S06 - 36C24724Q1000 AMENDMENT 0001.pdf

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Attached to
Radiation Survey Testing Federal contract opportunity
Solicitation number
36C24724Q1000
Issued by
Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 7

About this file

This document is a business associate agreement between the Department of Veterans Affairs (VA) Veterans Health Administration (VHA) and the contractor. The agreement establishes requirements for the use and disclosure of protected health information (PHI) by the contractor, in accordance with HIPAA and related regulations. Key details include:

The contractor will provide services to, for, or on behalf of the VA VHA, which will require the disclosure of PHI to the contractor. The agreement outlines the contractor's obligations in handling PHI, such as implementing safeguards, reporting incidents, mitigating harm, entering into subcontractor agreements, providing PHI access and amendment, and returning/destroying PHI upon contract completion. The agreement also states the VA VHA's obligations, such as not requesting improper uses/disclosures of PHI and obtaining necessary individual authorizations. The agreement may be terminated by the VA VHA for a material breach by the contractor.

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Text version

5. PROJECT NUMBER (if applicable)

CODE 7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER 3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO. 1. CONTRACT ID CODE

FACILITY CODE CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office. is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER 16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30 PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243

(Type or print) (Type or print)

(Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code)

(If other than Item 6)

(Specify type of modification and authority)

(such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

1 7

534-25-1-062-0001

None

Department of Veterans Affairs VISN 7 Network Contracting Office 3 FL Directors Office 3700 Crestwood Parkway Duluth GA 30096

Department of Veterans Affairs VISN 7 Network Contracting Office 3 FL Directors Office 3700 Crestwood Parkway Duluth GA 30096

To all Offerors/Bidders

36C24724Q1000

08-22-2024

X

X x

X 1

Business Associate Agreement is a part of this solicitation, please see additional pages 2-7 below.

All other terms and conditions remain the same.

Earnest Ellison Contracting Officer

BUSINESSASSOCIATEAGREEMENTBETWEENTHEDEPARTMENTOF
VETERANSAFFAIRSVETERANSHEALTHADMINISTRATION,, AND

Purpose. The purpose of this Business Associate Agreement (Agreement) is to establish requirements for the Department of Veterans Affairs (VA), Veterans Health Administration (VHA), and in accordance with the Health Insurance Portability and Accountability Act (HIPAA), the Health Information Technology for Economic and Clinical Health Act (HITECH) Act, and the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules (“HIPAA Rules”), 45 C.F.R. Parts 160 and 164, for the Use and Disclosure of Protected Health Information (PHI) under the terms and conditions specified below.

Scope. As described this Agreement and other applicable contracts or agreements, will provide services to, for, or on behalf of .

In order for to provide such services, will disclose PHI to and will use or disclose PHI in accordance with this Agreement.

Definitions. Unless otherwise provided, the following terms used in this Agreement have the same meaning as defined by the HIPAA Rules: Breach, Data Aggregation, Designated Record Set, Disclosure, Health Care Operations, Individual, Minimum Necessary, Notice of Privacy Practices, PHI, Required by Law, Secretary, Security Incident, Subcontractor, Unsecured PHI, and Use.

“Breach” shall have the same meaning as described at 45 C.F.R. § 164.402. For the purposes of this Agreement, Breach shall refer to an acquisition, access, use, or disclosure of PHI in a manner not permitted by the HIPAA Rules or by this Agreement.

“Business Associate” shall have the same meaning as described at 45 C.F.R. § 164.402. For the purposes of this Agreement, Business Associate shall refer to , including its employees, officers, or any other agents that create, receive, maintain, or transmit PHI as described below.

“Covered Entity” shall have the same meaning as the term is defined at 45 C.F.R. § 160.103. For the purposes of this Agreement, Covered Entity shall refer to .

“Incident” shall have the same meaning as described in VA Handbook 6500.2, Management of Breaches Involving Sensitive Personal Information, which is an event that has resulted in, or had the potential to result in, unauthorized access to or disclosure of VA sensitive personal information in a manner not permitted under the applicable confidentiality provisions. An incident that involves access or disclosure of PHI in a manner not permitted under the HIPAA Privacy Rule is presumed to be a breach unless Business Associate demonstrates that there is a low probability that the PHI has been compromised based on a risk assessment using at least the listed factors in the Breach Notification Rule.

“Protected Health Information” or “PHI” shall have the same meaning as described at 45 C.F.R. §

160.103. “Protected Health Information” and “PHI” as used in this Agreement include “Electronic

Protected Health Information” and “EPHI.” For the purposes of this Agreement and unless otherwise provided, the term shall also refer to PHI that Business Associate creates, receives, maintains, or transmits on behalf of Covered Entity or receives from Covered Entity or another Business Associate of

Covered Entity.

“Subcontractor” shall have the same meaning as the term is defined at 45 C.F.R. § 160.103. For the purposes of this Agreement, Subcontractor shall refer to a contractor of any person or entity, other than

Covered Entity or Business Associate, that creates, receives, maintains, or transmits PHI under the terms of this Agreement.

Terms and Conditions. Covered Entity and Business Associate agree as follows:

1. Ownership of PHI. PHI is and remains data owned by Covered Entity as long as Business Associate creates, receives, maintains, or transmits PHI, regardless of whether a compliant Business Associate

Agreement is in place.

2. Use and Disclosure of PHI by Business Associate. Unless otherwise provided, Business Associate:

A. May not use or disclose PHI other than as permitted or required by this Agreement, or in a manner that would violate the HIPAA Privacy Rule if done by Covered Entity, except that it may use or disclose

PHI:

(1) As required by law or to carry out its legal responsibilities;

(2) For the proper management and administration of Business Associate; or

(3) To provide Data Aggregation services relating to the health care operations of Covered Entity.

B. Must use or disclose PHI in a manner that complies with Covered Entity’s minimum necessary policies and procedures.

C. May de‐identify PHI created or received by Business Associate under this Agreement, provided that the de‐identification conforms to the requirements of the HIPAA Privacy Rule and that such de‐ identified information is used solely for purposes of providing or improving Business Associate’s services for Covered Entity or for another lawful purpose approved in advance and in writing by Covered Entity.

Business Associate shall not sell or market de‐identified data sets created from Covered Entity’s PHI.

3. Obligations of Business Associate. In connection with any Use or Disclosure of PHI, Business Associate must:

A. Consult with Covered Entity before using or disclosing PHI whenever Business Associate is uncertain whether the Use or Disclosure is authorized under this Agreement.

B. Implement appropriate administrative, physical, and technical safeguards and controls to protect PHI and document applicable policies and procedures to prevent any Use or Disclosure of PHI other than as provided by this Agreement.

C. Provide satisfactory assurances that PHI created or received by Business Associate under this

Agreement is protected to the greatest extent feasible.

D. Notify Covered Entity no later than twenty‐four (24) hours after Business Associate’s discovery (as described in (1) below) of any incident, such as a potential access, acquisition, use, disclosure, modification, or destruction of either secured or unsecured PHI in violation of this Agreement “that (A) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of VA information or a VA information system” accessible by VA users “or (B) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies,” per the Federal Information Security Management Act, 44 USC 3501‐3518.

(1) For purposes of this notification, an incident as described above will be treated as discovered by

Business Associate when such event is known to any employee, officer, or other agent (other than the individual who committed the incident) of Business Associate or, by exercising reasonable diligence, would have been known to an employee, officer, or other agent of Business Associate.

(2) Notification shall be sent to and and to the VHA Health Information Access Office, Business Associate Program Manager by email at VHABAAIssues@va.gov.

(3) Absent Covered Entity’s request or approval, Business Associate shall not directly notify individuals or the Department of Health and Human Services of incidents involving PHI created or received by

Business Associate as an agent of Covered Entity.

E. Provide a written report to Covered Entity of any potential access, acquisition, use, disclosure, modification, or destruction of either secured or unsecured PHI in violation of this Agreement, including any Breach of PHI, within ten (10) business days of the initial notification to the Covered Entity.

(1) The written report of an incident as described above will document the following:

(a) The identity of each Individual whose PHI has been, or is reasonably believed by Business

Associate to have been, accessed, acquired, used, disclosed, modified, or destroyed;

(b) A description of what occurred, including the date of the incident and the date of the discovery of the incident (if known);

(c) A description of the types of secured or unsecured PHI that was involved;

(d) A description of what is being done to investigate the incident, to mitigate further harm to

Individuals, and to protect against future Security Incidents; and

(e) Any other information as required by 45 C.F.R. §§ 164.404(c) and 164.410.

(2) The written report shall be addressed to:

and submitted by email to and to the VHA Health Information Access Office , Business Associate Program Manager at VHABAAIssues@va.gov

F. To the greatest extent feasible, mitigate any harm due to a Use or Disclosure of PHI by Business

Associate in violation of this Agreement that is known or, by exercising reasonable diligence, should have been known to Business Associate.

G. To the extent feasible, use only agents and Subcontractors that are physically located within a jurisdiction subject to the laws of the United States or its Territories.

H. Enter into Business Associate Agreements with contractors and Subcontractors as appropriate under the HIPAA Rules and this Agreement. In doing so, Business Associate:

(1) Must ensure that the terms of any Agreement between Business Associate and a contractor or

Subcontractor are at least as restrictive as Business Associate Agreement between Business Associate and Covered Entity.

(2) Must ensure that contractors and Subcontractors agree to the same restrictions and conditions that apply to Business Associate and obtain satisfactory written assurances from them that they agree to those restrictions and conditions.

(3) Unless approved by Covered Entity in advance and in writing, may not amend any terms of such

Agreement, in any way to make them inconsistent with the obligations of Business Associate or any contractors or Subcontractors in connection with or in consideration of the HIPAA Rules or this

Agreement.

I. Within five (5) business days of a written request from Covered Entity:

(1) Make available information for Covered Entity to respond to an Individual’s request for access to

PHI about him/her.

(2) Make available information for Covered Entity to respond to an Individual’s request for amendment of PHI about him/her and, as determined by and under the direction of Covered Entity, incorporate any amendment to the PHI.

(3) Make available PHI for Covered Entity to respond to an Individual’s request for an accounting of

Disclosures of PHI about him/her.

J. Business Associate shall not take any action in response to an individual’s request for access, amendment, or accounting and shall direct the individual to contact the VHA Privacy Office at 1‐877‐

461‐5038.

K. To the extent Business Associate is required to carry out Covered Entity's obligations under Subpart E of 45 CFR Part 164, comply with the provisions that apply to Covered Entity in the performance of such obligations.

L. Provide to the Secretary of Health and Human Services and to Covered Entity records related to Use or Disclosure of PHI, including its policies, procedures, and practices, for the purpose of determining

Covered Entity’s, Business Associate’s, or a Subcontractor’s compliance with the HIPAA Rules.

M. Upon completion or termination of the applicable contract(s) or agreement(s), return or destroy all

PHI and other VA data created or received by Business Associate during the performance of the contract(s) or agreement(s). No such information will be retained by Business Associate unless retention is required by law or specifically permitted by Covered Entity. If return or destruction is not feasible, Business Associate shall continue to protect the PHI in accordance with the HIPAA Rules or this

Agreement and use or disclose the information under this Agreement only for the purpose of making the return or destruction feasible, as required by law, or as specifically permitted by Covered Entity.

Business Associate shall provide written assurance that either all PHI has been returned or destroyed, or any information retained will be safeguarded and used and disclosed only as permitted under this paragraph.

N. Be liable to Covered Entity for civil or criminal penalties imposed on Covered Entity, in accordance with 45 C.F.R. §§ 164.402 and 164.410, and with the HITECH Act, 42 U.S.C. §§ 17931(b), 17934(c), for any violation of the HIPAA Rules or this Agreement by Business Associate.

4. Obligations of Covered Entity. Covered Entity agrees that it:

A. Will not request Business Associate to make any Use or Disclosure of PHI in a manner that would not be permissible under Subpart E of 45 C.F.R. Part 164 if made by Covered Entity, except as permitted under Section 2 of this Agreement.

B. Will promptly notify Business Associate in writing of any restrictions on Covered Entity’s authority to use or disclose PHI that may limit Business Associate’s Use or Disclosure of PHI or otherwise affect its ability to fulfill its obligations under this Agreement.

C. Has obtained or will obtain from Individuals any authorization necessary for Business Associate to fulfill its obligations under this Agreement.

D. Will promptly notify Business Associate in writing of any change in Covered Entity’s Notice of Privacy

Practices, or any modification or revocation of an Individual’s authorization to use or disclose PHI, if such change or revocation may limit Business Associate’s Use and Disclosure of PHI or otherwise affect its ability to perform its obligations under this Agreement.

5. Amendment. Business Associate and Covered Entity agree to enter into good faith negotiations to amend this Agreement, as necessary, for Covered Entity and Business Associate to comply with the requirements of the HIPAA Rules or other applicable law.

6. Termination.

A. Automatic Termination. This Agreement will automatically terminate upon completion of Business

Associate’s duties under all underlying Agreements or by termination of such underlying Agreements.

B. Termination Upon Review. This Agreement may be terminated by Covered Entity, at its discretion, upon review as provided by Section 9 of this Agreement.

C. Termination for Cause. In the event of a material breach of this Agreement by Business Associate, Covered Entity:

(1) Will provide Business Associate written notice of the material breach and an opportunity for

Business Associate to cure the breach or end the violation within the reasonable time specified by

Covered Entity and;

(2) May terminate this Agreement if Business Associate does not cure the breach or end the violation within the reasonable time specified by Covered Entity.

D. Effect of Termination. Termination of this Agreement will result in cessation of activities by Business

Associate involving PHI under this Agreement.

E. Survival. The obligations of Business Associate under Section 3 above shall survive the termination of this Agreement as long as Business Associate creates, receives, maintains, or transmits PHI, regardless of whether a compliant Business Associate Agreement is in place.

7. No Third‐Party Beneficiaries. Nothing expressed or implied in this Agreement confers any rights, remedies, obligations, or liabilities whatsoever upon any person or entity other than Covered Entity and

Business Associate, including their respective successors or assigns.

8. Other Applicable Law. This Agreement does not abrogate any responsibilities of the parties under any other applicable law.

9. Review Date. The provisions of this Agreement will be reviewed by Covered Entity every two years from Effective Date to determine the applicability and accuracy of the Agreement based on the circumstances that exist at the time of review.

10. Effective Date. This Agreement shall be effective on the last signature date below.

Department of Veterans Affairs

Veterans Health Administration

By: By:

Name: Name:

Title: Title:

Date: Date:

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