36C24718Q9566-001.pdf

STATEMENT OF WORK

Ophthalmic Image and Data Management System

Planning UID: VA-18-00039347

Funding UID: 534-18-2-2290-0021

EER: 32850

Ralph H. Johnson VA Medical Center, Charleston SC

A. PURPOSE

The purpose is to procure a comprehensive, integrated ophthalmic image and data management system for the Ralph H.

Johnson VA Medical Center located at 109 Bee St., Charleston, SC and eye clinics located at the RHJVAMC’s community based outpatient clinics. System must interface with the RHJVAMCs electronic medical record and existing eye equipment enabling consolidated storage, transfer, review and analysis of eye tests and exams conducted at any of the above-listed sites. The Contractor shall provide all necessary tools, interfaces, equipment/hardware, software, licenses, delivery, installation, warranty, and training.

B. BACKGROUND

The RHJVAMC and its CBOCs have many 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 workflow that yields less than optimal image quality after scanning. Furthermore, accessing the scanned data is cumbersome for the eye physicians. 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 RHJVAMC electronic medical record. The system should also facilitate review of the data by eye care providers for treatment decision making purposes.

RHJVAMC’s Eye Clinics are requesting an eye care data management computer interface for its ZEISS systems that it currently does not have. Ophthalmology’s current ZEISS equipment (including CIRRUS 5000 HD OCT tomography scanning systems and Humphrey HFA ophthalmic perimeters) currently have minimal communication with PACS. This service requires an image and data management system to store and access raw data from the ZEISS legacy instruments. This equipment will provide better access to care for the Veterans and allow us to meet access measure per VA directives.

C. PERFORMANCE PERIOD

Work at the Government site shall not take place on Federal holidays unless directed by the Contracting Officer (CO).

Contractor may work outside normal business hours as mentioned in the quotation. Any additional charges beyond the quoted amount must have prior approval by the CO/COR. Performance Period expected to be early FY18 Q4, starting at an estimated July 01, 2018 and lasting 5 days for vendor to complete installation and training.

D. TYPE OF CONTRACT

Firm-Fixed Price

E. SCOPE

Contractor must supply, install, and train staff on the use of eye image and data management system at the RHJVAMC as well as its community based outpatient clinics.

a. As per the Brand Name J&A, the suggested OEM is Zeiss. The items preferred are Zeiss Forum Archive Version 4.2 OR EQUAL, Zeiss Forum Archive Glaucoma Workplace, Zeiss Cataract Suite, and Zeiss Retina Workplace.

b. All products must meet all salient characteristics defined in Section F.

The contractor shall provide on-site installation, staff training, and unlimited phone support throughout the upgrade process.

The process may vary depending on specific needs of the RHJVAMC, but shall include the following at a minimum:

i. The contractor will provide the Image and Data Management System on a CD/DVD or another agreed upon media method by the vendor and VA. A copy of the software will be archived by the VA.

ii. Designated VA HTM/IT staff will install the application on a Windows Server 2016 R2 virtual server.

iii. The server and associated VistA elements shall be configured in accordance to VA requirements.

iv. An isolated test patient run will be performed to verify successful data transfer.

v. Upon successful testing, the application will be implemented for full operation.

The contractor shall conduct a coordination call to help identify any variation needed. The coordination call shall be conducted within 14 calendar days of the contract award, as scheduled by the RHJ VAMC Healthcare Technology Management Service and contractor. If there are no foreseen delays, the upgrade process shall be scheduled to begin within 30 calendar days after the coordination call.

F. SPECIFICATIONS AND SALIENT CHARACTERISTICS

1. The system will provide eye exam and testing data viewing stations for exam rooms and staff workstations

2. Single Server Configuration @ Main Site – Cache Server & CBOC

3. Support integrated review of multiple glaucoma-related tests (visual fields, OCT scans, fundus images) by a provider to facilitate treatment decision making

4. The eye data management system will integrate, save, and upload test and examination data from all sites and equipment.

5. The equipment shall be compatible with the equipment, infrastructure, and supplies already in use at the RHJVAMC and named outpatient clinics.

Characteristics requirements for Zeiss Forum Image and Data Management System:

• Image and Data Management/PACS System must be FDA 510k approved and listed as a Medical Device.

• Image and Data Management System/ PACS must provide “Post Processing Analysis, Dynamic Review/Manipulation of RAW data” functionality for ZEISS Cirrus HD-OCT. Glaucoma must also provide quoted analysis for the ZEISS HFA Instruments as well.

• Image and Data Management/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.

• Image and Data Management/PACS System must have functionality to enable real-time and dynamic editing/manipulation of all prior Visual Field Test data for all Glaucoma patients and allow for Baseline changes, real-time report generation for any VFI date, display RealEye images and data from the new ZEISS HFA 3 instruments.

• Image and Data Management System must support DICOM standards and Work-List functionality to create and send patient demographics to a specific or all instruments via a DICOM work-list within the eye clinic’s network.

• Combined Report: HFA-Cirrus reports for Structure Function analyses in Single Display with OD-OS on one (1) page print out from data of Cirrus HD OCT and a Humphrey Visual Field. If Combined Report is procured as option of FORUM.

• Image and Data Management System must have Bi-directional DICOM capabilities to send both DICOM Modality Work-lists containing Consult/Order details to instruments within the eye-clinics network and receive back the diagnostic test results and RAW data for storage within the Image and Data Management System for access.

• Image and Data Management/PACS System must connect to any brand of non-DICOM diagnostic instrument with export capabilities, and convert the diagnostic test results into a DICOM compatible file containing all patient demographical information, UID’s, Accession number, Device name and type, laterality and other key pieces of data with the least amount of user interaction.

• Image and Data Management/PACS System must not require the use of an external PC or import computer for a DICOM compatible modality.

• Image and Data Management/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 Image and Data Management/PACS System.

• Image and Data Management/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 within the Image and Data

Management System if Glaucoma Workplace is procured as a part of FORUM

• Image and Data Management /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.

• Image and Data Management /PACS must be able to display and allow the clinician to scroll through the various ZEISS Cirrus

Macula Cube B-scan slices, within in the Image and Data Management System viewer.

• Image and Data Management /PACS System must be able to display all Cirrus HD-OCT past and present test data from one or more ZEISS Cirrus instruments located in one or more clinics. This date must be accessible to enable viewing and manipulation at the workstation.

• Image and Data Management /PACS System must be able to automatically label images and reports coming from the instruments DICOM Header to enable the clinician to sort test data by visit date/s, modality type/s, right eye, left eye or both eyes.

• Image and Data Management /PACS System must be able to tag individual test reports/images as Favorites to enable easy access on future patient visits

• Image and Data Management System must be able to display images in pre-formatted clinical display groupings for

Glaucoma, Retina and Cataract cases.

G. SYSTEM REQUIREMENTS

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

H. TRAINING

1. Contractor shall provide comprehensive training on the use of the equipment for the operating clinicians. This training program shall include at the minimum the following: (i) Technical Training, (ii) Operational Training, and (iii) Hardware and Software Trouble-shooting. Training shall occur onsite during normal business hours, 8:00am-4:30pm, Monday through Friday. Competency assessments shall be provided with the training.

2. 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 diagnostics exercises. Competency assessments shall be provided with the training.

I. TESTING AND CERTIFICATION

Upon installation of each piece of equipment in the system, the Contractor shall notify the COR in writing that the system is ready for acceptance testing, and that it meets all requirements as specified. Upon receipt of this notification, RHJVAMC 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.

J. GOVERNMENT ACCEPTANCE TEST

Contractor shall perform the 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 piece of equipment. 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.

K. INSTALLATION

1. Contractor shall provide all labor, materials, tools, equipment and etc. to prepare for the installation of the equipment at the RHJVAMC and the named community VA clinics.

2. Contractor will install all equipment and ensure that it is fully operational. Status will be verified by HTM

3. All employees of general contractor and subcontractors shall comply with the RHJVAMC policy on Healthcare Industry Representatives, including, but not limited to, vendor credentialing, check-in procedures when at the facility, and display of name badges.

4. Contractor shall be responsible for removing all packing materials and related waste and dispose of offsite.

L. EVALUATION CRITERIA

1. Technical Capability

a) Image Quality

b) System Speed and Reliability

c) Integrated Data Functions

d) Patient Safety features

e) Integration with existing ophthalmic surgery equipment, infrastructure and supplies

2. Past Performance

3. Proximity of service personnel

4. Warranty

M. CHANGES TO STATEMENT OF WORK

Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

N. CONTRACTOR EXPERIENCE REQUIREMENTS

KEY PERSONNEL

Key personnel will be identified in the proposal and shall be considered key personnel essential for the successful completion of the work performed under the contract. The contractor agrees that such personnel shall not be removed, diverted or replaced from the work without prior written approval of the Contracting Officer. The contractor shall submit written notice of proposed personnel changes to the Contracting Officer for approval at least thirty (30) business days in advance.

WORK HOURS

The services covered by this contract shall be furnished by the contractor as defined herein. The contractor shall not be required, except in case of emergency, to furnish such services on a Federal Holiday or during off duty hours as described below.

The following terms have the following meanings:

(1) Normal working hours: Monday through Friday, 8:00 a.m. – 4:30 p.m., excluding federal holidays.

(2) Federal Holidays: The 10 holidays observed by the Federal Government are:

New Year’s Day Martin Luther King’s Day President’s Day Memorial Day

Independence Day Labor Day Columbus Day Veterans Day

Thanksgiving Day Christmas Day

Any other day specifically declared by the President of the United States to be a federal holiday. When one of the holidays falls on 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.

NOTE

Payment of invoices may be delayed if the requirements are not properly completed or communicated with the Healthcare

Technology Management Service as required above.

CONTRACTOR STATUS

The contractor must have an “Active” Status in the System for Award Management (www.sam.gov). The contractor must have an established business, with an office and full-time staff. If subcontractors are used, the CO must approve them in advance.

O. REPORTING

The field service engineer shall report to the HTM service at Ralph H. Johnson VA Medical Center in Charleston, SC. A service report and invoice shall be provided at the completion of the work.

http://www.sam.gov/