SOURCES SOUGHT NOTICE.pdf

Sources Sought Notice

*= Required Field Sources Sought Notice

SUBJECT* SOURCES SOUGHT FOR RALS MIDDLEWARE TO TRANSFER DATA FROM TESTING

INSTRUMENT TO VETERAN INFORMATION SYSTEM TECHNOLOGY ARCHITECT(VISTA)

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 66048

REQUIREMENT NUMBER* 36C255-24-AP-1178

RESPONSE DATE/TIME/ZONE 03-07-2023 11:00AM CENTRAL TIME, CHICAGO, USA

RECOVERY ACT FUNDS N

SET-ASIDE TBD

PRODUCT SERVICE CODE* 7H20

NAICS CODE* 513210

CONTRACTING OFFICE ADDRESS Department of Veterans Affairs

Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048

POINT OF CONTACT* Teresa Cabanting

PLACE OF PERFORMANCE

ADDRESS Kansas City VAMC Kansas City, MO

POSTAL CODE 64128

COUNTRY USA

ADDITIONAL INFORMATION

AGENCY CONTACT’S EMAIL ADDRESS teresa.cabanting@va.gov mailto:teresa.cabanting@va.gov

DESCRIPTION

THIS IS A SOURCES SOUGHT

DISCLAIMER

This Sources Sought is issued solely for information and planning purposes and does not constitute a solicitation. All information received in response to this Sources Sought that is marked as proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract.

Responders are solely responsible for all expenses associated with responding to this

Sources Sought.

The submission of pricing, capabilities for planning purposes, and other market information is highly encouraged and allowed under this Sources Sought in Accordance

With (IAW) FAR Part 15.201(e).

SOURCES SOUGHT DESCRIPTION

This is NOT a solicitation announcement. The purpose of this sources sought is to gain knowledge of potential qualified sources and their size classification relative to NAICS

513210. Responses to this Sources Sought will be used by the Government to make appropriate acquisition decisions and after review of the responses to this Sources

Sought, a solicitation announcement may be published. Responses to this Sources

Sought are not considered adequate responses for a solicitation announcement.

The information identified below is intended to be descriptive, not restrictive, and to indicate the quality of the supplies that will be satisfactory. It is the responsibility of the interested source to demonstrate to the Government that the interested parties can provide the supplies that fulfill the required specifications and/or the authority from the manufacturer to distribute the supplies.

If you are interested and are capable of providing the sought-out supplies, please provide the requested information indicated below in #1 thru 4. Response to this

Sources Sought should include company name, address, point of contact, EUI, and size of business pursuant to the following questions:

1. Is your company considered small under the NAICS code identified under this

Sources Sought?

2. Please provide your SAM.gov Unique Entity ID (UEI) number.

3. Does your company have a Federal Supply Schedule (FSS) contract with GSA, VA NAC, or any other Federal contract, that can be utilized to procure the requirement listed above? If so, please provide the contract number.

4. Does your company have an Authorized to Distribute letter from the manufacturer? If so, please provide a copy.

Please submit your capabilities that show clear, compelling, and convincing evidence that you can provide the requirement described in the following Statement of Work.

Responses to this notice shall be submitted via E-mail are due on or before March 7, 2024 by 11:00 a.m. Central and sent to Teresa Cabanting at teresa.cabanting@va.gov.

Send all questions to Teresa Cabanting at teresa.cabanting@va.gov. Telephone responses or questions shall not be accepted.

If a solicitation is issued it shall be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this Sources Sought. Responses to this Sources Sought notice are not a request to be added to a prospective offerors list or to receive a copy of the solicitation.

The Department of Veterans Affairs (VA), VISN 15 Network Contracting Office, is seeking sources that can provide the following:

Statement Of Work

SCOPE OF PROCUREMENT:

This is a new requirement to obtain the necessary software and hardware to provide

“Middleware” to transfer data from testing instruments to the Veteran Information

System Technology Acrchitect (VISTA). The desired point of care interface shall have the capability of performing transmission of results from point of care analyzers to

VISTA.

1.1. DEFINITIONS:

1.1.1. Business Associate Agreement (BAA)- A business associate is an entity, including an individual, company, or organization that, on behalf of

VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receives, uses, or discloses VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule.

1.1.2. Memorandum of Understanding (MOU) – An agreement used to document the terms and conditions of sharing data and information resources in secure manner. Supporting information in the MOU will define the purpose of the interconnection, identify relative authorities, specify the responsibilities of both organizations and define the terms of the agreement. The MOU provides details pertaining to apportionment of cost and timeline for terminating or reauthorizing the interconnections.

1.1.3. Interconnection Security Agreement (ISA) – An agreement that details how the interconnection is established or maintained. A system interconnection is a direct connection between two or more information technology (IT) systems for the purpose of sharing data, and other information resources. The VA uses the ISA to formally document the reasons, methodology, and approvals for interconnecting IT systems; to identify the basic components of an interconnection; to identify methods and levels of interconnectivity; and to discuss potential security risks associated with the interconnections.

1.2. GENERAL REQUIREMENTS

1.2.1. Operational and Technical Features-

1.2.1.1. A uni-directional or bi-directional, computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation and connection to the VA computerized hospital information system.

1.2.1.2. Interface must be able to support multiple barcode formats (Code

39, Code 128) that may be enabled concurrently.

1.2.1.3. Interface must accept, at a minimum, 10 alphanumeric characters in operator, patient, and reagent lot number identifier fields.

1.2.1.4. An instrument management system that provides/maintains the following:

1.2.1.4.1. Quality Control:

1.2.1.4.1.1. On-board QC data management system with minimum

storage capacity of 600 QC files and includes Levy-Jennings graphs.

1.2.1.4.1.2. Ability to store quality control values for second lot number during crossover studies. Ability to retain quality control data from both original and new lot numbers when performing cross-over studies.

1.2.1.4.1.3. Ability to retain quality control data from second lot number when put into use.

1.2.1.4.1.4. Ability to enter customized QC ranges for each method, including electronic/internal controls.

1.2.1.4.1.5. Automatic lockout from patient testing when quality controls fall outside ranges specified in data manager.

1.2.1.4.2. Maintenance:

1.2.1.4.2.1. Ability to monitor instrument performance including, but not limited to, errors, alerts, and download history.

1.2.1.4.2.2. Continuous monitoring of vital instrument functions with immediate operator notification of failure(s). A record(s) of the vital instrument function failure(s) must be maintained and stored electronically on-board the equipment.

1.2.1.4.2.3. Capability to capture, store and print the following information:

1.2.1.4.2.3.1. Instrument maintenance information.

1.2.1.4.2.3.2. Patient demographic information.

1.2.1.4.2.3.3. Specimen results.

1.2.1.4.3. Data Management System must have:

1.2.1.4.3.1. Ability to enter and document reagent data to include, but not limited to, lot number, level, expiration date, and acceptable ranges.

1.2.1.4.3.2. Ability to enter lot numbers manually and with barcode technology to add new reagents in use and track reagent stability throughout the testing process.

1.2.1.4.3.3. Ability to enter operator demographics, including name, unique ID, home institution (if shared server), home location within facility, and defined access to each facility download location.

1.2.1.4.3.4. Ability to enter custom dates for operator certification and competency, including initial, most recent, and expiration

(lockout) specifically for each method.

1.2.1.4.3.5. Ability to manage patient and quality control data, including exporting of results, building reports and workload summaries.

1.2.1.4.3.6. Ability to search quality control and patient data for each method using filters

1.2.1.4.3.7. Ability to define normal ranges and flag abnormal results.

1.2.1.4.3.8. Ability to configure bidirectional devices directly from data manager.

1.2.1.4.3.9. Ability to configure multiple levels of operator and password access

1.2.1.4.3.9.1. Ability to connect the following equipment to the VISTA computer system:

1.2.1.4.3.9.1.1. Clinitek Status +

1.2.1.4.3.9.1.2. Avoximeter 1000E

1.2.1.4.3.9.1.3. Gems 4000

1.2.1.4.3.9.1.4. Hemachron Signature Elite

1.2.1.4.3.9.1.5. Manual Test Entry option

1.2.1.4.3.9.2. Option to connect the following equipment to the

VISTA computer system:

1.2.1.4.3.9.2.1. Heparin Management System

1.2.1.4.3.9.2.2. i-STAT

1.2.1.4.3.9.2.3. Coaguchek XS plus

1.2.1.4.3.9.2.4. Inform II

1.2.1.4.3.9.2.5. Ability to access data from current interface system in a read only manner for a minimum of two

(2) years should the version of the software change substantially.

1.2.2. Value added

1.2.2.1. The following would be of added value to the award:

1.2.2.1.1. Option to test and renew operator competency when specified requirements are met. Preferred system will allow at least 2 criteria to be defined (i.e. quiz and QC) with automatic, defined renewal of competency upon completion of both items.

1.2.2.1.2. Ability to test user competency using electronic quizzes.

1.2.2.1.3. Technical assistance center shall be available by telephone 24 hours per day, 7 days per week with maximum call back response time of 1 hour.

1.2.3. Support Features-

1.2.3.1. Documentation:

1.2.3.1.1. A current editable electronic (Microsoft Word) copy of the instrument operating guide(s) and procedures shall be provided to each site.

1.2.3.1.2. The document(s) shall be formatted in accordance with current, approved CLSI guidelines.

1.2.3.2. Training. The Contractor shall provide training program that is coordinated with and timely to the installation, sufficient to the size and scope of the facility’s service. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair.

1.2.3.3. Upgrades - The Contractor shall provide upgrades to the software to maintain the integrity of the system and the state-of –the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system upgrades” that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the BPA;

however, it does refer to significant changes in the hardware.

1.2.4. Interface Requirements-

1.2.4.1.1. The Contractor shall provide all necessary software support for insuring that successful interfacing has been established, including interface development, remotely through an already existing VPN

Connection between vendor and the Customer’s network.

1.2.4.1.2. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. Information necessary to make the determination for type and amount of interfacing equipment is supplied in Attachment A.

1.2.4.1.3. If there are any software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system.

1.2.4.1.4. The Specimen Management system must be computer interface compatible with the current VA laboratory information system and existing universal interface. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

1.2.4.1.5. Contractor will supply a Project Manager to manage the overall implementation and organize the necessary resources to provide technical guidance and implementation of the interface.

1.2.4.1.6. Contractor will supply Interface Resource staff to support interface development and required integration testing.

1.2.4.1.7. Interface should currently be in use at a VA facility.

1.2.5. Implementation/transition timeframe - The implementation of the services/requirements on or no later than 7/1/2019.

1.2.5.1. Transition to include all services for installing/adding current equipment, training of personnel and any/all materials and supplies.

1.2.5.2. For additional equipment, contractor shall provide a quotation and implementation for adding new equipment along with any associated server specifications.

1.2.6. The Contractor will identify if removable media is required to perform their duties. The Clinical Engineering Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device/system. Any Contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility.

1.2.7. Contractor/subcontractor must not destroy information received, gathered / created from the VA, or by the Contractor while performing this requirement without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA

Records Control Schedules, and VA Handbook 6500.1, Electronic Media

Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met must be sent to the VA Contracting

Officer within 30 days of termination or completion of this requirement

1.2.8. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media

Sanitization upon: (i) completion or termination of the BPA or (ii) disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier. Media

(hard drives, optical disks, CDs, back-up tapes, etc.) used by the

Contractors/subcontractors that contain VA information must be retained by the VA for sanitization or destruction or the Contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements.

This must be completed within 30 days of termination or completion of the

BPA or disposal or return of the IT equipment, whichever is earlier.

1.2.9. Bio-Medical devices and other equipment or systems containing media

(hard drives, optical disks, etc.) with VA sensitive information must not be returned to the Contractor at the end of lease, for trade-in, or other purposes. The options are:

1.2.9.1. Contractor must accept the system without the drive;

1.2.9.2. VA’s initial medical device procurement includes a spare drive which must be installed in place of the original drive at time of turn-in; or

1.2.9.3. VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

1.2.10. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

1.2.10.1. The equipment Contractor must have an existing BAA if the device being traded in has protected health information stored on it and hard drive(s) from the system are being returned physically intact; and

1.2.10.2. Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or BPA.

1.2.10.3. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The Information Security

Officer (ISO) needs to maintain the documentation.

*EACH VENDOR WILL NEED TO PROVIDE AN APPROVED COPY OF THEIR;

• BUSINESS ASSOCIATE AGREEMENT (See Template in Section D)

• MEMORANDUM OF UNDERSTANDING(MOU)

IF NO BAA OR MOU HAS BEEN APPROVED, ONE WILL NEED TO BE

APPROVED PRIOR TO AWARD.

End of Statement of Work