preparing an rfp for a digital pathology system · pantanowitz et al. ascp press. 2012:105 -115....

Preparing an RFP for a Digital Pathology System

Liron Pantanowitz MDVice Chairman for Pathology InformaticsUniversity of Pittsburgh Medical Center

DISCLOSURE

In the past 12 months, I have had a significant financial interest or other relationship with the manufacturer(s) of the following product(s) or provider(s) of the following service(s) that may be discussed in my presentation.

Medical advisory board for Leica & IbexConsultant for Hamamatsu

Outline

1. Define a request for proposal (RFP) and how it can be used to evaluate digital pathology vendors

2. Explain the various components of a RFP used to select a new digital pathology system

3. Describe how playscripts can influence the RFP process

Request For Proposal (RFP)

What is an RFP?• “An invitation to vendors, often through a

bidding process, to submit a detailedproposal on their product & services inresponse to specific stated requirements”

Weiner & Winsten. In: Pathology Informatics. Pantanowitz et al. ASCP Press. 2012:105-115

Wikipedia

RFP Purpose

• Identify potential vendors (suppliers) for a new (digital pathology) solution:– Solicit vendors to participate– But, not an offer to contract

RFP Process

• Detailed list of mandatory functions, technical requirements & desired features.

• Each feature is ranked & weighted for importance & priority.• Differentiates & “screens out” vendors before next steps.• Some institutions may require using a formal RFP process.• An RFP is only 1 step of many in the overall selection process.


Steps to LIS SelectionWeiner & Winsten. In: Pathology Informatics. Pantanowitz et al. ASCP Press. 2012:105-115

Steps in the ProcessCreate a project team

Requirements definition

Identify viable candidates

Obtain system & corporate information

Obtain cost quotations

Telephone reference checks

Onsite demonstrations

Site visits

Contract negotiations

Corporate visit

To RFP or Not?

Pros• Structured approach• Reduces selection risk• Guarantees transparency• Compiled list of requirements• Includes more details than referral

sites will answer

Cons• Outdated method• Cookie-cutter approach• Vendors may inflate claims• Vendor’s good at an RFP response

may not be the best choice• May not yield best vendor

UPMC RFP Experience• Based on our prior experience with implementing Omnyx we knew what

we did/did not want.• Our selection was not based solely on cost, but also considered:

– Vendor reputation & maturity– Product innovation & functionality– Scalability & risk of being locked-in– Open system with next gen tools– Innovative partnership with UPMC

• There are no public ratings (e.g. KLAS) or comparisons (e.g. CAP Today) for digital pathology systems.

• We adopted a formal approach (e.g. PMO* involved, RFP process) with no short cuts! *PMO = project management office

Where to Start with an RFP

• 3 ways to begin:• Suggestions from key stakeholders • Structured interview of stakeholders• Use a standard set of requirements

– From past informatics projects– Institutional RFP template

Steps to LIS DPS SelectionWeiner & Winsten. In: Pathology Informatics. Pantanowitz et al. ASCP Press. 2012:105-115

Steps in the Process What we didCreate a project team We engaged our PMO & identified stakeholders

Requirements definition Gap analysis based on our experience with Omnyx

Identify viable candidates Approached hardware & software vendors

Obtain system & corporate information We used a formal RFP process

Obtain cost quotations Budgeted by our information services division

Telephone reference checks Limited “fully digital” pathology laboratories

Onsite demonstrations We employed playscripts

Site visits Limited “fully digital” users in the USA

Contract negotiations Handled by our supply chain management team

Corporate visit Key meetings to discuss partnership terms

Key Stakeholders• Department of Pathology

• Division of Informatics• Pathology leadership• Lab staff (AP supervisor,

histology manager)

• Hospital administration• Information services division• Enterprise services division

• Determine which of these players are your key decision-makers.

RFP Process Guidance• Plan upfront to establish the project scope

– Define what you want/need (gap analysis)– Address business, feature, and functionality requirements– Determine if integration is required (e.g. LIS)

• Who is going to pay for the system?– How much do they need to be involved?

• Send out requests to multiple vendors– Some may decline (takes effort to complete a complex RFP)

• Include many digital pathology vendors:– Hardware &/or software product suppliers

• Appoint a single point-of-contact person• Rank vendor RFP responses

– Consider using weighted scores (for importance & priority)• Select some (not all) vendors for on-site demonstrations

Intended Use Questions to Consider

• What is my intended use (frozen sections, image analysis, fluorescence research, digital slide teaching sets, etc.)?

• What is my existing IT infrastructure (e.g. network, storage) & support?• Need for occasional scans vs. high volume throughput work?• Type of glass slides to be scanned (e.g. plastic coverslips, whole mount,

consults with foreign barcodes)?• Type of cellular material to be digitized (e.g. frozen sections, cytology)?• Does my lab require WSI-LIS integration (i.e. workflow preference)?• What software tools are necessary (e.g. telepathology, algorithms)?

• How much can I afford to spend?

Evans AJ et al. Arch Pathol Lab Med. 2017; 141:944-959

Expected Costs

Direct Costs• Hardware (WSI scanner) & software • Other computer equipment (e.g. monitors, servers)

Indirect Costs• Maintenance fee (annual)• Licensing fees• Additional software (educational package, image analysis)• LIS vendor integration (customization)• IT costs (personnel, operations)• Facility renovations

Example of Request For Proposal with scoring grid

Example: RFP StructureCriteria Availability Response Your Score

Application Requirements

Do you have a module to share cases internally?

Infrastructure Requirements

Do you have a data flow diagram you can provide ?

Example: RFP StructureCriteria Availability Response Your Score

Application Requirements

Do you have a module to share cases internally?

Yes Our system has a telepathology module that is used to share digital slides with colleagues


Do you have a data flow diagram you can provide ?

Yes Diagram attached with RFP

WSI System Deployment. Pantanowitz L. Digital Pathology. ASCP Press. 2017; Page 73.

Digital Pathology SystemAbels & Pantanowitz. J Pathol Inform. 2017; 8:23

A: Image acquisition (WSI scanner)B: Workstation (WSI display)

UPMC Integration Overview (Case Management)

Track & Sign CMS

• Patient/case/slides

• Barcode-driven

• Gross photos

• WSI

• Sharing WSI

• Tracking assets

• Search function

• Reporting

General Application Functionality• Is the system based on an open architecture that allows it to interface with other systems?• Can the system process inbound & send outbound HL7 messages ?• Does your application interface (bidirectionally) with our LIS?• Describe specifically what data flows in through these interfaces.• Is the application web enabled, client/server or a mixture of the two? • Is there a limit to how many concurrent users can use the application ?• Does the product provide an Application Programming Interface (API)?• Describe how your system addresses security (e.g. encryption, audits, anti-virus, etc.)• Are there any third party software license and support fees involved (e.g. TeamViewer)?• Can the application meet and exceed (e.g. 99.5%) availability per year (e.g. 1.83 days)?• Are new releases included in the support agreement?

Hardware Requirements

• What types of WSI scanners do you have?(e.g. large/small footprint, low/high volume, brightfield/fluorescence)

• Do you have a dedicated frozen section scanner (live view)?

• Does you scanner offer multiple objectives (e.g. low/high, oil magnification)?

• Do you offer z-stacking for cytology slides?• Explain how your scanner grips/moves slides to be scanned.• What is your scanner’s failure rate?• How quickly does your scanner scan a slide?• Does your scanner have the ability to read barcodes?• Can your scanner easily produce DICOM images?

Digitization FeaturesScan times

• Range = 1-8+ minutes per 15x15 mm2

• Reported scan times differ (min per mm2)• Scan method not a big deal (e.g. line vs. tile)• Increases with different parameters:

– Tissue size, density, magnification & z-stacking• True throughput (turnaround time) includes:

– Slide preparation (e.g. trimming labels)– Slide loading (e.g. vertical vs horizontal)– Digitization (line/tile based methods, dual sensor)– QC checks (e.g. automated, manual override)

Scan features• Automated (walk away capability, continuous loading, tissue detection)• Manual (override, scan user defined areas, focus correction, etc.)• Different magnifications

– Low mag – for routine surgical pathology– High mag – for select cases (hemepath, microorganisms)

Hybrid Robotic + WSI Scanners

Sakura Precipoint Leica (Aperio) Objective Imaging

Mikoscan

VisionTek M6 M8 LV1 Glissando SL5

2.5x, 10x, 20x, 40x 20x or 40x 2.5x, 5x, 10x, 20x, 40x, 63x 20x or 40x 2x, 4x, 10x, 20x, 40x

Fraggetta F et al. J Pathol Informatics 2017; 8:51

Sakura stainer slide racks fit inside Aperio scanner racks

Software Requirements• Do you have software for case/patient/image management?• How do you add patients in your lab management module ?• How do we search (query tool) your database of WSI?• How does your application handle unmatched slides?• Does your software work with other vendor's scanners? • Do you have a consult solution, for sending/receiving cases

from internal/external sites?• Can pathology reports be generated by your system?• Do you have a tumor board solution?• Do you have an education platform?• How do you perform image analysis?• Do you have a research platform?

Vendor Support & Training

Support• Explain your technical support infrastructure and options available. • Include terms and costs in the explanation.

– How many employees are dedicated to technical support?– Is support staff available to come on-site if requested?

• What level of support is available (e.g. 365 x 24 by 7)? • Describe available support related to hardware, software and customization.

Training• Describe support provided during the Design and Implementation phases.• Is on-site, virtual, or other training offered to help users and technical personal?• What type of training materials exist (e.g. manuals, troubleshooting scenarios)?


• Can you provide Development, Test, and Production application environments?• Do you have a data flow diagram that you can provide? • Specify your hardware requirements for servers.• Does the system use a centralized or distributed server model?• What is the recommended desktop configuration for optimal client performance? • Does the client application work on Citrix?• Please describe mobile technologies that your system supports.• Do you have the ability to migrate historical images into your system?

Additional Considerations• Treat information as confidential (if marked as such).• Insist on having a WSI scanner present for the demo.• Ask to scan some of your own (± challenging) slides.• Find out if you can trade in your old WSI scanners.• Lock-out specs (may avoid unwanted but lowest bid).• Expect elusive uncomfortable FDA-related discussions.• Understand vendor licensing terms & maintenance fees.• Pricing may be difficult to pin down early on the process.• Get to know your institution’s purchasing agent (e.g. SCM).• Be prepared for flattery and praise!

Watch Out For• Immature vs. Best-of-Breed digital solution:

- e.g. re-vamped Radiology based platform • Responses with most items only in future availability.

- i.e. Not an “out of the box” solution• Unwanted extra bells & whistles (e.g. molecular tools).• Being locked in (e.g. image format, restricted scanner variety).• Buying more than you need (e.g. product + services).• Keeping demo devices on site > 90 days (anti-kickback rules).

Playscripts

• Describe various workflow operations.• “Show us how your system handles…..(scenario)”• Provides a common baseline for vendors.• Helps prepare for onsite demonstrations.• Compares vendor system performance.• Checks alignment with internal processes.


Playscript #1

• We receive a 3 part biopsy case from screening colonoscopy

• Initial H&E’s are cut• A complete diagnosis can be made from

these slides• How would we do this work using your

digital pathology system?

Expectation

• Support primary diagnosis for surgical pathology• FDA approval plan for clinical use• Scanned WSI quality• Barcode readability• Viewer functionality• Bidirectional LIS integration:

– Handle case/part level detail– Facilitate reporting

Playscript #2

• We receive a biopsy from a colon mass in a patient with a prior history of malignancy

• An initial H&E section is made• Prior history needs to be reviewed• Additional levels as well as some

immunostains are required• Intradepartmental consultation is needed for

this case• How would we do this work using your digital

pathology system?

Expectation

• Same functionality needed as for playscript #1• Greater EHR integration:

– Access to EMR clinical history– Allow LIS orders for IHCs– Additional WSI case matching

• Support (internal) telepathology– Formal consult (report generation)– Curb-side consult (rapid advice)– Simultaneous user viewing

Playscript #3• We receive a surgical resection of a pancreatic mass

that was previously biopsied by FNA and core biopsy at our institution.

• Prior to gross examination, an intraoperative consultation was performed.

• Comparison with prior material is necessary.• Gross images of the specimen were obtained and

biomarker immunostains need to be ordered.• The case is also presented at a tumor board.• How would we do this work using your digital

pathology system?

Expectation

• Access to prior LIS data.• Comparison with prior WSI.• Scan frozen section slides with artifacts.• Manage rapid frozen section workflow.• Support gross pathology (static) images.• Offer tumor board module.

Playscript #4

• We receive a consultation request from an outside institution to be performed on WSI scanned by the outside institution.

• How would we do this work using your digital pathology system?

Expectation

• Handle foreign WSI formats.• Secure cloud-based image exchange.• Telepathology end-to-end solution:

– Clinical: viewing, communication, reporting– Operational: tracking, audits, billing

• International telepathology footprint & experience.

Playscript #5

• We receive a core biopsy with invasive ductal carcinoma of the breast.

• Tissue is stained for ER, PR, HER2 and Ki-67.• Image analysis is required and needs to be

reported in the final diagnosis.• How would we do this work using your

digital pathology system?

Expectation

• Image analysis availability• FDA-approved breast biomarker apps.• Handle image analysis workflow:

– Integrated platform– Reporting capability

Final RFP Score Sheet

UPMC Experience – Deal Breakers

• Unwillingness to formally respond to our RFP.• Refusal to share certain items except in person.• Failure to show stakeholders an actual scanner.• Lack of interoperability, especially with our LIS.• No FDA clearance for products on the roadmap.• Locked down and inaccessible WSI database.• Closed system inhibiting computational pathology.• Reputation (e.g. scanner reliability, image quality).

Take Home Message

• To RFP or not FRP? In my experience proved to be valuable.• Structured approach to selecting a digital pathology system

will serve you well.• Principles of selecting a digital pathology system are similar

to those used for an LIS.• Playscripts for various multi-step workflows can supplement

the RFP process.

[email protected]

mailto:[email protected]

preparing an rfp for a digital pathology system · pantanowitz et al. ascp press. 2012:105 -115....

Documents