36C25722Q0222.docx

SUBJECT*

SLEEP SYSTEM

GENERAL INFORMATION

Medical Service

3404 Kaydence Ct

Killeen TX

COUNTRY

CONTACT INFORMATION

Network Contracting Office 17

5441 Babcock Road Ste. 302 San Antonio TX 78240

POINT OF CONTACT*

Contract Specialist Dr. Vinicky Ann Ervin Ph.D.

vinicky.ervin@va.gov Please title email as follows: Bed Rentals 36C25722Q0222

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

Presolicitation Notice Presolicitation Notice

DESCRIPTION

Presolicitation Notice

Easy III PSG 54 Channel System

Q-Video Software

Easy III PSG Reader License, CD - first copy

Easy III License for Citrix Server

Application Server License (Office Server)

Small Form Factor Desktop PC

Flat Panel Wide Screen Monitor 24"

Audio Monitoring with 100' cable

HD Camera/IR Kit (drop ceiling mount)

20' Cable for remote input box

Easy III Amplifier Wall Mount Bracket

Power Com Holder for Wall or T2 Cart

CadLink Client license with Auto Archive

10 pack CadLink Client Licenses with Auto Archive

1-Year Easy III PSG Yearly Service Contract - Level 4

On Site Installation with Training, 1 day

LOCAL STOCK NUMBER: TRAINING

On Site additional day(s) Training

LOCAL STOCK NUMBER: TRAINING

General Requirements: Brand name or equal Sleep System are needed for the Temple, TX in accordance with the following requirements above:

SALIENT CHARACTERISTICS

· Customizable user interface

· Advanced amplifier design

· MPEG-4 video with proprietary Q-Video® technology

· Integrated scheduler/calendar

· Powerful remote monitoring capabilities

· Rapid montage setup and editing on-the-fly

· Continuous EEG Monitoring for critical care patients

· Ambulatory recording configurations

· Creative workflow and file management features

· User access audit trails

· Flexible report generator using Microsoft Word

· Internal library of management reports

· Unsurpassed product reliability and after sale support

· Clinical database to review patient population details and record access information

· On-line seizure detection option with auditory and visual notifications

Page 1 of

STATEMENT OF WORK

Medical Service- Sleep Systems Introduction/Background

1. The Central Texas Veterans Health Care System (CTVHCS)- Killeen Sleep Lab, seeks to purchase eight (8) Easy III PSG 54 Channel Systems with CadCare Service Agreement. Service is unable to effectively resolve technical issues presented with current equipment. Repeated trials and patches from original equipment manufacturer were futile. OIT has confirmed system is not compatible with security software. Manufacturer has no remedy and has no plans of such. In an effort to standardize continuum of care, Medical service aims to procure sleep systems utilized by Department of Defense.

1. Statement of Need CTVHCS requires sleep systems to maintain its sleep lab located in Killeen, Tx. Following items shall be included:

2. Scope of Work The vendor shall:

· Eight (8) Easy III PSG 54 Channel Systems with CadCare Service Agreement, and auxiliary supplies, to the pulmonary sleep section of Medical Service Located at 3404 Kaydence Ct Killeen, Tx Zip 76542 within 30 days of purchase order receipt.

· Install product, software, and demonstrate product functions.

· Provide eight (8) days of on site, with Clinical Applications Specialists.

3. Technical Specifications Equipment shall meet or exceed the following:

· Fully operable on VA Network

· Amplifier and Headbox combined

· Remote Access

· Customer Service 24/7

· Use of various manufacturers’ Disposables

· Ability to monitor multiple patients simultaneously

· Extended Service Contract

· Equipment calibration during study capability

· Impedence and Bio-cal completion at bedside

· Montage variability during study

· Automatic EEG arousal and event association

· Insert screen shots in physician report

· Customizable reports

4. Cost Requirement includes Easy III PSG 54 Channel sleep systems, auxiliary supplies, product and software installation, onsite training, and extended warranty.

i. Life-cycle cost - The scope of this acquisition does not contemplate extraneous life-cycle cost as mitigated through extended warranty coverage.

ii. Should-cost and design-to-cost evaluations were administered during the market research phase. This is considered an urgent need; Providers, Medical Staff, Sleep lab Technicians and the Program Specialist comprised the multi-functional team. They reviewed pricing, clinical concerns and long-term improvements. The vendor selected met the standards of use and compatibility concerns of CTVHCS.

5. Capability or Performance The procurement of this equipment will facilitate Sleep lab clinical staff in neurological diagnosis. The sleep lab has limited space, which creates a high demand. The desired outcome of acquisition is a seamless transition to Windows 10 interface, while avoiding disruptions in patient care. Requirement eliminates faulty wiring in ceiling that has been noted in safety evaluations. Proposed system streamlines workspace and decreases hazards in clinical setting.

6. Delivery or Performance-Period Requirements It is imperative that the required equipment is received in a timely manner. Delivery time for the equipment shall be within 30 days following receipt of purchase order.

7. Budgeting and funding Purchase shall be funded through CTVHCS logistics primarily. CTVHCS will seek reimbursement for sleep lab equipment per JIFF agreement.

8. Security Considerations C&A requirements do not apply and a security Accreditation Package is not required.

GENERAL

Contractors, contractor personnel, subcontractors, 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.

The Certification requirements do not apply, and a security accreditation package is not required.

ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

A contractor/subcontractor shall request logical (technical) or physical access to VA information for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

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 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 follow 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 during 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 enough 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.

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.

SURRENDER OF HDD AND MEDIA SANITIZATION PROCEDURES

Contractor will be required to remove HDD for disposal by approved Central Texas Veterans Health Care System methods.

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.

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. However, it is the policy of VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency.

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

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

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

(2) Description of the event, including:

(a) date of occurrence;

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

(3) Number of individuals affected or potentially affected;

(4) Names of individuals or groups affected or potentially affected;

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

(6) Amount of time the data has been out of VA control;

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

(8) Known misuses of data containing sensitive personal information, if any;

(9) Assessment of the potential harm to the affected individuals;

(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages 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.

TECHNICAL SPECIFICATIONS

· Fully operable on VA Network

· Amplifier and Headbox combined

· Remote Access

· Customer Service 24/7

· Use of various manufacturers’ Disposables

· Ability to monitor multiple patients simultaneously

· Extended Service Contract

· Equipment calibration during study capability

· Impedence and Bio-cal completion at bedside

· Montage variability during study

· Automatic EEG arousal and event association

· Insert screen shots in physician report

· Customizable reports

· Customizable user interface

· Advanced amplifier design

· MPEG-4 video with proprietary Q-Video® technology

· Integrated scheduler/calendar

· Powerful remote monitoring capabilities

· Rapid montage setup and editing on-the-fly

· Continuous EEG Monitoring for critical care patients

· Ambulatory recording configurations

· Creative workflow and file management features

· User access audit trails

· Flexible report generator using Microsoft Word

· Internal library of management reports

· Unsurpassed product reliability and after sale support

· Clinical database to review patient population details and record access information

· On-line seizure detection option with auditory and visual notifications

· Compatible with VA/DOD current equipment