Updated PFT body Diffusion SOW.docx

Performance Work Statement

PFT Body Diffusion Systems 598-21-3-784-0312

Central Arkansas Veterans Healthcare System Little Rock, AR

08/09/2021

2.5 SALIENT CHARACTERISTICS

On-board analyzers for spirometry (FVC, SVC, MVV), lung subdivisions (VTG, FRCpl, RV, TLC, Raw, Conductance and specific resistance, and Resistance volume loops) Real-time DLCO (both single breath and intrabreath) MIP/MEP and pre/post bronchodilator 1 year warranty

2.5.3 GAS x 2

2.5.4 GAS x 1

2.5.5 Vyntus One Sample Line x 2

2.5.6 DVT Volume Sensor, Complete x 1

2.5.9 Cardiosoft ECG for Vyntus x 1

2.5.12 Oro Nasal 7450 V2 Mask (size Medium) x 1

2.5.13 Ambu Bluesensor R ECG electrode single use x 1

2.5.14 SES Client Device configuration as network client x 1

Spirometry (VTG, FRCpl, RV, TLC, Raw, Conductance and specific resistance, and Resistance volume loops) Real-time DLCO

MIP/MEP

Pre/post bronchodilator Standard software including:

Guidance and stabilitrac instruction applications Pre-formatted reports and reference sets with design tools for modification Automated interpretation algorithms QA checks Physician interpretation templates 1 Year warranty

2.5.17 Standard Cart x 1

2.5.18 SES Client device to be configured as network client x 1

2.5.19 Additional Breathing Circuit for Vyntus BODY x 1

2.5.21 Seat License for SES x 2

2.5.22 SentrySuite Software License for Review Station x 1

2.5.26 2-day Customer hosted Service Training Course on VYNTUS BODY System x 1

2.5.27 3-day Customer hosted Service Training Course on VYNTUS ONE System x 1

2.6 DELIVERY AND INSTALLATION

8.2 ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. The contractor will not have access to VA Desktop computers nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.

b. The contractor will not have access to protected Patient Health Information (PHI) nor will they have the capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. All research data available for Contractor analyses is de-identified.

c. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

d. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

e. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

f. Central Arkansas Veterans Healthcare system and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of Central Arkansas Veterans Healthcare system or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to Central Arkansas Veterans Healthcare system. The agency must report promptly to NARA in accordance with 36 CFR 1230.

g. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government's behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to Central Arkansas Veterans Healthcare system control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand-carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

h.The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and Central Arkansas Veterans Healthcare system guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

i.The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with Central Arkansas Veterans Healthcare system policy.

j.The Contractor shall not create or maintain any records containing any non-public Central Arkansas Veterans Healthcare system information that are not specifically tied to or authorized by the contract.

k.The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

l. The Central Arkansas Veterans Healthcare system owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which Central Arkansas Veterans Healthcare system shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

m. Training. All Contractor employees assigned to this contract who create, work with or otherwise handle records are required to take [Agency]-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

8.3. VA INFORMATION CUSTODIAL LANGUAGE

a. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes.

The options are:

(1) Vendor must accept the system without the drive;

(2) VA’s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

(3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase occur that may

(4) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

(a) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact;

(b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be preapproved and described in the purchase order or contract.

8.4 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 COR 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.

8.5 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 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); VA information, obtain monetary or other

(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 $37.50 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.

8.6 CONFIDENTIALITY AND NONDISCLOSURE

It is agreed that:

a. 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.

b. 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.

c. 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.

8.7 REFERENCE (S):

1. VA Affairs Handbook 6500, Risk Management Framework for VA Information Systems – Tier 3: VA Information Security Program, 10 Mar 2015.

2. Veterans Health Administration Procurement Manual (VHA PM) – 11/3/2014.

3. VA Handbook 1901.01, Health Information Management and Health Records – 19 Mar 15.

4. VHA Handbook 1605.5, Business Associate Agreements – 22 July 2014

5. Memo: VA Maintenance/Installation (Warranty) Contracts (VAIQ 7058822), 24 Mar 2011.

6. VA Directive 0735, Homeland Security Presidential Directive 12 (HSPD-12) Program, dated February 17, 2011.

7. Veterans Affairs Handbook 6500.6 Contract Security, 12 Mar 2010.

8. Health Insurance Portability & Accountability Act (HIPAA) Privacy Rule (See 45 CRF 164, 502(a)(1).

9. VA Directive 0710, Personnel Security and Suitability Program, dated June 4, 2010.

10. VA Directive 6066, Protected Health Information.

11. Privacy Act of 1974 (5 U.S.C. 552a).

12. Homeland Security Presidential Directive (HSPD-12),

13. Federal Information Processing Standards Publication (FIPS) 201, Personal Identity Verification (PIV) of Federal Employees and Contractors, dated Feb 25, 2005, amended by FIPS 201-1, March 2006.

14. Social Security Act (42 U.S.C. § 1395x(u)): Health care and other related services, as mentioned in HIPAA regulations, are defined in detail under Section 1861(s) http://www.ssa.gov/OP_Home/ssact/title18/1861.htm.

15. VA Directive 6512, Secure Wireless Technology, dated 4 Nov 2009

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