DOD - Statement of work_13Nov2020.docx

STATEMENT OF WORK

13 November 2020

Medical Device Implant Tissue Tracking (MDITT)/UDI Tracker

DESCRIPTION OF SERVICES-UDITRACKER

UDI Tracker is a web-based tracking product that was specifically developed for healthcare organizations that handle tissue and implants. UDI Tracker streamlines processes and eliminates time spent preparing for an audit, by completely automating the chain of custody and beyond – from receipt of items to tracking inventory through use, documenting key information and managing critical recalls. The UDI Tracker product encompasses Tissue & Implant Tracking, Chain of Custody Compliance, UDI-Ready bar code scanning and optional modules such as Radio Frequency Identifier (RFID), Active Directory, Materials Management Information System, (MMIS), Software System Integration, and Outbound Case Entry.

The UDI Tracker Basic Product contains the following main components:

· Inventory Management

· Transfers (Chain of Custody)

· Case Management

· Alerts & Notifications

· Temperature Log

· RFID

· Admin Each one of the above menus has sub-menus that assist the healthcare organization in creating, editing, viewing the inventory items, and managing all aspects pertaining to a hospital.

Inventory Management UDI Tracker’ s Inventory module allows the healthcare organization to fully track and manage tissue and implant items upon receipt at the hospital and while being stored until clinical use. Information such as the product code/description, lot number, serial number, expiration date, quantity, location, RFID, and inventory type (Owned, Consigned or Brought-in/Bill-only) are easily accessed and managed. Users can easily receive shipments, create inventory items, view current tissue & implant inventory, reserve inventory items for an upcoming case and manage par and re-order levels. Within Inventory Management, the healthcare organization has the following options:

• Receive Shipments

• Shipments Pending Receipt

• Available Inventory List

• Reserve Inventory

• Manage Par and Re-order Levels

• Add Items Direct to Inventory

• Tissue Supplier Registration Documents Transfers UDI Tracker’s Transfers module provides a platform to document the chain of custody for tissue and implant inventory within the hospital, fulfilling Joint Commission’s regulatory handling requirements. Hospitals are also able to transfer items between departments, view issued items and return inventory back to the supplier and document this activity. Within the transfers module the healthcare organization has the following options:

• Transfer Inventory

• Internal Transfer

• Transfer Requests

• Supplier Returns

• Issued Inventory

Case Management:

UDI Tracker’s Case Management module allows healthcare organizations to create and edit procedures/cases where tissue and implant items were used and document this data. The hospital will also be able to document associated tissue preparation solutions and automatically return the tissue card to the supplier. Adverse events that involve tissue or implant items, occurring during a case, can be documented and viewed. Within the Case Management module the healthcare organization has the following options.

• Create Case

• Completed Cases

• Adverse Events

Alerts and Notifications – Landing Page:

UDI Tracker’s Alerts and Notifications module is where all the information of the other modules comes together in one clear and concise view. The details of important notifications and alerts are easily viewed and presented in the order of safety and compliance. The hospital will be able to see any and all expiring inventory, pending transfers, shipments pending receipt, and expiring tissue supplier registrations. Within Alerts and Notifications module the healthcare organization can view the following:

Expiring Inventory:

• Temperature Log

• Adverse Events

• Overdue Reserved Inventory

• Overdue Issued Inventory

• Transfers Pending Receipt

• Shipments Pending Receipt

• Expiring Tissue Supplier Registrations Each of the above items will provide detail to assist the healthcare organization to take action and resolve the alert items.

Temperature Log:

UDI Tracker’ s Temperature Log module provides users with a compliance platform to document information regarding the storage and control over temperature-sensitive inventory items. Within the Temperature Log module the healthcare organization has the following options:

• Create New Temperature Log

• Temperature Log Admin:

UDI Tracker has a robust Admin module that allows the healthcare organization to manage and configure user and program settings including:

• Interface History

• Interface Resolution

• Customize Labels

• View Activity Log

• Configure Tracking

• Configure Time

• Configure Alerts

• Configure Cases

• Configure Bar Code Scanning/Generation

• Configure RFID

• RFID History

• User Management

Implementation/Integration/Training:

Timeline:

Customer shall sign SOW and issue its purchase order (if Customer Purchase Order is necessary prior to payment) for implementation/integration and first year’s fees simultaneously. Payment of implementation/integration and first year’s fees is required prior to commencement of implementation/integration services (“Installation”).

Standard InVita installation commences promptly after receipt of payment above and is completed within forty-five (45) days thereafter. InVita and Customer shall mutually agree on date and time Installation Services shall commence; provided that should Customer cause any delay in InVita’s ability to perform Installation and other Services, such delay shall not alter the Services Effective Date, payments due on any anniversary of the Term or any renewal of the Term.

Two (2) weeks prior to on-site implementation, Customer will send to In Vita information separately request by InVita’s information technology team in order to create Customer’s individual account and personalize Customer’s database experience.

Staffing:

InVita assigns experienced professionals who bring the proper credentials and knowledge. Assignment of final staff will occur following Customer’s execution of this SOW. InVita reserves the right to change the InVita team members who will be working on this project but will inform the customer of such changes.

Training:

Contractor Training Schedule UDITracker Training Program Early Stage Training Project Implementation Day 1 – 15

Training Area Audience Medium Length

Description: This training is approximately one hour in length but may require different audiences participating in different sessions. Training will be conducted via WebEx and will be a summary presentation that will serve to provide the health system’s implementation team with a strong baseline of information that will assist in the implementation of the UDITracker product. This training is conducted BEFORE the Configuration Questionnaire Workbook is completed by the health system.

Materials Provided: The above training materials will consist of live demonstrations, Configuration Questionnaire Workbook, Configuration User’s Manual and PowerPoint handouts.

Final Stage Training Project Implementation Day 45 – 60

Training Area Audience Medium Length

Administrative, Full Access & Add-View

Case Entry

Receive Shipment ONLY

Temperature Log ONLY

View ONLY

Description: This training is approximately one full business day in length but may require different audiences participating in different sessions. Training will be conducted onsite at the hospital facility and will be an in-depth presentation that will serve to train-the-trainer and will be the final training for these key functional areas of UDITracker. Your assigned Implementation Specialist will also assist the facility staff to do a full physical inventory of the hospital’s tissue items. Product code, ID/Serial/Lot #, expiration date and any other relevant data for each item will be entered into the hospital’s database in UDI Tracker.

Materials Provided: The above training materials will consist of live demonstrations and handouts.

Sustainment Training:

Current and new users have 24x7 access to our in-product online Help Center featuring documentation such as full User Guides, shorter Quick Sheets specific to certain functions as well as Video Tutorials. Also, InVita offers sustainment training on all the training areas listed above as well as the ability to customize a training specific to facility needs. Sustainment training can be delivered on-line or in person and additional charges may apply.

Maintenance and Support Services InVita shall use commercially reasonable efforts to enable Customer’s Authorized Users to access the Services in a production environment as permitted herein 24 hours a day, 7 days a week, 365 days a year (“Uptime”) with 99.4% average uptime availability (excluding Permitted Downtime) measured on a monthly basis. InVita’s provision of maintenance and support set forth herein is expressly contingent on InVita having prompt, full and unimpeded remote root access to the Services and requisite access to Customer Systems. “Permitted Downtime” shall mean (i) InVita’s routine preventive, diagnostic maintenance services and support services to provide Updates and Enhancements, (ii) Force Majeure Events or (iii) Customer’s equipment malfunctions.

Maintenance of the Products includes the operating system, application and hardware as it applies to an ongoing working software product.

If indicated above, InVita shall provide the following “Maintenance and Support Services” to Customer:

On Site Training: $1,000 per day plus associated travel costs