Summary:
Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Dermcare Physicians and Surgeons laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . 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 procedure and record review and interview, the laboratory failed to verify at least twice annually procedures it performs that are not included in subpart I of this part as evidenced by the following: A review of the laboratory's policies and procedures revealed that their was no twice annual accuracy verification procedure for the following tests that were implemented after the last CLIA recertification survey: 1. Potassium Hydroxide (KOH); 2. Wet prep; and, 3. Tzanck smear. The histotechnician interviewed on 1/2/18 at 9:15 AM confirmed that twice annual accuracy verification procedures had not been set up for the above examinations. . 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 procedure manual review and interview, the laboratory director failed to approve, sign, and date all laboratory procedures as evidenced by the following: A 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 -- review of the laboratory procedure manual revealed that the laboratory director had not documented a review and approval of the following newly implemented procedures: 1. Potassium Hydroxide (KOH); 2. Wet prep; and, 3. Tzanck smear. The histotechnician confirmed in an interview on 1/2/18 at 9:08 AM that the laboratory director had not documented a review and approval of the procedures. -- 2 of 2 --