewed for TP testing in the subspecialty of routine chemistry. Patient: Testing Date: QC performed: A00148489 10/15/2024 No 3. Interview with the laboratory representative on 04/09/2026, at 11:55 am, confirmed the laboratory failed to ensure two levels of QC materials were ran each day of testing for one of six patient testing dates reviewed for TP testing in the subspecialty of routine chemistry from 2024 through the date of survey, 04/09/2026. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --