Att K - SOW.docx

RFP # 27-88055 Metabolic Formula for Clinics Exhibit A

STATEMENT OF WORK

I. EXECUTIVE SUMMARY

The Indiana Department of Health (IDOH) is required by statute and regulation to provide metabolic formula to any individual who was identified through newborn screening to have an inborn error of metabolism. The overall vision of the metabolic formula program is to provide metabolic formula directly to the individual’s residence in a timely, efficient, and affordable manner.

II. BACKGROUND AND CURRENT STATE

The Indiana Department of Health currently relies on five (5) separate vendors to supply and ship metabolic formula directly to patients’ residences. While this approach ensures continuity of service, it requires multiple vendor relationships and individualized coordination to maintain compliance with statutory obligations. Any lapse in these services would directly jeopardize patient access to medically necessary metabolic formula, placing individuals at significant health risk.

III. SCOPE OF WORK

1. Objectives of the Engagement To fulfill the vision, the IDOH metabolic formula program expects the following from the contracted vendor:

i. Make available the MMCAP pricing for the complete line of prescription metabolic formulas from Abbott, Ajinomoto Cambrooke, Mead Johnson, Nutricia, and Vitaflo.

1. Respondent must be able to supply all items that are listed within attachment here: IDOH Metabolic Formulary updated 2026.07.09-COPY 1 due to the essential nature of these products for individuals on the program to meet their dietary needs.

ii. IDOH representative will place the individual’s metabolic formula order based on clinical guidance from partner organizations. Participants on the program have individual needs based on their specific condition and preference in consultation with their dietician.

iii. Ship metabolic formula directly to the individual’s home residence within one business day of placing the order. See Key Performance Indicators section for additional information.

iv. Ensure all individual residence information is kept confidential, not disclosed to unauthorized parties, and maintained in a secure database. See Compliance Requirements section for further details.

v. Provide tracking information including order confirmation, shipping notification, delivery confirmation, and any delay notifications to appropriate IDOH contact via a mutually agreed upon secure, encrypted method.

vi. Ensure all orders placed by IDOH are invoiced promptly after the order is placed and shipped, and at a minimum on a monthly basis.

2. Deliverables The Contractor shall provide, at a minimum, the following deliverables. Each deliverable must include the required compliance evidence and will be subject to formal review and approval by the State. Deliverables should be submitted in both editable and PDF formats and stored in a state-owned repository. Deliverables with Acceptance Criteria include, but are not limited to:

i. Project Management Plan (PMP) A concise plan outlining how the Contractor will coordinate, communicate, and manage order intake, delivery workflows, issue escalation, and quality controls throughout the contract.

Acceptance Criteria:

· Delivered within the required timeframe.

· Includes schedule, staffing roles, communication plan, risk/escalation process, quality approach, and change‑control method.

· Clearly describes order intake workflow and delivery coordination with IDOH.

· Submitted in editable and PDF formats.

· Approved in writing by IDOH.

ii. Monthly KPI Performance Report A monthly report showing measurable delivery performance, including timeliness, accuracy, and exceptions for all metabolic formula orders.

Acceptance Criteria:

· Submitted by the 10th calendar day of each month.

· Includes order IDs, confirmation timestamps, shipment timestamps, delivery timestamps, and exception codes/reasons.

· Accurately calculates one‑business‑day delivery compliance.

· Uses minimum necessary PII/PHI and applies de‑identification where feasible.

· Submitted in editable and PDF formats.

· Accepted by IDOH upon verification of completeness and accuracy.

IV. PROJECT MANAGEMENT

The Contractor shall deliver an initial draft of the Project Management Plan (PMP) upon execution of the contract. A final PMP shall be submitted no later than 15 days after the execution of the contract, subject to State review and approval.

The PMP shall be appropriate to the scope of services defined in this Statement of Work and shall include:

· A schedule outlining key milestones, including onboarding, system setup, communication protocols, and commencement of order fulfillment.

· A project organization chart or staffing overview identifying primary Contractor contacts and roles responsible for order management, coordination, issue resolution, and reporting.

· A communication plan that defines methods, points of contact, and expected responsiveness for coordination between the Contractor and IDOH.

· An issue and risk management process, including escalation paths for any disruptions affecting ordering, delivery, or compliance with required timeframes.

· A quality management approach describing how the Contractor will ensure timely, accurate order processing, proper handling of patient information, and adherence to delivery requirements.

· A change control process for reviewing and approving any modifications to processes, contacts, or deliverables during the contract term that is not already outlined in the Contract.

The PMP shall be updated as necessary throughout the contract and will remain subject to State approval.

V. COMPLIANCE REQUIREMENTS

1. Statewide IT Policies, Procedures, and Standards The State has robust and comprehensive security standards that permeate all levels of the organization. The Indiana Office of Technology (IOT) has been tasked with establishing and maintaining these security standards. The security standards include assessing security risks, developing, and implementing effective security procedures, and monitoring the effectiveness of those procedures. If the proposed solution involves information technology-related products or services, all such products or services are to be compatible with any of the technology standards found in the Statewide IT Policies, Procedures, & Standards (https://www.in.gov/iot/policies-procedures-and-standards/) that are applicable, including the assistive technology standard. The Contractor will be required to sign a Non-Disclosure Agreement (NDA) to access the more sensitive standards and policies. The Contractor should review the Statewide IT Policies, Procedures, & Standards and ensure their proposed solution meets all standards therein.

2. Artificial Intelligence Standards The State has adopted an enterprise-level policy governing the use of Artificial Intelligence (AI) within state government. The State’s AI Policy is issued and monitored by the Office of the Chief Data Officer (OCDO), in cooperation with the Chief Privacy Officer (CPO) and the Management Performance Hub (MPH). As a complement to the AI Policy, the State Agency Artificial Intelligence Systems Standard outlines the rationale behind the AI Readiness Assessment Process required for the implementation or any use of AI by a state agency. That Standard outlines the requirement for the submission of a Readiness Assessment Questionnaire prior to implementation or use of an AI tool or system. Any proposed solution meeting these requirements must support the State’s AI Policy and follow the AI Readiness Assessment Process. See https://www.in.gov/mph/AI/ for more detailed information.

VI. KEY PERFORMANCE INDICATORS

The State will use Key Performance Indicators (KPIs) to measure performance and outcomes of the Contract. The specific KPIs and their targets will be defined and agreed upon by the State and the Contractor during the initial phases of the requirements under the Contract. At a minimum, on time delivery at quality standards of the scope provided within the budget set forth in the Contract will each be measured.

1. Net Promoter Score The State will collect a modified Net Promoter Score from customers to this Contract in its discretion. Low ratings on the modified Net Promoter Score or failure to meet any other KPIs may be deemed, at the discretion of the State, to constitute default under the Contract.

2. Order Processing and Delivery The Contractor shall ensure all metabolic formula orders are delivered to the patient’s residence within one (1) business day of the order confirmation timestamp. For purposes of this Contract, a Business Day means 8:00 AM to 5:00 PM Eastern Time, Monday through Friday, excluding State‑recognized holidays. Orders received and confirmed by 3:00 PM Eastern shall be required to be delivered by the end of the next Business Day. Orders confirmed after 3:00 PM Eastern shall be required to be delivered by the end of the second Business Day. The Contractor shall time‑stamp order receipt/acceptance and apply this definition for KPI measurement. Compliance with this KPI will be monitored and enforced through the following requirements:

i. Order Confirmation Timestamp The Contractor shall provide an electronic confirmation for each order, including the exact date and time the order was received and accepted for fulfillment. This timestamp initiates the one (1) business day delivery requirement.

ii. Shipment Notification The Contractor shall provide shipment notification for each order, including shipment date and time, carrier information, tracking number, and service level. Shipment must occur early enough to ensure delivery within one (1) business day of the order confirmation timestamp.

iii. Delivery Confirmation (Primary KPI Measure) The Contractor must provide proof of delivery for each order, including delivery date and time and carrier‑verified confirmation. Delivery must occur within one (1) business day of the order confirmation timestamp.

iv. Monthly KPI Reporting The Contractor shall submit a monthly performance report that includes:

1. Total number of orders received

2. Percentage of orders delivered within one (1) business day

3. Percentage of orders shipped in time to support one‑day delivery

4. A list of exceptions with documented reason(s)

v. Exception Handling Exceptions attributable to the Contractor (e.g., processing delays, inventory issues, shipping method selection not capable of meeting one‑day delivery) shall count against KPI compliance. Exceptions outside the Contractor’s control (e.g., invalid addresses, patient‑provided errors, carrier‑verified force majeure events) may be excluded at the State’s discretion.

vi. Audit Rights The State reserves the right to audit Contractor records, including order confirmation timestamps, shipment details, tracking information, and delivery confirmations to validate KPI compliance. The Contractor shall maintain complete and accurate records supporting all reported metrics.

vii. Performance Deficiency and Remedies Failure to meet the delivery KPI shall be considered a performance deficiency and may trigger corrective action or other remedies outlined in the Contract. Repeated failure to meet this requirement may constitute contractor default.

VII. END OF CONTRACT TRANSITION AND TURNOVER

The Contractor shall develop a turnover plan within six months of Contract execution, detailing activities for transferring responsibilities, non-proprietary components, data, and operational documentation to the State or its agent. The turnover plan shall be mutually maintained throughout the term of the Contract. The Contractor shall maintain mutually agreed upon staffing levels during turnover and commence training and shadowing four months prior to contract end for staff who will assume operations. The State will approve the designated Turnover Manager. The Contractor shall provide a knowledge transfer checklist (for example procedures, contacts, training materials) and deliver a data disposition certificate confirming deletion or return of State data within six months after contract completion unless otherwise agreed.