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This is a combined synopsis/solicitation for commercial items prepared in accordance with (IAW) the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The Government reserves the right to make no award from this solicitation. Â
This is a request for quote (RFQ), and the solicitation number is 36C25023Q0355. The Government anticipates awarding a firm-fixed price Purchase Order resulting from this solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circulars 2023-01, effective 12/30/2022. The associated NAICS Code is 334510, Electromedical and Electrotherapeutic Apparatus Manufacturing. Â
The Department of Veterans Affairs, Network Contracting Office 10, is soliciting quotes from Laborie s Service Disabled Veteran Owned Small Business ( SDVOSB) Authorized Distributors to supply the Chalmers P. Wylie VA Ambulatory Care Center Laborie s Intelligent Cath-ID System for supporting patient safety, enhancing urodynamics quality and facilitating RFID traceability. This is a direct replacement for the existing unit that was damaged in a flood. Respondents to this solicitation must fully demonstrate their capability by supplying detailed quote information, along with any other documents necessary to support the requirements below. However, we believe only Laborie or Laborie s SDVOSB Authorized Distributors can supply the requested Aquarius CT System.
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Quotes are to be provided to Gina P. Crank, Contracting Officer, via email at gina.crank@va.gov, no later than February 27,  2023, by 5:00 PM EST. No telephone calls will be accepted. No submission received after the above-mentioned date and time will be accepted.Â
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STATEMENT OF WORK (SOW)

PROGRAM REQUESTOR/MANAGER).
Name:
Andrew Blanford
Section:
HTM (Healthcare Technology Management)
Address:
420 North James Rd, Columbus, OH 43219
Phone Number:
(614)388-7137
Fax Number:

E-Mail Address:
Andrew.Blanford@va.gov

2. Contract Title. Acquisition of the Laborie Urodynamics Aquarius CT system
3. Background. Chalmers P Wylie VAAMC needs the new Laborie urodynamics CT Aquarius system to provide the veterans, the best diagnostic care, all diagnostic high tech imaging equipment needs to be operating at peak performance, Laborie Urodynamics CT device provides clinical staff with clear images to accurately make diagnosis for veteran patients. The old Laborie urodynamics device was damaged by water during a pipe burst emergency. A service agreement is needed to ensure that equipment is fully functioning to meet patient clinical demands and integrated with the patient s chart in the new Cerner Oracle EHR.
4. Scope. Contractor shall provide personnel to complete the task of providing full-service maintenance to the Laborie Urodynamics CT and its associated parts located at the Department of Veterans Affairs Central Ohio Healthcare System, Columbus, Ohio.

5. Specific Tasks.

Provide all repairs, calibrations, and to these instruments and associated components.
Provide all parts and labor (and return shipping costs if needed) associated with the repair and/or calibration of these instruments as incurred during this contract.
Provide technical support and answer any questions regarding the HL7 interface, the software, devices, or connectivity components at the VA Central Ohio Healthcare System, Columbus, Ohio during the period of service.
Provide software and patch upgrades as they become available.
Check in Requirements:

The Field Service Engineer must report to the Healthcare Technology Management (HTM) Department of the Ambulatory Care Center to sign in with HTM staff before work begins. Submit any mobile media devices that would be used on the system for a virus scan. Upon completion of work, the Field Service Engineer must report to HTM to sign out and brief HTM Staff or Supervisor if HTM Staff is unavailable concerning completion of service. At the end of briefing Field Service Engineer will sign out in the HTM Department. HTM can be reached at 614-388-7273.

6. Performance Monitoring

Contractor shall provide Field Service Report and upon completion of work
7. Security Requirements
Service & Maintenance will follow the security requirements as per VA s Medical Device Protection Program (MDPP) which protects VA s medical devices through a comprehensive security initiative that encompasses pre-procurement assessments, medical device isolation architecture (MDIA), communication, validation, scanning, access control list remediation, patching, and secure remote connectivity.

General Security

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

Access to VA Information and VA Information Systems

A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use. At the close of each work period, government facilities, equipment, and materials shall be secured.

All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. A BI is not required per VA Information and Information System Security/Privacy Requirements for IT Contracts dated August 2008 if the following exception applies:

Contract Personnel with limited and intermittent access to equipment connected to facility networks on which limited VA sensitive information may reside, including medical equipment contractors who install, maintain, and repair networked medical equipment such as CT scanners, EKG systems, ICU monitoring, etc. In this case, Veterans Health Administration facilities must have a duly executed VA Business Associate Agreement (BAA) in place with the vendor in accordance with VHA Handbook 1600.1, Business Associates, to assure compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) in addition to the contract. Contract personnel, if on site, should be escorted by VA IT Staff.

VA Information Custodial Language

Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

9. Other Pertinent Information or Special Considerations. N/A

10. Risk Control
SECURITY INCIDENT INVESTIGATION

The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

To the extent known by the contractor/subcontractor, the contractor/subcontractor s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

LIQUIDATED DAMAGES FOR DATA BREACH

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.

Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:
Notification.
One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports.
Data breach analysis.
Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution.
One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and
Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

SYSTEM INTERCONNECTION

Any VA External Computer System interconnections between VA Systems on the VA Network and VA Business Partner Systems residing outside the VA Network if required will require a signed Memorandum of Understanding (MOU) and Interconnection Security Agreement (ISA) collectively known as MOU ISA between the VA and the VA Business Partner.

Place of Performance.

All work will be performed at the VA ACC, 420 N James Road, Columbus, Ohio 43219
The 11 Federal Holidays observed by the Federal Government are:
New Year s Day January 1
Martin Luther King s Birthday 3rd Monday in January
Presidents Day 3rd Monday in February
Memorial Day Last Monday in May
Juneteenth Day June 19
Independence Day July 4
Labor Day 1st Monday in September
Columbus Day 2nd Monday in October
Veterans Day November 11
Thanksgiving Day 4th Thursday in November
Christmas Day December 25th
The President of the United States of America may declare additional days as a Federal holiday, and if so, this holiday will automatically be added to the list above. When a holiday falls on a Sunday, the following Monday shall be observed as a Federal holiday. When a holiday falls on a Saturday, the preceding Friday shall be observed as a Federal Holiday.

ITEM INFORMATION
ITEM NUMBER
DESCRIPTION OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
0001

1.00
EA
$
$

UDS-1.AQUARIUS CT SYSTEM-TO INCLUDE FEATURES AND COMPONENTS LISTED ON QUOTE NUMBER BC010623CTV. ***REPLACEMENT FOR MX1796248***
LOCAL STOCK NUMBER: UDS-1

Funding/Req. Number: 1

757-23-2-096-0167


GRAND TOTAL
$
The following solicitation provisions apply to this acquisition:
FAR 52.212-1, INSTRUCTIONS TO OFFERORS COMMERCIAL ITEMS (JUNE 2020)
FAR 52.212-3, OFFERORS REPRESENTATIONS AND CERTIFICATIONS COMMERCIAL ITEMS (FEB 2021)
Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required.
The following contract clauses apply to this acquisition:
FAR 52.212-4, CONTRACT TERMS AND CONDITIONS COMMERCIAL ITEMS (OCT 2018)
ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS COMMERCIAL ITEMS
Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.
The following clauses are incorporated into 52.212-4 as an addendum to this contract:
FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)
FAR 52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE (JUL 2016)
FAR 52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS (DEC 2013)

VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020) 852.203-70, 852.232-72, 852,233-70, 852.233-71 852.246-71, 852.247-71, 852.270-1
VAAR 852.212-71 GRAY MARKET LANGUAGE (MAY 2016)

FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Jan 2021
The following subparagraphs of FAR 52.212-5 are applicable:
[52.203-6, 52.204-10, 52.209-6, 52.219-6, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-40, 52.222-50, 52.223-18, 52.225-1, 52.225-13, 52.232-18, 52.232-19, and 52.232-33.]
All quoters shall submit the following: A completed schedule with pricing, adequate documentation detailing the capabilities of the product.
All quotes shall be sent to the electronically via email to Gina P. Crank @ gina.crank@va.gov.
Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government.
The award will be made to the response most advantageous to the Government.
Responses should contain your best terms and conditions.
To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:
"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."
OR
"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"
Quoters shall list exception(s) and rationale for the exception(s), if any.
Quotes are to be provided to Gina P. Crank, Contracting Officer, via email at gina.crank@va.gov, no later than February 27, 2023, by 5:00 PM EST. No telephone calls will be accepted. No submission received after the above-mentioned date and time will be accepted.Â
Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).
Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below.
Point of Contact
Gina P. Crank
Contracting Officer
Network Contract Office (NCO) 10
Office: 614-625-1236
Email: gina.crank@va.gov

DEPARTMENT OF VETERANS AFFAIRS
Justification for Single Source Awards IAW FAR 13.106-1
For
Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C250-23-AP-1805

1. Contracting Activity: Network Contract Office (NCO) 10, 2780 Airport Drive, Suite 340, Columbus, OH 43219. Department of Veterans Affairs, VISN 10, Chalmers P. Wylie VA ACC, 420 North James Road, Columbus, Ohio, 43219 using 757-23-2-096-0167.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: Aquarius CT Urodynamic System to be used for urodynamic studies.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Laborie Medical Aquarius CT Urodynamic System equipment enables clinicians to do comprehensive testing with fewer cables and other physical impediments that constrain their patients when using traditional technologies. As an industry standard, the Laborie Medical equipment represents the most diverse and technically capable option for urodynamic studies such as: Free uroflowmetry; post-void residual volume; multichannel cytometry; urethral pressure profilometry; electromyography (EMG) measurement of electrical activity in the bladder neck and assessing the tightness along the length of the urethra. This is the only urodynamic equipment of this size to have enhanced video image integration options which are comparable to a full-size comprehensive diagnostic suite. This system provides full compatibility and integration with VISTA and Cerner EHRM, which is a necessity for our facility. The Aquarius CT System is a direct replacement for a unit which was damaged in a flood, causing a stoppage in patient care offered. Alternate product(s) would result in an additional delay, requiring additional supplies and training for staff.

4. Description of market research conducted and results or statement why it was not conducted: VIP search completed by Supreet Kaur concluded that OEM is the exclusive distributor for this product(s). Contracting Officer performed VIP search using NAICS 334510 resulted 180 SD/VOSBs. Adding keywords resulted 30 SDVOSBs and 4 VOSBs. However, the OEM has provided their 3 SDVOSBs that are authorized to distribute this requirement. This requirement will be competed amongst those SDVOSBs. As mentioned above, this is a direct replacement unit that was damaged in a flood. The VA Rule of Two is Attainable.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.
Gina P. Crank
Contracting Officer

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