United States

Molecular Pathology Laboratory Network

250 East Broadway Avenue, 37804, Maryville, TN, United States

A2LA 3765.01ISO 15189Register refreshed 2026-11-06

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Scope lines: 13
A2LA certificate: 1
Site in our directory: 1

A2LA accredited scope

What this lab is accredited for

We could not match the method references in this lab’s scope to published test standard numbers. The full scope as published is below.

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A2LA certificate 3765.01 · 13 lines

Line	Method	Matrix	Range
1	-	Bone Marrow (BM) Core Biopsy; Bone Marrow (BM) Aspirate; Peripheral Blood (PB); Formalin Fixed Paraffin Embedded (FFPE); Fresh Tissue; Pathology Material; Fine Needle Aspirations (FNA); Amniotic Fluid; Cerebrospinal Fluid (CSF); Cervical Swabs; Urethral Swabs; Urine (U); Other Bodily Fluids (BF); BM Blot Show page text Extracted from the scope document; tables may not line up. View scope for the original. (A2LA Cert. No. 3765.01) 06/23/2025 Page 1 of 12 SCOPE OF ACCREDITATION TO ISO 15189:2022 MOLECULAR PATHOLOGY LABORATORY NETWORK, INC. 250 East Broadway Avenue Maryville, TN 37804 Dr. Mark Stonecypher Phone: 865 380 9746 CLINICAL Valid To: May 31, 2027 Certificate Number: 3765.01 In recognition of the successful completion of the A2LA evaluation process, accreditation is granted to this laboratory to perform the following types of testing on human samples, including Bone Marrow (BM) Core Biopsy, Bone Marrow (BM) Aspirate, Peripheral Blood (PB), Formalin Fixed Paraffin Embedded (F FPE) and Fresh Tissue, Pathology Material, Fine Needle Aspirations (FNA), Amniotic Fluid, Cerebrospinal Fluid (CSF) , Cervical Swabs, Urethral Swabs, Urine (U), and Other Bodily Fluids (BF): Specialty Sub Specialty Test/Analyte Method(s) Matrix(ces) Pathology Histopathology Bone Marrow Pathology Evaluation Microscopic Evaluation of Bone Marrow Biopsy / Clot Prep (H&E) and Peripheral / Aspirate Smears; Additional Stains as Required (Special Stains, Immunohistochemistr y) BM Core Biopsy, BM Aspirate, BM Blot, PB Image Analysis Aperio System FFPE Immunohistochemistry Antibodies / Markers Automated Immunohistochemistry Stainin g FFPE Special Stains Manual Histochemistry Staining FFPE Surgical Pathology Consultation Microscopic Evaluation of Previously Prepared Surgical Specimens (H&E Slides and Other Material); Additional Stains or Studies as Required (Special Stains, Immunohistochemistry, Gene Rearran gement, etc.) Pathology Material Histopathology – Immunostains 34BE12 (CK HMW) Immunohistochemistry Staining FFPE Alk-1 (CD246) Immunohistochemistry Staining FFPE	-
2	-	Anaplastic Large Cell L; ymphoma; FISH FNA, FFPE; FFPE Show page text Extracted from the scope document; tables may not line up. View scope for the original. (A2LA Cert. No. 3765.01) 06/23/2025 Page 2 of 12 Specialty Sub Specialty Test/Analyte Method(s) Matrix(ces) Pathology Histopathology – Immunostains (cont.) ALK 2p23 Rearrangement Anaplastic Large Cell L ymphoma FISH FNA, FFPE Androgen Recepto r Immunohistochemistry Staining FFPE Annexin A1 Immunohistochemistry staining FFPE Arginasse-1 Immunohistochemistry Staining FFPE Bcl-2 Immunohistochemistry Staining FFPE Bcl-6 Immunohistochemistry Staining FFPE BerEP4 Immunohistochemistry Staining FFPE BOB1 Immunohistochemistry Staining FFPE BRAF Immunohistochemistry Staining FFPE CA 19.9 Immunohistochemistry Staining FFPE Caldesmon Immunohistochemistry Staining FFPE Calretinin Immunohistochemistry Staining FFPE Cam 5.2 (CK7/CK8) Immunohistochemistry Staining FFPE CD10 Immunohistochemistry Staining FFPE CD103 Immunohistochemistry Staining FFPE CD117 Immunohistochemistry Staining FFPE CD138 Immunohistochemistry Staining FFPE CD15 Immunohistochemistry Staining FFPE CD163 Immunohistochemistry Staining FFPE CD19 Immunohistochemistry Staining FFPE CD1a Immunohistochemistry Staining FFPE CD2 Immunohistochemistry Staining FFPE	-
3	-	FFPE Show page text Extracted from the scope document; tables may not line up. View scope for the original. (A2LA Cert. No. 3765.01) 06/23/2025 Page 3 of 12 Specialty Sub Specialty Test/Analyte Method(s) Matrix(ces) Pathology Histopathology – Immunostains (cont.) CD20 Immunohistochemistry Staining FFPE CD21 Immunohistochemistry Staining FFPE CD22 Immunohistochemistry Staining FFPE CD23 Immunohistochemistry Staining FFPE CD25 Immunohistochemistry Staining FFPE CD3 Immunohistochemistry Staining FFPE CD30 Immunohistochemistry Staining FFPE CD31 Immunohistochemistry Staining FFPE CD33 Immunohistochemistry Staining FFPE CD34 Immunohistochemistry Staining FFPE CD36 Immunohistochemistry Staining FFPE CD38 Immunohistochemistry Staining FFPE CD4 Immunohistochemistry Staining FFPE CD42b Immunohistochemistry Staining FFPE CD43 Immunohistochemistry Staining FFPE CD45 Immunohistochemistry Staining FFPE CD45RO Immunohistochemistry Staining FFPE CD5 Immunohistochemistry Staining FFPE CD56 Immunohistochemistry Staining FFPE CD57 Immunohistochemistry Staining FFPE CD61 Immunohistochemistry Staining FFPE CD68 Immunohistochemistry Staining FFPE CD7 Immunohistochemistry Staining FFPE CD79a Immunohistochemistry Staining FFPE	-
4	-	FFPE Show page text Extracted from the scope document; tables may not line up. View scope for the original. (A2LA Cert. No. 3765.01) 06/23/2025 Page 4 of 12 Specialty Sub Specialty Test/Analyte Method(s) Matrix(ces) Pathology Histopathology – Immunostains (cont.) CD8 Immunohistochemistry Staining FFPE CD99 Immunohistochemistry Staining FFPE CDK4 Immunohistochemistry Staining FFPE CDX 2 Immunohistochemistry Staining FFPE CEA Immunohistochemistry Staining FFPE Chromogranin Immunohistochemistry Staining FFPE CK 5/6 Immunohistochemistry Staining FFPE CK 8/18 Immunohistochemistry Staining FFPE CK20 Immunohistochemistry Staining FFPE CK7 Immunohistochemistry Staining FFPE CMV Immunohistochemistry Staining FFPE c-MYC Immunohistochemistry Staining FFPE Cyclin D1 Immunohistochemistry Staining FFPE Cytokeratin AE1/AE3 Immunohistochemistry Staining FFPE D2-40 Podoplanin Immunohistochemistry Staining FFPE Desmin Immunohistochemistry Staining FFPE DOG1 Immunohistochemistry Staining FFPE E-cadherin Immunohistochemistry Staining FFPE EGFR Immunohistochemistry Staining FFPE EMA Immunohistochemistry Staining FFPE Epstein Barr Virus Early RNA Automated Chromogenic In-situ Hybridization Staining FFPE	-
5	-	FFPE Show page text Extracted from the scope document; tables may not line up. View scope for the original. (A2LA Cert. No. 3765.01) 06/23/2025 Page 5 of 12 Specialty Sub Specialty Test/Analyte Method(s) Matrix(ces) Pathology Histopathology – Immunostains (cont.) ER Immunohistochemistry Staining FFPE ERA Immunohistochemistry Staining FFPE Factor XIIIa Immunohistochemistry Staining FFPE FOX P3 Immunohistochemistry Staining FFPE GCDFP-15 (BRST2) Immunohistochemistry Staining FFPE Glycophorin A Immunohistochemistry Staining FFPE Granzyme B Immunohistochemistry Staining FFPE Helicobacter pylori Immunohistochemistry Staining FFPE Hep-Pa r-1 (HSA) Immunohistochemistry Staining FFPE HER2 (Ventana) Immunohistochemistry Staining FFPE HMB45 Immunohistochemistry Staining FFPE HMB-45 Red Immunohistochemistry Staining FFPE HSV 1 & 2 Immunohistochemistry Staining FFPE Human Herpesvirus Type 8 Immunohistochemistry Staining FFPE Kappa ISH Immunohistochemistry Staining FFPE Ki-67 Immunohistochemistry Staining FFPE Lambda ISH Immunohistochemistry Staining FFPE Mammaglobin Immunohistochemistry Staining FFPE MDM2 Immunohistochemistry Staining FFPE Melan A (Mart1) Immunohistochemistry Staining FFPE Melan A Red Immunohistochemistry Staining FFPE MLH-1 Immunohistochemistry Staining FFPE MSH2 Immunohistochemistry Staining FFPE MSH6 Immunohistochemistry Staining FFPE	-
6	-	FFPE Show page text Extracted from the scope document; tables may not line up. View scope for the original. (A2LA Cert. No. 3765.01) 06/23/2025 Page 6 of 12 Specialty Sub Specialty Test/Analyte Method(s) Matrix(ces) Pathology Histopathology – Immunostains (cont.) MUC-1 Immunohistochemistry Staining FFPE Multiple Myeloma Oncogene 1 Immunohistochemistry Staining FFPE Myeloperoxidase Immunohistochemistry Staining FFPE Napasin A Immunohistochemistry Staining FFPE NSE Immunohistochemistry Staining FFPE OCT2 Immunohistochemistry Staining FFPE p16 Immunohistochemistry Staining FFPE P504S Immunohistochemistry Staining FFPE p-53 Immunohistochemistry Staining FFPE P57 Kip2 Immunohistochemistry Staining FFPE p-63 (Nuclear Stain) Immunohistochemistry Staining FFPE PAN-TR K Immunohistochemistry Staining FFPE Pax-5 Immunohistochemistry Staining FFPE Pax-8 Immunohistochemistry Staining FFPE PD-1 Immunohistochemistry Staining FFPE PD-L1 Immunohistochemistry Staining FFPE PLAP Immunohistochemistry Staining FFPE PMS2 Immunohistochemistry Staining FFPE PR Immunohistochemistry Staining FFPE PRAME Immunohistochemistry Staining FFPE PRAME Red Immunohistochemistry Staining FFPE PSA Immunohistochemistry Staining FFPE PSAP Immunohistochemistry Staining FFPE RCC Immunohistochemistry Staining FFPE	-
7	-	FFPE; PB, BM Aspirate; FNA, FFPE; PB, BM Aspirate, FNA, Fresh Tissue Show page text Extracted from the scope document; tables may not line up. View scope for the original. (A2LA Cert. No. 3765.01) 06/23/2025 Page 7 of 12 Specialty Sub Specialty Test/Analyte Method(s) Matrix(ces) Pathology Histo pathology – Immunostains (cont.) S-100 Immunohistochemistry Staining FFPE S-100 Red Immunohistochemistry Staining FFPE SMA Immunohistochemistry Staining FFPE Smooth Muscle Myosin Immunohistochemistry Staining FFPE SOX-10 Immunohistochemistry Staining FFPE SOX-11 Immunohistochemistry Staining FFPE Synaptophysin Immunohistochemistry Staining FFPE Tag-72 Immunohistochemistry Staining FFPE TdT Immunohistochemistry Staining FFPE TTF-1 Immunohistochemistry Staining FFPE Tyrosinase Immunohistochemistry Staining FFPE vonWillebrand (F-8) Immunohistochemistry Staining FFPE Vimentin Immunohistochemistry Staining FFPE Wilms Tumo r Immunohistochemistry Staining FFPE Molecular Pathology Acute Myeloid Leukemia Frontline Panel: -5/5q-, - 7/7q-, t(8;21), CBFB, MLL (KMT2A) FISH PB, BM Aspirate Acute Myeloid Leukemia Secondary Panel: MECOM, NUP98, DEK::NUP214 / t(6;9), BCR::ABL1 / t(9;22), TP53 FISH PB, BM Aspirate ALK 2p23 Rearrangement Anaplastic Large Cell Lymphoma FISH FNA, FFPE AML1::ETO / t (8;21) FISH PB, BM Aspirate, FNA, Fresh Tissue ATM/CEP11 Deletion 11q22.3 FISH PB, BM Aspirate, FNA, Fresh Tissue	-
8	FISH; qRT-PCR	PB; BM Aspirate; FNA; Fresh Tissue; FFPE; U; Bladder Washings	-
9	FISH; PCR	PB; BM Aspirate; FNA; Fresh Tissue; FFPE	-
10	-	PB; BM Aspirate; FNA; Fresh Tissue; FFPE; Frozen Tissue Show page text Extracted from the scope document; tables may not line up. View scope for the original. (A2LA Cert. No. 3765.01) 06/23/2025 Page 10 of 12 Specialty Sub Specialty Test/Analyte Method(s) Matrix(ces) Pathology Molecular Pathology (cont.) MYD88 PCR PB, BM Aspirate Myelodysplasia Panel [-5/5q-, -7/7q-, +8,20q-] FISH PB, BM Aspirate, FNA, Fresh Tissue Myeloproliferative Neoplasms Panel [+8, BCR::ABL1, 13q-, 20q-] FISH PB, BM Aspirate, FNA, Fresh Tissue NUP98 Gene Rearrangement FISH PB, BM Aspirate, FNA, Fresh Tissue PDGFRB Gene Rearrangement FISH PB, BM Aspirate, FNA, Fresh Tissue Plasma Cell Neoplasms Panel [1p-, 1q+, +5, +9, t(11;14), +15, 13q-, +15, 17p-] Reflex t(4;14) / t (14;16) FISH PB, BM Aspirate, FNA, Fresh Tissue PML::RARA / t(15,17) FISH PB, BM Aspirate, FNA, Fresh Tissue ROS1 FISH FFPE TEL::AML1, t(12;21) FISH PB, BM Aspirate, FNA, Fresh Tissue TP53 / 17p13 Deletion FISH PB, BM Aspirate, FNA, Fresh Tissue Trisomy 12 FISH PB, BM Aspirate, FNA, Fresh Tissue Trisomy 5, 9, 15 FISH PB, BM Aspirate, FNA, Fresh Tissue Trisomy 8 FISH PB, BM Aspirate, FNA, Fresh Tissue Genetics B-cell Immunoglobulin Heavy Chain Gene Rearran gement Next Generation Sequencing PB, BM Aspirate, FFPE, Frozen Tissue BRAF Mutation Analysis Next Generation Sequencing FFPE, PB, BM Aspirate Colon Cancer NGS Next Generation Sequencing FFPE IgVH Somatic Hypermutation Next Generation Se quencing PB, BM Aspirate KRAS Mutation Next Generation Sequencing FFPE Heme Malignancy Panel Next Generation Sequencing PB, BM Aspirate	-
11	Next Generation Sequencing; Hologic Aptima COMBO® 2 TMA; PCR; Hologic Aptima HPV 16, n 18/45 Genot; Hologic Aptima HPV; Hologic Aptima® Trichomonas vaginalis; Culture / G-banding; Flow Cytometry	FFPE; PB, BM, FNA, Fresh Tissue, Frozen Tissue; PB, BM Aspirate, FFPE; ThinPrep, SurePath, Cervical Swab, Urethral Swab, U; PB, Fresh Tissue, Frozen Tissue, Swab, CSF, Cervical Cells, ThinPrep, SurePath, Amniotic Fluid; ThinPrep, SurePath; ThinPrep, SurePath, Cervical Swab, Urethral Swab, U; ThinPrep, Swab, U; BM Aspirate; PB; Fresh Tissue, Tumor; PB; Bronchoalveolar Lavage	-
12	-	PB, PB Smear; PB, BM Aspirate, BM Core Biopsy, Fresh Tissue, BF, FNA, CSF; PB, BM Aspirate Show page text Extracted from the scope document; tables may not line up. View scope for the original. (A2LA Cert. No. 3765.01) 06/23/2025 Page 12 of 12 Specialty Sub Specialty Test/Analyte Method(s) Matrix(ces) Hematology Hematology (cont.) Flow Cytometry and Morphology Flow Cytometry & PB Slide Review PB, PB Smear Flow Cytometry Leukemia / Myeloma / Lymphoma Flow Cytometry PB, BM Aspirate, BM Core Biopsy, Fresh Tissue, BF, FNA, CSF Paroxysmal Nocturnal Hemoglobinuria - High Sensitivity (FLAER, CD14, CD24, CD59 ) Flow Cytometry PB, BM Aspirate	-
13	Extracted from the scope document; tables may not line up. View scope for the original. For the tests to which this accreditation applies, please refer to the laboratory’s Clinical Scope of Accreditation. Accredited Laboratory A2LA has accredited MOLECULAR PATHOLOGY LABORATORY NETWORK, INC. Maryville, TN for technical competence in the field of Clinical Testing This laboratory is accredited in accordance with the recognized International Standard ISO 15189:2022 Medical laboratories – Requirements for quality and competence. This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (refer to joint IAF-ILAC-ISO Communiqué dated November 2021). Presented this 23rd day of June 2025. _______________________ Mr. Trace McInturff, Vice President, Accreditation Services For the Accreditation Council Certificate Number 3765.01 Valid to May 3 1, 2027

Ranges are reproduced from the accredited scope document as published, and only where we found that range printed in the document for the line. Otherwise the cell reads “See scope document”. An absent range means the register did not state one. Line numbers are ours, for cross-reference; they follow the order of the scope document.

Location

250 East Broadway Avenue, Maryville, TN, 37804, US

35.75647, -83.97046

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Accreditation data refreshed from the A2LA register on 2026-11-06.

This page mirrors a public register. For a purchasing, audit or regulatory decision, confirm against the A2LA entry linked above.