Statement of Work.pdf

STATEMENT OF WORK

Pharmacy IV Cleanroom Maintenance and Repair

West Texas VA Health Care System

EQUIPMENT IDENTIFICATION:

QleanAir USP 797/800 compliant pharmaceutical grade modular, adaptable IV cleanroom

GENERAL:

West Texas VA Health Care System has requirement for a vendor to provide maintenance and service to the QleanAir USP 797/800 cleanroom in existing VA space for VA staff pharmacy.

Provide biannual system performance audits, software updates as required and other service and maintenance as needed for the QleanAir USP 797/800 Cleanroom.

SCOPE OF WORK:

The scope of work shall generally consist of, but not necessarily be limited to, providing biannual audits, software updates as required and other service and maintenance as needed for QleanAir Cleanroom. Contractor will provide all necessary periodic maintenance required to maintain the clean room in operational status that meets USP 797/800 compliance requirements .

HOURS OF COVERAGE:

a. Normal hours of coverage are Monday through Friday from 8:00 am to 5 pm, excluding holidays. All service/repairs will be performed during normal hours of coverage unless requested or approved by COR or his designee. The Vendor shall follow all federal, state, Veterans Affairs and local code/regulations/standards.

b. Preventive maintenance will be performed as scheduled by COR or his designee

Preventive maintenance will be performed during normal hours of coverage.

NOTE: Hardware/software update/upgrade installations will be scheduled and performed during normal hours of coverage at no additional charge to the government.

c. Federal Holidays observed by the WTVAHCS are:

New Years' Day Labor Day

Martin Luther King Day Columbus Day

Presidents' Day Veterans' Day

Memorial Day Thanksgiving Day

Independence Day Christmas Day

When a holiday falls on a Sunday, the following Monday shall be observed as a legal holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a legal holiday by U.S. Government agencies. Also included, would be any other day specifically declared by the President of the United States of America to be a National Holiday.

CONTRACTOR QUALIFICATIONS/REQUIREMENTS:

a. The contractor’s field personnel shall have training on fundamental practices and precautions within USP 797 and operation of ISO 5 clean rooms. (e.g. gowning, gloving, and hand washing procedures)

b. The contractor shall have the capacity to test the clean room HEPA filters at the air handler via large smoke injection machine in addition to hand held wand for filter bypass testing.

c. The contractor must maintain a file sharing website / web-based application that will maintain test results and reports for at least 8 months for the government to access and download.

d. The contractor shall ensure a certification certificate is presented to the VA demonstrating compliance with respect to the requirements of USP 797 and or USP 800.

The Certifying individual must be a Registered Certification Professional for Sterile

Compounding Facilities as defined by CETA CAG standards. The Certificate will show the test date and the expiration date and be signed by a licensed certifying agency.

SECURITY REQUIRMENTS

a. Information System Officer, Information Protection: The contractor will not have access to VA Desktop computers.

b. Privacy Officer: During the services provided to the VA, if removal of equipment from the

VA is required, any memory storage device will remain in VA control and will not be removed from VA custody. All research data available for Contractor analysis is de -identified. The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. Consistent with the requirements of 38 U.S.C. 5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. However, it is the policy of VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency.

c. Training: Per VA Handbook 6500.6, Contract Security Appendix C, All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security

Training Requirements.]

(5) The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

(6) Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

1. Records Manager.

a. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

b. 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.

c. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

d. 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 by the Freedom of Information Act.

e. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

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

g. 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. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

h. 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.].

i. 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.

j. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by

Government and Agency guidance for protecting sensitive and proprietary information.

Record Retention & Storage:

(1) Federal Records related to this policy, regardless of medium, shall be created, maintained, and dispositioned in accordance with the VHA Records Control Schedule (RCS) 10-1, General Records Schedule (GRS) or other NARA-approved records schedule, if applicable.

(2) Federal Records shall be stored per the National Archives & Records Administration (NARA) Facility Standards for Records Storage, as described in 36 Code of Federal Regulations (CFR) 1234