SOW Sources Sought.pdf

Department of Veterans Affairs

VA Boston Healthcare System

Statement of Work (SOW)

Reusable Medical Device (RMD) Transport Services

Prepared for: VA Boston Healthcare System

Table of Contents

1. Purpose

2. Scope

3. Performance Requirements

4. Vehicle & Equipment Standards

5. Personnel Requirements

6. Regulatory Compliance

7. Documentation & Chain of Custody

8. Quality Assurance

9. Safety & Security

10. Environmental & Emergency Preparedness

11. Additional Requirements

12. Contractor Compliance Checklist

1. Purpose To obtain non-personal, non-emergency ground transportation services for the safe, secure, and compliant transport of Reusable Medical Devices (RMDs), laboratory specimens, mail totes, general supplies, and laundry between VA Boston Healthcare System (VABHS) campuses: Jamaica Plain, West Roxbury, Brockton, and Lowell CBOC. Transportation of VA personnel and patients is prohibited in the performance of this effort.

2. Scope The Contractor shall provide all labor, supervision, vehicles, equipment, fuel, insurance, and materials necessary to transport clean and soiled RMDs, and other designated items in accordance with applicable federal, state, and local regulations, including ANSI/AAMI ST79:2017, AAMI TIR109:2025, OSHA Bloodborne Pathogen Standard (29 CFR 1910.1030), and DOT Hazardous Materials Regulations (49 CFR Parts 171–180). VABHS staff will be providing the cargo to the contractor in bins and labeled accordingly.

3. Performance Requirements

All RMD must be transported in accordance with all local, state, and federal regulations, including and specified regulations for bio-hazardous materials. All efforts shall be made to ensure the integrity of all items delivered will not be compromised due to improper temperature conditions, rough handling, shift damage during transport and/or negligence.

Scheduled deliveries will be two round trips per day, Monday through Friday (excluding federal holidays). Additional trips as needed. Prompt pickup and delivery. Chain of custody shall be maintained. Temperature control between 66–72°F shall be maintained. Physical separation of clean and contaminated items shall be maintained. The dimensions of the bins for the scheduled deliveries are approximately 19 inches wide, 12 inches tall, 24 inches long with a quantity range between 1 to 3 bins.

Schedule of Pick-Ups and Drop-offs:

Monday – Friday Schedule Time General

Description Building/Room Notes

0900 EST Pick up @ VA West Roxbury

Building 2, Basement AB05

Clean, sterilized

RMD

1130-1200 EST Drop off / Pick up @ Lowell CBOC

Drop off clean RMD Pick up soiled RMD

1430-1500 EST Drop off @ VA West Roxbury

Building 2, Basement AB05

Drop off soiled RMD

As needed schedule (Contingencies) will be planned the day before the pick up and drop off is needed. The Contractor will be notified the day prior and be expected to provide the service starting at or around the hours between 0500-0700 AM EST. The dimensions of the bins for the contingencies are approximately 16 inches tall, 30 inches long, 20 inches wide with a quantity range between 1 to 3 bins.

As Needed Schedule (Contingencies) Time General

Description Building/Room Notes

Determined on an as needed basis

Pick up and Drop off @ VA West Roxbury / Jamaica Plain / Brockton

Round trip.

WX: Building 2, Basement AB05

JP: Building 1, Rm

SP2D 2074

BK: Building 32, Rm

RMD (clean or soiled

In the event, the CONTRACTOR is unable to perform services or have services performed as required, the CONTRACTOR shall immediately notify the COR and CO and provide an explanation for non-performance.

The CONTRACTOR shall notify the COR at the earliest time available, but no later than the next business day of the CONTRACTOR knowledge of any conditions which may adversely affect the CONTRACTOR’s ability to perform under the term and conditions as stated in the specifications of this SOW (e.g., union strikes, vehicle problems and/or licensure issues)

The CONTRACTOR shall phone the COR at the phone numbers indicated below if the scheduled pick-up time cannot be met for any reason; to include inclement weather.

4. Vehicle & Equipment Standards Vehicles must have partitioned cargo areas labeled CLEAN and DIRTY/BIOHAZARD, non-porous disinfectable surfaces, spill kits, PPE, first aid kits, and securement systems.

Transport carriers must be leak-proof, rigid, sealable, labeled, and cleaned after each use.

All vehicles used in performance of this contract shall be registered, licensed and meet the minimum vehicle requirements as mandated by the Department of Transportation. The Government reserves the right to inspect the vehicles and investigate the responsibility of contractor to perform the work outlined in this contract and reject any offer should contractor be lacking.

To avoid cross contamination, vehicles used to transport RMD between health care facilities shall provide for the physical separation of clean sterile items from biologically dirty/soiled items, per ANSI/AAMI ST79, Section 6.5. The vehicle cargo compartment must be partitioned, and each section labeled with placards designating as “CLEAN” and/or “DIRTY

/BIOHAZARD.” All surfaces of the interior vehicle that encounter deliverable items during transport must be wipeable non-porous surfaces that can be intermediate level disinfected.

RMD shall not be transported in the trunk of a car as temperature and humidity levels cannot be controlled.

Physical separation and signage examples:

Dirty RMD cargo will be double containerized.

Firstly, RMD will be containerized in a medical grade, rigid, puncture proof, red biohazard marked transport container with a secure latching lid.

RMD transport container example:

The Second container will be a red storge tote with a securable enclosure lid and affixed with a dirty transportation tag or sticker.

Red Storage tote and dirty transportation sticker example:

Commented [JM1]: Can we incorporate cargo container sizes and dimensions?

Commented [JM2]: Can we incorporate the second container size and dimensions here too?

Clean RMD cargo will be packaged individually in peel packs or as sets placed inside a cassette and wrapped in a blue drape; then transported in a green storage tote affixed with a clean tag or sticker.

Peel pack and cassette examples:

Clean transportation sticker example:

The ground transport vehicle shall be stocked with a shelf life current, “SPILL KIT” for bio-hazard spill cleanup. CONTRACTOR will ensure that the driver has been trained on proper use of spill kits to collect, contain, and dispose of spilled biomatter and chemicals. The CONTRACTOR will ensure the vehicle is outfitted with the necessary personal protective equipment (PPE) and first aid kit. Signage will be posted to identify the location of the spill kit and first aid kit.

First aid kit and spill kit signage examples:

The RMD cargo will be loaded in a manner that protects the devices from shift damage during transportation. Bio-hazard transport bins with latching lid will be placed within a storage tote with securable closure lid. Totes will be secured in place using straps and anchor points.

Cargo anchor point and cargo strap example:

Any sterile items that are dropped should be considered contaminated and reprocessed, even if no damage to packaging is evident.

Direct contact with sterile packages shall be avoided. This includes any touching or excessive handling of packages.

The storage tote will be provided to the CONTRACTOR driver to be placed in a vehicle that maintains temperature compliance.

At any time that RMD cargo is in the vehicle, the air conditioning will remain in operation.

The cargo area will have a dedicated air conditioning system independent of the passenger area environmental controls.

Cargo compartment dedicated air conditioner example:

Temperature shall be maintained per AAMI/ANSI ST79 regulations for sterile RMD.

Temperature 66 – 72oF

The CONTRACTOR driver shall ensure that the vehicle meets the temperature requirements prior to loading RMD, throughout transit, and upon and during delivery.

The temperature of the ground transport cargo area will be recorded on the vehicle transportation checklist (attachment A) prior to departure and upon arrival to the receiving facility. The transportation checklist will be initialed by the CONTRACTOR driver and VABHS employee. All transportation manifests will be retained as a permanent record.

The vehicle interior must be terminally cleaned (i.e., intermediate level disinfected) after each RMD delivery. Suitable intermediate level disinfectants are hospital grade quaternary ammonia and isopropyl blends. The disinfectant will be applied per the manufacturer’s instructions for use (IFU).

5. Personnel Requirements Drivers must be 18+, hold a valid commercial license, pass background checks and drug screening, and be trained in OSHA, DOT, AAMI TIR109, and IAHCSMM standards. Uniforms and visible ID badges required. Drivers shall wear distinctive clothing items to identify them as employees of the courier company. Drivers shall be able to speak, understand and write English. Drivers shall possess VA Boston Security Officer approved picture identification showing driver name and company name. Contractor is responsible for the actions and conduct of its employees and shall assure that they are consistently compliant with all VA building and parking regulations, policies and guidelines while conducting business on Government property and for the VA. Drivers shall observe the smoking and tobacco policies of the VA. Employees working for the Contractor shall not be considered Government employees. The Contractor shall provide Workers Compensation, Professional Liability insurance, health examinations, Income Tax Withholding and Social Security Payments for all W2 employees. Alternatively, contractor may also utilize the services of “similarly situated” independent contractors who are of the same socio-economic category as the prime. Utilizing the services of an independent contractor who is not “similarly situated” will be designated as a subcontractor and not count towards the Limitations of Subcontracting requirement that contractor personnel perform at least 50% of the work.

Contractors shall confirm compliance with the Limitations of Subcontracting FAR Clause 52.219-14.

6. Regulatory Compliance Contaminated RMDs must be collected in leak-proof containers, kept moist, and transported promptly. Clean RMDs must be packaged and labeled. Documentation includes manifests, temperature logs, and cleaning records.

7. Documentation & Chain of Custody Transportation manifests must include date/time, origin/destination, temperature logs, driver and receiver initials. Weekly cleaning logs and monthly reports to COR. Incident reports within 24 hours.

8. Quality Assurance Contractor must implement a Quality Control Plan (QCP). VA COR will conduct inspections and reviews. Contractors must maintain training and performance records and resolve complaints.

The COR will periodically evaluate the contractor’s performance in accordance with the following Quality Assurance Plan.

9. Safety & Security Vehicles must remain locked when unattended. RMDs must not be abandoned. No transport of VA personnel or access to VA systems. Contractor liable for loss or damage.

10. Environmental & Emergency Preparedness Vehicles must operate safely in inclement weather. Spill kits and PPE must be available.

Contractor must notify COR/CO of disruptions.

11. Additional Requirements Contractors must comply with COVID-19 protocols, insurance requirements, and provide evidence of licensure, insurance, and training prior to contract initiation.

VABHS reserves the right to inspect contractor's equipment and vehicles or require documentation of compliance with contract specifications, and State laws, rules, regulations and guidelines governing transportation vehicles. The CONTRACTOR shall submit to and participate in any periodic review of service practice requests. VABHS inspections of contractor equipment will not constitute a warranty that the contractor's vehicles and equipment are properly maintained.

VABHS reserves the right to restrict the use of CONTRACTOR equipment and vehicles that are not in compliance with contract requirements. The restriction on such equipment and vehicles should not relieve the contractor from performing in accordance with the contract and without additional cost to VABHS.

Throughout the performance periods of the contract, it shall be the contractor’s responsibility to ensure that vehicles meet all current applicable Federal, State and local specifications and regulations including, but not limited to, licensing, registration, and safety standards. The vehicle must have alarm system that indicates when vehicle is backing up; back up lights with a built-in alarm constitute a backup alarm system.

The CONTRACTOR shall make all reasonable provisions to protect items being transported against loss. Should RMD be lost or stolen while in the CONTRACTOR possession they shall reimburse VABHS for the replacement value. The vehicle will not be left unattended while conducting delivery. The cargo area air conditioner must remain on during the entirety of the delivery to maintain specified environmental conditions.

Should any RMD be lost, damaged, or stolen while in the CONTRACTOR possession, they shall submit a written report to the COR within twenty-four (24) hours, explaining the circumstances.

The CONTRACTOR staff are required to interrupt their work at any time so as not to interfere with the normal functioning of the medical facility, including utility services, fire protection systems, and passage of facility patients, personnel, equipment and emergency and/or service carts. These interruptions should only be occasional. Any interruptions considered to be excessive should be brought to the attention of the CO and COR.

12. Contractor Compliance Checklist To be completed and verified for each transport trip. Must be retained and submitted weekly. Includes checks for vehicle configuration, temperature control, documentation, PPE, training, and chain of custody.

Attachment A:

Requirement Compliant (✔) Notes

Vehicles have partitioned cargo areas labeled CLEAN/DIRTY ☐

Cargo area temperature maintained at 66–72°F ☐

Transport carriers are leak-proof, rigid, and labeled ☐

Drivers trained in OSHA, DOT, AAMI TIR109 ☐

Daily manifests include temperature logs and signatures ☐

Weekly cleaning logs submitted ☐

Spill kits and PPE stocked in vehicles ☐

Chain of custody maintained ☐

Clean and soiled items physically separated ☐

Transport carriers cleaned after each use ☐

Requirement Compliant (✔) Notes

Personnel wear uniforms and visible ID ☐

Quality Control Plan implemented ☐