PWS (updated).DOCX

Performance Work Statement (PWS) Medical Gases (Bulk and Cylinders) Irwin Army Community Hospital Fort Riley, KS

1. General

1.1. Requesting the contractor to provide bulk & bottles medical-grade gases (bulk liquid oxygen, bottled oxygen, nitrogen, carbon dioxide, lung diffusion gas) for the period of 1 June 2020-30 May 2021, plus four option years to Irwin Army Community Hospital, Fort Riley, KS.

1.2. The tanks located at building 650 Huebner Road consist of: a 1,500 gallon main tank, with a full level of 135in, and an alarm point of 40, and a 500 gallon reserve tank, with a full level of 52in and an alarm set point of 20.

1.3. All bulk tanks are required to be equipped with Telemetry Systems.

1.4. Prior to first filling of bulk oxygen tanks, the contractor shall perform in-service training to include the following facets for contractor owned and Government owned systems: the refill procedure, any preventive maintenance support requirements that may be needed from the medical center systems, and an explanation of all the volume alarm and low pressure set-points.

1.5. The marked Government owned bulk oxygen storage tanks and appurtenances will be maintained by and at the expense of the Government, in a manner that will ensure compliance with applicable regulations, standards and normal good practices.

1.6. Contractor Management Reporting (CMR): The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract via secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil/, and then click on "Department of the Army CMRA" or the icon of the DoD organization that is receiving or benefitting from the contracted services.

Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year. Contractors may direct questions to the help desk by clicking on "Send an email" which is located under the Help Resources ribbon on the right side of the login page of the applicable Service/Component's CMR website.

The required data fields include: (1) Contracting Office, Contracting Officer, or also known as the Contracting Officer’s Representative (COR); (2) Contract number, including task and delivery order number; (3) Beginning and ending dates covered by reporting period; (4) Contractor's name, address, phone number, e-mail address, identity of Contractor employee entering data; (5) Estimated direct labor hours (including sub-Contractors); (6) Estimated direct labor dollars paid this reporting period (including sub-Contractors); (7) Total payments (including sub-Contractors); (8) Predominant Federal Service Code (FSC) reflecting services provided by Contractor (and separate predominant FSC for each sub-Contractor if different); (9) Estimated data collection cost; (10) Organizational title associated with the Unit Identification Code (UIC) for the Army Requiring Activity (the Army Requiring Activity is responsible for providing the Contractor with its UIC for the purposes of reporting this information); (11) Locations where Contractor and sub-Contractors perform the work (specified by zip code in the United States and nearest city, country, when in an overseas location, using standardized nomenclature provided on website); (12) Presence of deployment or contingency contract language; and (13) Number of Contractor and sub-Contractor employees deployed in theater this reporting period (by country). As part of its submission, the Contractor shall provide the estimated total cost (if any) incurred to comply with this reporting requirement.

As part of its submission, the contractor will also provide the estimated total cost (if any) incurred to comply with this reporting requirement. The specific formats for the XML direct transfer may be downloaded from the website.

2. Government Furnished Equipment

2.1. If contractor owned equipment is required, in the event of an emergency, each Government facility that requires installation of contractor owned equipment shall provide a suitable location and foundation for the installation of the contractor owned bulk oxygen tank(s). Additionally, each facility shall provide access to an electrical power source and hook-up to a facility-maintained alarm system. The contractor shall perform the hook-up of contractor owned equipment to the facility-maintained alarm system.

2.2. 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 Government Point of Contact (POC)) at the ordering agency.

3. Contractor-Furnished Equipment

3.1. For those facilities requiring contractor owned tanks, the contractor shall provide, install and maintain bulk oxygen tank(s) with appropriate back-up system(s). Any of the contractor equipment will need to mark for identification. Through the duration of the contract, the contractor shall be liable for the integrity, suitability, and safety of contractor owned tank(s) that will insure compliance with applicable regulations, standards and normal good practices. The tank capacity and reserve system shown in the schedule are minimum capacities required by the using facilities. Manifold, cylinders for the reserve supply, liquid converter, alarm switch, regulator, valves, level indicator, and any other devices or connections required for proper tie-ins with the facility’s gas system shall be furnished by the contractor, without cost to the Government. The manifold or liquid converter shall deliver gas at a pressure and rate of flow adequate to supply the system. Each liquid oxygen storage container shall have an outlet that allows access for testing the purity of the oxygen.

3.2. All equipment and materials required to perform on the contract (other than what is specifically listed in section 2, Government-Furnished Property) shall be provided by the contractor. Contractor owned equipment shall be installed, inspected and maintained by the contractor without additional cost to the Government. (i.e., all installation, inspection and maintenance costs shall be included in the contract’s monthly equipment rental fee for the applicable facility). Contractor owned equipment shall be kept in good operating condition and appearance, in accordance with applicable regulations, standards and normal good practices. The contractor shall be provided reasonable access to the bulk oxygen systems for this purpose.

4. Installation of Contractor-Owned Equipment

4.1. Unless otherwise directed by the using facility, contractor owned equipment shall be installed by the effective date of the contract and shall be connected to the medical gas system on that date, provided: that the contractor shall be allowed a maximum of ninety days after receipt of notice of award to complete installation. If the contractor’s equipment replaces equipment already in use, the exchange of equipment shall be accomplished without interruption of gas supply to the using facility. Contractor installed equipment shall remain the property of the contractor and shall be removed upon termination of the contract, when directed by the ordering facility and in full cooperation with the succeeding contractor so as to avoid interruption of gas supply.

4.2. To permit orderly transition from one contractor to another, the contractor shall continue to honor the contract’s monthly equipment rental fee and bulk oxygen contract price for a maximum of ninety days beyond the scheduled expiration of the contract period, unless transition from one contractor to another is completed prior to the ninety day transition period. For any partial month, the contractor shall prorate the monthly equipment rental fee accordingly. The contractor shall continue to provide and maintain its equipment during this transition period.

4.3. All contractor owned equipment shall be installed in accordance with NFPA 50: Standard for Bulk Oxygen Systems at Consumer Sites, 2001, NFPA 99 Standard for Health Care Facilities, 2002 Edition, and FDA’s Current Good Manufacturing Practices (CGMP) Regulations. The contractor shall comply with all OSHA standards and applicable safety requirements, including proper signage and use of personal protective equipment.

5. Quality Assurance Specifications and Requirements

5.1. All medical gas manufacturers and fillers of medical gases must be registered with FDA as drug manufacturers. All oxygen shall be manufactured, processed, packed, transported, and stored according to FDA’s Current Good Manufacturing Practices (CGMP) regulations, and all labeling shall comply with FDA’s labeling regulations (21 CFR Part 201).

5.2. All liquid bulk gases delivered under the contract shall be medical-grade and shall meet or exceed the standards cited in the current edition of the United States Pharmacopoeia/National Formulary (U.S.P.).

5.3. A valid certificate of analysis shall be provided with each delivery of liquid oxygen.

5.3.1. The certificate shall include, at a minimum:

a) Supplier’s name and complete address

b) Name of the Product (i.e. Oxygen U.S.P.)

c) An Air Liquefaction Statement where appropriate

d) Lot number or other unique identification number

e) Actual analytical results for full U.S.P. monograph testing. (A statement that only states that the product meets the minimum purity of 99.5%, etc. is not acceptable.)

f) Test method used to perform the analysis. (A statement such as “Meets U.S.P. specifications” is not acceptable; nor would “Tested via Servomex” be acceptable since the specific model number is not provided.)

g) Signature of authorized supplier representative and date.

5.4. Material Safety Data Sheets shall be provided to the facility COR upon request.

5.5. A copy of all inspection reports shall be provided to the facility POC upon the completion of any contractor owned or Government owned bulk oxygen system inspections that are required by regulation.

5.6. All contractors owned equipment shall be maintained or repaired in accordance with NFPA 50: Standard for Bulk Oxygen Systems at Consumer Sites, 2001 and FDA’s Current Good Manufacturing Practices (CGMP) Regulations.

6. Applicable Regulations & Standards

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 solicitation are listed. Contractor is responsible for remaining compliant with any future revisions that are effective at the time of contract performance.

a) Title 21, Code of Federal Regulations, Parts 210 & 211 - CGMP regulations for supplying medical grade oxygen.

b) 29 CFR 1910.104 Applies to the installation of bulk oxygen systems on industrial and institutional consumer premises

c) 49 CFR – Transportation

d) Federal Food, Drug, and Cosmetic Act

e) NFPA 50: Standard for Bulk Oxygen Systems at Consumer Sites, 2001 Edition

f) NFPA 99: Standard for Health Care Facilities, 2015 Edition

g) U.S.P. 23Density data and volume measurement equivalents published in Compressed Gas Association Pamphlet No. P-6, titled "Standard Density Data, Atmospheric Gases and Hydrogen," shall be used when necessary to convert measurement of gases from one form to another. For example, the following conversion factor shall apply for conversion from gallons to cubic feet.

h) Calculation based on data in CGA P-6 1 ft³ liquid O2 = 860.6 ft³ gas (Table 1) 1 ft³ liquid O2 = 7.48052 gal ((Table 2) Therefore:7.48052 gal (1 ft³) liquid O2 = 860.6 ft³ gas 1 gal liquid O2 = 860.6 ft³ gas 7.48052 1 gal liquid O2 = 115.05 ft³ gas or more commonly quoted as 1 gal liquid O2 = 115.1 ft³ gas

8. Payment method:

8.1. Invoices: Payment will be made by Defense Finance and Accounting Service, (DFAS), Indianapolis, IN, after receipt of services. Contractor submits their 2-n-1 invoice in the Procurement Integrated Enterprise Environment (PIEE) for payment. The Contracting Officer’s Representative (COR) shall verify for acceptance to be submit to DFAS Indianapolis. Government Payment will only be authorized for services actually rendered. Advance payments under this contract are not authorized.

9. TOBACCO FREE MEDICAL CAMPUS (TFMC)

The Contractor shall ensure that all employees comply with the U.S. Army Medical Command and MTF smoking policies while performing services under this contract. Smoking restrictions will apply at any location or building where healthcare activities are performed under this contract.

In accordance with Army Regulation 600-63, paragraph 7-3, 14 April 2015; Operations Order 15-48 (Army Medical Command (MEDCOM) Tobacco Free Living – USAMEDCOM), 8 May 2015; and any Operations Order, regulation or other instruction implementing, defining or otherwise addressing the Tobacco Free Medical Campus (TFMC) on any military installation or DoD-controlled location, Contractor personnel are prohibited from using any tobacco product on or within any TFMC while performing under this contract. TFMCs are established at each installation or DoD-controlled location and include: (1) any property or non-residential building that is operated, maintained or assigned to support medical activities, including but not limited to, hospitals, medical laboratories, outpatient clinics (including medical, dental, and veterinary facilities), or aid stations operating for the primary purpose of delivering medical care and services for DOD eligible beneficiaries and/or meeting the mission of the Army Medical Command; (2) all other facilities in which medical activities or administration take place, to include HQ MEDCOM and Defense Health Headquarters; (3) all internal roadways, sidewalks and parking lots; and (4) all sidewalks, parking lots and grounds external but adjacent to the building or related to the migratory corridors surrounding the medical facility. The Contractor shall obtain from the COR any orders, regulations, instructions or other documents implementing, defining or otherwise addressing the TFMC for any given installation or DoD-controlled location where Contractor personnel may perform under this contract and shall instruct Contractor personnel on the TFMC limitations for installations or DoD-controlled locations where they may perform under this contract.

10. Acronyms

10.1 This section lists acronyms that are used in this Statement of Work BOP – Federal

CCF – 100 cubic feet

CF – Cubic feet

CGA – Compressed Gas Association

CGMP – Current Good Manufacturing Practices

CO – Contractor owned

COR - Contracting Officer Technical Representative

DOD – Department of Defense

DOT – Department of Transportation

FDA – U.S. Food & Drug Administration

GO – Government owned

NFPA – National Fire Protection Association

OGA – Other Government Agency (Other than VA)

OSHA – U.S. Department of Labor, Occupational Safety and Health Administration

USP – United States Pharmacopeia

VA – Department of Veterans Affairs

REQUIREMENT & USAGE

(A, G, M, etc.)

Annual Usage

Oxygen (0OXYGENK200)

Nitrous Oxide (0NITROXIDEH64)

Carbon Dioxide (0CARDIOXIDEG50)

Carbon Dioxide (0CARDIOXIDEE)

Lung Diffusion Gas

(0LUNGDIFFGAS)

Other Equipment or Testing Charges

Hydro Static Testing (0HYDROTEST CHARGE) Required annually Per bottle/cylinder

(END OF PERFORMANCE WORK STATEMENT)