Summary:
Summary Statement of Deficiencies D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the 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: Based on record review and an interview, the Laboratory Director failed to ensure that the quality assessment programs were established and maintained to assure the quality of the laboratory services performed and to identify failures in quality as they occur in the subspecialties of mycology and parasitology. All patients tested at this laboratory have the potential to be affected. Findings Include: 1. Review of the laboratory's quality assessment policy and procedure, on 12/20/18 at 2:26 pm, failed to find quality assessment policies and procedures for the potassium hydroxide (KOH) skin prep for fungus and scabies. 2. Review of the laboratory's quality assessment documentation, on 12/20/18 at 2:43 pm, failed to find documentation for the quality assessment of the KOH skin prep for fungus and scabies. 3. An interview with the Laboratory Director, on 12/20/18 at 3:39 pm, confirmed that the laboratory's quality assessment program failed to include the KOH skin prep for fungus and scabies. 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 --