STATEMENT OF WORK REVISED AMENDMENT 0001.pdf

B.2 STATEMENT OF WORK

Central Texas Veterans Affairs Health Care Systems (CTVHCS) Medical Cylinders and Gases

Statement of Work

1. SCOPE OF WORK:

The purpose of this Statement of Work is to provide medical cylinders and gases for the Central Texas VA Health Care System (CTVHCS) and clinics (See Section 5, below). This requirement is for a single award Indefinite Delivery Indefinite Quantity (IDIQ), base plus 4-option year period of performance contract. The contract items will be ordered by Ordering Officers or via task/delivery order by a Contracting Officer.

1.1 This Contract will be utilized throughout the Central Texas Veterans Health Care System, to include current and potential future Outpatient Clinics. The gases to be purchased include all items listed in Attachment D.1.

1.2 The contract items will be ordered and delivered to the specified location departments listed in section 5.

1.2.1 The Contractor shall maintain one-hundred percent accountability of all Medical Gas cylinders in the contractors possession until the CTVHCS accepts receipt. All Equipment and Materials (e.g. Department of Transportation (DOT) certified delivery and transport vehicles, certified medical gas technician(s), hydrostatic tested approved cylinders) required to perform on the contract, other than Government owned cylinders shall be provided by the Contractor.

1.3 The contract Period of Performance (POP) awarded under this solicitation will be in effect from the Base Year of November 5th, 2025 – November 4th, 2026 – plus four (4) one-year option periods:

- November 5th, 2026 – November 4th, 2027 (Option Year 1)

- November 5th, 2027 – November 4th, 2028 (Option Year 2)

- November 5th, 2028 – November 4th, 2029 (Option Year 3)

- November 5th, 2029 – November 4th, 2030 (Option Year 4)

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/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:

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

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

2.3 All products, equipment, and services provided under this contract award shall be in compliance with all applicable Federal, state, and local regulations.

3. MONTHLY RENTAL OF CONTRACTOR OWNED CYLINDERS:

For cylinders not owned by the government, the government will rent each cylinder by the month at the prices in attachment D.1.

4. DELIVERY REQUIREMENTS:

4.1 All transportation charges for cylinders shall be included in the price of the gas. Additional charges such as delivery fees, hazardous material fees, fuel surcharges shall NOT be billed to or collected from the facilities for orders received under this contract unless otherwise specified in this contract (i.e. emergency deliveries).

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

4.3 Facility Locations based on the addresses and departments are listed in Section 5. It is the responsibility of the Contractor to ensure each VA Facility Clinic receives their orders on the specified delivery dates NLT 4:00pm. The number and location of services located within CTVHCS may increase or decrease based on the Government’s need to provide health care to Veterans.

4.4 Delivery Schedule: Representatives shall be available during the hours of Monday through Friday, 7:30am – 4:00pm.

5. DELIVERY ADDRESSES AND DEPARTMENTS:

After contract award, the VA POC will provide the listed clinic building/room numbers to the contractor. The estimated quantities and frequency are just an estimate.

1. Central Texas Veterans’ Health Care System (1901 Veterans Memorial Dr., Temple, TX 76504)

i. Department: Infection Prevention and Control–Estimated QTY and frequency of deliveries: PAR level 6 WABS biweekly (12 monthly)

ii. Department: Derm – (Dewars). Estimated QTY and frequency of deliveries: 2 Refills monthly

iii. Department: Women health- Estimated QTY and frequency of deliveries: PAR 12 WABS biweekly (24) monthly

iv. Department: Nursing- Estimated QTY and frequency of deliveries: PAR level 12 WABS bi-weekly (24 monthly)

v. Department: ICU- Estimated QTY and frequency of deliveries: PAR level 12 WABS biweekly (24 monthly).

vi. Department: Pulmonary- Estimated QTY and frequency of deliveries: PAR level 12 WABS biweekly (24 monthly)

vii. Department: Surgical- Estimated QTY and frequency of deliveries: PAR level 10 CO2, 2NCO biweekly (20 CO2, 4NCO monthly)

viii. Department: GI/Endoscopy- Estimated QTY and frequency of deliveries: PAR level 6 WABS, 4 CO2 BIWEEKLY (12WABS, 8 CO2 monthly)

ix. Department: Emergency- Estimated QTY and frequency of deliveries: PAR level 12 WABS biweekly (24 WABS monthly)

x. Department: Primary Care- Estimated QTY and frequency of deliveries: PAR level 6 WABS biweekly (12 WABS monthly)

xi. Department: Imaging- Estimated QTY and frequency of deliveries: PAR level 6 WABS biweekly (12 Monthly)

xii. Department: Physical Medicine and Rehab- Estimated QTY and frequency of deliveries: PAR level 5 WABS biweekly (10 monthly)

xiii. Department: Prosthetics- Estimated QTY and frequency of deliveries: PAR level 4 WABS biweekly (8monthly)

xiv. Department: Cardiology - Estimated QTY and frequency of deliveries: PAR level 6 WABS biweekly (12 monthly)

xv. Department: Blind Rehab- Estimated QTY and frequency of deliveries: PAR Level 6 WABS biweekly 12 (monthly)

xvi. Department: Whole Health- CLC - Estimated QTY and frequency of deliveries: PAR level 6 WABS biweekly (12 Monthly)

xvii. Department: Research- Estimated QTY and frequency of deliveries: PAR level 6 WABS biweekly (12 Monthly)

2. Temple VA Clinic Annex (4501 S. General Bruce Dr., STE 75, Temple, TX 77845)

i. Department: Care in the community- Estimated QTY and frequency of deliveries:

PAR level 20 WABS monthly

3. Brownwood CBOC (2600 Memorial Park Dr., Brownwood, TX 76801)

i. Department: Care in the community- Estimated QTY and frequency of deliveries: Par level 12 WABS MONTHLY

4. Austin Outpatient Clinic (AOPC) (7901 Metropolis Dr., Austin, TX 78744)

i. Department: Pathology and Lab- Estimated QTY and frequency of deliveries: PAR level 6 WABS monthly

ii. Department: Women Clinic- Estimated QTY and frequency of deliveries: 6 WABS per month

iii. Department: Medical- Estimated QTY and frequency of deliveries: Par level 6 WABS monthly

iv. Department: Imaging- Estimated QTY and frequency of deliveries: 6 WABS monthly

v. Department: Emergency- Estimated QTY and frequency of deliveries: PAR Level 12

WABS monthly

vi. Department: Nutrition and Food- Estimated QTY and frequency of deliveries: PAR level 6 WABS monthly

vii. Department: Research- Estimated QTY and frequency of deliveries: Par level 6 WABS monthly

5. Cedar Park VA Clinic (1401 Medical Pkwy, STE 400, Cedar Park, TX 78613)

i. Department: Care in the Community- Estimated QTY and frequency of deliveries:

PAR level 6 WABS monthly

6. La Grange CBOC (2 St Marks Place, La Grange, TX 78945)

i. Department: Care in the community - Estimated QTY and frequency of deliveries:

PAR 6 WABS monthly

7. Doris Miller VA Medical Center (4800 Memorial Dr., Waco, TX 76711)

i. Department: Imaging- Estimated QTY and frequency of deliveries: PAR level 6 WABS monthly

ii. Department: Women Clinic- Estimated QTY and frequency of deliveries: PAR level 6 WABS monthly

iii. Department: Whole Health- Estimated QTY and frequency of deliveries: PAR Level 6 WABS monthly

iv. Department: Pathology and Lab- Estimated QTY and frequency of deliveries: PAR Level 6 WABS monthly

v. Department: Medical- Estimated QTY and frequency of deliveries: PAR level 6 WABS monthly

vi. Department: Dermatology - Estimated QTY and frequency of deliveries: PAR 1 fill monthly.

vii. Department: Physical Medicine and Rehab- Estimated QTY and frequency of deliveries: PAR 6 WABS monthly

8. Bryan College Station CBOC (1651 Rock Prairie Rd, Ste. 100, College Station, TX 77845)

i. Department: Care in the Community- Estimated QTY and frequency of deliveries: 1 50L DEWAR refill monthly.

9. VISN 17 Center of Excellence (4800 Memorial Dr., Bldg. 93, Waco, TX 76711)

i. Department: Care in the Community- Estimated QTY and frequency of deliveries:

PAR level 6 WABS monthly

6. ORDERING:

Orders shall only be placed by the appointed Ordering Officers (OO) for this Contract or via a delivery/task order from a Contracting Officer. A list of appointed OOs will be provided to the vendor. Updates to the OO list will be provided to the vendor throughout the life of the contract.

7. DELIVERY AND BILLING

7.1 Contractor must make deliveries not later than five (5) calendar days after receipt of order unless a specified date for delivery has been agreed to within the order (excluding Federal Holidays).

7.2 If the Contractor is unable to complete delivery within 5 calendar days of receipt of order, the contractor must reach out to requestor via phone and/or email providing reason for delay as well as expected delivery date and time or provide alternate source of supplies at no additional cost to

CTVHCS.

7.3 The Contractor will provide emergency contact information for after hours and weekends, calls will be acknowledged within one hour with deliveries being made within 24 hours.

7.4 The Technician shall deliver clean and dust-free medical gas cylinders to the designated medical services at each facility and pick up any empty cylinders belonging to the contractor.

7.5 All CTVHCS VA facilities have the right to refuse dirty cylinders or cylinders that do not meet applicable regulations and standards. The Contractor must replace rejected cylinders within 24 hours at no additional cost to the government.

7.6 The technician is required to provide the POC with a legibly signed and dated electronic delivery ticket after each delivery.

7.7 The technician shall deliver the medical gas cylinders to the specified location(s) in Section 5, when ordered. The Contractor is required to provide the facility order form and delivery ticket to the POC. The following information applies to all deliveries, regardless of the time or day of execution.

7.8 The delivery slip/ticket for Government Furnished Equipment (GFE) must include:

a. The number of cylinders being delivered

b. The number of cylinders being picked up

c. If one-for-one matching is not accurate, missing cylinder quantities will be identified and documented on the delivery slip of government-owned cylinders.

d. The technician and VA receiving shall sign the delivery slip.

7.9 The delivery slip/ticket for contractor-provided cylinders must include:

a. Contract Number, Facility PO Number or Delivery Order number

b. Location Name and Account number for the specific delivery location

c. Date of Order

d. Date of Delivery

e. Item number(s) (LIN) and/or product identification number(s)

f. Quantity of each gas and cylinder ordered

g. Items ordered and not delivered

h. The number and type of cylinders being delivered

i. The number and type of cylinders being picked up

j. The technician and VA receiving shall sign the delivery slip.

7.10 Contractor shall provide access to the scanned copy of the delivery slip to the POC through electronic means (e-mail or otherwise).

8. HOURS OF COVERAGE:

8.1 The vendor shall provide telephone support 24 hours a day, 7 days a week.

8.2 Vendor shall provide unscheduled maintenance (called upon to repair/fix any faulty equipment being rented despite the vendor having any schedule for their equipment maintenance if they have one) Mondays - Fridays, 7:30 AM-4:30 PM local site time, Mondays – Fridays excluding Federal Holidays.

8.3 The vendor shall provide planned maintenance scheduled at a mutually agreeable time Mondays - Fridays, 7:30 AM-4:30 PM local site time excluding Federal Holidays.

8.4 The POC or designated alternate shall provide reasonable access to the equipment, reasonable working space, and a reasonable safe, hazard-free operating environment for the contractor’s employees and representatives providing services here under during hours of coverage.

8.5 Federal Holidays observed by the CTVHCS, and any other day declared a holiday by the President of the United States:

Federal Holidays Date of Observation New Year’s Day January 1 Birthday of Martin Luther King, Jr. Third Monday in January Washington's Birthday Third Monday in February Memorial Day Last Monday in May Juneteenth June 19 Independence Day July 4 Labor Day First Monday in September Columbus Day Second Monday in October Veterans Day November 11 Thanksgiving Day Fourth Thursday in November Christmas Day December 25

8.6 When a holiday falls on a Sunday, the following Monday will be observed as a legal holiday.

When a holiday falls on a Saturday, the preceding Friday is observed by US Government agencies.

9. CYLINDERS AND OTHER CONTAINERS:

9.1 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.

9.2 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.

9.3 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 September 2013.

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 May 2013. 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 cryo-band applied at the top of the container with the drug product name repeated around the entire container.

9.5 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.

9.6 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.

9.7 Hydrostatic Testing shall be performed in accordance with CGA’s Publication -- C- 1, Methods for Hydrostatic Testing of Compressed Gas Cylinders, dated January 2016.

9.8 Visual inspection shall be performed in accordance with the applicable CGA Publications C- 6 --Standards for Visual Inspection of Steel Compressed Gas Cylinders, dated May 2013 or C-

6.1 -- Standards for Visual Inspection of High-Pressure Aluminum Compressed Gas Cylinders, dated May 2013.

9.9 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 attachment D.1.

9.10 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.

9.11 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.

9.12 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.

These cylinders shall become Government property. The Government will not pay cylinder rental fees from the date of audit.

9.13 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.

9.14 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 included in contract pricing.

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

OWNED CYLINDERS:

The contractor’s price for the gas shall include the furnishing 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. In addition to the 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 October 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. LICENSING, AUTHORIZATION, AND SELLING PERMISSIONS:

12.1 If the Contractor is the manufacturer of the medical gas being supplied under this contract, it shall annually provide verification that it holds current licensing, permits, certifications or registrations required by the FDA and the states in which this contract is performed.

12.2 If the Contractor is not the manufacturer of the medical gas being supplied under this contract, the Contractor shall annually provide verification that the manufacturer from which it obtains the medical gas provided to VA under this contract holds current licensing, permits, certifications or registrations required by the FDA and the states in which this contract is performed. In addition, the Contractor shall provide annual updates to any agreements it has with the medical gas manufacturer affirmatively demonstrating that the Contractor has authorization by the manufacturer to resell the medical gas the Contractor is providing under this contract. In the event of a change in manufacturer, 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’s current licenses, permits, certifications or registrations required by the FDA and the states in which this contract is performed. The Contractor shall also provide a copy of its agreement with the new manufacturer demonstrating that the Contractor has authorization by the manufacturer to resell the medical gas the Contractor intends to provide under this contract.

13. NARA RECORDS MANAGEMENT LANGUAGE FOR CONTRACTS:

13.1 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.

13.2 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.

13.3 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.

13.4 Central Texas Veteran Affairs Health Care System (CTVHCS) 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 CTVHCS 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.

13.5 In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to CTVHCS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

13.6 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 vehicle]. 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 CTVHCS 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 vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

13.7 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 CTVHCS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

13.8 The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with CTVHCS policy.

13.9 The Contractor shall not create or maintain any records containing any non-public CTVHCS information that are not specifically tied to or authorized by the contract.

13.10 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.

13.11 CTVHCS 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 CTVHCS 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.

13.12 Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #10176, Privacy and Information Security, Rules of Behavior. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

13.13 The C&A requirements do not apply, and a Security Accreditation Package is not required.

B.2 STATEMENT OF WORK