36C25018Q9290-000.docx

FedBizOpps Combined Synopsis/Solicitation Notice

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* = Required Field FedBizOpps Combined Synopsis/Solicitation Notice Rev. March 2010

AQUARIUS CT

43219-1834 36C25018Q9290 06-22-2018 N 334510 Department of Veterans Affairs 2780 Airport Dr., Suite 340 Columbus OH 43219-1834 Percy Johnson percy.johnson2@va.gov 614 257 5534 Department of Veterans Affairs Chalmers P. Wylie Ambulatory Care Center 420 North James Rd Columbus, OH 43219

USA

www.va.gov Department of V.A.

percy.johnson2@va.gov Contracting Officer This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is 36C25018Q9290 and is issued as a request for quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-98. The associated NAICS code is 334510, ELECTROMEDICAL AND ELECTROTHERAPEUTIC APPARATUS MANUFACTURING. The Small Business Standard is 1,250 employees. This is a total Service Disabled Veteran Owned Small Business set-aside. The requirement is for acquisition of the Aquarius CT Urodynamic System, to be delivered to the Chalmers P. Wylie Ambulatory Care Center, 420 N. James Rd, Columbus OH 43219 and shall be FOB Destination.

PAPER COPIES OF THIS SOLICITATION WILL NOT BE AVAILABLE. This solicitation documents and incorporates provisions and clauses in effect through FAC 2005-98. It is the responsibility of the contractor to be familiar with the applicable clauses and provisions. The clauses may be accessed in full text at these addresses: https://www.acquisition.gov/Far/. The selected Offeror shall comply with the following commercial item terms and conditions, which are incorporated herein by reference: FAR 52.212-1, Instructions to Offerors -Commercial Items, FAR 52.212-3, Offeror Representations and Certifications-Commercial Items - the selected offeror shall submit a completed copy of the listed representations and certifications or confirm that the annual representations and certifications was completed electronically via the SAM website accessed through http://www.acquisition.gov;

FAR 52.212-4, Contract Terms and Conditions-Commercial Items;52.232-40

FAR 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items, paragraph (a) and the following clauses in paragraph (b): 52.203-6, 52.204-10, 52.209-6, 52.211-6, 52.219-6, 52.219-8, 52.219-14, 52.219-28, 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, and

52.232-33. The full text of the referenced FAR clauses may be accessed electronically at https://www.acquisition.gov/far/.

The following VAAR Clauses apply

852.203-70 Commercial Advertising

852.211-70 Service Data Manuals 852.219-10 VA Notice of Total Service Disabled Veteran Owned Small Business Set-Aside

852.232-72 Electronic submission of payment requests

852.246-70 Guarantee (at least one year)

852.246-71 Inspection

The Following VAAR Provisions apply

852.211-72 Technical Industry Standards

Quotes are to be emailed Percy Johnson at percy.johnson2@va.gov, no later than 22 June 2018 1:00 p.m. EST

ITEM INFORMATION

Aquarius CT Urodynamics System 1 AQS2000-S Aquarius CT Urodynamic Analyzer System 1 TRA1002 Urocap V 1 COM450 Computer, Industrial PC 1 MON185 Monitor, Flat Panel, 19" LCD, Wide (NEC) 1 PER225 Periph

Funding/Req. Number: 1

757-18-3-096-0217

SOFTWARE 1 LAB1001 LABORIE Software, NGM Urodynamics Software Package, CT Software 1 LIS224 i-List, Office Reporter, English, Windows XP/ Windows 7 1 CDR120 CD/ DVD, LABORIE Software System, Customize

Funding/Req. Number: 1

757-18-3-096-0217

ROAM 2 RMX100 ROAM DX

Funding/Req. Number: 1

757-18-3-096-0217

EMG 1 FEA262 High Fidelity EMG 1 FEA263 Features, EMG, 2nd Channel ROAM 1 1 CAB1032 NGM_EMG Non-Shielded w/ 5pin Lemon, 9 in. 1 ELE350 Electrode, Lead, EMG, Set of 2 Red, 1 Green- Non-Shielded 1 CAB1

Funding/Req. Number: 1

757-18-3-096-0217

TDPC AIR CHARGED INTERFACE Roam 1 1 MSM1017 Mechanical Assembly Sensor Holder- Clip 1 TRA615 Transducer, TDOC Cable- P(ves) UDS Roam, 8 in. 1 TRA616 Transducer, TDOC Cable- P(Abd) UDS Roam, 8 in. 1

Funding/Req. Number: 1

757-18-3-096-0217

COMMODE CHAIR AND FUNNEL 1 CHA102 Funnel, Washable 1 CHA181 Folding Commode Chair

Funding/Req. Number: 1

757-18-3-096-0217

PRINTER CAB1056 USB printer cable 1 PRI110 Printer, all in one, HP Envy 4520 1 POW1016 Power Cord, 1 Ft., C7 Power Cable, 2 Prong Plug 1 CAB465 Cable, Power Supply Connector Converter to Plug into LI

Funding/Req. Number: 1

757-18-3-096-0217

SENSORY ARRAY ACCESSORIES 2 MSM1069 DUMMY INFUSION HOOK

Funding/Req. Number: 1

757-18-3-096-0217

UROSTYM - PELVIC FLOOR REHAB 1 PER500 Peripherals, Serial Adapter 1 PRO180 Urostomy Unit 1 CAB347 RS232 Extension Cable 1 MAN483 Urostym Quick Start Guide 1 MAN095 Manuals, Password Quick Start Guide, Funding/Req. Number: 1

757-18-3-096-0217

UROSTYM SOFTWARE 1 LAB596 UROSTYM Biofeedback Software - Basic Package 1 LIS224 i-LIST, Reporter, English 1 SOF006 Nitro PDF 1 FEA271 Features, Games 1 FEA350 Features, Notification 1 FEA450 Features

Funding/Req. Number: 1

757-18-3-096-0217

COMPUTER 1 COM532 Laptop Computer 4 HAR010 Hardware, Velcro Strap 1 POW320 Power Cord

Funding/Req. Number: 1

757-18-3-096-0217

MANOMETRY/PRESSURE BIOFEEDBACK 1 TRA168 Transducer, Medex MX960 Pressure Transducer Adapter Cable 1 FEA320 Software Feature, Manometry

Funding/Req. Number: 1

757-18-3-096-0217

LINE ISOLATION TRANSFORMER 1 LIT030 Line Isolation Transformer, 120V 1 POW005 Medical Grade Power Cord

Funding/Req. Number: 1

757-18-3-096-0217

PRINTER 1 PRI110 Printer, All in one, Envy 4520 1 CAB1056 USB printer cable 1 POW320 Power Cord

Funding/Req. Number: 1

757-18-3-096-0217

CART 1 CAR527 Signature Pedestal Stand including printer shelf with basket

Funding/Req. Number: 1

757-18-3-096-0217

SONESTA PROCEDURE TABLE 1 SON5031 Urodynamic Procedure Table S3 w SON5031 - Features (User Manual Included): w with three electric motor controls for height, seat, and back adjustments. w Infinite

Funding/Req. Number: 1

757-18-3-096-0217

EDUCATION COURSE EXPIRES ONE YEAR AFTER SYSTEM PURCHASE 1 COU001 Electrical Stimulation & Biofeedback: How it Works in the Pelvic Floor Rehabilitation Process How to identify pelvic floor disorders n

Funding/Req. Number: 1

757-18-3-096-0217

INSERVICE KIT 1 pct. 10 ELE428 Electrode, Neotrode II, Patch, 3/PK, touchproof w/ leads 1 pk 10 ELE425 Electrode, Neotrode, Patch, 3/PK 3 PRB450 Probe, Classic Vaginal Din Connection 2 PRB085 Probe, va

Funding/Req. Number: 1

757-18-3-096-0217

INSERVICE KIT 1 pk 10 ELE428 Electrode, Neotrode II, Patch, 3/PK, touchproof w/ leads 1 pk 10 ELE425 Electrode, Neotrode, Patch, 3/PK 3 (three total) PRB450 Probe, Classic Vaginal Din Connection 2

Funding/Req. Number: 1

757-18-3-096-0217

SHIPPING CHARGE

Funding/Req. Number: 1

757-18-3-096-0217

GRAND TOTAL

STATEMENT OF WORK (SOW)

1. Contract Title. Aquarius CT Urology

2. Background. Chalmers P. Wylie needs to purchase a new Aquarius CT for the urology department because they are having to send out many patients into the private sector for this procedure that could be done here with this equipment. This piece of equipment will aide in the increase in patient care that the urology department is seeing and help our Veterans get more of their urology care done here at Chalmers P. Wylie.

3. Scope. Aquarius CT will be delivered to Chalmers P. Wylie VA.

4. Specific Tasks. The Contractor will deliver, install and conduct training as described in the Contract awarded by the Contracting Officer.

4.1 Task 1 - Enterprise Management Controls.

4.1.1 Subtask 1 - Integration Management Control Planning. reporting and program reviews. Provide the centralized administrative, clerical, documentation and related functions.

4.1.2 Subtask 2 - Contract Management.

Deliverables:

Laborie/Aquarius CT Urodynamics Analyzer Sys/AQS2000-S

Laborie/Urocap V/TRA1002

Laborie/Computer, industrial PC/COM450

Laborie/Monitor, Flat panel, 19" LCD Wide (NEC)/MON185

Laborie/Peripherals, mouse, USB with PS2 adapter/PER225

Laborie/Peripherals, keyboard, Dell, 104 keys, full size/PER101

Laborie/Peripherals, mouse pad/Per184

Laborie/USB cable/CAB1000

Laborie/110V power cord/POW005

Laborie/Software/software, NGM Urodynamics software pkg, CT software/LAB1001

Laborie/Software/i-List, Office reporter, English, Windows XP/Windows 7/LIS224

Laborie/Software/CD/DVD, software system, customized, with manuals/CDR120

Laborie/Software/Aquarius LT/CT/XT manual air charged/MAN049

Laborie/Software/Manual, unpackaging guide for Aquarius NGM syt/MAN1010

LaborieSoftware//Hasp key/SOF397

Laborie/Roam/Roam DX/RMX1000

Laborie/EMG/High Fidelity EMG/FEA262

Laborie/EMG/Features, EMG, 2nd channel/FEA263

Laborie/EMG/Roam 1/NGM_EMG Non-shielded w/5pin LEMO, 9"/CAB1032

Laborie/EMG/Roam 1/Electrode, lead, EMG, set of 2 red, 1 green, non-shielded/ELE350

Laborie/EMG/Roam 1/EMG, Touch proof shorting leads, non-shielded/CAB151

Laborie/EMG/Roam2/ NGM_EMG non-shielded w/5 pin, lemo, 6'/CAB1034

Laborie/EMG/Roam 2/electrode, lead, EMG, set of 2 red, 1 green, non-shielded/ELE350

Laborie/EMG/Roam 2/Touch proof shorting leads, non-shielded/CAB151

Laborie/TDOC Air-Chrg Interface/Roam 1/Mechanical assembly sensor holder, clip/MSM1017

Laborie/TDOC Air-Chrg Interface/Roam 1/transducer, TDOC cable-P(ves)UDS roam, 8"/TRA615

Laborie/TDOC Air-Chrg Interface/Roam 1/transducer, TDOC cable-P(abd)UDS roam, 8"/TRA616

Laborie/TDOC Air-Chrg Interface/Roam 1/transducer, TDOC cable-P(ura)UDS roam, 8"/TRA617

Laborie/TDOC Air-Chrg Interface/Roam 1/hardware, lanyard, adjustable length w/breakaway clasp, 2cmx125cm/HAR575

Laborie/TDOC Air-Chrg Interface/Roam2/TDOC holder assembly/MSM1068

Laborie/TDOC Air-Chrg Interface/Roam2/transducer, TDOC woth mini Lemo Pves, 6'/TRA619

Laborie/TDOC Air-Chrg Interface/Roam2/transducer, TDOC woth mini Lemo Pabd, 6'/TRA620

Laborie/TDOC Air-Chrg Interface/Roam2/transducer, TDOC woth mini Lemo Pura, 6'/TRA621

Laborie/Commode chair and funnel/funnel, washable/CHA102

Laborie/Commode chair and funnel/folding commode chair/CHA181

Laborie/Printer/USB printer cable/CAB1056

Laborie/Printer/Printer, all in one, HP Envy 4520/PRI110

Laborie/Printer/Power cord, 1', C& power cable, 2 prong plug/POW1016

Laborie/Printer/cable, power supply connector converter to plug into LIT, North America/CAB465

Laborie/Printer/Printer shelf/shelf-static/MSM1044

Laborie/Sensory Array Accessories/Dummy infusion hook/MSM1069

Laborie/Urostym-Pelvic Floor Rehab/peripherals, serial adapter/PER500

Laborie/Urostym-Pelvic Floor Rehab/Urostym unit/PRO180

Laborie/Urostym-Pelvic Floor Rehab/RS232 extension cable/CAB347

Laborie/Urostym-Pelvic Floor Rehab/Urostym quick start guide/MAN483

Laborie/Urostym-Pelvic Floor Rehab/manuals, password quick start guide, English/MAN095

Laborie/Urostym-Pelvic Floor Rehab/CD/DVD, software syt, customized, w/manuals/CDR120

Laborie/Urostym-Pelvic Floor Rehab/LIT cable/LIT080

Laborie/Urostym-Pelvic Floor Rehab/Fuse, slow blow/FUS245

Laborie/Urostym-Pelvic Floor Rehab/cable, snap-on filter/CAB572

Laborie/Urostym-Pelvic Floor Rehab/cable, urostym channel 1/probe adapter/CAB896

Laborie/Urostym-Pelvic Floor Rehab/EMG headstage cable, channel 2, 10'/CAB906

Laborie/Urostym-Pelvic Floor Rehab/EMG lead set/ELE350

Laborie/Urostym Software/UROSTYM biofeedback software-basic pkg/LAB596

Laborie/Urostym Software/i-List, reporter, English/LIS224

Laborie/Urostym Software/Nitro PDF/SOF006

Laborie/Urostym Software/features, games/FEA271

Laborie/Urostym Software/features, notification/FEA350

Laborie/Urostym Software/features, questionaire/FEA450

Laborie/Urostym Software/features, stimulation/FEA465

Laborie/Urostym Software/Hasp key/SOF397

Laborie/Computer/laptop computer/COM532

Laborie/Computer/Hardware, velcro strap/HAR010

Laborie/Computer/power cord/POW320

Laborie/Manometry/Pressure Feedback/transducer, Medex MX960 Pressure transducer adapter cable/TRA168

Laborie/Manometry/Pressure Feedback/software feature, manometry/FEA320

Laborie/Line Isolation Transformer/line isolation tranformer, 120V/LIT030

Laborie/Line Isolation Transformer/Medical grade power cord/POW005

Laborie/Printer/printer all in one Envy 4520/PRI110

Laborie/Printer/USB printer cable/CAB1056

Laborie/Printer/power cord/POW320

Laborie/Cart/Signature pedestal stand including printer shelf w/basket/CAR527

Laborie/Sonesta Procedure Table/urodynamic procedure table S3/SON5031

Laborie/Sonesta Procedure Table/Arm rest right and left (universal)/SON099

Laborie/Sonesta Procedure Table/leg rest/SON072

Laborie/Sonesta Procedure Table/Leg rest holder (single packed)/SON071

Laborie/Sonesta Procedure Table/fold up foot rest/SON031

Laborie/Sonesta Procedure Table/seat cushion w/out cutout/SON220

Laborie/Sonesta Procedure Table/neck pillow/SON086

Laborie/Sonesta Procedure Table/universal urodynamic funnel $ funnel holder/SON065

Laborie/Sonesta Procedure Table/seat cushion with cut out/SON220

Laborie/Sonesta Procedure Table/Sonesta seat covers/SON009

Laborie/U2-1 Flowstar NS, includes finnel, urine container, and roll of thermal paper/MMS wired flow sensor/Flowsensor3

Laborie/U2-1 Flowstar NS, includes finnel, urine container, and roll of thermal paper/MMS flowsensor thermal printer/UFS Main

Laborie/U2-1 Flowstar NS, includes finnel, urine container, and roll of thermal paper/Flowstand height adjustable for Flowsensor MK-III/Flowstand

5. Performance Monitoring As determined necessary by the Contracting Officer

6. Security Requirements 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.

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.

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.

The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

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).

Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract 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 of the contract.

The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

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.

Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

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 With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

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.

The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

7. Place of Performance:

Chalmers P. Wylie Ambulatory Care Center 420 N. James Road Columbus Ohio 43219

8. Delivery Schedule: 45 days after contract award

EVALUATION CRITERIA/SUBMISSION OF OFFER

All questions shall be submitted in writing in response to the Solicitation and are due no later than 20 Jun 2018 at 1:00 PM, EST. Questions shall be emailed to percy.johnson2@va.gov on or before the date and time stated. Any Government responses, answers and/or comments to all questions will be posted by 21 Jun 2018.

Percy Johnson Contracting Officer Network Contracting Office (NCO) 10 Officer: 614 257 5534 Email: percy.johnson2@va.gov

Evaluations will be conducted under FAR Part 13, and any subsequent award will be made to the offeror that provides the Lowest Price Technically Acceptable to the Government. A proposed delivery/installation schedule will be provided.