VISN 23 Electroporesis Lab Tests SOW.docx

VA Midwest Healthcare Network - VISN 23 Statement of Work Protein Electrophoresis Analyzer

DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

SCOPE OF PROCUREMENT:

1) BASIC REQUIREMENT:

It is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VISN 23) to establish a five-year “cost per test” or “reagent rental” agreement supporting capillary ion electrophoresis testing of serum and urine.

VISN 23 is requesting an all-inclusive system which can analyze serum and urine samples by capillary ion electrophoresis. The cost per test or reagent rental is to include reagents, controls, calibrators, consumables, analyzers (capillary ion electrophoresis), installation, validation, interfacing, training, technical support, preventative maintenance, service (including parts, labor, and travel), UPS, computer, printer, monitor and all shipping costs during the term of the agreement. Contractor agrees to the following terms of the CPT or reagent rental agreement exclusively with the VISN 23 facilities listed below and awarded in the final agreement. However, as requirements change, facilities within VISN 23 may be added or deleted by supplemental agreement of the Government and the Contractor. Additional tests/reagents/instrumentation may be added to the agreement by modification as new technology becomes available on the market.

Participating Facilities:

· VA Medical Center, Iowa City, IA

· VA Nebraska-Western Iowa Health Care System, Omaha, NE The testing system must be able to perform the required testing as described below and meet the performance characteristics as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). Instrument and testing methods must be FDA approved. The only system that meets our requirements and has FDA approval of our test menu is the Sebia Capillary’s 3 Octa. These can be purchased directly through the manufacturer, Sebia. There are no authorized distributors. Therefore, this will be a sole source procurement.

Test Menu:

Schedule of Items

6) COST PER TEST / REAGENT RENTAL:

New analyzers shall be provided under this analyzer lease contract agreement, Capillary’s 3 Octa. All new equipment shall be shipped within 30 days of receipt of award. The cost per test or reagent rental is to include reagents, controls, calibrators, consumables, analyzers (capillary ion electrophoresis), installation, validation, interfacing, training, technical support, preventative maintenance, service (including parts, labor, and travel), UPS, computer, printer, monitor and all shipping costs during the term of the agreement. Contractor shall retain ownership of the analyzers. Upon termination of the contract, the Biomedical department will remove the hard drive and terminate it according to policies and procedures. The analyzers will be the contractor’s responsibility to dismantle, decontaminate, and remove from premises within 60 days after expiration of contract. All costs for removal and return to contractor shall be borne by the contractor. Due to space constraints, analyzers will require moving, once. They will be in a temporary location for validation and need to be moved to a permanent location when they are put into production. Vendor will be responsible for moving analyzers for this one time move, at no cost to the Government.

7) ANALYZER MAINTENANCE:

Contractor agrees to maintain the analyzers in good working condition and will repair or replace any defects during the contract period (including parts, labor, and travel).

All new equipment shall be shipped within 30 days of receipt of award. Consumables shall arrive within five calendar days after receipt of an order. The vendor will schedule with the VISN 23 Laboratories for installation of equipment and training of key equipment operators, which shall be scheduled as soon as possible after receipt of equipment at VISN 23 Laboratories. Consumable orders will be placed by authorized VISN 23 laboratory personnel on an on-demand, as needed basis.

The contractor shall provide the following information to expedite orders:

Preferred method of ordering:

Telephone number:

Fax number:

Email address:

Point of contact name, email address, and phone number:

9) DELIVERIES:

All consumables shall be delivered FOB Destination to specified VISN 23 Laboratory and shall arrive within 5 calendar days after receipt of an order. All deliveries shall be accompanied by a delivery ticket or packing slip which shall contain: the vendors name, purchase order number, date of order, date of delivery, and an itemized list of products furnished including product description, stock number, and quantity shipped. Failure to produce this will cause there to be nonpayment for shipped items.

Iowa City, IA 52246 2208

VA Nebraska-Western Iowa HCS 4101 Woolworth Ave Omaha, Neb. 68105

Delivery times: Between 8:00 am and 3:30pm Monday-Friday, except Federal Holidays

10) PRODUCT QUALITY AND QUALITY CONTROL:

All products offered to the VISN 23 Laboratories must be of the same consistent high quality as would be offered to the general commercial public in the United States. VISN 23 Laboratories will not be financially liable for unacceptable materials (such as damaged goods). No product substitutions will be accepted without prior written approval by the VA Contracting Officer. All defective or inferior products must be replaced within 48 hours at no cost to the VISN 23 Laboratories.

The Contractor will immediately notify the VISN 23 Laboratories of any recalls of product or other important safety issues. As appropriate, the Contractor will replace and/or reimburse recalled/defective products at no cost to the government. The Contractor may be liable for costs of processing recalls, i.e., administrative, and clinical services to replace recalled/defective products.

11) ROTATION OF STOCK:

To assure rotation of stock at the distributor, each lot of a product received must have an out date the same or later than the lot previously received. Only one lot of any item may be shipped per delivery, unless part is the “old” lot previously received and part is the “new” lot which will be shipped the next delivery.

12) HAZARDOUS MATERIALS:

Upon award, the contractor shall provide VISN 23 Laboratories with a listing of the vendor’s products used with the analyzers that are considered hazardous. The listing should also include a determination as to what can be considered harmless to be disposed of by normal methods, such as disposing in the sink or disposing in the trash, and what must be specially handled for disposal and how it is handled. The contractor is required to provide a list identifying any "hazardous materials" that may be provided as a part of this contract that are defined as hazardous under the latest version of Federal Standard No. 313. SDS shall be available when requested by the VISN 23 Laboratories.

13) SECURITY:

A. Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

B. Vendor must ensure their use of this technology/standard is consistent with VA policies and standards, including, but not limited to, VA Handbooks 6102 and 6500; VA Directives 6004, 6512, 6513, and 6517; and National Institute of Standards and Technology (NIST) standards, including Federal Information Processing Standards (FIPS). Users must ensure sensitive data is properly protected in compliance with all VA regulations.