C04_Attachment 1 - PWS 1232SA26Q1214 .docx

Performance Work Statement (PWS) NBAF – BDM STERIS Total Care Service Contract Period of Performance: 03/01/2026 – 02/28/2031

1. Purpose The purpose of this contract is to provide OEM Total Care service coverage for STERIS Vaporized Hydrogen Peroxide (VHP) decontamination systems and one STERIS Reliance 380PG laboratory washer located within the Biologics Development Module (BDM) at the National Bio & AgroDefense Facility (NBAF), Manhattan, KS.

The contractor shall provide comprehensive preventive and corrective maintenance that ensures these devices remain fully functional, validated, and aligned with current STERIS specifications.

2. Background BDM operations rely on STERIS VHP systems for high level decontamination of equipment, materials, and biocontainment areas. The Reliance 380PG lab washer is essential for cGMP compliant cleaning workflows.

STERIS is the sole OEM for parts and service for these devices and provides Total Care plans covering all labor, travel, and maintenance parts, reducing operational downtime and ensuring safe, reliable operation.

3. Equipment Covered Under This PWS

3.1 VHP Low Temperature Sterilization Units

VHP Victory Units (x2)

• SN: 0213024001

• SN: 0214224001

VHP Flex Units (x2)

• SN: 0219124001

• SN: 0215024001

VHP AR1200 Units (x4)

• SN: 0215014002

• SN: 0215624001

• SN: 0216424001

• SN: 0214324001

3.2 STERIS Laboratory Washer

Reliance 380PG Pharmaceutical Grade Washer

• SN: 3603919001

• Coverage: Total Care

• PM Inspections: 4 per year

4. Scope of Work The Contractor shall provide OEM Total Care support for all equipment listed in Section 3.

Total Care includes:

1. Preventive Maintenance (PM)

2. Corrective Maintenance (Repair visits)

3. Labor, travel, and standard maintenance parts

4. Priority technical support

5. Documentation of all services performed

6. Access to online service request portals

7. Response time obligations (4 hour phone, 48 hour onsite)

5. Service Requirements

5.1 Preventive Maintenance (PM)

PM shall follow STERIS’ current OEM Preventive Maintenance Checklists (PMCL).

Based on STERIS guidance:

PM services shall include:

• OEM system calibration

• Functional testing and validation

• Safety checks

• Replacement of PM designated parts

• Documentation of results and identified issues

5.2 Corrective Maintenance

• STERIS shall provide unlimited repair visits under Total Care (excluding parts listed under OEM exclusions).

• Response timeline:

– Phone triage within 4 hours

– Onsite service within 48 hours

• All labor and travel included.

• Parts included except for OEM excluded categories (e.g., >$5,000 components, upgrades, misuse damage).

5.3 Technical Support

• 24/7 priority technical support

• Routing of calls by serial number

• Access to customer care center

5.4 Documentation & Reporting

STERIS shall provide:

• Service reports within 5 business days

• PM checklists

• Corrective action reports

• Calibration documentation when applicable

• Annual service summary

• Access to digital service history

5.5 Service Hours

• Normal working hours: Mon–Fri, 8:00 AM–5:00 PM (excluding federal holidays).

• Work outside these hours must be preapproved by the COR and is billable unless covered under contract.

6. Contractor Responsibilities STERIS shall:

• Provide OEM certified technicians

• Maintain all equipment per OEM standards

• Supply PM kits and in scope repair parts

• Verify compliance with current safety and operational guidelines

• Maintain confidentiality of NBAF records

• Provide recall alerts and updates

7. Government Responsibilities NBAF shall:

• Provide safe access to equipment

• Ensure access and escort requirements

• Provide utilities (power, steam, water, compressed air)

• Provide hazard and safety information specific to the area

8. Deliverables

9. Quality Assurance & Acceptance

• The COR will verify service completion and inspect all documentation.

• Acceptance is contingent on equipment returning to normal operational status and meeting OEM tolerances.

10. Period of Performance 03/01/2026 – 02/28/2031

11. Security & Safety Requirements

• All contractor personnel shall meet NBAF entry, PPE, and biosafety requirements.

• Contractor must comply with USDA/ARS security procedures and escort rules.

• Contractor shall follow hazard communication protocols and facility restrictions.

12. Special Terms & Conditions As defined in Steris Total Care:

• Excludes major component replacements >$5,000

• Excludes misuse, abuse, improper installation

• Services only performed on equipment accessible at time of visit image1.png