Intraoperative Neuromonitoring Service (IONM) Cleveland VA Medical Center (LSCVAMC) located at 10701 East Blvd. Cleveland Ohio 44106
The Louis Stokes Cleveland VA Medical Center (LSCVAMC) located at 10701 East Blvd. Cleveland Ohio 44106 is seeking a contractor that can meet/exceed the Government s objectives for the following requirement: Intraoperative Neuromonitoring Service (IONM). Services shall be provided by contractor technicians and shall be overseen by the Attending Surgeon. Technician services are provided on-site in the LSCVAMC operating rooms. The Contractor shall have a sufficient number of fully trained technicians and interpreting physicians to ensure that qualified individuals provide services on an as needed basis as specified by the LSCVAMC. The Contractor shall acquire, maintain and provide in good working order the dedicated equipment, technology and software required for the Technicians provide IONM services. The costs of repair and/or replacement of such equipment, technology or software will be the sole responsibility of the Contractor. The Contractor agrees to abide by LSCVAMC s policies and procedures regarding the maintenance, use and safety of any clinical equipment utilized by Technicians in the operating rooms AT LSCVAMC. Utilities: LSCVAMC shall, at no cost to the Contractor, provide all utilities, operating room apparel, and computer networking assistance reasonably necessary for the Contractor to perform the IONM services. Work Hours: Due to the nature of the amount of healthcare coverage needed - the Contractor shall not be required to adhere a set schedule, predetermined work hours, or tour of duty . The conditions for attendance will be based on the surgical service needs of the LSCVAMC. Procedure: LSCVAMC will make every effort to communicate need for service to Contractor at least 48 hours prior to procedure. Contractor will be expected to provide services when medical care necessity requires notice of less than 48 hours such as emergent cases. Cases may be scheduled by LSCVAMC in a variety of ways, including by phone, e-mail or by fax. Contractor will provide single point of contact for scheduling purposes. Notice and Cancellation: The LSCVAMC will provide Contractor with at least (12) hours notice on cancelled cases that are considered routine cancellations. If Contractor is informed of cancellation less than (12) hours prior to scheduled start of procedure, Contractor will be able to submit invoice for ¼ contracted case amount to cover costs incurred for late cancellation. Instruction to Offerors Guidance: This Sources Sought notice is not a Request for Quote (RFQ)/Request for Proposal (RFP) and no solicitation is being issued at this time. This notice shall not be construed as a commitment by the Government to issue a solicitation or to ultimately award a contract, nor does it restrict the government to a specific acquisition approach. Any information provided to the Government as a result of this sources sought notice is strictly voluntary. Responses will not be returned. No entitlement to payment or direct or indirect costs or charges by the Government will arise as a result of contractor submission of responses or the Government s use of such information. This Sources Sought Notice is for planning purposes only and is intended to identify eligible contractors in any socioeconomic category who can support this requirement. An eligible contractor is a contractor who possesses the qualifications, capability, and relevant experience to meet/exceed the government s Statement of Objectives for this requirement. Instructions for Submission: Interested contractors shall respond by e-mail only to Brandi Holland, Contract Specialist at Brandi.Holland2@va.gov. Responses are due no later than Monday, June 17, 2019 by 12:00 p.m. Eastern Standard Time (EST), Columbus, OH. Respondents shall include as part of their submission: Indicate if you can meet/exceed the government s objective and provide Complete Intraoperative Neuromonitoring (IONM) Service and Perform all aspects of IONM as needed, including but not limited to the following modalities: somatosensory evoked potentials (SSEP), motor evoked potentials (MEP), electromyography (EMG), electroencephalography (EEG), cortical mapping, brain stem recordings, etc. A brief summary of relevant experience, relevant past contracts, and applicable qualifications/capabilities (as it pertains to this requirement) must be included. (It is the government s expectation that the contractor would be able to provide a detailed, innovative plan and a cost-effective pathway/solution to meet/exceed the objectives that are contained in the document entitled Statement of Work (SOW). See subsequent pages to follow. Statement of Work (SOW) NEUROMONITORING SERVICES The Contractor shall provide intraoperative neuromonitoring (IONM) for the Louis Stokes Cleveland VA Medical Center (LSCVAMC). Services shall be provided by contractor technicians and shall be overseen by the Attending Surgeon. Technician services are provided on-site in the LSCVAMC operating rooms. The Contractor shall have a sufficient number of fully trained technicians and interpreting physicians to ensure that qualified individuals provide services on an as needed basis as specified by the LSCVAMC. 1. Duties/Qualifications On site IONM technicians must be certified to provide intra-operative monitoring. The Contractor shall ensure the technicians assigned to perform in operating rooms possess knowledge of the effects of anesthesia and of various artifacts such as electrical interference from operating room equipment, etc, to be able to assess their effects on the data collected during the surgical procedure. Technician must have knowledge of potential morbidity caused by the monitoring process itself, quality control systems, performance testing and the calibration of equipment. The contractor provides the equipment necessary to effectively communicate the intra-operative interpretation of data. The technicians will provide recommendations based upon interpretation of monitoring results to the Attending Surgeon and operating room personnel. Remote IONM certified physicians to provide recommendations and interpretation of monitoring to the on-site technician. The Contractor shall ensure the physicians are certified in IONM and have completed the credentials process through the LSCVAMC credentialing office. Contractor to provide the equipment necessary to effectively interpret the intra-operative data communicated from the technician. The physician will communicate and information that needs relayed to the Attending Surgeon through the Technician. 2. Technical Services Provide a trained technician, equipment and all necessary accessories for requested surgical procedures in the operating room. Perform all aspects of IONM as needed, including but not limited to the following modalities: somatosensory evoked potentials (SSEP), motor evoked potentials (MEP), electromyography (EMG), electroencephalography (EEG), cortical mapping, brain stem recordings, etc. Obtaining consent from patient for IONM services prior to procedure and furnishing copy to the government to be included in the patients record. Communicate results of monitoring in real time to operating surgeons, anesthesiologists and other appropriate members of the surgical team in the operating room. Apply electrodes to the patient as needed for monitoring requested modalities and remove electrodes at the end of the procedure. If applicable, assist the surgical team in explaining IONM to the patient pre-operatively. Participate in LSCVAMC s quality assurance program as required. The contractor shall also have physicians available and credentialed through the VA to be utilized for interpretation of the monitoring results as needed. 3. Scope of Monitoring Services During the Term of this Agreement, the Contractor shall provide Monitoring Services to LSCVAMC at the request of the Attending Surgeon or other appropriate members of the LSCVAMC surgical team. The request shall be pursuant to the written order of the Attending Surgeon at LSCVAMC. The Monitoring Services shall include neurophysiologic monitoring of the patient during the surgical procedure (Technical Services) by a qualified technician and Interpretation of the monitoring (Interpretation Services) by certified Neurologist for IONM. Contractor shall coordinate provision of services with the Attending Surgeon or designee. Contractor is responsible for provision of all supplies in support of the services it provides. Contractor will complete all administrative tasks and required documentation immediately following procedure. Complications or incidents incurred during the administration of this contract will be reported within 24 hours of discovery to the Attending Surgeon and the LSCVAMC Surgery Service COTR. The Contractor may be required to provide evidence of follow-up through a written report of the incident, describing the event, analysis of cause and effect, and corrective action taken. If such a report is requested by the COTR or other LSCVAMC designee, this will be done within three (3) working days of the verbal report. 4. Qualifications Each Technician who provides Technical Services at LSCVAMC shall be adequately trained to perform the Technical Services and shall provide the Technical Services in accordance with the standards of care applicable to such services, including those established by the American Society of Electroneurodiagnostic Technologists (ASET) and/or the American Society of Neurophysiological Monitoring (ASNM). The Contractor shall provide evidence of Technician s training and case experience. LSCVAMC may request removal from the contract of any Technician at the discretion of LSCVAMC. If LSCVAMC makes such a request, it shall provide written reasons for its action to the Contractor. Each Physician who provides Interpretation Services at LSCVAMC shall be adequately trained to perform the Interpretation Services and shall provide the Interpretation Services in accordance with the standards of care applicable to such services, including those established by the American Society of Neurophysiological Monitoring (ASNM). The Contractor shall provide evidence of Physician s training, credentials and case experience. LSCVAMC may request removal from the contract of any Physician at the discretion of LSCVAMC. If LSCVAMC makes such a request, it shall provide written reasons for its action to the Contractor. 5. Credentialing Credentials: The Contractor will maintain employee files on all Technicians and Physicians and will provide copies of specific documentation to LSCVAMC. LSCVAMC shall notify The Contractor of its requirements, if any, regarding computer access and other VA and LSCVAMC requirements specific to Technician presence in the operating room and remote access of interpreting Physician. Identification Badges: An identification (ID) badge will be issued by the VA to the contract personnel providing services to LSCVAMC. The appropriate ID badge shall be worn at all times while on Government facility grounds, clearly displayed on the outermost garment. 6. LSCVAMC Responsibilities Orientation: LSCVAMC will provide Technician with a reasonably appropriate orientation to the facility and its applicable policies, procedures, rules and regulations, including those relating to infection control, safety management and confidentiality. Evaluation: LSCVAMC personnel will periodically provide input to the Contractor for purposes of evaluating the competency and performance of each Technician who provides Technical Services at LSCVAMC. No Discrimination: LSCVAMC will not discriminate against any Technician on the basis of race, religion, color, national origin, sex, age, disability or any other basis prohibited by law. 7. Equipment Equipment: The Contractor shall acquire, maintain and provide in good working order the dedicated equipment, technology and software required for the Technicians provide IONM services. The costs of repair and/or replacement of such equipment, technology or software will be the sole responsibility of the Contractor. The Contractor agrees to abide by LSCVAMC s policies and procedures regarding the maintenance, use and safety of any clinical equipment utilized by Technicians in the operating rooms AT LSCVAMC. Utilities: LSCVAMC shall, at no cost to the Contractor, provide all utilities, operating room apparel, and computer networking assistance reasonably necessary for the Contractor to perform the IONM services. 8. Universal Precautions Exposure Prevention: LSCVAMC will provide Technicians all personal protective equipment, including gloves, gowns, and other supplies necessary to comply with Centers for Disease Control guidelines, as appropriate to the Technicians individual responsibilities. The Contractor shall provide all Technicians with appropriate information, and, upon request, shall provide LSCVAMC with documentation of such information, regarding exposure prevention, use of personal protective equipment, and infection control. The Contractor shall offer to Technicians at substantial risk of directly contacting body fluids, opportunities to obtain antibody and or antigen testing and vaccination in accordance with requirements of the Occupational Health and Safety Administration and Centers for Disease Control. Post-Exposure: In the event of an exposure, the Contractor and LSCVAMC will cooperate, in accordance with applicable LSCVAMC policy, regarding offering appropriate post-exposure testing to the affected Technician. LSCVAMC will use its best efforts to appropriately test the source patient and to obtain that patient's consent to disclosure of test results to Technician and The Contractor. The Contractor will be responsible for providing appropriate follow up medical care and counseling, if applicable, and record-keeping. 9. Personal Hygiene and Clothing Contract health care providers shall be neat, clean, well groomed and shall otherwise exercise good personal hygiene. Appropriate LSCVAMC attire shall be worn at all times within the operating room and other areas as designated by the LSCVAMC. Medical scrubs provided by the LSCVAMC are not to be worn or removed from outside the LSCVAMC facility. 10. Health Requirements Contract health care providers shall not perform services under this contract unless a pre-assignment medical examination has been performed and is on file with Contractor. Pre-assignment medical examinations shall be the responsibility of the Contractor at no cost to the Government. Contractor will furnish copies of completed information as needed by the Government. As a condition of employment Occupational Safety and Health Administration (OSHA) requires that all contract staff who will have occupational exposure to blood, other body fluids, or other potentially infectious materials, shall receive Hepatitis B vaccine, sign a voluntary declination or have documented proof of immunity to Hepatitis B infection. The immunization shall be the responsibility of the Contractor at no cost to the Government. Contract health providers having patient contact or exposure to biological or pathological specimens shall be immunized against, be granted an immunization waiver or have documented proof of immunity to: rubella, mumps, polio and Hepatitis B. In addition, contract health care providers shall be free of infectious diseases (to include but not limited to active Tuberculosis and Viral Hepatitis) that might reasonably be expected to place other workers, patients or the public at risk. Contractor shall provide the COTR with certification that Technician have completed the medical evaluation required above, a minimum of five (5) working days prior to performance of contract services. This certification shall state the date that the examination was completed, the doctor s name that performed the examination, a statement concerning the physical health of the individual and the following statement: Technician is not suffering from contagious diseases to include, Tuberculosis and Hepatitis. The Government may take nose and throat cultures from Technician when required by Government Infection Control Committees (ICC). When a Technician has been found medically unfit for providing services required under this contract, they shall be required to discontinue working immediately. Contract Technician will not return to work until given clearance by the appropriate physician. The Government will provide emergency health care for injuries sustained while on duty for contract health care providers. These services will be billed to the Contractor at the current full reimbursement rate. 11. Scheduling Work Hours: Due to the nature of the amount of healthcare coverage needed - the Contractor shall not be required to adhere a set schedule, predetermined work hours, or tour of duty . The conditions for attendance will be based on the surgical service needs of the LSCVAMC. Procedure: LSCVAMC will make every effort to communicate need for service to Contractor at least 48 hours prior to procedure. Contractor will be expected to provide services when medical care necessity requires notice of less than 48 hours such as emergent cases. Cases may be scheduled by LSCVAMC in a variety of ways, including by phone, e-mail or by fax. Contractor will provide single point of contact for scheduling purposes. Notice and Cancellation: The LSCVAMC will provide Contractor with at least (12) hours notice on cancelled cases that are considered routine cancellations. If Contractor is informed of cancellation less than (12) hours prior to scheduled start of procedure, Contractor will be able to submit invoice for ¼ contracted case amount to cover costs incurred for late cancellation. 12. Records All records produced in the performance of this contract and all evaluations of patients are the property of, and subject to the exclusive control of, the Government. The Contractor may retain a copy of all such records or evaluations, but may not provide further copies or disclose the information from such records or evaluations to any other party. A complete and accurate copy of the full written report of IONM will be provided to the Attending Surgeon within one (1) hour of the completion of each procedure for documentation purposes. Confidentiality of Information: Unless otherwise specified, all financial, statistical, personnel and/or technical data which is furnished, produced or otherwise available to the Contractor during the performance of this contract are considered confidential business information and shall not be used or released for purposes other than performance of work under this contract. All patient medical records and related documents maintained by LSCVAMC shall belong to and be the sole property of the Government and LSCVAMC. LSCVAMC acknowledges that the Contractor needs to record and maintain certain patient information in the course of providing and billing for the monitoring services. Consent and Disclosure: LSCVAMC acknowledges that the Contractor is relying on LSCVAMC to obtain all necessary consents and authorizations from LSCVAMC patients to perform the IONM services. LSCVAMC agrees that, with respect to the IONM services, LSCVAMC is solely responsible for and has complied with the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") requirements for distributing all required information pertaining to LSCVAMC patients' privacy rights. LSCVAMC shall be solely liable for, and shall fully indemnify and hold the Contractor, its officers, directors, owners and employees, harmless against any and all claims by LSCVAMC patients or their representatives related to the failure by LSCVAMC or the Contractor to disclose or obtain patients' consent for the IONM services. Request for Service: LSCVAMC shall ensure that the Attending Surgeon s request for IONM services is documented in writing and included in the patient s medical record. LSCVAMC shall provide The Contractor with a copy of such request upon request and shall fully indemnify and hold The Contractor, its officers, directors, owners and employees, harmless against any and all claims or losses related to the failure by LSCVAMC to document the Attending Surgeon s request for IONM services. 13. Insurance Since this is a non-personnel service contract the contractor is required to have their own insurance. Both parties shall maintain professional liability (malpractice) insurance and general liability insurance providing coverage of at least $1 million per occurrence and $3 million annually. Each party shall provide the other on request with a certificate of insurance evidencing such coverage and shall provide at least ten (10) days prior written notice of any material change in such coverage. Liability insurance may be on either an occurrences basis or on a claims-made basis. If the policy is on a claims-made basis, an extended reporting endorsement (tail) for a period of not less than 3 years after the end of the contract term must also be provided. 14. Indemnification Indemnity: Each party shall indemnify and hold harmless the other and its directors, officers, employees and agents, from any and all claims (including third party claims), demands, judgments, damages, liabilities, losses and expenses actually incurred (including reasonable attorney s fees) arising out of the negligent acts or omissions or intentional misconduct of such party, its employees, or agents, in the discharge of its or their professional responsibilities under this Agreement. The provisions of this Section 13(a) shall survive the expiration or termination of this Agreement. Limitations on Indemnity: The parties' obligations under Section 13(a) above are expressly conditioned upon the following: (i) that the party from whom indemnification is sought shall be notified promptly in writing by the party seeking indemnification of any claim or suit of which it may be aware involving services provided under this Agreement; (ii) that the parties shall cooperate in a reasonable way to facilitate the settlement or defense of the claim or suit (provided, however, that the indemnifying party shall not admit fault on behalf of, or agree to a settlement without the consent of, the party to be indemnified); (iii) that the claim or suit does not arise, in whole or in part, from the malpractice or negligent act or omission of the party seeking indemnification; and (iv) that the indemnifying party's liability under this Agreement shall be limited to the amount of funds paid to and received by it under any then-existing program of insurance or self-insurance with respect to such losses. 15. Non-solicitation; Employment The Contractor, its officers, directors, employees and agents, shall not, directly or indirectly, on their own behalf or on behalf of others, employ or solicit for employment any person employed by LSCVAMC. The provisions of this shall not apply to general advertisements for employment opportunities. 16. Access to Records If this Agreement is subject to Section 952 of the Omnibus Reconciliation Act of 1980, 42 U.S.C. §1395x(v)(1)(I) (the "Statute") and the regulations promulgated thereunder, 42 C.F.R. Part 420, Subpart D (the "Regulations"), The Contractor shall, until the expiration of four (4) years after furnishing of IONM services pursuant to this Agreement, make available, upon proper request, to the Secretary of Health and Human Services and to the Comptroller General of the United States, or any of their duly authorized representatives, the Agreement and the books, documents and records of The Contractor that are necessary to certify the nature and extent of the IONM services furnished pursuant to this Agreement for which payment was may be made by LSCVAMC. 17. Confidentiality; HIPAA Each party acknowledges that information or materials belonging to the other party that it may have access to or use of are of a special and unique character, are not known to the public, may not be disclosed and are considered by the other party as confidential ( Confidential Information ). Moreover, each party acknowledges that this Agreement, and the terms set forth herein, constitutes Confidential Information. Having acknowledged the foregoing, each party agrees: (a) a party may disclose the other party s Confidential Information to its employees and subcontractors who have a need to know; (b) a party may disclose Confidential Information if so required by law (including court order or subpoena), provided that the party provides the other with prompt notice of the legal process to allow such party to take action to prevent the disclosure and, if disclosure is required, disclose only the minimum amount of information necessary to comply with the legal process. Unless otherwise authorized, upon the termination of this Agreement, each party shall promptly return to the other party its Confidential Information or certify that such Confidential Information, including all copies, have been destroyed. Notwithstanding the above, a party shall not be liable for the reproduction, disclosure or use of any Confidential Information if such Confidential Information is: (a) publicly available or later becomes available other than through a breach of this Agreement; (b) lawfully known to the party, or its respective employees, agents or subcontractors prior to the original disclosure by the other party or is independently developed by the party; or (c) subsequently lawfully obtained by the party, or their respective employees, agents or subcontractors from a third party without obligations of confidentiality. The provisions of this Section 16(a) shall survive the termination or expiration of this Agreement. 18. Term This contract shall begin on the effective date and shall continue for one year. Four option years may be exercised for this contract. 19. No Referrals The parties agree that there is no requirement that either party make any referrals to, or be in a position to make or influence referrals to, or otherwise generate business for, the other party as a condition for entering into and performing under this Agreement. 20. Relationships Independent Contractor: The services rendered by the Contractor are rendered in the capacity of an independent Contractor. The Government will evaluate the quality of both professional and administrative services for purposes of contract inspection and acceptance. The Government retains no direct control over professional assessments and/or recommendations. The Contractor shall be solely responsible for any and all liability caused by the acts or omissions of its agents or employees. The Contractor shall not in any manner represent or infer that it is an instrumentality or agent of the United States Government. The parties agree that the Contractor and LSCVAMC are independent contractors under this Agreement, and neither party to this Agreement shall be deemed the agent, partner, employee, representative or joint venture of the other party. Employee Status: The parties acknowledge and agree the Technologists are not employees of LSCVAMC and LSCVAMC assumes no responsibilities as to the Technologists may be imposed upon an employer under any law, regulation or ordinance. Technologists are employees of the Contractor and The Contractor shall be responsible for withholding federal and state income taxes, paying social security taxes and unemployment insurance, and maintaining worker s compensation insurance coverage in an amount and under such terms as are required by law. 21. Payments Contractor shall accept payment for services rendered under this contract as payment in full and will not bill the veteran or his/her third party insurer for any services covered under this contract or for additional services for which the VA pays the Contractor outside the contract. Invoice and Payment Contractor shall submit invoices in original addressed to: VAFSC, P.O. Box 149971, Austin, TX 78714. Invoices submitted for payment shall be reviewed for accuracy, verified against time records and attendance logs and shall be subject to approval by the Government prior to remittance of payment. Any discrepancies found shall be brought to the attention of the Contractor and shall be resolved. A corrected invoice must then be submitted by the Contractor as instructed by the Government. Patients shall not be invoiced for services. The invoice MUST be itemized to include the following information. Billing: Contractor will provide LSCVAMC with invoice within 30 days of procedure. Invoice must be limited to (1) procedure per invoice. Invoice will detail: Name and address of Contractor Contractor s tax ID number Date of treatment(s) *Hours of IONM service provided. Name of Technician. Name of Attending Surgeon. First initial of patient s last name and the last (4) digits of patient s Social Security number. Description of services rendered Fees being charged for services rendered Contractor s invoice number and date of invoice. Contract number. Contract s purchase order number. * Contractor will be paid a set amount per procedure for IONM services and not on a per hour basis. The itemized invoice shall be verified for certification by the COTR or LSCVAMC designee. 22. Contractor Personnel Security Requirements All contractor employees who require access to the Department of Veterans Affairs computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Office of Security and Law Enforcement prior to contract performance. This requirement is applicable to all subcontractor personnel requiring the same access. If the investigation is not completed prior to the start date of the contract, the contractor will be responsible for the actions of those individuals they provide to perform work for VA. Position Sensitivity The position sensitivity has been designated as low. Background Investigation The level of background investigation commensurate with the required level of access is National Agency Check with Written Inquiries. Contractor Responsibilities The contractor shall bear the expense of obtaining background investigations. If the investigation is conducted by the Office of Personnel Management (OPM), the contractor shall reimburse VA within 30 days as follows, per provider: High Risk: $3,015.00 Moderate Risk: $825.00 Low Risk: $230.00 SAC: $24.00 The contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain a U.S. citizenship and are able to read, write, speak and understand the English language. The contractor shall submit or have their employees submit the following required forms to the VA Office of Security and Law Enforcement within 30 days of receipt: Standard Form 85P, Questionnaire for Public Trust Positions Standard Form 85P-S, Supplemental Questionnaire for Selected Positions FD 258, U.S. Department of Justice Fingerprint Applicant Chart VA Form 0710, Authority for Release of Information Form Optional Form 306, Declaration for Federal Employment Optional Form 612, Optional Application for Federal Employment The contractor, when notified of an unfavorable determination by the Government, shall withdraw the employee from consideration from working under the contract. Failure to comply with the contractor personnel security requirements may result in termination of the contract for default. Government Responsibilities The VA Office of Security and Law Enforcement will provide the necessary forms to the contractor or to the contractor s employees after receiving a list of names and addresses. Upon receipt, the VA Office of Security and Law Enforcement will review the completed forms for accuracy and forward the forms to OPM to conduct the background investigation. The VA facility will pay for investigations conducted by the Office of Personnel Management (OPM) in advance. In these instances, the contractor will reimburse the VA facility within 30 days. The VA Office of Security and Law Enforcement will notify the contracting officer and contractor after adjudicating the results of the background investigations received from OPM. The contracting officer will ensure that the contractor provides evidence that investigations have been completed or are in the process of being requested. End, Contractor Personnel Security Requirements 23. Computer/Information Security The contractor shall ensure adequate LAN/Internet, data, information, and system security in accordance with VA standard operating procedures and standard contract language, conditions, laws, and regulations. The contractor s firewall and web server shall meet or exceed the government minimum requirements for security. All government data shall be protected behind an approved firewall. Any security violations or attempted violations shall be reported to the VA project manager and the VHA Headquarters Information Security Officer as soon as possible. The contractor shall follow all applicable VA policies and procedures governing information security, especially those that pertain to certification accreditation. 24. 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 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. 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. 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. VA INFORMATION CUSTODIAL LANGUAGE 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). 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE 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. 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. 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. 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. 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. 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. 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: SECURITY INCIDENT INVESTIGATION 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. 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. 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. 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. 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. G. 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.] 2. 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. 3. 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.
36C25019Q0893 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 10
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