Summary:
Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to follow their policy to perform and document daily quality control (QC) on the first case of the day for 7 of 10 patients (PT#2, PT#3, PT#4, PT#6, PT#7, PT#8 and PT#9) reviewed who had Mohs Micrographic Surgery (Mohs) performed in 2021 and 2022. Findings include: 1. The laboratory's Policy "Histopathology Procedures for MOHs Surgery", was signed by the laboratory director on 01/08/22. On page 31 of the policy/procedure manual it states, " All quality control is performed by the surgeon at the time of the slide reading for the first case of the day...Any problems will be noted on the quality control sheet and brought to the attention of the surgeon and/or laboratory director." 2. On 06/14/22 at 10:05a, SP-2 (Mohs Lab Supervisor) acknowledged the laboratory never documented daily Quality Control (QC), and that QC was only performed once every 100 slides. 3. Review of patient medical records indicated the following patients had Mohs without daily QC documentation: PT#2 on 03/19/2021 PT#3 on 06/04/2021 PT#4 on 08/27/2021 PT#6 on 12/10/2021 PT#7 on 01/21/2022 PT#8 on 03/04/2022 PT#9 on 05/27/2022 4. Annual Test Volume for subspecialty of Hispathology for MOHs is approximately 500. 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 --