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Zeiss Eye Data Management System Ophthalmology


Pennsylvania, United States
Government : Federal
RFP
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COMBINED SYNOPSIS SOLICITATION
(i) This is a combined synopsis/solicitation for ZEISS Integrated Ophthalmic Data Management System, BRAND NAME ONLY, as 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; quotes are being requested and a written solicitation will not be issued. A firm-fixed price purchase order is anticipated.
(ii) The solicitation number is 36C24418Q9349 and is issued as a request for quotation (RFQ).
(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-95
(iv) This solicitation is set aside 100% for Service-Disabled Veteran-Owned Small Businesses and the associated NAICS 339112 code has a small business size standard of 500.
(v) Contract Line Items (CLIN):
ITEM INFORMATION
ITEM NUMBER
DESCRIPTION OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
0001

1.00
EA
__________________
__________________

FORUMSPEC


0002

1.00
EA
__________________
__________________

Zeiss OS/FORUM Archive and Viewer PKG
LOCAL STOCK NUMBER: 000000-2131-312-PRO


0003

1.00
EA
__________________
__________________

Zeiss OS/ Forum Viewer License-Volume Pack 25X
LOCAL STOCK NUMBER: 000000-2133-317-PRO


0004

1.00
EA
__________________
__________________

Zeiss OS/Forum Glaucoma Workplace 2.0
LOCAL STOCK NUMBER: 000000-2078-492-PRO


0005

1.00
EA
__________________
__________________

Zeiss OS Forum Glaucoma WorkplaceUser Volume pack 25X
LOCAL STOCK NUMBER: 0000002133-359-PRO


0006

1.00
EA
__________________
__________________

zEIOSS OS/ ZEISS RETINA WORKPLACE 1.0
LOCAL STOCK NUMBER: 0000002130-283-PRO


0007

1.00
EA
__________________
__________________

ZEISS OS/LICENSE ZEISS RETINA WORKPLACE USER-VOLUME PACK 25X
LOCAL STOCK NUMBER: 0000002133-315-PRO


0008

1.00
EA
__________________
__________________

ZEISS OS/FORUM ASSIST MATCH 1.4 (V4.0)
LOCAL STOCK NUMBER: 26002-1158-323-PRO


0009

2.00
EA
__________________
__________________

ZEISS OS / FORUM BI-DIRECTIONAL DICOM INTERFACE LICENSE TO CZM INSTRUMENT (V3)
LOCAL STOCK NUMBER: 3066601-8530-101-PRO


0010

7.00
EA
__________________
__________________

ZEISS OS/FORUM INTERFACE LICENSE TO 3RD PART DICOM INSTRUMENTS INCLUDES LINK NET 1.0 & 3RD PART DICOM INSTRUMENT
LOCAL STOCK NUMBER: 306601-8530-103-PRO


0011

1.00
EA
__________________
__________________

ZEISS OS/FORUM HL-7 INTERFACES
LOCAL STOCK NUMBER: 306601-8530-107-PRO


0012

2.00
EA
__________________
__________________

ZEISS OS/HFA II-I V5.0 NETPRO W/DICOM 2.0 GATEWAY
LOCAL STOCK NUMBER: 266002-1140-383-PRO


0013

1.00
EA
__________________
__________________

ZEISS OS/CARL ZEISS MEDITEC INC FORUM ON SITE INSTALL & TRAINING
LOCAL STOCK NUMBER: 266002-1131-909-PRO


0014

150.00
HR
__________________
__________________

ZEISS OS ENTERPRISE ARCHITECTURE DESIGN PER HOUR
LOCAL STOCK NUMBER: 266002-1150-893-PRO


0015

1.00
EA
__________________
__________________

ZEISS OS CONNECTIVITY SERVICE PLAN ANNUAL
LOCAL STOCK NUMBER: 266002-1130-065-PRO


0016

1.00
EA
__________________
__________________

WARRANTY
LOCAL STOCK NUMBER: 3PWRNTY






GRAND TOTAL
__________________


B.2 DELIVERY SCHEDULE

ITEM NUMBER
QUANTITY
DELIVERY DATE
0001
SHIP TO:
SEE STATEMENT OF WORK


150 DAYS ARO

(vi) Products must be Brand Name in the following specifications:

STATEMENT OF WORK
PURPOSE
The purpose is to procure a comprehensive, integrated ophthalmic data management system for the Corporal Michael J. Crescenz VA Medical Center located at 3900 Woodland Avenue and satellite eye clinics located in the following cities: Gloucester and Willow Grove. The system must interface with the Corporal Michael J. Crescenz VA Medical Center electronic medical record and existing eye equipment enabling consolidated storage, transfer, review and analysis of eye tests and exams conducted at any of the eye clinic locations. The Contractor shall provide all necessary tools, interfaces, equipment/hardware, software, licenses, delivery, installation, warranty, and training.

BACKGROUND
The Corporal Michael J. Crescenz VA Medical Center and its community satellite outpatient clinics have many varied eye testing and exam systems. At present, these systems operate independently and very few are interfaced with the facility s electronic medical record. Test and exam data is routinely printed and then scanned into the medical record, a very labor intensive system that yields less than optimal image quality after scanning. Furthermore, accessing the scanned data is cumbersome for the eye providers. This request is to acquire a data management system that will integrate eye data from these systems, store the information, and transfer it to the CVAMC electronic medical record. The system should also facilitate review of the data by eye care providers for treatment decision making purposes.

SCOPE
Contractor must supply, install, and train staff on the use of eye data management system at CVAMC as well as its community based outpatient clinics.
Suggested manufacturer is Zeiss. The items preferred are: Forum Viewer License, Forum Glaucoma Workplace 2.0, Forum Glaucoma Workplace User, Zeiss Retina Workplace 1.0, License Zeiss retina Workplace User, Forum Assist Match 1.4, Forum Bi-Directional DiCOM Interface License to CZM Instrument (V3), Forum Interface License to 3rd Party DiCOM Instruments includes Lint Net 1.0 + 3rd Party DiCOM Instrument, Forum-HL7 Interfaces (Includes EMR, HIS, HL7-ADT, and HL7-ORM) (V3), HFA II-I V5.0 Netpro W/DiCOM 2.0 Gateway, Carl Zeiss Meditec , Inc. Forum On-Site Installation & Training, Enterprise Architecture Design, Connectivity Service Plan (Annual), Server and 28 Monitors (24 ).
All products must meet salient characteristics

SPECIFICATIONS AND SALIENT CHARACTERISTICS
The system will provide at least 23 eye exam and testing data viewing stations for exam rooms and staff workstations
Server Configuration @ Main site and CBOC connectivity
The eye data management system will integrate, save, and upload test and examination data from the main campus and CBOC s.
Support integrated review of multiple glaucoma-related tests (visual fields, OCT scans, Fundus images) by a provider to facilitate treatment decision making
Equipment is not inclusive of all eye lane equipment: Nidek topographer, Lenstar, Ellex A/B Scan, Heidelberg Spectralis HRA + OCT, Fundus Camera, HFA 750i with DiCOM Gateway, Topcon TRC-NW65, and Carl Zeiss HFA 750
The equipment and components shall be compatible with CVAMC equipment, infrastructure, and supplies already in use
The licensing fees shall be updated on an annual basis
The viewer package must be able to seamlessly integrate archived images and new images
The system must be able to integrate all images related to glaucoma from the HVF and OCT machines and perform an analysis of change or stability through time
The PACS system must be listed in the VistA approved DiCOM modality interfaces
PACS system must be FDA 510K approved
The PACS system must be configured so that it can send the patient demographic to a specific instrument work-list and/or all instruments located in Eye Care
No manual entering of patient demographic data is required at the PACS system or on the DiCOM capable instrument
PACS system must connect to any brand of non-DiCOM capable diagnostic instrument with an export capability and label the device type and laterality in the PACS system
The PACS system must be able to automatically send images and reports from the instrument to its system via a DiCOM gateway.
The PACS system must be able to access all Zeiss data that would be on the VA s server.
The PACS system must be able to download all past raw data from one or more Zeiss field Analyzers or other Zeiss equipment acquired within the main clinic and all satellite CBOC s.
The PACS system must be able to create in its viewer all past visual field test reports in color from one or more Zeiss Field Analyzers located in the main clinic and all satellite CBOC s.
The PACS system must be able to display Zeiss Field Analyzer Glaucoma Progression Aalysis (GPA) and enable the clinician to manipulate data and store baseline changes at the PACS workstation.
The PACS system must be able to present VFI Index, Mean Deviation, Pattern Standard Deviation and Global Indices at a glance summary of all past and present tests.
The PACS system must be able to automatically label images and reports coming from the various instruments to enable the clinician to sort test data by visit date(s), modality type(s), right eye, left eye, or both eyes.
The PACS system must be able to display images in pre-formatted clinical display groupings for Glaucoma, Retina and Cataract cases.
The PACS system viewer must be able to display images in a format of left eye/right eye format
Must be compatible with VistA and DiCOM
The PACS system must be able to be accessed and used at any Corporal Michael J. Crescenz VA location
PACS system must be able to create Consults or Orders from CPRS or VistA and transfer the patient demographic data into its system with VA VistA being specified as the Issuer of Patient ID. No manual entering of patient demographic data is required at the PACS system or on the DICOM capably instrument.
PACS system must able to send the Consult or Order to the instrument s DICOM modality worklist.
PACS system must connect any brand of non-DICOM capable diagnostic instrument with an export capability, and label the device type and laterality in the PACS system.
PACS system must be able to automatically send images and reports from the instrument to its system via a DICOM gateway.
The PACS system must not require the use of an external PC or import computer for a DICOM capably instrument modalities.
PACS system must be able to store and access raw instrument data from Zeiss Field Analyzer, Zeiss Cirrus HD-OCT, Zeiss Visucam Fundus Camera and Zeiss FF450/Visupac Fundus Camera systems.
PACS system must be able to download all past raw data from one or more Zeiss Field Analyzers, Zeiss Cirrus HD-OCT s, Zeiss Visucam Fundus Camera and Zeiss FF450/Visupac Fundus Cameras acquired within the main clinic and all satellite clinics upon installation of the PACS system.
PACS system must create in its viewer all past visual field test reports in color from one or more Zeiss Field Analyzers located in the main clinic and all satellite clinics at the time of installation
PACS system must be able to display Zeiss Field Analyzer Glaucoma Progression Analysis (GPA) and enable the clinician to manipulate data and store baseline changes at the workstation.
PACS system must be able to present VFI Index, Mean Deviation, Pattern Standard Deviation and Global Indices at a glance summary of all past and present tests.
PACS system must be able to display all Cirrus HD-OCT past and present test data from one or more Cirrus instruments located in one or more VA clinics. This date must be accessible to enable viewing and manipulation at the workstation.
PACS system must be able to display and allow the clinician to scroll through the various Cirrus Macula Cube B-scan slices.
The PACS system must be able to download at time of installation all past Zeiss Visucam Fundus Camera and Visupac Fundus Camera photographic images.
PACS system must be able to automatically label images and reports coming from the instruments to enable the clinician to sort test data by visit date/s, modality type/s, right eye, left eye or both eyes.
PACS system must be able to display images in pre-formatted clinical display groupings for Glaucoma, Retina and Cataract cases.
PACS system viewer must be able to display images in a right eye / left eye display format
PACS system must be able to tag individual test reports/images as Favorites to enable easy access on future patient visits.
Vendor must provide onsite installation and training
Vendor must provide timely on-site support as needed


SYSTEM REQUIREMENTS
Contractor shall provide a projected schedule in term of days from the time of the award addressing (at a minimum) the following milestones: verification that all system quantities and configurations are accurate, manufacture or purchase/assembly of all parts and/or equipment; delivery to identified location, and complete installation of hardware.

TRAINING
Contractor shall provide comprehensive training on the use of the equipment for operating clinicians. This training program shall include at a minimum following: Technical Training, Operational Training, and Hardware/Software trouble shooting. Training shall occur onsite during normal business houses, 8:00am 4:30pm, Monday through Friday. Competency assessments shall be provided with the training.
Contractor shall provide technical training for two biomedical engineering personnel. The cost for this training and all training related expenses such as travel, lodging, and other expenses are included in the contract price. This training shall cover the preventative maintenance, troubleshooting, and general maintenance of the equipment. Training shall allow for classroom instruction as well as individual hands on programming, troubleshooting and diagnostic exercises. Competency assessments shall be provided with the training.

TESTING AND CERTIFICATION
Upon installation of each piece of equipment and software in the system, the Contractor shall notify the COR that the system is ready for acceptance testing, and that it meets all requirements as specified. Upon receipt of this notification, CVAMC ophthalmic staff will perform the acceptance testing within two (2) business days. Submission of this notification of system readiness shall be accomplished by the contractor prior to the beginning of the scheduled Government Acceptance Test.

TESTING AND CERTIFICATION
Contractor shall perform Government Acceptance Test in the presence of the COR and designated Ophthalmology Staff for proof-of performance. Upon completing the Government Acceptance Test successfully, Contractor shall document the success of this Government Acceptance Test on Contractor s company form which will be certified by the COR s signature as an evidence of Government Acceptance of the referenced pieces of equipment and software. A copy of this document shall be furnished to the COR and the Contracting Officer before Contractor s Representative at the end of each testing.

INSTALLATION
Contractor shall provide all labor, materials, tools, equipment to prepare for the installation of the equipment at the CVAMC and the outpatient CBOC s.
This equipment will be installed per ZEISS standard
All employees of the general contractor and subcontractors shall comply with CVAMC policies including but not limited to: vendor credentialing, parking, check-in procedures, name badges, smoking policies and confidentiality.
Contractor is responsible for removing all packing materials and related waste and dispose of off-site

EVALUATION CRITERIA

Technical Capability
Image Quality
System Speed and Reliability
Integrated Data Functions
Patient Safety Features
Integration with existing ophthalmic equipment, infrastructure and supplies
Warranty
Past Performance


(viii) The provision at 52.212-1, Instructions to Offerors -- Commercial, applies to this acquisition and the following clauses AND instructions are added as addenda:
CLAUSES:
52.214-21 Descriptive Literature (APR 2002)
852-219-10 VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside

(a) Gray market items are Original Equipment Manufacturer s (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers.B No remanufactures or gray market items will be acceptable.
B
(b) Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM s warranty and service are provided and maintained by the OEM.B All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions.

(c) The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract.B Accordingly, the VA reserves the right enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA s election, allowing the Vendor toB replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discovery of such items.B
(ix) Evaluation of this requirement will be based on PRICE and TECHNICAL ACCEPTABILITY.
(x) Offerors are advised to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with its offer if has not been completed on SAM.gov.
(xi) The clause at 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition and the following clauses are added as addenda:
(End of Clause)
52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)
This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):
http://farsite.hill.af.mil
https://acquisition.gov/far
(End of Clause)

852.203-70 Commercial Advertising (JAN 2008)
852.246-71 Inspection (Jan 2008)
(xii) The clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes Or Executive Orders -- Commercial Items, applies to this acquisition and the following additional FAR clauses cited in the clause are applicable to the acquisition:
52.204-10 Reporting Executive Compensation & First-Tier Subcontract Awards (OCT 2015)
52.209-6 Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (OCT 2015)
52.219-28 Post Award Small Business Program Representation (JUL 2013)
52.222-19 Child Labor--Cooperation with Authorities and Remedies (FEB 2016) (E.O. 13126)
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)
52.225-3 Buy American--Free Trade Agreements--Israeli Trade Act (MAY 2014)
52.225-13 Restrictions on Certain Foreign Purchases (JUNE 2008)
52.232-34 Payment by Electronic Funds Transfer--Other than System for Award Management (JUL 2013)
(xiii) There are no additional contract requirements, terms or conditions.
(xiv) The Defense Priorities and Allocations System (DPAS) ratings are NOT APPLICABLE.
(xv) Quotes must be emailed to thomas.cossentino@va.gov and received no later than 4PM on 7/30/2018
Quotes may be submitted on this document (If you use this form, Include your company information name, address, phone number, POC, POC email, and DUNS #) or the vendor s own form.
If you are not the manufacturer than an AUTHORIZED DISTRIBUTOR LETTER needs to be provided with your quote in order to be considered for the award.
NO LATE QUOTES WILL BE ACCEPTED
(xvi) For information regarding the solicitation, please contact Thomas A. Cossentino at thomas.cossentino@va.gov

Thomas A. Cossentino
thomas.cossentino@va.gov

Thomas A. Cossentino

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