36C10G18Q9098-0001000.docx

5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2.

AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE

OF PAGES

10A. MODIFICATION OF

CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

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:

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

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ 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 ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV.

11/2016) is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO:

Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITE M 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES

SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR

43.103(b).

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 r eference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS

ENTERED INTO

PURSUANT TO AUTHORITY OF:

D. OTHER

BY

Contractor

16C. DATE SIGNED

14.

DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

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

15A. NAME

AND TITLE OF SIGNER

16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS

OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) 09-05-2018

NONE

36C10G U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center 10300 Spotsylvania Ave | STE 140 Fredericksburg VA 22408 36C10G U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center 10300 Spotsylvania Ave | STE Fredericksburg VA 22408 To all Offerors/Bidders

36C10G18Q9098 08-13-2018

X X X ** HOUR & DATE for Receipt of Offers is EXTENDED to:

OCT 5, 2018 @ 2:00PM EST

X

The purpose of this solicitation amendment is to change this RFQ from full and open competiton to a SDVOSB Set-Aside.

Also, to provide the Governments responses to questions received and extend the closing date to

October 5, 2018 at 2:00PM EST.

Beth Davis Contracting Officer - C4 Solicitation Number:

36C10G18Q9098

Notice Type:

Combined Synopsis/Solicitation

Synopsis:

COMBINED SYNOPSIS/SOLICITATION

This is a combined synopsis/solicitation for Brand name or equal commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.

Solicitation number 36C10G18Q9098 is issued for this combined synopsis/solicitation; this solicitation is being issued as a Request for Quote (RFQ). This combined synopsis/solicitation incorporates provisions and clauses in effect through Federal Acquisition Circular (FAC) 2005-99, dated 16 Jul 2018.

Requirement Description:

The Department of Veterans Affairs (VA) is transforming the service it provides to Veterans through the MyVA effort. MyVA was established in July 2015 to modernize the Department’s culture, processes, and capabilities to put the needs, expectations and interests of Veterans and their families first. This effort is highly visible, with significant attention within the highest levels of government, the public, and the press.

As this transformation progresses, VA's mission requirements to support America’s Veterans are growing more quickly than its budget. Key elements of VA’s expanded mission requirements include:

· 15% expansion in the number of Veterans enrolled in VA Healthcare from FY 2009 through FY 2016.

· More than 100% increase between FY 2009 and FY 2016 in the number of 100% disabled Veterans cared for by VA.

· 6% increase in the number of medical appointments scheduled in FY 2016 vs FY 2014.

· More than 300% increase between FY 2009 and FY 2016 in the number of Veterans receiving education benefits through the VA.

In order to ensure we are able to continue to provide Veterans with the benefits and care they have earned through their selfless service, VA is changing the way we do business. Specifically, we are improving the management of our supply chain to aggregate demand and facilitate ease of ordering in the field. Throughout VA, we are moving from local contracting to national contracting whenever feasible. Simplified ordering processes will drive volume towards suppliers with national contracts. Simultaneously, greater cost transparency throughout the VA will allow clinicians and VA leaders to select medical equipment that optimizes Veteran outcomes at the lowest cost.

For our suppliers, we anticipate that these changes will ease the process of doing business with the VA and drive down our suppliers’ costs. We welcome opportunities to work closely with suppliers to further reduce costs. In return, we expect that suppliers will offer the VA value commensurate with VA’s status as the largest integrated healthcare provider in the United States. Specifically, VA expects that it will receive the most favorable prices, warranties, conditions, benefits, and terms for the same product as those given by the supplier to any provider in the country. We expect that VA’s large volumes will increasingly be directed toward those suppliers best able to offer value to the VA. VA looks forward to collaborating with its suppliers to further drive down costs in order to deliver optimal value to our Veterans.

In light of this transformation, the VA has a requirement to purchase Humidifiers Airway Heat Moisture Exchange to deliver patient care at its VA Medical Centers around the country. Humidifiers Airway Heat Moisture Exchange are typically canister type devices, designed to be connected in-line with the patient's artificial airway for passive capture of exhaled heat and moisture for use in warming and humidifying inspired gases. A single-award Firm-Fixed Price Requirements contract will be awarded for the purchase of Brand Name or Equal equipment in accordance with all terms, conditions, provisions, specifications, and schedule of this solicitation herein. Quotes shall contain the terms for cost/price and technical capabilities of the Brand Name or Equal equipment. The Government reserves the right to award without discussions.

The associated North American Industrial Classification System (NAICS) code for this procurement is 339112 – Surgical and Medical Instrument Manufacturing and the associated size standard is 1,000 employees. This procurement action is issued as a Service Disabled Veteran-Owned Small Business (SDVOSB) set-aside.

This acquisition is for a single-award Firm-Fixed Price Requirements contract in accordance with FAR Part 16.5 for Fisher & Paykel® brand name or equal Humidifiers Airway Heat Moisture Exchange and related equipment and accessories as identified in ATTACHMENT A - HUMIDIFIERS AIRWAY HEAT MOISTURE EXCHANGE – PRICE/COST SCHEDULE. All interested companies shall provide a quote for all Contract Line Item Numbers (CLINs) listed in ATTACHMENT A - HUMIDIFIERS AIRWAY HEAT MOISTURE EXCHANGE – PRICE/COST SCHEDULE.

The ordering period is for one year with two 12-month option years. Delivery is FOB destination. Firm-Fixed Price Orders will be placed against this contract in writing and will provide the delivery locations, delivery dates and exact quantities.

The FAR provision at 52.212-1, Instructions to Offerors – Commercial, applies to this acquisition including attached addenda to the provision.

The FAR provision at 52.212-2, Evaluation -- Commercial Items, and the specific evaluation criteria as attached addenda also applies to this acquisition The Offeror is to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with its offer.

Clause at 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition and a statement regarding any addenda to the clause. Addendum is attached.

Clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items, applies to this acquisition and a statement regarding which, if any, of the additional FAR clauses cited in the clause are applicable to the acquisition. Addendum is attached.

All interested Offerors must be registered in the System for Award Management (SAM) prior to receiving an award. You may access SAM at https://www.sam.gov/portal/public/SAM/.

Questions regarding this combined synopsis/solicitation are due via email by 2:00PM EST on September 19, 2018 to Ninatile.Bacote@va.gov. No calls will be accepted.

Quotes are due via email by 2:00PM EST on October 5, 2018 to Ninatile.Bacote@va.gov.

Product Description Salient Characteristics Literature Review Humidifiers Airway Heat Moisture Exchange

1. SCOPE OF WORK

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Humidifiers: Airway, Heat Moisture Exchange product line as a candidate for a VA-wide (otherwise referred to as “national”) single Requirements contract award. Humidifiers Airway Heat Moisture Exchange are typically canister type devices, designed to be connected in-line with the patient's artificial airway for passive capture of exhaled heat and moisture for use in warming and humidifying inspired gases. The contractor must demonstrate the ability to meet all requirements of the solicitation. The objective is to provide Humidifiers Airway Heat Moisture Exchange to be used by clinicians throughout the VA medical centers and facilities. The period of performance is for one 12-month base period with two 12-month option periods.

2. REQUIREMENT

This requirement will be IAW FAR clause 52.211-6, “Brand Name or Equal” which requires that the offeror indicate each product that is being offered as an “equal” product. For each equal product, the offeror must include a description reflecting the characteristics and level of quality that will satisfy the salient physical, functional, or performance characteristics of the equal product(s) specified in the solicitation. The offeror also must clearly identify the item by brand name (if any) and make/model number. Finally, the offeror must include descriptive literature, such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the contracting officer, and clearly describe any modifications it plans to make to a product to make it conform to the solicitation requirements.

Humidifiers Airway Heat Moisture Exchange

The Department of Veterans Affairs (VA) is seeking vendors who can provide Fisher & Paykel brand name or equal of Humidifiers: Airway, Heat Moisture Exchange commodities as listed below that meet all the following salient characteristics:

Salient Characteristics (SC)

SC #

(PAGE & PARAGRAPH)

VENDORS ARE REQUIRED TO SITE WHERE IN THEIR TECHNICAL LITERATURE THESE SC’s ARE REFLECTED.

Questions Received from Vendors Humidifiers Airway Heat Moisture Exchange

1. Does the SAC plan to comply with FAR 19.201(a) which requires small business have maximum practicable opportunity? The FAR states:

“It is the policy of the Government to provide maximum practicable opportunities in its acquisitions to small business, veteran-owned small business, service-disabled veteran-owned small business, HUBZone small business, small disadvantaged business, and women-owned small business concerns. Such concerns must also have the maximum practicable opportunity to participate as subcontractors in the contracts awarded by any executive agency, consistent with efficient contract performance.”

Answer: Per Federal Register Vol. 83, No. 105 dated Thursday, May 31, 2018 there is a Class Non Manufacture Waiver for Continuous Positive Airway Pressure (CPAP) devices, Bilevel Positive Airway Pressure (BiPAP) devices, and other products intended to treat sleep apnea by keeping a person’s airways open during sleep under NAICS codes 339112 (surgical and medical instrument manufacturing) and 339113 (surgical appliance and supplies manufacturing), and PSC 6515 (medical and surgical instrument, equipment and supplies). This requirement now falls under the class waiver and will be set aside for Service Disabled Veteran Owned Small Business.

2. In order to provide the maximum practicable opportunity for small business, will the SAC take the minimally required effort to request an NMR waiver from the SBA for this acquisition? Since there are no small businesses that manufacture either the Brand Name devices or any equivalent, SBA approval is assured and quick. Such a waiver request seems required if the SAC is truly committed to maximum practicable opportunity for small business.

Answer: Per Federal Register Vol. 83, No. 105 dated Thursday, May 31, 2018 there is a Class Non Manufacture Waiver for Continuous Positive Airway Pressure (CPAP) devices, Bilevel Positive Airway Pressure (BiPAP) devices, and other products intended to treat sleep apnea by keeping a person’s airways open during sleep under NAICS codes 339112 (surgical and medical instrument manufacturing) and 339113 (surgical appliance and supplies manufacturing), and PSC 6515 (medical and surgical instrument, equipment and supplies). This requirement now falls under the class waiver and will be set aside for Service Disabled Veteran Owned Small Business.

3. Since these RFP items are CPAP accessories (e.g. for CPAP usage only), they are covered by the new NMR Class Waiver for PAP and Accessories recently approved by the SBA. Since there is an NMR class waiver already in place, and since these RFP items are available from small businesses, why has the SAC not chosen to apply the existing NMR and make this a small business set-aside? Using an existing NMR class waiver seems required if the SAC is truly committed to maximum practicable opportunity for small business.

Answer: Per Federal Register Vol. 83, No. 105 dated Thursday, May 31, 2018 there is a Class Non Manufacture Waiver for Continuous Positive Airway Pressure (CPAP) devices, Bilevel Positive Airway Pressure (BiPAP) devices, and other products intended to treat sleep apnea by keeping a person’s airways open during sleep under NAICS codes 339112 (surgical and medical instrument manufacturing) and 339113 (surgical appliance and supplies manufacturing), and PSC 6515 (medical and surgical instrument, equipment and supplies). This requirement now falls under the class waiver and will be set aside for Service Disabled Veteran Owned Small Business.

4. Request you check 52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns as applicable since this clause is required. (Note that RFP C.12 (a) states that this clause is included on page 16, but does not check the clause on page 4).

Answer: 52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns will be removed from the solicitation due to the new SDVOSB Set Aside.

5. Request you confirm that a HUBZone Small Business submitting to this unrestricted competition will be provided the 10% price evaluation preference, and that the Limitations of Subcontracting requirements to perform 50% shall not apply since there is an NMR Class Waiver for these items.

Answer: 52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns will be removed from the solicitation due to the new SDVOSB Set Aside.

6. Since this requirement exceeds $500,000 in value, request you check 52.219-9 Small Business Subcontracting Plan as applicable.

Answer: 52.219-9 will not be checked, during market research it was found that there are no subcontracting possibilities.

7. To ensure the VA can best ensure any large business prime contractor will comply with the required Small Business Subcontracting Plan, request you check 52.219-16 Liquidated Damages—Subcontracting Plan as applicable.

Answer: A Small Business Subcontracting Plan will not be included.

8. Request you check 52.242-5, Payments to Small Business Subcontractors as applicable, since there will be a small business subcontracting requirement established by the required Small Business Subcontracting Plan.

Answer: A Small Business Subcontracting Plan will not be required.

9. Request you add the required VAAR 852-219-9 VA Small Business Subcontracting Plan Minimum Requirements to the RFP. To determine the Small Business Subcontracting Plan goals, this VAAR clause states:

“the minimum goals for award of subcontracts to service-disabled veteran-owned small business concerns and veteran-owned small business concerns shall be at least commensurate with the Department's annual service-disabled veteran-owned small business and veteran-owned small business prime contracting goals for the total dollars planned to be subcontracted.”

Answer: A Small Business Subcontracting Plan is not required.

10. The VA’s prime contracting goals established by the Secretary are 10% SDVOSB and 12% VOSB. To meet the VAAR requirement to be “commensurate”, the RFP small business subcontracting goals for SDVOSBs and VOSBs must be 10% and 12%. Since this is often an area of confusion for large business offerors, please confirm that these are the minimum goals for any Small Business Subcontracting Plan:

a. VOSB 12% (commensurate with VA prime goal)

b. SDVOSB 10% (this 10% is included in VOSB 12%)

c. HUBZone small business 3%

d. Woman-owned small business 5%

e. Small Disadvantaged Business 5% Answer: A Small Business Subcontracting Plan is not required.

11. Please confirm that any Small Business Subcontracting Plan requires review by VA OSDBU and by the SBA Procurement Center Representative, prior to Contracting Officer review and approval.

Answer: A Small Business Subcontracting Plan is not required.

12. A veteran’s preference evaluation preference factor is required in all VAAR 812 acquisitions based on VAAR clarifications that implement VetsFirst posted by the VA in the Federal Register in April 2018. To comply with VetsFirst, VAAR 812 commercial item acquisitions must include 852.215-70 Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors (DEC 2009). Including this clause, by itself, does not comply with VetsFirst requirements to provide preferences and priorities to SDVOSBs and VOSBs. A second step is required to ensure that a specific evaluation factor is included in the 52.212-2 evaluation criteria and reflected in the award decision.

For example, if the SAC decides to make this a small business set-aside, a revised RFP evaluation process might state in FAR 52-212.2 Evaluation of Commercial Items:

Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

1. Technical Capability Factor Technical Capability will be evaluated to determine if the items proposed meet requirements.

2. Socio-economic Factors in order of precedence below

3. Price Factor When factors 1 and 2 are combined, they are slightly more important than price alone.

If the current SAC acquisition continues as unrestricted, then 52.212.2 might state:

Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

1. Technical Capability Factor Technical Capability will be evaluated to determine if the items proposed meet requirements.

2. Socio-economic Factors in order of precedence below

3. Price Factor When factors 1 and 2 are combined, they are slightly more important than price alone.

Answer: Per Federal Register Vol. 83, No. 105 dated Thursday, May 31, 2018 there is a Class Non Manufacture Waiver for Continuous Positive Airway Pressure (CPAP) devices, Bilevel Positive Airway Pressure (BiPAP) devices, and other products intended to treat sleep apnea by keeping a person’s airways open during sleep under NAICS codes 339112 (surgical and medical instrument manufacturing) and 339113 (surgical appliance and supplies manufacturing), and PSC 6515 (medical and surgical instrument, equipment and supplies). This requirement now falls under the class waiver and will be set aside for Service Disabled Veteran Owned Small Business. Based on this change, the provisions will be amended.

13. I know a few months ago I provided some info for an RFI on our hardware. My understanding at the time was the VA was considering a sole source formulary. Is that what this solicitation is for?

Answer: This is a Brand Name or Equal restricted to Service Disabled Veteran Owned Small Business.

14. If so, what about the components that go along with the equipment? For the PT101, there are some other set up items that will be needed to work properly.

Answer: The solicitation will proceed as is and not add the accessories as they are not critical for operating the equipment.

See attached document: ATTACHMENT A - PRICE COST SCHEDULE - HUMIDIFIERS AIRWAY HEAT MOISTURE EXCHANGE.

See attached document: ATTACHMENT B - CONTRACT ADMINISTRATION - HUMIDIFIERS AIRWAY HEAT MOISTURE EXCHANGE.

See attached document: ATTACHMENT C - CONTRACT CLAUSES - HUMIDIFIERS AIRWAY HEAT MOISTURE EXCHANGE.

See attached document: ATTACHMENT D - SOLICITATION PROVISIONS - HUMIDIFIERS AIRWAY HEAT MOISTURE EXCHANGE.

See attached document: ATTACHMENT E - REPORTING TOOL - HUMIDIFIERS AIRWAY HEAT MOISTURE EXCHANGE.