Summary:
Summary Statement of Deficiencies D0000 An entrance conference was held 08/09/2018 with the Laboratory Director. The survey process was discussed. An opportunity for questions and comments was given. Based upon the onsite survey conducted 08/09/2018, this facility was found to be in substantial compliance for the specialties/subspecialties in which it was surveyed. An exit conference was held 08/09/2018 with the Laboratory Director. The standard level deficiencies cited were discussed. The process for submitting the corrections was explained. An opportunity for questions and comments was provided. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual, laboratory records, and staff interview, it was revealed that the laboratory's Quality Assurance (QA) plan failed to identify discrepancies in the evaluation of the Potassium hydroxide (KOH) twice annual verification assessments. Findings included: 1. The laboratory's procedure titled "KOH Procedure: Potassium Hydroxide (KOH) Examination of Skin, Hair, or Nails" stated "Any discrepancies will be noted and remediation will be offered, if necessary. These results will be monitored in the monthly QA checklist performed by the Laboratory director." 2. Review of the laboratory record titled "Proficiency Testing: KOH Review Form" stated the following questions: Do you concur with the results: Yes/No Any