Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF DECEMBER 12, 2015 FBO #5132
DOCUMENT

65 -- Dual Chamber external pacemaker - Attachment

Notice Date

12/10/2015
 

Notice Type

Attachment
 

NAICS

339113 — Surgical Appliance and Supplies Manufacturing
 

Contracting Office

Department of Veterans Affairs;VAMC Providence;830 Chalkstone Avenue;Providence RI 02908
 

ZIP Code

02908
 

Solicitation Number

VA24116N0089
 

Response Due

12/14/2015
 

Archive Date

1/13/2016
 

Point of Contact

Michael Stephens
 

E-Mail Address

3-7100<br
 

Small Business Set-Aside

N/A
 

Description

Department of Veterans Affairs Veterans Health Administration Sources Sought Notice - Pacemaker - Medtronic Dual Chamber external pacemaker with single and dual chamber capability This is a Sources Sought notice and not a request for quotes. This request is solely for the purpose of conducting market research to enhance VHA's understanding of the market's offered products, services and capabilities. The Government will not pay any costs for responses submitted in response to this Sources Sought. This Sources Sought notice provides an opportunity for respondents to submit their notice of ability, and their available products and services in response to the requirement described below. Vendors are being invited to submit information relative to their potential of fulfilling the requirement below, in the form of a capability response that addresses the specific requirement identified in this Sources Sought. The Veterans Health Administration (VHA) is seeking a vendor to provide the following products and services below, brand name or equal in specifications. Please see the General Requirements section below for the requested products/services and descriptions. This Sources Sought is to facilitate the Contracting Officer's review of the market base, for acquisition planning, size determination, and procurement strategy. GENERAL REQUIREMENTS - BRAND NAME OR EQUAL SUBMISSION The Department of Veterans Affairs is seeking vendors who can provide the following line items, brand name or equal, based on the descriptions below. All brand name or equal responses shall meet or exceed the required specifications/features. 5392 Kit - The Dual Chamber model 5392 is the next generation temporary pacemaker with both single and dual chamber pacing capability. It has enhanced user interface with improved visibility and increased responsiveness. It also features an improved low battery indicator. RESPONSE COMMITMENT I.NOTES: A.All questions, comments or concerns should be directed to: Michael.Stephens@va.gov B.Submittals furnished will not be returned to the sender. No debriefs will be conducted. Eligibility in participating in a future acquisition does not depend upon a response to this notice. C.Proprietary information is neither requested nor desired. If such information is submitted, it must clearly be marked "proprietary" on every sheet containing such information, and the proprietary information must be segregated to the maximum extent practicable from other portions of the response (e.g., use an attachment or exhibit). II.TIMELINE : A.This request will close on stated date within the Government Point of Entry (GPE). III.Requested information: Interested parties shall provide the following information in addition to your capability response: A.Format: 1.MS Word or pdf format (please ensure email is under 5 mb) 2.Page limit - 5-8 pages (please make the response as brief and concise as possible) 3.Company name and Sources Sought number listed on each page 4.Proprietary information MUST be marked as such, on a page-by-page basis. B.Submittal: 1.In your response, please provide the following information based on the requirement. a.Your company's capability of fulfilling this requirement and providing the products as it is described. b.If you are submitting an equal product, please provide detailed information, specs, brochures, etc., for all of your equal items/products. c.Does your company carry these products on the FSS schedule? 2.Please also provide name of company, company address, a contact person's name, telephone number, fax number and email address. 3.DUNS number, and indicate if actively registered on System for award management (SAM) 4.Contractual vehicles the company holds, such as NAC or GSA schedules. 5.Socio-economic Status & NAICS Code: State the size of your company [e.g., 8(a) (including graduation date), HUBZone-certified small business, Service-Disabled Veteran-Owned small business, small business, large business, etc.]. Notes: 1. This Sources Sought is for planning purposes only, and does not constitute a commitment, implied or otherwise, that a procurement action will follow. The Department of Veterans Affairs will use the information submitted in response to this notice at its discretion and will not provide comments to any submission; however, The Department of Veterans Affairs reserves the right to contact any respondent to this notice for the sole purpose of enhancing The Department of Veteran Affairs understanding of the notice submission. 2. The content of any responses to this notice may be reflected in any subsequent solicitation, except for content marked or designated as business confidential or proprietary which will be fully protected from release outside the government. The Department of Veteran Affairs Contracting Office POC: Michael Stephens Contracting Specialist Email: Michael.Stephens3@va.gov Statement of Work Dual Chamber External Pacemaker replacement "Objectives The objective of this requirement is to purchase 9 dual chamber external pacemakers to replace the existing end of single and dual chamber pacemakers at the West Haven campus of VA Connecticut Healthcare system. "Scope Vendor shall work with Medical Center to implement the installation of: o9 Dual Chamber external pacemakers model 5392 with minimum of 1 year warranty "Capable of doing both single and dual chamber pacing oDelivery charges oInitial onsite clinical education on External pacemakers oTrade-in credit for existing 6 Medtronic single and 3 dual chamber external pacemakers "Schedule All service and/or installation is to be pre-scheduled (by vendor with agreement by customer) to have minimal impact on existing Medical Care functions. Ideally service can be conducted during the work day of 8am to 5pm. During warranty period, vendor will provide all servicing repairs to restore the full use of the device, if there are any breakdowns in function. All repairs are to be physically started within 12 hours of notification (or 8 business hours, whichever is shorter), and completed within 24 hours (or 8 business hours after start for repair). Telephone support is to be available via a response within two hours of leaving a message with the vendor call center. Service is to be requested and coordinated only through the designated Contracting Officer Technical Representative (COTR), so as to be assured that it is covered within the scope of the contract (work day 8-5 typical), and so that records are available for inspection by accrediting organizations. Any services not coordinated by the COTR will not be considered completed, and will be considered to fail to meet the terms of the contract. "General All persons servicing the device shall be able to provide proof of competency, as shown by training conducted on said system. Proof shall be provided upon demand, and be immediately sent via fax, upon demand. It is anticipated that any hospital regulatory inspections (JCAH, etc.) will have the vendor providing proof that they meet industry standards of quality, and traceable standards, as used to calibrate this device-system; at the time of the maintenance event. Technicians servicing the system will be able to provide proof that they meet the standards of Information, and Background Security (investigation via the NACL process), and Hospital Environment Safety as required of all systems service in a Federal Government facility, or a regulated hospital environment. "Information Security Requirements - as mandated: 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. 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. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS a.A contractor/subcontrator 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. 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. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE a.For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor's security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COTR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA's network involving VA information must be reviewed and approved by VA prior to implementation. b.Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII. c.Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor's systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government-owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks. d.The contractor/subcontractor's system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA's POA&M management process. The contractor/subcontractor must use VA's POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re-authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary. e.The contractor/subcontractor must conduct an annual self assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COTR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost. f.VA prohibits the installation and use of personally-owned or contractor/subcontractor-owned equipment or software on VA's network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA- approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE. g.All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract. h.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: (1)Vendor must accept the system without the drive; (2)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 (3)VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. (4) 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; (a)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 (b)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. (c)A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation. 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. 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. SECURITY CONTROLS COMPLIANCE TESTING On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-day's notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time. 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 SecurityAwareness 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.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PrVMAC650/PrVAMC650/VA24116N0089/listing.html)
 

Document(s)

Attachment
 

File Name: VA241-16-N-0089 VA241-16-N-0089.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2458327&FileName=VA241-16-N-0089-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2458327&FileName=VA241-16-N-0089-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: VA Medical Center;950 Campbell Ave;West Haven, CT

Zip Code: 06516-2770
 

Record

SN03966516-W 20151212/151210234555-c211f70156bb39e7d5f71291bc0c7489 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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