PWS Freezerworks Software Support - RFI 36C26225Q1406.pdf

PERFORMANCE WORK STATEMENT

1. Background

Phoenix VA Healthcare System (PVAHSC) requires continued use of Freezerworks software within its Research Program for maintenance of numerous research projects.

This software manages a database of over 152,000 research samples from at least 20 research studies of at least 4 investigators at PVAHCS. More samples are added weekly.

Freezerworks can track the position of samples stored within PVAHCS. Currently it tracks over 152,000 samples located in -80 degree freezers and frozen cell stocks. This software is highly specialized for the purpose of tracking samples and has a complete audit trail that is compliant with 21 CFR part 11. It allows for individual user log in so the information than can be seen can be limited to those that should have access to certain studies.

Some samples in this database may contain HIPAA identifiers. The database is located on a VA server and access is limited to personnel with log in IDs and passwords specific for Freezerworks. These IDs are limited access to specific study samples and/or freezer locations to which they have access as a member of a study team in Research. The tissue bank coordinator has full access to the database and is fully compliant with all the required privacy training.

Continued use of this software is imperative due to prohibitive cost of transferring over 152,000 samples already loaded into the system, which was extensively time consuming and costly in use of manpower. Attempting to transfer the over 152,000 samples into a new systemcould result in data loss which would be catastrophic to active research projects.

Dataworks Development has worked with O&IT remotely and no vendor ever comes to the VA to work on any equipment.

2. Salient Characteristics

2.1. Freezerworks software support via phone, e-mail, or online remote Internet session.

2.2. Freezerworks software upgrade and maintenance releases at no additional charge.

2.3. Enrollment into any of the scheduled Freezerworks software webinar training sessions at no additional charge.

2.4. Assistance with bar code printer setup and connection to Freezerworks software.

2.5. Freezerworks database diagnostics.

2.6. Assessment for custom Freezerworks software features (does not include custom programming or modifications).

2.7. Freezerworks support services providing unlimited access to product support team.

3. Vendor Responsibilities

3.1. The Contractor shall treat all deliverables under the contract as property of the U.S.

Government for which the Government shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3.2. The 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 records.

3.3. 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 release by the Freedom of Information Act.

3.4. The Government Agency owns the rights to all data, records, supporting documentation (paper and electronic), produced as part of this contract.

3.5. The Contractor must deliver enough technical documentation with all data deliverables to permit the Agency to use the data.

3.6. The Contractor is required to obtain the Contracting Officer’s approval prior to engaging in any contractual relationship in support of this contract requiring the disclosure of information, documentary material, and/or records generated under or relating to this contract. The contractor is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

3.7. No disposition of documents shall 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 files 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.

3.8. At the conclusion of the contract, the vendor will not retain any of the data, it will be retained by the Phoenix VA Health Care System.

4. Security and HIPPA Compliance

4.1. The software has the capability to grant access to Patient data (PII or PHI). This is provided in the user’s profile which is set and controlled by our Research FreezerWorks administrator.

4.2. VA Research works in coordination with our local OIT that works with the vendor.

4.3. The vendor does not have direct access to the VA server that maintains the records. The Research FreezerWorks administrator coordinates and work through IT for any upgrades or patches.

4.4. In reference to Handbook 6500.6 Appendix A Checklist Block 6, the vendor does not have access to the VA’s Network. Therefore, the C&A requirements do not apply, and a Security Accreditation Package is not required.

4.5. In reference to Block 7, the information is captured, stored and produced on VA Servers. Therefore, the following from Appendices B and C apply:

4.6. Appendix B:

4.6.1. 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.

4.7. Appendix C:

4.7.1. VA maintains and updates the software behind the VA’s firewall and coordinates any updates with the Vendor. The vendor does not have access or expose to VA sensitive information.

4.7.2. If the contractor is required to be on site for more than two consecutive days, Privacy Training, TMS Course VA10203, is required and available at https://www.tms.va.gov/SecureAuth35/.

4.7.3. The contractor will provide all consumable supplies necessary for training and competency assessment of hospital staff. Proof of training will be provided to the COR upon request.

5. Delivery and Shipping Information

5.1. The contractor shall provide the following for shipment and delivery of equipment:

PVAHCS

Attention: Janet Fawcett at x5930 or Edyta (Edie) Domian at x6697 Research Service, Building 21, Room 116 J (RS/151) 650 E. Indian School Road Phoenix, AZ 85012-1892 Email: janet.fawcett@va.gov or edyta.domian@va.gov Phone: (602) 277-5551 ext.5930 or 6697 mailto:janet.fawcett@va.gov mailto:edyta.domian@va.gov

PERFORMANCE WORK STATEMENT