75A50122R00018 0001 Questions and Answers.pdf

(x)

75A50122R00018 x x

1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR

OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

x

ASPR/SNS

ATLANTA, GA 30341

2945 FLOWERS ROAD

ASPR/SNS

US DEPT OF HEALTH & HUMAN SERVICES

ASPR/SNS

ATLANTA, GA 30341

2945 FLOWERS ROAD

ASPR/SNS

ASPR/SNS

07/26/20220001

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

07/07/2022

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

E. IMPORTANT: Contractor is not is required to sign this document and return __________________ copies to the issuing office.

ORDER NO. IN ITEM 10A.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

This Amendment is being issued to provide Answers in response to Questions submitted against RFP 75A50122R00018, Ventilator and PAPR System Management, Maintenance and Storage.

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

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

LAWRENCE R. MCCOY

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .

RFP Q & A for 75A50122R00018 Page 2 of 4

Question 1: B.1 Description Supplies and Services:

With the ODC CLIN’s being a pass through with cost plus G&A can the government can you provide Not to Exceed (NTE) dollar ($) values for all ODC CLIN’s?

Answer 1: ODC CLIN NTE Costs:

• Ventilator, Other Direct Cost ODC (Parts & Labor) Time and Material (T & M) Not to Exceed (NTE) $1,300,000.

• Powered Air Purifying Respirator (PAPR), Other Direct Cost (ODC) (Parts & Labor) T &

M NTE $104,610.

Question 2: C.4 Technical Requirements: A.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.

Question 2A: Can the government please confirm that battery replacement should be charged under the FFP CLIN (s)?

Answer 2A: Routine battery replacement service shall be part of the Firm Fixed Price (FFP) cost.

Battery damage outside of routine service will be a case-by-case consideration for the government to approve under T & M Contract Line-Item Number (CLINs').

Question 2B: Can the government please confirm that battery replacement will not be included when not applicable/feasible as in the case where the battery is integral to the unit (and not replaceable) E.g. – ADG PAPR’s?

Answer 2B: Battery replacement is not applicable to batteries integrated into devices that cannot be replaced. Devices that fail to operate due to internal batteries shall be reported to the government, the government will instruct the vendor on applicable disposition actions.

Question 3: C.4 Technical Requirements A. 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.

Does the government require inventory, annual inspection, and replacement as necessary on all component level ancillary supplies?

Answer 3: The government requires annual inspection and replacement as necessary on all component level ancillary supplies for complete FFP ventilator and PAPR kits as detailed in Attachment A-Ventilators Models, Ventilator Supplies, and PAPR Ancillary Supplies. Inventory

RFP Q & A for 75A50122R00018 Page 3 of 4 reports and annual inventories will be managed at the kit level. Component level ancillary supplies within a kit will be managed by the vendor.

The government requires annual inspection on all component level ancillary supplies for complete EUA ventilator, PAPR kits, and Resupply (RSK) kits as detailed in Attachment A-Ventilators Models, Ventilator Supplies, and PAPR Ancillary Supplies. Inventory reports and annual inventories will be managed at the kit level. Component level ancillary supplies within a kit will be managed by the vendor. Replacement of component level supplies will be a case-by-case consideration for the government to approve under T & M CLINs.

Question 4: C.4 Technical Requirements: A.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.

What is the expectation of the Government when EUA devices reach labeled end-of-life or expiration date?

Answer 4: Expectation of the government when EUA devices reach labeled end-of-life or expiration date would be to report the expiration of the devices to the government. The government will deliberate and provide disposition instructions of the devices to the vendor.

Question 5: C.4 Technical Requirements: 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.

PAPR systems are non-serviceable items, therefore no corrective maintenance can be performed outside of unit or accessory replacement. Does the government expect PAPR repairs beyond the replacement of damaged or expired parts and accessories?

Can the government please confirm that all corrective maintenance shall be billable under T&M CLINs?

RFP Q & A for 75A50122R00018 Page 4 of 4

Answer 5: PAPR devices are non-serviceable and expected not to be repaired should they be deemed unserviceable. Maintenance or replacement of component parts such as cords, filters, straps etc.…will be a case-by-case consideration for the government to approve under T & M CLINs.

Question 6: Attachment A-Ventilators Models, Ventilator Supplies, and PAPR Ancillary Supplies:

Does the government require replacement insurance on all government stored inventory? Can the government please provide the total dollar ($) value of all government owned assets that will be stored at contractor facility.

Answer 6: The government is self-insured and does not require replacement insurance on all inventory stored by the vendor. However, if the vendor is negligent in safeguarding assets or damages product, the government may seek reimbursement from the vendor. Total cost of inventory is $2,083,360,626.96.