Summary:
Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Through a review of the laboratory policy and procedure manual and interviews with laboratory staff, it was determined the laboratory's policies could not be followed by laboratory personnel. Survey findings include: A. A review of the laboratory policy and procedure manual revealed six procedures in the manual are titled "Laboratory Procedure". Each procedure has differences from the others. The procedure titled, "Mohs Procedure" is in the manual four times and includes differences in three of the four procedures. B. In an interview, at 9:50 a.m. on 6/15/2022, laboratory employee #2 (as listed on the form CMS-209) confirmed multiple written procedures for the same laboratory activity were included in the policy and procedure manual and further confirmed the differences in the procedures made it impossible for laboratory employees to follow the procedures as written. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. 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 -- This STANDARD is not met as evidenced by: Through a review of the "Quality Control Staining" log and the "Mohs Log" it was determined the laboratory failed to document stain quality control on two of sixteen days that patient slides were stained and examined in the laboratory. Survey findings include: A. Through a review of the "Mohs Log" it was determined that patient slides were stained and examined on 2/8/22, 2/9/22, 2/10/22, 2/14/22, 2/28/22, 3/7/22, 3/14 /22, 3/21/22, 4/11/22, 4/18/22, 4/25/22, 5/2/22, 5/9/22, 5/23/22, and 6/6/22. B. A review of the "Quality Control Staining" log revealed the laboratory did not document quality control on 2/8/22 or on 5/2/22. On 2/8/22 seven patient cases were documented and on 5/2/22 five patient cases were documented. C. In an interview, at 10:44 on 6/15/2022, laboratory employee #2 (as listed on the form CMS-209) confirmed the laboratory failed to perform stain quality control on two of sixteen days of testing. -- 2 of 2 --