DRAFT Statement of Need -Bio-Rad QC.docx

Statement of Need

A. General

The Abie Abraham VA Healthcare Center located at 353 North Duffy Rd, Butler, PA requires Quality Control results to validate whether an instrument is operating within pre-defined specifications and guidelines. When in range it this infers that the test results are reliable. Once the test system has been validated, patient results can be used for diagnosis, prognosis, or treatment planning. Validation occurs by comparing daily QC results to a laboratory- defined range of Quality Control values.

B. Objective

The contractor shall be responsible for providing the Quality Control Materials used to validate the laboratory instruments. The contractor will be responsible for monthly updates of materials shipped from the vendor and will be sent via e-mail to the Core Lab contact at the Abie Abraham HCC, Butler VA. All deliveries will be made to the dock area of the Abie Abraham HCC 353, North Duffy Road, Butler, PA 16001. The attached Materials list is an estimate of quantities of materials and may include more or none of the estimated quantity that is listed.

C. REQUIREMENT OVERVIEW

Quality Control materials will be ordered by the Laboratory Staff. Bio-Rad Specialty Immunoassay Quality Control Materials with the longest outdates, preferable a year outdated on the same lot number, will be shipped when the order is placed. The Quality Control Materials will be scheduled for shipment according to the needs of the Core Lab. Materials will be shipped within 3 business days of the order placement.

The Contractor will deliver all items to the loading dock of the Abie Abraham HCC located at 353 North Duffy Road, Butler, PA 16001. The five-year estimated Quality Control Materials that are required:

D. PERFORMANCE PERIOD

The period of performance (POP) shall be defined as follows:

1) Normal business hours are Monday through Friday from 7:00 am to 4:30 pm, excluding holidays and weekends.

Federal Holidays observed by Veterans Health Administration are: New Years' Day, Labor Day, Martin Luther King Day, Columbus Day, Presidents' Day, Veterans' Day, Memorial Day, Thanksgiving, Independence Day, Christmas Day, and Juneteenth.

2) All deliveries will be during normal business hours of coverage unless requested or approved by Government POC.

E. Privacy

1) The Contractor will not have access to protected Patient Health Information (PHI) nor will they have capability of accessing patient information. This is for commodities only.

F. Security

1) The contractor will not have access to VA Desktop computers. They will not have access to online resources belonging to the VA or the U.S. government.

G. Records Management

1) “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.2) Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3. Applied to records created, received, or maintained by Contractors pursuant to their VA contract

4. May include deliverables and documentation associated with deliverables

2) The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

3) The VA owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VA shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

4) Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

5) The Government Agency owns the rights to all data/records produced as part of this contract.

6) The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractors must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

7) Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

8) No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

H. Contact Information

Provided upon award.