Summary:
Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on lack of proficiency records to date May 10, 2023, and interview with the laboratory assistant, the laboratory failed to establish a means to verify the accuracy of the non-regulated analyte for KOH testing twice a year. Findings: 1. Lack of proficiency records for 2021, 2022 and to date April 11, 2023, showed the laboratory failed to prove accuracy on the non-regulated analyte KOH exam. 3. Interview with the laboratory assistant on May 10, 2023 at 2:00 PM confirmed the laboratory failed to establish a means to verify the accuracy of the non-regulated analyte KOH testing twice per year. 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 --