Attachment - SOW Corneal Topography Unit Terre Haute Pkg. 15.docx

FY21-15 l JSN: M6045 l Corneal Topography Unit

Veteran Health Indiana (VHI) Terre Haute VA Clinic Initial Outfitting, Transition & Activation Statement of Work Corneal Topography Unit (JSN: M6045)

Veteran Health Indiana 5080 Bill Far Drive Terre Haute, IN 47803 Terre Haute VA Clinic Project INtroduction Veteran Health Indiana (VHI) has a requirement to purchase Corneal Topography Unit (JSN: M6045) with an authorized vendor to supply and deliver the item(s) identified in Table 1 below. See salient characteristics below. This is a brand name or equal requirement. This requirement is in support of the activation of VHI Terre Haute VA Clinic Project. The new outpatient clinic has the need for one (1) Corneal Topography Units to be used by the Optometry Department. The OCULUS Inc. Pentacam AXL is the basis for design.

Table 1 – Package Items Summary

Additional Item Requirements The vendor will provide service manuals that includes theory of operation, maintenance requirements, repair information, schematics, part lists and troubleshooting information in electronic format for use by the VA IT Operations Department.

Date of manufacture must not be greater than 2 years before the purchase order date. The equipment must not be used or refurbished and must have the latest manufacturer’s software/hardware updates installed. Any batteries provided with the unit will not be manufactured more than 12 months before the purchase order issue date.

general conditions Site Address The address of the Terre Haute VA Clinic is provided below.

5080 Bill Far Drive Terre Haute, IN 47803 Delivery Schedule Items shall be delivered no earlier than the estimated delivery start date and no later than the delivery end date listed in Table 2 below.

Table 2 – Anticipated Building Outfitting Schedule

Schedule and Order Management The above delivery schedule is based upon the current construction schedule due to the nature of activation efforts and construction timelines and dates may vary and shift. Delivery dates need to be flexible. The delivery of items for installation are dependent upon the completion of applicable areas within the building. If there is a delay, the Contractor may be required to adjust the delivery date at no cost to the Government. The Contractor will coordinate with the on-site POC’s before delivery.

The awardees actual delivery dates will be confirmed by VA upon award.

Post-award, the vendor will coordinate delivery identified in this document with the VA prior to beginning any work (See Section 2.4). Once the dates have been confirmed, modifications to the schedule are subject to written approval by the CO, COR, and the vendor.

Delivery and Receiving Delivery and receipt of the proposed items is anticipated to be directed to the location identified below. Confirmation of delivery location will be provided post-award. To coordinate delivery, contact VA POC Julie Webb at (317) 988-2747, Julie.Webb@va.gov; SME Solutions POC Soren Nicholson at (719) 761-4387, Soren.Nicholson@sme-solutions.co; Robert Stonerook at (706) 304-7194, Robert.stonerook@sme-solutions.co; and Jerrell (Jeff) Cockrell at (636) 395-9761, Jerrell.cockrell@sme-solutions.co.

☒ Terre Haute VA Clinic (Direct Delivery to address detailed in paragraph 2.1)

☐IOT&A Contractor-Provided Warehouse The vendor is required to define the need for a staging area to accommodate item delivery, if needed. Post-award, this information will be confirmed with the vendor.

The delivery of items identified in this document shall take place during normal loading dock business hours which are defined as: 8:15 AM to 3:00 PM Eastern Standard Time, Monday through Friday, and excluding Federal Holidays Delivery trucks will not be permitted to remain at the loading dock. Trucks shall be unloaded, moved from the dock, and then brought back to the dock if required to haul out any waste, tools, or excess materials.

Labeling of delivered items shall include the VA facilities contract number and VA purchase order number for identification and reference upon receipt of product.

NOTE: Due to the COVID19 situation, masks are required to be worn by all individuals when in common areas on VA property. Any individuals who need to enter the building for installation &/or training will be required to be screened by the site staff prior to entry. Please allow time for this in your schedule.

Clean Up and Disposal There are no dumpsters available for vendor use.

The removal of waste and/or excess material shall be conducted through the loading dock area.

Assembly, Installation, and Calibration Required (Yes ☒ No ☐) The vendor is required to manage and coordinate installation at the VHI Terre Haute VA Clinic with the COR or his representative IOT&A POC.

On-site assembly and installation of items, and performance of services identified in this document shall take place during normal business hours which are defined as: 8:00 AM to 4:30 PM Eastern Standard Time, Monday through Friday, and excluding Federal Holidays.

Proposed installation date will occur after delivery of equipment. Current timeframe of delivery is August 18th, 2021 – September 17, 2021.

The vendor is required to define the need for a staging area to accommodate item assembly and installation, if needed. Post-award, this information will be confirmed with the vendor.

The vendor is required to provide tools, labor and materials to complete assembly and installation of the items detailed in this document.

The vendor shall protect all finished spaces and surfaces as required from delivery and installation damage. The vendor shall use covering and protection to the extent necessary to prevent damage to finished spaces. Any damage occurred during delivery and installation is the responsibility of the vendor. The vendor will be responsible for paying for and repairing any damage or noted deficiencies to finished spaces and surfaces that occur because of the vendor’s (or associated sub-contractors) installation.

During the entire duration of assembly and installation, the vendor will have a competent representative on-site as the vendor’s contact, and to serve as the interface between the vendor and the VHI Terre Haute VA Clinic. On-site representative can be the installer. All instructions provided from COR to the representative will be binding as if given to the vendor’s main contact. The COR may provide specific instructions, however, only the Contracting Officer may change the terms or conditions of the contract.

Training Required (Yes ☒ No ☐) The vendor is required to provide live clinical training on set up, operation, shut down, and troubleshooting procedures to nursing staff.

The vendor shall coordinate training dates with the on-site Project Manager. Post-award, these dates will be confirmed with the vendor to meet the clinical schedule. Proposed training date will occur after installation of equipment.

Current timeframe of training is October 2021.

The vendor shall provide documentation and/or certification to each staff member that has successfully completed the training.

Confidentiality and Non-Disclosure This equipment does connect to a VA network. Therefore, in accordance with Appendix A, Handbook 6500.6 Checklist, block 6, the C&A requirements do apply to this requirement, and a Security Accreditation Package is required.

This equipment does hold or store patient information. Therefore, in accordance with Appendix A, Handbook 6500.6 Checklist block 7, Appendix B and C provisions apply.

Appendix B: The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

Appendix C: VA will own this equipment. If vendor needs access during delivery, assembly, install or repair, the contractor shall be escorted by a VA employee to ensure there is no exposure to VA sensitive information. If the contractor is required to be on site for more than two consecutive days, VHA Privacy Training, TMS Course VA10203, is required and available at https://www.tms.va.gov/SecureAuth35/. The contractor will provide all consumable supplies necessary for training and competency assessment of hospital staff. Proof of training will be provided to the COR upon request.

Salient Characteristics M6045, Corneal Topography Unit Total Quantity: 1 ☒ Network Required if Checked ☒ Manufacturer Certified Installation Required if Checked ☒ BMET Training Required if Checked ☒ End User Training Required if Checked

Basis of Design is Oculus Inc. Pentacam AXL, MFG P/N: 70100-G Brand Name or equal Salient Characteristics:

Computerized corneal mapping system for pre- and post- surgical diagnosis of astigmatism, refractive error, irregularly shaped corneas and other eye conditions. The unit performs analysis of 5,000 - 6,000 different points on a ring pattern reflected from the patient's cornea to quantify the curvature and contours of the corneal surface.

· Contact-free

· All-in-one table-top device

· Single measuring operation for anterior segment tomography and optical biometry

· Integrated axial length measurement

· Automatic measurement activation

· Fast Screening Report to quickly identify abnormalities found in common pathologies

· IOL Calculator:

· Both treated and untreated eyes

· Spherical, aspherical, multifocal, and toric IOL calculation

· Toric IOL calculation based on total corneal refractive power

· Enhanced Ectasia Display required for:

· Early detection of corneal ectasia

· Detection of forme-fruste keratoconus

· Combines anterior and posterior corneal elevation data

· Tomographical Keratoconus Classification

· Belin ABCD Keratoconus Staging

a. Required for monitoring keratoconus progression after Corneal Cross Linking (CXL)

i. Anterior radius of the curvature

ii. Back radius of the curvature

iii. Corneal thickness

iv. Distance corrected visual acuity

· Belin ABCD Progression Display

a. Required for progress analysis after Corneal Cross Linking (CXL) treatment

b. Direct comparison of right and left eye

c. Must allow direct comparison of up to eight exams per eye (1-Anterior radius of curvature 2-Back/Posterior radius of curvature 3-Corneal thickness 4-Distance corrected visual acuity

· Qualitative assessment of the cornea for:

· Topography and Elevation Maps of the Anterior and Posterior Corneal Surface

· Overall pachymetry

· Corneal Optical Densitometry display

· Glaucoma screening to include:

· Pachymetry-based IOP correction

· Chamber angle and chamber volume

· Iridocorneal angle

· Display pachymetry progression to permit an assessment of corneal structure

· Elevation data

· PNS and 3D Cataract Analysis

· Opacities of the cornea, crystalline lens or of IOLs, PCO (posterior capsular opacification) are made visible by blue light illumination. This software allows automatic and objective three-dimensional measurement of the lens opacity. This parameter assists in the settings of phaco machines as well as femto laser assisted cataract surgery.

· Cataract Pre-OP display

· Premium IOL selection in 4 steps

· Spherical

· Multifocal

· Toric

· Aspherical

· Comparative displays for follow-up

· Required to show progression from multiple visits / procedures

· Comparison and superimposition of Scheimpflung images

· Contact Lens Fitting

· Parameters required: Refractive values, Central radii, Cornea Diameter

· Network ready (DICOM)

· EHMR Compliant Computer Requirements:

· Core i5 or higher (or equivalent and higher)

· M.2 SSD (solid state drive) 512gig or higher

· 16gig RAM

· 22” monitor screen or larger

· Ability to add software modules for future needs

· FDA approved

· Include Color LaserJet Printer

· Include Installation & Training

· Include Shipping & Handling

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