Summary:
Summary Statement of Deficiencies D0000 A Provider Performed Microscopy (PPM) Clinical Laboratory Improvement Amendments (CLIA) survey was completed on March 4, 2020. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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: Based on review of the Provider-Performed Microscopy (PPM) Surveyor Tool with the Laboratory Director (LD), the laboratory was not performing Proficiency Testing (PT) or Peer Review, to verify accuracy of the Potassium Hydroxide (KOH) test twice a year. Findings: 1. During a discussion with the LD, covering the PPM Surveyor Tool, the LD stated that the laboratory was not performing PT, or Peer Review twice a year to verify accuracy of the Potassium Hydroxide (KOH) test. 2. Interview with the LD on March 4, 2020 at approximately 2 pm, in the LD's office, the LD confirmed that PT or Peer Review was not being performed. 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 --