EBMS Donor Sustainment Re-Compete RFI v5.pdf

EBMS Donor Sustainment RFI

Sources Sought Notice for Enterprise Blood Management System – Donor (EBMS-D)

The Defense Health Agency (DHA) is issuing this sources sought synopsis as a means of conducting market research to identify parties having an interest in and the resources to meet requirements for EBMS-D. Enterprise Blood Management System – Donor (EBMS-D) and its associated components (i.e. Analytics), an FDA-regulated Class II medical device. This includes the configuration, implementation, and maintenance activities required to deploy new versions of

WellSky™ Donor (future releases and/or upgrades of application software throughout the life of the sustainment contract) to include interfaces with other clinical systems (i.e. CHCS and other specified government interfaces). This also includes the maintenance and sustainment of the

HBSS on the EBMS production, training, and testing servers and the management of HBSS on all EBMS servers at Wilford Hall Ambulatory Surgical Center (WHASC) data center San

Antonio, TX, all COOP EBMS servers.

Enterprise Blood Management System (EBMS)

EBMS is a DoD Mission-Essential, Acquisition Category III Program consisting of two

Increments:

• Increment 1 – Enterprise Blood Management System – Donor (EBMS-D): Manages blood donation and donor deferral, as well as the laboratory and distribution modules, which manage the manufacturing and distribution of various blood products.

• Increment 2 – Enterprise Blood Management System – Transfusion (EBMS-T): Manages the receipt, inventory, and final disposition of blood products. EBMS-T also supports a lookback capability for managing blood products, a learning system for training/reference, and data analytics.

Both EBMS Increments are FDA 510(k) cleared Class II medical devices manufactured by

WellSky™ (previously known as Mediware). EBMS-D consists of the LifeTrak® Blood Donor

Management Commercial-Off-The-Shelf (COTS) product. EBMS-T consists of WellSky™

Transfusion (previously known as HCLL™) Blood Bank Management and Transfusion Services

COTS product.

Provide enterprise blood donor management system operations and sustainment by supporting the full spectrum of donor screening, registration functions, and all blood manufacturing functions to include but not limited to donor collection, component preparation, testing, labeling, shipping, reporting, and sharing appropriate information between individual centers across all centers and in standard formats to other MHS IT systems.

This support shall include installation and sustainment of all testing, training, and production environments, Donor Center installs, customer support, system, and infrastructure maintenance at MHS Enterprise Service Operations Center (MESOC), Aurora, test environments, and quality assurance. This support also includes change and configuration management of current and future versions of LifeTrak® to ensure production of safe, pure, and potent blood products.

This support also includes the configuration, implementation, and maintenance activities required to deploy new versions of LifeTrak® (future releases and/or upgrades of application software throughout the life of the sustainment contract) to include interfaces with other clinical systems (i.e. CHCS and other specified government interfaces). All components of the application software, including reports, are required to perform accurately and contain no defects on all versions. All supporting and third party software shall be tracked to ensure that all versions are current. Tracking of expiration dates, licenses, end of life notifications, and cybersecurity compliances are some of the attributes to be tracked, in addition to others that may be identified during the contract period.

In addition, the Contractor shall manage the Host Based Security System (HBSS) on the

Enterprise Blood Management System (EBMS) production, training, and testing servers located at three MHS sites (San Antonio, TX; Aurora, CO; Allegany Ballistics Laboratory (ABL), or an equivalent testing center). HBSS is a DoD COTS suite of software applications used within the

DoD to monitor, detect, and counter attacks against DoD computer networks and systems. The

EBMS servers (i.e. Automated Patient Backup Card (APBC), mobile server, etc.) will be managed using HBSS, Anti-Virus/Anti-malware, monitoring, and management administration software packages installed by the Contractor, EBMS, and HBSS administrators.

DHA reserves the right to contact the submitting parties for further clarifications. Any response submitted for this RFI constitutes consent for that submission to be reviewed by military personnel, Government civilians, and associated support contractors. No information will be disclosed outside DHA, and DHA will not provide feedback to any information submitted.

Submissions to this RFI are deemed to be DHA property which shall not be returned to sender.

The Government will not pay for any information received in response to this notice, nor will the

Government compensate a respondent for any costs incurred in developing the information provided. This RFI is only a market research effort to understand industry’s capability, and there is no solicitation at this time. The description of the requirement is not intended to be all-inclusive, and new information is welcome. Submission of any information in response to this

RFI is purely voluntary, and contact with anyone other than the contacts listed in this RFI is prohibited.

There is no solicitation at this time. This request for capability information does not constitute a

Request for Proposals (RFP). Submission of any information in response to this market survey is purely voluntary; the Government assumes no financial responsibility for any information or costs incurred. All costs associated with responding to this notice will be solely at the interested party’s expense. Not responding to this notice does not preclude participation in any future

RFP, if any is issued.

If your company has the potential capacity to perform these contract services, please provide the following information:

RFI questions:

How does your company maintenance and management of FDA 510(k) cleared Class

II Medical Devices, specifically Blood Establishment Computer Software and

Accessories? Please provide demonstrated experience and/or past contract information, if any.

What experience does your company have in working with DoD Cybersecurity directives and issues? Please provide your approach and/or methods for handling

DoD Cybersecurity Directives.

What recruitment capabilities does your company have to quickly employ/ fill positions with qualified candidates to respond to any changes in contract requirements?

Draft PWS-Submit any comments/questions regarding the draft PWS. Include the page number and paragraph of the draft PWS with each comment/question.

All responses must include the following information: 1) company name, address, email address, website address, telephone number, and size and type of ownership for the company;

and 2) tailored capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of organizational and staff capability.

It should demonstrate the Offeror's experience and expertise to provide the services identified above within the time frame required and without substantial duplication of cost to the

Government. It should include the name, number, and type of any contracting vehicles held. If significant subcontracting or teaming is anticipated in order to deliver technical capability, vendors should address the administrative and management structure of such arrangements. In addition, if a small business, indicate what portion of the work is within your capabilities.

Closing date for this RFI and for the submission of responses is 20 April 2020 AT 11:00 AM

(Local time San Antonio Texas).All responses should be submitted electronically using PDF or

MS Word.

*Total e-mail file limit size is restricted to 5MB. Files exceeding this threshold shall be submitted over multiple messages, and be identified as “Message #x of #x”.

Email shall send to:

karon.g.martin.civ@mail.mil

In accordance with FAR 10.001(b), potential sources are not to submit more than the minimum information necessary. In accordance with FAR 15.201, responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Any potential set-aside for this requirement will be based on the responses to this Sources Sought and additional market research. Maximum participation by small business, veteran-owned small business, service-disabled veteran-owned small business, HUBZone small business, small disadvantaged business, mailto:karon.g.martin.civ@mail.mil and women-owned small business concerns is encouraged. ANY CONTRACT THAT MIGHT

BE AWARDED BASED ON INFORMATION RECEIVED OR DERIVED FROM THIS

SOURCES SOUGHT WILL BE PART OF A COMPETITIVE PROCESS. At this time, the

DHA does not guarantee any future contracts; and, responses to this Sources Sought do not bind

DHA to any agreement with the responder, be it explicit or implied.

No Solicitation or Marketing Materials shall be submitted. Any response submitted for this Sources Sought constitutes consent for that submission to be reviewed by military personnel, Government civilians, and associated support contractors who are regulated.

No information will be disclosed outside DHA. DHA will not provide feedback to any information submitted. Submissions to this Sources Sought is deemed to be DHA property which shall not be returned to sender. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions.

The Government will not pay for any information received in response to this notice, nor will the

Government compensate a respondent for any costs incurred in developing the information provided. This Sources Sought is a market research effort to understand industry’s capability.

New information is welcome. The description of the requirement is not intended to be all-inclusive. There is no solicitation at this time. Submission of any information in response to this

Sources Sought is purely voluntary. Contact with anyone other than the contacts listed in this

Sources Sought is prohibited.