DOCUMENT
65 -- CIRRUS - Attachment
- Notice Date
- 8/23/2017
- Notice Type
- Attachment
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- Department of Veterans Affairs;Network Contracting Office 4;1010 DELAFIELD ROAD;PITTSBURGH, PA 15215
- ZIP Code
- 15215
- Solicitation Number
- VA24417Q1561
- Response Due
- 8/30/2017
- Archive Date
- 9/14/2017
- Point of Contact
- AMANDA SAUNDERS
- Small Business Set-Aside
- Service-Disabled Veteran-Owned Small Business
- Description
- COMBINED SYNOPSIS SOLICITATION (i) This is a combined synopsis/solicitation for CIRRUS, BRAND NAME OR EQUAL, 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 VA244-17-Q-1561 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 1000. (v) Contract Line Items (CLIN): ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 Zeiss OS: Cirrus HD-OCT Model 5000 with AngioPlex OCT LOCAL STOCK NUMBER: 266002-1161-980-PRO 1.00 EA __________________ __________________ 0002 ZEISS OS \F\ FORUM BI-DIRECTIONAL DICOM INTERFACE LICENSE TO\F\ CZM INSTRUMENT (V3) \F\ EA\F\ LOCAL STOCK NUMBER: 306601-8530-101-PRO 1.00 EA __________________ __________________ GRAND TOTAL __________________ DELIVERY SCHEDULE ITEM NUMBER QUANTITY DELIVERY DATE 0001 SHIP TO: 460 WILMINGTON DEPARTMENT OF VETERANS AFFAIRS WILMINGTON VA MEDICAL CENTER /5th Floor Optometry 1601 KIRKWOOD HWY WILMINGTON, DE 19805 USA 1.00 30 DAYS ARO MARK FOR: (302) 994-2511 4457 lashaunda.isaac@va.gov 0002 SHIP TO: SAME AS CLIN 0001 1.00 SAME AS CLIN 0001 (vi) Comparable products must be Brand Name or Equal in the following specifications: STATEMENT OF NEED GENERAL: The Optometry Department, located within the Wilmington VAMC, Wilmington, DE proposes purchasing an purchase an Optical Coherent Tomograph (OCT) with Angioplex and retinal camera and software that accompanies this system to work properly for the Optometry clinic in Wilmington. This device is an imaging tool used to visualize arteries and veins in the eye. This would allow providers to make accurate diagnoses. SPECIFICATIONS: Capability to capture and provide OCT Angiography in 1 single image (without motion tracking scan) to allow for visualization of both microvascular and structural information in a noninvasive dye free scan by the OCT. Capability to import and integrate the Cirrus Model HD OCT 4000 raw data. The raw data must be available and interchangeable between the Cirrus 4000 and Cirrus 5000 unit (or new unit being procured). Ability to import and integrate the Current Cirrus Model HD OCT 5000 raw data. The raw data must be interchangeable between the new unit and existing Cirrus 5000 equipment currently owned on site so that one database is shared between all of the OCT units within either FORUM as well as available on the each Cirrus 5000 so that the exact same data is acquired and integrated between the new unit and current Cirrus 5000 units presently used on site. Ability to store RAW Data in FORUM PACS for manipulation within FORUM Retina Workplace Application. Ability to store RAW Data in FORUM PACS for Manipulation within CIRRUS Review Software. Ability to store RAW Data in FORUM PACS for Manipulation within FORUM Glaucoma Workplace. Integration of data must offer the ability to compare 8 tests in one glance under the GPA Glaucoma Progression Analysis in one view. Ability to provide a report for Ganglion Cell Analysis that is derived from a scan must be comprised of 6mmx6mm cube scan with a minimum by 200x200 line scan pattern with no more than 30 microns between each slice. Total data points for Ganglion Cell Scan must be at minimum over 40 million data points. Minimum pupil requirements as low as 2.0mm. The unit must have and built-in LSO Fundus Camera (Line Scanning Laser Ophthalmoscope). The unit offers the ability to merge with the Humphrey Visual Field unit to provide a 1 page report within FORUM that is inclusive of Structure and Function one 1 page printout. HARDWARE SOFTWARE REQUIREMENTS The unit must be a spectral domain OCT The unit s A-scan depth needs to be 2.0mm (in tissue) with 1024 points Fundus Imaging: Methodology - Line scanning ophthalmoscope (LSO) Live fundus image - during alignment and during OCT scan Field of view - 36 degrees Wx 30 degrees H Iris Imaging: Methodology - CCD Camera Resolution - 1280 x 1024 Live iris image - During alignment Fixation parameter needs: Internal fixation focus adjustment - -20D to +20D (diopters) Additional required needs: Capture and provide OCT angiography which allows for visualization of both micro vascular and structural information in a non-invasive dye free scan. Provide exact macular scan patterns of 128 B-scans by 512 A-scans with exact scanning speeds at 27,000 scans per second. Must be a 90-degree configuration, ergonomically correct for technician operation. Must have a wireless mouse configuration Must be a self-contained unit. Provide an automated glaucoma scan report on the same page with HFA 750i and/or HFA3 860 Ability to produce Guided Progression Analysis (GPA); display the forecasted Measurements in future years (trend analysis is not acceptable). Must be FDA approved for use on patients. DELIVERY: The contractor shall deliver all items at no additional cost. All deliveries shall be made Monday- Friday, 8:00 a.m. 3:30 p.m. 3. PRICING SCHEDULE: VA anticipates award of a contract on a firm fixed unit price basis. 4. PERFORMANCE, DELIVERY, INSPECTION AND ACCEPTANCE: 4.1 The contractor will provide all materials required to completely install and make fully operational ZEISS OS Cirrus HS system. Backorders: If there is a backorder on any of the requested items, the contractor must contact the VA no later than 24 hours. The contractor will offer the VA substitute of equal or higher quality. If acceptable to the VA, the substitute may be made part of the contract with a bilateral modification. 4.2 Warranty: The contractor warrants/guarantees all items against defective material and/or workmanship for a minimum of one year from the date of receipt. The contractor agrees to furnish without additional cost to the government, all labor and materials necessary to correct defects that were detected during the guarantee period. The Contractor shall immediately notify all affected VA s and contracting activities in the event of a product recall, removal, required adjustments, or required modification that is suggested or mandated by the contractor, distributor, manufacturer, or any regulatory or official agency. The information that shall be included in this notification include: A complete item description, identification. Administrative identification data including contract number, order numbers, and order date. Reasons for recall, removal, adjustment, or modification. Instructions for appropriate corrective action. 5. EDUCATION/ TRAINING: 5.1 The contractor shall provide any and all technical training required in order for VA staff to fully utilize the equipment. The training, OCT with Angioplex, will include 3 optometry staff over a four hour period on the day of installation. The contractor will provide installation and face to face training on the equipment. SECURITY & TRAINING REQUIREMENTS 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). 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: Vendor must accept the system without the drive; 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 VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. 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; 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 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 pre-approved and described in the purchase order or contract. 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. 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. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $______ per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: (1) Notification; (2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports; (3) Data breach analysis; (4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution; (5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and (6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. TRAINING All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems: Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems; Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training; Successfully complete the appropriate VA privacy training and annually complete required privacy training; and Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.] The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete. Complete VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information training by using VA s TMS system (https://www.tms.va.gov/). Contractors may use the TMS Managed Self Enrollment method to complete the training in TMS. The COR must ensure that all contractors are validated in the PIH domain. Complete the hard copy version of VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information. Signed training documents must be submitted to the COR. Training must be completed prior to the performance of the contract and annually thereafter. Proof of training completion must be verified and tracked by the COR. A BAA is not required since the purpose of this contract is for healthcare operations specifically tied to treatment. (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: 52.211-6 Brand Name or Equal (AUG 1999) 52.214-21 Descriptive Literature (APR 2002) 852.211-73 Brand Name or Equal. (JAN 2008) 852-219-10 VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside (ix) Evaluation of this requirement will be based on PRICE ONLY. (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) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (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 amanda.saunders@va.gov and received no later than NOON EST on 8/30/2017. Quotes may be submitted on this document or the vendor s own form. NO LATES WILL BE ACCEPTED (xvi) For information regarding the solicitation, please contact Amanda Saunders at amanda.saunders@va.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PiVAMC646/PiVAMC646/VA24417Q1561/listing.html)
- Document(s)
- Attachment
- File Name: VA244-17-Q-1561 VA244-17-Q-1561.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3751967&FileName=VA244-17-Q-1561-000.docx)
- Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3751967&FileName=VA244-17-Q-1561-000.docx
- Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
- File Name: VA244-17-Q-1561 VA244-17-Q-1561.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3751967&FileName=VA244-17-Q-1561-000.docx)
- Place of Performance
- Address: WILMINGTON VA MEDICAL CENTER;1601 KIRKWOOD HWY;WILMINGTON, DE
- Zip Code: 19805
- Zip Code: 19805
- Record
- SN04643244-W 20170825/170823233351-c5d980cb71beb2bded627ffbdfdaee15 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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