Summary:
Summary Statement of Deficiencies D5517 MYCOLOGY CFR(s): 493.1263(a)(c) The laboratory must check each batch (prepared in-house), lot number (commercially prepared), and shipment of lactophenol cotton blue when prepared or opened for intended reactivity with a control organism(s). (c) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and staff interview on 10/20/2020, the laboratory failed to perform a positive quality control organism on new lot numbers of Dermatophyte Testing Media (DTM) received 02/03/2020 and 09/29/2020. The findings include: Findings include: Review of the Policy and Procedure Manual revealed the Media and Stain Quality Control Record included "Must Do QC Positive Growth Test Per Lot #". 1. Record review revealed DTM lot number 453461 was received 02/03/2020. However, there was no documentation of quality control performed to confirm positive growth. 2. Record review revealed DTM lot number 467199 was received 09 /29/2020. However, there was no documentation of quality control performed to confirm positive growth. Interview with testing personnel at 10:45 AM on 10/20 /2020, revealed the laboratory failed to have a system in place to ensure policy was followed and a positive control was performed on new lot numbers of Dermatophyte Testing Media. 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 --