Draft Med Gas and Liquid Oxygen PWS.pdf

DRAFT

Statement of Work (SOW) Medical Gas Support

Special Warfare Medical Group Fort Bragg, North Carolina

Part I

General Information

1. General Requirements

1.1. Description of Services/Introduction: The Contractor shall provide all personnel, supervision, and other items necessary to provide the required consumable end-items as defined in this SOW. The Contractor shall provide the required items in accordance with (IAW) the terms and conditions of the contract and consistent with the standards established in this SOW.

1.2. Objectives: The Contractor shall provide all labor and materials to deliver the following medical gases to the requiring facility throughout the period of performance:

• Nitrogen 6000 PSI and Oxygen H Contractor-owned medical gas cylinders

• Refill 20 lb. and 40 lb propane and M22, 040 and D Government-owned cylinders

The Contractor shall pick up all empty cylinders, return full and swap out any rental cylinders each week. All the handling of cylinders, to include transportation and delivery, shall be performed by the Contractor. The quantities provided in the contract line items (CLINs) are estimates of the facility’s annual requirements for medical gases. Weekly pick up cylinders may vary from week to week but in no event shall exceed the amount issued on the delivery order. The Contractor shall only bill the Government cylinders refilled.

• Liquid Oxygen

• 450 liter microbulk liquid oxygen tank system to include tank, reserve, flow control and installation.

Maintenance for 450 liter microbulk liquid oxygen tank system

The Contractor fill the 450 liter tank monthly or on request from the customer and provide all necessary maintenance and services on this tank. The quantities provided in the contract line items (CLINs) are estimates of the facility’s annual requirements for liquid oxygen. Monthly liquid oxygen requirements may vary from month to month but in no event shall exceed the amount issued on the delivery order. The Contractor shall only bill the Government for the number of liters filled per service.

1.3. Delivery Period: The delivery periods shall be for one (1) Base Ordering Period of 12 months, and four (4) 12-month option ordering periods.

1.4. General Information

1.4.1. Quality Assurance Specifications and Requirements: All medical gas manufacturers and fillers of medical gases must be registered with Federal Drug Administration (FDA) as drug manufacturers. All medical gases delivered 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). All medical gases delivered 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.). A valid certificate of analysis (COA) shall be provided with each delivery of the medical gases provided. The certificate shall include, at a minimum, the following:

• Supplier’s name, complete address, and name of the product

• An Air Liquefaction Statement where appropriate

• Lot number or other unique identification number

• Actual analytical results for full U.S.P. monograph testing

• Signature of authorized supplier representative and date

Material Safety Data Sheets shall be provided to the Contracting Officer Representative (COR) upon request. A copy of all inspection reports shall be provided to the COR upon the completion of any contractor-owned system inspections that are required by regulation. All contractor-owned equipment shall be maintained or repaired in accordance with FDA's CGMP Regulations.

1.4.1.1. The Contractor must fill and deliver all the medical gas cylinders with gas product and liquid oxygen tank with liquid oxygen in compliance with the state of North Carolina and federal codes. All cylinders must have Lot Numbers labeled on each cylinder delivered. The Delivery Ticket must be signed by the Contractor after products are delivered. The purity of medical gas oxygen must be no less than 99% when delivered.

1.4.2. Delivery Schedule Coordination: The Government will issue task orders on a monthly basis. After contract award, the COR and the Contractor may agree upon a defined delivery schedule, i.e. Thursdays on a weekly basis.

Within 48 hours of each scheduled weekly pickup, the COR will confirm the quantity of cylinders required to be filled for that week. Within 24 hours of delivery, the Contractor shall notify the facility of the estimated time of delivery.

1.4.3. Cylinder and Tank Sizes: Cylinder sizes listed in Technical Exhibit 1 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.

1.4.4. 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.

1.4.5. Recognized Federal Holidays: The Contractor is not required to deliver on recognized federal holidays. The recognized federal holidays include:

New Year’s Day Labor Day Birthday of Martin Luther King Jr. Columbus Day Presidents Day Veterans Day Memorial Day Thanksgiving Day Juneteenth Day Christmas Day Independence Day

1.4.5.1. Holidays on Saturday or Sunday: Should the previously scheduled delivery occur on a holiday, then the COR shall coordinate an alternate delivery with the Contractor for that occurrence.

1.4.6. Hours of Operation: The Contractor shall be responsible for providing the items, between the hours of 7:30 AM – 3:00 PM Monday through Friday, except federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. Delivery will be made weekly. In the event there is an emergency delivery needed, the order will be placed by the COR/Alternate COR only.

1.4.7. Place of Performance: Contractor shall provide deliveries at three (3) separate locations on Fort Bragg: Bldg 5- 3845 Combat Medic Drive, Bldg 352 Virgin Street and National Training Area 1 (NTA1) vic Hwy 690/Vass Road.

1.4.8. Qualifications.

1.4.8.1. General:

1.4.8.1.1. License and Insurance Requirements: The Contractor shall be responsible for ensuring all Delivery Drivers performing work under this contract possess and maintain current a commercial driver’s license (CDL), and evidence of sufficient vehicle insurance to enter the Fort Bragg installation. The driver will have all the safety equipment to include Personal Protection Equipment (PPE) needed to safely load and unload the medical gas cylinders. The Contractor must inform the COR/Alternate COR of any changes in delivery schedules one week in advance.

1.4.8.1.2. U.S. Citizenship: Contractor personnel performing work under this contract shall be U.S. citizens unless the provisions of Army Regulation 25-2, Information Assurance, have been fully completed and approval has been granted by the Government for the non-U.S. citizen to perform the required support.

1.4.8.2. Security:

1.4.8.2.1. Access and general protection policy and procedures. All contractor employees, including subcontractor employees, requiring access to an Army or USSOCOM controlled installation, facility, or area shall comply with applicable security policies and procedures (provided by the government representative). This includes policies pertaining to the use or prohibition of electronic recorders, devices, cameras, etc. If the Contractor is required to take photographs or videos on a Government Installation, the Contractor must obtain written permission from the Senior Commander. The Contractor shall also provide all information required for background checks to meet installation and facility access requirements to be completed by the installation Provost Marshal Office, Director of Emergency Services, or Security Office. The Contractor workforce must comply with all personal identity verification requirements as directed by DoD, HQDA, USSOCOM, USASOC and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should Force Protection Condition (FPCON) at any individual facility or installation change, the government may require changes in contractor security matters or processes.

1.4.8.2.2. AT Level I training. All contractor employees, including subcontractor employees, requiring access to an Army or USSOCOM controlled installation, facility, or area shall complete AT Level I Awareness Training within 60 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever applies. The contractor shall submit certificates of completion for each affected contract employee and subcontract employee to the COR (or to the contracting officer, if a COR is not assigned) within 90 calendar days after completion of the training by all employees and subcontractor personnel. This is an annual training requirement. AT Level I training is available at: https://jkodirect.jten.mil/Atlas2/faces/page/login/Login.seam.

1.4.8.2.3. For contractors that do not require CAC, but require a federal ID access to a DoD facility or installation.

Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR190-13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations. When issued by local authority the Contractor shall report departed employees and the dates their local identification cards were returned to the COR or the Installation issuing facility as of the last day of the month on a monthly basis. The report will include the names and circumstances of those departed employees whose local identification card was not retrieved. Negative reports are required.

1.4.8.2.4. Requirement for OPSEC training. Per AR 530-1, Operations Security, new contract employees must complete OPSEC Level I training within 30 calendar days of reporting for duty. All contract employees must complete annual OPSEC Awareness Training.

1.4.8.2.5. Will be escorted in areas where they may be exposed to classified and/or sensitive materials. All contractor employees, including subcontractor employees who are not in possession of the appropriate security clearance, will be escorted in areas where they may be exposed to classified and/or sensitive materials. The Contractor will coordinate with the COR and/or the facility security office for access when required. (Use when security clearances are not required, i.e. facility repair or construction)

1.4.8.2.6. Pre-Screen applicants using E-Verify Program. The Contractor must pre-screen applicants using the E- Verify Program (http://www.dhs.gov/E-Verify) website to meet the established employment requirements. The Contractor must ensure that the applicant has two valid forms of government issued identification.

http://www.dhs.gov/E-Verify

1.4.8.2.7. Contractor responsible for ensuring security documentation is completed by applicants. The Contractor must facilitate the security screening process for CRPs (US/non-US citizens who do not require a security clearance and/or access to classified information) by ensuring the applicants complete the required security documentation (Privacy Act Advisement, SF 85P, Fingerprint Cards, OFI Form 86C Special Agency Check (SAC), Intelligence Security Questionnaire, and a National Intelligence Agency Spreadsheet). The Contractor is responsible for translation services required for non-English speaking / writing applicants for assistance in completing the security screening packets. A blank security CI-screening packet will be provided to the Contractor by the Contracting Office upon request. For Linguist support, the Contractor must acquire a PSI-CoE PSIP account to submit the required background investigations. An initial list of applicants must be provided to the COR later than 7 business days after the initial contract award to start the CI-focused security screening process.

1.4.9. Contracting Officer Representative (COR): The KO will identify the COR by separate letter of appointment.

The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: Assures that the Contractor performs the technical requirements of the contract; performs inspections necessary in connection with contract performance; maintains written and oral communications with the Contractor concerning technical aspects of the contract; monitors Contractor's performance and notifies both the KO and Contractor of any deficiencies. A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting contract.

PART 2

DEFINITIONS & ACRONYMS

2. DEFINITIONS AND ACRONYMS:

2.1. DEFINITIONS:

CONTRACTOR. Any individual, firm, corporation, partnership, association, or other legal non-Federal entity that enters into a contract directly with the DOD to furnish services, supplies, or construction.

CONTRACTING OFFICER (KO). A person with authority to enter into, administer, and/or terminate contracts, and to make related determinations and findings on behalf of the Government. Note: The only individual who can legally bind the Government.

CONTRACTING OFFICER'S REPRESENTATIVE (GOVERNMENT). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor, as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

CONTRACTOR PERSONNEL. Contractor and subcontractor contractor employees performing working under this contract.

DEFECTIVE SERVICE. An output that does not meet the standard of performance associated with the SOW.

QUALITY ASSURANCE. A planned and systematic pattern of all actions necessary to provide confidence that adequate technical requirements are established; products and services conform to established technical requirements; and satisfactory performance is achieved. For the purposes of this document, quality assurance refers to actions by the Government.

QUALITY CONTROL. All necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

WORK DAY. The length of time during a day in which the Contractor provides services in accordance with the SOW is the work day. It is also referred to as Business Day.

WORK WEEK. Monday through Friday, unless otherwise specified.

2.2. ACRONYMS:

AR Army Regulation FDA Food and Drug Administration CDL Commercial Driver’s License IAW In accordance with CFR Code of Federal Regulations iRAPT Invoicing, Receipt, Acceptance, and Property Transfer CGA Compressed Gas Association KO Contracting Officer CGMP Current Good Manufacturing Practices PPE Personal Protection Equipment CMR Contractor Manpower Reporting SOW Performance Work Statement COA Certificate of Analysis QA Quality Assurance DA Department of the Army QC Quality Control DFARS Defense Federal Acquisition Regulation

Supplement SOFARS Special Operations Federal Acquisition Regulation

Supplement DOD Department of Defense USASOC United States Army Special Operations Command DOT Department of Transportation U.S.P United States Pharmacopoeia/National Formulary FAR Federal Acquisition Regulation

PART 3

GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

3. GOVERNMENT FURNISHED ITEMS AND SERVICES:

3.1. Cylinders-Government Owned

The Government may provide any variation of the following types of cylinders for the Contractor to re-fill upon request:

M22 O40 D Cylinder H Cylinder 20 lb Propane Tank 40 lb Propane Tank

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES:

4.1. General: The Contractor shall furnish all supplies, equipment, facilities and services required to perform work and delivery the requested items under this SOW that are not listed under Part 3 of this SOW.

4.2 Cylinders-Contractor Owned

The Contractor shall provide and fill any variation of the following types of cylinders upon request:

Nitrogen 6000 PSI -tank

Oxygen USP H

4.3 Liquid Oxygen Tank-Contractor Owned

The Contractor shall provide and maintain 450-liter microbulk liquid oxygen tank system to include tank, reserve, flow control and installation. The contractor will fill the 450-liter tank with liquid oxygen monthly and upon request.

PART 5

SPECIFIC TASKS

5. SPECIFIC TASKS:

5.1. Basic Services. The Contractor shall deliver filled cylinders containing the requested medical gases at three (3) separate locations on Fort Bragg. The Contractor shall provide all labor and materials to deliver contractor-owned gas cylinders, and refill government-owned cylinders to the requiring facility throughout the period of performance as outlined in this SOW. The Contractor shall fill and maintain the specified liquid oxygen tank at the JSOMTC. The Contractor shall provide all labor and materials to deliver liquid oxygen to the requiring facility and maintain the specified liquid oxygen tank at the JSOMTC throughout the period of performance as outlined in this SOW

5.1.1. Deliveries shall be made on a weekly basis. In the event there is an emergency delivery needed, the order will be placed by the COR.

5.1.1.1. The Contractor must inform the COR/Alternate COR of any changes in delivery schedules one week in advance.

5.1.2. At the time of each delivery, the Contractor shall provide a legible signed and dated written document that identifies the tank level prior to fill, the level after fill, and the quantity delivered. This document must be counter-signed by a facility representative supervising the delivery. If for any reason the Contractor is unable to make delivery at an agreed upon day or time, the Contractor shall provide 24-hour notice to the COR. The COR is responsible for communicating local issues, such as ordering and delivery instructions.

5.1.3. The Contractor shall have an established system by which the distribution of each lot of gases can be readily determined to facilitate its recall, if necessary.

5.1.4. The Contractor shall conduct maintenance on customer-owned and rental cylinders. As part of the maintenance, the Contractor shall scrape and replace labels, document lot numbers for FDA tracking and lot numbers annotated on delivery tickets and invoice.

5.1.5. The Contractor shall be responsible for all testing of contractor-owned cylinders, as well as the hydrostatic testing of government-owned cylinders.

5.1.6. The Contractor shall be responsible for all testing and maintaining of contractor-owned liquid oxygen tank.

PART 6

APPLICABLE PUBLICATIONS

6. APPLICABLE PUBLICATIONS (CURRENT EDITIONS):

6.1. 6.1. Vendor will comply with all state and federal laws and regulations that govern the scope of this service.

PART 7

TECHNICAL EXHIBIT LISTING

7. TECHNICAL EXHIBIT LIST:

Technical Exhibit 1- Cylinder Specifications

Technical Exhibit 2- Liquid Oxygen Tank Specifications

Technical Exhibit 3- Estimated Workload Data

Technical Exhibit 4- Deliverables Schedule

TECHNICAL EXHIBIT 1

Cylinder Specifications

Cylinder Specifications:

20 lb Propane Tank

40 lb Propane Tank

6,000 PSI Nitrogen Tank

Oxygen Tanks:

M22

D Cylinder

H Cylinder

TECHNICAL EXHIBIT 2

Liquid Oxygen Tank Specifications

Liquid Oxygen Tank Specifications:

450-liter microbulk liquid oxygen tank system with reserve and flow control

TECHNICAL EXHIBIT 3

ESTIMATED WORKLOAD DATA

This technical exhibit lists the estimated workload data based on annual historical consumption figures. Be advised that the historical data being provided may not be inclusive of all requirements as outlined in the current SOW, which is subject to increases and decreases in workload, and SHOULD NOT be considered as absolute in terms of present or future requirements. This data is included for informational purposes only. OFFERORS ARE

CAUTIONED TO USE AT OWN RISK.

Contractor-Owned Cylinders Nitrogen 6000 PSI 8 Cyl

Oxygen USP H 8 Cyl Liquid Oxygen 450 Liter 1 Tank

Government-Owned Cylinders Propane #20 54 Cyl Propane #40 20 Cyl

Oxygen USP M22 330 Cyl Oxygen 040 64 Cyl

Oxygen USP D 279 Cyl

TECHNICAL EXHIBIT 3

DELIVERABLES SCHEDULE

Deliverable Frequency # of Copies

Medium/Format Submit To

SOW

Paragraph Filled Medical Gas Cylinders

Weekly as Ordered As Ordered

Physically Delivered to the Facility

Government 1.4.2,1.4.6 and 5.1.1

Fill Liquid Oxygen Tank

Monthly as Ordered

As Ordered

Physically Delivered to the Facility

Government 1.4.2,1.4.6 and 5.1.6

DoD Information Assurance Awareness Training

Within 15 days of contract award

One Electronic Copy

Certificate delivered via email

Contracting Officer &

COR

1.6.8.1.9

OPSEC Training 15 calendar days of their reporting for duty

One Electronic Copy

Certificate delivered via email

Contracting Officer &

COR

1.4.8.2.4 iWATCH Training:

60 calendar days of contract award and within 30 calendar days of new employees'

One Electronic Copy

Certificate delivered via email

Contracting Officer &

COR

1.6.8.1.7