Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: The surveyor's review of 2 of 2 laboratory procedure manuals and an interview with the laboratory director revealed the laboratory failed to twice annually verify the accuracy of the potassium hydroxide (KOH) microscopic examinations it performed. The findings include: 1. The laboratory Mohs Lab Policy and Procedure Manual (CLIA Manual) and KOH Procedure Manual did not describe a procedure to verify the accuracy of the KOH microscopic examinations performed by 2 of 2 laboratory testing personnel. 2. The laboratory performed 325 KOH microscopic examinations between July 2025 and June 2026. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: The surveyor's review of 2 of 2 laboratory procedure manuals and an interview with the laboratory director revealed the laboratory director failed to establish a quality assessment program for the potassium hydroxide (KOH) microscopic examinations it performed. The findings include: 1. The laboratory Mohs Lab Policy and Procedure Manual (CLIA Manual) and KOH Procedure Manual did not describe a procedure to 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 -- twice annually verify the accuracy of the KOH microscopic examinations performed by 2 of 2 laboratory testing personnel. See D tag D5217. -- 2 of 2 --