AMP Core Labs

Director: Erika Crouch, MD, PhD
Lab Manager: Tom Fitzgerald

Phone: 314-747-2086
Email: ampcorelab@path.wustl.edu

Location: West Building 4718-4721


Overview

cap_cert_large_web_colorThe Anatomic and Molecular Pathology (AMP) Core Labs is a CAP/CLIA certified and HIPAA compliant resource that provides services in anatomic pathology. These include: routine histology (e.g., tissue processing and embedding, sectioning, histochemical staining), automated immunohistochemistry, as well as coring of paraffin blocks prior to molecular testing.

The Histology Lab performs paraffin embedding of fixed tissues or cell blocks, sectioning of paraffin or frozen blocks, and a wide variety of histochemical staining procedures.

The Immunohistochemistry Lab performs immunostaining of fixed and embedded human tissues, including tissue microarrays, usually by immunoperoxidase techniques. The lab has automated testing protocols for a large number of well-characterized commercial antibodies.

The Molecular Pathology lab provides resources for molecular and genetic analysis of fresh or fixed and embedded tissues. At present, these services are limited to departmental faculty and trainees.


Access

Service available to: Washington University only.

Priority service given to: Clinical testing within the Department of Pathology & Immunology.  However, selected intra- and extra-departmental basic and translational research projects are supported by prior agreement.

The Lab emphasizes histological procedures and immunohistochemical assays. Although the facilities described on the website also include a Molecular Pathology Lab and a Digital Imaging Lab, these resources are currently limited to training in the Department. At the time of accessioning, research orders are placed in one of several queues designed to optimize workflow through the lab.


Services and pricing

  • Tissue processing and paraffin embedding
  • Microtomy to generate tissue sections
  • H and E and special histochemical stains
  • Immunohistochemistry (Immunoperoxidase) on fixed and paraffin embedded human tissues

Billing policies

Optimization charges for IHC

  • Optimizations for non-Ventana reagents are usually open-ended projects with no predictable outcome or turnaround time. These require prior arrangements and are only performed under specific circumstances.
  • The first round of optimization with a user provided antibody and positive controls has a one-time set-up charge plus a run charge. Subsequent optimization runs for the same antibody are charged at the established run charge.
  • The implementation of a new double immunostaining assay for the automated platform using previously optimized antibodies usually requires additional optimization  because only a single retrieval condition can be used for both reagents. The usual one-time set-up and charges are billed, with subsequent runs charged as above. If two previously unoptimized antibodies are used, then the initial set-up charge is triple the usual rate.
  • For a new Ventana antibody that has been previously optimized in the BJ lab, minimal optimization should be needed if the BJ protocol is provided. Accordingly, there is no set-up charge, just the run charge.
  • In some situations, a User Antibody may have been characterized prior to the implementation of more standardized procedures and documentation in August 2009. In this situation, it is necessary to submit an optimization order because the information is not always reliable and reagent properties can change over time.

Routine run charges for IHC

  • Run charges are calculated on a per slide basis, as a base charge plus the cost of antibody (see price listing below). The base charge includes overhead for the equipment, bulk reagents, and technical time. Ventana reagents predictably increase by 3% per year. Costs for sectioning paraffin blocks are charged separately according to the histology price listing.
  • The investigator covers the costs of antibody for their experiments.  If the Core has an active protocol, the investigator is charged for the actual amount of antibody used on each slide.  This per slide pricing is provided by Ventana for their pre-diluted antibodies (see Ventana price listing).
  • For previously optimized antibodies in the Core inventory it is advisable to examine representative test samples for each new project prior to performing the actual assay.  Such slides will be charged like test slides.
  • If the Core does not have an active protocol the investigator must cover the full cost for the purchase of the antibody. Adjustments can be made if there are already plans to add the antibody to the test menu and it can be predicted that the antibody will be fully utilized prior to the expiration date. If stored by the Core, unused antibody will not be used for other projects without the investigator’s permission. However, no antibody will be held in the Core beyond its expiration date.
  • If an antibody is purchased by the investigator or if the lab buys it on behalf of the investigator (i.e., the purchase of antibody is billed to investigators account) there will be no additional per slide antibody charge. However, if the antibody is to be used on the Ventana, the investigator will be charged for any registered dispensers (prep kits) or non-standard ancillary reagents.
  • The pricing structure for positive and negative control slides is the same as described for test slides. The cost reflects the actual cost of control immunoglobulins. At least one suitable positive and/or negative control is required for every research run and there are a maximum of 30 slides per run.
  • There is no charge when immunostaining is repeated because of a lab error.  The Core will also absorb the costs for cutting of additional sections and for loss of primary antibody. The Lab assumes no responsibility for failed testing if non-approved charged slides are provided.

Clinical trials

  • Price estimates for grant applications will be calculated based on the best estimate of costs for the anticipated funding period. The cost for Ventana antibodies and reagents increase by 3% per year.
  • Pricing includes a minimum 20% lab overhead charge to cover costs associated with administering the workflow within the Lab. Depending on the complexity of a planned study initial set-up charges could apply.
  • A price estimate is only applicable to the indicated project; a new estimate is required for each project and to any change in the scope of work for an existing project.
  • The Lab can only support testing that utilizes established, approved clinical workflows, i.e., validated tests performed using the approved clinical protocols and platforms.
  • The Lab does not have resources to interpret tests and does not assume responsibility for any activities upstream or downstream of the Lab. The latter activities are usually handled by the clinical trial coordinator or administrator under supervision of the investigator.
  • The investigator is responsible for identifying study pathologists and insuring that all professional effort is funded via the grant or contract.
  • Pricing for clinical trials requires prior review by the Pathology and Immunology Business Office.  Depending on the project, additional institutional fees may apply.

Antibody availability and pricing

Antibody Clone Antibody Cost / Slide
ALK1 ALK01 $3.54
bcl-2 124 $5.10
bcl-6 GI191E/A8 $5.03
Beta-catenin 14 $3.43
C-kit YR145 $2.54
CA 125 OC125 $2.83
CA 19-9 121 SLE $2.83
Calcitonin polyclonal $2.83
Caldesmon E89 $4.46
Calretinin SP65 $3.40
CD10 SP67 $3.40
CD138 B-A38 $3.40
CD15 MMA $2.60
CD163 MRQ-26 $5.03
CD1a EP3622 $3.84
CD2 MRQ-11 $5.03
CD20 L26 $2.60
CD21 2G9 $3.40
CD23 SP23 $6.95
CD25 4C9 $5.03
CD3 2GV6 $2.60
CD30 Ber-H2 $3.59
CD31 JC70 $5.03
CD34 QBEnd/10 $2.83
CD4 SP35 $5.03
CD43 L60 $2.60
CD45 RP2/18 $2.60
CD5 SP19 $4.10
CD56 123C3.D5 $5.10
CD57 NK-1 $4.46
CD61 2f2 $3.59
CD68 KP-1 $2.83
CD7 SP94 $3.66
CD79a SP18 $3.55
CD8 SP57 $4.10
CD99 O13 $3.24
CDX – 2 EPR2764Y $5.03
CEA (mono) TF 3H8-1 $2.83
CEA (poly) polyclonal $4.75
Chromogranin LK2H10 $2.60
CK 5/6 D5/16B4 $3.66
CK-CAM 5.2 CAM 5.2 $3.40
CK-HMW 34BE12 $2.83
CK-pan AE1/AE3/PCK26 $2.83
CK19 A53-B/A2.26 $3.40
CK20 SP33 $2.83
CK7 SP52 $3.24
CK8/18 B22.1 & B22.3 $3.48
Collagen Type IV CIV22 $2.83
Cyclin D1 SP4-R $5.03
D2-40 (podoplanin) D2-40 $5.03
Desmin DE-R-11 $2.60
EMA E29 $3.24
ER SP1 $4.22
Factor XIIIa AC-1A1 $4.46
GCDFP-15 EP1582Y $4.46
GFAP EP672Y $5.19
Glycophorin A GA-R2 $5.03
Glypican-3 GC33 $5.23
Granzyme B polyclonal $5.03
HCG polyclonal $2.60
Hepar 1(Hepatocyte specific antobody) OCH1E5 $4.60
IgG4 MRQ-44 $3.32
Inhibin R1 $2.73
INI-1 (BAF47/SNF5) MRQ-27 $4.01
Ki-67 30-9 $6.95
Lysozyme polyclonal $2.60
Mammaglobin 31A5 $5.03
Melan A A103 $4.38
MLH1 M1 $5.23
MPX polyclonal $2.83
MS Actin HHF35 $2.83
MSH-2 G219-1129 $5.03
MSH-6 44 $5.25
MUM1 MRQ-43 $5.07
Myogenin F5D $2.73
Napsin A polyclonal $5.03
Neurofilament 2F11 $2.83
NSE E27 $2.83
OCT-4 MRQ-10 $5.03
P16 E6H4 $12.73
P53 Bp53-11 $4.46
p63 4A4 $6.95
PAX5 SP34 $5.03
PLAP NB10 $2.60
PMS2 EPR3947 $5.03
PR 1E2 $9.22
PSA ER-PR8 $2.83
PSAP PASE/4LJ $2.83
RCC PN-15 $3.40
S100 polyclonal $2.60
SMA 1A4 $2.73
Synaptophysin MRQ-40 $4.76
TdT polyclonal $12.68
Thyroglobulin 2H11+6E1 $2.60
TTF-1 8G7G3/1 $5.03
Vimentin V9 $2.60
WT1 6F-H2 $5.03

Routine histology pricing

Prices as of 1/1/13

Services Price*
Processing and embedding paraffin blocks $5.49 per block
Non-routine specimen handling or sectioning $3.00 per block
Paraffin Sections Unstained sections (First Section) $10.91 per slide
Paraffin Sections Unstained sections (additional per block) $3.00 per slide
Paraffin Sections Hematoxylin and eosin (H&E) $17.33 per slide
Special stains $22.69 per slide
Frozen Sections Unstained sections Inquire
Frozen Sections Hematoxylin and eosin (H&E) Inquire
Frozen Sections Special stains Inquire

*DRTC members are eligible for a discount.

Immunohistochemistry prices

Prices as of 1/1/13

Services Price Per Slide*
Immunoperoxidase – unstained sections of formalin-fixed paraffin embedded tissue using previously optimized assay and Core antibody $29.60 + actual cost of antibody used
Immunoperoxidase – unstained sections of formalin-fixed paraffin embedded tissue using previously optimized assay and antibody provided by user $29.60
Optimization user provided antibody or probe for automated or manual assay Inquire**
In Situ Hybridization using optimized automated assay and user provided probe Not currently offered

*  Each run also requires at least one positive tissue and one negative reagent control. The positive and negative control slides are charged at the same price per slide as above. Additional charges accrue if the protocol requires additional amplification (approximately $4.00/slide) or CC2 for antigen retrieval(approximately $2.00/slide).  For more extended studies, it should be noted that the costs of Ventana antibodies and ancillary reagents predictably increase by 3% per year and these additional costs should be considered when preparing the budget.

** Investigators must consult in advance with the Laboratory Manager. Charges include an initial set-up fee and a per run charge. For optimization and studies with antibodies not in Ventana dispensers an additional cost for the dispenser / prep kit will be added. The time required for antibody optimization is highly variable. Optimization might require only a few hours if the antibody has previously been reported to work on formalin fixed-paraffin embedded tissues and if positive control tissues have been identified.

Tissue Microarray Prices

TMA orders are only accepted after prior approval of the project and with a collaborating pathologist to assist in TMA design. Lab functions are limited to the fabrication of previously designed arrays and there is no guaranteed turnaround time. Please see the TMA FAQ.

The charge for tissue microarrays is per core, regardless of the number of paraffin blocks or cores per block. In addition, an initial technical setup charge and/or hourly pathologist charges will usually apply; an estimate can be provided. The rates for unstained slides and histochemical or immunohistochemical stains are the same as above.

Molecular pathology pricing

Service Price
BAC DNA (midiprep) Preparation and End Sequence Validation $100.00
BAC Retrival (from CTD library) $45.00
Bacterial Colony Screening by PCR (per amplicon) $10.00
Cell Block Preparation (15ml or less) $25.00
Cell Block Preparation (greater than 15ml) $45.00
Cell Line Culture (per week) $35.00
Cell Line  – Freezing $20.00
DNA or RNA Quantification $5.00
Punch of Block for Nucleic Acid Preparation $17.00
Nucleic Acid Preparation (DNA or RNA) from FFPE Section $60.00
Nucleic Acid Preparation (DNA or RNA) from Fresh Tissue $65.00
DNA Purification (gel extraction) $25.00
Preparation of DNA for Sequencing Analysis (per amplicon) $20.00
Dnase Treatment $20.00
Gel Electrophoresis (1-6 samples)  (7+ samples $5.00 ea) $20.00
Immunohistochemical Stain (excludes price of antibody) $85.00
Interphase CISH (per probe) per slide $150.00
Interphase FISH (per probe) per slide $175.00
Labeling of BAC DNA $100.00
Long Term Storage of Bacterial Strains $15.00
Miniprep of Bacterial DNA $35.00
MiRNA Preperation from FFPE Section $65.00
Onestep RT-PCR $25.00
PCR (per amplicon) $10.00
PCR Product Subcloning (first sample) ($25.00 ea addtional) $55.00
Quantitative PCR using SYBR Green Chemistry (per amplicon) $15.00
Quantitative PCR using Taqman Chemistry (per amplicon) $15.00
Restriction Enzyme Digestion $7.00
Reverse Transcription of RNA Sample $15.00
Cytology
 Automated or Manual Pap Stain  $10.00
 Cytospin  $20.00
 Automated or Manual Diff Quick Stain  $12.00
Thin Prep  $35.00

Equipment

  • Automated tissue processors and embedding station
  • Cassette and slide labelers
  • Microtomy stations
  • Leica Autostainers
  • Cryostat
  • Ventana Benchmark Autostainers

Specimen requirements and handling

Guidelines for handling & fixation of tissues

Fixation

The quality of assays performed on fixed and paraffin-embedded tissues is influenced by many pre-analytical factors including the type of fixative, the efficiency and duration of fixation, and the conditions of tissue processing.  For any clinical or research study, it is important to control as many of these variables as possible. For most clinical investigations or clinical trials it is desirable to have biospecimens harvested, fixed, and processed in the same manner as clinical biopsies or excisions.

To this end, the AMP Core Labs has implemented protocols for tissue processing and embedding that closely resemble those used by the pathology labs at Barnes-Jewish Hospital and many (most) other clinical settings. However, initial handling and the initiation of tissue fixation are usually performed by the submitter.

In general, fixation of tissues in the clinical setting relies on standardized commercial preparations of 10% neutral buffered formalin (NBF).   This is a ready-to-use solution of approximately 4% formaldehyde that contains buffer salts and a small amount of methanol.  Buffering is required to minimize time-dependent acidification, which can be deleterious to tissues, while the methanol is required to minimize time dependent polymerization of formaldehyde, which diminishes the efficiency of fixation. Despite these precautions, the fixative has a finite shelf-life, and must be used prior to the indicated expiration date, usually within 2 years of manufacture.

Sources of formalin

The most widely used and reliable source of neutral buffered 10% formalin is Richard-Allan Scientific.  It can be obtained from a large number of different distributors, including Thermo Fisher Scientific. However, several distributors prepackage the fixative in small, polypropylene containers with an inner seal and a 90 ml volume of fixative; this is suitable for most types of small biopsies. Barnes-Jewish Hospital and WU Pathology Services purchase their pre-filled containers from Cardinal Health.

This product provides a safe primary transport container and eliminates the need for staff to handle the fixative. It is important to stock no more NBF than can be used within the estimated shelf-life, to insure reproducible fixation.

Guidelines for formalin fixation of specimens

  1. Fixation conditions should be standardized as much as possible. Ideally, tissues should be fixed in formalin for 16-24 hours or more at room temperature to achieve complete penetration and stable crosslinking. Under-fixation is usually more deleterious than over-fixation. Note: the current CAP mandated minimum fixation time for clinical assessment of predictive biomarkers for breast cancer (i.e., ER, PR, and Her-2 receptor expression) is 6 hours, with a maximum time of 72 hours.
  2. Tissues should be immersed as soon as possible but within one hour of removal from the body. If necessary tissues can be briefly placed on a saline moistened gauze sponge; however, even brief placement of a small biopsy on a dry surface can be deleterious.
  3. For all clinical studies, including clinical trials, the time of the procedure and the total formalin fixation time must be documented on the requisition and/or specimen container.
  4. Tissues should be < 3 mm in thickness to help insure rapid fixation. Although needle or core biopsies do not usually present problem, tissue blocks obtained from larger specimens should be carefully trimmed.
  5. After complete fixation in formalin, some research tissues can be safely transferred to 70% ethanol at 4 deg C until processing. As indicated above, under-fixation should be avoided. Note that premature transfer to ethanol can permit reversal of some crosslinks, resulting in underprocessing during tissue processing.
  6. Formalin is the only fixative validated for clinical immunohistochemistry, interphase FISH, or next generation sequencing. For predictive biomarker studies in the clinical setting, alternative fixatives, post-fixation storage in ethanol, and/or decalcification cannot be used without prior validation or appropriate disclaimers on the report.

Precautions when working with formalin

Formalin is a hazardous solution that fixes by gradually penetrating the tissue and crosslinking proteins. Inhalation and physical contact should be minimized. It is important to wear appropriate personal protective equipment and consult with the manufacturer’s MSDS before handling. At a minimum, gloves and eye protection are recommended when working with open containers of formalin.

Required procedures for submission of clinical specimens

All specimens submitted for lab services must be properly transported to the lab.

Transport for referred clinical testing at Washington University Medical Center is coordinated by Diagnostic Laboratory Services (DLS).

Clinical research specimens obtained in BJH operating or procedure rooms will usually be delivered by the study coordinator or via the Tissue Repository according to a pre-determined schedule. Transport is coordinated by the study coordinator or designee, not by lab staff.

Regardless of origin, all specimens submitted to the lab must be accompanied by a pre-approved requisition that contains all required identifiers. Note: Clinical trials use a requisition form designed to meet the needs of the trial. However, the requisition must always include the name of the research study or clinical trial, the name of the principal investigator, and the approved unique patient identifiers (usually a pre-assigned patient ID number).

Specimens for clinical testing will only be accepted from approved health care providers. The lab provides no direct to patient testing. Specimens for clinical trials will only be accepted from a registered lab user. Requisitions must always include the full name, title, e-mail address, phone and fax numbers of the submitter(s), i.e. the contact person or physician at the submitting facility.

A “specimen inventory” must be provided; i.e., the specific specimens submitted for analysis must be enumerated and described on the appropriate requisition.The type of fixative and date and time of initial fixation should also be recorded.

Each primary specimen container must have an easily legible, water-proof label affixed to the side of container (not the lid).The label must include: a) required unique patient identifiers, and b) any specimen identifiers if more than one sample is submitted for the same patient. Specimens for clinical trials must also include the study name or number.

Specimens lacking the required information cannot be accessioned, resulting in potential delays. These issues will be brought to the attention of the Lab Manager, Director of Clinical Operations, or Lab Director.

General shipping and packaging information

The Lab does not coordinate shipping of research specimens from outside sites but recommends the following:

Packaging, labeling, and shipping are always subject to the relevant International Air Transport Association (IATA) and Department of Transportation (DOT) regulations applicable to diagnostic specimens. The sender should be advised to consult with their institution’s EH&S office or shipping department for more information.

Wet-fixed specimens do not usually require any specific thermal protection. However, paraffin-embeded tissue blocks or unfixed tissues in saline should be shipped with a frozen gel ice-pack during the warmer months.

As an additional precaution against misidentification of a specimen, no more than one patient’s specimen(s) should be shipped per package.

Instructions for packing “wet”, fixed or unfixed specimens for shipping

General policies

Any fresh tissues  or tissues in fixative are considered diagnostic specimens for purposes of transport. All specimens require secure packaging, individual specimen labels with required identifiers, and an approved requisition containing all required information.

Transport for referred clinical testing at Washington University Medical Center is coordinated by Diagnostic Laboratory Services (DLS).

Clinical specimens that originate within the Medical Center must use approved specimen containers and be transported by trained pathology transport staff.

The primary container must be a labeled screw top container with a water proof seal. Commercial, pre-filled specimen containers are ideal.  These container(s) should then be placed within a sealable plastic transport bag (e.g., Ziploc) or other approved secondary container.

Research specimens can be hand-delivered to the lab by WU investigators using appropriately labeled primary containers and packaging (see below) and the approved order form.

Clinical or research specimens delivered from outside  the Medical  Center are subject to IATA and DOT regulations and require appropriate, primary, secondary and outer packaging depending on the contents and carrier (see below).  Access Courier is used by BJH and WU Pathology Services.

General guidelines for off-site shipping

The following guidelines are based on CDC recommendations, and are only a guide.  Submitters are responsible for insuring full regulatory compliance by following shipping instructions provided to approved submitters.

Primary packaging

The primary container must be a labeled screw top container with a water proof seal. Commercial, pre-filled specimen containers are ideal. As an additional precaution, the lid should be secured with tape or parafilm. These container(s) should then be placed within a sealable plastic transport bag (e.g., Ziploc).

For commercial transport, the primary containers should be individually wrapped in sealable plastic bags containing absorbent material; this material will protect the contents from breakage and absorb any leaked contents.

There are volume and weight restrictions for primary containers, but these far exceed the usual specimen shipment.  (The liquid volume or solid weight of primary containers must not exceed 4L or 4 kg; individual primary containers cannot contain more than 1L of liquid.)

Secondary packaging

Use additional and sufficient absorbent material around the primary packaging in the secondary packaging to absorb the entire contents of all primary containers in case of leakage or damage.

Secondary packaging must meet the IATA packaging requirements for diagnostic specimens including 1.2 meter (3.9 feet) drop test procedure.

The secondary container must also be large enough for all markings, labels, and shipping documents (e.g., air waybill).

Leak-proof cold packs must be placed inside insulated packaging, for example Styrofoam box. Outer packaging will be necessary for such packages, as described below.

Outer packaging

An overpack must be used if cold packs are used OR if the secondary packaging is not large enough for all the labels, markings, and documents.

An itemized list of contents must be enclosed just inside the outermost packaging layer, and placed in a sealed plastic bag to protect from moisture.

Labeling of outermost packaging

Each package and the air waybill must be marked with the name, address, and telephone number of the responsible person submitting the package.

For purposes of shipping, both research and clinical specimens should be considered diagnostic specimens. Each package must be labeled as “BIOLOGICAL SUBSTANCE, CATEGORY B” and “UN 3373” in the “Nature and Quantity of Goods” box on the air waybill and outer packaging.

Note: additional packaging and labeling regulations apply in the event dry ice is included or for any international shipments.

Shipping address and directions for couriers

All specimens should be addressed to:

AMP Core Labs
Washington University School of Medicine
Department of Pathology & Immunology
425 S. Euclid Ave, Campus Box 8024
4th Floor West Bldg, St Louis, MO 63110

Couriers can deliver specimens directly to Lab 4721 on the 4th floor of the West Building at the South Medical Campus.

Special instructions

Services for Clinical Trials Involving Predictive Biomarkers

The histology and immunohistochemistry areas are organized and equipped to perform laboratory testing for predictive biomarker assays in support of approved clinical trials. Lab management can assist investigators in the early phases of trial development by providing: assay protocols for approved tests, technical and workflow information, and cost estimates.

Predictive biomarkers

The existing test menu includes selected assays of hormone receptor expression and tumor cell proliferation.

Regulatory environment

The Labs are CAP/CLIA-certified and HIPAA compliant. Beyond regulatory compliance, the Labs have a “total test” philosophy that attempts to standardize or define as many variables as possible. This extends from recommendations regarding initial tissue handling and fixation, to standardized processing and embedding, section preparation, and immunostaining.

In vitro diagnostic tests on the Ventana platform

The Labs support selected basic and translational investigations, often employing new immunologic reagents and/or protocols. However, clinical testing is largely restricted to internally verified FDA-approved reagents on the automated Ventana Medical Systems platform.

Accessioning and tracking

Specimens for approved clinical studies can enter the lab in at least 2 ways: as archived paraffin tissue blocks, or as recently harvested tissues in fixative.  The latter tissues are transferred from the Tissue Repository and accessioning in CaTissue. Specimens for trials administered at the Medical Center are accessioned into WU Research CoPath, under the licensing agreement of CoPath Plus with Barnes-Jewish Hospital. However, the anonymized specimens can also be tracked from accessioning through completion of testing via the Lab’s browser-based tracking system, with automatic email notifications at critical steps of the process.

Pathology support

The Core Labs performs predictive biomarker assays and carefully monitors the quality of each assay. However, lab personnel do not interpret or analyze the data. Interpretation rests with the designated pathologist(s) that are co-investigators supported by the grant or contract. The pathologist is usually an attending surgical pathologist in the Division of Anatomic and Molecular Pathology. Results are reported via WU Research CoPath, as for diagnostic specimens.

Procedures for initiating a new clinical trial

Approval of clinical trial (CT)

 Investigators must communicate with the Lab Director or Lab Manager about potential clinical trials well in advance of any start date. Our decision to support a trial hinges on a number of factors including: departmental priorities, identification of an appropriate study pathologist by the investigator, compatibility with existing clinical workflows, and the projected workload for the lab.

If it is determined that the trial can be supported a written summary of the trial must be provided by the investigator. The summary should describe the study design and type of testing required, the duration of the study and planned patient accrual, and the tentative start date. This information along with contact details of the investigator and study coordinator are documented in the Lab’s server-based Clinical Trials Log.

Pricing estimates are subject to the prior approval of the Business Office; this is necessary to help insure cost recovery and inclusion of appropriate overhead charges. Modifications to the study design that impact on testing will usually require reevaluation and new price estimates. Pricing provided for one trial will not usually apply to another.

Trial logistics

 Clinical trial specimens are often initially received by the Tissue Repository, but can also be received by the trial office from participating medical centers.  Regardless of how the specimen will enter the system the investigator must identify a study coordinator who will serve as the primary contact, assume responsibility for generating any online lab service requests, and/or arrange for transport of all case materials to and from the Lab.

Creating test protocols

All clinical trial specimens are accessioned, tracked, and reported in CoPath as a WCT specimen type. A specific test protocol is created in CoPath with the assistance of the study coordinator or investigator and the CoPath administrator. The test protocol always includes the assigned study name, but may include other information if more than one specimen is to be received for a given patient.

For some trials multiple specimens may be received for the same patient at different times during the study with different procedures performed on each specimen.  In such cases the study coordinator must provide sufficient information on each order to insure that the appropriate protocol is used. The terminology used for each successive specimen should be standardized and documented in the Clinical Trials Log at the time of setup. It is never the responsibility of lab staff to determine the type of testing that applies to a given trial specimen.

Creating a project on the Webportal

Although all clinical trial specimens are accessioned in CoPath, cases are often also accessioned into the Webportal-based ordering and tracking system to: assist lab management with monitoring overall clinical and research workflow, allow the study coordinator to generate a requisition for trial specimens that are not initially received by the Tissue Repository, and/or permit the study coordinator to track the status of specimens online.

The Lab Manager interacts with the clinical trial coordinator to create a Webportal project with an appropriate trial name, shared user name and password, and contact information for any electronic notifications. The same project is used for submitting online orders for each patient specimen associated with a given clinical trial.

Special considerations for receiving and accessioning

For some trials a specimens may be received as more than one part, with each part receiving its own CaTissue number. In this situation, the CaTissue number for the first part (A) is used as the first name according to the CT specimen naming convention. Other parts are described and identified in the gross description. In some cases, the last name corresponds to the trial name, with the first name representing some other participant identifier. The Lab does not offer complex grossing functions or distribute received specimens to other laboratories.

Case completion

For specimens that involve pathological interpretation, the sign-out of the case occurs when the pathologist signs-out the case in CoPath.  For specimens that do not, the sign-out occurs when the last part of the order is completed. The Lab will provide one semail notification to a predetermined individual, usually the study coordinator, that indicates that the laboratory component has been completed.

Obtaining lab services for drug eligibility studies

For these studies patient slides or blocks of tissue are sent to an outside reference lab for testing to determine whether a patient is eligible to participate in a clinical trial. The Lab performs processing and embedding of a tissue biopsy and/or prepares stained or unstained sections.

Before submitting specimens, new requestors must establish an account by contacting the Lab Manager. The requestor will provide required contact and billing information and be provided with an appropriate username and password. At present, the majority of submissions are handled by the Clinical Research Specialist in the Division of Medical Oncology.

The WebPortal based system is efficient and well tested with a robust FAQ on this web site. The WebPortal provides automatic email notifications of received and completed orders and permits online tracking of status.

  1. Submitting the order: The study coordinator/requestor for the requesting department submits orders via the WebPortal. Specific details like fixation time, number of slides required, etc. are provided in the order form.
  2. Delivery of Specimens: The specimen and a copy of the online order form are delivered to Room 4721 by the study coordinator and placed in the appropriate “drop-off” bin.
  3. Receiving Specimens: The specimen is received and accessioned by the Lab Services Coordinator (LSC) into Webportal-based tracking system.
  4. Order Completion: After completion of the required services the order is signed-out in Webportal by the LSC and an email is automatically sent to the study coordinator.
  5. Pickup: The requested materials are picked up from Room 4721 by the study coordinator or designee.
  6. Billing: Billings are submitted to the Pathology Business office via the Webportal.

Detailed contact information

Location & Hours of Operation: The Lab is located at the South Medical Campus on the 4th floor of the West Building (Suite 4718-4721). Lab services in support of research activities are available Monday through Friday from 8:30 am to 4:30 pm.

General Lab E-mail: ampcorelab@path.wustl.edu

CLIA Laboratory Manager:
Tom Fitzgerald, M.S. (ASCP)
Tel: (314) 747-2086
Fax: (314) 747-5642
E-mail: tfitzgerald@path.wustl.edu

CLIA Laboratory Director:
Directed by: Erika C. Crouch M.D., Ph.D.
Tel: (314) 454-8462
Fax: (314) 454-5917
E-mail: crouch@path.wustl.edu

Clinical Laboratory Supervisor:
Autumn Watson
Tel: (314) 362-7468
Fax: (314) 747-5642
E-mail: awatson@pathology.wustl.edu

Cytopathology Research
Directed by: Dr. Cory Bernadt, M.D., Ph.D.
Staffed by: Xiaopei Zhu
Tel: (314) 747-1069
Fax: (314) 747-5642
E-mail: xzhu@path.wustl.edu

Molecular Pathology Research
Directed by: Dr. John Pfeifer, M.D., Ph.D.
Staffed by: Xiaopei Zhu
Tel: (314) 747-1069
Fax: (314) 747-5642
E-mail: xzhu@path.wustl.edu

Mailing/Shipping Address:
AMP Core Labs
Washington University School of Medicine
Department of Pathology & Immunology
425 S. Euclid Ave, Campus Box 8024
4th Floor West Bldg, St Louis, MO 63110