1. Theradoc Subscription and Support SOW.docx

NIH Clinical Center Department of Clinical Research Informatics Statement of Work

Background

The mission of the National Institutes of Health (NIH) is to uncover new knowledge that will lead to better health for everyone. The NIH accomplishes that mission by conducting research in its own laboratories; supporting the research of non-Federal scientists in universities, medical schools, hospitals, and research institutions throughout the country and abroad; helping in the training of research investigators; and fostering communication of biomedical information.

The NIH Clinical Center (CC) is a 200-bed federally funded, biomedical research hospital located on the NIH campus in Bethesda, Maryland. The Clinical Center is the delivery setting for all NIH intramural clinical research protocols. The hospital complex consists of two main facilities that are connected to each other by “bridges”. The original 14-story building is 2.5 million square feet and continues to house the clinical laboratories, imaging sciences, surgical suites, and several outpatient clinics. The new 870,000 square foot facility houses inpatient units and day hospitals. The Clinical Center accounts for about half of all NIH-funded clinical research beds in the United States and accommodates about 7,000 inpatient and 70,000 outpatient visits a year. Patients are admitted to the NIH Clinical Center from all over the world for the sole purpose of participating in a clinical research protocol.

The Department of Hospital Epidemiology Services (HES) conducts active infection surveillance for all inpatient and outpatient units to identify and track health care associated infections, identify organisms with unusual sensitivity patterns, establish baseline infection rates and identify increases above the expected level. HES monitors all inpatients and outpatients, i.e., high risk intensive care patients; hematopoietic stem cell and solid organ transplants; outpatients with follow-up on culture; patients with active lines. At any given time, approximately 100 - 400 patients could be under surveillance.

TheraDoc is an application used in Hospital Epidemiology Services in the NIH CC. The primary component is the Infection Control Assistant, which provides real-time surveillance and alerts for infection analysis. Live data from various sources is sent to TheraDoc from CRIS Sunrise (Admission, Discharge, Transfer, and Patient Demographic information) to help trace infections across the hospital. Other interfaces include Radiology results, Lab results, and Pharmacy orders. TheraDoc consolidates all of this information in a single location for quick analysis on patients. Future enhancements include the implementation of new VAD, vital sign, and surgical interfaces, as well as new modules to support Pharmacy use, including an Adverse Drug Events Assistant, Clinical Alerts Assistant, and Antibiotic Assistant

Purpose

This request is for the renewal of Premier Healthcare TheraDoc license subscriptions and support contract to support the Clinical Center’s Hospital Epidemiology system.

Scope

The vendor will provide a proposal for items listed below. The Clinical Center will use this contract to obtain additional modules as released by the vendor along with implementation services needed to upgrade the current system or install new features or modules.

Annual Subscription

Infection Control Assistant® provides a consolidated workflow designed for infection preventionists (“IPs”) to identify, investigate, document and report healthcare associated infections in real time. IPs are empowered with clinical insights and flexible tools that support house-wide and targeted surveillance efforts. Efficiencies in practice are demonstrated with the ability of the user to:

• Analyze data on demand.

• Identify and confirm valid HAIs faster.

• Streamline and facilitate compliance with local and federal HAI reporting mandates.

• Spot trends that could be missed by manual surveillance.

• Mitigate risk and exposure with quick identification of patients with multidrug-resistant organisms (“MDROs”).

• Reduce time to isolation and risk of exposure.

• Focus on process and prevention efforts with the time saved.

Pharmacy Assistant™ is a consolidated workflow designed for pharmacists to achieve their overall department goals related to medication management. Pharmacists are empowered with clinical insights and the flexible tools necessary to help them:

• Analyze data on demand.

• Identify opportunities to optimize drug therapy in real time with alerts

· Streamline and facilitate reports on initiatives.

• Spot trends that could be missed by manual surveillance.

• Mitigate risk with quick identification of patients requiring intervention.

• Reduce time to intervention.

• Focus on process and prevention efforts with the time saved.

Maintenance and Support Requirements

The Offeror shall provide maintenance for the system application software as specified in this contract. The Offeror shall provide Service Level Agreements (SLAs) to meet the maintenance terms and conditions. The SLAs shall address but are not limited to the following elements: Service policies and procedures including security and software support, on call/on site service priorities, thresholds, response time, resolution/fix time, reporting and escalation procedures.

The Offeror shall grant, in accordance with the terms and conditions contained in this contract, a non-exclusive, irrevocable and subscription license to use the Software. This includes custom software products, e.g., interfaces, developed by the Offeror; custom software products will remain the intellectual property of the Offeror, but will be perpetually licensed to NIH under the same terms as the generally released software products.

The Offeror shall provide all fixes and patches to the Production System Problem occasioned by the maintenance call within forty-eight (48) hours of the maintenance call.

If the Production System is down or major portions of the system remain unavailable or patient safety is at risk, the Offeror shall provide the fix within two (2) hours of problem determination.

Production System Problem – major portions of system usable and mission critical workload can continue

In the event the Offeror makes generally available modifications to its software that were developed to address present or future requirements for NIH, such modifications shall be provided to the Government at no cost. The Offeror also agrees to provide updated documentation, user guides, and technical bulletins necessary to implement, use, and support such modifications at no cost to the Government.

During the life of the contract, the Offeror shall also provide regular enhancements to keep its Software current with the latest versions of operating system and other related Software.

The Offeror shall provide fixes and patches to software problems identified in maintenance calls or as provided to any other customers using the Software. If the fix or patch provided by the Offeror in response to a maintenance call is a permanent fix, then the Offeror shall provide a permanent correction of the errors and applicable documentation at no additional cost to the Government.

Period of Performance

Base Year: October 1, 2025 to September 30, 2026 Option Year 1: October 1, 2026 to September 30, 2027 Option Year 2: October 1, 2027 to September 30, 2028

Section 508

Section 508 does not apply to this requirement. All Electronic and Information Technology (EIT) procured through this procurement must meet the applicable accessibility standards at 36 CFR 1194, unless an agency exception to this requirement exists. 36 CFR 1194 implements Section 508 of the Rehabilitation Act of 1973, as amended, and is viewable at http://accessboard.gov/sec508/508standards.htm Part 1194. Contractors are now responsible for indicating on each line item in the procurement whether products or services are compliant or noncompliant with the accessibility standards at 36 CFR 1194

Place of Performance

Delivery Location, Schedule, and Instructions

Shipment of deliverable items specified in the Scope of Work shall be delivered to the National Institutes of Health, Clinical Center within thirty (30) calendar days after receipt of Purchase Order. The delivery must be noted as an inside delivery to the address listed below.

Department of Clinical Research Informatics 10 Center Drive, Room 1c290 Bethesda, MD. 20892

Government Furnished Equipment (GFE)

There are no government furnished equipment requirements for this order.

Acceptance Criteria

The items listed in the scope of this document must be received and in full working order to be accepted as final by the Clinical Center.

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