SOW Med Repack Matls and PM Equipment Service Plan.docx

Scope of Work Medication Repackaging Materials and 12-month Preventive Maintenance Equipment Service Plan For the Indiana State Psychiatric Hospital Network (ISPHN)

Overview The Contractor shall provide a comprehensive 12-month Consumables Service Plan for the medication repackaging equipment listed in Appendix A. This plan shall include preventative maintenance, software license updates, and staff training to support the ongoing operation of medication repackaging systems.

Some of the equipment is aging and may require replacement, while newer units remain fully serviceable. To support long-term operational continuity, the Contractor shall offer the option to purchase new equipment for ISPHN.

These services are essential to ensure the safe, compliant, and reliable performance of critical pill-packaging systems. All work must adhere to applicable healthcare regulations and sanitation standards, including but not limited to those set forth by The Joint Commission and the Centers for Medicare and Medicaid Services (CMS). Contractor shall also comply with all applicable ISPHN policies and any facility-specific policies and operating procedures.

Respondent Options

· Bidders may submit proposals for any portion of the Scope of Work, including software licensing, consumables, preventive maintenance, emergency service, and equipment purchase.

· Bidders are encouraged to include pricing and specifications for new equipment, even if submitting proposals for service or supply components only.

· The State prefers a single, network-wide contract to streamline operations and accountability. However, multiple contracts may be awarded if deemed in the State’s best interest.

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.

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

· Provide all necessary consumables and software updates 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 within 30 business days of request.

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

· Priority 1 (critical) failures must be resolved within 24 hours.

Delivery & Facility Coordination Supplies and Consumables

· Ship all consumables specified in Appendix B: Consumables Specifications within five (5) business days of order, with no minimum purchase required.

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

Hardware Requirements

· Respondents shall include pricing and specifications for the purchase and installation of new medication repackaging equipment, similar or comparable to those listed in Appendix A. This option may be exercised at the State’s discretion during the contract term. Equipment proposals must include software licensing, training, acceptance testing, and must meet the specifications outlined in this Scope or provide equivalent functionality.

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.

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

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:

· Daily operational procedures

· Preventive maintenance tasks

· 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 and Repairs

· Priority 1 (critical) failures must be resolved within 24 hours.

· 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.

Contractor Qualifications

· Demonstrated experience servicing Auto-Print, and/or Euclid Cadet machines.

· Authorized service provider for Pak-EDGE® software and/or 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 and Key Performance Indicators (KPIs)

1. Consumables Supply KPIs:

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

· Bidders shall include pricing for quantities not to exceed those listed in Appendix B.

· 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. Immediate telephonic diagnostics shall be provided upon notification, with escalation to on-site corrective maintenance if unresolved within two (2) hours.

· 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:

· Equipment must meet or exceed specifications outlined in Appendix A.

· 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.

Deliverables Table This table serves as a quick-reference overview of each contract deliverable and its corresponding Key Performance Indicators. Bidders should use this to guide proposal development, pricing, and implementation planning. Additionally, State and ISPHN staff may reference it to monitor performance and ensure all deliverables are fulfilled in accordance with the agreed standards.

· 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.

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

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

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

· 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.

· 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.

Budget Table Bidders may submit proposals for any portion of the Scope of Work, including software licensing, consumables, preventive maintenance, emergency service, and equipment purchase. Bidders must complete the applicable portions of this Budget Table for the goods and services they wish to provide. Any sections left blank will be considered as non-bids for those lines only.

Not Applicable

Appendix A Equipment Inventory and Locations

Below is an inventory of equipment and specifications, listed by facility.

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.

Logansport State Hospital

1098 S. State Rd. 25 Logansport, IN 46947

Euclid Cadet Vantage packager.

Madison State Hospital

711 Green Road Madison, IN 47250

AutoPrint Unit Dose System Model 1179, Mfg date 1/2020.

Control module model 9300 series 1.

NeuroDiagnostic Institute

5435 E. 16th St.

Indianapolis, IN 46218

AutoPrint Unit Dose System Model 1179, Mfg date 1/2017.

Control module model 9300 series 1

Richmond State Hospital

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

AutoPrint Unit Dose System Model 1179, Mfg date 09/2023.

Control module model 9300 series 1

Appendix B Consumables Specifications

B.1 Heat-Sealable Packaging Film

· Size: 6″ × 900′ roll

· Specifications:

· Low-temperature activation (≤150 °F) compatible with automated unit-dose packagers

· Puncture- and moisture-resistant, FDA Title 21 CFR Part 820 compliant

· Lot number and expiration date on every roll

· Currently using SUPERTHERM 2.0

· Evansville State Hospital, Qty 6

· Madison State Hospital, Qty 6

· NeuroDiagnostic Institute, Qty 6

· Richmond State Hospital, 8

B.2 Amber Blister Pack Sheets

· Size: 6″ × 1800′ roll

· Specifications:

· UV-protective amber PET/PE laminate for light-sensitive meds

· Tamper-evident seal integrity, meets USP <671> and FDA packaging standards

· Lot number and expiration date on every roll

· Currently using SUPERCEL 2.0 Amber

· Evansville State Hospital, Qty 4

· Madison State Hospital, Qty 4

· NeuroDiagnostic Institute, Qty 4

· Richmond State Hospital, Qty 7

B.3 Red Blister Pack Sheets

· Size: 6″ × 1800′ roll

· Specifications:

· UV-protective amber PET/PE laminate for light-sensitive meds

· Tamper-evident seal integrity, meets USP <671> and FDA packaging standards

· Lot number and expiration date on every roll

· Currently using: SUPERCEL 2.0 Red

· NeuroDiagnostic Institute, Qty 1

B.4 Unit-Dose Aluminum Foil Sheets (Euclid Cadet Vantage)

· Size: Pre-cut sheets or roll stock sized to Euclid Cadet Vantage format

· Specifications:

· Aluminum foil gauge 0.04 mm minimum; heat-seal compatible

· Barrier properties: water-vapor transmission ≤0.5 g/m²/24 h

· Non-toxic, pharm-grade; FDA Title 21 CFR Part 175 compliant

· Lot number and expiration date on every pack

· Currently using: Euclid Unit-Dose Aluminum Foil Sheets

· Logansport State Hospital, Qty 6

B.5 Heat-Sealable Thermal Film (Euclid Cadet Vantage)

· Size: Polyester/PE composite film, 4″ width × 450′ roll (or pre-cut sheets)

· Specifications:

· Low-temperature activation (≤140 °F) for foil-film lamination

· Tensile strength ≥35 MPa; puncture resistance ≥10 N • FDA-compliant material

· Lot and expiration dated

· Currently using: Euclid Heat-Sealable Thermal Film

· Logansport State Hospital, Qty 5

B.6 Clear Top Film (Euclid Cadet Vantage)

· Size: Polyester-based clear film, 6″ width (or pre-cut sheets)

· Specifications:

· Thickness: 0.15 mm ±0.02 mm; light-transmittance ≥90%

· Heat-seal compatible with Euclid Cadet Vantage foil/film

· FDA Title 21 CFR Part 170 compliant

· Lot and expiration dated

· Currently using: Euclid Clear Top Film

· Logansport State Hospital, Qty 1