STATEMENT OF WORK (SOW)
Anatomic Pathology Specimen Tracking System
VISN 15 Pathology and Laboratory Services
1.0 General
1.1 The Contractor shall provide and configure an Anatomic Pathology (AP) Specimen Tracking System to support end to end tracking of AP specimens, cassettes, and slides from accessioning through final disposition in alignment with the Federal EHR Baseline and Oracle Health Commercial Model.
1.2 The solution shall fully support high volume AP laboratory operations, including complex workflows and telepathology/digital pathology use cases.
1.3 The AP Specimen Tracking System shall have pre existing Oracle Health CareAware device drivers and pre existing integration with Oracle Health Advanced Barcoding and Tracking (AB&T); custom development of CareAware drivers or AB&T integration for the proposed product is out of scope for this effort.
1.4 The proposed AP Specimen Tracking System shall demonstrate a production implementation of CareAware and AB&T integration with Oracle Health in a hospital AP environment.
1.5 The system shall support barcode driven workflows to reduce manual data entry, minimize typographical errors, and improve patient safety, including support for multiple patient identifiers on blocks and slides consistent with applicable VA/VHA policy.
2.0 Scope
2.1 The AP Specimen Tracking System shall be utilized for all Anatomic Pathology and Cytology specimens within the Pathology and Laboratory Services at the following sites:
St. Louis Pathology and Laboratory Services
Kansas City Pathology and Laboratory Services
Marion Pathology and Laboratory Services
The Contractor shall provide services and support at the locations identified in this Statement of Work. The Government reserves the right to add, remove, or modify locations and facilities as mission requirements evolve across the current and future operational footprint. The Contractor shall accommodate these changes within the scope of the contract without disruption to services. Any adjustments to pricing, schedule, or resources resulting from such changes shall be addressed through the appropriate contractual modification process in accordance with the applicable Changes clause.
2.2 The system shall support workflow at a minimum for accessioning, specimen receipt, grossing, embedding, microtomy, staining, slide distribution, sign out, archival, and pathologist workstations at each of the sites listed in Section 2.1. At the pathologist workstation, the system shall support pathologist review of digital and/or physical slide information and shall enable the pathologist to originate orders for additional stains and recuts as part of the sign out workflow.
2.3 The Contractor shall provide all necessary software and hardware (including required drivers) to support connectivity with the VA Federal EHR environment and related AP instruments, in accordance with Federal EHR Baseline and Oracle Health guidance, for all sites listed in Section 2.1.
2.4 The Contractor shall provide any ancillary components (for example, barcode scanners, label printers, workstations, and interfaces) required for the AP Specimen Tracking System to function as specified at each site.
2.5 Site specific details such as floor plans, existing equipment inventories, and local interface diagrams are provided in Attachment A.
3.0 Applicable Documents
3.1 The Contractor shall perform all work in accordance with the most current versions of, but not limited to, the following as applicable:
Federal EHR Baseline guidance for Anatomic Pathology and AP specimen tracking.
Oracle Health Model and configuration guidance for AP components (including PathNet and AP Clinician Summary MPage).
VA/VHA directives and handbooks related to patient identification, barcoding, and laboratory operations (e.g., two patient identifier requirements).
VA Technical Reference Model (TRM) and Enterprise Risk Assessment (ERAR) requirements for software solutions.
4.0 Integration and Workflow Requirements
4.1 The Contractor shall integrate the AP Specimen Tracking System with the VA Federal EHR using existing Oracle Health CareAware and AB&T capabilities to enable barcode driven workflows for specimen receipt, grossing, embedding, microtomy, staining, slide distribution, and archival at St. Louis, Kansas City, and Marion Pathology and Laboratory Services.
4.2 The solution shall support automated printing and association of barcode labels for containers, cassettes, and slides in accordance with Federal EHR Baseline standards at each site.
4.3 The Contractor shall ensure that workflows configured in the AP Specimen Tracking System are compatible with Oracle Health AP components (for example, PathNet and AP Clinician Summary MPage) and adhere to Model compatible configuration patterns identified by Oracle Health.
4.4 For any of the sites that do not yet implement an AP Specimen Tracking System, the Contractor shall support manual AB&T usage via the AP Clinician Summary MPage with manually operated cassette and slide printers, consistent with Baseline guidance.
4.5 The system shall support configuration of barcode and label formats to enable interoperability with in house and third party AP instruments (for example, immunohistochemistry stainers, special stainers, cytology equipment, and slide imagers), without requiring custom software development.
4.6 Site specific interface endpoints, network details, and instrument connectivity requirements are further described in Attachment A.
5.0 Leica Cerebro as Exemplar Solution
5.1 An AP Specimen Tracking System of the type represented by Leica Cerebro is recognized within the Federal EHR Baseline as a solution that possesses pre existing CareAware drivers and AB&T integration and satisfies the Baseline standard for AP specimen tracking integration.
5.2 Baseline recommends that such a deployment serve as the first AB&T/CareAware/specialty vendor implementation and the model for subsequent AP specimen tracking deployments across VA.
5.3 Leica Cerebro is identified as an approved exemplar AP Specimen Tracking System for the purposes of this requirement; offerors may propose Leica Cerebro or an equivalent AP Specimen Tracking System that meets or exceeds all technical and integration requirements specified in Sections 1.0 and 4.0.
5.4 Any proposed alternative to Leica Cerebro shall provide documented evidence of existing Oracle Health CareAware drivers and AB&T integration and shall be capable of supporting national standardization of configuration and content as directed by VA Baseline governance.
6.0 National Standardization and Configurability
6.1 The Contractor shall support VA efforts to develop and enforce national standards for AP Specimen Tracking Systems, including a single national configuration, national technical integration points, and standardized clinical and business content across St. Louis, Kansas City, and Marion Pathology and Laboratory Services.
6.2 The AP Specimen Tracking System shall be configurable to align with these national standards, including the ability to adjust workflows, label formats, and integration parameters without custom code changes.
6.3 The Contractor shall participate, as requested, in VA National Standardization Projects related to AP tracking and digital pathology, providing technical information, configuration support, and test environments necessary to validate a single, reusable interface pattern for the approved AP Specimen Tracking System.
6.4 The Contractor shall ensure that AP tracking configuration and integration can be replicated consistently across VA sites, including St. Louis, Kansas City, and Marion Pathology and Laboratory Services, in accordance with Federal EHR Baseline governance.
7.0 Performance Requirements
7.1 The system shall support high volume AP operations (e.g., hundreds of tissue blocks and slides per day) with performance adequate to avoid workflow bottlenecks and delays in diagnosis at each site.
7.2 The system shall provide reliable barcode scanning and label printing at all configured workstations and support near real time data exchange with the VA Federal EHR and connected instruments.
7.3 The Contractor shall ensure that all delivered hardware and software are new (or otherwise compliant with VA acquisition requirements) and meet all manufacturer specifications and VA technical standards.
8.0 Place of Performance
8.1 Place(s) of performance under this SOW are:
St. Louis Pathology and Laboratory Services
Kansas City Pathology and Laboratory Services
Marion Pathology and Laboratory Services
8.2 The Contractor shall coordinate delivery, installation, and on site work with the designated VA point(s) of contact at each implementation site.
8.3 Additional site specific logistics information (e.g., loading dock access, storage locations, and staging areas) is provided in Attachment A.
9.0 Period of Performance
9.1 The period of performance, including implementation, configuration, testing, training, and warranty/initial support, shall be defined in the contract and/or order and may include base and option periods as determined by the Contracting Officer.
10.0 Deliverables
10.1 AP Specimen Tracking System software licenses, including all required modules and interfaces.
10.2 All required hardware components (for example, scanners, label printers, workstations, and servers) as specified in the Contractor s accepted proposal and in accordance with VA technical standards for each site.
10.3 System configuration documentation, including:
Workflow configuration
Label and barcode formats
Interface and integration specifications
Site specific parameters (as applicable for St. Louis, Kansas City, and Marion)
10.4 Test plans and test reports demonstrating successful integration with Oracle Health CareAware, AB&T, and relevant AP components, and successful execution of VA approved test cases.
10.5 User and technical documentation, including administrator and super user guides.
10.6 Training materials as described in Section 12.0.SOW-AP-Workflow.docx+1
10.7 Any site specific implementation artifacts identified in Attachment A (e.g., completed pre installation checklists, environmental readiness forms) shall be submitted as part of the deliverables.
11.0 Maintenance and Support
11.1 The Contractor shall provide maintenance and support services in accordance with the awarded contract, to include software updates/upgrades, defect correction, and technical support during VA defined support hours.
11.2 The Contractor shall provide all necessary updates to maintain compatibility with Oracle Health and VA infrastructure, including required patches for CareAware and AB&T integration.
11.3 The Contractor shall provide remote and, when required, on site support to address issues impacting clinical operations at any of the listed sites, consistent with agreed response and resolution times.
12.0 Training
12.1 The Contractor shall provide on site or virtual training (basic operating and maintenance) during installation or system updates and shall conduct instructional sessions for end users, super users, and technical support staff at St. Louis, Kansas City, and Marion Pathology and Laboratory Services, as required by VA.
12.2 The Contractor shall provide training materials (handouts, manuals, and other media) in sufficient quantity for each participant at no additional cost to the Government.
12.3 The Contractor shall provide access to a technical support specialist during initial go live to assist in workflow optimization, issue resolution, and user questions.
12.4 The Contractor shall provide training for newly onboarded end users at each site (St. Louis, Kansas City, and Marion Pathology and Laboratory Services) on an ongoing basis throughout the period of performance, to accommodate staff turnover and new hires. New user training shall be delivered within [30 calendar days] of a request by the COR or designated site point of contact and may be conducted onsite or virtually at the Government's discretion.
12.5 The Contractor shall provide one (1) annual refresher/advanced training slot per site per period of performance for designated "super users," to reinforce workflow proficiency, cover system updates or configuration changes implemented since the prior training cycle, and address advanced troubleshooting topics. This annual super user training is in addition to the initial super user training required under Section 12.1.
12.6 All training required under Sections 12.1, 12.4, and 12.5 shall be provided at no additional cost to the Government, consistent with Section 12.2, and training materials shall be updated as necessary to reflect current system configuration.
13.0 Security and Privacy
13.1 The Contractor shall comply with all applicable Federal and VA information security and privacy requirements for systems that store, process, or transmit VA data, including Veterans health information.
13.2 The AP Specimen Tracking System shall support appropriate user authentication, authorization, and audit logging in accordance with VA policy.
13.3 The Authorization requirements do not apply, and that a Security Accreditation Package is not required.
14.0 Contractor Personnel and Management
14.1 The Contractor shall be responsible for employing technically qualified personnel to perform the work specified in this SOW and shall maintain the organization and administrative control necessary to ensure that work delivered meets contract specifications and requirements.
14.2 Changes to key Contractor personnel during installation and support are acceptable, provided that replacement personnel have comparable qualifications and experience; the Contractor shall notify the Contracting Officer s Representative (COR) of such changes.
15.0 Government Responsibilities
15.1 VA will provide reasonable access to facilities, systems, and personnel necessary for the Contractor to perform installation, integration, testing, and training activities at St. Louis, Kansas City, and Marion Pathology and Laboratory Services.
15.2 VA will identify points of contact for clinical, laboratory, technical, and contracting oversight for each site.
16.0 Quality Assurance and Acceptance
16.1 The Government will evaluate Contractor performance and deliverables against this SOW and any associated Quality Assurance Surveillance Plan (QASP) using methods such as direct observation, review of documentation, and user feedback.
16.2 System acceptance at each site will be based on successful completion of installation, configuration, testing (including integration and workflow validation), and training, as well as demonstration that the system meets the functional and performance requirements described herein.
17.0 Clauses and Provisions
17.1 All applicable VA and Federal acquisition clauses and provisions (e.g., FAR, VAAR, and agency specific terms) shall apply as incorporated into the contract by the Contracting Officer. This SOW does not supersede any mandatory clauses or provisions included in the award.
