Attachment- Statement of Work- VISN 19 Medical Gas.docx

Statement of Work (SOW) VISN 19 Medical Gases IDIQ

1. SCOPE OF CONTRACT:

1.1. The purpose of this award is to establish an Indefinite Delivery Indefinite Quantity (IDIQ) Contract for rental and filling of medical cylinder gases utilized at the VISN 19 facilities, and their community-based clinics. 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. See: “Attachment 1- Medical Gas Items” for list of gases for each station and the annual estimated quantities.

1.2. The contract items will be ordered by VISN 19 facilities and delivered to the respective location of the ordering facility. Each facility will designate point of contact (POCs) for this contract. See: “Attachment 2- VISN 19 Locations” and “Attachment 3- VISN 19 Authorized Caller List” for each facility delivery location address, and designated points of contact.

1.3. The quantities shown in the pricing sheet are estimates of each activity's annual requirements. There is no express or implied guarantee that these quantities will be purchased. The pricing sheet 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).

1.4. Government POCs have been designated for each ordering facility. The POCs are responsible for local contract administration issues such as ordering and providing specific delivery instructions.

2. CONTRACTOR RESPONSIBILITIES:

2.1. The 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. The 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. Within 15 days after the contract award, the contractor shall contact the POCs to finalize the ordering method and clarify the specific details of any delivery instructions. If agreement cannot be reached between the contractor and POC regarding any issue, the matter shall be referred to the Contracting Officer for resolution.

2.4. The contractor shall have 24 hour/7day emergency service response available for delivery of emergent VAMC medical gases or repair of liquid systems. (See: paragraph 4.6 Emergency Delivery).

2.5. The 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 POC. Invoices shall be submitted separately monthly.

2.6. The contractor shall provide all equipment and materials necessary for performance of the requirements of the contract.

2.7. Contractor shall, in conjunction with medical center staff, provide a minimum of one (1) on-site inventory per year per medical center as requested by the medical Center.

2.7.1. Designated VA Personnel will escort the contractor to each location where cylinders are stored, including any CBOC within 50 miles of the main facility.

2.7.2. If the CBOC(s) are more than 50 miles from a main facility, the inventory will be conducted by designated and trained VA personnel.

2.8. At CBOC(s) locations that have piped in systems utilizing large size (K, and/or T) cylinders, the contractor will disconnect the empty tank and connect the full tanks.

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. Tanks shall be filled to the maximum functional capacity at each refilling procedure unless otherwise specified by the facility or as agreed upon by a written document signed and dated by the government POC.

3.2. All products, equipment, and services provided under this awarded contract shall follow all applicable Federal, state, and local regulations.

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

3.4. In addition, the following specifications are incorporated into the award and resulting contracts:

3.4.1. Federal Specification BB-C-l O l D, Carbon Dioxide (C02) Technical and USP, dated 3/17/2011.

3.4.2. Compressed Gas Association (CGA) Publications G-7 - Compressed Air for Human Respiration, Dated May 2008, and ANSI/CGAG-7.1-Commodity Specification for Air, dated October 2011.

3.4.3. VHA Patient Safety Advisory ID: AD24-01 Alerts and Recalls IS SR-46197. Low-flow Oxygen Regulators, dated January 2024

4. DELIVERY REQUIREMENTS:

4.1. The delivery time is specified by the Order. The number of days specified shall be the number of calendar days after an order is placed. 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. Delivery shall be performed during normal business hours excluding federally observed holidays.

4.2.1. BUSINESS HOURS: Monday through Friday from 8:00 am - 4:30 pm.

4.2.2. FEDERAL HOLIDAYS: The following holidays are observed by the Department of Veterans Affairs: New Year’s Day, Martin Luther King’s Birthday, Washington’s Birthday, Memorial Day, Juneteenth Independence Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving, Christmas day, and any day specifically declared to be a national holiday. Should a holiday fall on a Saturday or Sunday (weekend), the holiday will occur on Friday (if the holiday falls on a Saturday), or Monday (for holidays falling on a Sunday).

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

4.4. 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 by both the facility POC and delivery driver.

4.5. If for any reason the contractor is unable to deliver at the agreed day or time, the contractor will provide 12-hour notice to the designated POC. The Contractor will find an alternate source and initiate its backup plan.

4.6. Emergency Delivery: the contractor will provide a response within (1) hour of the emergency request and deliver within (6) hours to the medical centers, and/or within (24) hours to the CBOCs. This emergency service will be provided 24 hours a day, 7 days a week, in accordance with the contract.

Contractor shall provide an emergency plan along with its proposal submission, to be evaluated as part of its technical evaluation.

Government facility personnel will be available for receipt of emergent cylinders requested up to the sixth hour after notification.

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. 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.

5.5. Regulators: Contractor shall be able to fill all Government owned cylinders with Low-flow (0-4L/min or 0-8L/min) Integrated Regulators and High-flow (0-15 L/Min or 0-25 L/min) integrated oxygen regulators, as specified in VHA Patient Safety Advisory ID: AD24-01 Alerts and Recalls IS SR-46197. Low-flow Oxygen Regulators

5.6. 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.

5.6.1. 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.

5.7. Hydrostatic Testing:

5.7.1. 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.

5.7.2. 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 CPR 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.

5.7.3. Hydrostatic testing shall be performed in accordance with CGA's Publication -- C-1, Methods for Hydrostatic Testing of Compressed Gas Cylinders, dated 7/17/09.

5.7.4. 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.

5.7.5. 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 on a separate purchase order issued by the ordering facility by request.

6. 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

7. 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 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. The contractor at no additional cost will provide transitional “Train the Trainer” training to designated VA personnel on the proper procedures involving the attachment of oxygen cylinders to manifold systems if required. In addition to the services listed in this paragraph, the contractor is responsible for all maintenance and testing of contractor-owned cylinders.

8. NON-REPAIRABLE GOVERNMENT PROPERTY

8.1. Prior to disposing of non-repairable government-owned cylinders, parts, fittings, and appurtenances, the contractor shall contact the ordering (owning) activity.

8.2. The contractor shall make disposition in accordance with the ordering activity's instructions.

8.3. 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 the Pricing Schedule.

8.4. The 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.

9. LOST OR DAMAGED CONTRACTOR-OWNED CYLINDERS:

The VA and the Contractor shall perform an annual, on-site inventory, of all Contractor owned cylinders to verify the accuracy of the end of month balance of rental cylinders based off the most recent invoice. Each VA facility will work collaboratively with the Contractor personnel to complete the inventory. The VA will obtain access to all pertinent areas and escort the Contractor personnel for the purpose of counting existing contractor owned cylinders at the specific VA facility. (see paragraph 2.7) For each contractor-owned cylinder lost or damaged beyond repair while in the Government's possession, the Government shall pay the Contractor the replacement value, less the allocable rental paid for that type of 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 will pay to the Government an amount equal to the replacement value, less allocable rental paid. The contractor shall maintain a tracking of the cylinders to ensure proper accountability and shall provide the ordering activities with the tracking data upon request.

9.1. Disposal of Government Owned Cylinders: Government owned cylinders that must be disposed of will be covered by a separate purchase order issued for the facility that requires disposal on its own separate Order against the IDIQ.

9.2. Repair of Government Owned Cylinders: Repairs on Government owned cylinders will be covered by a separate purchase order issued for the facility that requires the repairs on its own separate Order against the IDIQ.

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.

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.

12. 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.

13. QUALITY ASSURANCE SPECIFICATIONS AND REQUIREMENTS:

13.1. All medical gas manufacturers and fillers of medical gases (such as the fill stations) 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).

13.2. 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.).

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

13.3.1. Supplier’s name and complete address

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

13.3.3. An air Liquefaction Statement where appropriate

13.3.4. Lot number or other unique identification number

13.3.5. 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.) 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.)

13.3.6. Signature of authorized supplier representative and date.

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

14. QUALIFICATIONS AND TRAINING:

14.1. 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.

14.2. Documentation will be provided to the VA Contract Officer at time of solicitation submission. The 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, POC or maintenance staff involved with the delivery procedure. This training may need to be conducted on various days to accommodate different staff, and ensure patient care is not affected.

15. IDENTIFICATION:

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

16. Point of Contact (POC):

16.1. The contractor will be provided with the contract information by the POC prior to the start date.

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

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

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

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

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

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

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

16.3. 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.

17. CONTRACTOR MANAGEMENT:

The 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.

18. KEY PERSONNEL: Key personnel are defined as the Contract Manager, and other designated individuals submitted by the contractor.

19. CONDUCT OF PERSONNEL:

19.1. 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.

19.2. The contractor is responsible for conduct of his or her employees. The conduct includes, but is not limited to personnel appearance, inappropriate or offensive clothing which could be construed as being lewd, obscene, racially or sexually offensive, etc.

19.3. Contractor employees shall conduct themselves in a socially acceptable manner. 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.

19.4. Contractor employees shall not consume alcohol or illegal drugs during working hours or at any other time the employees are performing work under this SOW.

20. VEHICLE CONDITION AND MARKINGS:

All Contractor-owned vehicles shall be maintained in an operational condition. Contractor vehicles shall be clearly marked with identification. Markings shall include, but not limited to, the Contractor’s name and telephone number on all equipment and vehicles used to carry out the requirements of the SOW.

· Contractor name.

· Telephone.

· State license tag.

· All required regulatory information.

21. REVIEWS:

21.1. Contracting Officer or POC 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 POC or other designated representatives 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 POC, whichever is appropriate.

21.2. POC 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 POC, CO and FCLO.

22. TRANSITION PERIOD:

22.1. Along with proposal submission, Contractor shall provide a plan for transitioning from the incumbent Contractor to the newly awarded Contractor. The transition period for the awarded Contractor to have all required medical gas cylinders, peripherals, accessories, labels, training, inventory, installation, etc., transitioned and fully operational shall be within 30 calendar days after approval of transition plan along with award. The contractor’s submitted transition plan shall not exceed the required 30-day period contained herein. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate contract for cause under the Termination for Cause clause of the contract. The VA shall have sole discretion in the decision to terminate for failure to comply.

22.2. Transition Plan: Will be evaluated along with submitted proposal as part of its technical evaluation.

23. Licensing, Authorization, and Selling Permissions

· If the contractor is the manufacturer of the medical gases being supplied under the resulting contract, it shall provide verification at the time of proposal submission that it holds current licensing, permits, certifications or registrations required by the FDA and the state(s) in which this contract is performed to distribute the medical gases and annually prior to any option year start date.

· If the contractor is not the manufacturer of the medical gases being supplied under the resulting contract: the contractor, at the time of proposal submission, shall provide verification that the manufacturer/medical gas fill stations from which it obtains the medical gases provided to VA under the resulting contract holds current licensing, permits, certifications or registrations required by the FDA and the state(s) in which this contract is performed to distribute the medical gases. This proof/verification shall be submitted at the time of proposal submission as part of the evaluation to determine contractor responsibility for award. In addition, the contractor shall provide annual updates to any agreements it has with the medical gas manufacturer/fill stations affirmatively demonstrating that the contractor has authorization by the manufacturer/fill stations to resell the medical gases the contractor is providing under this resulting contract. A copy of the agreement must be submitted at the time of proposal submission as part of the evaluation to determine the contractor responsibility for the award. In the event of a change in manufacturer/fill stations, the contractor shall provide advance notice to the VA prior to the change taking place and shall provide copies of the new medical gas manufacturer/fill station’s current licenses, permits, certifications or registrations required by the FDA and the state(s) in which this contract is performed to distribute the medical gases. The contractor shall also provide a copy of its agreement with the new manufacturer/fill station demonstrating that the contractor has authorization by the manufacturer/fill station to resell the medical gases the contractor intends to provide under the resulting contract.

Throughout the term of this contract, the contractor or its medical gas delivery company shall maintain all federal, state, and local licenses applicable to the contractor as well as any required FDA certifications to distribute the medical gases.