RFI_-_ASPR_Dialysis_Care.pdf

REQUIREMENTS and SOW Assistant Secretary for Preparedness and Response (ASPR)

Office Assistant Secretary Portable Dialysis Platforms and Support

RFI-ASPR-ORM-75A50119R00038

Background and Need:

To address the needs of ASPR to support frail populations affected by natural and intentional disasters, and ensure that populations can be cared for in a manner that reduces the burden of transport, portable hemodialysis capabilities need to be incorporated into Federal Medical

System and Disaster Medical Assistance Team caches. A typical response requires the relocation/airlift of approximately 100 dialysis outpatients and comes with significant cost burden to HHS.

This solicitation is seeking current FDA-approved, commercial dialysis platforms that can create their own dialysate from potable water sources, using standard 15A or 20A outlets to carry out hemodialysis treatments in temporary outpatient care facilities. ASPR is seeking to procure a support cache of systems and materials, preventative maintenance support, and training for

ASPR Teams to deliver hemodialysis care in temporary outpatient centers.

Statement of Work:

Anticipated Period of Performance

Base Period 24 Months

Option Period 24 Months

CLIN 0001- Base - Dialysis systems. New equipment, fully-operational, assembled, tested, and configured to include all associated cabling, plumbing and consumables. Lease of fifty (50) systems. Leasing period of performance will be twenty-four (24) months. See above for

Minimum Specifications.

QUANTITY - 1 EACH - Unit Price $ / Total Price $

CLIN 0002 - Base - Installation and 24-month maintenance and support for hardware and software

QUANTITY - 1 Job - Total Price $.

CLIN 0003 – Base – System Shipping

CLIN 0004 - Base- Consumables – All required consumables to perform hemodialysis on up to

100 patients, assuming 5-day per week clinical operation and 3 patients/system/day.

See above for Minimum Specifications.

QUANTITY - 1 Job - Unit Price $ / Total Price $

CLIN 0005 – Base – Consumable Shipping – All required shipping costs for consumables to perform hemodialysis on up to 100 patients simultaneously, assuming a 5-day per week clinical operation and 3 patients/system/day.

QUANTITY - Multiple Jobs - Total Price $.

CLIN 0006 - Base- Training – Training for healthcare providers and technical support staff. See above for Minimum Specifications.

CLIN 0007 - Base- Maintenance – Routine and field maintenance of dialysis systems. See above for Minimum Specifications.

CLIN 0008- OPTION- Dialysis systems. New equipment, fully-operational, assembled, tested, and configured to include all associated cabling, plumbing and consumables. Lease of additional fifty (50) systems during emergencies. Leasing period of performance will be twenty-four (24) months. See above for Minimum Specifications.

QUANTITY - 1 EACH - Unit Price $ / Total Price $

CLIN 0009 - OPTION - Installation and 24-month maintenance and support for hardware and software on dialysis systems leased under CLIN 0008.

CLIN 0010 – OPTION – System Shipping. Shipping of dialysis systems leased under CLIN

0008 during emergencies.

CLIN 0011 - OPTION- Consumables – All required consumables to perform hemodialysis on up to 200 patients, assuming 5-day per week clinical operation and 3 patients/system/day.

See above for Minimum Specifications.

CLIN 0012 –OPTION– Consumable Shipping – All required shipping costs for consumables to perform hemodialysis on up to 200 patients simultaneously, assuming a 5-day per week clinical operation and 3 patients/system/day.

QUANTITY - Multiple Jobs - Total Price $.

CLIN 0013 – OPTION - Maintenance – Routine and field maintenance of additional dialysis systems leased under CLIN 0008. See above for Minimum Specifications.

NOTE: Any additional features/options does not add value to the requested purchase. The

Government is requesting minimum specifications with award to the Best Value offeror.

The required initial delivery is eight weeks after date of contract award. Early delivery is acceptable. Offers must include all costs including shipping costs in quotes, if applicable.

Incorporated provisions and clauses are those in effect through the most current Federal

Acquisition Regulation. The provision at FAR 52.212-1, Instructions to Offerors - Commercial

Items applies to this solicitation. The provision at FAR 52.212-3, Offeror Representations and

Certifications - Commercial Items applies to this solicitation. Clauses 52.212-4, Contract Terms and Conditions - Commercial Items and 52.212-5, Contract Terms and Conditions Required to

Implement Statutes or Executive Orders-Commercial Items also apply to this solicitation.

The provision at FAR 52.217-5, EVALUATION OF OPTIONS and FAR clause 52.217-7, OPTION FOR INCREASED QUANTITY - SEPARATELY PRICED LINE ITEM apply to this solicitation.

Requirements:

The table below lists the system minimum requirements for the portable dialysis capability build:

Function Requirements

Dialysis

Treatment

Blood Flow Up to 400 mL/min

Maximum Ultrafiltration Rate

2,000 mL/hour

Dialysate Flow 100, 200, 300 mL/min

Dialysate Preparation Standard 45X proportioning

Potassium Settings 1K, 2K, 3K, 4K

Calcium Settings 2.5 Ca

Sodium Settings 135-145 mEq/L

Bicarbonate Settings 30-40 mEq/L

Dialysis Temperature 36-38 °C

Dialyzers

Compatible with commercially available high-flux dialyzers

Consumables

Saline Bolus

All required consumables to perform hemodialysis on up to 100 patients concurrently, with an option for emergency procurement of consumables to support a total of 200 patients concurrently, assuming 5-day per week clinical operation and 3 patients/system/day.

Consumable push pack for initial 72 hour operation will be developed and provided by Performer. Consumable storage and delivery thereafter will be the responsibility of the Performer.

Automatic with

Blood Pressure

Wireless Connectivity

(OPTIONAL)

volume tracking

Integrated blood pressure cuff

Two-Way Data Transfer

Dialysate

Production

Input Water Source EPA Quality Drinking Water

Incoming Temperature Range

5-32 °C

Incoming Pressure Range

30-80 PSIG

Filtration Integrated Sediment, Carbon, RO, Ultrafilter

Outputs Purified Water

AAMI standards met

Maintenance Disinfection Automated daily heat disinfection Weekly chemical disinfection

Filter Replacements Individually replaceable by user

Routine Maintenance Provided by manufacturer within up to 5 USG-Controlled locations Includes weekly chemical disinfection, filter replacement and other routine maintenance as required

Field Maintenance Provided as Level-2 maintenance by manufacturer – systems or components shipped to central depot(s) for repair.

Logistics for transport of portable systems from warehouses, staging areas, or during recovery operations where they can be readily accessed will be the responsibility of the Performer.

Training

Curriculum Development

Generate a curriculum for healthcare providers (inclusive of credentialed personnel and technicians) for operation and care of portable dialysis technologies. This includes (but may not be limited

to) Dialysate circuit overview, system setup, disinfection, degassing, de-aeration, dialysate proportioning, formulation, dialysate modeling, dialysate monitoring, monitors, alarms and interventions, ultrafiltration, rinsing and contingency procedures (loss of power, loss of water, etc.).

Curriculum will be developed in a standard training and a train-the-trainer format.

Curriculum Delivery Deliver a curriculum for healthcare providers (inclusive of credentialed personnel and technicians) for operation and care of portable dialysis technologies.

This includes (but may not be limited to) Dialysate circuit overview, system setup, disinfection, degassing, de-aeration, dialysate proportioning, formulation, dialysate modeling, dialysate monitoring, monitors, alarms and interventions, ultrafiltration, rinsing and contingency procedures (loss of power, loss of water, etc.). Curriculum will be delivered in ASPR-defined locations a minimum of four (4) times a year and a maximum of ten (10) times a year.

Support Vendor must provide at a minimum two (2) years of support for all hardware, software, and consumable components associated with the portable dialysis system.

Condition

New equipment, fully operational, assembled, tested, and configured to include all associated cabling and consumables.

Contractors must be actively registered in the System for Award Management (SAM)

(https://www.sam.gov/portal/public/SAM/) to be eligible for award. Instructions for registration are available at the website.

Capability statements should be e-mailed directly to Tasha.McMillian@hhs.gov. Submissions received after the specified date and time will not be considered.

mailto:Tasha.McMillian@hhs.gov