36C26320Q0332 revised.pdf

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. DUNS: DUNS+4:

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. 2/2012)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 60

36C263-20-AP-1585

36C26320Q0332 03-20-2020

Steve Hernandez 03-26-2020 12:00 pm

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

1303 5th St, Suite 300 Coralville IA 52241

X 100

X

325120

1000 Employees

N/A

Iowa City VA Health Care System 601 Highway 6 West Iowa City IA 52246

1303 5th St, Suite 300 Coralville IA 52241

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971

See CONTINUATION Page

BPA for Bulk Medical Grade Oxygen to be delieved to

Des Moines VA medical Center

See CONTINUATION Page

Steve Hernandez Contract Specialist

36C26320Q0332

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT

2018)

C.2 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2020)

C.3 52.216-18 ORDERING (OCT 1995)

C.4 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.5 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.6 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018)

C.7 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

C.8 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.9 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

C.10 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (OCT 2018)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (DEC 2019)

E.3 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.4 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

ITEMS (DEC 2019)

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 36C263

1303 5th St, Suite 300

Coralville IA 52241

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other []

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.

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center

PO Box 149971

Austin TX 78714-9971

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

AMENDMENT NO DATE

Medical Grade Bulk Oxygen

Statement of Work

VA Central Iowa Health Care System (VA-CIHCS)

Des Moines Medical Center

1. General

1.1 The purpose of this contract is to establish a source of supply of medical-grade liquid bulk oxygen for the Des Moines Iowa VA Health Care facility. The Government facility does not own its own bulk oxygen tank system, a new Contractor-owned tank system with an appropriate back-up system (i.e., reserve tank system or cylinder bank) is necessary. Specifications for the facility are listed in the below document. Through a bilateral modification, the Government may add new method of receiving bulk oxygen based on advancement in technology that will benefit the product and/or service during the specified period of performance. All contract terms and conditions shall remain the same and agreed upon rates to share costs of new industry standards are to be documented, signed and dated by the Contracting Officer (CO) and Contractor.

1.2 Location/Facility Requirements: All supplies of medical-grade liquid bulk oxygen shall be delivered to the Des Moines Iowa VA Health Care facility location located at 3600 30th street Des Moines, IA 50310. The Contractor shall have a facility and/or resources physically located in the geographic area, in which they will supply of medical-grade liquid bulk oxygen.

1.3 The Contractor will be required to make deliveries of medical grade liquid bulk oxygen over the life of the contract. The quantities shown are estimates of the facility’s annual requirements.

There is no express or implied guarantee that these quantities will be purchased. The Government is anticipating awarding a Base Plus Four (4) contract for a total of five (5) years.

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All contracts awarded under the solicitation will include a +/- 10% increase or decrease of usage; which may be exercised by the Government.

1.4 The Contractor will be provided with names and contact information of the primary Contracting Officer Representatives (CORs) within 20 days after award of the Contract for the facility. The following information applies to all deliveries, regardless of the time or day of execution: Bulk Cylinder(s) shall be filled to the maximum functional capacity during each refilling procedure unless otherwise specified in the facility requirements or as agreed upon in a written document signed and dated by the Contracting Officer (CO).

1.5 Request for delivery slips will be placed via telemetry, the setting will be approved by VA safety and other personnel to guarantee the VA is not without product for a maximum of 3 calendar days. VA-CIHCS will process all orders through the Contractor’s web portal or online electronic ordering system. There shall be no limit on the number of orders placed by facilities in a day. The request for delivery slips will otherwise be submitted electronically or a called order by the COR or designated representative. All confirmation responses will be processed within 24 hours of the orders are submission. Requests for delivery shall be placed with Contractor through the following: (Offeror to complete)

FAX Number: ______________________________

Phone Number:

Department: ________________________________

Name of Contact Person: ______________________

Address: ___________________________________

Email: _____________________________________

Website: ___________________________________

1.6 The Contractor shall provide written procedures, annual in-service training for VA staff on protocols to ensure safety on and around the tank systems. The Contractor will provide additional safety training as needed by the facility to accomplish emergency shutdowns or other sudden, unplanned termination of the refilling process. The Contractor shall have the technical capability to work and train as required at no additional cost to the VA. Contractor shall provide 24/7 emergency contact name(s), telephone number(s), fax number(s) and email addresses during training. The VA must be trained by Contractor to be proficient to adapt to any new electronic system specifications required to accept electronic orders from the VA.

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2. Acronyms

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

BOP – Federal Bureau of Prisons

CCF – 100 cubic feet

CF – Cubic feet

CGA – Compressed Gas Association

CGMP – Current Good Manufacturing Practices

CLIN – Contract Line Item Number

CO – Contractor owned

COR - Contracting Officer Representative

DOD – Department of Defense

DOT – Department of Transportation

FDA – U.S. Food & Drug Administration

GO – Government owned

IHS – Indian Health Service

NFPA – National Fire Protection Association

USP – United States Pharmacopeia

OGA – Other Government Agency (Other than VA)

VA-CIHCS – Veterans Affairs – Central Iowa Health Care System

OSHA – U.S. Department of Labor, Occupational Safety and Health Administration

3. Government-Furnished Property

3.1 The Des Moines VA Facility bulk oxygen storage tank systems are Contractor Owned, the Government furnished property is the tank pad and utilities lines to the tank location.

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3.2 Prior to award all Bulk Tank System and materials shall be inspected by the Contractor at the Contractor’s expense. The Contractor shall keep the Government Furnished Property in good operating condition, clean from debris and in accordance with applicable regulations and standards. The Contractor shall notify the COR of any issues related to the Contractor not being able to perform their duties of filling the bulk oxygen tank system due to the tank system, pad or access to the tank system. Each facility shall provide the Contractor reasonable access to the facility(ies) they are responsible for.

3.3 The Contractor shall be responsible for annual maintenance and testing of government-owned property to ensure safety is in accordance with applicable regulations and standards.

3.4. Government-owned appurtenances that do not meet compliance required by the Contractor must inform the COR and provide an option to complete the work by the Contractor with a competitive quote separating rates for parts and labor. The COR will determine if the quote is fair and reasonable or provide work to another vendor to complete that meet the minimum specs required for continued service.

3.5 The Contractor can include a separate Contract line Item Number (CLIN) to cover maintenance for Government-owned appurtenances for the life of the contract to cover all parts, components, separators and labor for all items associated with maintenance of the tank systems and accessories.

4. Contractor-Furnished Bulk Tank System

4.1 For the Des Moines VA Facility, the current tank system will not remain in use. The Contractor shall provide, install and maintain a new bulk oxygen tank system with appropriate back-up system(s). Through the duration of the Contract, the Contractor shall be liable for the integrity, suitability, and safety of Contractor-owned bulk oxygen tank system(s) that will insure compliance with applicable regulations, and standards. The Des Moines facility requires installation of Contractor owned Bulk Tank System, and shall provide a suitable location and foundation for the installation of the Contractor owned bulk oxygen tank system. Upon award the Contractor will provide all bulk oxygen tank installation site and utility specifications.

Additionally, the facility shall provide access to an electrical power source and hook-up to a facility-maintained alarm system. The Contractor shall perform the hook-up of Contractor owned Bulk Tank System to the facility-maintained alarm system. The Contractor shall work with the VA electricians and the Contractor will have the required conduits on site. Through the duration of the contract, the Contractor shall be liable for the integrity, suitability, and safety of Contractor owned tank system(s) that will insure compliance with applicable regulations, standards and commercial practices. The tank system capacity and reserve system shown below are minimum capacities required by the Des Moines Iowa VA facility. The option for the facility to expand their capacity to ensure facility is meeting minimum needs for growth throughout the life of the contract will be assessed annually by the facility. Facility will identify additional Bulk Oxygen Tank System as needed on campus. The Contractor shall work with the

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VA facility engineers and plumbers to locate the correct pipes for temporary tank system hook

up. A complete VA approved contingency plan must be tested prior to swap out. During the tanks swap out the vendor shall furnish without cost to the Government:

The manifold, cylinders for the reserve supply and portable supply of tank system, 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. All contingency items, H cylinders and portable tank systems will be removed within a week after the swap out. The manifold or liquid converter shall deliver of medical-grade liquid bulk oxygen at a pressure and rate of flow adequate to supply the system. Each liquid oxygen storage container shall have an outlet that allows access for testing the purity of the oxygen.

Des Moines Iowa VA Health Care facility Current Bulk Oxygen Tank Sizes

Primary Bulk Tank Capacity: 3,000 GLS

Back up Tank Capacity: 500 GLS

Estimated Annual Bulk Oxygen Use: 22,000 CCF

4.2 All Bulk Tank System and materials required to cover all components and separators of the tank system to perform on the contract (other than what is specifically listed in section 3, Government-Furnished Property) shall be provided by the Contractor. Contractor owned Bulk Tank System shall be 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 contract’s monthly Bulk Tank System rental fee for the applicable facility). Contractor owned Bulk Tank System shall be kept in standard commercial operating condition and appearance, in accordance with applicable federal and state laws, regulations, and standards of commercial practices. The Contractor shall be afforded reasonable access to the bulk oxygen systems for this purpose.

5. Installation and Service of Contractor-Owned Bulk Tank System

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5.1 To permit orderly transition from one Contractor to another, the Contractor shall continue to honor the contract’s monthly Bulk Tank System rental fee and of medical-grade liquid bulk oxygen contract price for a maximum of ninety (90) days beyond the scheduled expiration of the contract period, unless transition from one Contractor to another is completed prior to the ninetieth day transition period. For any partial month, the Contractor shall prorate the monthly Bulk Tank System rental fee accordingly. The Contractor shall continue to provide and maintain its Bulk Tank System during this transition period. The Contractor shall provide an implementation plan that must meet the installation period.

5.1.1. Phase In: The billing period shall begin on the noted transition date. Payments shall be assessed based on the providers established rate and prorated from setup date. Prorated monthly rates are based on a 30-day month.

5.1.2. Phase Out: The Contractor realizes that the supplies being provided under this contract are vital and must be continued uninterrupted. The outgoing Contractor shall not remove any Bulk Tank System from the facility until replacement Bulk Tank System has been installed. The outgoing Contractor shall coordinate transition of Bulk Tank System / services with the incoming Contractor as soon as possible, but not to exceed ninety (90) days from date of contract expiration. If additional transition time is required beyond contract expiration, a separate Purchase Order shall be issued to the Contractor for payment of services on a pro-rated basis.

Prorated monthly rates are based on a 30-day month.

5.1.3. During transition both Phase In and Phase Out, from one Contractor to another, the awarded Contractor must reconcile in conjunction with the Government and the outgoing Contractor an implementation plan, in writing. The plan is to include the timeline of events associated with a tank system swap, document the agreed upon responsibilities of each party at each participating facility.

5.2 Unless otherwise directed by the using facility, Contractor owned Bulk Tank System shall be installed by ninety (90) days from the effective date of the contract and shall be connected to the of medical-grade liquid bulk oxygen system on that date; provided. If the Contractor’s Bulk Tank System replaces Bulk Tank System already in use, the exchange of Bulk Tank System shall 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.

5.3 All Contractor owned Bulk Tank System shall be installed in accordance with NFPA 55:

Compressed Gases and Cryogenic Fluids Code, Current Edition, NFPA 70 Electrical Code, 10 | P a g e

Current Edition, NFPA 99 Standard for Health Care Facilities, 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 Bulk Tank System.

5.4 A copy of the state’s pharmaceutical license shall be provided at time of solicitation submission.

6. Delivery of Medical Liquid Bulk Oxygen

6.1 Bulk oxygen orders will be placed via telemetry and delivered to the ordering facilities.

6.2 The Contractor shall deliver medical-grade liquid oxygen within the time frame specified on the Government’s delivery order. Unless otherwise authorized the, the facility shall accept deliveries Monday through Friday, between the hours of 8:00am and 4:30pm. The time frame identified may be either the number of calendar days after receipt of the Government’s order (standard delivery is not greater than three (3) business days), the specific days of the week for delivery, the specific time intervals between deliveries, a specified reorder point based on telemetry, or other specified ordering and delivery method, mutually agreed upon with the facility COR. If the time frame for Contractor delivery is not identified the Contractor must provide 24-hour notice prior to delivery or upon mutual agreement between the facility COR and Contractor, alternate ordering/delivery methods such as pre-scheduled deliveries, calling for tank system level readings, installing a telemetry unit, etc. may be arranged. The process of all orders will be agreed upon by the COR and Contractor. If for any reason the Contractor is unable to make delivery at the agreed upon day or time, the Contractor shall provide 24-hour notice to the COR and must initiate an alternate backup action. In accordance with VHA Patient Safety Alert dated April 5, 2004, all deliveries must be monitored by a qualified and trained technical representative that will be designated by each facility and identified during site inspection. Contractor will be provided with names and contact information of primary and back-up facility representatives.

This applies to all deliveries regardless of time or day of execution.

6.3 Tank systems(s) will be filled to maximum functional capacity at each refilling procedure unless otherwise agreed upon in a written document signed and dated by the COR.

6.4 At the time of each delivery, Contractor shall provide a legible signed and dated invoice available in electronic form. Minimum invoice includes the tank system level prior to fill, the level

11 | P a g e after fill, and the quantity delivered. This document must be countersigned by the facility representative supervising the delivery. Delivery audits will be performed and matched for accuracy. Any missing data will be identified and documented to be on the electronic delivery slip, therefore a hand-written document will be required additionally for invoicing purposes.

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

Failure of the Contractor to remain current with agreed delivery schedule, or failure on telemetry notification does not constitute an “emergency” for purposes of charging an emergency delivery fee.

Once validated, the facility will 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.

6.6 A Contractor’s “fill rate” is defined by the maximum fill capacity of each tank system delivered on the delivery date. The Contractor shall have a fill rate of 95% or greater for each recurring medical liquid bulk oxygen request for delivery slip. This will be measured monthly against the invoice and used as a performance measurement. The following incidents listed below can negatively impact the Contractor’s fill rate:

6.7 The Contractor will not be required to make delivery on federally observed holidays.

When the normal delivery day falls on a federal holiday, the Contractor shall make delivery on the next work day following that holiday. The following holidays are observed by the Federal Government:

New Year’s Day

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

Presidents Day (3rd Monday in February)

Memorial Day (last Monday in May)

Independence Day (July 4th)

Labor Day (1st Monday in September)

Columbus Day (2nd Monday in October)

Veterans Day (November 11th)

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Thanksgiving Day

Christmas Day

Or any day that is declared a national Holiday per Executive Order by the President

Note: If the holiday falls on a Saturday, it will be officially observed on the Friday before the holiday. If the holiday falls on a Sunday, it will be officially observed on the Monday following the holiday.

7. Quality Assurance Specifications and Requirements

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

7.2 All liquid bulk oxygen delivered under the 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.).

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

a) Supplier’s name and complete address

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

c) An Air Liquefaction Statement where appropriate

d) Lot number or other unique identification number

e) Actual analytical results for full U.S.P. monograph testing. (A statement that only states that the product meets the minimum purity of 99.5%, etc. is not acceptable.)

f) Test method used to perform the analysis. (A statement such as “Meets U.S.P.

specifications” is not acceptable; nor would “Tested via Servomex” be acceptable since the specific model number is not provided.)

g) Signature of authorized supplier representative and date.

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7.4 Material Safety Data Sheets shall be provided to each facility COR upon request.

7.5 A copy of all inspection reports shall be provided to each facility COR upon the completion of any Contractor owned or government owned bulk oxygen system inspections that are required by regulation at a minimum done annually.

7.6 All Contractor owned Bulk Tank System shall be maintained or repaired in accordance with NFPA 55 (Current Edition) and FDA’s Current Good Manufacturing Practices (CGMP) Regulations.

8. 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 is responsible for ensuring that all products, Bulk Tank System and services provided under the contract are in compliance with applicable 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.

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

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

49 CFR – Transportation

Federal Food, Drug, and Cosmetic Act

NFPA 55: Compressed Gases and Cryogenic Fluids

NFPA 70: Electrical Code

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NFPA 99: Standard for Health Care Facilities

U.S.P. 23

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. For example, the following conversion factor shall apply for conversion from gallons to cubic feet.

Calculation based on data in CGA P-6

1 ft³ liquid O2 = 860.6 ft³ gas (Table 1)

1 ft³ liquid O2 = 7.48052 gal (Table 2)

Therefore:

7.48052 gal (1 ft³) liquid O2 = 860.6 ft³ gas

1 gal liquid O2 = 860.6 ft³ gas

7.48052

1 gal liquid O2 = 115.05 ft³ gas or more commonly quoted as 1 gal liquid O2 = 115.1 ft³ gas

9. CONDUCT OF PERSONNEL:

9.1. Contractor employees shall conduct their selves in a manner socially acceptable, act responsibly and with respect. Loudness, vulgarity, rudeness, or other similar offensive conduct by an employee of the Contractor will be grounds for denying the employee further access to the VA premises.

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9.2. The Contractors employee(s) shall wear visible identification on uniform shirt and badge at all times while on the premises and the delivery truck must be clearly and appropriately labeled with Contractor signage when on VA medical facility, Warehouse, CBOC, etc.

9.3 The Contractor must be familiar with the location of the facility tanks prior to delivery and must, comply with rules associated to entering the VA medical facility.

10. Emergency Supply Support

The Des Moines Iowa VA Health Care facility is designated as a Federal Emergency Medical Facility with significant contingency and emergency response roles. Accordingly, the Contractor shall provide contingency plan to offer strategies to provide emergency supply support during major catastrophic events. These strategies shall include additional methods of contacting for ordering medical gas and offering Federal Emergency Medical Facilities, at no cost, the option to pre-prepare order lists tailored to potential catastrophic events likely to occur in their area (fire, mass contamination, epidemic, earthquake, tornados, typhoons, etc.). Because of the emergency nature of these orders the Contractor must perform with full delivery to the facility of the required quantities of 90% or more of the order within 24 hours of callout by the facility, or their geographical area(s) as designated by the CLIN(s), with 99% or more of all remaining order delivered within the next 24 hour period (the fee for calling out these pre-prepared orders shall be fixed in accordance with emergency fee). This performance requirement applies whether a single facility or multiple facilities are impacted by the catastrophe.

11. Reviews, Ordering, Invoice and Payment

11.1. The COR or Facility POC will conduct at a minimum monthly review of invoices to reconcile the difference of filled CCF per tank system as indicated on the delivery ticket with the Contractor.

11.2 After deliveries are made an invoice must match and include the legible signed and dated electronic document that identifies the tank system level prior to fill, the level after fill, and the quantity delivered.

Contractor shall list in the spaces below the name(s) and address(es) of customer service departments with whom the Government facilities will place orders:

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Company Name:

Address:

Phone No.:

Fax No.:

Contact Name:

Email:

Company Name:

Address:

Phone No.:

Fax No.:

Contact Name:

Email:

1) The CORs shall provide a list of authorized orders. All orders are to include the signature of the COR before orders are placed. Orders placed without the CORs authorization is not allowed and will not be paid by the purchase order.

2) The COR may request a spreadsheet or invoice review prior to Contractor submission of invoice or certification of invoice. The spreadsheet is to reflect all the orders delivered, emergency fees and monthly Bulk Tank System rental fees.

Contractor must provide sample copy for approval at time of award submission.

3) No advance payments shall be authorized, and no purchase card orders will be allowed/authorized. Payment shall be made on a monthly basis for product provided during the billing month in arrears in accordance with FAR 52.212-4, para.

(i) upon submission of a properly prepared invoice for prices stipulated in this contract for products delivered and accepted in accordance with the terms and conditions of the contract, less any deductions stipulated in this contract.

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B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBE

R

DESCRIPTION OF

SUPPLIES/SERVIC

ES

QUANTIT

Y

UNI

T UNIT PRICE AMOUNT

12.00 MO ________________

BULK TANK RENTAL

1.00 YR ________________

BUL OXYGEN REFILLS

4.00 QR ________________

PREVENTATIVE MAINTENANCE

4.00 JB ________________

EMERGENCY DELIVERY FEE

GRAND TOTAL ________________

See attached document: S02_Oxygen_Tank_Site_Plan_DMBulkOxygen2020.

B.3 DELIVERY SCHEDULE

ITEM NUMBER QUANTITY

DELIVERY

DATE

12.00

1.00

4.00

4.00

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

ITEMS (OCT 2018)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered;

and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212- 5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in 32.608-2 of the Federal Acquisition Regulation in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause)

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

ITEMS

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.2 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS

(JAN 2020)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204–23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L.

115–91).

(3) 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (AUG 2019) (Section 889(a)(1)(A) of Pub. L. 115–232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[] (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

[] (2) 52.203-13, Contractor Code of Business Ethics and Conduct (OCT 2015) (41 U.S.C.

3509).

[] (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

[X] (4) 52.204–10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) (Pub. L. 109–282) (31 U.S.C. 6101 note).

[] (5) [Reserved]

[] (6) 52.204–14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[] (7) 52.204–15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[X] (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (OCT 2015) (31 U.S.C. 6101 note).

[] (9) 52.209-9, Updates of Publicly Available Information…