RFI TISSUE TYPING COURIER SERVICES PWS 2.9.2026.pdf

Performance Work Statement

Bronx Lab Courier Services

General

Introduction:

This requirement is to seek for a contractor that provides Courier Service for Tissue Typing and Immunogenetic Lab Services, Kidney Tissue Biopsies, and specialized medical equipment that ensure liability of organ and tissue transportation. The Contractor must provide timely, secure, and compliant transport of biological materials, organs, blood, and transplant-related equipment. The contractor must be available 24/7/365, this includes weekends and federal holidays. The contractor must be capable of responding to both scheduled and unscheduled critical requests with no delays.

Background / Objective:

The James J. Peters (JJP) Veterans Affairs Medical Center (VAMC) Transplant Program relies on external laboratory partnerships to support critical transplant-related diagnostics and logistics.

These services are essential throughout all phases of transplant care—pre-transplant, intra-operative, and post-transplant. The program requires courier services capable of providing both scheduled and unscheduled critical deliveries promptly, securely, and in compliance with regulations and standards by federal, state, local laws, and guidelines and protocols from organizations and agencies.

Additionally, the courier service must ensure the timely delivery of blood and tissue samples for diagnostic testing in post-transplant patients experiencing complications. These services are essential and crucial for guiding clinical decisions and ensuring positive transplant outcomes.

Place of Performance – The Courier shall be delivering or picking up - from and to.

Department of Veterans Affairs James J. Peters VA Medical Center 130 West Kingsbridge Road Bronx, NY 10468

Designated Pathology Testing Laboratory for Tissue Typing and Immunogenetics Lab Services:

Rogosin Institute 505 E 70th St, New York, NY 10021

Designated Organ Procurement Organization (OPO) in New York:

LiveOnNY 30-30 47th Avenue, 9th Floor, Long Island City, NY 11101

Kidney Tissue Biopsy Transportation: The radius is within 50 miles for routine kidney transfers this covers NYC and Long Island hospitals. The specific address will be provided upon request.

Period of Performance:

The IDIQ Fixed Price Ordering Period shall be five (5) years.

Days of Performance:

All services shall be performed continuously, 24 hours a day, 7 days a week, including weekends and all federal holidays, throughout the contract period.

Definitions and Acronyms –

• Blood Sample: A sample of a patient’s blood used for tissue typing, crossmatching, or post-transplant monitoring.

• Chain of Custody: A documented process ensuring the secure handling and tracking of medical materials from pickup to delivery.

• Courier Services: Qualified and experienced Courier transporting medical materials, including organs, blood, tissue specimens, and equipment, under time-sensitive and regulated conditions.

• Equipment: Medical devices or supplies required to support transplant procedures or organ preservation, including transport containers, perfusion pumps, biopsy kits, and temperature-controlled storage units.

Examples from logistics providers cover surgical instruments, and loaner devices

• Increasing Organ Transplant Access (IOTA): Centers for Medicare and Medicaid Services (CMS)--led initiative to expand access to organ transplantation for Veterans through improved coordination and logistics.

• JJP VAMC: James J. Peters VA Medical Center, Bronx, NY – the originating site for this contract.

• Medical Equipment: Typical items in transplant logistics include medical devices and equipment such as surgical kits, implants, monitoring devices.

• NYVA: New York Veteran’s Affairs

• Organ: A whole or partial human organ intended for transplantation, including but not limited to kidneys, livers, and pancreas, requiring preservation and urgent transport.

• Routine “Scheduled” Delivery: A pre-arranged transport request with a defined pickup and delivery time. Typical turnaround time is 24 to 48 hours.

• STAT Delivery: An unscheduled, critical transport request that must be fulfilled immediately to support transplant or diagnostic needs. It must be delivered within one (1) hour.

• Tissue Specimen: A biological sample (e.g., biopsy) collected for diagnostic testing, including kidney tissue for pathology review.

• Urgent Delivery: An urgent delivery refers to the expedited transportation and delivery of the request to meet time-sensitive needs. It prioritizes speed and efficiency to ensure that the delivery is made as quickly as possible. It must be delivered within four (4) hours.

Scope of Work:

The contractor must provide same-day delivery of time-sensitive medical materials unless otherwise instructed by the requestor. All services must comply with applicable federal, state, VA-specific regulations, and standards. Only those services explicitly described in this PWS are authorized.

• There will be different delivery requests. The Contractor must be available 24/7, 365 days all year-round service.

• The VA will ensure that Organ, blood, specimen samples and medical equipment are protected from extreme heat/cold and safely transported in protective storage or packaging in accordance with OSHA regulations, OPO, UNOS, FDA, CDC, and any special instructions provided by the facility.

• The Contractor shall ensure that the package is safe during delivery, implementing measures to protect it from damage, loss, theft, or any other risks. This includes proper handling, tracking, and timely communication to ensure the integrity and security of the contents throughout the entire delivery process in accordance with regulations and standards OPO, UNOS, FDA, CDC, and any special instructions provided by the facility.

• Each delivery service needs a tracking number and requires signature from the receiving party.

Specific Tasks:

The contractor shall coordinate closely with the NY VA Renal Transplant Program to ensure timely and compliant execution of all requests.

Task One – Communication and Coordination The contractor must communicate effectively and in a timely manner with the JJP VAMC Transplant Team regarding the status and completion of each delivery. Updates shall be provided upon request and in accordance with established communication protocols.

Task Two – Delivery Requests The contractor must respond immediately to delivery requests initiated by the JJP VAMC Transplant Team. All medical material transport—including organs, blood, tissue specimens, and equipment will be scheduled upon request and must be delivered without delay upon receipt of the order.

Task Three – Regulatory and Logistical Compliance The contractor must coordinate with JJP VAMC staff to ensure all deliveries comply with applicable logistical, regulatory, and safety requirements. Reference Safety and Compliance section.

Deliverables:

• Requirements

The Contractor must:

Ensure chain-of-custody documentation for all deliveries

Provide real-time tracking and delivery confirmation Comply with OSHA Bloodborne Pathogens Standard (29 CFR

1910.1030) Follow CDC guidelines for specimen transport Maintain HIPAA compliance with patient-related materials Use temperature-controlled transport and secure vehicle storage Ensure courier personnel are uniformed and carry vendor-issued photo ID Provide orientation and safety training as required Report any incidents, delays, or safety violations within 24 hours

Deliveries may be requested at any time during the contract period and must be fulfilled in accordance with the following requirements:

Service Availability: The contractor must provide on-demand courier services 365 days, 24 hours a day, 7 days a week, including weekends and federal holidays, as well as the days declared federal holidays by the President.

Response Time: Deliveries must be processed immediately upon request and completed as soon as possible. Scheduled and Non-Scheduled deliveries must be completed within the timeframes specified by the JJP VAMC Transplant Team.

Requests STAT Urgent Routine

Urgency Immediate impacts life-saving decisions

Prompt, significant but not life-threatening

Regular care, ongoing monitoring, or non-direct life threatening

Turnaround Time Within one hour Within a few hours (2-

4 hours)

Within 24-48 hours, facility will determine date and time

Tracking and Confirmation: A record must be kept including a tracking number, the date, time, and the name of the requestor. A signature is required from the receiving party to confirm delivery and maintain chain of custody.

Biannual Reporting: Provide biannual billing and activity reports listing all patients and deliveries completed during the previous six-month period.

Compliance: In the event of any conflict between a delivery order and the terms and conditions of the contract, the contract shall govern. The contractor shall promptly notify the COR and CO of any such conflict and await written instructions by the Contracting Officer before proceeding.

Type of Contract: IDIQ Fixed Price.

IDIQ Contract Minimum and Maximum: The government will order a minimum quantity or value of $1,000.00 and a maximum quantity or value of $80,000.00. These limits apply to the total sum of all orders placed throughout the duration of the contract.

Invoicing- A hard copy of the invoice must be submitted through Tungsten Network monthly.

The invoice must detail the services rendered.

Contractor Furnished Items – The Contractor shall provide their own equipment or supplies necessary to ensure a secure and safe delivery of the items during transport.

Qualifications, Training, Certifications, and Licenses- For local transportation of specimens, organs, and medical transplant materials, courier services must adhere to various qualifications, certifications, and licenses to ensure safety, regulatory compliance, and the integrity of transported items.

The contractor must provide documentation for the following:

Hazardous Materials Transportation Certification:

Certification through the Department of Transportation (DOT) for handling and transporting hazardous materials within local jurisdictions.

Biological Substance Training:

Training that complies with OSHA's Bloodborne Pathogens Standard (29 CFR 1910.1030).

Training in handling and transporting biological substances, following guidelines from the CDC and OSHA.

Organ Transplant Transportation Training:

Specific training for the local handling and transportation of organs, in accordance with guidelines from relevant health organizations.

Bloodborne Pathogen Certification:

OSHA-compliant training on exposure control plans and the use of personal protective equipment (PPE) to prevent exposure to infectious materials.

Courier Licensing:

A valid courier or transportation business license as required by local authorities to legally operate within the region. The driver must also have a valid driver’s license and safe driving history.

Specific State and Local Licenses and Certifications:

Additional licenses or certifications as required by state or local health departments for handling and transporting medical materials.

Essential Training:

Chain of Custody Training:

Training to maintain a secure and documented chain of custody for all transported specimens and organs, ensuring traceability and security.

Temperature Control Training:

Training in the proper use of temperature-controlled packaging and handling to maintain specified temperatures for specimens and organs during local transport.

HIPAA Training:

As medical couriers often handle patient information and records along with specimens, they must adhere to HIPAA (Health Insurance Portability and Accountability Act) privacy and security rules.

Other information-

Quality Control:

The contractor shall develop and maintain an effective quality control program to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor’s quality control program is the means by which he assures himself that his work complies with the requirement of the contract.

Quality Assurance:

The government will evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan. This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

Contracting Officer Representative (COR):

The (COR) will be identified by separate letter. The COR monitors all technical aspects of the contract and assists in contract administration. The letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially regarding changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

Special Instructions:

The transportation of organs is a highly specialized process regulated by various health organizations and institutions to ensure the safety and viability of organs for transplantation.

The guidelines and protocols for handling such sensitive cargo are typically provided by the following entities:

Organ Procurement Organizations (OPOs): These organizations coordinate the donation, recovery, preservation, and transportation of organs. They provide specific instructions to couriers on how organs should be handled and transported.

Hospitals and Transplant Centers: The medical centers involved in organ transplants often have their own protocols and guidelines, which are communicated to couriers to ensure that organs are handled according to medical standards.

UNOS (United Network for Organ Sharing): UNOS provides national guidelines and policies regarding organ allocation and transportation. They may also offer specific handling procedures to couriers involved in the transportation process.

Regulatory Agencies: Organizations like the FDA (Food and Drug Administration) and CDC (Centers for Disease Control and Prevention) may provide regulations and guidelines concerning the transportation of biological materials, including organs.

Medical Device Manufacturers: When transporting organs using specific medical devices designed for preservation (like Organ Care Systems), the manufacturers of these devices provide detailed usage and handling instructions to ensure the organs are maintained at optimal conditions during transit.

Couriers must be trained to follow these guidelines meticulously to ensure the organs arrive in the best possible condition for transplantation.

Vehicles:

The suggested vehicles for each device are designed to fit within the cabin or trunk of standard SUVs, minivans, medical couriers, or dedicated Organ Procurement Organization (OPO) vehicles. The positioning of these devices must be kept upright during transport unless otherwise specified by the facility. The information provided in the device chart below is approximation.

Device Dimensions Weight

LifePort Kidney Transporter

Estimated 24″ × 14.5″ × 14.25″ (≈62 × 37 × 36 cm) ~45 lb (20.4 kg)

Waters RM3 Renal Preservation System Estimated 15.6" x 11.7" x 13.3" Lightweight

KidneyVault® Estimated 20.25” L x 16” W x 18.5” H Compact portable.

XVIVO Kidney Assist™

Estimated 1120 mm x 925 mm x 625 mm (Outer packaging)

Estimated 28,4 kg (including oxygen cylinder, ice and perfusion solution)

Arrival and Access:

Contractor personnel must check in at the front desk/lobby upon arrival at JJP VAMC or any affiliated facility.

Government-issued photo identification must be presented upon request. The Courier must be wearing their company’s Identification (ID) badge, it must be visible and always worn while on VA property or associated locations of pickup and delivery.

Orientation and Training:

Contractor personnel may be required to complete a facility-specific orientation or safety briefing prior to initiating services at JJP VAMC.

The contractor shall ensure that all personnel are familiar with VA protocols relevant to their duties.

Safety, Protocol, and Compliance:

The contractor must actively coordinate with JJP VAMC staff to ensure every delivery meets regulatory and safety standards.

1. OSHA Standards

a. Bloodborne Pathogens (29 CFR 1910.1030): Implement an Exposure Control Plan for handling blood, organs, and tissue samples. Includes PPE, training, and spill response.

b. Hazard Communication (29 CFR 1910.1200): Proper labeling and SDS for chemicals (e.g., dry ice).

c. PPE Requirements (29 CFR 1910 Subpart I): Eye, face, and respiratory protection for couriers handling biological materials.

2. VA Transport Protocols

a. VHA Directive 1102.03: Solid Organ and Stem Cell Transplantation—defines responsibilities and timing requirements.

b. VHA Directive 1081.02: Biological implants and devices—handling, tracking, and documentation.

c. Chain of Custody: Maintain documented pickup/drop-off times, signatures, and temperature logs for organs and specimens.

d. Service Level for STAT: Pickup within 2 hours of request, drop-off within 2 hours of pickup.

3. Additional Compliance Measures (COR-Directed)

a. Implement any facility-specific protocols identified by the COR (can vary and depend on need for each delivery), such as:

b. Enhanced temperature monitoring (continuous data loggers).

c. Secure handoff procedures at VA facilities.

4. Coordination Responsibilities

a. Pre-Delivery Communication: Confirm pickup/drop-off details with JJP VAMC staff.

b. Documentation: Provide chain-of-custody logs and compliance reports to COR.

c. Incident Reporting: Immediately report any delays, spills, or non-compliance events. The contractor must integrate OSHA safety standards, VA transplant logistics protocols, and any COR-directed measures into daily operations.

Coordination with JJP VAMC staff ensures compliance and timely delivery of critical medical materials.

5. CDC guidelines for specimen and organ transport

6. VA Directive 7700 – Occupational Safety and Health

7. Vehicles must be adequate to ensure proper and secure delivery.

8. All interactions must comply with HIPAA, VA privacy regulations, and guidelines and protocols for handling such sensitive cargo.

Incident Reporting:

Any incidents involving accidents, delays, specimen integrity, safety violations, or privacy breaches must be reported to the COR within 24 hours of occurrence.

Responsibility for Compliance:

The contractor is responsible for identifying and complying with any additional applicable directives, publications, or regulations not listed above that are required for the safe and lawful execution of services.

Failure to comply with these special instructions may result in corrective action, suspension of work, or termination of the contract, as determined by the Contracting Officer.

Meetings: kickoff meeting and routine progress meetings

Coverage and Staffing:

The contractor must maintain sufficient staffing and the appropriate vehicle coverage to meet the volume and urgency of transplant-related courier needs.

Service disruptions or delays due to inadequate coverage are not acceptable.

Non-Compliance:

In the event of contractor non-compliance with any provision of this Performance Work Statement (PWS), the following process shall apply:

The Contracting Officer or their designated representative will notify the contractor in writing of the specific non-compliance and the corrective action required. Upon receipt of such notice, the contractor shall immediately take all necessary steps to correct the identified deficiencies.

Delivery of this notice to the contractor or their on-site representative shall be deemed sufficient for the purpose of notification.

If the contractor fails or refuses to comply promptly with the corrective action, the Contracting Officer may issue a stop-work order for all or part of the contract and may initiate default proceedings in accordance with applicable federal acquisition regulations.

Phase In / Phase Out Period:

To ensure continuity of services and minimize disruptions to transplant logistics operations, the contractor shall participate in a Phase-In / Phase-Out period as follows:

Phase-In Period The contractor shall have qualified personnel available during the sixty (60) calendar days following contract award to prepare for full performance.

During this period, the contractor shall:

1. Become familiar with all performance requirements outlined in the PWS.

2. Coordinate with the JJP VAMC Transplant Team and COR to establish communication protocols.

3. Ensure all equipment, vehicles, and systems are operational and compliant with

VA standards.

4. Complete any required orientation or facility-specific training.

Phase-Out Period If the contract is not renewed or is transitioned to another vendor, the contractor shall:

1. Cooperate fully with the incoming contractor and the COR to ensure a smooth transition.

2. Provide all necessary documentation, reports, and logistical support to prevent service disruption.

3. Maintain full performance standards until the final day of the contract period.

Other Related Services (Not Included in the Scope of Work):

Only those services explicitly described in this Performance Work Statement (PWS) are authorized under this contract. Any additional services not expressly stated in the PWS are not authorized and shall not be performed unless approved through a written modification issued by the Contracting Officer.

No other individual, including the Contracting Officer’s Representative (COR) or other

VA personnel, is authorized to request or approve additional work.

If the contractor performs services not authorized by the Contracting Officer, such services will be considered inclusive and non-reimbursable under the terms of this contract.

Any services deemed vital to the continued functioning of the systems or performance of the work may only be added through a formal contract modification.