36C24224Q0195.docx

36C24224Q0195

A.1 VAAR 852.219-76 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—CERTIFICATE OF COMPLIANCE FOR SUPPLIES AND PRODUCTS (JAN 2023) (DEVIATION)

(a) Pursuant to 38 U.S.C. 8127(l)(2), the offeror certifies that—

(1) If awarded a contract (see FAR 2.101 definition), it will comply with the limitations on subcontracting requirement as provided in the solicitation and the resultant contract, as follows:

(i) [ ] In the case of a contract for supplies or products (other than from a nonmanufacturer of such supplies), it will not pay more than 50% of the amount paid by the government to it to firms that are not certified SDVOSBs listed in the SBA certification database as set forth in 852.219–73 or certified VOSBs listed in the SBA certification database as set forth in 852.219–74. Any work that a similarly situated certified SDVOSB/VOSB subcontractor further subcontracts will count towards the 50% subcontract amount that cannot be exceeded. Cost of materials are excluded and not considered to be subcontracted.

(ii) [ ] In the case of a contract for supplies from a nonmanufacturer, it will supply the product of a domestic small business manufacturer or processor, unless a waiver as described in 13 CFR 121.406(b)(5) is granted. The offeror understands that, as provided in 13 CFR 121.406(b)(7), such a waiver has no effect on requirements external to the Small Business Act, such as the Buy American Act or the Trade Agreements Act.

(2) Manufacturer or nonmanufacturer representation and certification. [Offeror fillin—check each applicable box below. The offeror must select the applicable provision below, identifying itself as either a manufacturer or nonmanufacturer]:

(i) [] Manufacturer or producer. The offeror certifies that it is the manufacturer or producer of the end item being procured, and the end item is manufactured or produced in the United States, in accordance with paragraph (a)(1)(i).

(ii) [ ] Nonmanufacturer. The offeror certifies that it qualifies as a nonmanufacturer in accordance with the requirements of 13 CFR 121.406(b) and paragraph (a)(1)(ii). The offeror further certifies it meets each element below as required in order to qualify as a nonmanufacturer.

[ ] The offeror certifies that it does not exceed 500 employees (or 150 employees for the Information Technology Value Added Reseller exception to NAICS code 541519, which is found at 13 CFR 121.201, footnote 18).

[ ] The offeror certifies that it is primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied.

[ ] The offeror certifies that it will take ownership or possession of the item(s) with its personnel, equipment, or facilities in a manner consistent with industry practice.

(iii) [ ] The offeror certifies that it will supply the end item of a small business manufacturer, processor, or producer made in the United States, unless a waiver as provided in 13 CFR 121.406(b)(5) has been issued by SBA. [Contracting Officer fill-in or removal (see 13 CFR 121.1205). This requirement must be included for a single end item. However, if SBA has issued an applicable waiver of the nonmanufacturer rule for the end item, this requirement must be removed in the final solicitation or contract.] or [Contracting officer tailor clause to remove one or other block under subparagraph (iii).] [ ] If this is a multiple item acquisition, the offeror certifies that at least 50% of the estimated contract value is composed of items that are manufactured by small business concerns. [Contracting Officer fill-in or removal. See 13 CFR 121.406(d) for multiple end items. If SBA has issued an applicable nonmanufacturer rule waiver, this requirement must be removed in the final solicitation or contract.]

(3) The offeror acknowledges that this certification concerns a matter within the jurisdiction of an Agency of the United States. The offeror further acknowledges that this certification is subject to Title 18, United States Code, Section 1001, and, as such, a false, fictitious, or fraudulent certification may render the offeror subject to criminal, civil, or administrative penalties, including prosecution.

(4) If VA determines that an SDVOSB/ VOSB awarded a contract pursuant to 38 U.S.C. 8127 did not act in good faith, such SDVOSB/VOSB shall be subject to any or all of the following:

(i) Referral to the VA Suspension and Debarment Committee;

(ii) A fine under section 16(g)(1) of the Small Business Act (15 U.S.C. 645(g)(1)); and

(iii) Prosecution for violating 18 U.S.C. 1001.

(b) The offeror represents and understands that by submission of its offer and award of a contract it may be required to provide copies of documents or records to VA that VA may review to determine whether the offeror complied with the limitations on subcontracting requirement specified in the contract or to determine whether the offeror qualifies as a manufacturer or nonmanufacturer in compliance with the limitations on subcontracting requirement. Contracting officers may, at their discretion, require the contractor to demonstrate its compliance with the limitations on subcontracting at any time during performance and upon completion of a contract if the information regarding such compliance is not already available to the contracting officer. Evidence of compliance includes, but is not limited to, invoices, copies of subcontracts, or a list of the value of tasks performed.

(c) The offeror further agrees to cooperate fully and make available any documents or records as may be required to enable VA to determine compliance. The offeror understands that failure to provide documents as requested by VA may result in remedial action as the Government deems appropriate.

(d) Offeror completed certification/fill-in required. The formal certification must be completed, signed and returned with the offeror’s bid, quotation, or proposal. The Government will not consider offers for award from offerors that do not provide the certification, and all such responses will be deemed ineligible for evaluation and award.

Certification I hereby certify that if awarded the contract, [insert name of offeror] will comply with the limitations on subcontracting specified in this clause and in the resultant contract. I further certify that I am authorized to execute this certification on behalf of [insert name of offeror].

Printed Name of Signee: ___________ Printed Title of Signee: _____________ Signature: ____________ Date: ______________ Company Name and Address: _______________ (End of Clause) A.2 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESSES (JAN 2023) (DEVIATION)

(a) Definition. for the Department of Veterans Affairs, ‘‘Service-disabled Veteran-owned small business concern or SDVOSB’’:

(1) Means a small business concern—

(i) Not less than 51 percent of which is owned by one or more service-disabled Veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled Veterans or eligible surviving spouses (see VAAR 802.201, Surviving Spouse definition);

(ii) The management and daily business operations of which are controlled by one or more service-disabled Veterans (or eligible surviving spouses) or, in the case of a service-disabled Veteran with permanent and severe disability, the spouse or permanent caregiver of such Veteran;

(iii) The business meets Federal small business size standards for the applicable North American Industry Classification System (NAICS) code identified in the solicitation document;

(iv) The business has been certified for ownership and control pursuant to 38 U.S.C. 8127, 13 CFR 128, and is listed as certified in the SBA certification database at https://veterans.certify.sba.gov/; and

(v) The business agrees to comply with VAAR subpart 819.70 and Small Business Administration (SBA) regulations regarding small business size, government contracting, and the Veteran Small Business Certification Program at 13 CFR parts 121, 125, and 128.

(2) The term ‘‘Service-disabled Veteran’’ means a Veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

(3) The term ‘‘small business concern’’ has the meaning given that term under section 3 of the Small Business Act (15 U.S.C. 632).

(4) The term ‘‘small business concern owned and controlled by Veterans with service-connected disabilities’’ has the meaning given the term ‘‘small business concern owned and controlled by service-disabled veterans’’ under section 3(q)(2) of the Small Business Act (15 U.S.C. 632(q)(2)).

(5) The term “SDVOSB participant” or certified SDVOSB means a small business that has been certified in the SBA Veteran Small Business Certification Program and listed in the SBA certification database (see 13 CFR 128.102).

(b) General. In order for a concern to submit an offer and be eligible for the award of an SDVOSB set-aside or sole source contract, the concern must qualify as a small business concern under the size standard corresponding to the NAICS code assigned to the contract and be listed as an SDVOSB participant in the SBA certification database as set forth in 13 CFR 128.

(1) Offers received from entities that are not certified SDVOSBs and listed in the SBA certification database at the time of offer shall not be considered.

(2) Any award resulting from this solicitation shall be made to a certified SDVOSB listed in the SBA certification database who is eligible at the time of submission of offer(s) and at the time of award.

(3) The requirements in this clause apply to any contract, order or subcontract where the firm receives a benefit or preference from its designation as an SDVOSB, including set-asides, sole source awards, and evaluation preferences.

(c) Representation. Pursuant to 38 U.S.C. 8127(e), only certified SDVOSBs listed in the SBA certification database are considered eligible to receive award of a resulting contract. By submitting an offer, the prospective contractor represents that it is an eligible and certified SDVOSB as defined in this clause, 13 CFR 121, 125, and 128, and VAAR subpart 819.70.

(d) Agreement/LOS certification. When awarded a contract action, including orders under multipleaward contracts, an SDVOSB agrees that in the performance of the contract, the SDVOSB shall comply with requirements in VAAR subpart 819.70 and SBA regulations on small business size, and government contracting programs at 13 CFR part 121 and part 125, including the non-manufacturer rule and limitations on subcontracting (LOS) requirements in 13 CFR 121.406(b) and 13 CFR 125.6. For the purpose of limitations on subcontracting, only certified SDVOSBs listed in the SBA certification database (including independent contractors) shall be considered eligible and/or ‘‘similarly situated’’ (i.e., a firm that has the same small business program status as the prime contractor). An otherwise eligible firm further agrees to comply with the required LOS certification requirements in this solicitation (see 852.219–75 or 852.219–76 as applicable). These requirements are summarized as follows:

(1) Services. In the case of a contract for services (except construction), the SDVOSB prime contractor will not pay more than 50% of the amount paid by the government to the prime for contract performance to firms that are not certified SDVOSBs listed in the SBA certification database (excluding direct costs to the extent they are not the principal purpose of the acquisition and the SDVOSB/ VOSB does not provide the service, such as airline travel, cloud computing services, or mass media purchases). When a contract includes both services and supplies, the 50 percent limitation shall apply only to the service portion of the contract.

(2) Supplies/products.

(i) In the case of a contract for supplies or products (other than from a non-manufacturer of such supplies), the SDVOSB prime contractor will not pay more than 50% of the amount paid by the government to the prime for contract performance, excluding the cost of materials, to firms that are not certified SDVOSBs listed in the SBA certification database. When a contract includes both supply and services, the 50 percent limitation shall apply only to the supply portion of the contract.

(ii) In the case of a contract for supplies from a non-manufacturer, the SDVOSB prime contractor will supply the product of a domestic small business manufacturer or processor, unless a waiver as described in 13 CFR 121.406(b)(5) has been granted. Refer to 13 CFR 125.6(a)(2)(ii) for guidance pertaining to multiple item procurements.

(3) General construction. In the case of a contract for general construction, the SDVOSB prime contractor will not pay more than 85% of the amount paid by the government to the prime for contract performance, excluding the cost of materials, to firms that are not certified SDVOSBs listed in the SBA certification database.

(4) Special trade construction contractors. In the case of a contract for special trade contractors, no more than 75% of the amount paid by the government to the prime for contract performance, excluding the cost of materials, may be paid to firms that are not certified SDVOSBs listed in the SBA certification database.

(5) Subcontracting. An SDVOSB subcontractor must meet the NAICS size standard assigned by the prime contractor and be certified and listed in the SBA certification database to count as similarly situated. Any work that a first tier SDVOSB subcontractor further subcontracts will count towards the percent of subcontract amount that cannot be exceeded. For supply or construction contracts, the cost of materials is excluded and not considered to be subcontracted. When a contract includes both services and supplies, the 50 percent limitation shall apply only to the portion of the contract with the preponderance of the expenditure upon which the assigned NAICS is based. For information and more specific requirements, refer to 13 CFR 125.6.

(e) Required limitations on subcontracting compliance measurement period. An SDVOSB shall comply with the limitations on subcontracting as follows:

[] By the end of the base term of the contract or order, and then by the end of each subsequent option period; or [] By the end of the performance period for each order issued under the contract.

(f) Joint ventures. A joint venture may be considered eligible as an SDVOSB if the joint venture complies with the requirements in 13 CFR 128.402 and the managing joint venture partner makes the representations under paragraph (c) of this clause. A joint venture agrees that, in the performance of the contract, the applicable percentage specified in paragraph (d) of this clause will be performed by the aggregate of the joint venture participants.

(g) Precedence. The VA Veterans First Contracting Program, as defined in VAAR 802.101, subpart 819.70, and this clause, takes precedence over any inconsistencies between the requirements of the SBA Veteran Small Business Certification Program and the VA Veterans First Contracting Program.

(h) Misrepresentation. Pursuant to 38 U.S.C. 8127(g), any business concern, including all its principals, that is determined by VA to have willfully and intentionally misrepresented a company’s SDVOSB status is subject to debarment from contracting with the Department for a period of not less than five years (see VAAR 809.406–2 Causes for Debarment).

(End of Clause)

A.3 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

The Contracting Officer reserves the right to designate an Administrative Contracting Officer (ACO) for the purpose of performing certain tasks/duties in the administration of the contract. Such designation will be in writing through an ACO Letter of Delegation and will identify the responsibilities and limitations of the ACO. A copy of the ACO Letter of Delegation will be furnished to the Contractor.

(End of Clause)

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

UEI:

EFT:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

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

ARE

ARE NOT ATTACHED.

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

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

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

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

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) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

528-24-3-4056-0017 36C24224Q0195 12-29-2023 Corey Swinton 838-433-7507 01-19-2024 4pm

EST

Department of Veterans Affairs Samuel S. Stratton VA Medical Center 113 Holland Avenue (2-90NCA) Albany

NY

12208-3410 X X 325120 1200 Employees N/A X Department of Veterans Affairs Buffalo and Batavia VA Facilities Addresses in the Statement of Work

Department of Veterans Affairs Samuel S. Stratton VA Medical Center Network Contracting Activity 113 Holland Avenue (2-90NCA) Albany

NY

12208-3410

Tungsten Network https://www.tungsten-network.com/ customer-campaigns/veteransaffairs/

See CONTINUATION Page The contractor shall provide medical grade liquid O2 outlined in the Statement of Work and RFQ.

This procurement is being procured in accordance with FAR 12 Acquisition of Commercial Items and FAR 13 Simplified Acquisition Procedures Please refer to Section: Instructions to Quoters for how to submit a proper quote and section Evaluation Commercial Items There will be no site visit Last day for all questions is 01/03/2024 at 12pm local time

SOLICITATION NOTICE OF TIERED EVALUATIONS

INCLUDING SMALL BUSINESSES

See CONTINUATION Page X X

COREY SWINTON

CONTRACTING OFFICER

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C242 COREY SWINTON

Department of Veterans Affairs Samuel S. Stratton VA Medical Center 113 Holland Avenue (2-90NCA) Albany NY 12208-3410

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

VISN 2 Medical Grade Liquid Bulk Oxygen

1) Introduction and Background

Engineering Service at all VISN 2 Medical Centers are committed to serving our Veterans patients, providing the best possible environment for health care to veterans and the highest standards of service to customers. We do this by improving and maintaining our physical structures and by providing the equipment and supplies necessary to support excellence in health care.

2) Objectives

Establish a committed source of supply and an IDIQ contract with a well-qualified firm to provide medical grade liquid bulk oxygen as described herein, The Veterans Health Administration (VHA), Veteran Integrated System Network (VISN) 2, Western New York, Buffalo and Batavia VA Medical Centers established an ongoing requirement for:

Buffalo rental of one (1) 6000 Gallon Vertical Medical Grade Liquid Oxygen Tanks and one (1) 1500 Gallon backup tank Batavia rental of one (1) 1500 Gallon Vertical Medical Grade Liquid Oxygen Tank and 10 (ten) H-size tanks as backup.

and the supply of medical-grade liquid bulk oxygen. The Government facilities does not own their own bulk oxygen tank systems, the contractor shall provide a contractor-owned tank system with an appropriate backup system (i.e., reserve tank or cylinder bank). The contractor shall provide all needed components to support a Food and Drug Administration (FDA) medical grade bulk liquid oxygen tank system in compliance with the National Fire Protection Agency (NFPA) 99: Health Care Facilities Code. Additionally, the contractor must utilize an off-site, automatic monitoring system (telemetry system) that independently monitors the system and notifies the contractor when refills are required.

3) Pricing Periods

This will be a five year (5) Ordering Period (with five (5) pricing periods) IDIQ contract.

· Pricing Period One – 4/1/2024 to 9/30/2024

· Pricing Period Two - 10/1/2024 to 9/30/2025

· Pricing Period Three - 10/1/2025 to 9/30/2026

· Pricing Period Four - 10/1/2026 to 9/30/2027

· Pricing Period Five - 10/1/2027 to 9/30/2028

4) Contract Values

a) The quantities shown in the price cost schedule are estimates of the facility’s annual requirements. There is no express or implied guarantee that these quantities will be purchased. The base pricing period under this solicitation will 10/1/2023 – 9/30/2024. Please note that this contract may include the installation of CONTRACTOR OWNED EQUIPMENT. If the contractor must install their bulk oxygen tank, there is a ninety-day (90) transition period at the beginning and end of the contract period.

b) The contract awarded under this solicitation will include a base pricing period plus (4) four (1) one year pricing periods.

5) Responsibilities

· Contracting Officer Representative (COR) has been designated for Bath facility. A letter of delegation that outlines the COR’s specific responsibilities will be provided to the contractor and CORs at the time of contract award. Within (15) fifteen days after notification of contract award the contractor shall meet with the CORs to ensure mutual understanding of the facility requirements relating to the ordering method and specific details of any delivery instructions that are included in the solicitation schedule.

· Prior to the first filling the contractor shall provide written procedures and initial in-service training at all facilities to VA staff on protocols to ensure safety on and around the tank systems at the time of initial filling of any new or upgraded bulk oxygen tank systems and to include the following facets for contractor owned and government owned systems.

a. The refill procedure,

b. Any preventive maintenance support requirements that may be needed from the medical center,

c. Review the preventive maintenance schedule on the contractor owned equipment and the frequencies the contractor shall be performing these procedures,

d. An explanation of all the volume alarms and low pressure set points,

e. Ensure that all valves are appropriately labeled in accordance with all rules, regulations, applicable codes and current NFPA-99 standards,

f. The contractor shall provide additional safety training and written procedures and as needed by each facility to accomplish emergency shutdowns or other sudden unplanned termination of the refilling process.

g. The contractor shall provide 24/7 emergency contract information to include names, telephone number(s), fax number(s) and email addresses that are actively answered 24 hours a day 7 days per week.

· Prior to the first filling and annually thereafter alarm set point testing and alarm signal verification at all Master Alarms shall be accomplished. Written verification must be presented through the use of a qualified third-party certifier in accordance with NFPA 99 for contractor owned and government owned systems.

· Any code deficiencies in the Medical Center’s existing system as defined by National Fire Protection Association (NFPA) 50, Section 1.3.3 “Bulk Oxygen Systems” shall be identified by the contractor. A detailed explanation of these deficiencies shall be presented in writing to each COR. Receipt of this written explanation must be signed for by each COR.

· Prior to first filling and annually thereafter the contractor shall verify in writing the accuracy of all gauges on contractor owned tanks. If the gauges are government owned contractor shall provide if requested after award a written proposal with price to verify the accuracy of the gauges. The US Government may choose to exercise this option at its desire.

6) Acronyms

This section lists acronyms that are used in this Statement of Work and other parts of the solicitation.

· CCF – 100 cubic feet

· CF – Cubic feet

· CGA – Compressed Gas Association

· CGMP – Current Good Manufacturing Practices

· COR – Contracting Officer Representative

· DOT – Department of Transportation

· FDA – US Food & Drug Administration

· GO – Government Owned

· NFPA – National Fire Protection Association

· OGA – Other Government Agency – (other than VA)

· OSHA – US Department of Labor Occupational Safety and Health Administration

· USP – United States Pharmacopeia

· VA – Department of Veterans Affairs

7) Ordering

· Medical Grade bulk liquid oxygen can be ordered through the telemetry systems based on automatic monitoring of the bulk liquid oxygen tank system’s established fill point. Orders with the contractor are considered to be placed when the telemetry system alerts the contractor that the fill point has been reached. VA facilities may accept the standard fill point established by the Contractor. However, VA Safety and/or Engineering personnel reserve the right to establish different fill point settings for the bulk liquid oxygen tank systems. Any amended fill point settings will be communicated to the Contractor by each facility’s Ordering Officer or COR.

· In the event telemetry is not used to signal the contractor to initiate a delivery request, orders shall be placed with the Contractor only by ordering officers through fax or e-mail at the address/fax number and contact listed below:

FAX Number:

Email Address:

Department:

Name of Contact Person:

Address

8) Delivery of Medical Liquid Bulk Oxygen

· Bulk oxygen is ordered by and delivered to the ordering facility in accordance with the unique delivery requirements in Section 20 (below).

· The contractor shall deliver medical-grade liquid oxygen within the time frame specified in Section 20 for each facility. The time frame identified may be either the number of calendar days after receipt of the Government’s order; the specific days of the week for delivery; the specific time intervals between deliveries; a specified reorder point; or other specified ordering and delivery method(s) and schedule.

· If the time frame for contractor delivery is not identified in the facility requirements the contractor shall provide 24-hour notice prior to delivery; or upon mutual agreement between the facility and the contractor, alternate ordering deliver methods such as pre-scheduled deliveries, calling for tank level readings, installing a telemetry unit etc. may be arranged. If for any reason the contractor is unable to deliver at the agreed upon day or time the contractor shall provide a 24-hour notice to the COR so that the facility can initiate an alternate backup action.

· In accordance with VHA Patient Safety Alert dated April 5, 2004, all deliveries shall be monitored by a qualified and trained technical representative that will be designed by the facility.

· Tank(s) shall be filled to maximum functional capacity each time the tank is refilled or as agreed upon in a written document signed and dated by the CORs.

· At the time of each delivery the contractor shall provide to the VA facilities a legible signed and dated document and/or electronic delivery slip that identifies the tank level prior to the fill, after the fill and the quantity delivered at the time of delivery. This document must be countersigned by the facility representative supervising the delivery. Delivery audits shall be performed by the facility and matched for accuracy. The driver shall convert gallons to ft3 (CF) and CCF quantity and shall list these numbers on the delivery slip to be consistent with the detail on the invoice so to provide accuracy for invoice certification.

· Emergency delivery shall be provided within 24 hours after receipt of the Government notification. Contractor shall respond to the facility COR by either telephone or email within one hour to confirm receipt of an emergency notification to ascertain the nature of the emergency. The emergency status shall be determined by the Government when conditions warrant, such as an actuated main bulk tank low level alarm, imminent alarm condition, or system leak requires a refill in 24 hours.

NOTE: Failure of the contractor to remain current with agreed delivery schedule and requirements does NOT constitute an “emergency” for the purposes of charging and emergency delivery fee.

· Once validated, the facility shall post the facility and Contractor contact names and numbers on the oxygen tank system and at each monitoring point at the facility so that 24/7 supplier staff coverage is assured.

· The contractor shall not be required to make non-emergency deliveries on federally observed holidays. When the normal delivery day falls on a federal holiday, the contractor shall deliver on the workday preceding that holiday. The following holidays are observed by the Federal Government (as well as any other day that is declared a national Holiday per an Executive Order issued by the President):

· New Year’s Day

· Martin Luther King’s Birthday (3rd Monday in January)

· President Day (3rd Monday in February)

· Memorial Day (last Monday in May)

· Independence Day (July 4th)

· Labor Day (1st Monday in September)

· Juneteenth (June 19th)

· Columbus Day (2nd Monday in October)

· Veterans Day (November 11th)

· Thanksgiving Day

· Christmas Day

NOTE: If the holiday falls on a Saturday, it is officially observed on the Friday before the holiday. If the holiday falls on a Sunday, it is officially observed on the Monday following the holiday.

9) Quality Assurance Specifications & Requirements

· All medical gas manufacturers and fillers of medical gases shall be registered with FDA as a drug manufacturer. All oxygen shall be manufactured, processed, packed, transported, and stored according to the FDA’s Current Good Manufacturing Practices (CGMP) regulations and all labeling shall comply with FDA labeling regulations (21CFR Part 201).

· All liquid bulk oxygen delivered under this contract shall be medical grade and shall meet or exceed the standards cited in the current edition of the United States Pharmacopoeia National Formulary U.S.P.

· A valid certificate of analysis shall be provided with each delivery of liquid oxygen. The certificate shall include at a minimum the following:

1. Prime Contractor’s name and complete address,

2. Name of the Product (i.e., Oxygen U.S.P.)

3. An Air Liquefaction Statement where appropriate,

4. Lot Number or other unique identification number,

5. Actual analytical results for full U.S.P. monograph testing is an FDA regulation under 21 CRF 211 Subpart E. (A statement that only states that the product meets the minimum of purity of 99.5% etc. is NOT acceptable.)

6. Test method used to perform the analysis must be based on approved methods from current good manufacturing practice for medical gases guidance. (A statement such as “Meets U.S.P. specifications” is NOT acceptable nor shall “Tested via Servomex” be acceptable since the specific model number is not provided.)

7. Signature of authorized supplier representative and date.

· A Safety Data Sheet (SDS) shall be provided to each facility COR prior to the first delivery.

· A copy of all inspection reports and training certificates shall be provided to each facility COR upon the completion of any Contractor owned or Government owned bulk oxygen system inspections that are required and at a minimum done annually and consistent with NFPA 55 and NFPA 99 code requirements.

· All contractors owned bulk tank systems shall be maintained or repaired in accordance with NFPA 50 Code requirements (Current Edition) and FDA’s Current Good Manufacturing Practices regulations.

· A copy of the preventive maintenance procedures and scheduled timeframes shall be provided to each COR prior to the exchange of contractor owned equipment and the first fill.

· Density data and volume measurement equivalents published in Compressed Gas Association Pamphlet No P-6 titled Standard Density Data Atmospheric Gases and Hydrogen shall be used when necessary to convert measurement of gases from one form to another.

10) Applicable Regulations & Standards

The following is a list of some of the regulations and standards that are applicable to this contract. The list is not comprehensive, and the contractor shall be responsible for ensuring that ALL products, bulk tank systems, and services provided under the contract are in compliance with applicable current Federal, State and Local regulations. If applicable, the editions in effect as of the date of this solicitation are listed. Contractor is responsible for remaining compliant with any future revisions that are effective at the time of contract performance.

Current Edition of:

1. Title 21 Code of Federal Regulations Parts 210 & 211 CGMP regulations for supplying medical grade oxygen.

2. 29 CFR 1910.104 applies to the installation of bulk oxygen systems on industrial and institutional consumer premises.

3. 49 CFR; Transportation

4. Federal Food, Drug and Cosmetic Act

5. NFPA 55: Compressed Gases and Cryogenic Fluids Code

6. NFPA 99; Standard for Health Care Facilities Code

7. U.S.P. 23

8. ANSI/CGA M-1 2018 Standard for Medical Gas Supply Systems at Health Care Facilities.

11) Contractor Furnished Equipment

· For those facilities having contractor owned bulk tank systems the contractor shall provide, install and maintain bulk oxygen tank system(s) with an appropriate back-up system through the duration of the contract. The contractor may either purchase the existing bulk liquid oxygen tank system from the incumbent (if available) or replace the current bulk liquid oxygen tank system with its contractor owned bulk liquid oxygen tank system. Throughout the duration of the contract, the contractor shall be liable for the integrity, suitability and safety of contractor owned tank system(s) that will ensure compliance with applicable regulations standards, and commercial practices. The tank capacity and reserve system shown in the schedule are minimum capacities required by the facility. The manifold or liquid converter must deliver medical-grade liquid bulk oxygen at a pressure and rate of flow adequate to supply the system. Each liquid oxygen storage container must have an outlet that allows access for testing the purity of the oxygen.

· The contractor shall install required valves in a location to allow for proper operation without the potential interference of ice buildup. Pipe insulation shall be installed to prevent ice buildup on piping, valves, unions, etc. prior to the first fill.

· For those facilities having contractor owned tanks the contractor shall provide telemetric equipment to take daily tank readings automatically. This is not a requirement for sites with government owned tanks, but for all facilities which have contractor owned tanks, this is a mandatory requirement.

· All equipment and materials required to perform the work in this contract (other than what is specifically listed in Government Furnished Property) shall be provided by the contractor. The contractor owned equipment shall be installed, inspected and maintained by the contractor without additional cost to the Government. (i.e., all installation, inspection and maintenance costs shall be included in the contractor’s monthly equipment rental fee for the facility. The contractor owned equipment shall be kept in commercial operating condition and appearance in accordance with applicable regulations standards and normal good practices. (Like-new condition). The contractor shall be provided reasonable access to the bulk oxygen systems for this purpose. The oxygen tanks shall be secured behind fence secured with a VA owned lock.

· The option for a facility to expand its capacity to ensure the facility is meeting minimum needs for growth throughout the life of the contract will be assessed by the individual facility. Each facility will identify any additional Bulk Oxygen Tank Systems it may need on its campus. The contractor shall work with the VA facility engineers and plumbers to locate the correct pipes for temporary tank system hook up. The VA facility will have full H cylinders as backup measures on hand to cover every inpatient bed currently hooked up to receive bulk oxygen from internal pipes.

· If the incoming contractor subleases the liquid bulk oxygen tank system from another company, the contractor shall provide a copy of the lease agreement to the VA. The contractor shall then, prior to the initial filling of the tank system, conduct necessary inspection and testing of the tank system to ensure proper and safe function and shall provide a certificate of analysis of the system to the VA. The contractor shall be responsible for maintaining the sub-leased liquid bulk oxygen tank system and must perform all required distribution fills and maintenance of the equipment.

· In addition to the maintenance requirements identified above, the contractor is also responsible for performing minor maintenance on all contractor-furnished bulk tank systems. Minor maintenance from the contractor shall include validating that the fittings are securely fastened to the system, testing, minor de-icing, and adjusting alarms as required. Training staff on de-icing is required for stations that reserve the right to de-ice. If false alarms are pinging from the tank system, the contractor shall fix and resolve the issue at no cost to the Government.

· The VA will report to the contractor any instances of major ice build-up on the tank system, vaporization tubes, or any connecting valves, tubing or pipes, or any other maintenance issue not covered by the minor maintenance performed by the contractor. Upon notification of the issue, the contractor shall perform an on-site inspection of the major icing issue/maintenance issue. The contractor shall furnish a detailed quote utilizing contract pricing for the removal of the ice within 24 hours of inspection. The VA will review the quote and, if the VA approves, issue a separate delivery order/task order to have the contractor perform the needed maintenance service. Contractor shall then perform the quoted service in order to maintain the equipment, so as not to cause damage and to ensure the continued proper operation of the bulk liquid oxygen tank system. The performance of this delivery order/task order is to be completed within 72 hours after receipt of order.

12) Installation of Contractor Owned (CO) Bulk Tank System

· In coordination with the using facility and the incumbent contractor, contractor-owned bulk tank systems must be installed, connected, and fully functional within ninety (90) days of the effective date of the contract. If the contractor’s bulk tank system replaces the incumbent’s bulk tank system or a GO bulk tank system already in use, the exchange of bulk tank system must be accomplished without interruption of medical grade liquid bulk oxygen supply to the using facility. Contractor installed bulk tank system shall remain the property of the contractor and shall be removed upon termination of the contract, when directed by the ordering facility and in full cooperation with the succeeding contractor to avoid interruption of medical grade liquid bulk oxygen supply.

· The contractor shall provide a complete contingency plan that must be approved and tested by VA’s Emergency Management Department prior to swap out. Portable tank systems, including refills if necessary, during the swap out, liquid converter, alarm switch, regulator, valves, level indicator, and any other devices or connections required for proper tie-ins with the facility's medical-grade liquid bulk oxygen system must be furnished by the contractor without cost to the Government during the swap out. If the VA requires additional contingency items, such as more than one portable tank system, the contractor shall provide these systems at no additional cost to the Government and remove them within a week after the swap out.

· Phase-in rental: The initial rental period shall begin on the date the bulk tank system is 100% operational. The initial rental amount shall be pro-rated based on the remaining days in the month the system becomes operational.

· All contractor owned bulk tank systems must be installed in accordance with NFPA 55: Compressed Gases and Cryogenic Fluids Code, Current Edition, NFPA 99: Health Care Facilities Code, Current Edition, and FDA's Current Good Manufacturing Practices (CGMP) Regulations. The contractor shall comply with all OSHA standards and applicable safety requirements, including proper signage and use of personal protective equipment.

Contractor shall have a CERTIFIED mobile portable unit available during the transition between the old and new systems. This system shall be used during the removal of the old system and prior to the final gas analysis testing and acceptance of the new system. In the event the hospital has a 50 PSI inlet, the portable system shall be 50 PSI compatible.

NOTE: There shall be no interruption of service to the facility.

· To permit orderly transition from one contractor to another, the contractor shall continue to honor the contract’s monthly equipment rental fee and bulk oxygen contract price for a maximum of (90) ninety days beyond the scheduled expiration of the contract period, unless transition from one contractor to another is completed prior to the (90) ninety-day transition period. For any partial month the contractor shall prorate the monthly equipment rental fee accordingly. The contractor shall continue to provide and maintain its equipment during the transition period.

· No guarantee is given or implied that the data included in the schedule regarding contractor owned equipment currently located at the facilities is complete and accurate as to the factors affecting the cost of furnishing and installing the required contractor owned tanks and appurtenances. Offerors are strongly encouraged to visit the facility site prior to submitting a bid and to take other steps as may be reasonably necessary to ascertain the nature and location of the work, the general and local conditions which can affect the work; any requirements to supply temporary fencing per OSHA standards; or the cost thereof. Failure to do so shall not relieve the offerors from the responsibility of estimating properly the difficulty and cost of successfully performing the work. Site visits may be arranged by contacting the Contracting Officer designated in the solicitation.

13) Licensing, Authorization, and Selling Permissions

· If the contractor is the manufacturer of the medical grade bulk oxygen being supplied under this contract, it shall annually provide verification that it holds current licensing, permits, certifications or registrations required by the FDA and the states in which this contract is performed.

· If the contractor is not the manufacturer of the medical grade oxygen being supplied under this contract, the contractor shall annually provide verification that the manufacturer from which it obtains the medical grade bulk oxygen provided to VA under this contract holds current licensing, permits, certifications or registrations required by the FDA and the states in which this contract is performed. In addition, the contractor shall provide annual updates to any agreements it has with the medical-grade oxygen manufacturer affirmatively demonstrating that the contractor has authorization by the manufacturer to resell the oxygen the contractor is providing under this contract. In the event of a change in manufacturer, the contractor shall provide advance notice to the VA prior to the change taking place and shall provide copies of the new medical-grade oxygen manufacturer’s current licenses, permits, certifications or registrations required by the FDA and the states in which this contract is performed. The contractor shall also provide a copy of its agreement with the new manufacturer demonstrating that the contractor has authorization by the manufacturer to resell the oxygen the contractor intends to provide under this contract.

· Throughout the term of this contract, contractor shall maintain all federal, state, and local licenses applicable to the contractor as well as any required FDA certifications.

14) Liability Insurance Requirement

· The contractor shall maintain liability insurance in the amount $1 million per occurrence and shall provide an annual Certificate of Liability to the VA.

15) Emergency Supply Support

· The contractor shall, upon contract award, provide a written action plan and protocols in place that shall ensure compliance with the VA’s requirements under the contract in the event of a declared National or State Emergency which affects the Contractor’s ability to perform. The contractor shall provide annual updates to this plan over the life of the contract. In the event the plan is implemented the contractor shall provide notification of implementation of the action plan and protocols within 48 hours of any declared National or State Emergency to the Contracting Officer and COR.