Attachment 1 Statement of Need v2 Mobile CCL Unit.docx

Statement of Need – Mobile CCL Unit Statement of Need

1. Title of Project: Mobile Cardiac Cath Lab Unit

2. Scope of Work: Provide mobile Cardiac Laboratory and complete set-up to serve as a temporary Cath lab for our patient volume demand and during the completion of the addition of the Cath lab for the Malcom Randall VA Medical Center (VAMC). The work covered under this contract consists of furnishing all labor, materials, tools, equipment, supervision, and necessary transportation to provide a fully functional mobile catheterization laboratory, with all required utilities and equipment, at Malcom Randall VA Medical Center.

SEPG Approval #: 251580 The mobile cardiac cath lab unit must provide all necessary equipment to include, but not limited to:

· Control Room

· Lab Procedure Room

· Ante-room

· Storage Room The mobile unit must meet or exceed the following requirements:

· Overall combined square footage must be a minimum of 400 square feet

· Provide a minimum of 12 data ports

· Compatible with VA OIT for wireless connection for portable cisco phones and VA WiFi

· Control Room:

· Climate controlled space with AC/heating with thermometer separate from procedure room.

· Phillips XPER Flex Cardio Hemodynamic Workstation with two monitors, minimum 22” viewing screen, for the following requirements:

· Hemodynamics

· Recording Case Details

· Phillips monitor for live x-ray recording

· Essential Enterprise Solutions Inc. (EESi) DICOM workstation

· Monitor for IVUS/FFR

· Network hook up for transferring FFR images from Volcano and OCT systems

· Power and data outlets to support 3 additional VA computers and one printer/copier/fax

· Speaker for intercom for procedure room.

· 2 phones, several phone lines

· Emergency lighting for power outages

· Hard coat flooring non-carpet

· Lead Apron storage rack mounted to wall (8-10 Aprons).

· Lab/Procedure Room:

· Philips Allura FD10 Floor-mount Digital Flat Panel Detector Cardiac Imaging System

· The system must be compatible with our current FFR, IVUS, OCT, and ISC

· 4 high resolution, minimum 17” viewing screen monitors on boom, for the following requirements:

· Live x-ray

· Still (freeze) Frame

· Hemodynamic

· IVUS

· 4 pressure channels and cardiac output

· CO2 monitoring

· Acist contrast power injector with outlet

· Code cart space with defibrillator with outlet.

· Code blue/emergency alert button, wired to main building.

· Data outlets to support four additional computers

· Hard coat seamless flooring

· AC/Heat and climate-controlled room with thermostat

· Electrical Outlets all on emergency backup generator

· Emergency lighting in case of power outage

3. Background: Currently, the 573 NF/SG VAMC Cardiology has a mobile cardiac cath unit on site. The contract on the current mobile cardiac cath unit expires 09/30/2021. A mobile cardiac cath unit was brought in to allow Cardiology to continue service and access to care during construction to the additional cath lab suite. By having the mobile cardiac cath lab on site: (1) patients are given timely care, (2) no interruptions of access to care, and (3) performing construction to cath lab suite. A mobile cardiac cath unit is still needed at the 573 NF/SG VAMC. Engineering has scheduled the construction of the cath lab suite at 573 NF/SG VAMC. To ensure continued service and access to care; there is a continued need to contract a mobile cardiac cath lab unit.

4. Period of Performance:

5. Type of Contract: A firm-fixed price

GENERAL REQUIREMENTS:

This project will provide a rental mobile cardiac cath lab at 573 NF/SG VAMC, Gainesville, FL.

The project consists of:

· Provide a rental mobile cardiac cath lab equipped with:

0. Philips Allura FD10 digital flat panel detector cardiac imaging system

0. Philips XPER Flex Cardio Hemodynamic Workstation

0. Acist Contrast Injector

0. EESi DICOM workstation

· Provide set-up and all required utilities and equipment

· Provide service and preventive maintenance of all the equipment during the period of performance

· Provide all required maintenance during the period of performance

· Unit shall fit in designated space provided along with required access ramp: 30 feet wide x 54 feet long The commercial contractor would be required to provide roundtrip delivery, set up and tear dismounting of the unit. Set up shall include, but not be limited to, connecting the electrical, water and sewage, and telecommunications/data.

Contractor would be responsible for all permits, inspections, and modifications to meet code regulations. VA engineering will provide necessary assistance electrical connections and plumbing. We will direct where the mobile cardiac cath lab unit will be placed. Contractor will be responsible for providing repairs of faulty equipment within 24 hours.

Installation:

· Contractor project management includes a dedicated project manager who coordinates go-live, pre-installation preparation calls, pre-install check-list, scheduling of service installation, single point of contact for go-live support, and project closure meeting to confirm successful go-live and transition to service.

· The Contractor shall provide a system Installation Plan (IP) to the Contracting Officer Representative (COR) for approval prior to the start of work. The COR shall approve the IP and return to the contractor. The IP shall include estimated timeline of start and completion and estimate unexpected delays/lead time.

· System configuration/implementation (e.g. configuring most of the database install/hardware, synchronizing other equipment to new system, setting up custom templates) shall occur prior to installation at least two (2) weeks in advance due to the nature of the recovery environment.

Test and Acceptance:

· Contractor shall test all equipment after installation.

· Contractor must provide a field service engineer to be present during installation, as well as, test and acceptance by the Government.

· The Government will accept equipment once installation and successful testing has been completed and approved.

Training and Simulation:

· Includes 2 days of on-site installation and training for Biomed/OIT/Cardiology/Radiology Safety by field service engineer.

· Includes 2 days of on-site staff training by clinical representative

· COR will arrange staff training with clinical representative that will follow installation that has been accepted by the Government.

SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES:

Special Requirements

· Contractor shall keep the area cleaned daily and haul away all construction debris. During installation, all materials and construction debris must be in a covered cart when entering and exiting the building.

· At end of performance, contractor shall remove all materials and construction debris from unit removal and restore area to original setting.

· Unit shall fit in designated space provided along with required access ramp: 30 feet wide x 54 feet long

· Unit shall be an elevated mobile unit to match current dock height and designated space provided.

· Install should be scheduled 10/1/2021 to prevent disruption in patient care.

Power Requirements The contractor will be required to provide and install necessary power connectors, wiring distribution, and any ancillary items needed to connect the unit to the current power source.

The government is prepared to provide a single electrical power source as required (3/N/PE AC 480V service fused at 200 amperes 60Hz ±1.0Hz) Maximum Voltage Variation The contractor will analyze the power source to ensure it meets with power requirements for the unit.

The government will be responsible for ensuring the quality (voltage, amperes, and voltage variations) to meet the requirements of the unit.

Mobile Grounding The contractor shall be responsible for properly grounding the unit. The contractor shall purchase all necessary grounding material and provide the labor for grounding.

Telephone and Data Service Requirements The mobile unit is supplied with four (4) telephone connections.

The contractor shall purchase and install four (4) Hubbell all weather telephone connections.

X-Ray System Requirements The mobile unit must be equipped with a Philips Allura FD10 floor-mount digital cardiac x-ray imaging system.

Data Service The contractor shall provide twelve (12) data line connections that utilize RJ-45 outlets.

The contractor shall provide the data connection cables for use with the data line connections. The additional connections will provide data flow for:

· XPER Hemodynamic Workstation

· Xcelera PACS viewing workstation

· Network hook up for their mobile Volcano and OCT system

· Pharmacy Pyxis

· GE Telligence Nurse Call System Compatible with VA OIT for wireless connection for portable cisco phones and VA WiFi Code Blue and Code Red Notification To facilitate the “Code Blue” system; the contractor will provide a duty station with connection to the GE Telligence Nurse Call System. This will require a data line.

Sanitary Sink The mobile unit must provide sanitary sink for us by system operators and patients as needed.

Water The contractor shall be required to make all necessary water and sewage connections as part of the setup process.

The government will provide a suitable water source and a suitable sewage disposal point.

GOVERNMENT RESPONSIBILITIES:

The Government will provide the following to properly operate the mobile unit:

(1) Provide site access and escorts through work areas as needed

(2) Provide suitable primary electrical power

(3) Provide water and sewage connections

(4) Provide adequate space for the system equipment

(5) Ensure power and data ports are active

(6) Identify and provide representatives for walk through and sign off of installation when complete

CONTRACTOR RESPONSIBILITIES:

The Contractor shall be responsible for the following:

(1) Contractor shall stage all equipment for installation.

(2) Contractor shall provide qualified personnel to install cable, monitors, system components, or accessories.

(3) Contractor shall be responsible for all system/software testing after installation and prior to Government acceptance.

(4) Contractor is responsible for securing all materials, equipment and tools while on Government property or in the Government facility. The Government is not liable for any lost or stolen items that are not properly secured.

(5) Contractor shall mount all hardware, displays, racks, switches, etc. necessary to complete installation.

(6) Contractor shall provide and install mobile cardiac cath lab.

OTHER CONSIDERATIONS:

(1) Contracting Officer Representative (COR): The Contracting Officer Representative shall be the technical point of contact for all work-related requirements. The COR does not have authorization to change, alter, or remove any requirements stated in the performance work statement. The Contracting Officer is the only Government authorized person to change the Statement of Work or any resultant contract.

(2) Place of Performance: North Florida/South Georgia Veterans Health System - Gainesville, FL

(3) Work Hours: Operational Hours are 0800-1630, Monday-Friday. Any deliveries or work requiring outside of operational hours must be coordinated and approved with the designated point of contact prior to arrival or work.

(4) Delivery: All deliveries shall be coordinated with the designated point of contact before arrival. Failure to coordinate delivery will be grounds to refuse delivery.

CONTRACTOR EXPERIENCE REQUIREMENTS:

Qualifications and Certifications

· The contractor shall be qualified and have the required levels of professional and technical experience to perform the work required by this statement of work.

Equipment

· All equipment, tools, etc., shall be properly maintained while on the project and shall be adequate, in quality and capacity, for proper execution of the work.

Scheduling and Hours of Work

· All work in areas involved shall be scheduled with the VA Engineering Service representative, Cardiology Program Coordinator, Cardiac Cath Lab Manager, and Cardiology Equipment Coordinator

· Work shall be scheduled for proper execution to completion of this contract

· The contractor will perform this work during normal business hours; however, some work areas access will be after hours and/or during the weekends

· The 10 holidays observed by the Federal Government, i.e., New Year’s Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas or any other day specifically declared by the President of the United States to be a national holiday

· For the transition period of current contract and new contract, preferably a weekend or holiday install to provide little to no disruption to service.

· Install should be scheduled by 10/01/2021 to prevent disruption in patient care.

Site Visits

· Job site shall be visited to verify all existing conditions and dimensions and the extent of work involved with the VA Engineering Service representative

· Visits to the site may be made by appointment only, during regular business hours, with the VA Contracting Officer Representative (COR).

Inspections

· All work shall be inspected during installation and at final completion by the VA technical representative.

Safety Regulations

· All applicable safety regulations shall be observed during all work of this contract

· The VA Safety Officer shall have full authority to see that the contractor obeys all safety rules and regulations relative to the fulfillment of this contract

· Provide the necessary barricades/signage where required

CONTRACT AWARD MEETING:

The contractor shall not commence performance on the tasks in this SON until the Contracting Officer (CO) has conducted a kickoff meeting or has advised the contractor that a kickoff meeting is waived.

(1) The contractor shall provide all labor, equipment, tools, materials, supervision, and other items necessary to deliver, install, and configure/implement the mobile cardiac cath lab at the 573 NF/SG VAMC Cardiology.

(2) The mobile cardiac cath lab shall meet all salient characteristics for design and accessories as outlined in request for proposals.

6. Scheduling and Hours of Work: Deliver all line items specified under Data/Deliverables to point of contact during scheduled time approved by VA team.

Subject Matter Expert Name(s), Service, Phone #, & Email:

7. Privacy Requirements:

Privacy Summary/Background: Maintenance of the mobile cath lab unit will be a combined effort by VA Cardiology, VA Biomedical Engineering, and VA OIT/IT. Contractor will not require access to VA sensitive information; VA sensitive information will only be used by VA personnel. Contractor will be notified and required for assistance during contract period of performance to troubleshoot unsuccessful attempts by VA personnel. This is an x-ray and recording unit that will store images and patient cases until transferred to VA PACS-Network; this happens upon procedure completion.

Electronic Storage Media Requirement: 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

GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/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

VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR.

SECURITY INCIDENT INVESTIATION

a. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

b. To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

b. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

c. Each risk analysis shall address all relevant information concerning the data breach, including the following:

a Nature of the event (loss, theft, unauthorized access);

b Description of the event, including:

i date of occurrence;

ii data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

iii Number of individuals affected or potentially affected;

iv Names of individuals or groups affected or potentially affected;

v Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

vi Amount of time the data has been out of VA control;

vii The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

viii Known misuses of data containing sensitive personal information, if any;

ix Assessment of the potential harm to the affected individuals;

x Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and xi Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

a Notification;

b One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

c Data breach analysis;

d Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

e One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and f Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

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:

a 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;

b Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

c Successfully complete the appropriate VA privacy training and annually complete required privacy training; and d 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.