6540--6540 - Notice of Intent to Sole Source Zeiss Eye Microscope CAVHCS Montgomery Alabama

***NOTICE OF INTENT TO SOLE SOURCE*** Synopsis: The Department of Veterans Affairs; RPO-E, Network Contracting Office (NCO) 7, located at 215 Perry Hill Road, Montgomery, Alabama 36109 intends to award a firm-fixed price sole source requirement to: PROAIM America, LLC. 16024 Manchester Road Suite 2000 Saint Louis, MO 63011 STATEMENT OF WORK GENERAL INFORMATION Purpose: Ophthalmology at Central Alabama Veterans Health Care System (CAVHCS), 215 Perry Hill Road, Montgomery, Alabama 36109 requires the brand name only purchase of a new Zeiss Anterior OPMI Lumera 700 surgical microscope system with CALLISTO Eye. Scope of Work: The contractor shall provide all resources necessary to accomplish the deliverables described in this statement of work (SOW), except as may otherwise be specified. Contractor shall procure, deliver, and install all software and hardware specified in this SOW. The contract will include all planning, labor travel, parts, and equipment required to provide and implement a digital surgical microscope. The contract shall include comprehensive device testing. The contractor shall also include clinical in-service for surgeons/ end users; the contract shall include any required on-going education and in-case support necessary to properly train surgeons thus that they may utilize the provided digital microscope safely and successfully without vendor support. The digital surgical microscope shall meet any technical and clinical elements, specific tasks, and terms and conditions included in the SOW for this procurement. Background: CAVHCS Ophthalmology currently utilizes a Zeiss OPMI Lumera microscope system in the OR for cataract surgeries. Ophthalmology is seeking an additional Zeiss microscope system with CALLISTO Eye for this requirement. Performance Period: Delivery of all items should be completed within 120 days from date of award. Implementation should be completed within 60 days after delivery. Type of Contract: Firm-Fixed-Price. Place of Performance: Delivery will be made to Central Alabama Veterans Health Care System (CAVHCS), 215 Perry Hill Road, Montgomery, Alabama 36109. Set-up/installation will be performed in Building 1, OR Suite. Hours of Operation: Warehouse deliveries are accepted between 8am and 3:30pm, Monday through Friday, excluding federal holidays. Hospital normal hours of operation are between 8am and 4:30pm, Monday through Friday, excluding federal holidays. Federal Holidays New Year s Day January 1st Martin Luther King s Birthday 3rd Monday in January President s Day 3rd Monday in February Memorial Day Last Monday in May Juneteenth June 19th Independence Day July 4th Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veteran s Day November 11th Thanksgiving Day Last Thursday in November Christmas Day December 25th REQUIREMENTS Technical and Implementation Elements Zeiss Anterior OPMI Lumera 700 Surgical Microscope System with CALLISTO Eye The microscope system shall be capable of software/computer aided cataract surgery. The microscope system and CALLISTO Eye shall be mounted on a rolling stand/cart. CALLISTO Eye shall be capable of DICOM image transfers. It will include any required DICOM software and licensing in order to utilize DICOM workflow within the VA setting. The proposed system shall be capable of interfacing with a Technical Reference Model (TRM) approved middleware that allows for enhanced ophthalmic workflow and image management. The middleware shall also have an approved Enterprise Risk Assessment (ERA) on file with VA thus that it may be implemented within the VA IT environment. Components include: Item Code Description 000000-2306-382-01PL7ANT CARL ZEISS MEDITEC USA ANTERIOR OPMI LUMERA 700 MICROSCOPE SYSTEM 000000-2306-382-10SCIXEN XENON SUPERLUX EYE 000000-2306-382-10LS2LED LED LIGHT SOURCE 000000-2306-382-10FCPWLS WIRELESS FOOT CONTROL 000000-2306-382-10FCPC3M 3M CABLE 000000-2306-382-10OHDISP OVERHEAD DISPLAY 000000-2306-382-90O200MM OBJECTIVE LENS F=200MM 000000-2306-382-90T180TS 180° TILTABLE TUBE 000000-2306-382-90EP10XM 10X EYE PIECES 000000-2306-382-20ASIWEZ ASSISTANT SCOPE W/ELEC ZOOM 000000-2306-382-90T180TA 180° TILTABLE TUBE (ASSISTANT) 000000-2306-382-90EP10XA 10X EYE PIECES (ASSISTANT) 000000-2306-382-30IDISYS INT. DATA INJECTION SYSTEM 000000-2306-382-30IKERAS INTEGRATED KERATOSCOPE RING 000000-2306-382-40TEHD3C INT. 3-CHIP HD CAMERA MEDILIVE 000000-2306-382-40USB1TB EXTERNAL MINI HDD USB 1TB 000000-2306-382-50CV372B CALLISTO EYE SOFTWARE VERSION 3.7.2 000000-2306-382-50CLICML ASSISTANCE MARKERLESS LICENSE 000000-2306-382-50CEONFS CALLISTO EYE ON FLOOR STAND 000000-2306-382-60ACBSET BASIC ASEPSIS SET 000000-2306-382-60CABSET SET OF CABLE BINDERS 000000-2306-382-10TILTMO MOTORIZED TILT 000000-1999-065 OPTIME SERVICE COMPLETE 1 YR 266002-1150-893 CALLISTO EYE - FORUM CONNECTION: ENTERPRISE ARCHITECTURE FOR DATA MANAGEMENT WORKFLOW, EHR INTEGRATION AND INSTRUMENT CONNECTIVITY 000000-2244-886-40FCZDIC FORUM-DICOM INTERFACE LICENSE TO CZM INSTRUMENT (V3) Implementation Requirements: Contractor is responsible for installation and configuration of the new microscope system. Only Original Equipment Manufacturer (OEM) trained Field Support staff may complete installation and configuration work. Contractor is responsible for installing and configuring all provided hardware and system software. Contractor is responsible for comprehensive system testing for the newly provided system. Testing documentation shall be provided to CAVHCS Biomedical Engineering prior to acceptance of equipment. Contractor shall certify that the microscope is safe and ready for use on patients. Contractor is responsible for providing in-service/training to CAVHCS surgeons, end-users and Biomedical Engineering staff. Contractor shall provide on-site training and support with CAVHCS surgeons during multiple surgical cases with the newly provided microscope system. Other Specific Tasks and Terms/ Conditions Contractor shall provide a listing of all recalls, Safety Alerts, and Field Engineering Change Notices pertaining to the proposed digital surgical microscope for the past 12 months. Contractor shall provide a copy of all service literature, including any necessary service and maintenance software, keys, and or passwords. Cleaning and disinfecting protocols for the proposed digital surgical microscope shall be provided and demonstrated to staff by the offering vendor. A list of acceptable cleaning and disinfecting chemistries shall be included with the purchase of the proposed systems. Contractor shall provide sterilization guides/ Instructions for Use (IFUs) for any equipment/ accessories included in the procurement that require sterilization and or high-level disinfection (HLD). All work shall be performed in a professional manner by an authorized service representative. If any deficiencies are found due to negligence of the service representative, the contractor shall be required to correct the deficiency to a fully operational status in accordance with manufacturer specifications at no additional cost to the Veteran Affairs (VA). The contractor shall present a neat appearance commensurate with that required of a professional. Contractor personnel shall comply with medical treatment facility policies regarding personal appearance and conduct. Smoking Policy Enforcement: Smoking is prohibited within the medical center and grounds. Safety shall be performed in accordance with NFPA 99, Chapter 7. This regulation can be reviewed in full text at the Biomedical Engineering Office. When required, the contractor s service representative shall comply with the Occupational Safety and Health Administration lockout/tagout standards while performing maintenance on equipment. The VA and the contractor s service representative shall exchange hazard communication information before the commencement of any repair. INVOICES 1. Payment will be made upon receipt of a properly prepared detailed invoice, prepared by the Contractor, validated by the Contracting Officer s Representative (COR), and submitted electronically through OB-10 (https://portal.tungsten-network.com/). 2. A properly prepared invoice will contain: a) Invoice Number and Date b) Contractor s Name and Address b) Accurate Purchase Order Number c) Supply or Service provided d) Total Amount Due SECURITY MARCH 12, 2010 VA HANDBOOK 6500.6 APPENDIX B VA ACQUISITION REGULATION SOLICITATION PROVISION AND CONTRACT CLAUSE NOTE: This clause will undergo official rule making by the Office of Acquisitions and Logistics. The below language will be submitted for public review through the Federal Register. The final wording of the clause may be changed from what is outlined below based on public review and comment. Once approved, the final language in the clause can be obtained from the Office of Acquisitions and Logistics Programs and Policy. 1. SUBPART 839.2 INFORMATION AND INFORMATION TECHNOLOGY SECURITY REQUIREMENTS 839.201 Contract clause for Information and Information Technology Security: a. Due to the threat of data breach, compromise or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with Federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format (e.g., paper, microfiche, electronic or magnetic portable media). b. In solicitations and contracts where VA Sensitive Information or Information Technology will be accessed or utilized, the CO shall insert the clause found at 852.273-75, Security Requirements for Unclassified Information Technology Resources. 2. 852.273-75 - SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES (INTERIM- OCTOBER 2008) As prescribed in 839.201, insert the following clause: 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. (END OF CLAUSE) MARCH 12, 2010 VA HANDBOOK 6500.6 APPENDIX C 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/subcontractor 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. c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness. d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor. e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. 3. VA INFORMATION CUSTODIAL LANGUAGE a. 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). 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 on site 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 to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. i. The contractor/subcontractor s firewall and Web services security controls, if applicable, shall meet or exceed VA s minimum requirements. VA Configuration Guidelines are available upon request. j. 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. l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR. 4. 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 other 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. 5. LIQUIDATED DAMAGES FOR DATA BREACH a. 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. b. The contractor/subcontractor shall provide notice to VA of a security incident as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination. c. Each risk analysis shall address all relevant information concerning the data breach, including the following: (1) Nature of the event (loss, theft, unauthorized access); (2) Description of the event, including: (a) date of occurrence; (b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; (3) Number of individuals affected or potentially affected; (4) Names of individuals or groups affected or potentially affected; (5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text; (6) Amount of time the data has been out of VA control; (7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); (8) Known misuses of data containing sensitive personal information, if any; (9) Assessment of the potential harm to the affected individuals; (10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and (11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised. d. 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 $37.50 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. 6. TRAINING a. 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: (1) 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; (2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training; (3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and (4) 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.] b. 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. c. 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. The C&A requirements do not apply and that a Security Accreditation Package is not required. The applicable NAICS code for this procurement is 334510 with a business size standard of 1250. The proposed contract is for Zeiss Anterior OPMI Lumera 700 Surgical Microscope System w/Callisto Eye for which the Government intends to solicit with a single source award to a Small Business This notice of intent is NOT a request for competitive proposals. If you have questions, please contact Contracting Officer Joseph Horn at contact@example.gov . Telephone requests or inquires will NOT be accepted.