SOO Neuromonitoring Service- New Orleans.pdf

Statement of Objectives (SOO) Complete Intraoperative Neuromonitoring Service (IONM)

Southeast Louisiana Veterans Health Care System New Orleans, Louisiana

1. Program Objective

1.1 The objective is to provide the equipment, labor, materials, accessories, and supplies necessary for a Complete Intraoperative Neuromonitoring (IONM) Service that supports any of the eight surgical operating rooms. The primary goal of IONM is the identification of intraoperative neural insults at a stage that allows intervention to eliminate or minimize resultant neural injury. To meet this goal, evoked potentials are monitored iteratively throughout a procedure with preservation or degradation of signals reflecting the state of the corresponding neural pathways. Alternatively, continuous data may be gathered using electroencephalography or electromyography to gain insight into the brain and nerves.

The Department of Veteran Affairs surgical specialties are located at Southeast Louisiana Veterans Health Care System (SLVHCS) Diagnostics and Treatment Building within Surgery Service located at 2400 Canal St, New Orleans, LA 70119.

2. Scope

2.1 The offeror shall provide as-needed and case-by-case service that enables SLVHCS to offer IONM options for patients under direct medical care within the operating room. The IONM services should be able to cover complex surgical procedures such as Spine Surgery, Neurosurgery, Vascular Surgery, Otolaryngology, Cardiac Surgery, Thoracic Surgery, Orthopedics, and, if necessary, Interventional Neuroradiology. The IONM Offeror must be experienced and available to cover scheduled and emergency cases 24/7/365, typically within one hour of notification (onsite technical and online remote physician services). Because of the complexity of the surgical procedures, the offeror will have experience providing service to veterans within a military, Naval, or VA medical center.

2.1.1 Complete Intraoperative Neuromonitoring (IONM) Service

The service must be capable of providing real-time data; in addition, the Offeror will offer the most recent technology and hardware. The Offeror will work closely with the surgeons, nursing staff, schedulers, Clinical Engineering, and Sterilization and Processing Service. If necessary, the system will be able to communicate with VISTA Imaging and Computerized Patient Record System (CPRS) to allow for the transfer of data into the patient's Electronic Medical Records. The proposed operating system must integrate into existing infrastructures and exchange data with other systems using common standard interfaces. Finally, the offeror’s responsible for providing a surgical system that can function with the current power (electrical) supply. The online Neurologists will provide real-time monitoring via HIPAA & HITECH (or similar) compliant telemedicine. The Offeror shall provide scheduled services throughout the contract period. In the event of the absence of the contractor’s personnel for any reason, the contractor shall be responsible for providing replacement personnel for the scheduled services. All and any replacement personnel must meet the Credentialing & Privileging requirements before providing care to SLVHCS patients. Finally, the Offeror will offer a complete Quality Assurance program that monitors and tracks any successes, complications, and trends reported to the SLVHCS Facility Surgical Work Group (FSWG) quarterly. The Quality Assurance Surveillance Plan (QASP) is managed by the Offeror and submitted quarterly to the COR.

2.1.2 Program Management

The offeror is expected to provide all project management services under this contract. The Government assumes project management services to be integral and inherent in performing all service tasks of this contract. As such, the project management services under this contract should be factored into the price of other services and not as separate CLINs on this contract. The offeror shall provide a draft comprehensive management plan with the proposal that includes all items necessary for the successful completion of this project. Face-to-face installation meetings and related activities shall begin within 30 days of contract award and shall be conducted at SLVHCS offices.

2.2 The Offeror shall participate in the simulations, be available in live surgical cases, and test the medical equipment prior to utilization.

2.3 All equipment must meet manufacturers’ and VA specifications. The Offeror will ensure that Clinical Engineering inspects the equipment each time it enters the medical facility.

2.3.1 The Offeror shall provide a backup that will remain onsite. The backup is for emergency use only so that the medical center does not have to cancel the surgical procedure due to mechanical failure.

2.4 The Offeror shall furnish all supplies, accessories, equipment, consumables, transportation, delivery, training, and services. The Offeror uses Right Fax to transmit the reports.

2.5 The Offeror uses Right Fax to transmit the reports.

2.6 The Offeror must be accredited and certified by The Joint Commission.

2.7 If necessary, The IONM will support Deep Brain Simulation and Transcranial Doppler cases.

2.8 The Offeror will ensure all professional staff have the necessary licenses and certifications. Must have CNIM – Certified Surgical Neurophysiologists.

2.9 The Offeror shall provide the necessary personnel to service more than two surgical operations simultaneously.

2.10 The Offeror shall have malpractice insurance.

2.11 Offeror shall provide staffing resumes, Basic Life Support licenses, and certifications.

2.12 Offeror shall provide a technical capability statement.

2.13 Offeror shall provide past performances.

3.0 Hardware Upgrades

It is expected that all equipment be kept up to date with modern technology and hardware. If hardware upgrades become available after the award of this contract but before installation of the equipment, the offeror must offer them to the Contracting Officer for consideration.

3.1 The equipment shall be FIPS 140-2 compliant.

3.2 The laptop shall be encrypted, and password protected to FIPS 140-2 encryption standards.

3.3 The Offeror shall comply with CA Directive 6500.

4.0 The IONM services should be able to cover complex surgical procedures such as Spine Surgery, Neurosurgery, Vascular Surgery, Otolaryngology, Cardiac Surgery, Thoracic Surgery, Orthopedics, and, if necessary, Interventional Neuroradiology.

5.0 PERIOD OF PERFORMANCE: The service agreement is for a 5-year ordering period.

• IONM Service Contract – base year 1 October 2025 – 30 September 2026

• IONM Service Contract - option year 1 1 October 2026 – 30 September 2027

• IONM Service Contract --option year 2 1 October 2027 – 30 September 2028

• IONM Service Contract - option year 3 1 October 2028 – 30 September 2029

• IONM Service Contract - option year 4 1 October 2029 – 30 September 2030

5.1 The Offeror shall provide a full-service plan that covers the complex surgical procedures, which includes but is not limited to the following:

• A method that minimizes the amount of time delay between surgical procedures.

• On-site and offsite personnel are available 24/7/365, which includes emergencies for requested surgical procedures. IONM services will be available for all federal holidays.

• Preventative maintenance of the medical equipment is the responsibility of the Offeror.

• The onsite IONM technologist must be within one hour of the medical center.

• The remote physician shall attend all surgical procedures.

• The IONM vendor shall have a 24-hour telephone call center.

• The IONM vendor shall have a scheduling program so that the medical center staff can schedule the patients.

• Contingency Plan: The IONM vendor shall provide a contingency plan for replacing staff that has been terminated or resigned and any staff that has been called out for sick leave or emergency leave.

6.0 PLACE OF PERFORMANCE: SLHVCS, Surgery Service, 2400 Canal Street, New Orleans, LA. 70112

7.0 DELIVERY, INSTALLATION, AND IMPLEMENTATION

7.1 DELIVERY

7.1.1 Offeror shall deliver all equipment, supplies, and disposables to the Southeast Louisiana

Veterans Health Care System (SLVHCS) Diagnostics and Treatment Building Surgery Service Located at 2400 Canal St, New Orleans, LA 70119 for each surgical case.

7.2 IMPLEMENTATION

7.2.1 Boosters and WIFI devices must be tested prior to the first surgical procedure.

7.2.2 The laptop devices must be tested prior to the first surgical procedure.

7.3 SITE CONDITIONS

7.3.1 There shall be no smoking, eating, or drinking inside the hospital at any time.

8.0. SECURITY REQUIREMENTS

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 onsite 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 considering 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 $______ 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.

d. VA training site is located at www.tms.va.gov There is only one course the contractor needs to complete and print the certificate at the end. A copy of the completed certificate must be submitted before work begins (within 5 business days of contract award).

Instructions to get to the Courses in TMS www.tms.va.gov

Log onto the site and create a new user account; if you already don’t have one. Search for your course entitled VA Privacy and Information Security Awareness and Rules of Behavior.

Complete course, print certificate (s), and sign/print contractor rules of behavior.

http://www.tms.va.gov/ http://www.tms.va.gov/

VA Learning University (VALU) Help Desk: 1-866-496-0463 valmshelp@va.gov

Examples

VA Privacy and Information Security Awareness and Rules of Behavior

7. CONFIDENTIALITY AND NONDISCLOSURE

It is agreed that:

1. The preliminary and final deliverables and all associated working papers, application source code, and other material deemed relevant by the VA which have been generated by the contractor in the performance of this task order are the exclusive property of the U.S.

Government and shall be submitted to the CO at the conclusion of the task order.

a. The CO will be the sole authorized official to release verbally or in writing, any data, the draft deliverables, the final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order presented to the contractor shall be submitted to the CO for response.

mailto:valmshelp@va.gov

b. Press releases, marketing material or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO.

8. WARRANTY

8.1 The Offeror shall provide at a minimum a one-year manufacturer’s warranty on all parts and labor.

8.2 The warranty shall include all travel and shipping costs associated with any warranty repair.

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