STATEMENT_OF_WORK_AND_GENERAL_SPECS_Med_Gas.pdf

STATEMENT OF WORK AND GENERAL SPECIFICATIONS FOR:

MEDICAL CYLINDER GAS

CROW SERVICE UNIT

Crow / Northern Cheyenne Hospital, Crow Agency, MT

Lodge Grass Clinic, Lodge Grass, MT

1. BACKGROUND:

The Crow Service Unit locations currently requires replenishment deliveries of various medical gases bi-weekly at minimum.

In use is: Liquid Nitrogen, Nitrogen, Nitrous Oxide, Carbon Dioxide, Liquid Oxygen & Oxygen Compressed.

2. SCOPE OF CONTRACT:

The purpose of this Request for Quotation (RFQ) is to award a firm-fixed price contract for medical cylinder gases utilized at the Crow Service Unit locations. The gases to be purchased include, but are not limited to Liquid Nitrogen, Nitrogen, Nitrous Oxide, Carbon Dioxide, Liquid Oxygen & Oxygen Compressed.

The contractor’s responsibilities are as follows:

a) Provide the gas cylinders for rental on the locations.

b) Weekly delivery will include exchanges of the ordered gases.

c) Deliver, when necessary, full cylinders and exchange them for emptied cylinders.

d) The contractor will maintain a current inventory of the bottled gas cylinders at the locations.

Site Visits:

Contractor will deliver full cylinders on a weekly basis as ordered.

All cylinders supplied through the contract shall be delivered to the following addresses as specified when the order is placed:

Crow / Northern Cheyenne Hospital

One Hospital Way Crow Agency, MT 59022

Lodge Grass Clinic Harding Ave & G Street Lodge Grass, MT 59050

The Contracting Officer Representative (COR) will be Marlin “Deano” Yarlott, Facilities Manager and will be responsible for placing orders against the awarded contract. The contractor shall deliver the items in accordance with each order. There is no express or implied guarantee that certain quantities will be purchased.

The contract awarded under this solicitation will be in effect from October 1, 2017 through September 31, 2018.

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 the 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 contractors and COR regarding any issue, the matter shall be referred to the Contracting Officer for resolution.

Contractor Requirements Contractor shall be in the bottled gas supply business and shall be capable of safely delivering full gas cylinders to the site.

3. GOVERNMENT RESPONSIBILITIES

The Government will provide secure storage locations for the bottled gases delivered to the facility. Access to the loading dock will also be available for the delivery truck to use if so desired. If the need for bottle exchanges between contractor visits arises, the facility manager will notify the contractor so that they can arrange delivery.

4. PRODUCT SPECIFICATIONS

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 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.

Tanks shall be filled to the maximum functional capacity at each refilling procedure unless otherwise specified by the facility or as agreed upon by a written document signed and dated by

COR.

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.

5. CYLINDERS AND OTHER CONTAINERS

5.1 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.

5.2 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 3/31/04. Vendor must provide a copy of the most recent version of this publication.

5.3 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 3/10/04. Vendor must provide a copy of the most recent version of this publication.

5.4 Valves

Valves shall comply with CGA Safety Bulletin SB-26 dated 11/26/01 and CGA Publication V-1- Compressed Gas Association Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connections, dated 11/14/05. Vendor must provide a copy of the most recent version to this publication with their offer. 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.

5.5 Hydrostatic Testing

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.

Hydrostatic testing shall be performed in accordance with CGA’s Publication—C-1, Methods for Hydrostatic Testing of Compressed Gas Cylinders, dated 9/7/04 or the most recent edition.

Visual inspection shall be performed in accordance with CGA Publications C-6—Standards for Visual Inspection of Steel Compressed Gas Cylinders, dated 8/16/05 or C-6-1—Standards for Visual Inspection of High Pressure Aluminum Compressed Gas Cylinders, dated 7/30/02 or most recent edition.

The contractor shall be responsible for all testing of contractor-owned cylinders.

5.6 Cylinder Sizes

Cylinder sizes shown in the item description indicate product capacity of the cylinder currently being used. All capacities are approximate, and IHS shall be billed only for the actual amount of gas delivered. In accordance with Federal Food, Drug and Cosmetic Act, the actual contents of the container must appear on the label.

5.7 Lost or Damaged Contractor-Owned Cylinders

For each contractor-owned cylinder lost or damaged beyond repair while in the Crow Service Unit’s possession, the Crow Service Unit shall pay to the contractor the replacement value, less the allocable rental paid for that cylinder. These cylinders shall become Crow Service Unit’s property. If any lost cylinder is located within 30 calendar days after payment by the Crow Service Unit, it may be returned to the Contractor by the service unit and the Contractor shall pay to the service unit an amount equal to the replacement value.

6. PRICE OF SERVICES FOR CONTRACTOR-OWNED CYLINDERS

6.1 Services included in the price of all gas contractor-owned cylinders The contractor’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. 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. Attaching of oxygen cylinders to manifold systems when required shall also be performed by the contractor at no additional cost.

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

6.2 Unlisted Services

Unlisted services (including palletizing when needed) are not covered by this contract and will be obtained by Crow Service Unit according to applicable procurement regulations.

6.3 Invoices

1. Exchanged Cylinder Invoice: All cylinders exchanged during a site visit shall be listed on an invoice along with applicable hazmat fees and delivery charges. Invoices shall be provided to the service unit no later than 5 days after a site visit where cylinders were exchanged.

2. Cylinder Rental Invoice: A monthly invoice for cylinder rental charges shall be submitted to the service unit at the end of the month.

7. MONTHLY/DAILY RENTAL OF CONTRACTOR-OWNED CYLINDERS AND LIQUID

CONTAINERS

When gases are ordered in cylinders or liquid containers owned by the contractor, the contractor shall not bill at a rate that is higher than their standard commercial rate.

8. INSTRUCTIONS FOR SUBMITTING PROPOSAL

Contractors intending to conduct business with the Federal Government must be registered with the System for Award Management (SAM). SAM is the primary Government repository, which retains information on Government contractors. You may register via the Internet at https://www.sam.gov or by calling (866) 606-8220.

Offers shall be submitted to the Crow Service Unit, One Hospital Way, Crow Agency, Montana

59022, no later than 4:00 p.m. MST, on September 21, 2017. The offer must be submitted in a sealed envelope, addressed to this office, showing the time specified for receipt, the solicitation number, and your company's name and address. Offers will be accepted via email. Offers can be emailed to Prudence Yellow Owl, prudence.yellowowl@ihs.gov. Include the solicitation number in the subject line.

The submitted proposal must stipulate that it is predicated upon all the terms and conditions of the RFQ. In addition, it must contain a statement in the effect that it is firm for a period of at least

90 days from the date of receipt by the Government.

mailto:prudence.yellowowl@ihs.gov

9. PROVISIONS & CLAUSES

The following clauses are incorporated by reference (52.252-2 Clauses Incorporated by Reference (Feb 1998)):

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1)

52.204-7 System for Award Management OCT 2016 52.204-13 System for Award Management Maintenance OCT 2016 52.204-9 Personal Identity Verification of Contractor Personnel JAN 2011 52.204-16 Commercial and Government Entity Code Reporting JUL 2016 52.209-2 Prohibition on Contracting with Inverted Domestic NOV 2015

Corporations – Representation 52.211-16 Variation in Quantity APR 1984 52.222-3 Convict Labor JUN 2003 52.222-21 Prohibition of Segregated Facilities APR 2015 52.222-26 Equal Opportunity SEPT 2016 52.223-18 Encouraging Contractor Policies to Ban Text Messaging AUG 2011

While Driving 52.232-18 Availability of Funds APR 1984 52.232-33 Payment by Electronic Funds Transfer – System of Award JUL 2013

Management 52.232-36 Payment by Third Party MAY 2014 52.233-3 Protest After Award AUG 1996

DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION

(HHSAR)(48 CFR Chapter 3) Clauses and Provisions

352.222-70 Contractor Cooperation in Equal Employment Opportunity DEC 2015

Investigations 352.223-70 Safety and Health DEC 2015 352.239-73 Electronic and Information Technology Accessibility Notice DEC 2015