36C24718Q0336-007.docx

STATEMENT OF WORK

Medical Gas Cylinders

1. SCOPE OF CONTRACT

1.1 The purpose of this solicitation is to establish consolidated contracts for medical gas cylinders utilized at the Ralph H. Johnson VA Medical Center located in Charleston, SC and supporting Community-Based Outpatient Clinics (CBOC) throughout Veterans Integrated Service Network (VISN) 7. 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, and specialty medical gas mixtures.

1.2 Hours of Operation: Services are to be performed during normal business hours, Monday through Friday, 8:00 AM – 3:00 PM EST; excluding Weekends and Federal Holidays. No overtime is allowed at this time. Telephone orders may be placed on an emergency basis only.

1.2 The contractor shall provide various medical gas cylinders that are listed under the Price/Cost Schedule of this document to obtain a one for one exchange consisting of empty medical gas cylinders for filled medical gas cylinders. The quantities shown in the schedule are estimates of each activity’s annual requirements. There is no express or implied guarantee that these quantities will be purchased. The schedule also 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 The contract awarded under this solicitation will be established for one (1) base period with the possibility of four (4) one-year option periods.

1.4 A Contracting Officer Representative (COR) has been designated 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 specific responsibilities will be provided to the contractor and COR at the time of contract award.

Within fifteen (15) days after contract award, the contractor shall contact the COR to finalize the ordering method and clarify the specific details of any delivery instructions that are included in the solicitation schedule. If agreement cannot be reached between the contractor and COR regarding any issue, the matter shall be referred to the Contracting Officer (CO) for resolution.

1.5 Place of Performance: The contractor shall provide various medical gas cylinders to the following locations upon when ordered by the COR or assigned VA Medical Center Personnel and delivered to the activities listed.

Ralph H. Johnson VA Medical Center 109 Bee Street, Charleston, SC 29401

Hinesville VA Outpatient Clinic 500 East Oglethorpe Highway, Hinesville, GA 31313

Savannah VA Outpatient Clinic 1170 Shawnee Street, Savannah, GA 31419

Myrtle Beach VA Outpatient Clinic 3381 Phillis Blvd., Myrtle Beach, SC 29577

2. PRODUCT SPECIFICATIONS

2.1 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.

2.2 In addition, the following specifications are incorporated into the solicitation and resulting contract:

BB-C-101D, Federal Specification: Carbon Dioxide (CO2): Technical and USP (07 MAR 2011)., This specification covers medicinal and non-medicinal carbon dioxide gases. The carbon dioxide shall be of the following grades, as specified (see 6.2): Grade A – Medical OR Grade B – Technical.

Compressed Gas Association (CGA) Publication Detail: G-7 – Compressed Air for Human Respiration (April 2014) and ANSI/CGA G-7.1 – Commodity Specification for Air (October 2011).

2.3 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.

3. DELIVERY REQUIREMENTS

3.1 The delivery time is specified in the schedule for each facility. The number of days specified 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.

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

3.3 Upon notification by the assigned COR or assigned VA Medical Center personnel, during an emergency for the required medical gas cylinders, the contractor shall ensure delivery is made within 24 hours.

3.4 The Contractor will deliver to the main facility located in Charleston, SC on a bi-weekly schedule consisting of every Tuesday and Thursday of the week.

· Empty tanks that are picked up on Tuesday, will be returned on Thursday of the same week, filled with the various gases it holds.

· Empty tanks that are picked up on Thursday, will be returned on Tuesday of the following week, filled with the various gases it holds.

· Delivery on these days must be made no later than 3:30 PM EST

· All medical gas cylinders will continue in this rotation except when each individual cylinder is required to go through its five (5) year hydro-static testing. The cylinder will be removed and rejoined within the cycle after testing is complete.

3.5 The contractor will be required to ensure signatures are obtained on the delivery documentation during the time of delivery at the warehouse or drop off location of each point required.

· No cylinders, at any time, will be left at the warehouse dock location or CBOC without obtaining a delivery confirmation signature by the warehouse or assigned VA Medical Center personnel.

· Confirmation number must be placed on the delivery paperwork and a copy is left with warehouse personnel upon each delivery.

· All medical gas cylinders will be stored in a rack located on the back dock of the main facility. Rotation and storage during the exchange of each medical gas cylinder will be conducted on this rack.

· No medical gas cylinder will be left on the warehouse dock (not in the rack) at any time.

3.6 During refill of the Medical Liquid Nitrogen Tank, Logistics personnel shall escort the vendor’s delivery driver to the Specialty Clinic where it will be exchanged and returned to service same day. This is required to completed in this manner, as the cycling out is unpredictable and based on needs.

3.7 All Occupational Safety and Health Administration (OSHA) and Hazardous Material regulations are to be adhered to upon delivery and handling of all various medical gas cylinders at all times.

4. NON-REPAIRABLE GOVERNMENT PROPERTY

4.1 Prior to disposing of non-repairable government-owned cylinders, parts, fittings, and appurtenances, the contractor shall contact the ordering (owning) activity. Contractor shall make disposition in accordance with the ordering activity’s instructions.

4.2 Contractors shall be paid for all services performed and authorized by the ordering activity, up to the determination that a cylinder is non-repairable, at the prices listed in Schedule B.

4.3 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.

4.4 If the activity requests, and the contractor agrees to dispose of any non-repairable government-owned property, the fee shall be negotiated and agreed upon between the two parties prior to the disposal of the property.

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 10/21/2011.

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 February 2008.

5.4 Valves

Valves shall comply with CGA Safety Bulletin SB-26 dated May 2007 and CGA Publication V-1 -- Compressed Gas Association Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connections, dated 11/14/05. Valve protection caps for cylinders designed 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

5.5.1 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.

5.5.2 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 been used exclusively for a specific gas may be considered acceptable evidence of the cylinders' eligibility for modified testing or inspection.

5.5.3 Hydrostatic testing shall be performed in accordance with Compressed Gas Association (CGA) Publication Detail: C-1 – Methods for Pressure Testing Compressed Gas Cylinders (February 2016).

5.5.4 Visual inspection shall be performed in accordance with the applicable CGA Publications C-6 --Standards for Visual Inspection of Steel Compressed Gas Cylinders, dated 3/8/07 or C-6.1 -- Standards for Visual Inspection of High Pressure Aluminum Compressed Gas Cylinders, dated 12/21/06.

5.5.5 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 prices listed in Schedule B.

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 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.

5.8 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 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 rental.

5.9 Lost or Damaged Contractor-Owned Cylinders

All Government-owned cylinders that may become lost while in the Contractor’s possession shall pay to the Government the replacement value of the cylinder, to include rental paid for that cylinder and shall become the property of the Contractor.

Any damaged or beyond repair Government-owned cylinders will be repaired or disposed of by the Government under a separate purchase order of the facility.

5.10 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.

5.11 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.

6. PRICE OF SERVICES FOR GOVERNMENT-OWNED 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 of contractor-owned cylinders.

7. MEASUREMENT 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 8/17/05 shall be used when necessary to convert measurement of these gases from one form to another; for example, from cubic feet to gallons.

8. ESTIMATED QUANTITIES LIST