36C24623Q0127 0001.docx

5. PROJECT NUMBER (if applicable)

CODE

7.

ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF

PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

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

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

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE

OF YOUR

ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERE

D CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES

SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR

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

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED

STATES OF AMERICA

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

15A. NAME AND TITLE OF SIGNER

16A. NAME AND TITLE OF

CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

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

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

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

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

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

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF

SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667 Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667 To all Offerors/Bidders

36C24623Q0127 11-07-2022

X x The purpose of this amendment to responses to questions, update Statement of Work, and Instructions To Offerors.

1. See RFQ 36C24623Q0271 questions and responses.

2. See updated Statement of Work.

3. See updated Instructions to Offe rors.

Solicitation closing time and date 9:00am EST on 11/9/2022.

Cherisse Hall Branch Chief, Supply 1

RFQ 36C24623Q0127

1. What is the current contract # for this requirement and if releasable -- who is the current provider?

No current provider, this is a new requirement.

1. Can you please provide the GOV’s rationale as to why this not an SDVOB Set Aside in accordance with VETS FIRST CONTRACTING PROGRAM?

This is a small business set-aside as determined by the Contracting Officer.

1. What is the GOV’s rationale for having price be the only evaluation factor for a critical supply such as medical gas, as well as cost competitiveness/reasonableness (i.e., Oxygen is a prescription drug)? How will the GOV validate that the “successful offeror” is technically capable? This is very peculiar because the RFQ specifically states the requirement for licensing in the State of North Carolina, as well as the METRO Fayetteville Community is one of the largest Veteran Populations in the US and the facility has (14) CBOCs as well to amplify the requirement? Please Note: Page 5 of 46 specifically state under CONTRACTOR RESPONSIBILITIES:

0. CONTRACTOR RESPONSIBILITIES: 2.1 Contractor shall be qualified and have the required levels of professional and technical experience to perform the work required by the statement of work.

· How is the GOV going to evaluate this with the only Criterion being “PRICE,” respectfully, this is not reasonable and in deference to the VETERANS FIRST CONTRACTING PROGRAM?

Requirement for licensing in the State of North Carolina not stated nor mentioned the RFQ.

RFQ amended to include evaluation factors: Price, Technical, and Past Performance.

1. Do any of the (14) CBOCs within the VA Fayetteville Health Care System require direct delivery? And if so, what are the gas requirements and estimated annual quantities for each CBOC requiring direct delivery?

No, only 2 locations Section 4.1 Fayetteville VAMC and Cottage 73

1. We did not see VAAR 852.219-78 Certificate of Compliance required in this RFQ – a requirement? Will the GOV Amend the RFQ to add in VAAR 852.219-78 whereas all offers must affirm by signature that they will do 50% of the Amount paid by the GOV (universally related to Contract Cost)? More so consistent with the Licensing Requirement as the offeror must affirm taking “ownership/responsibility for the item….” (Which translates into licensed in the State of NC)

No, 852.219-78 relates to SDVOSB OR VOSB set-aside this is a small business set-aside.

· https://www.va.gov/oal/library/vaar/vaar852.asp#85221978 – this is a requirement yet missing from the RFQ. Will an Amendment be posted requiring a signed Certificate of Compliance, which is significant in that the COC benchmarks an offeror’s affirmation? No

· [ ] 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. Meaning the offeror must be licensed to distribute Medical Grade Oxygen & Specialty Gases for human consumption (which the FDA Classifies as a prescription drug) in the State of CA (because the SDVOB awardee takes ownership of the Gas when delivered)

· [ ] In the case of a contract for supplies or products (other than from a non-manufacturer of such supplies), it will not pay more than 50% of the amount paid by the government to it to firms that are not VIP- listed SDVOSBs as set forth in 852.219-10 or VOSBs as set forth in 852.219-11. Any work that a similarly situated VIP-listed 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.

1. Please confirm the duration of the contract – Is this a Base + (4) Options or only a (1) Year requirement?

Base with four option years (see price cost schedule and 36C24623Q0127 line-item template)

1. Page 6 of 46 states:

Respectfully, this is very confusing and not a best practice? If an emergency is “truly and emergency” wouldn’t the facility Representative (with Cell phone contact) remain at the facility in response to an emergency delivery requested by the GOV? This verbiage is nonstandard nationwide? Rhetorically, how can a vendor provide an EAP when the GOV will only stay for X amount of hours? This request is in response to VETERAN CARE?

Section 4.5 Emergency Delivery – the contractor agrees to and shall have an emergency response plan that provides for emergency deliveries within 6 hours after notification, 24 hours a day,7 days a week, in accordance with the contract.

1. The RFQ States:

LIABILITY INSURANCE REQUIREMENTS

The Contractor is required to maintain liability insurance in the amount of $1,000,000.00 per occurrence. The ACORD Certificate of Liability must be provided within ten (10) calendar days of contract award and annually via email to the CO.

Can the GOV please confirm is this merely GENERAL LIABILITY INSURANCE of… is this required of licensing for NAICS 325120 – Distribution of Cryogenic Gases (very high risk) – can the GOV clarify the requirement? As a practical matter, the amount (one million) has very little to do with what is being converted?

Liability insurance is not stated nor mentioned in the RFQ.

1. Are the GOV G and H Cylinders the only GFE requirement?

Section 1.5 Schedule of Items

1. Oxygen Medical; Built-in Regulator, 720 per year

2. Carbon Dioxide; Medical (Size E), 24 per year

3. Lung Diffusion (Size G), 24 per year

4. Nitrous Oxide; Medical (Size E), 24 per year

5. Carbon Dioxide; Medical (USP50), 24 per year

6. Nitrogen, Medical Grade (Size H), 24 per year

7. Medical Gas, Blood Gas Mix 4.001% CO2, 15.95% 02, BAL Nitrogen (Size 200), 24 per year 8. Monthly Rental Cylinders-Sizes: A, B, C, D, E charged monthly

9. Monthly Rental Cylinders-Sizes other than: A, B, C, D, E, charged monthly

10. Monthly Rental-walk O2 about, size E cylinder charged Monthly, 864 per year

11. Nitrous Oxide USP Size 56lbs, 48 per year

12. Oxygen USPMEDICAL PURE 200 CGA 540—Delivered to Cottage #73 installed by the vendor and empty cylinders removed by the vendor, 384 per year

13. Oxygen USPMEDICAL PURE EA CGA 870, 144 per year

14. Oxygen USP Medical EA CGA 870 MRI, 72 per year

15. Emergency Delivery, 24 per year

16. USP Air and Liquid Nitrogen are not needed at the facility at this time

17. All Cylinders will be Contractor owned

1. There is no mention of a requirement for Liability insurance for offerors. How is the GOV going to discern that the offeror is properly insured for NAICS 325120/221210? Specifically – how do offerors validate they have the correct type of Liability Insurance to the GOV – does this have to be affirmed to the GOV at the time of bid submission (if not, an awarded firm could be turned down, or not be able to afford this coverage in the amounts the GOV requires respective to NAICS 325120 -- which is the NAICS this is being solicited for)? This is important because there are very few underwriters that will insure small businesses for compressed gases – hence the GOV’s requirement is met -- would be covered if the Insurance Certificate lists the applicable NAICs?

Liability insurance is not stated nor mentioned in the RFQ.

1. Is there any requirement for USP Air or Liquid Nitrogen as mentioned on PG 4 of 57 of the RFQ (Section 1.1 of the SOW) within “The gases to be purchased include...?”

No, removed from Statement of Work.

1. Are there any GOV Owned Cylinders or is the requirement only for Contractor Owned (Rentals)?

Contractor Owned (Rental)

1. Are there multiple delivery points at the VAMC or are deliveries to singular delivery point (i.e., Loading Dock or Cylinder Storage Cage)?

Section 4.1 Fayetteville VAMC has 2 storage cages and Cottage 73 (installation and delivery)

1. PG 12 of 57, Sec 11. Release of Liability – How can contractors openly agree to indemnify the GOV for all potential liabilities when no specific references are made? This is too vague and is nonstandard – request this language be removed. This is not viable in that the RFQ, as presented, is asking the Vendor to release the GOV of any liability (in advance) even if the GOV is negligent? This is why Question 7 is salient because the vendor MUST BE LICENSD FOR THE WORK BEING PERFORMED (distribution of cryogenic gases.)

Release of Liability is not stated nor mentioned in the RFQ.

Section 11 title is Contracting Officer’s Representative (COR).

1. Please add a CLIN for “hydrostatic Testing” as the RFQ States:

6.5. At the request of the VA facility, the Contractor shall perform Hydrostatic testing on GFE at the price indicated in the LIN on this contract. Contractor shall provide results in writing for each specific tank tested indicating whether the tank is compliant or not compliant. The Contractor shall return any non-compliant GFE back to the ordering facility on the next delivery at no additional cost to the VA with documentation and clear marking on the GFE to label it defective. The Contractor shall proceed to fill all compliant GFE cylinders and deliver them per normal procedure.

Not applicable- there is no 6.5.

Section 6 Price of services for Government-Owned and Contractor-Owned Cylinders

1. This is a valid Contract Cost – as the RFQ states “at the request of the GOV” when in actuality – cylinder “come up for test” based on their last test, and RAS cannot fill cylinders out of test – GFE Hydrostatic testing is a common CLIN!”

“At the request of the GOV” is not stated nor mentioned in the RFQ.

Section 5.5 D. The contractor shall be responsible for all testing of contractor-owned cylinders at no additional cost to the Government. The government shall pay for the hydrostatic testing of government-owned cylinders at the listed prices in.

1. 7Q: Paragraph states. The Contractor shall provide training to VA staff upon request at no additional cost to the Government. The training shall insure VA employees are proficient and able to safely operate medical gas cylinders and appurtenances in the event of equipment change, technology upgrades and/or any new system/manufacturer specification change. RAS would provide initial transition training – for Nurse Educators, receiving personnel, etc. yet the annual CARES Commission Training requirement is a GOV responsibility. After transition, RAS would work with the Facility for sustainment training, but this will be a quote cost, as we do not know the scope, nor complexity of the GOV requirement – to meet an internal requirement (CARES Commission).

Not applicable Section 7 title is Measurement and conversion computation, atmospheric gases, and hydrogen Additionally: Can the GOV clarify – RAS does not evaluate our GOV’s counterpart as to their level of competency to do their job? Also, the “initial training” is fairly standard contract language, but not “ANY TIME” at no cost (when we incur a cost)?

Section 9.2 does not state “any time” but various times to accommodate different shifts.

1. Q: 8.1. The Contractor shall provide an orientation meeting and training for each of the 19 main VA facilities within 60 business days of contract award. This orientation meeting will cover information on delivery, orders, Contractor’s points of contact, etc. Can the GOV clarify the number (19) “main facilities?” We have the VAMC and (12) CBOCs. Are there any other facilities in addition to the award to constitute (19) total Facilities?

No, only 2 locations Section 4.1 Fayetteville VAMC and Cottage

Section 8 Quality Assurance Specifications and Requirements.

8.1 states All medical gas manufacturers and fillers of medical gases shall 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).

B.2 STATEMENT OF WORK

SCOPE OF CONTRACT

1.1 The purpose of this solicitation is to establish a base plus four (4) option years contract for Medical Gases utilized at the Veterans Affairs Medical Centers located at Fayetteville, VA Medical Center and the Cottage #73, 2300 Ramsey St. Fayetteville, NC 28301. The gases to be purchased include, but are not limited to Oxygen USP, Carbon Dioxide USP, Nitrogen NF, Nitrous Oxide USP, Helium USP, Compressed Air, and Special Medical Gas Mixtures.

1.2 The contract items will be ordered by and delivered to the logistics designated Point of Contact at the individual facilities listed on the Medical Gas Delivery Schedule. The quantities shown in the schedule are estimates for the facility’s annual requirements. There is no express or implied guarantee that these quantities will be purchased. The schedule indicates whether the contractor will fill government owned (G) cylinders, will provide contractor owned (C) cylinders, or will be servicing the facility with a combination of both (C/G).

1.3 In case of emergencies the contractor shall delivery contracted items within 24 hours of service call.

0. A Contracting Officer Representative (COR) has been designated for each ordering facility and will be the main point of contact in the solicitation schedule for the ordering facility. The COR is responsible for local contract administration issues such as ordering and providing specific delivery instructions. A letter of delegation that outlines the COR’s responsibilities will be provided.

0. Schedule of Items are as follows.

1. Oxygen Medical; Built-in Regulator, 720 per year

2. Carbon Dioxide; Medical (Size E), 24 per year

3. Lung Diffusion (Size G), 24 per year

4. Nitrous Oxide; Medical (Size E), 24 per year

5. Carbon Dioxide; Medical (USP50), 24 per year

6. Nitrogen, Medical Grade (Size H), 24 per year

7. Medical Gas, Blood Gas Mix 4.001% CO2, 15.95% 02, BAL Nitrogen (Size 200), 24 per year

8. Monthly Rental Cylinders-Sizes: A, B, C, D, E charged monthly

9. Monthly Rental Cylinders-Sizes other than: A, B, C, D, E, charged monthly

10. Monthly Rental-walk O2 about, size E cylinder charged Monthly, 864 per year

11. Nitrous Oxide USP Size 56lbs, 48 per year

12. Oxygen USPMEDICAL PURE 200 CGA 540—Delivered to Cottage #73 installed by the vendor and empty cylinders removed by the vendor, 384 per year

13. Oxygen USPMEDICAL PURE EA CGA 870, 144 per year

14. Oxygen USP Medical EA CGA 870 MRI, 72 per year

15. Emergency Delivery, 24 per year

16. USP Air and Liquid Nitrogen are not needed at the facility at this time

17. All Cylinders will be Contractor owned

1. CONTRACTOR RESPONSIBILITIES:

2.1 Contractor shall be qualified and have the required levels of professional and technical experience to perform the work required by the statement of work.

2.2 Contractor shall comply with any certifications required by Local, State or Federal Department of Health regulations for transporting cylinders of any type. Proof may be requested by the requiring facility at any time.

2.3 Contractor shall, within 10 days (or sooner) after contract award, contact the COR to verify the ordering method and clarify the specific details of any delivery instructions outlined in the solicitation schedule.

2.4 Contractor shall have 24 hour/7day emergency service response available for delivery of urgent VAMC medical gasses or repair of liquid systems. Refer to 4.2.

2.5 Contractor shall ensure the cylinders are following applicable Federal and State Regulations. Annual cylinder testing/inspections, i.e., hydrostatic tests or leak pressure test requirements by NFPA, shall be coordinated with the COTR. Invoices shall be submitted separately monthly.

2.6 Contractor shall provide all equipment and materials necessary to perform the requirements of the contract.

2.7 Contractor shall, in conjunction with medical center staff, provide up to two on-site inventories per year per medical center as requested by the upon medical center request.

1. PRODUCT SPECIFICATIONS

3.1 All medical gases shall conform to specifications prescribed in the United States Pharmacopeia and the National Formulary. All medical gas manufacturers and fillers of medical gases shall be registered with the FDA; and all medical gases shall be manufactured, processed, packed, transported, and stored according to the FDA’s Current Good Manufacturing Practice (CGMP) regulations and Title 21, Code of Federal Regulations, Parts 210, 211 and 201 for labeling.

3.2 In addition, the following specifications are incorporated into the solicitation and resulting contracts:

1. Federal Specification BB-A-1034B, Air, Compressed, for Breathing Purposes, dated 27-Dec-1995.

1. Federal Specification BB-C-101B, Carbon Dioxide (CO2) Technical and USP, DATED 15-PR-1971

1. Compressed Gas Association (CGA) Publications G-7 – Compressed Air for Human Respiration, dated 8/3/03, and ANSI/CGA G-7.1 – Commodity Specification for Air, dated 12/29/07.

3.3 All products, equipment, and services provided under the contract awarded under this solicitation shall be in compliance with all applicable Federal, State, and Local regulations.

1. DELIVERY REQUIREMENTS - Transportation of Oxygen will be made in accordance with 49CFR

4.1 The delivery time is specified in the schedule. The specified number of days shall be the number of calendar days after receipt of order. The schedule lists delivery instructions that are unique to each facility. FOB point is destination. All transportation charges for cylinders shall be included in the price of the gas. Additional charges such as delivery fees, hazardous materials fees, fuel surcharges, etc. shall NOT be billed to or collected from the facilities for orders received under this contract. The delivers will be made to 2 Cylinder storage cages.

Deliveries and install to Cottage#73 (Oxygen USPMEDICAL PURE 200 CGA 540). At this time, no deliveries will be to the CBOC’s.

4.2 Upon delivery, the delivery driver and facility POC (Point of Contact) will conduct a tank count. Cylinders will be logged in on the ledger with the delivery date and driver ID specified. The tank delivery will be signed for by both the facility POC and delivery driver.

4.3 Pickup of empty cylinders, the delivery driver and facility POC will conduct an empty tank count. Cylinders picked up will be adjusted on the tank ledger with the pickup date and driver ID specified. The tank pick up will be signed for by both the facility POC and delivery driver.

4.4 If for any reason the contractor is unable to deliver at the agreed upon day or time, the contractor will provide 12-hour notice to the COR. The Contractor will find an alternate source and initiate its backup plan. In accordance with VHA Patient Safety Alert dated April 5, 2004, all deliveries must be monitored by a qualified and trained representative i.e., Contracting Officer Representative (COR). 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.

4.5 Emergency Delivery – the contractor agrees to and shall have an emergency response plan that provides for emergency deliveries within 6 hours after notification, 24 hours a day, 7 days a week, in accordance with the contract.

Contractor shall provide emergency plan on date of solicitation submission

Government facility personnel will be available for receipt of emergent cylinders requested up to the sixth hour after notification. This service shall be provided at a fair market value fee.

4.6 Deliveries of refills shall be made Monday through Friday between 0800 and 1600 (excluding holidays which are listed below). If a holiday falls on the specified delivery dates, then next day delivery is expected, or immediate delivery arrangements need to be made with the COR.

4.7 FEDERAL HOLIDAYS OBSERVED:

Juneteenth

4.8 Safety Data Sheets shall be provided to the facility COR upon request at no additional charge.

4.9 At the time of each delivery, the contractor shall provide signed and dated invoices. Documents will be counter-signed by the facility representative supervising the delivery.

Medical Center/Delivery Address Delivery Days Delivery Times

FAYETTEVILLE, VAMC

2300 Ramsey St.

Fayetteville, NC 28301

5. CYLINDERS AND OTHER CONTAINERS

5.1 Laws and Regulations

Cylinders and other containers for gaseous and liquid forms of gases shall comply with the Department of Transportation specifications and shall be maintained, filled, marked, labeled, and shipped to comply with current DOT regulations (Title 49-Transportation, Code of Federal Regulations.) Filling, packaging, labeling, etc., for medical gases shall also comply with the Federal Food, Drug, and Cosmetic Act.

5.2 Marking

In addition to marking required by the aforementioned laws and regulations, marking shall comply with CGA Publication C-7 – Guide to Preparation of Precautionary Labeling and Marking of Compressed Gas Containers, dated 6/27/00.

5.3 Color Coding

Cylinders shall be color coded in accordance with CGA Publication C-9 – Standard Color Marking of Compressed Gas Containers Intended for medical Use, dated 1/1/88.

5.4 Valves

Valves shall comply with CGA Safety Bulletin SB-26 and CGA Publication V-1 – Compressed Gas Association Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connections, dated 12/31/00. Valve protection caps for cylinders designated to receive such caps shall be securely attached to the cylinders in a manner to protect the valves from injury during transit and delivery to the purchaser’s receiving area. For liquid containers, all fittings must be permanently brazed to prevent their removal. In addition, each container should contain a 360-degree cryoband applied at the top of the container with the drug product name repeated around the entire container.

5.5 Hydrostatic Testing:

A. Retest Date: If applicable DOT regulations would require retesting of cylinder within three (3) months after scheduled date of shipment to Continental U.S. destination, or within six (6) months after scheduled date of shipment to overseas destination, cylinder shall be retested. Contractor will be required to retest any Government-Owned cylinder when requested by ordering activity, regardless of scheduled retest data.

B. Hydrostatic testing shall be performed in accordance with CGA’s Publication – C-1, Methods for Hydrostatic Testing of Compressed Gas Cylinders, dated 12/01/96.

C. Visual inspection shall be performed in accordance with the applicable CGA Publications C-6 – Standards for Visual Inspection of Steel Compressed Gas Cylinders, dated 1/1/93 or C-6.1 – Standards for Visual Inspection of High-Pressure Aluminum Compressed Gas Cylinders, dated 4/1/95.

D. The contractor shall be responsible for all testing of contractor-owned cylinders at no additional cost to the Government. The government shall pay for the hydrostatic testing of government-owned cylinders at the listed prices in.

5.6 Cylinder Sizes:

Cylinder sizes shown in the item description indicate product capacity of the cylinder currently being used. All capacities are approximate, and the Government shall be billed only for the actual amount of gas delivered. In accordance with the Federal Food, Drug and Cosmetic Act, the actual contents of the container must appear on the label.

5.7 Lost or Damaged Contractor-Owned Cylinders

5.8.1 The contractor must submit a list, quarterly, of lost or damaged cylinders to include replacement costs for all individual cylinders lost or damaged while in the government facility’s custody. Loss of usage must not commence prior to 60 days of notification of any such loss or damage.

5.8.2 For each contractor-owned cylinder lost or damaged beyond repair while in the Government’s possession, the Government shall pay to the Contractor the replacement value, less the allocable rental paid for that cylinder. These cylinders shall become Government property. If any rental lost cylinder is located within 30 calendar days after payment by the Government, it may be returned to the Contractor by the Government, and the Contractor shall pay to the Government an amount equal to the replacement value, less the rental computed in accordance with section 9 of the Statement of Work.

6. PRICE OF SERVICES FOR GOVERNMENT-OWNED AND CONTRACTOR-OWNED CYLINDERS

6.1 Services Included in the Price of Gas (both Government and Contractor-Owned Cylinders):

The offeror’s price for the gas shall include the furnishing, at no additional cost, of all services which are required at each and every filling of a cylinder to comply with applicable regulations, specifications, and normal good practices. Such services shall include, but not be limited to: tags indicating cylinder is “Full”, “In Use”, or “Empty”; inspection, testing, evaluation, and cleaning services required at every filling; pin-indexing, when required, and attachment of Government-furnished warning tags, when required. Attaching of oxygen cylinders to manifold systems, when required, shall also be performed by the contractor at no additional cost. In addition to services listed in this paragraph, the contractor is responsible for all maintenance and testing of contractor-owned cylinders.

6.2.2 Unlisted Services: Unlisted services (including palletizing, when needed) are not covered by this contract and should be obtained by the ordering office according to applicable procurement regulations.

7. MESAUREMENT AND CONVERSION COMPUTATION, ATMOSPHERIC GASES AND HYDROGEN:

Density data and volume measurement equivalents printed in CGA Publication P-6 – Standard Density Data, Atmospheric Gases and Hydrogen, dated 3/8/00 shall be used when necessary to convert measurement of these gases from one form to another: for example, from cubic feet to gallons.

8. QUALITY ASSURANCE SPECIFICATIONS AND REQUIREMENTS:

8.1 All medical gas manufacturers and fillers of medical gases shall 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).

8.2 All 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.).

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

1. Supplier’s name and complete address

1. Name of the product (i.e., Oxygen U.S.P.)

1. An air Liquefaction Statement where appropriate

1. Lot number or other unique identification number

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

1. 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.)

1. Signature of authorized supplier representative and date.

8.4 A copy of all inspection reports conducted by OSHA, JC. Or any other regulatory agency shall be delivered to the facility COR, upon the completion of any oxygen system inspections that are required by regulation.

9. QUALIFICATIONS AND TRAINING:

9.1. The contractor shall provide records of training and competency assessment of contractor personnel involved with the performance of this contract (Delivery). All new contractor personnel will have completed all required training (i.e., the safe use, storage and handling of medical gases/cylinders, dangers, etc.) prior to delivery of oxygen and/or other medical gases. Documentation will be provided to the VA Contract Officer at time of solicitation submission.

9.2. Contractor will provide initial training and annual refresher training (i.e., the safe use, storage and handling of medical gases/cylinders, dangers, etc.) at no extra cost, to any of the following hospital personnel i.e. Security police, COR or maintenance staff involved with the delivery procedure. This training may need to be conducted at various times to accommodate different shifts.

10. IDENTIFICATION:

The Contractors employee(s) shall always wear visible identification while on the premises of the VA medical facility, Warehouse, CBOC, etc.

11. CONTRACTING OFFICER’S REPRESENTATIVE (COR):

11.1 The contractor will be provided the contract information by the COR prior to the start date.

11.2 Performance of work under this contract shall be subject to the technical direction of the COR, or a representative designated in writing. Technical direction MUST be within the scope of the SOW. The COR DOES NOT have the authority to issue technical direction that:

i. Constitutes a change of assignment or additional work outside the specification(s)/work statement

ii. Constitutes a change as defined in the clause entitled “Changes”.

iii. In any manner cause an increase or decrease in the contract price, or the time required for contract performance.

iv. Changes any of the terms, conditions, or specification(s)/work statement of the contract.

v. Interferes with the Contract’s right to perform under the terms and conditions of the contract.

vi. Directs, supervises or otherwise controls the actions of the Contractor’s employees.

11.3 Technical direction may be oral or in writing. The COR shall confirm oral direction in writing within three (3) workdays, with a copy to the CO.

11.4 The Contractor shall proceed promptly with technical direction issued by the COR. If, in the opinion of the Contractor, any direction of the COR, or his/her designee, falls within the limitations in (ii) above, the contractor shall immediately notify the CO no later than the beginning of the next workday.

11.5 Failure of the Contractor and the Contracting Officer to agree that technical direction is within the scope of the contract the direction shall be subject to the terms of the clause entitled “Disputes”.

12. CONTRACTOR MANAGEMENT:

Contractor shall provide a point of contact (POC) and perform continual management of the functional areas contained in this SOW. A Contractor employee shall be designated to act for the POC when work is being performed in the Contract Manager’s absence. Key personnel are defined as the Contract Manager, and other designated individuals submitted by the contractor.

13. CONDUCT OF PERSONNEL:

14.1 Personnel employed by the Contractor in the performance of this SOW or any representative of the Contractor entering the VA premises shall be subject to inspections by the Government.

14. REVIEWS:

14.1 Contracting Officer or COR is authorized to review by on-site survey, review of records, or by any other reasonable manner, the quality of services rendered under this contract. All records will be reviewed by the COR or other designated representative of the VA. Payments will be denied when such service does not support the charges or if the service is deemed not necessary or inappropriate. Such determinations shall be made by the CO or COR, whichever is appropriate.

14.2 COR or Facility POC will conduct a quarterly inventory to reconcile the number of cylinders on hand to the number of cylinders held on the ledger. A report of the inventory will be provided to the COR, CO and FCLO.

15. CONTRACT AWARD AND ADMINISTRATION:

15.1 The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this contract. In the event the Contractor effects any changes at the direction of any person other than the Contracting Officer, the change shall be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.

15.2 Invoice and payment – Payment to be made monthly, in arrears, upon receipt of a properly prepared invoice by the designated POC. The invoice must be itemized to include the following information:

· Time period of service

· Description of services to include type and quantity of cylinders

· Unit Cost billed

· Extended amount due

· Invoice number

· Date of service

· Contract number

Invoices rendered not containing the above information are considered incomplete and will be returned for immediate correction.

15.3 No contract will be awarded nor payment made to any individual or entity that appears on the Health and Human Services Office of Inspector General’s (HSS/OIG) List of Excluded Individuals/Entities, or any other Government sponsored list that identifies Contractors as being ineligible for contract award(s).

E.1 INSTRUCTIONS TO OFFERORS

FAR PART 13 SIMPLIFIED ACQUISITION PROCEDURES

Note that FAR Part 13 Simplified Acquisitions Procedures for Certain Commercial items procedures will be used. A contractor may be eliminated from consideration without further exchanges if technical and/or pricing quotes are not among those Offerors considered most advantageous to the Government based on the best value determination.

Pricing Pricing shall be submitted on the Attachment A. Price/Cost Schedule. The following fields require completion on the attachment. Do not change the format or add/delete any columns in the Excel Spreadsheet.

A. Submission of Quotes

1. Quotes shall be based on requirements contained in the Statement of Work (SOW).

Quotes shall include:

a. Quote Form (Standard Form 1449) – Original Signature and Date, Contract Administration Data, DUNS Number, Acknowledgement of Solicitation Amendments.

b. A completed price/cost schedule and attachments addressing all CLINS

2. Offerors shall submit their quotes via email to Daleta Coles at daleta.coles@va.gov by 09:00 A.M. EST, November 9, 2022. All offerors shall be submitted in electronic format (PDF or Word) Via Email. The subject line should read 36C24623Q0127 – Medical Gas and Cylinder Rental for the Fayetteville VAHCS.

Note: Quotes received after the due date and time shall not be considered.

B. Amendments:

Amendments to this solicitation will be posted on https://sam.gov/. Paper copies of the amendments will NOT be individually mailed. By registering to receive notifications on https://sam.gov/, offerors will be notified by email of any new amendments that have been issued. No other notifications of amendments will be provided. Potential Offerors are advised that they are responsible for obtaining and acknowledging any amendments to the solicitation. Failure to acknowledge an amendment may result in your quote being considered unacceptable.

1.0 INSTRUCTIONS FOR QUOTE SUBMISSION:

Quotes shall be assembled by the following Sections; each section shall be easily identified.

Section A - Quote Form (Standard Form 1449) Signed and dated, including the North American Industry Classification System (NAICS) code and small business size standard in Block 10. Data Universal Numbering System (DUNS) Number shall be entered with the Offerors name and address in the block.

Section B – Pricing Pricing shall be submitted as requested in accordance with Section B, Price/Cost Schedule. The Government will evaluate the total price (including all options); proposed prices should reflect a clear understanding of the requirements and be commensurate with the Statement of Work (SOW).

Section C – Offerors Representations and Certifications A completed copy of the representations and certifications at FAR 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the offeror shall complete electronically). An offeror shall complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at https://www.sam.gov/SAM/.

All Offerors shall be registered and current in the System for Award Management (SAM) database at the time of quote submission and at the time of award.

Section D – Technical/Management Approach Offerors shall submit an offer that addresses all aspects of the Statement of Work.

The technical approach should be as detailed as necessary to fully explain the proposed methods and rationale; it should reflect a clear understanding of the nature of the work being undertaken.

Section E – Past Performance Identify all federal, state, and local government contracts as well as any private/commercial contracts of similar scope, size, complexity that are ongoing or have been completed within the last three (3) years. List the following information for each contract:

· Company Name and Address

· Description of Services Performed

· Name, Telephone Number and Email Address of Responsible individuals who have first-hand knowledge of performance relative to similar type of services

· Dates of Contract Performance

· Contract Number (if applicable)

· Contract Type (e.g. fixed-price, cost reimbursable) and total contract value

2.0 AWARD BASIS FOR EVALUATION METHOD

(a) Basis of Award. This procurement is being conducted pursuant to FAR Part 13 procedures. The Government intends to award a contract resulting from this solicitation to the responsible offeror whose quote, conforming to the solicitation, that represents the best benefit to the Government at a price that can be determined reasonable. The Government will evaluate technical approach, past performance, and price.

Factor 1: Technical Approach Contractors shall provide:

· Local, State, or Federal Department of Health Transportation of Cylinders Certification

· FDA Certification

Factor 2: Past Performance Past performance information will be utilized to determine the quality of the contractor’s past performance as it relates to the probability of success of the required effort. The Government will evaluate customer satisfaction, responsiveness to customer needs, and past demonstration of meeting delivery schedules and the delivery of quality services. Emphasis will be on recent, relevant past performance in the previous three (3) years. Recent is defined as work performed within the last three (3) years. Relevant is defined as work similar in size and scope of the work described in the Statement of Work (SOW).

Past performance information is one indicator of a quoter’s ability to perform the contract successfully. Current and relevant information, source of information, context of data, and general trends in Contractor’s performance shall be considered as it pertains to the performance of work described in this solicitation. Quoters may provide information on problems encountered on identified contracts and the quoter’s corrective action. The Government shall consider this information as well as information obtained from any other sources when evaluating the quoter’s past performance.

Since the Government may not necessarily interview all of the sources provided by the quoters, it is incumbent upon the quoter to explain the relevance of the data provided. Quoters are reminded that the Government may elect to consider data obtained from other sources.

Quoters with no relevant past performance or whom information is not available, shall not be evaluated favorably or unfavorably on past performance, but may be considered less favorably than a quoter with favorable performance history.

Factor 3: Price Prices shall be submitted in accordance with the Price/Cost Schedule contained in the Solicitation. Total price will be evaluated by the Government. In evaluating the quoter’s proposed price for this project, the Government concern includes determining price reasonableness.

Reasonableness determinations will be made by determining if competition exists, by comparing proposed cost/price with established commercial prices, other contract vehicles, and/or by comparing proposed cost/price with the Independent Government Cost Estimate (IGCE). The IGCE is not releasable to the public.

(b) Options. The Government will evaluate quotes for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that a quote is unacceptable if the option prices are significantly unbalanced or if the quoted price for the basic requirement or any option exceeds the amount of funding available for any of those requirements. Evaluation of options shall not obligate the Government to exercise the option(s).

3.0 TECHNICAL QUESTIONS

Offerors should submit all technical questions regarding this solicitation to the Contracting Officer in writing, via email, to Daleta Coles at daleta.coles@va.gov on or before 09:00 A.M. EST November 4, 2022.

Address Subject Line: 36C24623Q0127 -Medical Gas and Cylinder Rental for the Fayetteville VAHCS.

Telephonic (verbal) questions Will Not be addressed.

All responses to questions, which may affect quotes, will be incorporated into a written amendment to the Request for Quote.

4.0 DUE DATES

All quotes shall be submitted by 09:00 A.M. EST, November 9, 2022, via email to Daleta Coles at daleta.coles@va.gov

Facsimile responses are not authorized under this announcement.

Medical Oxygen/Gas and Cylinder Rental image1.jpeg image2.jpeg