Optical coherence Tomography Imaging Systems

Added: Aug 19, 2016 11:00 am This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice and in accordance with the simplified acquisition procedures authorized in FAR Part 13. This announcement constitutes the only solicitation; proposals/quotes are being requested and a written solicitation will not be issued. All offerors must also be registered on www.sam.gov. Any amendments issued to this solicitation will ONLY be available on the FBO website (www.fbo.gov ).



II. This solicitation is issued as a Request for Quotation (RFQ). Submit written quotes on RFQ number

VA246-16-Q-1173 This solicitation is a Brand Name or Equal request for Optical Coherence Tomography (OCT) to be delivered to the Department of Veterans Affairs (VA) Medical Center at Charlotte, North Carolina, which meets the requirements within this solicitation.



III. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-87 The North American Industry Classification System Code is 339115 and the size standard is 1,000 employees. NOTE: All interested Service Disabled/Veteran Owned Small Business (SDVOSB/VOSB) Offerors must be listed and registered in Vetbiz.gov to be considered for award.



V. This combined solicitation/synopsis is for purchase of the following commercial supplies which meet the following salient characteristics and requirements of the brand name or equal system. Any "Or Equal" response shall identify manufacturer and include parts list, along with details on how such item(s) match or exceed the salient characteristics.



STATEMENT OF WORK

Optical Coherence Tomography (OCT) and Visual Field Solutions for the Charlotte HCC

1. Summary of Requirement



The Department of Veteran Affairs is currently standing up its new Health Care Center in Charlotte, NC. The medical Center is currently seeking an Optical Coherence Tomography (OCT) Solutions.

2. Scope



The Contractor shall be required to furnish all items, to include but not limited to, project management, labor, equipment, materials, travel and any incidentals required to satisfy the requirements of this Statement of Work. The Contractor shall also be responsible for timely delivery, training, and site deployment to ensure the successful completion of the tasks as outlined in this Statement of Work.



3. Deliverables

3.1 Minimum Continuity Requirements:

The solution must have the ability to import and integrate the facilities existing Cirrus Model HD OCT 4000 raw data to a single machine for the purpose of comparing and contrasting data, located at the Charlotte CBOC. The raw data must be interchangeable between the Cirrus 4000 and item offered. The Governments objective is to implement the patients' data from the Cirrus 4000 and incorporate it into the item offered, which allows for continuity, continual, and precise progression data management. The RAW data needs be interchangeable/ compatible. If not, all data from the Cirrus 4000 becomes only a static report of PDF that cannot be built on, meaning that the Doctor starts over with regards to historical data and new "Baselines", which has already been determined to not be in the best interest of the Government. It shall be the Contractor's responsibility to migrate data from existing Government owned equipment to offered equipment.

The exiting Government equipment is located at:

Charlotte CBOC

8601 University East Drive

Charlotte, NC 28213



3.2 Equipment

At a minimum the offered equipment shall possess the following characteristics to meet the minimum needs of the Government:

3.2.1 Optical Coherence Tomography (OCT) with Angio

OCT Imaging

Methodology - Spectral domain OCT

Minimum Optical Source - Superluminescent diode (SLD), 840 nm

Minimum Scan Speed - 27,000 - 68,000 A-scans per second

Minimum A-scan depth - 2.0 mm (in tissue), 1024 points

Minimum Axial resolution 5 µm (in tissue)

Minimum Transverse resolution 15 µm (in tissue)

Fundus Imaging

Methodology - Line scanning ophthalmoscope (LSO)

Live fundus image - During alignment and during OCT scan

Minimum Optical source - Superluminescent diode (SLD), 750 nm

Minimum Field of view - 36 degrees W x 30 degrees H

Minimum Frame rate - > 20 Hz

Minimum Transverse resolution - 25 µm (in tissue)

Iris Imaging

Methodology - CCD camera

Minimum Resolution - 1280 x 1024

Live Iris Image - During alignment

Essential Physical Characteristics

Power: Dual Voltage 110V & 240 V

Max Size: 26"L x 18"W x 21"H

Max Weight: 80 lbs.

Max Size (table) 39"L x 22"W

Other Requirements

Network

" Network

o DICOM connectivity

o Data Import

o Import data from current machine

o Single source machine

o Compare & contrast decades worth of clinical data/exams to monitor patient's progress

o Annotate Change analysis from past tests

o Maintain patient's analysis continuity

o Interfaces with clinical records in a fashionable & organized manner on past data

All prior data acquisition on current patient population was obtained by Zeiss through its software & normative data base. Therefore, alternative data base must be able to correlate with current system. By doing so, this would enhance the ability to perform progression analysis.



Minimum Wide Angle to Angle - 15.5mm x 2.9mm

Minimum HD Cornea - 9mm x 2mm

Minimum HD Angle - 6mm x 2.9mm

DICOM conformant, must be able to import raw data & algorithms of existing HVF 750i

Display: 19" Color

Operating System: Windows 7 or compatible

Minimum Hard Drive/Storage: 750 GD / >80,000 scans

Minimum Memory: 4 GB

Min USB Port: 6 EA



Humphrey Field Analyzer

Items offered shall already on the approved list to interface with VISTA Imaging. The government will accept items that are not on the approved list, nor items pending approval etc... Possess FORUM Connectivity & DICOM Connectivity, Touch Screen Display, USB Port and Keyboard. Shall meet UL, CSA & CE Standards.

Fixation Control

Heijl-Krakau blind spot monitor

Video Eye Monitor

Gaze Tracking

Head Tracking

Vertex Monitoring

Operator Interface

Stimulus

White on White

Red-or Blue-on-White

Blue-on-yellow

General Testing

Stimulus: Goldmann I-V

Foveal Threshold

Automatic Pupil Measurement

Liquid Trial Lens

Software

" Network

o DICOM connectivity

o Data Import

o Import data from current machine

o Single source machine

o Compare & contrast decades worth of clinical data/exams to monitor patient's progress

o Annotate Change analysis from past tests

o Maintain patient's analysis continuity

o Interfaces with clinical records in a fashionable & organized manner on past data

All prior data acquisition on current patient population was obtained by Zeiss through its software & normative data base. Therefore, alternative data base must be able to correlate with current system. By doing so, this would enhance the ability to perform progression analysis.

Single Field Analysis

Glaucoma Hemifield Test

Visual Field Index

Guided Progression Analysis

Serial Field Overview

Other Requirements

Minimum Hard Drive/Storage: 500 GB

Printer

USB Ports

Essential Physical Characteristics

Power: Dual Voltage 110V & 240 V

Max Size: 26"L x 18"W x 21"H

Max Weight: 80 lbs.

Max Size (table) 39"L x 22"W

3.3 User and Service Manuals



The vendor shall provide two (2) complete unabridged printed sets, as well as electronic version of operator manuals, service manuals, electronic schematics, troubleshooting guides and parts list for each type of equipment purchased for each medical center. These manuals shall include cleaning instructions.

Service manuals will be supplied during biomed training program.



3.4 Training



A. End-User Staff

The Contractor shall provide end-user staff and super users with training on proper care, use, cleaning and user maintenance functions. The selected vendor must provide initial education to clinical personnel at the site. Initial education will include organized classes, at a minimum training sessions will be conducted onsite. The vendor will provide electronic training materials (handouts, visual aids, user assessment, etc.) and vendor staff to complete the training.



3.5 Project Plan

The contractor shall submit a Project Plan in response to this solicitation. This plan shall include, at a minimum, the Contractor's approach to Site Deployment/phase-in of new equipment.

3.6 Security Requirements



Network Security and Patient Data Privacy: All vendors are required to submit Manufacturer Disclosure Statement for Medical Device Security (MDS2) VA Form 6550 with their solicitation if any component of proposed system requires connection to the VA network or retains patient information; this form is included as an attachment. This document covers most pertinent information related to networking and risk exposure for medical devices.



3.7 Warranty

Contractor shall provide warranty terms on for consideration.

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR

INCLUSION INTO CONTRACTS, AS APPROPRIATE

1. GENERAL

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.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontrator 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.

b. 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

3. VA INFORMATION CUSTODIAL LANGUAGE

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).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor's information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA's information is returned to the VA or destroyed in accordance with VA's sanitization

requirements. VA reserves the right to conduct onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. 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.

d. 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.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. 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 the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

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.

k. 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.

INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

h. 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 vendor at the end of lease, for trade-in, or other purposes. The options are:

(1) Vendor must accept the system without the drive;

(2) VA's initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

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

(4) 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;

(a) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and

(b) 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 preapproved and described in the purchase order or contract.

(c) 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 ISO needs to maintain the documentation.

6. SECURITY INCIDENT INVESTIGATION

a. 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.

b. 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.

c. 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.

d. 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 to 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. Her



BAA is required

Price Schedule

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

0001 HD-OCT (MODEL 5000) Manufacture: Zeiss

BRAND NAME OR EQUAL

Bidding on:

Manufacturer name: _______________

Brand:_____________

Part No.:______________

possessing the salient characteristics as describe in section B and statement of work for Charlotte VAMC 2.00 EA __________________ __________________

0002 HFA3 MODEL 860

W/LIQUID TRIAL LENS, RELEYE, KINETIC, GPA, HEAD TRK, GAZE TRK, PRINTER & TABLE

BRAND NAME OR EQUAL

Bidding on:

Manufacturer name: __________________

Brand:_____________

Part No.:______________

possessing the salient characteristics as describe in section B and statement of work for Charlotte VAMC 2.00 EA __________________ __________________

0003 ANTERIOR SEGMENT PREMIER MODULE CIRRUS 5000 (IMAGING ONLY) INCLUDES: EXTERNAL

BRAND NAME OR EQUAL

Bidding on:

Manufacturer name: ________________

Brand:___________

Part No.:______________

possessing the salient characteristics as describe in section B and statement of work for Charlotte VAMC

2.00 EA __________________ __________________

GRAND TOTAL __________________



VII. Item(s) are to be delivered within 45 days After Receipt of Order (ARO), FOB Destination to VA Medical Center, 1100 Tunnel Road, Charlotte, North Carolina 28208.

The following Federal Acquisition Regulations (FAR) and Veterans Affairs Acquisition Regulations (VAAR) provisions and clauses are applicable to this acquisition and can be viewed in full text using the following web addresses: http://www.acquisition.gov/far/index.html and http://www.va.gov/oal/library/vaar/

FAR Provisions

52.204-7 System for Award Management (JUL 2013)

52.211-6 Brand Name or Equal (AUG 1999)

52.212-1 Instructions to Offerors -- Commercial Items (OCT 2015)

52.212-2 Evaluation - Commercial Items (OCT 2014)

52.216-1 Type of Contract (APR 1984)

52.233-2 Service of Protest (SEPT 2006)



FAR Clauses

52.212-3 Offeror Representations and Certifications - Commercial Items (APR 2016)

An offeror shall complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://sam.gov.



52.212-4 Contract Terms and Conditions - Commercial Items (MAY 2015)

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (MAR 2016). The following clauses under subparagraph (b) apply:

52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards (Jul 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note)

52.209-6 Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Oct 2015)

52.219-27 Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011)

52.222-3 Convict Labor (June 2003)

52.222-19 Child Labor-Cooperation With Authorities and Remedies (Feb 2016)

52.222-21 Prohibition of Segregated Facilities (Apr 2015)

52.222-26 Equal Opportunity (Apr 2015)

52.222-36 Equal Opportunity for Workers with Disabilities (Jul 2014)

52.222-50 Combating Trafficking in Persons (Mar 2015)

52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011)

52.225-1 Buy American - Supplies (May 2014)

52.225-13 Restriction on Certain Foreign Purchases (Jun 2008)

52.232-34 Payment by Electronic Funds Transfer--Other Than System for Award

52.203-16 Preventing Personal Conflicts of Interest (DEC 2011Management (Jul 2013)

52.203-17 Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights (APR 2014)

52.203-99 Prohibition on Contracting With Entities That Require Certain Internal Confidentiality Agreements (DEVIATION 2015-02) (FEB 2015)

52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper (MAY 2011)



VAAR Clauses and Provisions

852.203-70 Commercial Advertising (JAN 2008)

852.211-70 Service Data Manuals (NOV 1984)

852.211-73 Brand Name or Equal (JAN 2008)

852.232-72 Electronic Submission of Payment Requests (NOV 2012)

852.246-70 Guarantee (JAN 2008)

852.246-71 Inspection (JAN 2008)

852.273-74 Award Without Exchanges (JAN 2003)

852.233-70 Protest Content/Alternative Dispute Resolution

852.233-71 Alternate Protest Procedure (JAN 1998)

852.211-72 TECHNICAL INDUSTRY STANDARDS (JAN 2008)





The Government intends to award a firm, fixed priced contract to the responsible offeror whose offer, conforming to the requirements in this request for proposal, will be most advantageous to the Government. A Lowest Price Technically Acceptable award will be made based on the evaluation of technical experts meeting the Salient Character tics and Statement of work.



VIII. Questions concerning this solicitation shall be addressed to Audrey Wooten, Contract Specialist, and e-mailed to Audrey.Wooten@va.gov no later than 3pm EST on August 23, 2016.



IX. Quotes are required to be received by the Contracting Officer electronically via email no later than 16:00 EST on August 25, 2016. NO FAXED OR MAILED OFFERS WILL BE ACCEPTED. Quotes received after this time/date will be considered late in accordance with FAR 52.212-1(f) and will not be evaluated. All quotes shall be emailed to Audrey.wooten@va.gov