Amendment_01_N62645-19-R-0024.docx

N626465-19-R-0024

AMENDMENT 0001

The purpose of this amendment is to revise the quantities in section B and on the pricing sheet, due to errors with calculations based on the number of sites. CLIN 0001, 0012, 0022, and 0023 have been revised.

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

The solicitation number is N6264519R0024. The solicitation is issued as a request for proposals (RFP). Provisions and clauses in effect through Federal Acquisition Circular 2005-95 are incorporated. It is the contractor’s responsibility to be familiar with the applicable clauses and provisions. The clauses may be accessed in full text at these addresses: https://www.acquisition.gov/. The NAICS code for this requirement is 333314, with a small business size of 500 employees.

The Naval Medical Logistics Command (NMLC) intends to negotiate a sole source contract under the authority of 10 USC 2304(c)(1) with Proaim Americas, LLC to provide contract for Enterprise Ocular Picture Archiving and Communication Systems (OPACS) in support of Navy, Army, and Air Force Military Treatment Facilities (MTFs) worldwide.

Attached is the solicitation the Government intends to issue to Proaim Americas, LLC.

PERFORMANCE WORK STATEMENT

Performance Work Statement (PWS) Ocular Picture Archiving and Communication System (OPACS)

1.0 INTRODUCTION

1.1 Overview. The Naval Medical Logistics Command has a requirement for an Enterprise Ocular Picture Archiving and Communication System (OPACS), hardware, software, and labor for multiple United States Department of Defense (DoD) Military Treatment Facilities (MTFs) worldwide.

1.2 Scope. The implementation of the Enterprise OPACS shall allow for advances in technology, standard communication protocols, and enhanced workflow efficiencies for DoD MTFs. The vendor shall meet all of the clinical, performance, and interface requirements stated in Section 2.0, “General Requirements”. The vendor shall provide all applicable hardware, software, licenses, warranties, associated project plan(s), installation plan(s), training, post-warranty service/maintenance for the system.

The OPACS shall be an Enterprise system that connects via a vendor neutral archive (VNA). The vendor shall provide OPACS servers to be hosted at specified MTFs. The local OPACS servers shall be configured to connect to the VNA, and also be configured to operate independently if the VNA connection becomes interrupted.

1.3 Type of Contract. The resultant award will be a five year, Indefinite Delivery Indefinite Quantity (IDIQ) contract. The IDIQ base contract will establish the overall terms and conditions, but site-by-site supplies and services shall be delivered after delivery orders are issued off of the IDIQ contract. In the event of a conflict between a delivery order and the basic contract, the basic contract terms and conditions supersede the delivery order.

2.0 GENERAL REQUIREMENTS

The OPACS shall have the ability to receive, view, and manipulate data and images captured by installed ocular equipment. The OPACS shall be able to perform interactive visual field analyses and post-processing analysis as required. The visual field interactive analysis allows combined reports from Optical Coherence Topographers (OCTs), Humphrey Field Analyzers (HFA) and fundus cameras. The OPACS shall be capable of storing and manipulating raw data specific to biometric data, target treatment zones, outcome measurements, referential documentation, and procedure note recordings. The OPACS shall be capable of performing post-processing analysis, dynamic review, and manipulation of the stored raw data. The OPACS shall have the ability to identify and monitor glaucoma and retinal diseases, utilizing specific glaucoma and retina protocols. The OPACS shall support real-time longitudinal, dynamic, and summative combinations of studies requiring FDA 510(k) medical device approval, used in diagnosis and treatment of patients. The OPACS shall be capable of supporting provider-directed applications of advanced algorithms and ocular protocols for the diagnosis and monitoring of eye diseases.

The solution shall be configurable per individual clinic to allow concurrent utilization of multiple role-based users within examination and screening rooms. The solution shall include the functionality to sort and filter studies, configurable by fields such as originating location, study date/time, modality, and ordering provider. The OPACS shall be capable of providing preconfigured ophthalmic displays, configurable by clinic. The OPACS shall permit remote viewing, manipulation, and application of scientifically validated analytical algorithms of ophthalmic images and data by users accessing it from any networked PC in the clinic. The OPACS solution shall be capable of acquiring images and diagnostic reports from all networked eye care devices. The vendor shall be capable of establishing Application Programming Interface (API) connections to the existing modalities where applicable. The vendor shall migrate data from existing modalities that will connect to the OPACS.

The OPACS shall have the ability to receive HL7 Admit Discharge Transfer (ADT), Order Message (ORM), or Scheduling Information Unsolicited (SIU) messages, including patient demographic data from the Composite Health Care System (CHCS) or MHS GENESIS. All studies shall be stored in Digital Imaging and Communications in Medicine (DICOM) format and adhere to the current DICOM standard. The OPACS shall provide a DICOM Modality Worklist (DMWL) for all networked ocular modalities. The DMWL shall be configurable by clinic. The solution shall be capable of automatic sending to a foreign, or vendor neutral archive (VNA), allowing the VNA act as the OPACS long-term archive for storage and retrieval. The system shall have a current Authority to Operate (ATO) granted by the Defense Health Agency (DHA) Authorizing Official (AO).

The vendor shall install an OPACS server at the receiving MTF. The MTF hosting the server shall be considered the territory management acquisition center (TMAC) for connection of local ophthalmology and optometry clinics into the OPACS system. Remote clinics connecting to the TMAC shall have full OPACS capabilities, although will not require a server on-site. The solution shall include an OPACS server which is able to store a minimum of sixty (60) months of ocular files for all clinics associated with the TMAC. The OPACS shall also be capable of operating as a keratometry backup solution host (KBUSH) for connected keratometers. There is an average of three (3) ancillary studies performed at each patient encounter. All eye care data and images will automatically be stored on the TMAC and KBUSH short-term storage array while simultaneously being sent to the local VNA server. Data and images shall automatically be purged from short-term storage on the OPACS server on a first-in-first-out basis to create space for additional studies. This feature shall be site configurable. Privileged users shall be able to selectively protect studies and reports from such automatic deletion. The system shall have a mechanism in place (e.g. DICOM storage commitment) to ensure only studies stored on the VNA are processed for deletion in the OPACS.

The system shall be capable of providing all requirements of this section without additional modification or expense.

3.0 VENDOR INSTRUCTIONS

The contractor shall provide a project plan timeline illustrating the OPACS implementation and training for the MTFs identified in Equipment Viewer License Tables (Attachment IV). The contractor shall provide a minimum one (1) year warranty upon the system acceptance at each clinic. The contractor shall provide two (2) operator manuals and two (2) service manuals for each clinic.

3.1 Project Plan. The OPACS installation shall include a complete project plan of action and milestones including a schedule, listing of all tasks, an anticipated timeline for equipment installation, and anticipated time of acceptance testing. The proposal shall identify the contractor project manager(s) point of contact (POC), and those who will manage pre-installation and installation actions. The contractor project manager(s) shall hold regular planning and status update teleconferences with the Government project team at the MTF(s). The contractor project manager(s) shall work with the MTF Government project team(s) to ensure that all ocular devices are properly accounted for and connected to the OPACS.

3.2 Implementation Plan. The implementation plan will ensure minimal disruption to clinical operations of the facility. The contractor shall provide a detailed installation plan by MTF and associated clinics. Copies of all documents will be provided in soft copy using standard Microsoft Office Suite document formats, such as MSProject (.mpp), MSWord (.docx), Excel Spreadsheets (.xlsx), Visio (.vsdx) and/or PowerPoint (.pptx), as appropriate. Adobe Acrobat portable document format (PDF) is also acceptable.

3.3 Acceptance Testing. The Government will perform acceptance testing (AT) once the contractor has issued Notice of Readiness to Inspect (NRTI) to the Contracting Officer. AT will be conducted at each MTF within 30 days of the Contracting Officer’s receipt of the NRTI. The contractor shall work with the government to determine whether performing AT in a geographic region is more advantageous than performing AT at individual MTFs.

4.0 TRAINING AND MAINTENANCE REQUIREMENTS

4.1 Training Plan. The contractor shall provide initial training and ongoing clinical training. The contractor shall provide training that begins with an initial introduction to the application, helping a first-time user to become familiar with the system. The contractor shall provide an ongoing training plan for all MTFs, such as ‘train the trainer’ methodology or by training a clinical ‘super-user’. The provided training shall include a mechanism that addresses recurring/refresher training to facilitate the MTF staff’s understanding of application updates, maintaining system competency levels, and meeting clinical requirements. Training shall encompass all role-based users (Ophthalmologist and/or Optometrist, the technician, and other clinical support personnel).

4.2 Warranty. The contractor shall provide full warranty support of all hardware and software, supplies and services for a period of not less than one (1) year, initiating from time of system acceptance at each facility. The contractor shall acknowledge that there will be no charge for services or software support during the warranty period. If hardware warranty is to be subcontracted, the Contractor will initiate contact with the Subcontractor in warranty support situations.

4.3 Post-Warranty Maintenance. The contractor shall provide a maintenance plan to support the OPACS for all periods following the conclusion of the base warranty. During each twelve (12) month option period on the delivery order, the contractor shall propose firm-fixed pricing for maintenance/service support that includes, at a minimum, warranty-level support and corrective maintenance services (Section 4.4) for the OPACS, including all associated hardware, firmware, software, parts, labor, remote Business to BusinessB2B support, travel, and expenses necessary to perform such services. The contractor shall provide telephonic communications to discuss technical matters relating to the performance of this contract. An English-speaking systems operator shall be available to answer technical questions regarding system operations and applications.

4.4 Corrective Maintenance. The contractor shall provide remote corrective or onsite maintenance between the hours of 0730-1700 local time, Monday-Friday, to include unlimited service calls. Telephonic support shall be available 24 hours per day, 7 days per week, excluding Federal Government holidays, which are identified online at the following site: https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact-sheets/holidays-work-schedules-and-pay. Corrective maintenance shall be completed during the hours specified in the contract. If corrective maintenance cannot be completed remotely, or the contractor does not have remote access via the DHA B2B Gateway, service shall be completed onsite by a qualified Field Service Engineer (FSE) or software support personnel.

4.4.1 Corrective Response. A contractor service technician shall respond via telephone within one (1) hour after receipt of trouble call, and provide remote service within two (2) hours or on-site service within twenty four (24) hours. The system shall be operational within forty eight (48) hours of the initial trouble call. Government request for corrective maintenance shall be placed by the MTFs Biomedical Engineering Division (BIOMED) and the COR shall be informed in writing.

4.4.2 Telephone Corrective Support. The contractor’s response to requests for service may include telephone consultation with the trained equipment user/operator and a contractor FSE. Telephone consultation 1) shall provide instruction in determining operator error; 2) shall determine the most likely cause of the problem; 3) shall determine if resolution of the problem requires the dispatch of a FSE; and 4) shall identify replacement parts likely to be required to return the equipment to 100% operational condition as specified by the OEM.

4.4.3 Remote Service. Contractor personnel performing remote service will interconnect through the established DHA B2B gateway. Contractor support personnel 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.

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

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

The contractor will comply with DoD guidance regarding allowable ports, protocols and risk mitigation strategies prior to accessing DoD/DHA networks. Contractor personnel providing remote service 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 support personnel will be required to complete applicable DoD cybersecurity training.

4.4.4. Contractor Firm-Fixed Pricing The contractor’s firm-fixed pricing shall be inclusive of all costs including parts, consumables, labor, travel, and shipping. The contractor FSE shall use its own service manuals, specifications, schematic diagrams, and parts lists to assist in the evaluation and repair of all equipment included in this contract.

4.4.5 Software maintenance. The Contractor shall provide updates and patches as needed, at no additional cost to the Government. The Contractor shall provide software revisions and updates, via field service changes or remote B2B patching, as required by the FDA or manufacturer-announced safety-hazard recalls as part of the contract at no additional cost to the Government. Updates shall be performed as soon as possible after release, no later than the first scheduled Preventative Maintenance visit following release. Any updates that have been identified as critical, or required for the proper operation of equipment, shall be installed within thirty (30) calendar days of release, in coordination with the government sponsor. All supplied software is to be warranted as current and free of defects, such as viruses.

4.4.5.1. Software update. A software update is defined as changes to the software that includes bug fixes and other small improvements. A software update does not require hardware upgrades. Software updates shall be provided by the contractor at no additional cost to the Government.

4.4.5.2. A software upgrade is defined as a version change of the software that offers a significant modification or major improvement over the current version. A software upgrade requires the purchase of the new version of the software. Software upgrades shall be priced in accordance with CLIN 0024.

4.4.6 Contractor Report Requirements. If onsite service is required, contractor FSE personnel shall check-in with BIOMED upon arrival at the Government site and again prior to departure. If remote or telephone support is utilized as the corrective action or in troubleshooting, the Contractor shall be in communication with BIOMED or the Duty BIOMED personnel at the time of remote troubleshooting or repair.

4.4.7. Service Reports The contractor shall provide a full service report to BIOMED within two (2) days of completion of all services performed, including remote corrective support. Each service report shall at a minimum document the following data legibly, in complete detail, and in English:

i. Name of Contractor

ii. Name of field service technician performing service

iii. Contractor log/control number

iv. Equipment identification factors to include: manufacturer, make, model, serial number, and Facility Equipment Control Number (ECN)

v. Description of problem reported by user

vi. Date & time of initial trouble call

vii. Date, time (beginning and ending), and hours on-site for service call (or remote)

viii. Itemized description of service performed to include, but not be limited to: parts used, parts number/nomenclature, problem/corrective action taken or recommended, communications had with MTF personnel

ix. Resolution or pending action

x. Signatures:

1. Field Service Technician performing services

2. BMET verifying service rendered (& Identify Medical Treatment Facility); signed documents should be sent to the COR.

xi. In the event that agents / sub-contractors are used in the performance of repairs, said agent shall be identified on the service report by company name and contact information (i.e., telephone number)

4.5 Contractor Responsibility. The contractor shall repair/replace damaged Government-owned equipment and property due to the negligence of the contractor or its representatives. All such replacement or repair shall be at the contractor's expense and shall be inspected to the satisfaction of the BIOMED representative/Technical Liaison.

4.6 Recalls and Updates. For all software covered under this contract, the contractor shall resolve all FDA recalls, manufacturer recalls, and other mandatory updates within thirty (30) calendar days of the OEM’s public notification. The contractor shall provide documentation to the Government of such installation and mandatory updates.

4.7 Removal of Government Property. No equipment shall be removed without the approval of the Contracting Officer’s Representative (COR) and Materials Management Department of the MTF. Property passes for equipment removal shall be obtained by the contractor via the Materials Management Department of the MTF. Any failure to obtain such passes which results in detainment or prosecution of contractor FSE personnel are the sole responsibility of the service contractor personnel. The contractor shall provide a detailed description of removed items in writing on the contractor’s company letterhead. For associated items/accessories, the contractor will provide a detailed written description and quantities of items to be removed. This description will include, as a minimum, the manufacturer’s serial numbers and facility equipment control numbers (ECNs) of all equipment and/or items removed. In the event that items/sub-assemblies/accessories are “repaired by replacement,” a detailed description of replaced items is to be included upon return of repaired components. No additional charge shall be allowed for work performed off-site, or any additional time required. All charges resulting from a contractor-determined requirement to transport Government-owned property, covered by this contract, to and from an alternate repair location shall be the responsibility of the contractor. The contractor shall provide insurance coverage for damage to or loss of equipment while in contractor custody.

4.7.1 Hard Disk and Solid State Drives (HDD & SSD). In regards to patient information confidentiality and privacy, all Contractors and/or service Contractors shall not remove equipment containing patient information from the MTF. Neither Hard Disk Drive (HDD) nor Solid State Drives (SSD) shall ever be removed from the MTF, by the Contractor under this maintenance agreement. Removal of protected health information (PHI) and personally identifiable information (PII) from the equipment prior to removal from site must be properly coordinated with the COR and Command Equipment Manager.

4.8 End of Service Life. For all equipment, hardware, software, and accessories, covered under the terms and conditions of this contract, the contractor shall notify the COR and applicable agency’s program management office (PMO) prior to this equipment’s commercial end of service life (EOSL). This notice shall be delivered in a timely manner, in writing on the Contractor’s letterhead, via email to the COR:

4.9. This specific contract deliverable shall supplement, but not supersede, any existing, external ‘End of Service Life Notification’ requirements, as set forth by other Government agencies, such as the Food & Drug Administration (FDA) or the Joint Commission.

4.10. Delivery of an EOSL notification shall not immediately remove the contractor’s liability of covering the equipment under the terms and conditions of this contract. Its delivery shall simply be a means to start a dialogue with the COR and NMLC about the parameters associated with the commercial EOSL for the specific make/model of medical equipment.

5.0 Service beyond the Scope of the Contract. The contractor shall not perform service on any system, network, or device that is not part of the OPACS. If during a maintenance action it is discovered that the nature of the problem is due to another system, device, or network component, the contractor shall immediately notify BIOMED.

6.0 QUALITY ASSURANCE SURVEILLANCE PLAN (QASP) MATRIX

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 all orders delivered against 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 anti-malware 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.