ASPR_Dialysis_RFP_75A50119R00038_FINAL.pdf

NOTE: In sealed bid solicitations “offer” and “Offeror” mean “bid” and “bidder.”

SOLICITATION

9. Sealed offers in original and 0 copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8 , or if handcarried, in the depository located in See Section L for Instructions until 3:00 PM EST 07/19/2019 (Hour) (Date)

CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

Tasha McMillian

B. TELEPHONE (NO COLLECT CALLS)

(202) 205-1502

C. E-MAIL ADDRESS

Tasha.McMillian@hhs.gov

11. TABLE OF CONTENTS

(x) SEC. DESCRIPTION PAGE(S) (x) SEC. DESCRIPTION PAGE(S)

PART I – THE SCHEDULE PART II – CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 01 X I CONTRACT CLAUSES 29

X B SUPPLIES OR SERVICES AND PRICES/COSTS 03 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

X C DESCRIPTION/SPECS./WORK STATEMENT 07 X J LIST OF ATTACHMENTS 31

X D PACKAGING AND MARKING 13 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 14

X K K

REPRESENTATIONS, CERTIFICATIONS, AND

OTHER STATEMENTS OF OFFERORS 32 X F DELIVERIES OR PERFORMANCE 16

X G CONTRACT ADMINISTRATION DATA 21 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 81

X H SPECIAL CONTRACT REQUIREMENTS 24 X M EVALUATION FACTORS FOR AWARD 96

OFFER (Must be fully completed by Offeror)

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within 120 calendar days (60 calendar days unless a different period is inserted by the Offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52-232-8)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(The Offeror acknowledges receipt of amend-ments to the SOLICITATION for Offerors and related documents numbered and dated:

AMENDMENT NO. DATE AMENDMENT NO. DATE

15A. NAME

AND

ADDRESS

OF

OFFEROR

DUNS CODE FACILITY 16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

(Type or Print)

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE 18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT 21. ACCOUNTING AND APPROPRIATION

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( ) 23. SUBMIT INVOICES TO ADDRESS SHOWN IN (4 copies unless otherwise specified)

ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 25. PAYMENT WILL BE MADE BY CODE

26. NAME OF CO (Type or print) 27. UNITED STATES OF AMERICA

(Signature of CO)

28. AWARD DATE

IMPORTANT -- Award will be made on this form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION / PREVIOUS EDITION IS UNUSABLE STANDARD FORM 33 (REV. 9-97) / Prescribed by GSA / FAR (48 CFR) 53.214(c)

RFP No. 75A50119R00038

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

3. SOLICITATION NO.

75A50119R00038

5. DATE ISSUED

07/06/2019

SOLICITATION, OFFER AND ̀ AWARD PAGE OF

PAGES

2. CONTRACT NO.

N/A

7. ISSUED BY

Department of Health and Human Services

OS/ASPR/ORM – O’Neil Office Building

200 C Street, SW

Washington, DC 20201

CODE

4. TYPE OF SOLICITATION 6. REQUISITION/PURCHASE NO.

SEALED BID (IFB)

X NEGOTIATED (RFP)

8. ADDRESS OFFER TO (If other than Item 7) mailto:Tasha.McMillian@hhs.gov

RFP No. 75A50119R00038

NOTE TO OFFERORS

The information in SECTION A – Solicitation/Contract Form, contains important information for any Contractor interested in responding to this solicitation. Any contract resulting from this solicitation will include in its SECTION A – Solicitation/Contract Form, accounting, appropriation and general information applicable to the contract award.

If your proposal is not received by the Contracting Officer (CO) or his/her designee at the time and place specified, it will be considered late and handled in accordance with the Federal Acquisition Regulation (FAR), FAR 52.215-1 (Instructions to Offerors – Competitive Acquisition), the Health and Human Services Acquisition Regulation (HHSAR), and HHSAR Clause 352.215-70, “Late Proposals and Revisions” located in section L of this solicitation.

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.

The contract schedule, set forth in SECTIONS B through H, contains contractual information pertinent to this solicitation. It is not an exact representation of the contract document that may be awarded as a result of this solicitation. The contract cost or price and other contractual provisions unique to the Contractor’s proposal may be included in the resultant contract.

The contract schedule is intended to provide the Contractor with information to aid in understanding the likely terms and conditions of any resultant contract.

Questions may submitted in writing via email no later than July 12, 2019 at 5pm EST.

Responses to those questions received by the deadline will be posted to www.fbo.gov no later than July 15, 2019 via an amendment. Proposals and supporting documentation must be e-mailed directly to Tasha.McMillian@hhs.gov AND one (1) original, signed copy of the proposal should be delivered no later than July 19, 2019 at 3pm EST. For drop off of proposals, you must allow sufficient time to make it through security in order to meet the deadline for the receipt of the proposal. Delivery address is O’Neil Office Building, 200 C Street, SW, Washington, DC 20201.

Proposals received after the specified date and time will not be considered for award.

https://www.sam.gov/portal/public/SAM/ http://www.fbo.gov/ mailto:Tasha.McMillian@hhs.gov

PART I – THE SCHEDULE

Section B – Supplies or Service and Cost/Price

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

This Solicitation (75A5011R00038) is 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.

ARTICLE B.2. CONTRACT TYPE

The Government anticipates awarding a single Firm Fixed Price (FFP) contract.

B.3 CLIN STRUCTURE

The Government’s CLIN structure is provided below.

Base Period 24 Months

CLIN 0001- 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 $0.00 / Total Price $0.00

CLIN 0002 – Shipping, Delivery and Acceptance

The shipping, delivery and acceptance of all dialysis systems and operational materials within both CONUS and OCONUS areas.

QUANTITY - 1 Job - Unit Price $0.00 / Total Price $0.00

CLIN 0003 – Installation and Maintenance

Installation and 24-month maintenance and support for hardware, software and related consumables

CLIN 0004 - 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 $0.00/ Total Price $0.00 CLIN 0005 –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 within both CONUS and OCONUS areas.

QUANTITY - Multiple Jobs - Unit Price $0.00/ Total Price $0.00

CLIN 0006 - Training

Training for healthcare providers and technical support staff within both CONUS and OCONUS areas. See above for Minimum Specifications.

CLIN 0007 - 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.

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

QUANTITY - 1 Job - Total Price $0.00/Total Price $0.00

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.

QUANTITY - 1 Job - Unit Price $0.00 /Total Price $0.00

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 $0.00

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

Option Period 24 Months

CLIN 1001- 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.

CLIN 1002 – Shipping, Delivery and Acceptance

CLIN 1003 – Installation and Maintenance

CLIN 1004 - Consumables

CLIN 1005 –Consumable Shipping –

All required shipping costs for consumables to perform hemodialysis on up to 100 patients

CLIN 1006 - Training

CLIN 1007 - Maintenance

CLIN 1008- OPTION- Dialysis systems. New equipment, fully-operational, assembled, tested, and configured to include all associated cabling, plumbing and consumables. Renewal of leasing for additional fifty (50) systems during emergencies. Leasing period of performance will be twenty-four (24) months. See above for Minimum Specifications.

CLIN 1009 - OPTION - Installation and 24-month maintenance and support for hardware and

CLIN 1010 – OPTION – System Shipping. Shipping of dialysis systems leased under CLIN 0008

CLIN 1011 - OPTION- Consumables – All required consumables to perform hemodialysis on up to

CLIN 1012 –OPTION– Consumable Shipping – All required shipping costs for consumables to

CLIN 1013 – OPTION - Maintenance – Routine and field maintenance of additional dialysis

NOTE: Any additional features/options does not add value to the requested purchase. The US Government is requesting minimum specifications with award to the Best Value offeror.

Performance Details

The required initial delivery is eight weeks after date of contract award. Early delivery is acceptable. Offerors must include all costs including shipping and handling, taxes, customs fees, and freight charges in proposals, if applicable.

Incorporated provisions and clauses are those in effect through the most current Federal Acquisition Regulation (FAR). 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.

The Government intends to award a single Firm Fixed Price (FFP) contract to the eligible, responsible offeror that represents the Best Value offer. In order to be determined technically acceptable: (1) the offeror must propose on all of the items specified, meeting the minimum specifications; (2) the offeror must meet the required delivery dates; and (3) the Government will consider past performance information in accordance with FAR 15.305 where negative information within CPARS may render a proposal being deemed technically unacceptable.

Offerors are encouraged to provide a detailed proposal that addresses each CLIN, for both the Base Period and the Option Period. Including a broad solution that does not include a sufficient level of detail may render the Offeror's proposal Technically Unacceptable.

Offerors shall include the following additional information with submissions: Offerors must provide supporting artifacts in the form of benchmarks and documentation demonstrating they have a commercially-available, FDA-cleared dialysis platform capable of producing dialysate from public tap water for in-center use. Point Of Contact (including phone number and email address), Contractor CAGE code, and Contractor DUNS.

SECTION C – Description/Specification/Statement of Work

Background

The Office of the Principal Deputy Assistant Secretary (OPDAS) is responsible for responding to public health emergencies that affect the US and Territories. OPDAS is seeking to develop and procure solutions to perform hemodialysis on displaced patients currently being treated in outpatient or in-home settings.

ASPR requires commercially-available, FDA-approved dialysis platforms that can create dialysate from potable water sources, and ensure the safety of patients using the technology at home or in a temporary outpatient care facility. This effort will develop a support cache of systems and consumables, a training program, preventative maintenance for dialysis units in storage and in the field, and invest in R&D efforts for future commercial platforms to be adapted to deliver dialysis care in or near disaster zones. This will also allow transition of these patients to in-home dialysis care, helping to achieve the goals of the HHS Transforming Kidney Care Initiative.

Scope

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.

Objective

The objective is 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 US Tax Payers.

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

Blood Pressure

Wireless Connectivity

(OPTIONAL)

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 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.

Statement of Work (SOW):

Base Period 24 Months

CLIN 0001- 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. The systems will be run using municipal water sources. All pipes, valves, taps and other fittings will be those used for the typical supply of drinking-water. See above for Minimum Specifications.

CLIN 0002 – Shipping, Delivery and Acceptance

CLIN 0003 – Installation and Maintenance

CLIN 0004 - Consumables

CLIN 0005 –Consumable Shipping – All required shipping costs for consumables to perform hemodialysis on up to 100 patients

CLIN 0006 - Training

CLIN 0007 - Maintenance

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.

CLIN 0009 - OPTION - Installation and 24-month maintenance and support for hardware and

CLIN 0010 – OPTION – System Shipping. Shipping of dialysis systems leased under CLIN 0008

CLIN 0011 - OPTION- Consumables – All required consumables to perform hemodialysis on up to

CLIN 0012 –OPTION– Consumable Shipping – All required shipping costs for consumables to

CLIN 0013 – OPTION - Maintenance – Routine and field maintenance of additional dialysis

Option Period 24 Months

CLIN 1001- 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. The systems will be run using municipal water sources. All pipes, valves, taps and other fittings will be those used for the typical supply of drinking-water. See above for Minimum Specifications.

CLIN 1002 – Shipping, Delivery and Acceptance

CLIN 1003 – Installation and Maintenance

CLIN 1004 - Consumables

CLIN 1005 –Consumable Shipping – All required shipping costs for consumables to perform hemodialysis on up to 100 patients

CLIN 1006 - Training

CLIN 1007 - Maintenance

NOTE: Any additional features/options does not add value to the requested purchase. The US Government is requesting minimum specifications with award to the Best Value offeror.

Performance Details The required initial delivery is eight weeks after date of contract award. Early delivery is acceptable. Offerors must include all costs including shipping and handling, taxes, customs fees, and freight charges in proposals, if applicable.

Offerors are encouraged to provide a detailed proposal that addresses each CLIN, for both the Base Period and the Option Period. Including a broad solution that does not include a sufficient level of detail may render the Offeror's proposal Technically Unacceptable.

Offerors shall include the following additional information with submissions: Offerors must provide supporting artifacts in the form of benchmarks and documentation demonstrating they have a commercially-available, FDA-cleared dialysis platform capable of producing dialysate from public tap water for in-center use. Point Of Contact (including phone number and email address), Contractor CAGE code, and Contractor DUNS.

SECTION D – PACKAGING, MARKING AND SHIPPING

ARTICLE D.1. POSTAGE AND FEES

All postage and fees related to submitting information, including forms, reports, etc., to the Contracting Officer or the Contracting Officer Representative shall be the responsibility of the Contractor. All items to be delivered under the contract shall be preserved, packaged, and packed in accordance with normal commercial practices to meet the packing requirements of the carrier and ensure safe delivery at the intended destination.

ARTICLE D.2. MARKING

All information submitted to the Contracting Officer or the Contracting Officer’s Representative under this contract shall be clearly marked to show the following information on the cover:

Name of the contractor

Contract Number

Consignee’s Name and

Address Title of the deliverables

Date of the Deliverables

ARTICLE D.3. GOVERNMENT ADDRESS

ASPR will inform the Contractor of the address where to ship any purchased equipment or supplies. Addresses may vary depending on where the items are needed.

Section E – Inspection and Acceptance

ARTICLE E.1. FEDERAL ACQUISITION REGULATION CLAUSES INCORPORATED BY

REFERENCE

This section or other parts of this contract may incorporate one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address:

https://www.acquisition.gov/far/

FAR 52.246-2 – Inspection of Supplies – Fixed Price (August 1996)

FAR 52.246-4 -- Inspection of Services- Fixed Price (August 1996)

Inspection and acceptance of the product, and documentation called for herein shall be accomplished by the Government COR. The COR will review, examine, and verify that all services and deliverables fulfill and are in compliance with the requirements and standards as stated in this contract. Technical inspection and acceptance will take place at:

Location to be Determined at time for award

Acceptance may be presumed unless otherwise indicated in writing by the Contracting

Officer or the CO’s duly authorized representative within 30 days of receipt.

ARTICLE E.2. CONTRACTOR’S PERFORMANCE

At the COR’s discretion, he/she and the Contractor’s program manager will meet to evaluate the manner in which the Contractor is performing in accordance with the contract requirements and standards such as: good workmanship, the Contractor’s record of forecasting and controlling cost; the Contractor’s adherence to contract schedule, Contractor’s history of reasonable and cooperative behavior and commitment to customer satisfaction, and generally, the Contractor’s business like concern for the interest of the customer. The Contracting Officer may attend these meetings. Formal performance reviews will be conducted at least annually on or about the anniversary date of the contract.

ARTICLE E.3. BASIS OF ACCEPTANCE

The Contractor’s performance and the quality of services provided hereunder shall be subject to final inspection and acceptance by the Contracting Officer in conjunction with the Contracting Officer’s Representative (COR). The Basis for Acceptance shall be compliance with the requirements set forth within the Statement of Work, Contractor’s https://www.acquisition.gov/far https://www.acquisition.gov/far

Proposal and other terms and conditions of the Contract. Deliverable items rejected under the contract shall be corrected in accordance with the applicable clauses.

SECTION F – DELIVERIES/PERFORMANCE

ARTICLE F.1. FAR 52.252-2 – Clauses Incorporated by Reference (JUN 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Full text may be accessed electronically at https://www.acquisition.gov/far/index.html

FAR 52.242-15 STOP-WORK ORDER (AUG 1989)

FAR 52.242 -17 GOVERNMENT DELAY OF WORK (APR 1984)

FAR 52.247-34 F.O.B. DESTINATION (Nov 1991)

ARTICLE F.2. PERIOD OF PERFORMANCE

The period of performance for the base period shall be twenty-four (24) months from the date of award. The option period shall be for twenty-four (24) months. The option period will be exercised at the sole discretion of the Government.

ARTICLE F.3. DELIVERABLES AND DELIVERY SCHEDULE

Deliverable Description Acceptance Criteria

Kick Off Meeting

Within 5 days of award Timely kick off meeting

Initial System Delivery – Base

Within 30 days from award – delivery of twenty-five (25) dialysis platforms to GVT-specified locations. This will be new equipment, fully-operational, assembled, tested, and configured to include all associated instruction manuals, cabling, plumbing and consumables.

Systems delivered and set up at defined locations within 30 days of award.

Final System Delivery – Base

Within 60 days from award – delivery of remaining twenty five (25) dialysis platforms to GVT-specified locations

Systems delivered and set up at defined locations

Initial System Delivery - Option

Within 7 days of option execution – delivery of twenty five (25) dialysis platforms. This will be new equipment, fully-operational, assembled, tested, and configured to include all

Systems delivered and set up at defined locations within 7 days of option execution.

associated instruction manuals, cabling, plumbing and consumables.

Final System Delivery - Option

Within 21 days of option execution – delivery of remaining twenty five (25) dialysis platforms. This will be new equipment, fully-operational, assembled, tested, and configured to include all associated cabling, plumbing and consumables.

Systems delivered and set up at defined locations within 21 days of option execution.

Initial Consumable Delivery – Base

Consumables to support dialysis care for one hundred (100) patients for 72 hours delivered to GVT-specified locations

All required consumables delivered to GVT-specified locations within 30 days

Final Consumable Delivery – Base

Consumables delivered at time-of-need to support up to one hundred (100) dialysis patients assuming 5 day/week operations

Uninterrupted supply of consumables to deliver dialysis care to up to one hundred (100) patients

Initial Consumable Delivery - Option

Consumables to support dialysis care for additional one hundred (100) patients for 72 hours delivered to GVT-specified locations

All required consumables delivered to GVT-specified locations within 7 days

Final Consumable Delivery - Option

Consumables delivered at time-of-need to support an additional one hundred

(100) dialysis patients assuming 5 day/week operations

Uninterrupted supply of consumables to deliver dialysis care to up to two hundred (200) patients

Training 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.

Acceptable curriculum developed and delivered via email within 30 days from award.

Training Delivery

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

First training delivered to GVT personnel within 45 days from award.

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.

Routine Maintenance – Base

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

Routine maintenance performed on all equipment.

Monthly maintenance reports delivered.

Field Maintenance – Base

Provide maintenance of up to fifty (50) 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.

All field maintenance performed within 24 hours of request. Performer must maintain an operational availability of at least 90%.

Monthly maintenance reports delivered

Routine Maintenance – Option

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

Routine maintenance performed on all equipment.

Monthly maintenance reports delivered.

Field Maintenance - Option

Provide maintenance of up to one hundred (100) 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.

All field maintenance performed within 24 hours of request. Performer must maintain an operational availability of at least 90%.

Monthly maintenance reports delivered.

Quarterly Reports

The report will have two (2) major sections.

1. Technical Status Report. The technical status report will detail

On or before forty-five (45) calendar days after the end of each calendar quarter throughout the term of this Agreement, the Performer technical reports on all problems, technical issues, major developments, and the status of equipment during the reporting period.

2. Business Status Report. The business status report shall provide summarized details of the resources status, and a quarterly accounting of current expenditures.

shall electronically submit or otherwise provide a quarterly report to the COR and CO.

Special Technical Reports

As agreed to by the Performer and COR, the Performer shall electronically submit or otherwise provide to the COR and CO special reports on significant events such as significant target accomplishments, significant equipment tests, failures, significant issues with consumables, or significant delivery issues.

As agreed to by the Performer and the COR, the Performer shall electronically submit or otherwise provide to the COR and CO special reports.

Final Report The Performer shall electronically submit a Final Report making full disclosure of all major deliverables upon completion of the contract or within sixty (60) calendar days of termination of the contract. The Final Report shall be marked with a distribution statement to denote the extent of its availability for distribution, release, and disclosure without additional approvals or authorizations.

The Final Report shall be marked on the front page in a conspicuous place with the following marking:

“DISTRIBUTION STATEMENT.

Distribution authorized to U.S.

Government agencies only to protect information not owned by the U.S.

Government and protected by a Performer’s “limited rights” statement, or received with the understanding that it not be routinely transmitted outside the U.S. Government. Other requests for this document shall be referred to

HHS/CO.”

Final report delivered within 60 calendar days upon the completion or termination of the contract.

ARTICLE F.4. REPORTS/DELIVERABLES

Successful performance of the final contract shall be deemed to occur upon performance of the work described in SECTION C of this contract, and upon delivery and acceptance of the items described above in F.3.

The Contractor shall be responsible for submission of all reports and deliverables. The approved file formats for all deliverables shall be specified in the award document.

ARTICLE F.5. OBSERVANCE OF LEGAL HOLIDAYS

The Department of Health and Human Services observes the following days as holidays:

New Year’s Day Inauguration Day (Every 4 Years, Washington, DC only) Martin Luther King’s birthday President’s Day Memorial Day Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day

Any other day designated by Federal law, Executive Order, or Presidential Proclamation.

When any such day falls on a Saturday, Friday is taken as the observation day. When the holiday falls on a Sunday, then Monday is the observation day. Observance of such days by Government personnel shall not be cause for additional period of performance or entitlement to compensation except as set forth in the contract. If the Contractor’s personnel work on a holiday, no form of holiday or other premium compensation will be reimbursed either as a direct or indirect cost.

ARTICLE F.6 NOTICE TO THE GOVERNMENT OF DELAYS

In the event the Contractor encounters difficulty in meeting performance requirements, or when the contractor anticipates difficulty in complying with the contract delivery schedule or completion date, or whenever the Contractor has knowledge that any actual or potential situation is delaying or threatens to delay the timely performance of this contract, the Contractor shall immediately notify the Contracting Officer, and the

COR, in writing, giving pertinent details, provided, however, that this data shall be informational only in character and that this provision shall not be construed as a waiver by the Government of any delivery schedule date, or any rights or remedies provided by law or under this contract.

SECTION G- CONTRACT ADMINISTRATION

ARTICLE G.1. CONTRACTING OFFICER (CO)

The Contracting Officer is:

TBD

The Contracting Officer (CO) is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions or other stipulations of this contract. Any other commitment, either explicit or implied, is invalid.

The CO is the only person with authority to act as an agent of the Government under this contract.

Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any prices incurred during the performance of this contract; (5) obligate or de-obligate funds into the contract; or (6) otherwise change any terms and conditions of this contract.

No information, other than that which may be contained in an authorized modification to this contract duly issued by the Contracting Officer, which may be received from any person employed by the

United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

ARTICLE G.2. CONTRACTING OFFICER’S REPRESENTATIVE (COR)

The Contracting Officer’s Representative (COR) is:

TBD

As delegated by the CO, the COR is responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and recommending to the

Contracting Officer changes in requirements; (2) assisting the CO in interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

ARTICLE G.3. CONTRACTOR POINT OF CONTACT

The Contractor’s Point of Contact is: TBD.

ARTICLE G.4. PAYMENT BY ELECTRONIC FUNDS TRANSFER

The Government shall use electronic funds transfer to the maximum extent possible when making payments under this contract.

ARTICLE G.5. MONTHLY INVOICE SUBMISSION

The Contractor shall deliver invoices electronically and simultaneously to: PSC, the Contracting

Officer Representative, the Contracting Officer and Contract Specialist electronically. Unless otherwise specified by the Contracting Officer, all invoices shall be addressed as follows:

The Contractor agrees to include, as a minimum, the following information on each invoice:

Contractor’s Name & Address

Contractor’s Banking Information (where payment is to be remitted)

Contractor’s Tax Identification Number (TIN)

DUNS Number

Contract Number

Requisition Number

Invoice Number

Invoice Date

Contract Line Item Number (CL IN)

Quantity Unit Price & Extended Amount for each line item

Total Amount of Invoice (to include the accumulative total(s), the period of performance of the contract and the period of performance of the billing period)

Name, title and telephone number of person to be notified in the event of a defective invoice

Payment Address, if different from the information in (b) (1).

The invoice shall be signed by a person authorized to bind the Contractor. The Contractor shall not submit an invoice prior to delivery of goods or services.

ARTICLE G.6. CONTRACT COMMUNICATIONS/CORRESPONDENCE

The Contractor shall identify all correspondence, reports, and other data pertinent to this contract by imprinting thereon the contract number from Page 1 of the contract.

ARTICLE G.7. STANDARDS OF CONDUCT

In performing this contract, Contractor personnel may be required to interact with high-level

Government and non-government officials. The Contractor shall ensure that all its personnel conduct their work in a professional and responsible manner.

ARTICLE G.8. EVALUATION OF CONTRACTOR PERFORMANCE

Purpose: In accordance with FAR 42.1502, the Contractor’s performance will be periodically evaluated by the government in order to provide current information for source selection purposes.

These evaluations will therefore be marked “Source Selection Information.”

Performance Evaluation Period: The Contractor’s performance will be evaluated annually.

Evaluators: The performance evaluation will be completed jointly by the Contracting Officer’s

Representative and the Contracting Officer.

Performance Evaluation Factors: The Contractor's performance will be evaluated in accordance with

SECTION M, Attachment #1, Contract Performance Evaluation Report and the Contractor

Performance Assessment Reporting System (CPARS).

Contractor Review: A copy of the evaluation will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor shall submit comments, rebutting statements, or additional information to the Contracting Officer within 30 calendar days after receipt of the evaluation.

Resolving Disagreements between the Government and the Contractor: Disagreements between the parties regarding the evaluation will be reviewed at a level above the Contracting Officer. The ultimate conclusion on the performance evaluation is a decision of the contracting agency. Copies of the evaluation, Contractor's response, and review comments, if any, will be retained as part of the evaluation.

Release of Contractor Performance Evaluation Information: The completed evaluation will not be released to other than Government personnel and the Contractor whose performance is being evaluated.

Disclosure of such information could cause harm both to the commercial interest of the Government and to the competitive position of the contractor being evaluated, as well as impede the efficiency of Government operations.

Source Selection Information: Departments and agencies may share past performance information with other Government departments and agencies when requested to support future award decisions. The information may be provided through interview and/or by sending the evaluation and comment document to the requesting source selection official.

Retention Period: The agency will retain past performance information for a maximum period of 3 years after completion of contract performance for the purpose of providing source selection information for future contract awards.

SECTION H – SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. CONFLICT OF INTEREST

The Contractor warrants that to the best of its knowledge and belief except as otherwise disclosed, no actual or apparent organizational or employee conflict of interest exists as defined below: a situation in which the nature of work under a Government contract and a Contractor's organization and any of its affiliate organizations or their successors in interest (hereinafter collectively referred to as the "Contractor"), financial, contractual or other interests are such that the appearance of the

Contractor's objectivity in performing the contract work may be impaired, may otherwise result in a biased work product, or may result in the contractor being given an unfair competitive advantage; or a financial interest or relationship, professional or otherwise, of an employee, subcontractor employee, or consultant (hereinafter referred to as "employee") with an entity that may actually impair or have the appearance of impairing the objectivity of the employee in performing the contract work, or an employee has had, currently has, or is reasonably expected to have, official responsibilities with an outside organization, or some other financial interest or business affiliation, such that a reasonable person with knowledge of the relevant facts might question the employee's objectivity/impartiality in performing the contract.

For purposes of paragraphs a(i) - (a)(iii), the financial interests and business affiliations of the employee's spouse, minor children, and business partners are imputed to the employee.

The Contractor agrees that if changes in their organization or employees have occurred that give rise to the appearance of a conflict of interest since submission of their final proposal revision

(FPR) and contract award or occur during the performance of this contract, it shall make an immediate and full disclosure to the Contracting Officer and Contracting Officer's Technical

Representative (COR) in writing. Such disclosure should include a description of the circumstances, and a description of any action which the Contractor has taken or proposes to take to avoid, neutralize, or mitigate any actual or apparent conflict of interest.

The Contractor has an ongoing responsibility to notify the Government Contracting Officer and COR in writing if any actual or apparent conflict of interest arises during the period of performance of the contract. The written notification must provide details of the conflict of interest and any planned mitigation.

The Contractor agrees to immediately notify the Contracting Officer and the COR of (1) any actual or apparent personal conflict of interest with regard to any of its employees working on, having published, or having access to information regarding this contract, or (2) any such information regarding this contract, when such conflicts have been reported to the contractor.

The Contractor agrees to notify the Contracting Officer and COR prior to incurring costs for that employee's work when an employee may have a conflict of interest. In the event that the conflict of interest does not become known until after performance on the contract begins, the Contractor shall immediately notify the Contracting Officer and COR of the conflict of interest. The employee shall recuse himself/herself from work on this contract when an actual or apparent conflict has been identified until such time as it is determined that the conflict does not exist or it is resolved. The

Contractor shall continue performance of this contract until notified by the Contracting Officer of the appropriate action to be taken.

The provisions of this clause shall be included in all subcontracts and consulting agreements to avoid, neutralize, or mitigate actual or apparent conflicts of interest.

ARTICLE H.2. TASK ORDER/DELIVERY ORDER CONTRACT OMBUDSMAN

In accordance with FAR 16.505(b)(8), the following individual has been designated as the HHS/ASPR Ombudsman for task order and delivery order contracts:

Schuyler Eldridge

HHS/ASPR/MFHC

O’Neil Office Building 200 C Street, SW Washington, DC 20201 Schuyler.Eldridge@hhs.gov

ARTICLE H.3. CONFIDENTIALITY OF INFORMATION

Confidential information, as used in this article, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the Government will furnish to the

Contractor or that the Contractor is expected to generate which is confidential. Similarly, the

Contracting Officer and the Contractor may, by mutual consent, identify such confidential information from time to time during the performance of the contract. Failure to agree will be settled pursuant to the "Disputes" clause.

If it is established elsewhere in this contract, that information to be utilized under this contract, or a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies, with respect to systems of records determined to be subject to the Privacy Act.

Confidential information, as defined in this article, shall not be disclosed without the prior written consent of the individual, institution, or organization.

Whenever the Contractor is uncertain with regard to the proper handling of material under the contract, or if the material in question is subject to the Privacy Act or is confidential information subject to the provisions of this article, the Contractor should obtain a written determination from the

Contracting Officer prior to any release, disclosure, dissemination, or publication.

Contracting Officer Determinations will reflect the result of internal coordination with appropriate program and legal officials.

mailto:Schuyler.Eldridge@hhs.gov

ARTICLE H.4. ACCESS TO DOCUMENTATION/DATA

The Government shall have physical and electronic access to all documentation and data generated under this contract, including: all data documenting Contractor performance, all data generated, all communications and correspondence with regulatory agencies and bodies to include all audit observations, inspection reports, milestone completion documents, and all Contractor commitments and responses. The Government shall acquire unlimited rights to all data funded under this contract.

ARTICLE H.5. IDENTIFICATION AND DISPOSITION OF DATA

HHS reserves the right to review any other data determined by HHS to be relevant to this contract.

ARTICLE H.6. DISSEMINATION OF INFORMATION

No information related to data obtained under this contract shall be released or publicized without the prior written consent of the COR and CO, whose approval shall not be unreasonably withheld, conditioned, or delayed, provided that no such consent is required to comply with any law, rule, regulation, court ruling or similar order; for submission to any government entity’ for submission to any securities exchange on which the Contractor’s (or its parent corporation’s) securities may be listed for trading; or to third parties relating to securing, seeking, establishing or maintaining regulatory or other legal approvals or compliance, financing and capital raising activities, or mergers, acquisitions, or other business transactions.

ARTICLE H.7. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.

ARTICLE H.8. PUBLICATION AND PUBLICITY

The Contractor…