Summary:
Summary Statement of Deficiencies 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 document review and staff interview, the laboratory failed to date revised procedures for one of one procedure manual covering three of three tests performed [Potassium hydroxide (KOH) preparations, Scabies preparation, and histology testing]. Findings include: 1. Review of procedure manual "IV Procedures for Tests Performed, C. Histology Specimens", signed by E3 (laboratory director) but no date of signature, indicated a change in procedure by adding employee E5 (medical doctor), hire date 10-03-18. The only date on the procedure was "Procedure began 07- 01-1982". 2. Review of procedure manual "KOH preparation" and "Skin Scraping for Scabies Preparation", signed by E3 (laboratory director) but no date of signature, indicated a change in procedures by adding employee E5 (medical doctor), hire date 10-03-18. The last update on the procedures was 12-06-1993. 3. On 10-16-19 at 2:05 PM E1 (medical assistant), confirmed the procedures were updated after E5 was hired, but no revision dates were added to the procedures. 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 --