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: Based on records review and an interview with the Mohs tech (not on CMS-209 form), the laboratory failed in 2023 to perform twice annual verification testing for Potassium Hydroxide (KOH) preparations. The laboratory performs approximately 75 KOH preparations per year. Findings include: 1. Records review revealed that the laboratory failed to perform twice annual accuracy verification for KOH preparations since testing began in July of 2023. 2. An interview with the Mohs tech (not on CMS- 209 form), on February 14, 2024, at approximately 12:00 PM, confirmed that the laboratory failed to perform twice annual accuracy verification for KOH preparations since testing began in July of 2023. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures manual, and an interview with the Mohs tech (not on CMS Form 209), the laboratory director (LD) failed to ensure that the laboratory's policies and procedures manual for quality assurance, and histopathology had been approved, signed, and dated by the current LD before use since the laboratory began testing in July of 2023. The laboratory conducts 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 -- approximately 325 histopathology tests annually. Findings include: 1. A review of the laboratory's policies and procedures manual for quality assurance, and histopathology revealed that the current LD had not approved, signed, or dated the laboratory's policies and procedures prior to their use in the laboratory. 2. Based on an interview with the Mohs tech (not on CMS Form 209), on February 14, 2024, at approximately 11:30 AM, confirmed that the current LD had not reviewed, signed, and dated the laboratory's policies and procedures manual for quality assurance, and histopathology prior to their use in the laboratory. -- 2 of 2 --