36C25619Q0411-000.docx

36C25619Q0411 FedBizOpps Combined Synopsis/Solicitation Notice

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* = Required Field FedBizOpps Combined Synopsis/Solicitation Notice Rev. March 2010 Q Complete Intraoperative Neuromonitoring Services Southeast Louisiana Veterans Healthcare System 2400 Canal Street New Orleans, LA 70119 70112 36C25619Q0411 03-19-2019 N 621999 Department of Veterans Affairs Southeast Louisiana Veterans HCS Network Contracting Office 16 1515 Poydras Street Suite 1100 New Orleans LA 70112 C. Robert Oravetz Department of Veterans Affairs Southeast Louisiana Veterans HCS Network Contracting Office 16 1515 Poydras Street Suite 1100 New Orleans, LA 70112 Department of Veterans Affairs Southeast Louisiana Veterans Healthcare System Surgery Service 2400 Canal Street New Orleans, LA 70119 70119 United States christopher.oravetz@va.gov christopher.oravetz@va.gov This is a combined synopsis/solicitation for commercial items, prepared in accordance with the format in Federal Acquisition Regulation (FAR 12.6) as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; offers are being requested and a written solicitation will not be issued.

Solicitation number 36C25619Q0411 is issued as a Request for Quote (RFQ). This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-96.

The Southeast Louisiana Veterans Health Care System (New Orleans VA Medical Center) located at 2400 Canal Street, New Orleans, LA 70119 is seeking a contractor that can meet/exceed the government’s objectives for the following requirement: Complete Intraoperative Neuromonitoring Service (IONM). The contractor will be required to provide the equipment, labor, materials, accessories, and supplies necessary for Complete Intraoperative Neuromonitoring (IONM) Service so that seven surgical operating rooms can be supported. The Complete Intraoperative Neuromonitoring (IONM) Services that are required include but are not limited to the following: As needed and case-by-case service that enables the facility to offer IONM options for patients under the direct medical care within the operating room. The “umbrella” of IONM services include complex surgical procedures such as: Spine surgery, Neurosurgery, Vascular Surgery, Otolaryngology, Cardiac Surgery, Thoracic Surgery, Orthopedics, and if necessary, Interventional Neuroradiology which are done during scheduled timeframes and during emergencies 24 hours a day, 7 days a week, & 365 day a year.

All work shall be completed in accordance with the Statement of Objectives (SOO) entitled, “Complete Intraoperative Neuromonitoring Service (IONM)” dated January 19th, 2019. The Statement of Objectives (SOO) contained within this solicitation is a non-negotiable document. Offers/quotes shall not include edits, revisions, additions, deletions, alterations, or track change comments to the Statement of Objectives (SOO).

The associated North American Industry Classification (NAICS Code) for this requirement is 621999 – All Other Miscellaneous Ambulatory Health Care Services. The size standard is $15 million.

This solicitation is set aside 100 % for small businesses (Total Small Business Set Aside). Offers shall only be accepted from small business contractors in the following categories to include but not limited to (8(a), HUB Zone, Small Disadvantaged Business, Any Minority Owned, Any Native American Owned, Service Disabled Veteran Owned, Veteran Owned, and Any Women-Owned Small Business).

When preparing offers in response to this solicitation offerors shall refer to FAR 52.212-1 (Instruction to Offerors) contained within this solicitation. FAR 52.212-1 (Instruction to Offerors) provides specific guidance/instructions for how offers are to be prepared and submitted in response to this solicitation. (The Contracting Officer will review all offers received and will determine if each offeror followed all of the offer preparation/submission instructions in this solicitation. Offerors who do not follow the offer submission instructions and/or an offeror's failure to address the technical factors (as listed in Volume 1- Technical Volume) shall be indicative of the Offeror's lack of understanding of the Government's requirement to include the offeror being considered to be nonresponsive to the requirements in the solicitation. Nonresponsive offers shall not be considered for contract award. FAR Part 52.212-2, Evaluation - Commercial Items provides the criteria for how offers/quotes will be evaluated.

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 PRICE/COST SCHEDULE YR=Year

· Deliverable 1 (Required Services) / Complete Intraoperative Neuromonitoring (IONM) Service

· Deliverable 2 (Required Services) / Program Management and Offeror Qualifications

· Deliverable 3 (Required Services) / Hardware Upgrades

· Service Agreement See Statement of Objectives (SOO) Sections 2.1.1, 2.1.2, 3.0, & 6 Base Year (not to exceed 12 months) Performance Period: Base year begins at the earliest available date following contract award

SUBTOTAL – BASE YEAR

· Deliverable 1 (Required Services) / Complete Intraoperative Neuromonitoring (IONM) Service

· Deliverable 2 (Required Services) / Program Management and Offeror Qualifications

· Deliverable 3 (Required Services) / Hardware Upgrades

· Service Agreement See Statement of Objectives (SOO) Sections 2.1.1, 2.1.2, 3.0 & 6 Option Year One (not to exceed 12 months) Period of Performance: Option Year One (1) begins immediately following the end of the performance period of the base year

SUBTOTAL – OPTION YEAR ONE

· Deliverable 1 (Required Services) / Complete Intraoperative Neuromonitoring (IONM) Service

· Deliverable 2 (Required Services) / Program Management and Offeror Qualifications

· Deliverable 3 (Required Services) / Hardware Upgrades

· Service Agreement See Statement of Objectives (SOO) Sections 2.1.1, 2.1.2, 3.0 & 6 Option Year Two (not to exceed 12 months) Period of Performance: Option Year Two (2) begins immediately following the end of the performance period of Option Year One (1).

SUBTOTAL OPTION YEAR TWO

GRAND TOTAL ALL CLINS / ALL YEARS (BASE YEAR AND OPTION YEARS 1 & 2)

Page 1 of Page 1 of

B.2 STATEMENT OF OBJECTIVES

Statement of Objectives (SOO) Complete Intraoperative Neuromonitoring Service (IONM) Southeast Louisiana Veterans Health Care System New Orleans, Louisiana January 19th, 2019

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 the 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 experience and available to cover scheduled and emergency cases 24/7/365, typically within one hour of notification (onsite technical and online professional services). Because of the surgical complexity, the Offeror will have experience providing service to veterans within a military, Naval, or VA Medical Center.

DELIVERABLES (REQUIRED SERVICES)

2.1.1 DELIVERABLE #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 have the ability 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. It is essential that the proposed operating system integrates into existing infrastructures and exchanges data with other systems using common standard interfaces. Finally, it is the responsibility of the offeror to provide a surgical system that has the ability to function with the current power (electrical) supply. The online Neurologists will provide real-time monitoring via HIPPAA & HITECH (or similar) compliant telemedicine. The Offeror shall provide scheduled services throughout the contract period. In the event of the absence of contractor’s personnel for any reason, the contractor shall bear the responsibility of providing replacement personnel to provide the scheduled services. All and any replacement personnel must meet the Credentialing & Privileging requirements prior to providing care to SLVHCS patients. Finally, the Offeror will provide a complete Quality Assurance program that monitors, track any successes or complications, and trends that are reported to the SLVHCS Facility Surgical Work Group (FSWG) quarterly. The Quality Assurance Surveillance Plan (QASP) is managed by the Offeror and presented to the FSWG.

2.1.2 DELIVERABLE #2: Program Management and Offeror Qualifications The offeror is expected to provide all project management services under this contract. Project management services are assumed by the Government to be integral and inherent in the performance of 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 provide, transport, install, participate in the simulations, be available in live surgical cases, and test the medical equipment prior to utilization.

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

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

2.5 The Offeror is responsible for any missing parts and components to complete the requested service.

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 that 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 one surgical operation simultaneously.

3.0 DELIVERABLE #3: Hardware Upgrades

It is expected that all equipment be kept up to date with modern technology and hardware. If hardware upgrades become available after award of this contract but prior to installation of the equipment, the offeror is required to 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 VA Directive 6500.

4.0 Section 4 removed.

5.0 PERIOD OF PERFORMANCE: The period of performance will be for a base year of 12 months and two option years that are each for a period of 12 months in length.

5.1 PLACE OF PERFORMANCE: Southeast Louisiana Veterans Healthcare System, 2400 Canal Street, New Orleans, LA. 70112.

6. SERVICE AGREEMENTS

6.1 Service Agreement: Base Period

The Offeror shall provide a full-service plan that covers the complex surgical procedures (such as: Spine surgery, Neurosurgery, Vascular Surgery, Otolaryngology, Cardiac Surgery, Thoracic Surgery, Orthopedics, and if necessary, Interventional Neuroradiology) which also 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 24/7/364 that includes emergencies for requested surgical procedures.

· Preventative maintenance of the medical equipment shall be the responsibility of the Offeror.

6.2 Service Agreement: Option Period 1

The Offeror shall provide a full-service plan that covers the complex surgical procedures (such as: Spine surgery, Neurosurgery, Vascular Surgery, Otolaryngology, Cardiac Surgery, Thoracic Surgery, Orthopedics, and if necessary, Interventional Neuroradiology) which also 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 24/7/364 that includes emergencies for requested surgical procedures.

· Preventative maintenance of the medical equipment shall be the responsibility of the Offeror.

6.3 Service Agreement: Option Period 2:

The Offeror shall provide a full-service plan that covers the complex surgical procedures (such as: Spine surgery, Neurosurgery, Vascular Surgery, Otolaryngology, Cardiac Surgery, Thoracic Surgery, Orthopedics, and if necessary, Interventional Neuroradiology) which also 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 24/7/364 that includes emergencies for requested surgical procedures.

· Preventative maintenance of the medical equipment shall be the responsibility of the Offeror.

7.0 CONDITIONS REQUIRED FOR EXECUTION OF SERVICES: During the execution of the contract and for all performance periods the contractor shall adhere to the conditions set forth in the contract clause 52.246-4 INSPECTION OF SERVICES—FIXED-PRICE (AUG 1996) which are listed below.

(a) Definitions. "Services," as used in this clause, includes services performed, workmanship, and material furnished or utilized in the performance of services.

(b) The Contractor shall provide and maintain an inspection system acceptable to the Government covering the services under this contract. Complete records of all inspection work performed by the Contractor shall be maintained and made available to the Government during contract performance and for as long afterwards as the contract requires.

(c) The Government has the right to inspect and test all services called for by the contract, to the extent practicable at all times and places during the term of the contract. The Government shall perform inspections and tests in a manner that will not unduly delay the work.

(d) If the Government performs inspections or tests on the premises of the Contractor or a subcontractor, the Contractor shall furnish, and shall require subcontractors to furnish, at no increase in contract price, all reasonable facilities and assistance for the safe and convenient performance of these duties.

(e) If any of the services do not conform with contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by reperformance, the Government may (1) require the Contractor to take necessary action to ensure that future performance conforms to contract requirements and (2) reduce the contract price to reflect the reduced value of the services performed.

(f) If the Contractor fails to promptly perform the services again or to take the necessary action to ensure future performance in conformity with contract requirements, the Government may (1) by contract or otherwise, perform the services and charge to the Contractor any cost incurred by the Government that is directly related to the performance of such service or (2) terminate the contract for default.

9. CONTRACTOR REQUIRED SERVICES (Summary):

9.1 The contractor is responsible for providing the services, tasks, and deliverables described herein and summarized below during the performance periods indicated.

IONM: Base Period (which includes Deliverables 1, 2, & 3 and the service agreement.

IONM: Option Year One (1) which includes Deliverables 1, 2, & 3 and the service agreement IONM: Option Period Two (2) which includes Deliverables 1, 2, & 3 and the service agreement

9. 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.

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.

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.

B.3 ADDENDUM TO STATEMENT OF OBJECTIVES

Master List-Vendor Questions & Responses Complete Intraoperative Neuromonitoring Service (IONM) Sources Sought Notice / 36C25619Q0249

How many surgeons will the contractor be covering?

Unknown

Yes

monitoring as well? If the answer is no, does the VA have an EMR of preference?

Yes / n/a

Please refer to the SOO, 1.1 – Program Objective.

Please refer to the SOO, 2.1.1, Deliverable #1

a. If this is a new requirement - Our experience working with DoD and VA customers yields that a large part of service integration success is connected to the Information Technology requirements for Professional IONM services. At what level and length have you discussed this requirement with your IT Leaders?

b. If there was a prior requirement, could you please list your annual case volumes for the prior option years (any and all available)?

New requirement

a. The Program Manager received Clinical Engineering and OI&T approval to utilize the Intraoperative Neuromonitoring.

b. N/A (New Requirement)

IONM?

Unknown – SLVHCS has not performed complex surgical cases utilizing IONM.

a. During any given day, how many operating rooms will utilize IONM services concurrently?

SLVHCS has a balanced operative schedule; each surgeon has specific block scheduling.

Unknown – SLVHCS has not perform complex surgical cases utilizing IONM. Properly scheduled management should allow 1 surgical case; however, SLVHCS is a 1-B complexity medical center; therefore, there may be opportunities to utilize IONM simultaneously.

Unknown – SLVHCS has not performed complex surgical cases utilizing IONM. (SLVHCS has not performed complex surgical cases since 2005).

across the stated service lines:

a. Spine surgery;

b. Neurosurgery;

c. Vascular Surgery;

d. Otolaryngology;

e. Cardiac Surgery;

f. Thoracic Surgery;

g. Orthopedics;

h. Neuroradiology.

a. Spine surgery - 3

b. Neurosurgery - 2

c. Vascular Surgery - 3

d. Otolaryngology - 2

e. Cardiac Surgery – n/a

f. Thoracic Surgery – n/a

g. Orthopedics - none

h. Neuroradiology – none

Question: Can VA please provide the Credentialing and Privileging requirements?

Eligibility Criteria: To be eligible to request clinical privileges, each practitioner must meet the following minimum threshold criteria:

Education: MD, DO or international equivalent Training: Successful completion of an ACGME accredited residency program in Neurology or equivalent (subject to review and approval) Certification: Desire current board certification in Neurology. If do not possess, encouraged to achieve board certification in Neurology within 2 years of initial appointment of the medical staff office.

Licensure: Full, Active, Current, and unrestricted license in any state Experience: Must have practiced within specialty of neurology or completed a residency or specialized training program.

For procedural privileges, must have learned and performed the procedures satisfactory during formal training; or have performed the procedures satisfactorily under delineated clinical privileges at another institution; or have performed the procedures under delineated clinical privileges at this institution to a level of skill satisfactory to the specialty section chief; or in exceptional circumstances have performed an acceptable number of procedures under supervision.

Health Status: health status consistent with physical and mental capability of satisfactorily performing the duties of the medical staff assignment within clinical privileges granted.

Language: English, proficiency

Core Privileges include a presentative but, of necessity, not exhaustive list of the cognitive and procedural skills that are normally taught in a residency training program. Admission, diagnosis, and treatment of patients with medical and surgical conditions ranging from those that pose no immediate significant threat to life or to long term functional status to those conditions that pose a threat to life or long-term function. May treat any neurology related conditions regardless of underlying medical condition or severity. Core Privileges include conducting telemedicine with appropriate training.

Question: Can the VA provide requirements of the management plan so that the offeror can ensure compliance?

No. Please refer to SOO, 2.1.1, 2.1.2, 2.2 - 2.9

The government submitted an Statement of Objective that the Offeror must present their business plan/bid that presents a comprehensive plan.

The government is looking for a Contractor to provide IONM services for our facility and it is expected that the Contractor be a/the Subject Matter Expert (SME) in this area. It is the government’s belief that a technical expert who has or who is already performing these services in a hospital environment is in the best position to provide the best plan for successful execution of IONM services in support of safe, reliable patient care in the facility.

Question: Will the VA provide a template or instructions of what to include in the QASP required? Will the QASP be required at time of proposal submittal?

Part 1--No, Refer to SOO, 2.1.1

Yes. A QASP must be submitted in conjunction with the Contractor’s plan for Complete IONM services. A QASP is a document that is used to maintain the quality control of services when performed. Generally speaking, a QASP is a living, working document that can be updated/revised during the performance period if needed and if mutually agreed to by both the government and the contractor.

Question: Should this requirement be included in section 2.1.1 or section 6. Service Agreements rather than 3. Hardware upgrades?

Yes. This information cited will be deleted from Section 3 and moved to Section 6. The information cited is already contained in Section 2.1.

Question: Is the VA requesting Personnel On-site 24/7/364? Can VA clarify On-site & Off-site Personnel?

Refer to SOO, 2.1. The contractor is expected to provide support to cover scheduled and emergency cases 24/7/365, typically within one hour of notification (onsite technical and online professional services)

Question: Should this be VA Directive 6500?

Yes. VA (not CA) Directive 6500

Question: Deliverable #2 requests a comprehensive management plan, which can be interpreted as a service plan – Can the Government please clarify are these 2 separate requirements that need to be addressed? Or are they the same in which the offeror would address 6. Service Agreements within Deliverable #2.

The government is looking for a Contractor to provide IONM services for our facility and it is expected that the Contractor be a/the Subject Matter Expert (SME) in this area. A Statement of Objective is being used for this requirement (in lieu of a Statement of Work or Performance Work Statement) because the government is looking for the best, and most effective contractor (technical) plan which will enable successful execution of Complete IONM services. Technical expertise with a focus on and experience in serving a veteran patient care population is especially important for this requirement.

Only one requirement; not two separate requirements. The government is requesting that the contractor provide a Complete IONM Plan which includes/encompasses all deliverables and includes the service agreement stipulations contained in the SOO. The “umbrella” of the Contractor’s Complete IONM plan must include all sections of the SOO.

What is the total anticipated IONM case volume per year?

Base year 120, option year 2 = 140, option year 3 = 160.

Concurrency: What are the Peak and Average volumes by day?

Repeat question. Unknown. SLVHCS has a balanced operative schedule; each surgeon has specific block scheduling.

SLVHCS has not perform complex surgical cases utilizing IONM. Properly scheduled management should allow 1 surgical case; however, SLVHCS is a 1-B complexity medical center; therefore, there may be opportunities to utilize IONM simultaneously.

How many surgeons are anticipated to use IONM?

Repeat Question. 8 surgeons are expected to use IONM

Please provide a breakdown of case types (% neuro, ortho, spine, vascular, ENT, etc.).

Repeat Question.

a. Spine surgery - 3

b. Neurosurgery - 2

c. Vascular Surgery - 3

d. Otolaryngology - 2

e. Cardiac Surgery – n/a

f. Thoracic Surgery – n/a

g. Orthopedics – none

h. Neuroradiology – none

What is the average case duration?

Repeat question. Unknown – SLVHCS has not performed complex surgical cases utilizing IONM.

Will the RFP please be provided in a Word document instead of PDF?

No. All documents when posted to a Government Point of Entry (GPE) (i.e. FedBizOpps) are done in PDF format to prevent edits to the document by Contractors. The SOO is a non-negotiable document and edits, revisions, additions, deletions, strikethroughs, and/or track changes to this document are not permitted.

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