SOW Bayesian Software 02.docx

Statement of Work (SOW) Electronic Drug Reference Subscription

1. Introduction and Overview

This statement of work is for a subscription to a Bayesian-guided medication dosing software from a contractor that can provide licensing rights. This subscription is to ensure clinicians have access to a reliable web-based therapeutic drug dosing and monitoring tool for complex clinical situations that require careful drug therapy evaluation and adjustment in a systematic and efficient manner. The software will include important pharmacokinetic parameters and empiric and patient-specific dosing recommendations; allow for graphical prediction and projection of theoretical doses at any drug dosing interval in order to optimize and achieve therapeutic drug levels; provide local storage of data and references for primary literature of clinicals models used; and lastly, be highly customizable, HIPAA and GDPR compliant, and meet VA information security requirements by only providing patient de-identification information on the web-based platform. Must be fully compliant with the IDSA/ASHP Vancomycin 2020 guidelines.

2. Background

Intravenous vancomycin remains an important first-line antibiotic used for treatment of serious methicillin-resistant Staphylococcus aureus (MRSA) infections. Recent Consensus Guidelines (Rybak MJ et al, AM J HEALTH-SYST PHARM, March 2020) for vancomycin therapeutic monitoring now recommend vancomycin dose optimization preferably using a Bayesian-guided software to achieve individualized targeted concentrations that maximize clinical efficacy while minimizing renal toxicity. Veterans Affairs Healthcare Systems are complex in scope of services; thus, clinical providers require access to a validated, systematic, and intuitive clinical tool to dose and monitor drug therapy safely.

3. Scope of Work

a. The contractor shall provide all resources necessary and have an established Business Associate Agreement with the Department of Veterans Affairs to meet requirements and accomplish the deliverables described in this statement of work (SOW), except as may otherwise be specified.

b. The contractor shall provide uninterrupted licensing and subscription services to a Bayesian-guided medication dosing software as stated herein for clinical staff within the VA Salt Lake City Health Care System.

4. Performance Period Contract will start December 12/1/2026 to 11/30/2027 with four 12-month renewal options.

Period(s) of Performance:

12/1/2026 to 11/30/2027 Base Year 12/1/2027 to 11/30/2028 Option Year 1 12/1/2028 to 11/30/2029 Option Year 2 12/1/2029 to 11/30/2030 Option Year 3 12/1/2030 to 11/30/2031 Option Year 4

5. Requirements

a. License rights to a web-based pharmacokinetics medication dosing software program from a contractor that can provide license rights equivalent to or exceeding the product listing offered by the proprietor.

b. Web-based program that can be found from any web browser with an internet connection.

c. Capability to integrate into VISTA and CERNER electronic health record (EHR) so the tool can automatically retrieve all required data available in the hospital’s health records and use to provide estimated dosing recommendations.

d. Provide input data storage capability with database searchable by patient name, patient identification, drug name, or date.

e. Unlimited and simultaneous user access must be available online 24 hours a day 7 days a week via web from any government owned equipment (authenticated by IP address) as well as remote access for virtual employees.

f. Provide capable de-identify patient data base for VA population

g. Software to include additional drug specific factors that may influence the patient’s pharmacokinetic profile or dosing regimen such as amputation, obesity, pregnancy, critically ill, burn patient, hematology/oncology patient, spinal cord injury, cystic fibrosis, significant drug-drug interactions, and drug-disease state interactions.

h. Software to include the option to incorporate patient specific data points age, gender, weight, height, renal function, dosage history, drug serum concentrations, dialysis history, and previous vancomycin history.

i. Software to display population pharmacokinetic parameters details such as clearance, volume of distribution, half-life, etc.

j. Drug monitoring to include serum level graphs with options to display population data, individual/patient specific data, therapeutic range, toxicity and serum levels.

k. Include ability to specify therapeutic targets (AUC, trough, peak) and receive recommended dose and interval based on selected target.

l. Ability to propose recommended dosing regimens with and without patient serum drug levels, with ability to incorporate non-steady state and irregular situations.

m. Program to provide warning to user if there is detection of a potentially toxic dose, serum level, or if outside recommended AUC range.

n. Program to have option for inter-site sharing of patient case data including drug dosing and monitoring information

o. Access to all drug kinetics offered within the program and any new drug kinetics added in the future.

p. Software to include Veteran population kinetic model using data based on the VA's specific population; model should be updated quarterly at a minimum; includes Vancomycin, Aminoglycosides, Antibiotics, Anticonvulsants, Antiarrhythmic, Antifungal, Oncology, Transplants medications.

q. Reports and data analytics to be made available to users quarterly for users to access, download and/or print.

r. Ability to generate patient specific and population reports that are customizable by the user.

6. Tasks and Associated Deliverables

a. The contractor shall provide a detailed proposal responsive to this SOW. All written deliverables shall be phrased in layperson language. Statistical and other technical terminology shall not be used without providing a glossary of terms.

b. The contractor shall provide uninterrupted licensing and subscription services to an electronic medical reference as stated herein.

c. The contractor shall provide product training, online tutorials, and promotional material.

d. Contractor shall also provide unlimited support via virtual training performed by a person with a clinical background during implementation.

e. Contractor shall provide technical support numbers. Customer service shall be available to provide unlimited technical support 24 hours a day, 7 days a week to troubleshoot website/connectivity issues. The contractor is expected to troubleshoot access as needed.

f. The contractor shall have the ability to provide usage statistics on a quarterly basis. The format of the usage statistics is provided either via email or contractor provided login.

g. Contractor to provide support documentation tools, such as clinical or technical manual.

7. Evaluation

Contractors shall allow a pre-identified panel of subject matter experts access to the Bayesian-guided medication dosing software to for evaluation purposes. Evaluation factors will be based on requirements and deliverables in this SOW, with focus of factors in section 5 “Requirements” of this SOW. A standardized list of evaluation factors will be used to evaluate requirements listed in this SOW.

8. Changes to Statement of Work Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

9. Travel The contractor is responsible for any travel expenses related to on-site training or other customer service tasks associated with deliverables.

10. Invoicing and Payment The contractor shall submit in arrears a properly completed itemized invoice in accordance with FAR clauses 52.212-4(g) Contract Terms and Conditions – Commercial Items via Tungsten Network, http://www.tungsten-network.com/US/. Invoices submitted for payment shall be reviewed for accuracy and shall be subject to approval by the Government prior to issuance of payment.

The invoice MUST be itemized to include the following information:

1. Facility name and address where service was provided

2. Contract number

3. Purchase order number

4. Hours

5. Cost

6. Date

No advance payments shall be authorized. Payment shall be made on a monthly arrears for services provided during the billing month in arrears in accordance with FAR 52.212-4, para. (i) Upon submission of a properly prepared invoice for prices stipulated in this contract for services delivered and accepted in accordance with the terms and conditions of the contract, less any deductions stipulated in this contract.

Payment of invoices may be delayed if the appropriate invoices as specified in the contract is not completed and submitted as required.