Att K - Scope of Work - rtp.pdf

Attachment K: Scope of Work RFP 26-86417 ISPHN Med Repack & Preventative Maintenance

Overview This section describes a comprehensive 12-month Consumables Service Plan for the medication repackaging equipment listed below. This plan covers preventive maintenance, software license updates, and staff training that support ongoing operation of medication repackaging systems.

Some units are aging and might need replacement during the service period, while newer units remain fully serviceable.

The service plan supports continuity of medication-repackaging operations at ISPHN facilities currently using the covered equipment, including Evansville, Madison, Richmond, and the NeuroDiagnostic Institute. These services support safe, compliant, and reliable operation of the medication-repackaging systems. Healthcare regulations and sanitation standards, including those set by The Joint Commission and the Centers for Medicare and Medicaid Services (CMS), govern services provided within ISPHN facilities.

Definitions

• Business Hours: 8:00 a.m. to 4:30 p.m. local time, Monday through Friday, excluding State holidays.

• Installation Notice: A formal written confirmation of successful product or system installation, documenting completion of the installation phase.

• Priority 1 (critical) failure: A complete equipment outage or safety-critical fault that prevents operation.

• Standard Operating Procedure (SOP): A detailed document outlining specific processes, procedures, supplies, and equipment required to consistently achieve the desired outcome.

Contractor shall:

Service Requirements Functional Requirements

• Maintain and extend the useful life of packaging equipment through routine preventive maintenance and prompt repairs, including ensuring that all software, firmware, and device-level configurations comply with the Statewide IT Policies, Procedures & Standards as applicable.

• Apply a facility-specific approach that accounts for differences in equipment configuration, operational workflow, and site-level requirements.

• Ensure data integrity, traceability, and compliance with federal and state pharmaceutical regulations.

• Provide consumables for purchase as needed to support uninterrupted and accurate packaging operations.

• Deliver hands-on training and clear documentation to empower pharmacy, information technology, and maintenance staff.

• Respond to all service requests within one (1) business day.

Performance Standards

• Schedule preventive maintenance visits requested by the State within thirty (30) business days;

contractor-initiated annual preventive maintenance visits are not subject to this scheduling window.

• Ship consumables within five (5) business days of order.

• Comply with all applicable healthcare regulations and sanitation standards, including those set by

The Joint Commission and CMS, as well as ISPHN policies and any facility-specific policies and operating procedures.

• Priority 1 (critical) failures must be resolved within 24 hours, with diagnostics and escalation handled in accordance with the Emergency Response & Repairs section.

Delivery & Facility Coordination Supplies and Consumables

• Ship all consumables specified in the Rate Chart in Exhibit 2 within five (5) business days of order, with no minimum purchase required. Failure to comply subject to service-level remedies as defined within the Contract.

• Ensure all items are sealed, labeled with lot numbers, meet manufacturer specifications, and comply with applicable safety standards.

Preventive Maintenance Service Plan

• Conduct annual on-site visits at each facility in accordance with manufacturer guidelines.

• Perform calibration, lubrication, mechanical inspections, barcode scanner checks, and software diagnostics.

• Replace filters, belts, and other wear items as recommended in the manufacturer’s preventive maintenance checklist at no additional cost.

Software Licensing and Updates

• Provide and renew appropriate software licensing for hospital equipment, ensuring access to the latest available version.

• Obtain State approval prior to installation of any software updates.

• Coordinate installation of software updates within 30 calendar days of State approval.

IT Standards and Compliance Requirements The Contractor shall comply with all applicable Indiana Office of Technology (IOT) standards. The following requirements are mandatory for any solution containing software, data exchange, or authentication components:

Accessibility (WCAG 2.1 AA) The solution must comply with WCAG 2.1 AA and support assistive technologies. The State may conduct accessibility audits and require remediation at no additional cost.

Data Exchange Standards All data exchanges must comply with State standards, including MuleSoft API Management for APIs and GoAnywhere Managed File Transfer (MFT). Interfaces must follow State-approved patterns for schemas, authentication, and error handling.

Authentication via Access Indiana All user-facing authentication components, if applicable, must utilize Access Indiana SSO unless an approved exception is granted by IOT.

Payment Processing Requirements If the solution involves payment processing, it must use State-approved processors or fully comply with PCI-DSS if outside statutory authority and approved by IOT.

Solution Configurability and Customization Preference The State requires a configuration-first approach. Customizations may only be proposed when configuration cannot satisfy requirements and must be approved in writing by the State. Vendor must document evaluation of out-of-the-box and configuration options before any customization request.

Installation, Setup, and Training

• Perform initial installation or re-installation of equipment modules as requested.

• Deliver one (1) day of on-site training per facility, covering:

o Daily operational procedures o Preventive maintenance tasks o Basic troubleshooting and emergency shutdown protocols

• Provide professionally designed and up-to-date user manuals, standard operating procedures, quick-reference guides, and training completion certificates.

Acceptance Criteria & Testing

• Demonstrate five (5) consecutive, error-free packaging cycles.

• Validate data traceability: scan barcodes end-to-end and verify database entries.

• Submit a signed Acceptance Certificate prior to invoicing for installation fees.

Emergency Response & Repairs

• Priority 1 (critical) failures must be resolved within 24 hours, with immediate telephonic diagnostics provided within two (2) hours of notification and escalation to on-site corrective maintenance if unresolved.

• Provide immediate telephonic diagnostics upon notification; escalate to on-site corrective maintenance if unresolved within two (2) hours.

• Supply and install approved replacement parts at mutually agreed pricing.

Documentation & Reporting

• Provide maintenance logs detailing preventive, corrective, and emergency maintenance performed at the completion of each site visit.

• Installation Notices for new equipment, confirming successful acceptance testing.

• Delivery logs for hardware and consumables, linked to billing documentation.

• Updates on any corrective actions taken.

Independent Verification and Validation (IV&V) If the State decides to add Independent Verification & Validation (IV&V) services as part of this Contract, the Contractor will copy the Indiana Department of Administration (IDOA) – IV&V Team member(s) on all project related communications (emails, meeting invites, collaboration tools, etc.) and will grant access to all documents and deliverables throughout the term of the Contract. If IDOA elects to deploy IV&V services in connection with this engagement, the IV&V Team will review and assess all deliverables to determine compliance with the State’s requirements set forth in the Contract including the Statement of Work. For contracts entered into, renewed, or amended after June 30, 2026, the IV&V Team shall serve as an approving authority, and no payment shall be issued to the Vendor unless and until IV&V has provided such approval.

Contractor Qualifications

• Demonstrated experience servicing Auto-Print machines.

• Authorized service provider for Pak-EDGE® UD First Data Bank software.

• Proven ability to supply consumables on a recurring schedule.

State Responsibilities

• Provide secure, on-site access to equipment and facilities.

• Coordinate staff availability for training and maintenance visits.

• Facilitate network access for software updates.

Deliverables & Key Performance Indicators (KPIs)

1. Consumables Supply KPIs:

• Consumables must be shipped within five (5) business days of order.

• All items must be sealed, labeled with lot numbers, meet manufacturer specifications, and comply with applicable safety standards.

• Delivery logs must be linked to billing documentation.

2. Preventive Maintenance & Repair of Packaging Equipment KPIs:

• Preventive maintenance visits must be scheduled within 30 business days of request.

• Annual onsite visits shall be conducted in accordance with manufacturer guidelines.

• Each visit must include equipment calibration, lubrication, inspection, barcode verification, and software diagnostics.

• Replacement of wear items shall be provided at no additional cost to the State.

• Priority 1 (critical) failures must be resolved within 24 hours, with immediate telephonic diagnostics provided within two (2) hours of notification and escalation to on-site corrective maintenance if unresolved.

• Provide maintenance logs detailing preventive, corrective, and emergency maintenance performed at the completion of each site visit.

3. Software Licensing & Updates KPIs:

• Maintain current licensing for all covered equipment.

• Install approved software updates within 30 calendar days of State approval.

4. Training & Documentation KPIs:

• Provide one (1) day of onsite training per facility.

• Training must include instructions on daily operations and preventive maintenance procedures.

• Provide professionally designed and up-to-date user manuals, standard operating procedures, quick-reference guides, and training completion certificates.

5. Optional Equipment Replacement at the State’s Discretion:

• The Contractor shall assist the State in identifying when replacement is more cost-effective than repair and shall document objective criteria for such determinations.

• The Contractor shall offer the State the option to buy new Auto-Print Plus (115V) 2.0 or the most current equivalent model at a fixed cost, inclusive of all applicable installation, training, and shipping and handling fees for each machine. This option may be exercised at the State’s discretion during the contract term.

• The option includes software licensing, training, and acceptance testing.

• The option includes any Indiana State Psychiatric Hospital Network (ISPHN) location, including Evansville State Hospital, Madison State Hospital, Logansport State Hospital, Richmond State Hospital, and/or NeuroDiagnostic Institute.

• Acceptance testing shall consist of five (5) consecutive error-free packaging cycles, validated barcode traceability, and signed Acceptance Certificate prior to invoicing.

• The State may purchase any number of replacement units at its discretion during the contract term, with no limit on quantity.

Equipment Inventory & Locations Below is an inventory of equipment and specifications, listed by facility. The Contractor shall accommodate inventory or facility changes, including additions such as Logansport State Hospital, as requested during the contract term.

Facility Address Equipment Evansville State Hospital

3400 Lincoln Avenue Evansville, IN 47714

AutoPrint Unit Dose System Model 1179, Mfg date 3/2008.

Control module model 9300 series 1

Madison State Hospital

711 Green Road Madison, IN 47250

Mfg date 1/2020.

NeuroDiagnostic Institute

5435 E. 16th St.

Indianapolis, IN 46218

Mfg date 1/2017.

Richmond State Hospital

498 N.W. 18th Street Richmond, IN 47374

Mfg date 09/2023.

Deliverables Table This table serves as a quick-reference overview of each contract delivery and its corresponding Key Performance Indicators. State and ISPHN staff may reference it to monitor performance and ensure all deliverables are fulfilled in accordance with the agreed standards.

# Deliverable Key Performance Indicators (KPIs) 1 Consumables Supply • Consumables must be shipped within five (5) business days of order.

• All items must be sealed, labeled with lot numbers, meet manufacturer specifications, and comply with applicable safety standards.

• Delivery logs must be linked to billing documentation.

2 Preventive Maintenance &

Repair of Packaging Equipment

• Preventive maintenance visits must be scheduled within thirty (30) business days of request.

• Annual onsite visits shall be conducted in accordance with manufacturer guidelines.

• Each visit must include equipment calibration, lubrication, equipment inspections, barcode verification, and software diagnostics.

• Replacement of wear items shall be provided at no additional cost to the State.

• Priority 1 (critical) failures must be resolved within 24 hours, with immediate telephonic diagnostics provided within two (2) hours of notification and escalation to on-site corrective maintenance if unresolved.

• Provide maintenance logs detailing preventive, corrective, and emergency maintenance performed at the completion of each site visit.

3 Software Licensing & Updates

• Maintain current licensing for all covered equipment.

• Install approved updates within 30 calendar days of State approval.

4 Training & Documentation • One (1) day of on-site training per facility.

• Training covers daily operation and preventive maintenance.

• Provide professionally designed and up-to-date user manuals, standard operating procedures, quick-reference guides, and training completion certificates.

5 Optional Equipment Replacement

• new Auto-Print Plus (115V) 2.0. or the most current equivalent model at a fixed cost

• Must include software licensing, training, and acceptance testing.

• Acceptance testing shall consist of five (5) consecutive error-free packaging cycles, validated barcode traceability, and signed Acceptance Certificate prior to invoicing.

KPI Compliance and Enforcement The Contractor shall meet all Key Performance Indicators (KPIs) identified in this Scope of Work. Failure to meet any KPI may require the Contractor to submit and implement a State-approved corrective action plan. Repeated or material failure to meet KPIs, or failure to implement corrective actions in a timely manner, may be deemed by the State to constitute a default under the Contract and may result in the remedies available to the State, up to and including termination of the Contract.

Exhibit 2 Financial Summary

Estimated Annual Usage-this will be used to compute the cost proposal.

Estimated Annual Usage is provided solely for the purpose of assisting Offerors in developing their cost proposals. The resulting contract shall not guarantee, require, or specify the quantity of any product ordered by individual facilities. All quantities listed represent the State’s estimated usage for a single contract year. For illustration, a listed Projected Annual Total of six (6) units reflects an estimated total of twenty-four (24) units over a four-year contract term. Annual Usage is expected to remain consistent for each contract year; however, actual orders may vary and shall be placed on an as-needed basis.

Item Description Unit of Measure

Evansville Madison Richmond NeuroDiagnostic Projected Annual Total

12-Month Preventive Maintenance Service Plan for one (1) packaging machine

EA 1 1 1 1 4

Pak-EDGE™ UD First Data Bank (1 Year/Renewal) for Pharmacy Unit Dose packaging equipment

EA 1 1 1 1 4

Auto-Print SUPERTHERM™, 2.0'- 5,400LFT (6x900')

EA 6 5 6 5 22

Auto-Print SUPERCEL™, 2.0' Amber - 10,800LFT (6x1800')

EA 3 3 3 3 12

Auto-Print SUPERCEL™, 2.0' Red EA 0 0 0 1 1

Rate Chart-to be done via cost proposal. Below is for informational purposes only Rate Chart is provided for the purpose of obtaining unit pricing for all goods and/or services included in this solicitation. Offerors shall enter the per-unit rate for each listed item; annual or aggregate totals shall not be submitted in this section. The State will use the completed Rate Chart to evaluate pricing and to establish the contract’s unit rates for each Contract Year. For clarity, Offerors shall provide the price per unit only, and not a cumulative annual amount, in the Rate Chart.

Contractor shall offer the State the option to buy new Auto-Print Plus (115V) 2.0 or the most current equivalent model at a fixed cost, inclusive of all applicable installation, training, and shipping and handling fees for each machine. This option may be exercised at the State’s discretion during the contract term.

Item Description Unit of Measure CY2027 Rate

CY2028

Rate

CY2029

Rate

CY2030

Rate

CY2031

Rate

CY2032

Rate

12-Month Preventive Maintenance Service Plan for one (1) packaging machine

EA

Pak-EDGE™ UD First Data Bank (1 Year/Renewal) for Pharmacy Unit Dose packaging equipment

EA

Auto-Print SUPERTHERM™, 2.0'- 5,400LFT (6x900')

EA (ROLL)

Auto-Print SUPERCEL™, 2.0' Amber - 10,800LFT (6x1800')

EA

Auto-Print SUPERCEL™, 2.0' Red

EA

Shipping and Handling not to exceed

Amount Only

Auto-Print Plus (115V) 2.0 or the most current equivalent model (option to buy)

EA

Financial Table-to be completed via cost proposal. The below is for informational purposes only.

Financial Table is provided for the purpose of capturing the Offeror’s extended pricing based on the unit rates entered in the Rate Chart. Offerors shall calculate and enter the total cost for each line item by multiplying the proposed unit rate by the Estimated Annual Usage. The Financial Table reflects annual totals for evaluation purposes only and may be used by the State to determine overall pricing for the contract term. Offerors shall not modify quantities listed in the Financial Table.

Deliverable CY2027 Projected Total

CY2028

Projected Total

CY2029

Projected Total

CY2030

Projected Total

CY2031

Projected Total

CY2032

Projected Total

ESH Preventive Maintenance Service Plan

MSH Preventive Maintenance Service Plan

RSH Preventive Maintenance

NDI Preventive Maintenance

ESH Pak-EDGE™ UD First Data Bank (1 Year/Renewal)

MSH Pak-EDGE™ UD First

RSH Pak-EDGE™ UD First

NDI Pak-EDGE™ UD First

ESH Consumables (Hospital) MSH Consumables (Hospital)

RSH Consumables (Hospital) NDI Consumables (Hospital) ESH Shipping & Handling MSH Shipping & Handling RSH Shipping & Handling NDI Shipping & Handling

Contract Total: $