Summary:
Summary Statement of Deficiencies D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) (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 the surveyor's review of the laboratory's policy and procedure, five patient records, preventive maintenance (PM) records, an interview on February 11, 2026, and an email communication on February 13, 2026, with the laboratory director (LD), it was determined that the laboratory failed to retain the quality system assessment records for at least two years. The findings include: 1. The laboratory's policy and documentation indicated that the preventive maintenance for the microscope was performed annually. 2. The surveyor reviewed the PM records and found that the laboratory had the 2023 service record but was unable to retrieve the 2024 and 2025 documentation potentially affecting all five patient records reviewed. 3. The LD stated in an interview on February 11, 2026, that the PM service records for the microscope for 2024 and 2025 were not located. This was further confirmed through an email from the LD on February 13, 2026. 4. According to the laboratory testing declaration form (Lab-144) submitted on February 11, 2026, the laboratory performed and reported approximately 9,700 patient cases during the time when quality system assessment records were not properly retained for 2024 and 2025. . D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; 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 -- This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policy and procedure, preventive maintenance records, randomly selected patient test records and an interview with the laboratory director on February 11, 2026, this deficiency in herein cited for the laboratory director due to failure to ensure that the quality system assessment records were retained for at least two years as required in 493.1105(a)(5). See D3039 -- 2 of 2 --