Summary:
Summary Statement of Deficiencies D0000 An offsite revisit survey was completed on April 08, 2026, for all previous deficiencies cited on March 04, 2026. All deficiencies have been corrected, and no new noncompliance was found. The facility is in compliance with all regulations. 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 review of the laboratory Quality Control (QC) records, Standard Operating Procedures (SOPs), as well as interview with the Laboratory Director (LD), the laboratory failed to retain all laboratory quality system assessment records for at least two years. FINDINGS: 1. There was no documentation of laboratory QC for calendar year 2025. 2. This is contrary to instructions indicated in the current, approved South Island Gastroenterology Associates, PC record retention SOP. 3. The LD confirmed the findings on March 4, 2026, at approximately 11:00 A.M. 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 --