RFP 75A50122R00018 Amendment Issued 8 August 2022.pdf

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

1. REQUISITION NUMBER PAGE OF

1 81

2. CONTRACT NO. 3. AWARD/

EFFECTIVE DATE

4. ORDER NUMBER 5. SOLICITATION NUMBER

75A50122R00018

6. SOLICITATION

ISSUE DATE

07/07/2022

7. FOR

SOLICITATION

INFORMATION CALL:

a. NAME

LAWRENCE MCCOY

b. TELEPHONE NUMBER (No collect calls) 8. OFFER DUE DATE/LOCAL TIME

08/08/2022 1300 ET

9. ISSUED BY CODE ASPR/SNS 10. THIS ACQUISITION IS X UNRESTRICTED OR

SET ASIDE:

% FOR:

ASPR/SNS

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

ASPR/SNS

2945 FLOWERS ROAD

HUBZONE SMALL

BUSINESS

SMALL BUSINESS PROGRAM

EDWOSB

NAICS:811219

ATLANTA, GA 30341 SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

SIZE STANDARD: $22.0

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

13b. RATING

14. METHOD OF SOLICITATION

SEE SCHEDULE DPAS (15 CFR 700)

RFQ IFB X RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE ASPR/SNS

US DEPT OF HEALTH

ASPR/SNS

2945 FLOWERS ROAD

& HUMAN SERVICES

ATLANTA, GA 30341

17a. CONTRACTOR/ CODE FACILITY 18a. PAYMENT WILL BE MADE BY CODE

OFFEROR CODE

TELEPHONE NO.

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

19.

20.

IS CHECKED

21.

SEE ADDENDUM

22.

23.

24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES

Period of Performance: 02/28/2023 to 08/27/2023

QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

X 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

X ARE

ARE

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA - FAR (48 CFR) 53.212

X 28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN 1

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

29. AWARD OF CONTRACT: OFFER

DATED . YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

HEREIN, IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (Type or print) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

LAWRENCE R. MCCOY

31c. DATE SIGNED

19.

ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

32a. QUANTITY IN COLUMN 21 HAS BEEN

STANDARD FORM 1449 (REV. 2/2012) BACK

RECEIVED INSPECTED ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

33. SHIP NUMBER 36. PAYMENT 37. CHECK NUMBER

COMPLETE PARTIAL FINAL

PARTIAL FINAL

38. S/R ACCOUNT NUMBER 40. PAID BY

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42d. TOTAL CONTAINERS 42c. DATE REC'D (YY/MM/DD)

41c. DATE

39. S/R VOUCHER NUMBER

35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER

32c. DATE

Preventive Maintenance Services (PMS), Management, & Storage for Ventilator & PAPR Systems 75A50122R00018

Page 3 of

Amendment: All responses shall be sent to the attention of the Contracting Officer, Lawrence McCoy, via e-mail at gwg8@cdc.gov. (See L.5 (7)).

B.1 DESCRIPTION SUPPLIES AND SERVICES Transition- In Period: February 28, 2023 - August 27, 2023

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

Not To Exceed

PRICE

11 Optional Line Item

The Contractor shall provide support services to Transition-In in accordance with Section C paragraph C.9 Transition Plan-In, as described in Section C, the Performance Work Statement.

This is only an estimate for evaluating purposes only. Offerors are expected to provide their break-out of costs required to accomplish the Transition-In Plan-specified in Section C.9.

This is an Optional Task: see B.2 below.

This is a Time and Materials Line item.

This is a Non-severable Line Item

1 LOT $ $

This is an estimate only and subject to change.

Base Period: August 28, 2023 - August 27, 2024

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

EXTENDED

PRICE

1 Ventilator Management, Maintenance, and

Storage for SNS ventilator kits, in accordance with the Performance Work Statement (PWS) is included below. Terms and Conditions contained herein.

This is a Firm Fixed Price Line item.

This is a severable Line Item

102,690 Kits (KT)

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

Not To Exceed

PRICE

2 Ventilator Repair for SNS Ventilators in accordance with the PWS is included below, Terms and Conditions contained herein. Total of 10,240 hours estimated annually based on historical data. This is an estimate only and subject to change.

This is a Time and Materials Line item.

This is a severable Line Item

10,240 Hours

Per hour

This is an estimate only and subject to mailto:gwg8@cdc.gov

Page 4 of

PRICE

Not To Exceed

PRICE

3 Ventilator Cleaning and Reconstitution for SNS

Ventilator kits (including ventilator and ancillary supplies) in accordance with the PWS is included below, Terms and Conditions contained herein Total of 20,480 hours estimated annually based on historical data.

This is a Time and Materials Line item.

This is a severable Line Item

20,480

This is an estimate only and subject to change.

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

Not To Exceed

PRICE

4 ODCs (Parts & Labor) for SNS Ventilator kits (including ventilators and ancillary supplies) in accordance with the PWS is included below, Terms and Conditions contained herein. This is only an estimate for evaluating purposes only.

This is a Time and Materials Line item.

This is a severable Line Item

1 LOT $ $

This is an estimate only and subject to change.

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

EXTENDED

PRICE

5 EUA Ventilator Kits Annual Function Check in accordance with the PWS is included below, Terms and Conditions contained herein.

This is a Firm Fixed Price Line item. This is a severable Line Item

64,884 Kits (KT)

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

EXTENDED

PRICE

6 Powered Air Purifying Respirator (PAPR) Management, Maintenance, and Storage for SNS PAPR systems, and ancillary supplies in accordance with the PWS is included below, Terms and Conditions contained herein.

This is a Firm Fixed Price Line item.

This is a severable Line Item

164,950 Kits (KT)

Page 5 of

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT PRICE Not To Exceed

7 PAPR Repair for SNS PAPR systems in accordance with the PWS is included below, Terms and Conditions contained herein. Total of 316 hours estimated annually based on historical data.

This is a Time and Materials Line item. This is a severable Line Item

Hours

Per hour

This is an estimate only and subject to change.

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

Not To Exceed

PRICE

8 PAPR Cleaning and Reconstitution for SNS PAPR systems, and ancillary supplies in accordance with the PWS is included below, Terms and Conditions contained herein. Total of 632 hours estimated annually based on historical data. This is an estimate only and subject to change.

This is a Time and Materials Line item.

This is a severable Line Item

This is an estimate only and subject to change.

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

Not To Exceed

PRICE

9 ODCs (Parts & Labor) for SNS PAPR systems, and ancillary supplies in accordance with the PWS is included below, Terms and Conditions contained herein. This is only an estimate for evaluating purposes only.

This is a Time and Materials Line item.

This is a severable Line Item

1 LOT $ $

This is an estimate only and subject to change.

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

Not To Exceed

PRICE

10 Ventilator, Ancillary supplies, and PAPR Transportation in accordance with the PWS is included below, Terms and Conditions contained herein. This is only an estimate for evaluating purposes only.

This is a Time and Material Line item.

This is a severable Line Item

1 LOT $ $

This is an estimate only and subject to change.

TOTAL POTENTIAL AGGREGATE PRICE of LINE ITEM's 1 through 11: $

Option Period 1: August 28, 2024 - August 27, 2025

PRICE

EXTENDED

PRICE

1001 Ventilator Management, Maintenance, and Storage for SNS ventilator kits in accordance with the Performance Work Statement (PWS) is included below, Terms and Conditions contained herein.

This is a Firm Fixed Price Line item.

This is a severable Line Item

102,690 Kits (KT)

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

Not To Exceed

PRICE

1002 Ventilator Repair for SNS Ventilators in accordance with the PWS is included below, Terms and Conditions contained herein. Total of 10,240 hours estimated annually based on historical data. This is only an estimate for evaluating purposes only.

This is a Time and Materials Line item.

This is a severable Line Item

10,240 Hours

Per hour

This is an estimate only and subject to change.

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

Not To Exceed

PRICE

1003 Ventilator Cleaning and Reconstitution for SNS Ventilator kits (including ventilators and ancillary supplies) in accordance with the PWS is included below, Terms and Conditions contained herein. Total of 20,480 hours estimated annually based on historical data. This is only an estimate for evaluating purposes only.

This is a Time and Materials Line item.

This is a severable Line Item

20,480 Hours

Per hour

This is an estimate only and subject to change.

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

Not To Exceed

PRICE

1004 ODCs (Parts & Labor) for SNS Ventilators, ventilator kits and ancillary supplies in accordance with the PWS is included below, Terms and Conditions contained herein. This is only an estimate for evaluating purposes only.

This is a Time and Materials Line item.

This is a severable Line Item

1 LOT $ $

This is an estimate only and subject to

EXTENDED

PRICE

1005 EUA Ventilator kits Annual Function Check in accordance with the PWS is included below, Terms and Conditions contained herein.

This is a Firm Fixed Price Line item.

This is a severable Line Item

64,884 Kits (KT)

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

EXTENDED

PRICE

1006 Powered Air Purifying Respirator (PAPR) Management, Maintenance, and Storage for SNS PAPR systems, and ancillary supplies in accordance with the PWS is included below, Terms and Conditions contained herein.

This is a Firm Fixed Price Line item.

This is a severable Line Item

164,950 Kits (KT)

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

Not To Exceed

PRICE

1007 PAPR Repair for SNS PAPR systems in accordance with the PWS is included below, Terms and Conditions contained herein.

Total of 316 hours estimated annually based on historical data. This is only an estimate for evaluating purposes only.

This is a Time and Materials Line item.

This is a severable Line Item

Hours

Per hour

This is an estimate only and subject to change.

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

Not To Exceed

PRICE

1008 PAPR Cleaning and Reconstitution for SNS PAPR systems, and ancillary supplies in accordance with the PWS is included below, Terms and Conditions contained herein. Total of 632 hours estimated annually based on historical data. This is only an estimate for evaluating purposes only.

This is a Time and Materials Line item.

This is a severable Line Item

Hours

Per hour

This is an estimate only

Not To Exceed

PRICE

1009 ODCs (Parts & Labor) for SNS PAPR systems, and ancillary supplies in accordance with the PWS is included below, Terms and Conditions contained herein. This is only an estimate for evaluating purposes only.

This is a Time and Materials Line item.

This is a severable Line Item

1 LOT $ $

This is an estimate only

Not To Exceed

PRICE

1010 Ventilator, Ancillary supplies, and PAPR

Transportation in accordance with the PWS is included below, Terms and Conditions contained herein. This is only an estimate for evaluating purposes only.

This is a Time and Material Line item.

This is a severable Line Item

1 LOT $ $

This is an estimate only

TOTAL POTENTIAL AGGREGATE PRICE of LINE ITEMs 1001 through 1010: $

Option Period 2: August 28, 2025 - August 27, 2026

PRICE

EXTENDED

PRICE

2001 Ventilator Management, Maintenance, and Storage for SNS ventilator kits in accordance with the Performance Work Statement (PWS) is included below, Terms and Conditions contained herein.

102,690 Kits (KT)

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

Not To Exceed

PRICE

2002 Ventilator Repair for SNS ventilator kits in accordance with the PWS is included below, Terms and Conditions contained herein. Total of 10,240 hours estimated annually based on historical data. This is only an estimate for evaluating purposes only.

This is a Time and Materials Line item.

This is a severable Line Item

10,240 Hours

Per hour

This is an estimate only and subject to change.

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

Not To Exceed

PRICE

2003 Ventilator Cleaning and Reconstitution for SNS Ventilator kits (including ventilators, and ancillary supplies) in accordance with the PWS is included below, Terms and Conditions contained herein. Total of 20,480 hours estimated annually based on historical data. This is only an estimate for evaluating purposes only.

This is a Time and Materials Line item.

This is a severable Line Item

20,480 Hours

Per hour

This is an estimate only and subject to change.

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

Not To Exceed

PRICE

2004 ODCs (Parts & Labor) for SNS Ventilator kits (including ventilators and ancillary supplies) in accordance with the PWS is included below, Terms and Conditions contained herein. This is only an estimate for evaluating purposes only.

This is a Time and Materials Line item.

This is a severable Line Item

1 LOT $ $

This is an estimate only

EXTENDED

PRICE

2005 EUA Ventilator Kits Annual Function Check in accordance with the PWS is included below, Terms and Conditions contained herein.

This is a Firm Fixed Price Line item.

This is a severable Line Item

64,884 Kits (KT)

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

EXTENDED

PRICE

2006 Powered Air Purifying Respirator (PAPR) Management, Maintenance, and Storage for SNS PAPR systems, and ancillary supplies in accordance with the PWS is included below, Terms and Conditions contained herein.

This is a Firm Fixed Price Line item.

This is a severable Line Item

164,950 Kits (KT)

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

Not To Exceed

PRICE

2007 PAPR Repair for SNS PAPR systems in accordance with the PWS is included below, Terms and Conditions contained herein. Total of 316 hours estimated annually based on historical data. This is only an estimate for evaluating purposes only.

This is a Time and Materials Line item.

This is a severable Line Item

Hours

Per hour

This is an estimate only and subject to change.

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

Not To Exceed

PRICE

2008 PAPR Cleaning and Reconstitution for SNS PAPR systems, and ancillary supplies in accordance with the PWS is included below, Terms and Conditions contained herein. Total of 632 hours estimated annually based on historical data. This is only an estimate for evaluating purposes only.

This is a Time and Materials Line item.

This is a severable Line Item

Hours

Per hour

This is an estimate only

Not To Exceed

PRICE

2009 ODCs (Parts & Labor) for SNS PAPR systems, and ancillary supplies in accordance with the PWS is included below, Terms and Conditions contained herein. This is only an estimate for evaluating purposes only.

This is a Time and Materials Line item.

This is a severable Line Item

1 LOT $ $

This is an estimate only

Not To Exceed

PRICE

2010 Ventilator, Ancillary supplies, and PAPR

Transportation in accordance with the PWS is included below, Terms and Conditions contained herein. This is only an estimate for evaluating purposes only.

This is a Time and Material Line item.

This is a severable Line Item

1 LOT $ $

This is an estimate only

TOTAL POTENTIAL AGGREGATE PRICE of LINE ITEMs 2001 through 2010: $

Option Period 3: August 28, 2026 - August 27, 2027

PRICE

EXTENDED

PRICE

3001 Ventilator Management, Maintenance, and Storage for SNS ventilator kits in accordance with the Performance Work Statement (PWS) is included below. Terms and Conditions contained herein.

102,690 Kits (KT)

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

Not To Exceed

PRICE

3002 Ventilator Repair for SNS ventilator kits in accordance with the PWS is included below, Terms and Conditions contained herein. Total of 10,240 hours annually estimated based on historical data. This is only an estimate for evaluating purposes only.

This is a Time and Materials Line item.

This is a severable Line Item

10,240 Hours

Per hour

This is an estimate only and subject to change.

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

Not To Exceed

PRICE

3003 Ventilator Cleaning and Reconstitution for SNS Ventilator kits (including ventilators and ancillary supplies) in accordance with the PWS is included below, Terms and Conditions contained herein. Total of 20,480 hours annually estimated based on historical data. This is only an estimate for evaluating purposes only.

20,480 Hours

Per hour

This is an estimate only and subject to change.

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

Not To Exceed

PRICE

3004 ODCs (Parts & Labor) for SNS Ventilator kits (including ventilators and ancillary supplies) in accordance with the PWS is included below, Terms and Conditions contained herein. This is only an estimate for evaluating purposes only.

This is a Time and Materials Line item.

This is a severable Line Item

1 LOT $ $

This is an estimate only

EXTENDED

PRICE

3005 EUA Ventilator Kits Annual Function Check in accordance with the PWS is included below, Terms and Conditions contained herein.

64,884 Kits (KT)

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

EXTENDED

PRICE

3006 Powered Air Purifying Respirator (PAPR) Management, Maintenance, and Storage for SNS PAPR systems, and ancillary supplies in accordance with the PWS is included below, Terms and Conditions contained herein.

This is a Firm Fixed Price Line item.

This is a severable Line Item

164,950 Kits (KT)

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

Not To Exceed

PRICE

3007 PAPR Repair for SNS PAPR systems in accordance with the PWS is included below, Terms and Conditions contained herein. Total of 316 hours estimated annually based on historical data. This is only an estimate for evaluating purposes only.

This is a Time and Materials Line item.

This is a severable Line Item

Hours

Per hour

This is an estimate only and subject to change.

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

Not To Exceed

PRICE

3008 PAPR Cleaning and Reconstitution for SNS PAPR systems, and ancillary supplies in accordance with the PWS is included below, Terms and Conditions contained herein. Total of 632 hours estimated annually based on historical data. This is only an estimate for evaluating purposes only.

This is a Time and Materials Line item.

This is a severable Line Item

Hours

Per hour

This is an estimate only

Not To Exceed

PRICE

3009 ODCs (Parts & Labor) for SNS PAPR systems, and ancillary supplies in accordance with the PWS is included below, Terms and Conditions contained herein. This is only an estimate for evaluating purposes only.

This is a Time and Materials Line item.

This is a severable Line Item

1 LOT $ $

This is an estimate only

Not To Exceed

PRICE

3010 Ventilator, Ancillary supplies, and PAPR

Transportation in accordance with the PWS is included below, Terms and Conditions contained herein. This is only an estimate for evaluating purposes only.

This is a Time and Material Line item.

This is a severable Line Item

1 LOT $ $

This is an estimate only

TOTAL POTENTIAL AGGREGATE PRICE of LINE ITEMs 3001 through 3010: $

Option Period 4: August 28, 2027 - February 27, 2028

PRICE

EXTENDED

PRICE

4001 Ventilator Management, Maintenance, and Storage for SNS ventilator kits in accordance with the Performance Work Statement (PWS) is included below. Terms and Conditions contained herein.

This is a Firm Fixed Price Line item.

This is a severable Line Item

102,690 Kits (KT)

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

Not To Exceed

PRICE

4002 Ventilator Repair for SNS ventilator kits in accordance with the PWS is included below, Terms and Conditions contained herein. Total of 10,240 hours annually estimated based on historical data. This is only an estimate for evaluating purposes only.

This is a Time and Materials Line item.

This is a severable Line Item

10,240 Hours

Per hour

This is an estimate only and subject to change.

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

Not To Exceed

PRICE

4003 Ventilator Cleaning and Reconstitution for SNS Ventilator kits including ventilators and ancillary supplies) in accordance with the PWS is included below, Terms and Conditions contained herein. Total of 20,480 hours annually estimated based on historical data. This is only an estimate for evaluating purposes only.

This is a Time and Materials Line item.

This is a severable Line Item

20,480 Hours

Per hour

This is an estimate only and subject to change.

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

Not To Exceed

PRICE

4004 ODCs (Parts & Labor) for SNS Ventilator kits (including ventilators and ancillary supplies) in accordance with the PWS is included below, Terms and Conditions contained herein. This is only an estimate for evaluating purposes only.

This is a Time and Materials Line item.

This is a severable Line Item

1 LOT $ $

This is an estimate only

EXTENDED

PRICE

4005 EUA Ventilator Kits Annual Function Check in accordance with the PWS is included below, Terms and Conditions contained herein.

This is a Firm Fixed Price Line item.

This is a severable Line Item

64,884 Kits (KT)

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

EXTENDED

PRICE

4006 Powered Air Purifying Respirator (PAPR) Management, Maintenance, and Storage for SNS PAPR systems, and ancillary supplies in accordance with the PWS is included below, Terms and Conditions contained herein.

This is a Firm Fixed Price Line item.

This is a severable Line Item

164,950 Kits (KT)

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

Not To Exceed

PRICE

4007 PAPR Repair for SNS PAPR systems in accordance with the PWS is included below, Terms and Conditions contained herein.

Total of 316 hours estimated annually based on historical data. This is only an estimate for evaluating purposes only.

This is a Time and Materials Line item.

This is a severable Line Item

Hours

Per hour

This is an estimate only and subject to change.

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

Not To Exceed

PRICE

4008 PAPR Cleaning and Reconstitution for SNS PAPR systems, and ancillary supplies in accordance with the PWS is included below, Terms and Conditions contained herein. Total of 632 hours estimated annually based on historical data. This is only an estimate for evaluating purposes only.

This is a Time and Materials Line item.

This is a severable Line Item

Hours

Per hour

This is an estimate only

Not To Exceed

PRICE

4009 ODCs (Parts & Labor) for SNS PAPR systems, and ancillary supplies in accordance with the PWS is included below, Terms and Conditions contained herein. This is only an estimate for evaluating purposes only.

This is a Time and Materials Line item.

This is a severable Line Item

1 LOT $ $

This is an estimate only

Not To Exceed

PRICE

4010 Ventilator, Ancillary supplies, and PAPR

Transportation supplies in accordance with the PWS is included below, Terms and Conditions contained herein. This is only an estimate for evaluating purposes only.

This is a Time and Material Line item.

This is a severable Line Item

1 LOT $ $

This is an estimate only and subject to change.

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT

PRICE

Not To Exceed

PRICE

4011 Option Line Item

The Contractor shall provide support services to Transition-Out in accordance with Section C paragraph C.10 Transition Plan - Out, as described in Section C, the Performance Work Statement. This is only an estimate for evaluating purposes only.

This is an Optional Task: see B.2 below.

This is a Non-severable Line Item

Period of Performance (POP): 60 days at the end of the contract; the exact POP will be established at the time of the exercise of option.

1 LOT $ $

This is an estimate only

TOTAL POTENTIAL AGGREGATE PRICE of LINE ITEMs 4001 through 4011: $

TOTAL POTENTIAL AGGREGATE PRICE of LINE ITEMs 1 through 4011: $

B.2 Optional Task– Separately Priced Line Items 11 and 4011

The Government may require the delivery of the numbered line items 11 and 4011, identified in the Schedule as option items for Transition-In and Transition-Out, in the quantity and at the price stated in the Schedule, up to the maximum quantity identified in the numbered line item. The Contracting Officer may award CLIN 11 for Transition-In at the time of initial Contract award. The Contracting Officer may exercise option CLIN 4011 for Transition-Out during the final period of performance of the contract; that final period of performance may be different than the last period currently shown as line item 4010. The exact period of performance for the option will be established at the time it is exercised and may be for a different period of time than other line items in this task order.

B.3 Description of Period of Performance and Contract Amount

(a) This Contract is anticipated to have a period of performance of five (5) years from date signed by the Government, consisting of a six-month Transition-In Period, twelve-month Base Period with three one-year option periods and one six-month option period.

(b) The contract may not exceed 5 years in length in accordance with FAR 17.204(e) to meet program requirements.

An annual review of the contract shall be made to determine if the contract continues to represent the best value to the Government. It is estimated that over the five (5) year period the total dollar volume for this contract shall not exceed $ unless agreed to by both parties. This amount is estimated at the time of issuance of this Contract and may be exceeded if such action is determined in compliance with federal law by the Contracting Officer.

(c) By signing this contract, the offeror agrees to provide continuous support of services and supply for the

Ventilator and PAPR System Preventative Maintenance, Management and Storage of the original awarded item(s) from which to satisfy the Government's requirement for the performance period of the awarded contract.

SECTION C- PERFORMANCE WORK STATEMENT

C.1 Background:

The mission of the Division of Strategic National Stockpile (DSNS), of the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR), is to ensure the availability and rapid deployment of life-saving pharmaceuticals, antidotes, other medical supplies, and equipment necessary to counter the effects of biological, chemical, radiological, natural disasters or other emerging infectious disease agents and pandemic events.

When state, local, tribal, and territorial public health and healthcare systems request federal assistance to support their response efforts, DSNS ensures that the right medicines and supplies get to those who need them most during a public health emergency or pandemic event.

Public health emergencies or pandemic events present multiple challenges to the health care environment and the ability of the respiratory therapist to provide mechanical ventilation to all persons in need. The Strategic National Stockpile (SNS) maintains a repository of ventilators and powered air purifying respirator (PAPR) systems that would be used to supplement the supply currently in use by the nation’s acute care facilities.

C.2 Purpose/Objectives:

U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Division of Strategic National Stockpile has a need for a comprehensive storage and maintenance contractor to oversee the service requirements, storage, deployment, replenishment of ancillary supplies, and recovery of ventilators, PAPRS, and other medical equipment that may be requested and allocated to areas of need. Table of ventilator kits, PAPR kits, and supplies with estimated pallet positions is attached (Attachment A).

C.3 Scope of Work:

Contractor shall be responsible to provide all capabilities, (such as but not limited to expertise, record management, labor, material, equipment, and properly licensed and secure facilities) and meet all of the current Federal, State, and Local regulatory requirements to include but not limited to the Occupational Safety and Health Administration (OSHA), National Institute for Occupational Safety and Health (NIOSH), and Department of Transportation (DOT) requirements to perform the services involved under this requirement.

Should the Government require deployment of the government-owned property while maintenance activities are being performed, the Contractor shall complete the maintenance activity to be fully operational and transport the government-owned property onto contractor managed transportation upon request. Shipping reports shall be provided to the DSNS representative prior to shipment and shall include truck number, air tracking information, location shipping to, item nomenclature, serial/lot numbers, and any special handling notes.

Contractor shall maintain inventory records on the government-owned property for the duration of the contract period of performance and provide the Government with reports that capture all maintenance activities pertaining to government- owned property. This reporting requirement includes making reports available monthly or as requested by the government. If government-owned property shipping is needed, the contractor shall provide shipping reports to the DSNS representative prior to shipment. The shipping report shall include truck number, air tracking information, location shipping to, item nomenclature, serial/lot numbers, and any special handling notes in spreadsheet format.

The contract shall allow for flexibility to accommodate for slight changes to the equipment such as serial numbers, kit components, ancillaries, and containerization.

C.4 Technical Requirements:

A. The contractor shall perform all ventilator and PAPR systems maintenance activities (such as but not limited to periodic inspections, testing, calibrations, charging, and scheduled part replacements to include batteries) in accordance with the latest version of the original equipment manufacturer (OEM) service manual.

1. All storage, inventory management, charging, and maintenance activities shall be performed at the contractor’s facility which adheres to medical equipment maintenance operations in compliance of Code of Federal Regulations (CFR) Title 10 Part 20, CFR Title 21 Parts 800-1299.

2. The contractor shall provide inventory management and storage for the Ventilators, PAPR system, and ancillary supplies. Recall, Inventory management levels, and Asset visibility of 100% accountability is required.

3. The contractor shall establish and maintain Preventive Maintenance (PM) for the Ventilators, PAPR systems and ancillary supplies. The PM program shall include inspection for mechanical defects, cleaning of interior and exterior, performance verification of operator controls and adjustments, calibration verification per original equipment manufacturer (OEM) specifications, inspection for ground integrity, and current leakage IAW National Electrical Code (NEC) Regulatory standards, and documentation of results. Additionally, replacement of batteries shall be performed within or outside the routine maintenance cycle.

4. Once the DSNS is activated and has orders that requires emergency deployment of Government property is required, the Contractor personnel shall arrive at the facility within 60 minutes of the Government call. The contractor shall load their owned or contracted trucks within 2 hours after arrival to the facility. The contractor shall be responsible to provide their owned or contracted air transportation to Hawaii, Alaska, and United States territories and associated islands.

5. Contractor shall provide licensed and trained personnel to operate vehicles to perform the safe movement of medical ventilator kits, PAPRs systems, and supplies between federal, state, and DSNS sites. Should the contractor have any delays that would impact scheduled delivery times, immediate notification shall be made to the DSNS.

6. The contractor shall provide transportation tracking information from their facility to the point of need and back when requested by the DSNS.

7. Should product be deployed, the Government shall coordinate with the Contractor to receive back ventilator kits and PAPR systems so that the Contractor shall then make them whole and fully ready to support the ASPR/DSNS mission to include:

a. Receipt and inspection of the ventilator kits and PAPR systems.

b. Clean all ventilators in accordance with the manufacturer’s operator’s manual. Contractor shall maintain documentation for each cleaning agent regarding effectiveness against organisms (spores, viruses, fungi, bacteria) including necessary concentrations and contact times. Safety data sheets shall be maintained for each chemical.

c. Inventory and document condition of recovered devices.

d. Estimated the time it shall take to make the ventilators serviceable to support the next mission.

e. Document damage, missing parts or report non-working equipment.

f. Perform all required maintenance activities and document

g. Replace used, damaged, expired dedicated (proprietary) or generic (universal) consumables/ancillaries/disposables in the ventilator kits and document the replacement.

h. Ensure consumables/ancillaries/disposables are kept in good condition showing no evidence of discoloration, cracks, or residue.

i. Report to the government the return of the ventilator kits back into serviceable status.

j. For every unit deemed unserviceable or that is issued out of the inventory; the contractor will offer a per unit cost reduction for the firm fixed price for preventive maintenance, storage, and management.

8. The contractor shall perform services, function tests, and calibrations to ensure the entire FDA approved ventilator operates in accordance with the manufacturer’s operator’s and service manuals. The Contractor shall replace used, damaged, or expired consumables, ancillaries, and disposables. Test equipment used in such activities shall be in alignment with the OEM recommendations and calibrated before use. Records of calibration shall be maintained for the duration of the Contract period of performance.

• Ventilators deemed as Emergency Use Authorization (EUA) by the FDA shall only receive functionality checks once a year. Battery charging if needed. Consumables and ancillaries needing replace shall be reviewed and approved by the DSNS and shall be paid by utilizing Ventilator T & M CLINS.

• Ventec High Flow Nasal Cannula kit is part of the Ventec V+ Pro Ventilator Kit response capability and shall be maintained in accordance with OEM operators and service manuals.

9. PAPR devices shall be function checked and inspected annually. Batteries shall be charged in accordance with manufacturers specifications. Consumables and ancillaries needing replace shall be reviewed and approved by the DSNS and shall be paid by utilizing PAPR T & M CLINS.

10. Report to the government the return of the ventilator kits and PAPR systems back into serviceable status.

B. The Contractor shall provide any corrective maintenance services necessary to maintain ventilators and PAPR systems within the original manufacturer specifications. Corrective maintenance shall include repairs for all listed ventilators and PAPR systems to include problems resulting from, but not limited to, unintentional damage, operator error, normal wear and tear, component part failures, environmental issues (e.g., water damage), replacement of damaged, used, expired ancillaries, or batteries, etc. at the contractor’s facility or wherever the ventilators may be deployed to in response to an emergency.

C. The Contractor shall conform to the following quality control practices and provide the following documents.

All references to “cGMP” in this contract refer to the current Good Manufacturing Practice (cGMP) Regulations promulgated by the US Food and Drug Administration (FDA).

1. Contractor shall be responsible to adhere to all applicable current Good Manufacturing Practice requirements and Government quality assurance requirements to ensure the appropriate operation of a government-contracted storage facility in regard to receiving, holding, maintenance, and shipping preparation of medical ventilators and supplies.

a) Contractor shall maintain and comply with Code of Federal Regulations (CFR) Title 10 Part

20, CFR Title 21 Parts 800-1299 and/or Contractor shall have certification to ISO 13485:2016 Medical Devices Quality Management Systems at all facilities housing government equipment

a. Quality Management System shall include:

• Quality Manual, Procedures and Training

• Ensuring Complete and Accurate Record Management

• Asset Inventory, Distribution and Lifecycle Management

• Periodic Preventive Maintenance and Calibration

• Coordination of Repair Completion by OEM

• Remediation of the Ventilator and Accessories after Deployment including

Decontamination, Replacement of Consumables, Clearing of Prior Patient Data and Operational Verification Check

• Risk Management

• Quality Control (QC) Inspections

b) Demonstration of successful FDA Quality System Inspection Technique (QSIT).

2. The Contractor shall design, establish, and document policies and procedures detailing each step of their services and storage process and submit them to the Contracting Officer Representative (COR) for review.

These policies and procedures must conform and be applicable to the governing regulations. The policies and procedures including all changes (redlines, description of changes, justification of changes, assessment of regulatory and process impacts, and approvals) shall be available to the Government upon its request. All policies and procedures that affect government property are subject to inspection and quality review by ASPR/DSNS. Documentation include but not limited to:

a. Document Control Program - the Contractor shall be responsible for maintaining a formal document control program to manage the approval, distribution, archival, and change control of all cGMP-relevant documents. This program shall at a minimum include standard operating procedures (SOPs), manuals and protocols, software and equipment validation documents, and training records covering the receiving, holding, and shipping preparation of product, and shall be made available to the Government. Controls shall be in place to ensure only current document revisions are used. All revisions of documents shall be retained.

b. Standard Operating Procedures - the Contractor’s performance responsibilities and activities shall be described and controlled in their SOPs covering the receiving, holding, maintenance, and shipping preparation of product. All Contractor employees performing under the existing contract shall be trained on all approved SOPs applicable to assigned tasks prior to performing the tasks in areas that may affect government-owned products or equipment. Current, approved, and controlled SOPs shall be readily available to Contractor employees at the facility.

c. Training Program - the Contractor shall be responsible to implement a training program that defines the training requirements for all employees performing under the existing contact, covering the receiving, holding, maintenance, shipping preparation, and transportation of product. Annual cGMP training shall be provided by the Contractor and conducted by qualified individuals to assure that employees remain familiar with cGMP’s. Training shall be performed each time a document change. All training shall be documented, and records properly maintained.

d. Deviation and Corrective Action Tracking - the Contractor shall be responsible for maintaining deviation and corrective action/preventive action (CAPA) systems and documenting non- conformances to approved procedures including root cause analysis and actions taken. These systems shall track and trend all deviations, system non-conformances, and CAPAs. The completed deviation report including product disposition, when applicable, may then be provided to the Contractor by the Government Quality Control Unit

(QCU).

3. Initially and annually the Government, represented by personnel of DSNS’s shall assess the Contractor’s facility and Quality Systems and make determinations regarding the site’s acceptability and compliance to store and handle the government-owned product properly and safely. The assessment agenda shall include, but not be limited to, a review of the following areas covering the receiving, holding, maintenance plans and shipping preparation of product.

a. Standard Operation Procedures

b. Software and equipment validations

c. Deviation system

d. Corrective Action and Preventive Action System

e. Quality Assurance

f. Change Control

g. Training management system

h. Facility maintenance

i. Equipment maintenance and calibration

j. Environmental Monitoring

k. Facility Sanitation program

l. Document control system

m. Vendor management program

n. Organization and personnel qualifications and responsibilities

o. Regulatory inspection history (482, 483, warning letter, etc.)

D. The Contractor shall be responsible to implement an internal audit program to assess all elements of their quality management system. Records of internal audit schedules and evidence of audit completion shall be made available to the Government. Internal audits shall include, but not be limited to:

a. Previous Audit Findings

b. Standard Operation Procedures

c. Software and equipment validations

d. Deviation system

e. Corrective Action and Preventive Action System

f. Quality Assurance

g. Change Control

h. Training management system

i. Facility maintenance

j. Equipment maintenance and calibration

k. Environmental Monitoring

l. Facility Sanitation program

m. Document control system

n. Vendor management program

o. Organization and personnel qualifications and responsibilities

E. The service contractor shall maintain a sufficient parts inventory to keep ventilator kit downtime to a minimum.

The inventory shall be replenished as needed to support the services outlined on this Performance Work Statement.

F. Contractor shall have a process to document and retain approvals for all infrastructure changes. Measures to maintain inventory controls and preservation of product shall be documented.

G. Contractor shall have a defined vendor management program. Approved suppliers shall be used to purchase parts.

A list of approved suppliers shall be maintained.

H. Contractor/s shall report shortages of parts and supplies to maintain units and advise the Government of inability to procure and maintain parts.

I. The Contractor shall report units deemed unserviceable and not being utilized for parts. The contractor shall provide a certificate/report identifying the units name, model number, and serial number for the no longer serviceable unit.

And upon the government’s approval, the contractor shall dispose of the equipment in compliance with applicable local, state, and federal regulatory requirements. Additionally, for every unit deemed unserviceable or that is issued out of the inventory; the contractor shall offer a per unit cost reduction for the firm fixed price for preventive maintenance, storage, and management.

J. Contractor shall have demonstrated experience and be responsible for coordinating warranty repairs from multiple OEM’s.

K. Contractor shall manage ventilator warranty repair coordination with manufacturers on behalf of the Government to repair, modify, correct as necessary any ventilator deficiencies. This includes hazard alerts, recalls, or mandatory updates from the manufacturer.

L. The contractor shall provide an inventory and maintenance management system that is transparent and directly accessible by the government. The contractor shall coordinate with the government towards a "real time” on-line electronic data interchange (EDI) that captures all transactions pertaining to the government-owned property and/or provide a digital dashboard to ASPR personnel that provides real-time readiness status.

1. Inventory and maintenance management system should be able to provide status and location confirmation for all units. Life history maintenance records including failure data, long-term condition changes supporting end-of-life, upgrade, and other replacement strategies. Inventory systems shall be maintained in accordance with National Institute for Standards and Technology (NIST) security standard NIST SP 800-171.

2. At a minimum, the Contractor shall maintain an inventory record and provide a monthly inventory status report of medical ventilators and PAPR systems serviced and moved. These reports must include notations of any ventilators damaged, lost, or theft. These reports shall be sent to assigned ASPR/DSNS Project Officer and Contracting Officer Representative by close of business the last day of the month. At a minimum, this report shall contain the following:

Store Keeping Unit (SKU) Information:

(1) Manufacturer and Model Number / Part Number

(2) SKU Description

(3) Unit of Measure

(4) Unit Cost

(5) Quantity transported

(6) Quantity on hand by facility

(7) Warehouse location/multiple warehouse/storage points

(8) Lot number

(9) Expiration date

(10) Condition Code (used to account for product recall, materiel complaints, etc.)

(11) Note Codes (materiel subject to damage by freezing, hazardous material, etc.)

Transactions:

(1) Receipts/partial and complete

(2) Report of item discrepancies

(3) Inventory transfers and value of inventory in transit

(4) Inventory count sheets (for physical inventories)

(5) Inventory valuation (and method such as latest acquisition cost)

(6) Deployment capacity (calculates number of units that can be rotated based on historical demand and SKU Shelf-Life/Expiration Date)

(7) Transportation time for the inventory transfers

Actions:

Model and Serial Number Date due for next operational check Date due for next periodic maintenance Date of last completed operational check Date of last completed periodic maintenance

Actions (Consumables):

Consumables Part numbers Consumables Lot Numbers Shelf-Life/Expiration Date (where applicable)

M. The Contractor shall maintain service event documentation/records during the duration of the contract period of performance. Upon completion of each preventive maintenance service or each corrective maintenance service, a service report or record must be created and maintained. These reports or records must be transferred to the incoming contractor and/or Government personnel at the expiration of the contract pursuant to Section C.10 Transition-Plan-Out. Service reports or records shall indicate all inspection and test results, devices/components checked, date/time, manufacturer, model, serial number, type of service provided, problems addressed, parts or components replaced/repaired, contractor personnel performing service, and service actions or pending actions.

N. Contractor shall support the design, configuration, and kitting of medical ventilators to included additional consumables and disposables for rapid deployment and long-term storage.

O. Contractor shall provide costs and rates for the contract line-items for the comprehensive ventilator and PAPR service contract listed below: See Attachment A.

C.5 Facility Requirements:

A. Physical Infrastructure. The Contractor shall provide medical equipment management facilities and logistics footprint across the Continental United States (CONUS). Specific facility criteria that shall be met:

1. Primary fixed facilities that are required shall be within 30 miles of International Airports in Atlanta, Baltimore, Salt Lake City, Memphis, Dallas, and Indianapolis where existing ASPR/DSNS warehouses and personnel are located. ASPR/DSNS personnel from those facilities shall have access for mission support activities for optimal response capabilities in the region they are responsible for. Additionally, the contractor shall allow ASPR/DSNS personnel access to support annual audits to meet Financial Management Office requirements for accountability at the contractor’s facility. Each of the contractor’s warehouses to support the requirements outlined shall be capable of supporting a minimum of 4,000 pallet positions (each) to include additional areas dedicated to supporting kitting, cleaning, logistics, clinical engineering, and transportation services for ventilators and PAPRs.

2. Contractors may propose additional facilities and plans. Additional facilities shall be within 30 miles of International Airports. Warehouses should include additional areas dedicated to supporting kitting, cleaning, logistics, clinical engineering, and transportation services for ventilators and PAPRs.

Additionally, the contractor shall allow ASPR/DSNS personnel access to support annual audits to meet Financial Management Office requirements for accountability at the contractor’s facility. Cities that may add operational value and may strengthen proposals for consideration would be in Seattle Washington, Newark New Jersey, Los Angeles California, Honolulu Hawaii, Anchorage Alaska, and San Juan Puerto Rico.

3. In addition to the storage, maintenance, and service facilities, the contractor shall have additional medical equipment facilities with supporting logistics & clinical engineering capabilities that may be used in cities throughout the nation and associated U.S. territories to support deployments, recoveries, and repairs as needed.

4. Combination of facility criteria and plans shall be evaluated towards a best value award. Upon award, immediate review and approval of the contractors proposed facilities and plans the DSNS must…