Summary:
Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on policy and procedure review and an interview with Laboratory Staff (LS), the laboratory failed to follow written policies and procedures for mycology proficiency testing. Findings Include: 1. Review of the laboratory's policies and procedures, provided on the date of the inspection, found a "Mycology" policy and procedure which contained the following statement: "This lab has joined a proficiency testing program with The American Proficiency Testing Institute. Membership receipt attached." 2. The Surveyor requested the laboratory's membership receipt from The American Proficiency Testing Institute from LS #2 . The LS #2 confirmed the laboratory was not a member of The American Proficiency Testing Institute, did not have a membership receipt, and was unable to provide the requested document on the date of the inspection. The interviews occurred on 12/19/2018 at 1:41 PM. D5485 CONTROL PROCEDURES CFR(s): 493.1256(h) If control materials are not available, the laboratory must have an alternative mechanism to detect immediate errors and monitor test system performance over time. The performance of alternative control procedures must be documented. 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 policy and procedure review, record review and an interview with Laboratory Staff (LS), the laboratory failed to have an alternative mechanism to detect immediate errors and monitor potassium hydroxide (KOH) performance over time when control material was not available. Findings Include: 1. Review of the laboratory's policies and procedures, did not find any instructions for KOH Quality Control testing procedures. 2. Review of the laboratory's "KOH LOG" did not contain a section for quality control. 2. An interview with LS #2 confirmed the laboratory did not have QC procedures for KOH testing. The interview occurred on 12/19/2018 at 1: 41 PM. D5779