A05 - SOW_Paperless Medication Guides.pdf

Statement of Work (SOW)

1. PROJECT TITLE: Paperless Medication Guide Solution for Billings Area IHS Pharmacy Programs

2. BACKGROUND/PURPOSE:

The Indian Health Service (IHS) Billings Area Pharmacy Programs require a paperless medication guide and patient education solution to provide FDA-required Medication Guides (MedGuides) for applicable prescription medications. Federal regulations and accreditation standards require that Medication Guides be made available to patients when specified medications are dispensed.

The purpose of this contract is to implement and maintain an Area-wide digital solution that enables patients and caregivers to access Medication Guides electronically at the point of dispensing. The solution shall support regulatory compliance, enhance patient education, and improve pharmacy workflow efficiency while minimizing reliance on paper distribution and manual processes.

3. SCOPE:

This Statement of Work covers the provision, implementation, and ongoing support of a paperless medication guide and patient education solution for Billings Area IHS pharmacy programs. The solution shall provide FDA-compliant Medication Guides in a digital format and be compatible with existing pharmacy management and prescription labeling systems used across Billings Area facilities.

The scope includes initial setup, configuration, training, and ongoing access to digital Medication Guides and related patient education content throughout the period of performance. The solution shall not require access to patient medical records, electronic health records, RPMS, or other systems containing protected health information.

Standalone or manual solutions that require pharmacy staff to separately distribute or manage Medication Guides outside of existing dispensing workflows do not meet the requirements of this Statement of Work.

4. APPLICABLE DOCUMENTS:

The Contractor shall comply with all applicable federal laws, regulations, and policies, including but not limited to:

• Food and Drug Administration (FDA) requirements for Medication Guides

• Federal Acquisition Regulation (FAR)

• HHS Acquisition Regulation (HHSAR)

• Applicable IHS and HHS information security and privacy requirements

5. CONTRACTORS RESPONSIBILITIES:

The Contractor shall:

• Provide a paperless medication guide solution that delivers FDA-required Medication Guides in a digital format.

• Ensure compatibility with ScriptPro pharmacy management and prescription labeling systems used by Billings Area IHS pharmacies to support automated, point-of-dispensing access to FDA-required Medication Guides without manual intervention.

• Provide access to Medication Guides through QR codes linked to medication identifiers.

• Maintain current and accurate Medication Guides, including updates reflecting

FDA labeling changes.

• Provide initial training and documentation for IHS pharmacy staff.

• Provide ongoing technical support and system maintenance throughout the period of performance.

• Ensure the solution does not access, store, or transmit patient-specific health information.

6. GOVERNMENT-FURNISHED EQUIPMENT AND INFORMATION:

The Government will provide access to existing pharmacy workflows, prescription labeling processes, and facility-specific contact information as necessary for implementation. No Government-furnished equipment is anticipated.

7. PLACE OF PERFORMANCE:

Services shall be performed remotely, except as necessary to support implementation across the Billings Area IHS pharmacy locations listed below. Patient access to Medication Guides shall be web-based.

Blackfeet Service Unit:

Blackfeet Community Hospital 761 Hospital Drive Browning, MT 59417

Heart Butte Health Station 81 Disney St.

Heart Butte, MT 59448

Crow Service Unit:

Crow/Northern Cheyenne Hospital 10111 South 7650 East Crow Agency, MT 59023

Lodge Grass Health Clinic 418 Harding Ave Lodge Grass, MT 59050

Pryor Health Station 2 Pryor Gap Road Pryor, MT 59066

Fort Belknap Service Unit:

Fort Belknap Hospital 670 Agency Main Street Harlem, MT 59527

Eagle Child Health Station 123 Whitecow Canyon Road Hays, MT 59527

Fort Peck Service Unit:

Verne E. Gibbs Health Center 108 H St E Poplar, MT 59256

Chief Redstone Clinic 550 6th Ave N Wolf Point, MT 59201

Northern Cheyenne Service Unit 420 N. Cheyenne Ave Lame Deer, MT 59044

8. PERIOD OF PERFORMANCE:

Base Period: June 1, 2026 – May 31, 2027

Option Year 1: June 1, 2027 – May 31, 2028

Option Year 2: June 1, 2028 – May 31, 2029

Option Year 3: June 1, 2029 – May 31, 2030

Option Year 4: June 1, 2030 – May 31, 2031

9. SECURITY:

The Contractor shall comply with all applicable IHS and HHS information security requirements. The solution shall not require access to, storage of, or transmission of protected health information (PHI) or personally identifiable information (PII). Any system access shall be limited to publicly accessible educational content.

10. QUALITY ASSURANCE:

The Government will monitor Contractor performance through review of deliverables, system availability, responsiveness to support requests, and compliance with the requirements of this Statement of Work. Acceptance of services shall be based on successful delivery of required functionality and adherence to contract terms.

11. INVOICE SUBMISSION AND PAYMENT:

Invoices shall be submitted through the Invoicing Processing Platform (IPP), a secure, web-based electronic invoicing system provided by the U.S. Department of the Treasury’s Bureau of the Fiscal Service, in partnership with the Federal Reserve Bank of St. Louis. The use of IPP shall take precedence over previously established invoicing procedures in accordance with HHSAR 352.232-71, Electronic Submission and Processing of Payment Requests”. The IPP website address is: https://www.ipp.gov.

Supporting documentation and invoices must be submitted no later than the 30th workday of the month after services have been provided. Changes or corrections shall be submitted by separate invoice. In addition to information required for submission of a “proper” invoice in accordance with FAR 52.212-4 (g) all invoices must include:

1. Invoice Date and Number

2. Contract Number

3. Charges for service or products identified BY LINE ITEM Number

4. Brief description of products or services rendered

5. Charges should follow Line Item structure on contract to include Quantity, Unit of Issue, Unit Price, and Total Amount as applicable

6. Dates of Service or Shipment

Invoices shall be prepared and submitted electronically and in accordance with rates and terms as stated in the contract. Invoices shall be submitted electronically in IPP through the US Treasury. Notification and a copy of the Invoice shall be submitted to:

COR: angela.troutt@ihs.gov; a copy of the invoice should be sent electronically to the COR at the address listed above.

12. CONTRACTING OFFICER AUTHORITY:

Authority to negotiate changes in the terms, conditions or amounts cited in this contract is reserved for the Contracting Officer.

13. SECTION 508 AND ACCESSIBILITY:

All Information and Communication Technology (ICT) deliverables under this contract (e.g., websites, applications, electronic documents, and multimedia) must comply with the Revised Section 508 Standards (36 CFR Part 1194) and the Web Content Accessibility Guidelines (WCAG) 2.1 Level AA standards. The Contractor shall ensure accessibility of all ICT deliverables and provide conformance documentation in the form of a Voluntary Product Accessibility Template (VPAT®) / Accessibility Conformance Report (ACR), or by completing the HHS Section 508 Accessibility Checklists. Although the Revised Section 508 standards reference WCAG 2.0 Level AA, HHS requires vendors to meet the updated WCAG 2.1 Level AA criteria. The current VPAT 2.5 template includes fields for reporting conformance to WCAG 2.1 and shall be used to document accessibility. The Contractor shall remediate any identified accessibility issues at no additional cost. The Contracting Officer will include the applicable Health and Human Services Acquisition Regulation (HHSAR) clauses 352.239-73 and 352.239-74 in the solicitation and resulting contract.

This product must conform to the Revised Section 508 (https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines) and WCAG 2.0 Level AA standards as outlined below.

Solicitations for supplies and services shall require the submission of a Section 508 Product Assessment Template. The template can be found at https://www.itic.org/policy/accessibility/vpat.

mailto:angela.troutt@ihs.gov