55- Solicitation 12258238 PWS.docx

DEFENSE HEALTH AGENCY

Performance Work Statement (PWS) Area Under the Curve (AUC) based vancomycin dosing tool using Bayesian modeling at Walter Reed National Military Medical Center (WRNMMC) 23 April 2025

1.0 PURPOSE

The purpose of this Performance Work Statement (PWS) is to acquire a Bayesian algorithm to calculate precise dosing regimentregimen in order to predict future AUC or serum levels as well as a toxicity probability function to be used within the Department of Pharmacy to accurately track and speculate vancomycin dosages for affected patients at Walter Reed National Military Medical Center (WRNMMC). This tool will support precision antimicrobial dosing using Area Under the Curve (AUC)-based pharmacokinetic modeling, enabling evidence-based, patient-specific vancomycin therapy that aligns with 2020 IDSA/ASHP therapeutic guidelines.

2.0 BACKGROUND

Vancomycin is a first-line antimicrobial agent for serious gram-positive infections, including methicillin-resistant Staphylococcus aureus (MRSA). Traditional dosing strategies based on trough concentrations have been replaced by AUC-guided approaches to enhance therapeutic efficacy while reducing nephrotoxicity. This is especially important in the critical care patient population, in which reaching therapeutic levels quickly is critical for optimal patient outcomes. WRNMMC seeks to implement a software platform to standardize and automate vancomycin AUC calculations, improve dosing precision by accommodating actual administration times of vancomycin doses, support antimicrobial stewardship, and reduce provider, and pharmacy staff workload. Additionally, bayesian software platform reduce workload for nursing staff associated multiple serum level sampling and costs for additional laboratory tests to be performed.

3.0 SCOPE

The contractor shall provide a secure, cloud-based software platform capable of the following tasks:

Drug Modules

· Robust, literature-curated pharmacokinetic models, available now and in the future

· Novel, curated models created from our internal data network (ahead of publication)

· Dose Assist℠

· Real-time PK advisories

· Efficacy and toxicity assessments

· Dosing regimens note generation (free-text and PDF)

· Customizable treatment course tags

· Incorporation of time-dependent PK covariates

· Pharmacogenetics (if applicable) Software as a Service Platform

· Real-time, interactive analytics dashboard, including:

· Patient demographics charts

· PK target attainment plots

· Clinical outcomes graphs

· Operational and sampling metrics Professional Services

· Implementation Model building, learning, validation and research

· Clinical Review and Protocol Enhancement

· Supporting AUC-based vancomycin dosing using Bayesian modeling

· Enabling real-time access to patient data (e.g., lab results, dosing history)

· Providing dose optimization recommendations to clinical staff

· Provide toxicity prediction with recommended dose

· Generating clinical documentation and dosing reports

· Supporting pharmacists, prescribers, and ASP stakeholders with tailored interfaces

· Ensuring compliance with HIPAA, DoD Cybersecurity, and DHA Risk Management Framework (RMF) standards if and whenever applicable.

· Web-based SaaS security requirements: No PHI or PII entered into calculators, only birth year and weight

4.0 OBJECTIVES AND TASKS

· Toxicity index: Clinical decision support includes predicted probability of toxicity associated with a specific dosing regimen considering the patient-to-patient variability this drug exhibits. This is the application of precision medicine to optimize patient safety outcomes in a drug that has narrow therapeutic window. Specifically, this feature allows end-user to pick a regimen not only predicted to achieve targets for clinical success but also associated with the lowest incidence of kidney injury (up to 30% among our beneficiaries). Vancomycin associated nephrotoxicity is associated with poor clinical outcomes including mortality, prolonged hospitalization, need for high level care requiring hemodialysis support and ultimately high healthcare cost per admission.

· Joint Commission requirement, accountability and tracking for vancomycin guideline adherence.

· IT support/data analysis that allows for in-depth analysis of clinical outcomes, user-specific productivity statistics, and other operational metrics such as therapy use day and associated cost.

4.1 Software Implementation

· Configure and deploy the AUC-based vancomycin dosing using Bayesian modeling for WRNMMC’s vancomycin therapeutic drug monitoring program

· Ensure tool is accessible via WRNMMC’s secure clinical network and user access is role-based

· Access to the software platform is classified as a Service as a Software (SaaS) and is performed via a website url.

4.2 Integration with EHR

· WRNMMC not seeking bi-directional integration with MHS Genesis in lieu of access to service via website platform

· Provide bi-directional integration with MHS GENESIS in case WRNMMC seeks this feature in the future.

· Enable manual or automatic import of demographic, dosing, and laboratory data based on the mode of platform.

4.3 Training and User Support

· Provide virtual or on-site training for clinical pharmacists, ASP personnel, prescribers, and supporting staff

· Deliver training materials, videos, and user guides

4.4 Technical Support and Maintenance

· Ensure responsive technical support with 24/7 availability for critical issues

· Provide ongoing platform updates, feature enhancements, and cybersecurity patches where applicable

· Support team must include Subject Matter Experts with expertise in Pharmacokinetics, and credentialed as PharmD, FRCP, MPH

4.5 Compliance and Security

· Ensure full compliance with federal health information privacy and cybersecurity standards, including HIPAA, NIST 800-53, and RMF accreditation requirements if and when platform is integrated with MHS Genesis. Current contract seeks website platform which bypasses this requirement.

· NO DoD CUI or PII / PHI will be entered into web-based SaaS system.

5.0 DELIVERABLES

Special Qualifications: Support team must include Subject Matter Experts with expertise in Pharmacokinetics, and credentialed as PharmD, FRCP, MPH

6.0 PERIOD OF PERFORMANCE

· The base period of performance shall be 12 months from the date of award, with four (4) one-year option periods.

7.0 PLACE OF PERFORMANCE

· Walter Reed National Military Medical Center 8901 Rockville Pike, Bethesda, MD 20889

· Remote work authorized for integration, support, and training personnel in compliance with DHA IT policy

8.0 SECURITY REQUIREMENTS

All software and services must comply with security requirements:

· Web-based solution. No PHI will be stored or transmitted outside of government-authorized systems

9.0 POINTS OF CONTACT

· Program Manager: TBA

· Contract Officer Representative (COR): TBA

· Contract Specialist: Ms. Cinthia Funes

· cinthia.g.funes.civ@health.mil

· Contracting Officer: Ms. Erica Oh

· erica.s.oh.civ@health.mil