36C24819Q1076-001.docx

STATEMENT OF WORK MEDICAL GASES

1. SCOPE OF CONTRACT

1.1 The purpose of this solicitation is to establish Contract for Medical Gases utilized at the Veterans Administration Medical Centers West Palm Beach Fl. The gases to be purchased include, but are not limited to compressed Medical Air USP, Oxygen USP, Carbon Dioxide USP, Nitrogen NF, Nitrous Oxide USP, Helium USP, Liquid Nitrogen Compressed Air and Special Medical Gas Mixtures.

1.2 The contract items will be ordered by and delivered to the Patient Support Service Materiel Management Division. The quantities shown in the schedule are estimates annual requirements. There is no express or implied guarantee that these quantities will be purchased. The contractor will fill government owned cylinders, will provide contractor owned cylinders, or will be servicing the facility with a combination of both.

1.3 The contract awarded under this solicitation will be in effect from date of award for one year plus four

(4) one-year option periods.

1.4 A Contracting Officer Technical Representative (COR) 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.

2. CONTRACTOR RESPONSIBILITIES:

2.1. 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.

2.2. The Contractor shall ensure the tanks are in compliance with applicable Federal and State Regulations. Annual tank testing/inspections, i.e., hydrostatic tests or leak pressure test requirements by NFPA, shall be coordinated with the COR. Invoices shall be submitted separately on a monthly basis.

2.3. The contractor shall provide all equipment and materials necessary to perform the requirements of the contract.

2.4. Government owned and rented oxygen tanks shall be labeled according to any applicable FDA, DOT, OSHA, or other requirements.

3. 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:

a. Federal Specification BB-A-1034B, Air, Compressed, for Breathing Purposes, dated 20-Dec-1985.

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

c. Compressed Gas Association (CGA) Publications G-7 – Compressed Air for Human Respiration, dated 1/1/90, and ANSI/CGA G-7.1 – Commodity Specification for Air, dated 12/29/07.

3.3 All products, equipment, and services provided under the contracts awarded under this solicitation shall be in compliance with all applicable Federal, state, and local regulations.

4. DELIVERY REQUIREMENTS

4.1 The delivery time for a non-emergency should be 15 days after receipt of contract or purchase order. The schedule lists delivery instructions that are unique to the West Palm Beach VA Medical Center. 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.

4.2 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 technical representative (COR) from OVAOPC. 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.

4.3 Deliveries of refills shall be made Monday thru Friday between 8-12pm (excluding holidays which are listed below) between the hours of 8 AM -12PM. If a Holiday falls on the specified delivery dates then immediate delivery arrangements need to made with COR.

4.4 FEDERAL HOLIDAYS OBSERVED:

New Year’s Day Labor Day

Martin Luther King Day Columbus Day

President’s Day Veterans Day

Memorial Day Thanksgiving Day

Independence Day Christmas Day

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

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

4.6 The contractor shall have an emergency response plan that provides for emergency deliveries of oxygen 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.

4.7 Delivery Address: Department of Veteran Affairs Warehouse Doc 7305 N Military Trail West Palm Beach Fl, 33410-6400

5. NON-REPAIRABLE GOVERNMENT PROPERTY

5.1 Prior to disposing of non-repairable government-owned cylinders, parts, fittings, and appurtenances, the contractor shall contact Logistics or COR. Contractor shall make disposition in accordance with the ordering activity’s instructions.

5.2 Contractors shall be paid for all services performed and authorized by the ordering activity, up to the determination that a cylinder is non-repairable.

5.3 Contractor shall not charge any additional types of fees, other than those specified above in paragraph 4.2, for the return of non-repairable cylinders to the ordering activity.

5.4 Contractor shall dispose of any non-repairable government-owned property medical gas tanks. Disposal fee shall be negotiated and agreed upon between the two parties prior to the disposal of the property.

5.5 Contractor shall replace all non-repairable government owned tanks. Charges of replacement shall be stated in invoice.

6. CYLINDES AND OTHER CONTAINERS

6.1 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.

6.2 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.

6.3 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.

7. CYLINDERS AND OTHER CONTAINERS (continued)

7.1 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.

7.2 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. Method: Government-owned cylinders which are eligible for extended hydrostatic retest period, testing by modified hydrostatic method, or visual inspection in lieu of hydrostatic testing, shall be serviced by the most economical means which will comply with Department of Transportation regulations (49 CFR 173.34) unless otherwise specified by the ordering activity. When modified or reduced DOT test requirements are contingent upon past usage of the cylinders, a written statement from the ordering activity indicating that the cylinders have used exclusively for a specific gas may be considered acceptable evidence of the cylinders’ eligibility for modified testing or inspection.

C. 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.

D. 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.

E. 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 6.2.

7.3 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.

8. CYLINDES AND OTHER CONTAINERS (continued)

8.1 Individual Agency Ownership of Cylinders:

Government-Owned cylinders shall remain the property of the individual ordering (owning) agency and shall not be exchanged for other cylinders, either government-owned or contractor-owned, without authorization of the ordering agency.

8.2 Lost or Damaged Contractor-Owned Cylinders

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 and amount equal to the replacement value, less the rental computed in accordance with section 9 of the Statement of Work.

8.3 Method of Shipment:

Empty Government-owned cylinders that are picked up from an ordering facility for re-fill or servicing shall be transported according to the Department of Transportation Regulations, using normal commercial practice to prevent damage to cylinders.

8.4 Transportation of Cylinders:

All transportation charges for empty government-owned and contractor-owned cylinders from the ordering facility to the contractor’s facility shall be at the expense of the contractor.

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

9.1 Services Included in the Price of Gas (Both Govt. 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 each and 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 or contractor-owned cylinders.

9.2 Services in Price of Gas Tank Refill for Government-Owned Cylinders:

* Please see price schedule

9.2.1 When required, the contractor shall perform additional services as described below. The price of these services shall not exceed the prices listed below. These rates are the maximum rates that shall be billed to the Facilities. However, the contractor should not bill at a rate that is higher than their standard commercial rate if those rates are lower than the prices listed below. All materials and components shall be furnished by the contractor.

* Please see price schedule

9.2.2 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.

10. 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.

11. QUALITY ASSURANCE SPECIFICATIONS AND REQUIREMENTS:

11.1. 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).

11.2. 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.).

11.3. A valid certificate of analysis shall be provided with each delivery of 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 proclaims 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.

11.4. Material Safety Data Sheets shall be provided to the facility COR, at the beginning of the contract period and upon request.

11.5. 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.

12. QUALIFICATIONS AND TRAINING:

12.1. 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 prior to delivery of oxygen. Documentation will be provided to the VA Contract Officer at time of solicitation submission

12.2. Contractor will provide initial training and annual refresher training, 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.

13. APPLICABLE REGULATIONS & STANDARDS:

13.1. Listed below are 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, equipment and services provided under the contract are in compliance with applicable Federal, State, and local regulations. Contractor shall remain compliant with any future revisions that are effective at the time of contract performance.

8.1a. Title 21, Code of Federal Regulations.

8.1b. Parts 210 & 211 – CGMP regulations for supplying medical-grade oxygen. (FDA) 8.1c. 49 CFR – Transportation of Oxygen.

13.2. The Contractor shall meet the applicable standard of Joint Commission on Accreditation of Healthcare Organizations Environment of Care Standards.

BASE REQUEST

Contractor is to provide pricing for tanks with regulators attached to them. The following list is tanks included but not limited to:

Government-Owned Tanks

Oxygen, Compressed H Tank

Air Compressed H Tank

Carbon Dioxide H Tank

Nitrogen Oxi de H Tank

Nitrogen Compressed H Tank

Nitrogen Oxi de E Tank

Oxygen, Compressed E Tank

Liquid, Nitrogen 160 Litre Tank

Helium, H Tank

Please note that if tanks are lost by subs or prime contracted personnel, that the prime contractor will be responsible for the costs, not the medical facility.

Please provide pricing at minimum for the following QTYs:

QTY

OPTION ITEMS

Option Item 1: Rentals include but is not limited to:

Oxygen, Compressed H Tank

Oxygen, Compressed E Tank

Nitrious Oxi de USP20

Compressed, Argon H Tank

Oxygen, Liquid Resevoir 41 Liters

Oxygen, Liquid Resevoir 41 Liters

Please provide pricing for daily, weekly, monthly tank rentals for the following:

QTY