SOW - Medical Cylinder Gas DRAFT.docx

MEDICAL CYLINDER GAS

STATEMENT OF WORK

1. SCOPE OF CONTRACT

1.1. The purpose of this solicitation is to establish consolidated contracts for medical cylinder gases utilized at Bay Pines VA Healthcare System, Lee County Healthcare Center and CBOC’s. 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 Appendix A for list).

1.2. The contract items will be ordered by and delivered to the individual activities listed in the schedule. The number of cylinders will vary monthly pending of each facilities requirement ranging from 1 to 1000. There is no express or implied guarantee that these quantities will be purchased. Additional gases not listed in Appendix A, if requested, must be approved by the CO as a change to the contract.

1.3. A Contracting Officer Representative (COR) has been designated in the solicitation schedule for each 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 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 for resolution.

2. Period of Performance:

The contract awarded under this solicitation will be in effect from through plus four (4) one-year option periods.

Ordering Period One: October 01, 2025 through September 30, 2026 Ordering Period Two: October 1, 2026 through September 30, 2027 Ordering Period Three: October 1, 2027 through September 30, 2028 Ordering Period Four: October 1, 2028 through September 30, 2029 Ordering Period Five: October 1, 2029 through September 30, 2030

3. Place of Performance (Delivery/Pick-Up Facility Locations**):

Bradenton Community-based Outpatient Clinic 5520 S.R. 64 Bradenton, FL 34208

C. W. Bill Young VAMC 10000 Bay Pines Blvd.

Bay Pines, FL 33744

Lee County VA Healthcare Center 2489 Diplomat Parkway East Cape Coral, FL 33909

Naples Community-based Outpatient Clinic 2685 Horseshoe Drive South, Suite 101 Naples, FL 34104

Palm Harbor Community-based Outpatient Clinic 35209 US Highway 19 North Palm Harbor, FL 34684

Port Charlotte Community-based Outpatient Clinic 4161 Tamiami Trail, Suite 401 Port Charlotte, FL 33952-9254

Sarasota Community-based Outpatient Clinic 5682 Bee Ridge Road, Suite 100 Sarasota, FL

Sebring Community-based Outpatient Clinic 5901 U.S. Highway 27 South Sebring, FL 33870

St. Petersburg Community-based Outpatient Clinic 840 Dr. MLK Jr. Street N St. Petersburg, FL 33705

**Additional facilities may be added/removed within geographical service area as directed by the Contracting Officer based on Bay Pines VA Healthcare System requirements/expansion. The COR will provide advanced notice to the Contracting Officer who will determine the extent of any change/change orders in coordination with the Contractor.

4. GENERAL REQUIREMENTS

4.1. For every task, the contractor shall identify in writing all necessary subtasks (if any), associated costs by task, and together with associated sub milestone dates. The contractor's subtask structure shall be reflected in the proposal.

4.2. All written deliverables shall be phrased in layperson language. Statistical and other technical terminology shall not be used without providing a glossary of terms.

4.3. Only offers including personnel, equipment, tools, materials, supervision, facilities, transportation, and other items and services necessary to perform refilling of government owned or rental Medical Gas Cylinders demonstrated through the RFI to meet Department of Veterans Affairs needs will be considered.

5. PRODUCT SPECIFICATIONS

5.1. 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.

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

5.2.1. Federal Specification BB-C-101D, Carbon Dioxide (CO2) Technical and USP, dated 3/17/2011

5.2.2. Compressed Gas Association (CGA) Publications G-7 – Compressed Air for Human Respiration, dated 26 Sep 2019, and ANSI/CGA G-7.1 – Commodity Specification for Air, dated 06 Mar 2018.

5.3. 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.

6. DELIVERY REQUIREMENTS

6.1. 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 hazardous materials fees, fuel surcharges, etc. shall NOT be billed to or collected from the facilities for orders received under this contract.

6.1.1. For standard requests – contractor shall acknowledge receipt of request and advise of delivery date/time not to exceed 2 business days.

6.1.2. For emergency requests – contractor shall acknowledge receipt of request and advise of delivery time not to exceed 24 hours.

6.1.3. Sub-contracting - If the contractor uses sub-contractors to fulfill delivery requirements, it is incumbent upon the contractor to receive relevant outage or insufficient stock information to meet the delivery specifications outlined, not to exceed the timeframes in 6.1.1. or 6.1.2.

6.2. Material Safety Data Sheets shall be provided to the facility COR upon commencement of contract and upon any CO-approved change-order wherein additional gases are added at no additional charge to the contract.

6.3. Service calls - The contractor shall respond to service calls immediately upon receipt of the service call. The Contractor shall not provide gases not included under this contract unless approved, either verbally or in-writing, by the Contracting Officer.

7. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES

7.1. Description of Tasks and Associated Deliverables: The contractor shall provide all personnel, equipment, tools, materials, supervision, facilities, transportation, and other items and services necessary to perform refilling of Government-owned or rental Medical Gas Cylinders.

7.1.1. TASK ONE: The Contractor shall be able to provide the full list of medical gases listed in Appendix A. The number of cylinders delivered monthly varies depending on the facility and type and may vary from 1 to 450 estimated.

7.1.1.1. DELIVERABLE ONE: The Contractor must provide the types and quantities of medical gases required by the facility within 2 business days for standard requests, and within 24 hours for emergency requests. Additional requirements may be added at the needs of the Government, via change order completed by the Contracting Officer. (See Appendix A for specific on type gases/numbers requested and estimated quantities)

7.1.2. TASK TWO: The Contractor will perform all work during business hours and ensure documentation for work performed is correct and properly submitted. Vendor must annotate delivery packing slip with type, size, and quantity of cylinders removed (picked up) and returned (filled). Packing slip should be legible and shall include only the gases that were delivered and shall match the CLINs on the contract including leading option year number, i.e. CLIN 0001, CLIN 4021, CLIN 2013.

7.1.2.1. DELIVERABLE TWO: The Contractor will perform all duties of this contract during normal work hours (7:00 AM to 4:30 PM) and after hours if emergencies arise. All performance must be documented and provided to the Warehouse function or local facility POC and a copy of the packing slip emailed to the COR. The packing slip must be legible and shall match the CLINs on the contract including the option year prefix number. The amount of tanks picked up and the amount of tanks delivered for any line item must be annotated clearly. The amount of Government-owned tanks that were filled with gases without removal or replacement of tank must be annotated clearly.

7.1.3. TASK THREE: The contractor must produce proof to the requiring activity of usage of tanks, purity of gases, recently completed hydrostatic testing of cylinders.

7.1.3.1. DELIVERABLE THREE: The Contractor will provide a consolidated quarterly usage report(s) to the COR. The contractor will provide MSDS sheets for all provided medical gases at the start of the contract, and when any gas is added to the contract. A log copy of completed hydrostatic testing on any government cylinders shall be kept and available to the requiring activity upon request.

7.1.4. TASK FOUR: The Contractor will conduct an inventory of tanks used throughout the listed facilities to determine new base rental requirements at the start of the contract. The Contractor will provide all necessary tanks to allow for previous contractor(s) tanks to be removed from service within 10 business days.

7.1.4.1. DELIVERABLE FOUR: The Contractor will, in coordination with POCs at the listed performance sites, conduct an inventory of all medical gas cylinders that will be covered by this contract. This inventory will be provided to the COR and Contracting Officer within 3 business days of completion of the inventory. The Contractor will schedule and provide replacement cylinders to the facility to allow for proper return of any previous contractor(s) rental cylinders within 10 business days.

7.1.5. TASK FIVE: The Contractor shall invoice monthly and in arrears to: VA Financial Service Center, 149971, Austin, TX 78714-9971 via the TUNGSTEN platform. Monthly invoices shall be submitted no later than the 10th of the next month following performance. Monthly invoices shall only be of the gases and quantities requested, and shall not include any zero quantity line items, or items not on contract. The items will be listed by their CLIN using the correct option year leading number, i.e. CLIN 0001, CLIN 4021, CLIN 2013.

7.1.5.1. DELIVERABLE FIVE: The contractor shall submit all invoices in the performance period(s) by the 10th of the following month. Invoices shall be legible, clear, and in accordance with the current performance period CLIN numbers, and values. The contractor shall not submit invoices that include any gases not on the contract’s approved pricing list. Any invoice that is found to not meet these requirements will be rejected and the vendor advised to resubmit a corrected invoice.

8. CHANGES TO STATEMENT OF WORK

Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

9. CYLINDERS AND OTHER CONTAINERS Laws and Regulations

9.1. 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.

9.2. Marking: In addition to marking required by the aforementioned laws and regulations, marking shall comply with CGA Publication C-7-DOT – Guide to Preparation of Precautionary Labeling and Marking of Compressed Gas Containers, dated 01 Jan 2004.

9.3. Color Coding: Cylinders shall be color coded in accordance with CGA Publication C-9 -- Standard Color Marking of Compressed Gas Containers For Medical Use, dated 26 Sep 2019.

9.4. Valves: Valves shall comply with CGA Safety Bulletin SB-26 dated August 2014 and CGA Publication V-1 -- Compressed Gas Association Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connections, dated 13 Sep 2019.

9.4.1. 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.

9.4.2. 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.

9.5. Hydrostatic Testing:

9.5.1. 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.

9.5.2. 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.

9.5.3. Hydrostatic testing shall be performed in accordance with CGA’s Publication -- C-1, Methods For Pressure Testing of Compressed Gas Cylinders, dated 01 Feb 2016.

9.5.4. Visual inspection shall be performed in accordance with the applicable CGA Publications C-6 --Standards for Visual Inspection of Steel Compressed Gas Cylinders, dated 19 Aug 2019 or C-6.1 -- Standards for Visual Inspection of High Pressure Aluminum Compressed Gas Cylinders, dated 19 Aug 2019.

9.5.5. The contractor shall be responsible for all testing of contractor-owned cylinders at no additional cost to the Government.

9.6. 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.

9.7. Medical Oxygen Cylinder Requirements: All medical oxygen cylinders used for direct patient provision (namely, Size “E” tank/cylinders) must be made of aluminum and include an integrated regulator. This prevents sources of rust from contaminating medical equipment, clothing, and facilities.

9.8. 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.

9.9. 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, computed in accordance with the contract.

9.10. 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.

9.11. 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.

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

10.1. 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.

10.1.1. Such services shall include, but not be limited to:

10.1.1.1. tags indicating cylinder is "Full," In Use," or "Empty";

10.1.1.2. inspection, testing, evaluation, and cleaning services required at each and every filling.

10.1.1.3. pin-indexing, when required,

10.1.1.4. and attachment of Government-furnished warning tags, when required.

10.2. Attaching of oxygen cylinders to manifold systems, when required, shall also be performed by the contractor at no additional cost.

10.3. In addition to services listed in this paragraph, the contractor is responsible for all maintenance and testing of contractor-owned cylinders.

11. 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 16 Oct 2012 shall be used when necessary to convert measurement of these gases from one form to another; for example, from cubic feet to gallons.

12. CONTRACTOR EXPERIENCE REQUIREMENTS – KEY PERSONNEL

Contractor’s Past and Present Performance will be reviewed by the Contracting Officer (CO) and Contract Officer’s Representative (COR) on an annual basis. This survey will be documentation of the contractor acceptable or unacceptable performance during the contract period.

13. SECURITY

13.1. If necessary to conduct contractual obligations on the premises of the VA facility/facilities, VA Police will issue photo identification badges directly to contractors’ and sub-contractors’ employees. VA will provide access into areas needed to perform the duties of this contract. These ID badges shall always be worn by these individuals while on VA property. Background investigation will be performed if necessary.

13.2. Contractor Responsibilities

The contractor shall be responsible for the actions of all individuals provided to work with the VA under this contract. In the event that damages arise from work performed by contractor provided personnel, under the auspices of this contract, the contractor shall be responsible for all resources necessary to remedy the incident.

14. CONFIDENTIALITY AND NONDISCLOSURE

14.1. The preliminary and final deliverables and all associated working papers, application source code, and other material deemed relevant by the VA which have been generated by the contractor in the performance of this task order are the exclusive property of the U.S. Government and shall be submitted to the COR at the conclusion of the task order.

14.2. The COR will be the sole authorized official to release verbally or in writing, any data, the draft deliverables, the final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order presented to the contractor shall be submitted to the COR for response.

14.3. Press releases, marketing material or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the COR.

15. SAFETY

Vendor shall meet all local, state and federal safety requirements during the installation and lease period. All tanks shall be securely transported and stored in accordance with all local, state, and Federal Department of Health Regulations.

16. PHASE-IN

16.1. The contractor shall agree to a minimum 60-day transitional period to allow enough time to utilize all medical gas inventory contained in cylinders, while transferring to future awardees contractors.

16.2. The government facility(s) will continue to incur rental charges and pay those charges accordingly under the awarded contract. Contracting must include this 60-day period in the contract to allow for adequate funding of rental charges.

RECORDS MANAGEMENT OBLIGATIONS

A. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes Bay Pines VA Healthcare System records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their Bay Pines VA Healthcare System contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. Bay Pines VA Healthcare System and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of Bay Pines VA Healthcare System or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to Bay Pines VA Healthcare System. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the contract. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to Bay Pines VA Healthcare System control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the contract. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and Bay Pines VA Healthcare System guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with Bay Pines VA Healthcare System policy.

8. The Contractor shall not create or maintain any records containing any non-public Bay Pines VA Healthcare System information that are not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The Bay Pines VA Healthcare System owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which Bay Pines VA Healthcare System shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take [Agency]-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.] D. Flowdown of requirements to subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.