DRAFT_PWS.pdf

Medical Gas Support Special Warfare Medical Group

Fort Bragg, North Carolina

Part I

General Information

1. GENERAL: This is a non-personal services contract. The Government shall not exercise any supervision or control over contractor personnel performing the services herein. Such contract service providers shall be accountable solely to the Contractor.

1.1. Description of Services/Introduction: The Contractor shall provide all personnel, supervision, and other items necessary to perform non-personal services as defined in this Performance Work Statement (PWS), except for those items specified as Government furnished property and services. The Contractor shall perform in accordance with (IAW) the terms and conditions of the contract and consistent with the standards established in this PWS.

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. propane and M22, 040 and D government-owned cylinders

The quantities provided are estimates of the facility’s annual requirements for medical gases. 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.

1.3. Period of Performance: The period of performance shall be for one (1) Base Year of 12 months, and four (4) 12-month option 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 Facility POC upon request. A copy of all inspection reports shall be provided to the Facility POC 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 Current Good Manufacturing Practices (CGMP) Regulations.

1.4.1.1. The Contractor must deliver the medical gas cylinders in compliance with the state of North Carolina and federal codes. All cylinders filled with gas product must be in compliance with state 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: Within 48 hours of contract award, the facility POCs will submit requests for delivery of medical gases and rental cylinders to the Contractor. The Contractor must notify the facility of the planned delivery, scheduled within the 48 hour window, including date and time. After contract award, the Facility POCs and the Contractor may agree upon a defined delivery schedule, i.e. Thursdays on a weekly basis.

1.4.3. Cylinder 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 perform services 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 Independence Day Christmas Day

1.4.5.1. Holidays on Saturday or Sunday: When a federal holiday occurs on a Saturday, federal employees are normally granted the previous Friday as the holiday observance. When a holiday occurs on a Sunday, federal employees are normally granted the following Monday as the holiday. The contractor shall work on the days the Government is scheduled to work.

1.4.6. Hours of Operation: The Contractor shall be responsible for providing services, 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 will provide service support 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.

1.4.8.1.3. 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.

1.4.9. Contracting Officer Representative (COR): The KO shall appoint a SWMG Government staff member as

COR.

1.4.10. COR Responsibilities and Limitations: 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.

1.4.11. Contractor Personnel Administrative Requirements:

1.4.11.1. Invoices: The Contractor shall submit monthly invoices for reimbursement citing the appropriate travel contract line item. Each individual travel instance must be captured; copies of receipts, travel vouchers, etc. shall be attached to the invoice to support charges. Original receipts shall be maintained by the Contractor and made available to Government auditors upon request.

PART 2

DEFINITIONS & ACRONYMS

2. DEFINITIONS AND ACRONYMS:

2.1. DEFINITIONS:

CONTRACTOR. A supplier or Contractor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime.

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. A service output that does not meet the standard of performance associated with the Performance Work Statement (PWS).

FACILITY. A building, structure, or other improvement to real property. It includes the usable space it contains and any interest in land, structure, or complex of structures together with any associated road and utility improvements necessary to support the functions of an Army activity or mission.

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 PWS 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 CDL Commercial Driver’s License CFR Code of Federal Regulations CGA Compressed Gas Association CGMP Current Good Manufacturing Practices CMR Contractor Manpower Reporting COA Certificate of Analysis COR Contracting Officer Representative DA Department of the Army DFARS Defense Federal Acquisition Regulation Supplement

DOD Department of Defense DOT Department of Transportation FAR Federal Acquisition Regulation FDA Food and Drug Administration IAW In accordance with iRAPT Invoicing, Receipt, Acceptance, and Property Transfer KO Contracting Officer PPE Personal Protection Equipment PWS Performance Work Statement QA Quality Assurance QC Quality Control USASOC United States Army Special Operations Command U.S.P United States Pharmacopoeia/National Formulary

PART 3

GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

3. GOVERNMENT FURNISHED ITEMS AND SERVICES: Not applicable.

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 under this PWS that are not listed under Part 3 of this PWS.

PART 5

SPECIFIC TASKS

5. SPECIFIC TASKS:

5.1. Basic Services. The Contractor shall provide services and support for 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 PWS.

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 Facility POC. The Facility POC 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 Delivery Driver shall have all the safety equipment to include Personal Protection Equipment (PPE) required to safely load and unload the medical gas cylinders.

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

PART 6

APPLICABLE PUBLICATIONS

6. APPLICABLE PUBLICATIONS (CURRENT EDITIONS):

6.1. The following is a list of some of the regulations and standards that are applicable to this contract. The list is not comprehensive, and the contractor is responsible for ensuring that all products, equipment and services provided under the contract are in compliance with applicable Federal, state, and local regulations. If applicable, the editions in effect as of the date of this contract are listed. The Contractor is responsible for remaining compliant with any future revisions that become effective during contract performance.

6.2. Title 21, Code of Federal Regulations, Parts 201, 210, and 211 - CGMP regulations.

6.2.1. Medical gases are subject to the requirements in 21 CFR § 211.150 – Distribution procedures.

6.3. 29 CFR 1910 Subpart H - Hazardous Materials

6.4. CFR Title 49 – Transportation

6.5. NFPA 55: Compressed Gases and Cryogenic Fluids Code

6.6. NFPA 99: Health Care Facilities Code

6.7. ASSE 6000 Medical Gas Systems Certification

6.8. Federal Food, Drug and Cosmetic Act

6.9. Cylinders and Other Containers:

6.9.1. 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.

6.9.2. 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 1012112011.

6.9.3. 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 3110104.

6.9.5. Valves shall comply with CGA Safety Bulletin SB-26 dated 0512007 and CGA Publication V-1 -Compressed Gas

Association Standard for Compressed Gas Cylinder Valve Outlet and Inlet. Connections, dated 11114105. 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.

6.10. Hydrostatic Testing:

6.10.1. 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.

6.10.2. 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, Qualification, maintenance and use of cylinders) 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.

6.10.3. Hydrostatic testing shall be performed in accordance with CGA's Publication -- C-1, Methods For Hydrostatic

Testing of Compressed Gas Cylinders, dated 07/17/2009.

6.11. Visual inspection shall be performed in accordance with the applicable CGA Publications C-6 --Standards for Visual

Inspection of Steel Compressed Gas Cylinders, dated 03/08/2007 or C- 6.1 -- Standards for Visual Inspection of High Pressure Aluminum Compressed Gas Cylinders, dated 12/2112006.

PART 7

TECHNICAL EXHIBIT LISTING

7. Technical Exhibit List:

7.1. Cylinder Specifications:

20 lb Propane Tank

6,000 PSI Nitrogen Tank

7.2. Oxygen Tanks:

M22

D Cylinder

H Cylinder

TECHNICAL EXHIBIT 2

HISTORICAL WORKLOAD DATA

This technical exhibit lists the estimated workload data based on historical figure. Be advised that the historical data being provided may not be inclusive of all requirements as outlined in the current PWS, 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.

Annual Historic Consumption:

*Propane 20# 12 Cyl Nitrogen 6000 PSI 6 Cyl

*Oxygen USP M22 330 Cyl *Oxygen 040 42 Cyl

*Oxygen USP D 279 Cyl Oxygen USP H 8 Cyl

*Bold represents Unit-owned cylinders