Reliance Pathology Partners Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Reliance Pathology Partners LLC on 03/30/22. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and phone interview with the Human Resource Manager, the laboratory failed to have the correct name of the laboratory where the professional component (slide interpretation) for histopathology testing was performed on 8 out of 8 (#1 #2, #3, #4, #5, #6, #7, #8) patient histopathology reports reviewed. Findings Included: Review of final histopathology reports dated 5/7/2020 for Patient #1, 5/22 /2020 for Patient #2, 06/14/2020 for Patient #3, 08/04/2020 for Patient #4, 04/08/2021 for Patient #5, 04/20/2021 for Patient #6, 05/19/2021 for Patient #7, and 10/04/2021 for Patient #8 revealed the wrong laboratory name where the professional component (slide interpretation) was performed. On 03/30/21 at 12:40 PM, the Human Resource Manager stated that she had not caught the mistake at this office. 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 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Reliance Pathology Partners LLC on 11/05/2019. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (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 Read - Only laboratory failed to document the negative reactivity for Histopathology for each Immunohistochemical (IHC) stain for 2 out of 2 years (2018-2019). Findings included: Review of patient reports showed that there was no documentation for the reactivity of the negative control. IHC stains at the laboratory include: B-cell lymphoma (BCL) 1, BCL -2, BCL -6, BerEP4 (known as epithelial cell adhesion molecule), Cluster of differentiation (CD) 3, CD5, CD10, CD20, CD34, CD43, CD45, CD68, CDX2, Carcinoembryonic Antigen(CEA), Cytokeratin (CK)5/6, CK7, CK20, D2-40 (new marker for lymphatic endothelium, Desmin, Epithelial Membrane Antigen (EMA), Endoplasmic Reticulum (ER), Human Herpes Virus (HHV8), Helicobacter pylori (h. pylori), Herpes Simplex Virus (HSVI /II), Ki-67 (protein encoded by the MKI67 gene), Melanoma Antigen Recognized by T-cells (MART-1), p16 (marker for human papillomavirus), p53 (marker for ovarian cancer), Pankeratin, Prostate Specific Antigen (PSA), s11 (cancer marker), Synaptophysin, and Thyroid Transcription Factor (TTF-1). The laboratory 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 -- 92 IHC stains from 1/22/2018 to 10/03/2019. On 11/05/19 at 10:45 AM, the Laboratory Manager and Laboratory Director stated they did not know that the laboratory needed to document the reactivity of a negative control. -- 2 of 2 --