N62645-19-Q-0031.docx

N6264519Q0031

Section SF 1449 - CONTINUATION SHEET

Authoritative Data Exchange/Subscription

FFP

The contractor shall provide Authoritative Data Exchange and Medical Logistics Database Subscription in accordance with the Statement of Work (SOW) for all locations listed in the SOW.

FOB: Destination

PSC CD: 7610

NET AMT

FFP

The contractor shall provide Authoritative Data Exchange and Medical Logistics Database Subscription in accordance with the Statement of Work (SOW) for all locations listed in the SOW.

NET AMT

FFP

The contractor shall provide Authoritative Data Exchange and Medical Logistics Database Subscription in accordance with the Statement of Work (SOW) for all locations listed in the SOW.

NET AMT

FFP

The contractor shall provide Authoritative Data Exchange and Medical Logistics Database Subscription in accordance with the Statement of Work (SOW) for all locations listed in the SOW.

NET AMT

FFP

The contractor shall provide Authoritative Data Exchange and Medical Logistics Database Subscription in accordance with the Statement of Work (SOW) for all locations listed in the SOW.

NET AMT

GENERAL CONTRACT INFORMATION

CONTRACTOR SUPPORT

Notice: Navy Use Of Support Contractor For Contract Closeout Functions

Naval Medical Logistics Command (NMLC) uses two private contractors in support of the contract closeout process. Those companies are Contracting Resources Group (CRG) of Federal Hill, MD, doing business under the authority of the Small Business Administration’s 8(a) program and the Ability One Program, doing business under the authority of the Javits-Wagner O’Day Act (41 U.S.C. § 47).

The contract closeout process includes activities such as processing deobligation modifications, obtaining contractor and requiring activity concurrence, preparing the DD-Form 1594 (Contract Completion Statement), and preparing closed files for archiving. Support contractors may perform additional administrative duties, including filing and processing simple administrative modifications. Performing these functions require the contractor employees to have access to the contract file. Therefore, information the Contractor provides to the Government or information already in the possession of the Government may be viewed by these support contractors in the course of performing contract close-out functions. The information that may be made available to the contractor may include pricing and technical responses and performance information.

NMLC has signed Non-Disclosure Agreements with each support contractor employee and has required both contractors to provide a Conflict of interest Mitigation Plan to ensure these employees are firewalled from all business development activity.

By signature of this contract, the quoter consents to access of their business sensitive/confidential or proprietary data by the Government’s support contractor personnel in order to perform close out services.

OTHER CONTRACTING REQUIREMENTS

Risk Management Framework (RMF)

The contractor shall comply with RMF requirements, as specified by the Defense Health Agency (DHA) that meet appropriate DoD, DHA and Navy Cybersecurity requirements. The contractor shall initiate the process by providing the required documentation necessary to submit their system to the Authorizing Official (AO) for assessment and authorization (A&A) for this contract. The requirements shall be met before the contractor's system is authorized to access DoD data or to interconnect with any DoD network or system that receives, processes, stores, displays or transmits DoD data. The contractor shall ensure the proper contractor support staff is available to participate in all phases of the RMF process. This includes, but is not limited to;

Attending and supporting RMF and A&A meetings with Navy and DHA cybersecurity representatives as required.

Support/conduct vulnerability mitigation to comply with cybersecurity controls listed in National Institute of Standards and Technology (NIST) Special Publication (SP) 800-53; Security and Privacy Controls for Federal Information Systems and Organizations and DHA Administrative Instruction 77. In order for a system to be authorized, there shall be zero Category 1 findings.

Support the A&A Team during system security testing.

Once the system has been authorized, the contractor shall maintain an acceptable security baseline consistent with the authorization granted by the AO throughout the life of the system. This includes ensuring that all vulnerabilities affecting the operating system, primary application, database and all third party software have validated and applied within 30 days.

Cybersecurity

The vendor shall establish appropriate administrative and technical safeguards to protect any and all data, to ensure the confidentiality, integrity, and availability of Government data under their control. At a minimum, this shall include provisions for vendor personnel security and electronic security.

The proposed system shall be capable of supporting the use of Defense Information Systems Agency (DISA) approved antimalware applications. The Navy uses McAfee Host Based Security System (HBSS) as their solution. The vendor shall provide technical specifications that clearly demonstrate whether the proposed solution can integrate and support, either fully or partially the operation without performance degradation of the medical system/device. In cases where the operation of HBSS is not technically achievable, the vendor shall provide detailed justification and a Plan of Actions and Milestones (POA&M) describing steps towards compliance with this requirement.

The vendor must provide their Antivirus (AV) policy and a list of AV Exceptions (if applicable) to the NMLC prior to AV installation on the system/device. AV must be installed on all devices before they are placed on the Navy network.

Systems shall be configured in such a way to allow for the updating of malware definition signatures on a scheduled basis. Scanning shall encompass the entire system (file system, operating system, real-time processes), by default. In cases where scanning of the entire system may negatively affect its operation, the vendor shall provide a detailed list of exclusions with justifications.

Vulnerability Management

Vulnerability mitigation strategies include security updates, service packs, and changes to operating procedures as physical and cyber vulnerabilities are detected. Operating systems, servers, development platforms and the application being delivered to the Navy shall be in compliance with all known applicable guidelines. The vendor shall agree to be proactive in working with the Navy to mitigate new threats as they emerge.

All vendor validated and approved patches, up to and including the date of install, must be loaded on the system prior to system go-live. Security scans will be run during government acceptance testing. All Category I (CAT I) findings must be remediated prior to government acceptance of the system. A CAT I vulnerability is any vulnerability, the exploitation of which will, directly and immediately result in loss of Confidentiality, Availability, or Integrity. There shall be no more than 10 Category II (CAT II) findings at the time of government acceptance. CAT II vulnerabilities are any vulnerability, the exploitation of which has a potential to result in loss of Confidentiality, Availability, or Integrity.

Domain Name System Realm/Directory Services

Contractor will be required to provide technical evidence, if applicable, whether client/server topology based medical systems can integrate with Directory Services and support LDAP authentication.

Local Privileged and Administrative User/Local System Accounts

Contractor shall create a single local user account with administrative/root level privileges for purposes of conducting system repairs and maintenance only. This account shall be separate and distinct from the built-in local administrative/root account provided by the Operating System and shall comply with DoD policy. All factors required to complete successful identification, authentication and authorization against the built-in local Administrative/Root level account shall be provided to the MTF Biomedical Engineering Department.

Complete administrative system rights shall be provided to the government System Administrator for the purpose of conducting device vulnerability scans as needed.

DHA Business to Business (B2B) Gateway. All contractor systems that will communicate with DON systems will interconnect through the established DHA Business to Business (B2B) gateway.

Contractors will connect to the B2B gateway via a contractor procured Internet Service Provider (ISP) connection and assume all responsibilities for establishing and maintaining their connectivity to the B2B gateway. This will include acquiring and maintaining the circuit to the B2B gateway and acquiring a Virtual Private Network (VPN) device compatible with the DHA VPN device. Maintenance and repair of contractor procured VPN equipment shall be the responsibility of the contractor.

Contractors shall configure their network to support access to government systems (e.g., configure ports and protocols for access).

Contractors shall provide full time connections to a TIER1 or TIER2 ISP. Dial-up ISP connections are not acceptable.

Contractors will comply with DoD guidance regarding allowable ports, protocols and risk mitigation strategies prior to accessing DoD/DHA networks. All contractors will be required to complete a DISA Form 2875, System Authorization Access Request form (SAAR) and submit it to the Navy PACS Office for processing. Contractor personnel will be required to complete applicable DoD cybersecurity training.

IPv6

The proposed system shall be Internet Protocol version 6 (IPv6) capable or the vendor shall provide a detailed project, migration or planning documentation to show when the proposed system shall be IPv6 capable.

Minimum IPv6 capabilities include:

· Conformant with the IPv6 standards profile contained in the DoD IT Standards Registry (DISR);

· Maintaining interoperability in heterogeneous environments with IPv4;

· Commitment to upgrade as the IPv6 standard evolves;

· Availability of vendor IPv6 technical support.

The contractor shall be able to demonstrate or provide documentation to prove that their product is IPv6 capable

Health Insurance Portability and Accountability Act (HIPAA)

The contractor shall comply with the HIPAA Act of 1996 (Public Law 104-191) requirements, specifically the administrative simplification provision s of the law and the associated rules and regulations published by the Secretary, Health and Human Services (HHS). This includes the Standards for Electronic Transactions, the Standards for Privacy of Individually Identifiable Health Information and the Security Standards.

Applicable References:

DoD Instruction 8510.01, Risk Management Framework (RMF) for DoD Information Technology (IT) NIST SP 800-37 Guide for Applying the Risk Management Framework to Federal Information Systems of February 2010, as amended NIST SP 800-53 Security and Privacy Controls for Federal Information Systems and Organizations, of 30 April 2013, as amended DoD Instruction 500.01 of 14 March 2014, DoD Cybersecurity DHA Administrative Instruction 77 of 28 May 2015 DoD Instruction 6025.18-R, DoD Health Information Privacy Regulation DoD Instruction 8580.02, Security of Individually Identifiable Health Information in DoD Health Care Programs

BUSINESS ASSOCIATE AGREEMENT

This Business Associate Agreement (BAA) incorporates HIPAA/HITECH Act requirements under the HHS Final Omnibus Rule (78 FR 5566, published 25 Jan 2013), effective 23 Sep 2013. This BAA is for use by MHS components outside of DHA.

Introduction

In accordance with 45 CFR 164.502(e)(2) and 164.504(e) and paragraph C.3.4.1.3 of DoD 6025.18-R, “DoD Health Information Privacy Regulation,” January 24, 2003, this document serves as a business associate agreement (BAA) between the signatory parties for purposes of the Health Insurance Portability and Accountability Act (HIPAA) and the “HITECH Act” amendments thereof, as implemented by the HIPAA Rules and DoD HIPAA Issuances (both defined below). The parties are a DoD Military Health System (MHS) component, acting as a HIPAA covered entity, and a DoD contractor, acting as a HIPAA business associate. The HIPAA Rules require BAAs between covered entities and business associates. Implementing this BAA requirement, the applicable DoD HIPAA Issuance (DoD 6025.18-R, paragraph C3.4.1.3) provides that requirements applicable to business associates must be incorporated (or incorporated by reference) into the contract or agreement between the parties.

(a) Catchall Definition. Except as provided otherwise in this BAA, the following terms used in this BAA shall have the same meaning as those terms in the DoD HIPAA Rules: Data Aggregation, Designated Record Set, Disclosure, Health Care Operations, Individual, Minimum Necessary, Notice of Privacy Practices (NoPP), Protected Health Information (PHI), Required By Law, Secretary, Security Incident, Subcontractor, Unsecured Protected Health Information, and Use.

Breach means actual or possible loss of control, unauthorized disclosure of or unauthorized access to PHI or other PII (which may include, but is not limited to PHI), where 12 Nov 2013 Page 2 of 10 persons other than authorized users gain access or potential access to such information for any purpose other than authorized purposes, where one or more individuals will be adversely affected. The foregoing definition is based on the definition of breach in DoD Privacy Act Issuances as defined herein.

Business Associate shall generally have the same meaning as the term “business associate” in the DoD HIPAA Issuances, and in reference to this BAA, shall mean the contractor.

Agreement means this BAA together with the documents and/or other arrangements under which the Business Associate signatory performs services involving access to PHI on behalf of the MHS component signatory to this BAA.

Covered Entity shall generally have the same meaning as the term “covered entity” in the DoD HIPAA Issuances, and in reference to this BAA, shall mean the Government facility(s) and office(s) that are supported under this contract.

DHA Privacy Office means the DHA Privacy and Civil Liberties Office. The DHA Privacy Office Director is the HIPAA Privacy and Security Officer for DHA, including the National Capital Region Medical Directorate (NCRMD).

DoD HIPAA Issuances means the DoD issuances implementing the HIPAA Rules in the DoD Military Health System (MHS). These issuances are DoD 6025.18-R (2003), DoDI 6025.18 (2009), and DoD 8580.02-R (2007).

DoD Privacy Act Issuances means the DoD issuances implementing the Privacy Act, which are DoDD 5400.11 (2007) and DoD 5400.11-R (2007).

HHS Breach means a breach that satisfies the HIPAA Breach Rule definition of breach in 45 CFR 164.402.

HIPAA Rules means, collectively, the HIPAA Privacy, Security, Breach and Enforcement Rules, issued by the U.S. Department of Health and Human Services (HHS) and codified at 45 CFR Part 160 and Part 164, Subpart E (Privacy), Subpart C (Security), Subpart D (Breach) and Part 160, Subparts C-D (Enforcement), as amended by the 2013 modifications to those Rules, implementing the “HITECH Act” provisions of Pub. L. 111-5. See 78 FR 5566-5702 (Jan. 25, 2013) (with corrections at 78 FR 32464 (June 7, 2013)). Additional HIPAA rules regarding electronic transactions and code sets (45 CFR Part 162) are not addressed in this BAA and are not included in the term HIPAA Rules.

Service-Level Privacy Office means one or more offices within the military services (Army, Navy, or Air Force) with oversight authority over Privacy Act and HIPAA privacy compliance.

I. Obligations and Activities of Business Associate

(a) The Business Associate shall not use or disclose PHI other than as permitted or required by the Agreement or as required by law.

(b) The Business Associate shall use appropriate safeguards, and comply with the DoD HIPAA Rules with respect to electronic PHI, to prevent use or disclosure of PHI other than as provided for by the Agreement.

(c) The Business Associate shall report to Covered Entity any Breach of which it becomes aware, and shall proceed with breach response steps as required by Part V of this BAA. With respect to electronic PHI, the Business Associate shall also respond to any security incident of which it becomes aware in accordance with any Information Assurance provisions of the Agreement. If at any point the Business Associate becomes aware that a security incident involves a Breach, the Business Associate shall immediately initiate breach response as required by part V of this BAA.

(d) In accordance with 45 CFR 164.502(e)(1)(ii)) and 164.308(b)(2), respectively), as applicable, the Business Associate shall ensure that any subcontractors that create, receive, maintain, or transmit PHI on behalf of the Business Associate agree to the same restrictions, conditions, and requirements that apply to the Business Associate with respect to such PHI.

(e) The Business Associate shall make available PHI in a Designated Record Set, to the Covered Entity or, as directed by the Covered Entity, to an Individual, as necessary to satisfy the Covered Entity obligations under 45 CFR 164.524.

(f) The Business Associate shall make any amendment(s) to PHI in a Designated Record Set as directed or agreed to by the Covered Entity pursuant to 45 CFR 164.526, or take other measures as necessary to satisfy Covered Entity’s obligations under 45 CFR 164.526.

(g) The Business Associate shall maintain and make available the information required to provide an accounting of disclosures to the Covered Entity or an individual as necessary to satisfy the Covered Entity’s obligations under 45 CFR 164.528.

(h) To the extent the Business Associate is to carry out one or more of Covered Entity's obligation(s) under the HIPAA Privacy Rule, the Business Associate shall comply with the requirements of HIPAA Privacy Rule that apply to the Covered Entity in the performance of such obligation(s); and

(i) The Business Associate shall make its internal practices, books, and records available to the Secretary for purposes of determining compliance with the HIPAA Rules.

II. Permitted Uses and Disclosures by Business Associate

(a) The Business Associate may use or disclose PHI only as necessary to perform the services set forth in the Agreement or as required by law. The Business Associate is not permitted to de-identify PHI under DoD HIPAA issuances or the corresponding 45 CFR 164.514(a)-(c), nor is it permitted to use or disclose de-identified PHI, except as provided by the Agreement or directed by the Covered Entity.

(b) The Business Associate agrees to use, disclose and request PHI only in accordance with the HIPAA Privacy Rule “minimum necessary” standard and corresponding DHA policies and procedures as stated in the DoD HIPAA Issuances.

(c) The Business Associate shall not use or disclose PHI in a manner that would violate the DoD HIPAA Issuances or HIPAA Privacy Rules if done by the Covered Entity, except uses and disclosures for the Business Associate’s own management and administration and legal responsibilities or for data aggregation services as set forth in the following three paragraphs.

(d) Except as otherwise limited in the Agreement, the Business Associate may use PHI for the proper management and administration of the Business Associate or to carry out the legal responsibilities of the Business Associate. The foregoing authority to use PHI does not apply to disclosure of PHI, which is covered in the next paragraph.

(e) Except as otherwise limited in the Agreement, the Business Associate may disclose PHI for the proper management and administration of the Business Associate or to carry out the legal responsibilities of the Business Associate, provided that disclosures are required by law, or the Business Associate obtains reasonable assurances from the person to whom the PHI is disclosed that it will remain confidential and used or further disclosed only as required by law or for the purposes for which it was disclosed to the person, and the person notifies the Business Associate of any instances of which it is aware in which the confidentiality of the information has been breached.

(f) Except as otherwise limited in the Agreement, the Business Associate may use PHI to provide Data Aggregation services relating to the Covered Entity’s health care operations.

III. Provisions for Covered Entity to Inform Business Associate of Privacy Practices and Restrictions

(a) The Covered Entity shall provide the Business Associate with the notice of privacy practices that the Covered Entity produces in accordance with 45 CFR 164.520 and the corresponding provision of the DoD HIPAA Issuances.

(b) The Covered Entity shall notify the Business Associate of any changes in, or revocation of, the permission by an Individual to use or disclose his or her PHI, to the extent that such changes affect the Business Associate’s use or disclosure of PHI.

(c) The Covered Entity shall notify the Business Associate of any restriction on the use or disclosure of PHI that the Covered Entity has agreed to or is required to abide by under 45 CFR 164.522, to the extent that such changes may affect the Business Associate’s use or disclosure of PHI.

IV. Permissible Requests by Covered Entity

The Covered Entity shall not request the Business Associate to use or disclose PHI in any manner that would not be permissible under the HIPAA Privacy Rule or any applicable Government regulations (including without limitation, DoD HIPAA Issuances) if done by the Covered Entity, except for providing Data Aggregation services to the Covered Entity and for management and administrative activities of the Business Associate as otherwise permitted by this BAA.

V. Breach Response

(a) In general.

In the event of a breach of PII/PHI held by the Business Associate, the Business Associate shall follow the breach response requirements set forth in this Part V, which is designed to satisfy both the Privacy Act and HIPAA as applicable. If a breach involves PII without PHI, then the Business Associate shall comply with DoD Privacy Act Issuance breach response requirements only; if a breach involves PHI (a subset of PII), then the Business Associate shall comply with both Privacy Act and HIPAA breach response requirements. A breach involving PHI may or may not constitute an HHS Breach. If a breach is not an HHS Breach, then the Business Associate has no HIPAA breach response obligations. In such cases, the Business Associate must still comply with breach response requirements under the DoD Privacy Act Issuances.

If the DHA Privacy Office determines that a breach is an HHS Breach, then the Business Associate shall comply with both the HIPAA Breach Rule and DoD Privacy Act Issuances, as directed by the DHA Privacy Office, regardless of whether the breach occurs at DHA or at one of the Service components. If the DHA Privacy Office determines that the breach does not constitute an HHS Breach, then the Business Associate shall comply with DoD Privacy Act Issuances, as directed by the applicable Service-Level Privacy Office. The following provisions of Part V set forth the Business Associate’s Privacy Act and HIPAA breach response requirements for all breaches, including but not limited to HHS breaches.

This Part V is designed to satisfy the DoD Privacy Act Issuances and the HIPAA Breach Rule as implemented by the DoD HIPAA Issuances. In general, for breach response, the Business Associate shall report the breach to the Covered Entity, assess the breach incident, notify affected individuals, and take mitigation actions as applicable. Because DoD defines “breach” to include possible (suspected) as well as actual (confirmed) breaches, the Business Associate shall implement these breach response requirements immediately upon the Business Associate’s discovery of a possible breach.

(b) Government Reporting Provisions

The Business Associate shall report the breach within one hour of discovery to the US Computer Emergency Readiness Team (US CERT), and, within 24 hours of discovery, to the DHA Privacy Office and the other parties set forth below. The Business Associate is deemed to have discovered a breach as of the time a breach (suspected or confirmed) is known, or by exercising reasonable diligence would have been known, to any person (other than the person committing it) who is an employee, officer or other agent of the Business Associate.

The Business Associate shall submit the US-CERT report using the online form at https://forms.us-cert.gov/report/. Before submission to US-CERT, the Business Associate shall save a copy of the on-line report. After submission, the Business Associate shall record the US-CERT Reporting Number. Although only limited information about the breach may be available as of the one hour deadline for submission, the Business Associate shall submit the US-CERT report by the deadline. The Business Associate shall e-mail updated information as it is obtained, following the instructions at http://www.us-cert.gov/pgp/email.html. The Business Associate shall provide a copy of the initial or updated US-CERT report to the DHA Privacy Office and the applicable Service-Level Privacy Office, if requested by either. Business Associate questions about US-CERT reporting shall be directed to the DHA or Service-Level Privacy Office, not the US-CERT office.

The Business Associate report due within 24 hours shall be submitted by completing the New Breach Reporting Form DD 2959 at the Breach Response page on the DHA Privacy Office web site and emailing that form to, as applicable, the DHA Privacy Office, the Service-Level Privacy Office, the Contracting Officer (CO) and Contracting Officer’s Representative (COR) and the Business Associate’s DoD point of contact (POC) unless the POC specifies another addressee for breach reporting. Encryption is not required, because Breach Report Forms should not contain PII/PHI. The email address for notices to the DHA Privacy Office is provided at the Privacy Office website breach response page. If electronic mail is not available, telephone notification is also acceptable, but all notifications and reports delivered telephonically must be confirmed by email as soon as technically feasible.

If multiple beneficiaries are affected by a single event or related set of events, then a single reportable breach may be deemed to have occurred, depending on the circumstances. The Business Associate shall inform the DHA Privacy Office as soon as possible if it believes that “single event” breach response is appropriate; the DHA Privacy Office will determine how the Business Associate shall proceed and, if appropriate, consolidate separately reported breaches for purposes of Business Associate report updates, beneficiary notification, and mitigation.

When a Breach Report Form initially submitted is incomplete or incorrect due to unavailable information, or when significant developments require an update, the Business Associate shall submit a revised form or forms, stating the updated status and previous report date(s) and showing any revisions or additions in red text. Examples of updated information the Business Associate shall report include, but are not limited to: confirmation on the exact data elements involved, the root cause of the incident, and any mitigation actions to include, sanctions, training, incident containment, follow-up, etc. The Business Associate shall submit these report updates promptly after the new information becomes available. Prompt reporting of updates is required to allow the DHA Privacy Office to make timely final determinations on any subsequent notifications or reports. The Business Associate shall provide updates to the same parties as required for the initial Breach Reporting Form. The Business Associate is responsible for reporting all information needed by the DHA Privacy Office to make timely and accurate determinations on reports to HHS as required by the HHS Breach Rule and reports to the Defense Privacy and Civil Liberties Office as required by DoD Privacy Act Issuances.

In the event the Business Associate is uncertain on how to apply the above requirements, the Business Associate shall consult with the DHA Privacy Office (or the Service-Level Privacy Office, which will consult with the Privacy Office as appropriate) when determinations on applying the above requirements are needed.

(c) Individual Notification Provisions

If the DHA Privacy Office determines that individual notification is required, the Business Associate shall provide written notification to individuals affected by the breach as soon as possible, but no later than 10 working days after the breach is discovered and the identities of the individuals are ascertained. The 10 day period begins when the Business Associate is able to determine the identities (including addresses) of the individuals whose records were impacted.

The Business Associate’s proposed notification to be issued to the affected individuals shall be submitted to the parties to which reports are submitted under paragraph V(a) for their review, and for approval by the DHA Privacy Office. Upon request, the Business Associate shall provide the DHA Privacy Office with the final text of the notification letter sent to the affected individuals. If different groups of affected individuals receive different notification letters, then the Business Associate shall provide the text of the letter for each group. (PII shall not be included with the text of the letter(s) provided.) Copies of further correspondence with affected individuals need not be provided unless requested by the Privacy Office. The Business Associate’s notification to the individuals, at a minimum, shall include the following:

—The individual(s) must be advised of what specific data was involved. It is insufficient to simply state that PII has been lost. Where names, Social Security Numbers (SSNs) or truncated SSNs, and Dates of Birth (DOBs) are involved, it is critical to advise the individual that these data elements potentially have been breached.

—The individual(s) must be informed of the facts and circumstances surrounding the breach. The description should be sufficiently detailed so that the individual clearly understands how the breach occurred.

—The individual(s) must be informed of what protective actions the Business Associate is taking or the individual can take to mitigate against potential future harm. The notice must refer the individual to the current Federal Trade Commission (FTC) web site pages on identity theft and the FTC’s Identity Theft Hotline, toll-free: 1-877-ID-THEFT (438-4338); TTY: 1-866-653-4261.

—The individual(s) must also be informed of any mitigation support services (e.g., one year of free credit monitoring, identification of fraud expense coverage for affected individuals, provision of credit freezes, etc.) that the Business Associate may offer affected individuals, the process to follow to obtain those services and the period of time the services will be made available, and contact information (including a phone number, either direct or toll-free, e-mail address and postal address) for obtaining more information.

Business Associates shall ensure any envelope containing written notifications to affected individuals are clearly labeled to alert the recipient to the importance of its contents, e.g., “Data Breach Information Enclosed,” and that the envelope is marked with the identity of the Business Associate and/or subcontractor organization that suffered the breach. The letter must also include contact information for a designated POC to include, phone number, email address, and postal address.

If the Business Associate determines that it cannot readily identify, or will be unable to reach, some affected individuals within the 10 day period after discovering the breach, the Business Associate shall so indicate in the initial or updated Breach Report Form. Within the 10 day period, the Business Associate shall provide the approved notification to those individuals who can be reached. Other individuals must be notified within 10 days after their identities and addresses are ascertained. The Business Associate shall consult with the DHA Privacy Office, which will determine which media notice is most likely to reach the population not otherwise identified or reached. The Business Associate shall issue a generalized media notice(s) to that population in accordance with Privacy Office approval.

The Business Associate shall, at no cost to the government, bear any costs associated with a breach of PII/PHI that the Business Associate has caused or is otherwise responsible for addressing.

Breaches are not to be confused with security incidents (often referred to as cyber security incidents when electronic information is involved), which may or may not involve a breach of PII/PHI. In the event of a security incident not involving a PII/PHI breach, the Business Associate shall follow applicable DoD Information Assurance requirements under its Agreement. If at any point the Business Associate finds that a cyber security incident involves a PII/PHI breach (suspected or confirmed), the Business Associate shall immediately initiate the breach response procedures set forthhere. The Business Associate shall also continue to follow any required cyber security incident response procedures to the extent needed to address security issues, as determined by DoD/DHA.

VI. Termination

(a) Termination. Noncompliance by the Business Associate (or any of its staff, agents, or subcontractors) with any requirement in this BAA may subject the Business Associate to termination under any applicable default or other termination provision of the Agreement.

(b) Effect of Termination.

(1) If the Agreement has records management requirements, the Business Associate shall handle such records in accordance with the records management requirements. If the Agreement does not have records management requirements, the records should be handled in accordance with paragraphs (2) and (3) below. If the Agreement has provisions for transfer of records and PII/PHI to a successor Business Associate, or if DHA gives directions for such transfer, the Business Associate shall handle such records and information in accordance with such Agreement provisions or DHA direction.

(2) If the Agreement does not have records management requirements, except as provided in the following paragraph (3), upon termination of the Agreement, for any reason, the Business Associate shall return or destroy all PHI received from the Covered Entity, or created or received by the Business Associate on behalf of the Covered Entity that the Business Associate still maintains in any form. This provision shall apply to PHI that is in the possession of subcontractors or agents of the Business Associate. The Business Associate shall retain no copies of the PHI.

(3) If the Agreement does not have records management provisions and the Business Associate determines that returning or destroying the PHI is infeasible, the Business Associate shall provide to the Covered Entity notification of the conditions that make return or destruction infeasible. Upon mutual agreement of the Covered Entity and the Business Associate that return or destruction of PHI is infeasible, the Business Associate shall extend the protections of the Agreement to such PHI and limit further uses and disclosures of such PHI to those purposes that make the return or destruction infeasible, for so long as the Business Associate maintains such PHI.

VII. Miscellaneous

(a) Survival. The obligations of Business Associate under the “Effect of Termination” provision of this BAA shall survive the termination of the Agreement.

(b) Interpretation. Any ambiguity in the Agreement shall be resolved in favor of a meaning that permits the Covered Entity and the Business Associate to comply with the HIPAA Rules and the DoD HIPAA Rules.

STATEMENT OF WORK

Statement of Work Medical Logistics Authoritative Data Exchange and Medical Logistics Database Subscriptions

PART 1

1.0 DEFINITIONS & ACRONYMS

1.1 Definitions:

1.1.1 Availability: Ensuring timely and reliable access to and use of information. Timely, reliable access to data and information services for authorized users.

1.1.2 Confidentiality: Preserving authorized restrictions on information access and disclosure, including means for protecting personal privacy and proprietary information.

1.1.3 Contracting Officer (KO): A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

1.1.4 Contracting Officer’s Representative (COR): An individual, including a contracting officer’s technical representative (COTR), designated and authorized in writing by the KO to perform specific technical or administrative functions. This individual does NOT have authority to change the terms and conditions of the contract.

1.1.5 External IT services: IT services that are outside the user organization’s Service authorization boundary and the user’s Service has no direct control over the application or assessment of required security controls. DoD organizations that use IT services are typically not responsible for authorizing them (i.e., issue an authorization decision), reference (DoDI 8510.01 p. 13). DoD organizations that use external IT services provided by a non-DoD Federal Government agency must ensure the categorization of the IS is appropriate to the confidentiality, integrity, and availability needs of the information and mission, and that the IS is operating under a current authorization from that agency. In accordance with DoD Instruction 8500.01, “Cybersecurity,” March 14, 2014, interagency agreements or Government statements of work for these external services must contain requirements for service level agreements (SLAs) that include the application of appropriate security controls.

1.1.6 Integrity: Guarding against improper information modification or destruction, inclusive of ensuring information non-repudiation and authenticity.

1.1.7 National Security Information: Information that has been determined pursuant to Executive Order 12958, as amended by Executive Order 13292 or any predecessor order, or by the Atomic Energy Act of 1954 as amended, to require protection against unauthorized disclosure and is marked to indicate its Classified status.

1.1.8 National Security System: Any information system (including any telecommunications system) used by or operated by an agency, or by a Contractor of an agency, or another organization on behalf of an agency having the function, operation, or use of which (i)involves intelligence activities; (ii) involves cryptologic activities related to national security; (iii) involves command and control of military forces; (iv) involves equipment that is an integral part of a weapon or weapons system; or (v) is critical to the direct fulfillment of military or intelligence missions (excluding a system that is to be used for routine administrative and business applications, for example, payroll, finance, logistics, and personnel management applications).

1.1.9 Non-personal services contract: a contract under which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

1.1.10 System Security Plan (SSP): Formal document that provides an overview of the security requirements for an information system and describes the security controls in place or planned for meeting those requirements. (Reference: NIST Special Publication 800-18, Revision 1)

1.1.11 Quality Assurance Surveillance Plan (QASP): An organized, written document specifying the surveillance methodology to be used for surveillance of Contractor performance. The Government may either prepare the QASP or require the offerors to submit a proposed QASP for the Government’s consideration in development of the Government’s plan.

1.1.12 Technical Liaison (TL): The individual designated and authorized in writing by the KO to assist the COR in performing specific technical or administrative functions. This individual does NOT have authority to change the terms and conditions of the contract.

1.2 Acronyms:

PART 2

2.0 GENERAL INFORMATION

2.1 This contract is to provide a Medical Logistics Authoritative Data Exchange and Medical Logistics Database Subscriptions.

2.2 Description of requirement: The Contractor shall provide a Medical Logistics Authoritative Data Exchange and Medical Logistics Database Subscription as defined in this Statement of Work (SOW), except for those items specified as Government furnished property and services. Immediately upon award, the Contractor shall be able to strictly adhere to the standards within this Statement of work (SOW).

2.3 Background:

2.3.1 The intent of this requirement is to support the Congressional guidance set forth in Title VII of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2017, as amended by the NDAAs for FY 2018 and 2019, that seeks to eliminate separate silos of military health and to integrate military healthcare under the authority, direction, and control (ADC) of the Defense Health Agency (DHA), consistent with the direction provided by the Secretary of Defense. The DHA Medical Logistics Division supports the DHA's Implementation Plan for transitioning the ADC of the military medical treatment facilities (MTFs) from the Services’ medical departments to the DHA beginning on 1 October 2019.

2.3.2 The Department of Defense (DoD) medical logistics community supports diverse lines of business (LOBs), to include: equipment property and biomedical maintenance management; pharmaceuticals and medical surgical inventory management; purchasing and quality assurance; and, assemblage and facilities management. The primary Information Systems (IS) supporting these LOBs are the Defense Medical Logistics Standard Support (DMLSS) system and the Theater Enterprise-Wide Logistics System (TEWLS). Over the last twenty (20) years, these two (2) systems have inherited as-built data from a number of Army, Navy and Air Force logistics and property legacy applications. As a result of these historical data merges, the two (2) aforementioned systems contain data variances and data diversion. The lack of authoritative source data has impeded effective decision analysis and constrained optimized business processes.

2.3.3 The Defense Health Agency (DHA) and Joint Medical Logistics Development Center (JMLFDC) have initiated a major technical refresh that will merge both the programmatic and technical components of all existing Defense Medical Logistics applications [DMLSS, TEWLS and Joint Medical Asset Repository (JMAR)] into a single program, the Defense Medical Logistics – Enterprise Solution (DML-ES) and a single application called LogiCole.

2.4 Objectives: Using industry standard data, the objective is to normalize, cleanse and structure an authoritative equipment and supply data standardization mapping process, allowing for enhanced audit readiness, increased business process effectiveness in new procurement standardization and existing product recall identification, and management of unnecessary data duplication.

2.5 Scope: To create an authoritative data exchange and database subscription service that support modernization and data standardization in Health Alerts and Equipment Management LOBs. The authoritative data exchange and database subscription services will be Information Technology (IT) services, external to the DoD. The IT services are not National Security Systems (NSS) and will neither interconnect with a NSS nor transmit National Security information. Specific subscriptions required will have the potential to fluctuate over time, based on the dynamic nature of the Government’s various LOBs and their respective accountable Government property and personnel changes. However, the aggregate requirement and level of effort will remain relatively constant over the life of the contract. Any changes will be executed through an official contract modification with approval signature by the Contracting Officer (KO).

2.5.1 The contract will establish terms and conditions, consistent with any trust relationship established with organizations owning, operating, and/or maintaining external information systems, allowing authorized individuals to access the information system from external information systems and process, store, or transmit organization-controlled information using external information systems.

2.7 Administrative Specifications

2.7.1 The list of locations the contractor will be providing subscription services is identified in Technical Exhibit 1.

2.7.2.1 Technical Liaisons are identified in Attachment 1.

2.7.3 The Contractor Point of Contact (POC). The Contractor shall provide, in writing, the name and telephone number of a primary and alternate, English-speaking, individual to act as their representative. The Contractor shall provide, in writing, an escalation process to follow if neither the primary nor alternate Contractor representatives can be reached. This escalation process shall also be usable in instances when neither the primary representative, the alternate representative, nor the Contractor personnel can effectively meet specific contractual deliverables.

2.7.3.1 Response time: Within two (2) hours of notification by the Government, the Contractor shall respond by telephone.

2.7.7 Modifications to Contract: Only the Contracting Officer has the authority to obligate the Government, and then only in writing. No modification or instruction from any party shall be construed to authorize the Contractor to take any action for which they expect compensation without written authorization from the Contracting Officer.

2.7.8 Compliance with Applicable Laws: Contractor shall be knowledgeable of and comply with all applicable Federal, State, and local laws, regulations, and requirements regarding the conduct of business.

2.7.9 Work Performed by Others. When work performed by the Government or other Contractors is expected to affect the Contractor’s performance of work, the Government shall coordinate with the Contractor and provide necessary information (plans, specifications, etc.) for such work to the Contractor that will allow the Contractor potential for scheduling allowances. The TLs shall resolve any schedule conflicts between the Contractor and work performed by the Government or other Contractors. Such actions shall not result in additional cost to the Government under this contract.

2.7.11 The Contractor shall use teleconferencing and web conferencing to facilitate communications, when required, to complete the associated tasks. The Government reserves the right to schedule meetings to discuss or resolve issues/problems, as it deems to be critical, at no additional cost to the Government.

2.7.12 Upon award and at time of any future request by the TLs, the Contractor will provide continuing education training to DoD personnel for the purpose of showing the full extent of all functions and features of the provided subscription services. This training can be conducted via Defense Connect Services (DCS), pre-recorded video tutorials accessible on an online portal, and/or in-person training.

2.8 Technical documentation and software: The Contractor shall obtain, have on file, and make available to its personnel all operational and technical documentation, which is required to meet the performance requirements of this Contract.