Summary:
Summary Statement of Deficiencies D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document the open dates for reagents used in their Hematoxylin & Eosin (H & E) stains. Findings include: Record review of the laboratory's logs titled "Reagent Log" and "Hematoxylin and Eosin Staining Maintenance Log" showed that the laboratory failed to record when the reagents where opened from 6/15/16 to 6/15/18. During an interview on 6/15/18 at 9:35 AM, Testing Personnel B stated they didn't record the open date for their reagents. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory's quality assessment (QA) plan failed to monitor, access and correct problems identified to ensure the accuracy of patient reports. Findings include: Review of the laboratory's monthly QA checklist documentation showed that the laboratory did not do any random monthly review of the Patient Log, Mohs Map and Mohs Operative Report to ensure accuracy from 6/15 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 -- /16 through 6/15/18. During an interview on 6/15/18 at 9:36 AM, Testing Personnel B stated they did not do monthly random checks of the Patient Log, Mohs Map and Mohs Operative Report to ensure accuracy from 6/15/16 through 6/15/18. -- 2 of 2 --