Performance Work Statement_Final Controlled Substance Bins.pdf

Performance Work Statement (PWS) – Controlled Substance Waste Disposal Services

1. General Information

The purpose of this contract is to ensure full compliance with VHA Directive 1108.01 and Title 21

Code of Federal Regulations (CFR) for the secure handling, deactivation, and disposal of controlled substances that are expired, damaged, returned, unusable, or otherwise unwanted.

The Contractor shall be registered with the DEA as a reverse distributor, where applicable, and shall comply with all federal, state, and local laws governing controlled substances, including but not limited to 21 CFR Parts 1300–1321.

All services must align with Drug Enforcement Administration (DEA) requirements, VA policies, and applicable healthcare and environmental industry standards.

2. Scope of Work

The Contractor shall provide all labor, materials, equipment, supervision, and technical expertise necessary to support a Controlled Substance Waste Disposal (CsRx) Program.

Services include:

• Provision, installation, and maintenance of secure disposal containers

• Continuous supply and replenishment of containers and contingency stock

• Training and program implementation support

• Compliance assurance and documentation

• Ongoing customer and technical support

3. Performance Requirements

3.1 Container System

Contractor shall provide and install 3-gallon containers (or adjusted sizes based on operational assessment).

Containers must:

Immediately deactivate controlled substances upon deposit

Prevent diversion and ingestion (chemical neutralization/solidification)

Be tamper-resistant and securely mounted with lockable brackets

Unlimited container replacement shall be included at no additional cost per location.

3.2 Installation

Contractor shall install containers at designated VA locations under facility supervision.

Installation must:

• Minimize disruption to patients, staff, and operations

• Comply with safety and facility standards

• Be completed within agreed timelines

• Written confirmation of completed installation shall be provided to the COR.

4. Delivery and Supply Chain Management

Contractor shall ensure uninterrupted supply of containers and materials.

Deliveries shall meet agreed service levels (e.g., within X business days of request).

Contingency inventory shall be maintained at VA facilities to prevent service interruptions.

5. Training Requirements

Contractor shall provide:

Initial on-site training at Palo Alto VA

Web-based training for satellite locations

Training shall include:

• Proper use of containers

• Safety procedures and spill response

• DEA-compliant handling and disposal practices

• Diversion prevention awareness

Contractor shall provide:

• Training materials and documentation

• Attendance records

The COR will verify completion of initial and recurring training in accordance with VA policy.

6. Self-Service Model

This is a self-service program:

• VA staff (EMS or designated personnel) will replace containers at the point of use.

• Contractor shall provide clear instructions, labeling, and ongoing support.

• Contractor shall ensure the process remains compliant with DEA and VA standards.

7. Quality Assurance and Compliance

The Contractor shall maintain a Quality Assurance/Quality Control (QA/QC) program that includes:

• Routine inspections and performance checks

• Documentation of all container distribution and disposal activities

• Corrective and preventive actions (CAPA)

• Compliance with DEA audit and recordkeeping requirements

The Contractor must support audit readiness, including:

• Chain-of-custody documentation

• Certificates of destruction (if applicable)

• Record retention per regulatory requirements

8. Diversion Prevention and Security

All systems must minimize risk of diversion of controlled substances.

Containers must:

Prevent retrieval of deposited substances

Neutralize pharmaceutical activity

Contractor shall implement industry best practices for:

Controlled substance security

Loss/theft reporting procedures

Incident escalation

9. Performance Metrics (KPIs)

The Contractor shall meet or exceed the following performance standards:

On-time delivery rate: ≥ 95%

System uptime/availability: ≥ 99%

Training completion rate: 100% of required staff

Incident response time: within X hours of notification

Compliance rate: 100% adherence to DEA and VA requirements

Semi-Annual and Annual Performance Evaluation:

• Performance metrics

• Cost analysis

• Program improvements

• Issue resolution tracking

10. Risk Management

The Contractor shall:

Identify potential risks (supply disruption, compliance gaps, diversion risks)

Maintain mitigation and contingency plans

Ensure continuity of operations under all conditions

11. Bin Management

VA Palo Alto retains the right to:

Add or remove containers as needed

Adjust placement for operational efficiency

Contractor shall accommodate changes without service disruption.

12. Disposal Responsibilities

VA staff will perform disposal actions following Contractor-provided training.

Contractor shall ensure disposal methods:

Meet DEA destruction standards

Render substances non-retrievable

Meet environmental and regulatory requirements

13. Locations

Services shall be provided at the following VA facilities:

1. Palo Alto VA Medical Center

3801 Miranda Avenue

Palo Alto, CA 94304-1207

2. Menlo Park Division

795 Willow Road

Menlo Park, CA 94025-2539

3. Livermore

4951 Arroyo Road

Livermore, CA 94550-9650

4. Fremont

39199 Liberty Street, Building B

Fremont, CA 94538-1501

5. San Jose VA Clinic

5855 Silver Creek Valley Place

San Jose, CA 95138-1059

Division / CBOC Location Building # Nursing Unit Room # of CS Waste container

Freemont - ACC B PACT 136

LVD ACC 62 PACT / SPECIALTY 302

LVD CLC 90 CLC1 B-104

MPD 350 TRS 119-med rm

MPD 351 TRS 119-med rm

MPD 352 TRS 119-med rm

MPD 347 Domiciliary E205 MPD ACC HT TRV 335 HT TRV n/a

MPD CLC 360 360D D-106

MPD CLC 360 360E E-108

MPD CLC 360 360F F-106

MPD CLC 360 360G G-106

MPD CLC 331 331B B102

MPD CLC 331 331D D102

MPD CLC 360 360A A105

MPD CLC 360 360B B105

MPD CLC 360 360D D108

MPD CLC 360 360E E108

PAD 100 3C C3-120A

PAD 100 3C Across Room 3C-119 Hallway

PAD 100 3C Across Room 3C-140 Hallway

PAD 100 2A A2-120A

PAD 100 2A Across room A2-119

PAD 100 2A Across room A2-140

PAD 100 MSICU Next to pharmacy Omnicell #1 Across from F3-329 (Rm 3)

PAD 100 MSICU Next to pharmacy Omnicell #2 Across from F3-307 (Rm 12)

PAD 100 MSICU Room F3-322

PAD 100 4A Next to pharmacy Omnicell #1 near room A4-140

PAD 100 4A Next to pharmacy Omnicell #2 near room A4-TC1

PAD 100 4A A4-120a

PAD 100 4A A4-120a

PAD 100 ED Adjacent to Med Room A1-224

PAD 100 ED Adjacent to Med Room A1-325G

PAD 100 IICU Next to pharmacy Omincell #1 F2-316a

PAD 100 IICU In front of Omnicell #2 next to F2-302

PAD 100 IICU F2-326

PAD 100 GI Endoscopy C1-221

PAD 100 OSS A3-120A

PAD 100 PACU F3-112

PAD 100 IR F1-175

PAD 100 Dialysis B2-102 C

PAD 100 OR OR1

PAD 100 OR OR2

PAD 100 OR OR3

PAD 100 OR OR4

PAD 100 OR OR5

PAD 100 OR OR6

PAD 100 OR OR7

PAD 100 OR OR8

PAD 100 Cath Lab Cath Lab Room #1 next to NL22A-19 (plug in)

PAD 100 Cath Lab Cath lab Room #2 next to E2-410-9 (plug in)

PAD 100 Cath Lab E2-427

PAD 500 WBRC A2-300A

PAD 500 PRC/CRC/SSP A1-300A

PAD 500 PRC/CRC/SSP A1-500A

PAD 500 PTRP A3-400A

PAD 7F SCI/D F-109A

PAD 7H SCI/D H-120

PAD 100 CENTRAL PHARMACY E1-120 ANTE ROOM

PAD N/A IV TRAILER T-100A

PAD 710 Animal Research Lab V-211

PAD - Mental Health 520 A /FOR A-15B

PAD - Mental Health 520 B/ Birch B-150

PAD - Mental Health 520 C/Cyprus C-150

PAD - Mental Health 520 D/Douglas D-150

PAD ACC / AIC 100 PAD Specialty C1-300

PAD CLC 100 2C C2-120a

PAD CLC 100 2C C2-120a

PAD CLC 100 4C C4-120a

PAD CLC 100 4C C4-120a

PAD GMC ACC 5 PAD GMC B 215

PAD GMC ACC 5 PAD GMC C 260

San Jose CBOC ACC N/A PACT Neighborhood 3, 2125 (Arch# 2049)

14. Documentation and Reporting

The Contractor shall provide:

• Installation confirmation reports

• Training completion records

• Inventory and usage tracking

• Compliance documentation

• Incident and corrective action reports

Reports shall be submitted monthly or as requested by the COR.

15. Continuous Improvement

The Contractor shall proactively recommend:

Process improvements

Cost efficiencies

Enhanced compliance measures

Technology upgrades aligned with industry best practices