Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Z UROLOGY on July 23, 2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: D5475 CONTROL PROCEDURES CFR(s): 493.1256(e)(3)(g) (e)(3) Check fluorescent and immunohistochemical stains for positive and negative reactivity each time of use. This STANDARD is not met as evidenced by: Based on record review and consultant interview, the laboratory failed to document the positive and/or negative control reactivity for the following immunohistochemical (IHC) stains: Cluster of Differentiation 44 cell surface glycoprotein IHC stain (CD44), ,Nuclear Non-histone Protein IHC stain (KI67), Tumor Suppressor protein IHC stain (P63), Prostate Adenocarcinoma IHC stain (P504S) for four out of six cases reviewed. Findings included: 1-Review of Form CMS-116 (03/240, revealed that the laboratory performed the interpretation of the IHC stains CD44, KI67, P63, P504S. 2- Review of "DAILY QUALITY CONTROL FOR IMMUNOS & SPECIAL STAINS" log for cases read on the following dates: P#1 (12/16/2024), P#2 (01/08/2025), P#3 (02 /13 /2025), P#4 (03/25/2025), P#5 (04/10/2025) and P#6 (05/13/2025), revealed that for cases: P#1, P#2, P#3 (no documentation of the acceptance of the positive and negative controls; P#3 was not documented the reactivity of negative control. Review of patients reports, revealed no documentation of the reactivity of the positive and negative controls. 3- During an interview on 07/23/2015 at 10:30 AM the consultant confirmed that the laboratory failed to document the reactivity of the positive and /or negative controls for the IHC stains reviewed above. 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 --