Summary:
Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the Technical Consultant, the laboratory did not retain lot number and expiration date records for the reagents they used for two of two manual tests reviewed. Findings include: 1. Review of laboratory records from January 2023 through October 2024 showed no evidence of lot number and expiration date records for the reagents the laboratory used for KOH (potassium hydroxide) or WBC (white blood cell) differential tests. 2. Interview with the Technical Consultant on November 6, 2024, at 11:15 AM confirmed the laboratory had not retained lot number and expiration date records for the reagents the laboratory used for the KOH and WBC differential tests. 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 --