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 a histology supervisor, the laboratory did not retain records of the lot number and expiration dates of stains and reagents used for hematoxylin and eosin (H&E) staining during 2021 or 2022. Findings include: 1. Review of laboratory records showed no evidence of records of the lot number or expiration dates of the stains and reagents used for H&E staining in 2021 or 2022. 2. Interview with a histology supervisor (staff A) on August 10, 2022 at 10:00 AM confirmed the laboratory did not retain records showing the lot number and expiration dates of the stains and reagents used for H&E staining. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures for tissue sample grossing and processing and interview with a histology supervisor, the laboratory director did not approve, sign and date the procedures used for patient testing. Findings include: 1. Review of laboratory procedures showed no evidence the laboratory director had approved the procedures. 2. Interview with a histology supervisor (staff A) on August 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 -- 10, 2022, at 9:55 AM confirmed the laboratory had no documentation to show the laboratory director approved, signed, and dated the procedures used for patient testing. -- 2 of 2 --