36C25719Q1357-002.pdf

Statement of Work

Liquid Nitrogen Purchase and Tank Rental STVHCS Blood Bank

SCOPE:

This is a request for the rental of liquid nitrogen cylinder tanks and as needed replacement of liquid Nitrogen that will be utilized in the Blood Bank Department of Pathology and Laboratory Department of South Texas Veterans Healthcare System (STVHCS), San Antonio, Texas. The proposed vendor will provide Medical Grade Liquid Nitrogen tanks that are used for the preservation of Stem cells that are needed for treatment of our patients on Chemotherapy and who are otherwise in a life and death situation without this treatment. The requirement contract would be for a base period and four option periods. The below listed items are required and specific, no substitutions can be made as this process is delicate in nature and any deviation in any form could make these cells inviable.

Delivery Detail:

Tanks(s) will be filled to maximum functional capacity. At the time of each delivery, contractor must provide a legible signed and dated written document that identifies the number of cylinders at the facility prior to delivery, the number of cylinders being delivered, the number of cylinders being picked-up, and the number of cylinders at the facility after the delivery has been made.

This document must be counter-signed by the facility representative supervising the delivery.

This applies to all deliveries regardless of time or day of execution.

Rental of cylinder tanks NI NF230LT22, and Tank Replacement used in Stem Cell Program:

• Six (6) tanks (NI NF230LT22)

• Liquid Nitrogen replacement of tanks occurs on Monday, Wednesday, Friday, three (2) tanks each time, 230 Liters each tank.

GOVERNMENT OWNED PROPERTY:

Government owned medical gas tank(s) and appurtenances will be maintained by and at the expense of the Contractor in a manner that will insure compliance with applicable regulations, and standards. Individual Agency Ownership of Cylinders: Government-Owned cylinders shall remain the property of the individual ordering (owning) facility and shall not be exchanged for other cylinders, either government-owned or contractor-owned, without authorization of the ordering agency.

CONTRACTOR FURNISHED EQUIPMENT:

For those facilities having contractor owned tanks, the contractor shall provide, install and maintain tank(s) with appropriate back-up system(s), if applicable, with approval from the COR.

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, and standards.

All equipment and materials required to perform on the contract shall be provided by the contractor. Contractor owned equipment shall be installed, inspected and maintained by the contractor at the Contractor s expense (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, and standards. The contractor shall be provided by each requiring facility reasonable access to the facilities for this purpose.

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. 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 to avoid interruption of gas supply.

Each Government facility that requires installation of contractor owned equipment shall provide suitable location and foundation for the installation of the contractor owned tank(s) in accordance with CGMP Standards. 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.

Transition Period/Installation of Contractor-Furnished Equipment:

To permit orderly transition from one contractor to another, the contractor shall continue to honor the contract s monthly equipment rental fee and gas contract price for a maximum of ninety days beyond the scheduled expiration of this contract, to include the base year and any option year. 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.

Phase In:

The incoming contractor shall replace all appropriate VA authorized (incumbent contractor-owned) equipment presently located at each facility with the incoming contractor beginning from the date of contract award. Incoming contractor shall coordinate with the incumbent contractor during the transition period relating to the removal of the incumbent contractor s equipment from each facility. The change shall include delivery, setup, and instruction as further specified herein, and shall be accomplished without disruption in supplies and services. The billing period shall begin on the noted transition date. Payments shall be assessed based on the providers established rate and prorated from setup date. Prorated monthly rates are based on a 30-day month.

Phase Out:

The contractor realizes that the services being provided under this contract are vital and must be continued uninterrupted. The outgoing contractor shall not remove any equipment from the facility until replacement equipment has been installed. The outgoing contractor shall coordinate transition of equipment / services with the incoming contractor as soon as possible, but not to exceed ninety (90) days from date of contract expiration. If additional transition time is required beyond contract expiration, a separate Purchase Order shall be issued to the contractor for payment of services on a pro-rated basis. Prorated monthly rates are based on a 30-day month.

During transition both Phase In and Phase Out, from one contractor to another, the contractor must reconcile in conjunction with the Government and the incoming Contractor, in writing, the accuracy of the cylinder count for each type of gases listed in this requirement, at each participating facility.

MEDICAL GAS SPECIFICATION AND REQUIREMENTS:

All medical gases 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.). Contractor 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. All products, equipment and services provided under this contract shall be in compliance with all applicable Federal, State and Local regulations.

A valid certificate of analysis shall be provided with each delivery of medical gases. The certificate shall include, at a minimum:

a) Supplier s name and complete address

b) Name of the Product

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%, 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.

In addition, the following specifications are incorporated into the contract:

a) Federal Specification BB-A-1034B Compressed Air, Breathing, dated 12-20-1985 and amended on 12-27-1995. http://everyspec.com/FED_SPECS/B/BB-A-1034B_9157/

b) Federal Specification BB-C-101C Carbon Dioxide (CO2) Technical and USP, dated 01-21- 2004. http://everyspec.com/FED_SPECS/B/download.php spec=BB-C-101C.009836.pdf

c) Compressed Gas Association (CGA) Publication G-7 Compressed Air for Human Respiration, dated 08-04-2003 and ANSI/CGA G-7.1 Commodity Specification for Air, dated 08-27-2004.

http://www.cganet.com.

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

A copy of all inspection reports shall be provided to the facility COR upon the completion of any contractor or government owned system inspections that are required by regulation.

http://everyspec.com/FED_SPECS/B/BB-A-1034B_9157/ http://everyspec.com/FED_SPECS/B/download.php http://www.cganet.com/

All Contractor owned equipment shall be maintained or repaired in accordance with FDA’s Current Good Manufacturing Practices (CGMP) Regulations.

ORDERING:

The Facility POC(s) will submit requests for delivery of medical gases and rental cylinders to the Contractor, no later than 05:00 PM CST for delivery within 24 hours, including weekends for emergency orders, via email or phone to the Contractor POCs to be provided at award. Vendor must notify the facility of the planned delivery, scheduled within the 24-hour window, including the date and time. After contract award, the Facility POCs and the Contractor may agree upon a defined delivery schedule, as required.

The contract shall provide a customer service POC to the CO, COR, and the Facility POC(s) no later than 10 business days after contract award and updated within 10 business days throughout the life of this contract if there are personnel changes.

At a minimum, the contractor will provide the following information:

1. Company Name

2. Address

3. Phone Number

4. Fax Number

5. contact Name

6. Email

DELIVERY REQUIREMENTS:

The contractor shall deliver to the facility, the medical gases identified in Section 1 Scope of this Statement of Work, in the frequency identified in that section. The Facility POC(s) (Point of contacts) will contact the Contractor to request refills of all medical gases supplied under this contract, as identified in Section 1 Scope, on an as needed basis, except those identified as a weekly requirement. Tanks(s) will be filled to maximum functional capacity at each refilling procedure unless otherwise specified in the facility requirements or as agreed upon in a written document signed and dated by the Facility POC.

The Facility POC(s) is responsible for communicating local issues, such as ordering and delivery instructions, within the terms and conditions of the signed contract. The terms and conditions outlined by this contract cannot be changed without signed modification by the Contracting Officer. Prior to first filling, and annually thereafter, the contractor must verify, in writing, the accuracy of all gauges on contractor owned tanks. On a quarterly basis, the Contractor shall take an inventory of actual cylinders, on-site at the facilities, to verify the accuracy of inventory counts.

The Contractor will provide 24/7 emergency contact name(s) and telephone number(s).

All Medical Gas deliveries shall be made in an enclosed or boxed truck. 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.

In accordance with VHA Patient Safety Alert dated April 5, 2004, all deliveries must be monitored by a qualified and trained technical representative that will be designated by each facility. Contractor will be provided with names and contact information of primary and back-up facility representatives (Facility POCs). This applies to all deliveries regardless of time or day of execution.

Upon delivery, the delivery driver and facility POC will conduct a cylinder count. Cylinders will be logged in on the Delivery Ticket with the delivery date and driver ID specified. The cylinder delivery will be signed for by both the facility POC and delivery driver. This information will the given to the COR.

Pickup of empty cylinders, the delivery driver and facility POC will conduct an empty cylinder count. Cylinders picked up will be adjusted on the Delivery Ticket with the pickup date and driver ID specified. The cylinder pick up will be signed for by both the facility POC and delivery driver. This information will be given to the COR.

The delivery time shall be Monday Friday between the hours of 8:00am 4:00pm Local Standard Time, excluding Federal Holidays. Delivery shall be within 24 hours after receipt of order. For delivery requests placed on Fridays, the delivery day shall be the following Monday. All transportation charges for cylinders shall be included in the price of the medical gas. Additional charges such as delivery fees, hazardous materials fees, fuel surcharges, shall NOT be billed to, or collected from, the facilities for orders received under this contract.

Emergency delivery will be provided within 24 hours after receipt of Government notification.

Contractor must respond to the facility by either telephone or email within one hour to confirm receipt of emergency notification to ascertain the nature of the emergency. Emergency status is determined by the Government when conditions warrant, such as an actuated imminent alarm condition, or system leak. Failure of the contractor to remain current with agreed delivery schedule and requirements does not constitute an emergency for purposes of charging an emergency delivery fee.

INVOICING:

The Contractor shall submit one invoice, monthly, for incurred charges related to medical gas refill and cylinder tank rental fees. The amount charged for cylinder tank rental shall be for the quantity and types of cylinders in facility inventory, as of the last day of the month. The facility shall not be invoiced for tanks for which the facility has requested removal. Medical gas shall be invoiced on the basis of volume for tanks delivered during the invoicing period (one month).

NON-REPAIRABLE GOVERNMENT PROPERTY:

Prior to disposing of non-repairable government-owned cylinders, parts, fittings, and appurtenances, the contractor shall contact the ordering (owning) activity. Contractor shall make disposition in accordance with the ordering activities instructions.

Contractor shall be paid for all services performed and authorized by the ordering activity in accordance with the price schedule. Contractor shall not charge any additional types of fees for the return of non-repairable cylinders to the ordering activity.

CYLINDERS AND OTHER CONTAINERS:

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, for medical gases shall also comply with the Federal Food, Drug, and Cosmetics Act, and the Food, Drug Administration.

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 January 01, 2014. https://www.cganet.com/ 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. https://www.cganet.com/

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 cryoband applied at the top of the container with the drug product name repeated around the entire container. https://www.cganet.com/

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. Contractor will be required to retest any Government-owned cylinder when requested by ordering activity, regardless of scheduled retest date.

NOTE: GOV Cylinders have both a 5 Year and a 10 Year Hydrostatic Testing required.

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) 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.

Hydrostatic testing shall be performed in accordance with CGA s Publication C-q, Methods For Hydrostatic Testing of Compressed Gas Cylinders, dated September 7, 2004.

https://www.cganet.com/

Visual inspection shall be performed in accordance with the applicable CGA publications C-6 Standards for Visual Inspection of Steel Compressed Gas Cylinders, dated August 16, 2005 or C-https://www.cganet.com/ https://www.cganet.com/ https://www.cganet.com/

6.1 Standards for Visual Inspection of High-Pressure Aluminum Compressed Gas Cylinders, dated July 30, 2002. https://www.cganet.com/

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:

E-Sized oxygen cylinder fixed regulator system requirements: Aluminum construction, easy-to-carry handle, minimum flow of 15 LPM, flow rates ranging from 0.25 LPM minimum to 25 LPM, a DISS 50 PSI fitting for transport ventilator hook-up, MRI compatibility and easy to read contents gauge.

The contractor must submit a list, quarterly, of lost or damaged cylinders to include replacement costs for any and all individual cylinders lost or damaged while in the government facility s custody. Loss of usage must not commence prior to 60 days of notification of any such loss or damage.

For each contractor-owned cylinder lost or damaged beyond repair while in the Government s possession, the Government shall pay to the Contractor a pre-negotiated fee. These cylinders shall become Government property. If the lost cylinders are found and returned to the Contractor after the Government has paid the Contractor the lost fee, the Contractor shall credit the Government the lost fee.

Method of Shipment: Empty Government-owned cylinders that are picked up from an ordering facility for re-fill or service shall be transported according to the Department of Transportation Regulations, using normal commercial practice to prevent damage to cylinders.

PRICE OF SERVICES FOR GOVERNMENT-OWNED AND CONTRACTOR-OWNED

CYLINDERS:

Services included in the Price of Gas (Both Government and 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 filling of a cylinder to comply with applicable regulations, and specifications. Such services shall include, but not be limited to: tags indicating cylinder as Full, In Use, or Empty; inspection, testing, evaluation, required at each 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 this paragraph, the contractor is responsible for all maintenance and testing of contractor-owned cylinders. Contractor will ensure all tanks are clean free from dirt/rust, i.e. acceptable use both inpatient/outpatient Health Care Environment. It is the respective using facilities responsibility to tag Contractor owned Cylinders by the internal VA user; i.e. cylinders charged against the balances of user entities must be tagged Laboratory to ensure proper inventory control and annotation on daily Delivery Orders to ensure VA entities maintain accountability between separate VA user Accounts.

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. https://www.cganet.com/

MONTHLY RENTAL OF CONTRACTOR-OWNED CYLINDERS AND LIQUID

CONTAINERS:

When gases are ordered in cylinders or liquid containers owned by the contractor, monthly rental rates shall apply to those cylinders or containers in the possession of the using activity on the specific day of the month (e.g. 15th, 25th, last day,).

Cylinders picked up by the contractor s truck: Ordering activities shall notify the contractor of the number and type of empty cylinders ready for return. No rental charges shall be applied to any cylinder five business days (Saturdays, Sundays, and Holidays excluded) after the ordering activity has notified the contractor. The day the contractor is notified is excluded from the five-day period. If the contractor is verbally notified of empty cylinders, the ordering activity will document the notification by making a record of the date, time, and contractor s representative contacted.

Cylinders returned by common carrier: Ordering activities returning empty contractor-owned cylinders will immediately notify the contractor in writing of the quantity and size of cylinders and the date they were turned over to the carrier. Rental charges shall not be applied after the date cylinders are picked up by the common carrier.

DELIVERY TICKET:

Each delivery should contain include a delivery ticket covering the following: Contract Number, purchase order number, delivery order number, date of order, date delivered, item number and/or product identification number, the number of cylinders at the facility prior to delivery, the number of cylinders being delivered, the number of cylinders being picked-up, and the number of cylinders at the facility after the delivery has been made.

CONDUCT OF PERSONNEL:

Contractor employees shall conduct their selves in a manner socially acceptable. Loudness, vulgarity, rudeness, or other similar offensive conduct by an employee of the Contractor will be grounds for denying the employee further access to the VA premises. The Contractors employee(s) shall always wear visible identification while on the premises of the VA medical facility, Warehouse, CBOC, etc.

REVIEWS:

COR or Facility POC(s) will conduct a quarterly inventory to reconcile the number of cylinders on hand to the number of cylinders held on the delivery ticket. A report of the inventory will be provided to the COR, CO.

Government Inherent Functions: Contractor shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees, selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy.

General Duties, Requirements, and Expectations:

1. Be professionally competent to handle required duties.

2. Work with staff to ensure safety measures are in place and documented.

3. Services provided under the terms of this contract are required to be in compliance with the American Association of Blood Banks (AABB) and College of American Pathologists (CAP) accreditation policies and all applicable Federal, State and Government laws required by the Veteran’s Healthcare System.

Information Systems Officer, Information Protection: The contractor will not have access to VA Desktop computers nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.

Privacy Officer: The contractor will not have access to Patient Health Information (PHI) nor will they have the capability of accessing patient information during the services provided to the

VA.

Records Manager: There will be no federal records created, maintained, used or dispositioned with this contract; regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.].