Attch 1 PWS Diabetes SME 24 Oct 19.pdf

DSMES Subject Matter Expert (SME) PWS 24 Oct 2019

PERFORMANCE WORK STATEMENT (PWS)

FOR

Subject Matter Expert (SME) for the Veterans’ Affairs Virtual Medical Center (VAVMC)

Diabetes Self-Management Education and Support (DSMES) Services

24 October 2019

1. Description of Services

1.1. 59th Medical Wing, 59th Medical Operations Group, 59th Medical Specialty Squadron-

Diabetes Center of Excellence. Joint Base San Antonio, Texas, has a requirement for a Subject Matter Expert (SME) for the Veterans’ Affairs Virtual Medical Center (VAVMC) Diabetes Self-Management Education and Support (DSMES) Services (referred to as the “DoD DSMES SME” throughout the rest of the PWS) (See Section 4 for Qualifications, Education and Experience requirements, Section 5 for Core Duties and Responsibilities and Section 6 for Place of Performance information) as described in this PWS. The SME will support the DSMES Program via the Veterans' Affairs Virtual Medical Center (VAVMC) System by Recruiting, Training, and Mentoring DoD and VA Providers as Faculty/Facilitators. This is a new requirement for a non-personal services.

1.2. The DoD DSMES SME and VA DSMES SME for the VA/DoD Joint Incentive Fund (JIF)

“Expanding the Virtual medical Center (VMC Platform for Patient and Provider Education” (refer to 1.3.2.) will collaborate to develop and update an educational and support program meeting the current National Standards for Diabetes Self-Management Education and Support, as well as, training and implementation strategies within the current policies set forth by their respective organizations.

1.3. Position Services. The services required on the projected contract are in the following market segment:

1.3.1. In 2003, the Joint Incentive Fund (JIF) was announced in the Memorandum for Agreement for DoD-VA Health Care Sharing Incentive Fund [Section 721(d), FY 2003 National Defense Authorization Act (NOAA), P.L. 107-314, and VA/DoD Joint Strategic Plan, Objective 2.3.3 under Goal 2 - High Quality Health Care). The purpose of the JIF is to carry out a program to identify, provide incentives to, implement, fund, and evaluate creative coordination and sharing initiatives at the facility, inter-regional, and nationwide levels.

1.3.2. The VA/DoD JIF, “Expanding the Virtual Medical Center (VMC) Platform for

Patient and Provider Education” is an approved proposal seeking to increase DoD and VA beneficiary access to essential ongoing diabetes self-management education and support (DSMES) via the VAVMC, an innovative telehealth platform, remotely.

DSMES is an interactive, collaborative, and ongoing process where people with or at risk for diabetes gain the knowledge and skills necessary to modify behavior and successfully manage the disease and related conditions.

2. Government-Furnished Property and Services.

2.1. The Government will provide use of all available support services, materials, publications and forms, and use of equipment for the projected contract. The Contractor shall maintain all Government furnished supplies, equipment, and work areas in a safe, orderly and clean condition.

2.2. The Government will provide a Wi-Fi and CAC enable laptop computer, as well as, headsets and associated hardware and software as well as the connectivity to the government network. With the direction and assistance of the Government representative(s), the Contractor shall provide the appropriate network connectivity as required for information systems access.

3. Contractor Furnished Items and Services

3.1. The Contractor shall furnish all personnel and services to comply with the requirements of the projected contract. Except where specifically identified as government-furnished supplies and services, Certificates/licenses/training, shall be maintained in a current status at all times while performing services under this contract. If at any time during the contract performance, a contractor employee failed to renew any required certifications/licenses prior to the expiration, he/she will not be allowed to work at/for a Military Treatment Facility, Hospital, or Clinic. This expense shall be borne by the contractor.

3.2. Compliance

3.2.1 The Contractor shall comply with all applicable Air Force Instructions (AFI) and Department of Defense (DoD) Regulations as outlined in Appendix A.

3.3. Conduct Requirements.

3.3.1. The Contractor shall not use Government facilities or other Government property for personal use or other business not related to the established contract.

3.3.2. Contractor shall not respond to any media inquiries nor provide interviews, comments, or any other responses to the media regarding any subject related to this contract. All inquiries or complaints from the media or other sources shall be immediately relayed to the cognizant government official.

3.3.3. The contractor shall ensure that its employees conduct themselves in a professional manner while on the installation and refrain from disruptive, offensive, or otherwise improper behavior that undermines order and discipline.

3.3.4. Smoking in AF Facilities. Contractors are advised that the AF has placed restrictions on the smoking of tobacco products in AF facilities. AFI 40-102, Tobacco Free Living in the Air Force, outlines the procedures used by the commander to control smoking in our facilities. Contractor employees and visitors are subject to the same restrictions as government personnel. Smoking is permitted only in designated smoking areas.

3.3.5. Joint Base San Antonio (JBSA) Traffic Code. All applicable Traffic Codes will be enforced and apply to all personnel operating vehicles on a JBSA installation. The governing instruction for all Traffic Codes is AFI 31-218(I) and AFMAN 31-116.

For a complete listing of all JBSA Traffic Codes and all other applicable traffic policies and procedures, please contact the Contracting Office.

3.3.6. Cell Phone Usage. Contractors are advised that DoD Instruction (DoDI) 6055.04 prohibits cellular telephone usage when approaching, entering or exiting any installation gate. Cell phone usage by drivers on installations is prohibited in moving vehicles unless used with a hands-free device. The installation Security Forces Squadron (SFS) is strictly enforcing this regulation. Those found in violation of this regulation are subject to be ticketed.

3.3.7. Government Computer Access Requirements. This contract requires contractor personnel to have access to government computers, contractor personnel requiring access to government computers shall successfully complete, a Tier 1 (T1) Background investigation request, before obtaining access to the computer. These investigations shall be submitted by the government at no additional cost to the contractor.

All contractor employees affected by this requirement must have completed an acceptable submission that complies with all directions for completion of the investigation request through the government security office within 30 calendar days of Contract Award or Notice of Award. To begin this process, all affected contractor employees must complete within 15 calendar days after Contract Award or Notice of Award a Standard Form 85 worksheet (downloadable from http://www.opm.gov/forms/pdf_fill/SF85.pdf ). The contractor shall notify the Contracting Officer Representative (COR) or Government Inspector when the worksheet is complete.

Contractor employee will report to Wilford Hall Medical Center (WHMC) for in-process, receive Government furnished materials and equipment, training and completion of his or her security package. If at any point after submission of the security worksheet, disqualifying information is discovered or developed, the government reserves the right to deny computer access. In this instance the Contracting Officer will notify the contractor of the denial. That individual will no longer be allowed to perform duties requiring computer access.

After submission and approval of the complete security package through the security office and completion of an adjudicated (T1), contractor employee may obtain his or her “Common Access Card” (CAC) for the duration of their contract. The (T1) adjudication process normally takes 2 to 5 months after submission of the package.

http://www.opm.gov/forms/pdf_fill/SF85.pdf

The contractor shall comply with DODD 5200.08R Physical Security Program, (Chapter 3, Section C.3) requirements.

3.3.8. Installation Access. Criminal History Check will be conducted on all prime/subcontractor employees requiring base access. The contractor shall provide the Contracting Officer and the Information Protection Office employee requiring base access within 3 working days after receiving award or Notice of Award.

Employee information shall include; employee’s name, date of birth, social security number, state driver’s license/state ID number and state of issue. Notifications of contractor employee additions and deletions shall be provided with the same information listed above and within 3 working days. Within 10 business days after receipt of the list the Government will notify the Contractor that installation access passes are available for those employees clearing the criminal history check. The duration of any pass issued will not exceed one year or the duration of the contract, whichever is shorter.

3.3.9. Government Data. The Contractor shall manage all data created for Government use or legally controlled by the Government, in support of the functional activity or required IAW with the records management procedures in Air Force Instruction (AFI) 33 - 322, Records Management Program, Air Force Manual (AFMAN) 33- 363, Management of Records, and the Air Force Records Disposition Schedule (AFRDS) located at https://www.my.af.mil/gcss-af61a/afrims/afrims/rims.cfm

3.3.10. Freedom of Information. The contractor shall not respond to any Freedom of

Information Act request or release any information in response to a Freedom of Information request. Any request for information received by the contractor under the Freedom of Information Act will be referred to the Contracting Officer.

3.3.11. Physical Security. The contractor shall comply with Force Protection Condition

(FPCON) procedures, Random Antiterrorism Measures (RAMS) and local search/identification requirements. The contractor shall safeguard all government property, including controlled forms, provided for contractor use. At the close of each work period, government training equipment, ground aerospace vehicles, facilities, support equipment, and other valuable materials shall be secured.

3.3.12. Additional Security Requirements. (T1) will be IAW Homeland Security

Presidential Directive 12 (HSPD-12) at https://www.dhs.gov/homeland-security-presidential-directive-12.

3.3.13. Air Force Antiterrorism (AT) Program. The AT program seeks to deter or limit the effects of terrorist acts against the AF by giving guidance on collecting and disseminating timely threat information, providing training to all AF members, developing comprehensive plans to deter and counter terrorist incidents, allocating funds and personnel and implementing AT measures. In accordance with AFI 10-245 paragraphs 2.18 and paragraph 2.25, DoD contractors and sub-contractor personnel shall be offered Level 1 – AT Awareness Training.

https://www.my.af.mil/gcss-af61a/afrims/afrims/rims.cfm

AT Awareness Training may be accomplished by either a Level I –qualified instructor, or by completing the “Force Protection” computer based training (CBT) course on the Advanced Distributed Learning System (ADLS).

https://golearn.csd.disa.mil/kc/login/login.asp or the Defense Technical Information Center (DTIC) at https://atlevel1.dtic.mil/at for individuals without access to NIPR, possessing a CAC card, nor enrolled in DEERS. Compliance with the training will be monitored by the Contracting Officer Representative ( COR).

3.3.14. Unescorted Entry to Restricted/Controlled Areas. If this contract requires unescorted entry to controlled or restricted areas, the contractor shall comply with DOD 5200.2-R, Appendix 1, and AFI 31-501, Personnel Security Program Management (Paragraph 3.24). If the performance of this contract requires unescorted entry to a restricted/controlled area, personnel must have a favorably adjudicated NACI investigation.

All contractor employees affected by this requirement must have completed an acceptable submission that complies with all directions for completion, of the investigation request through the government security office within 30 calendar days of Contract Award or Notice of Award. To begin this process, all affected contractor employees must complete within 15 calendar days after Contract Award or Notice of Award Standard Form 85P worksheet that can be downloaded from http://www.opm.gov/forms/pdf_fill/SF85P.pdf .

The contractor shall notify the Contracting Officer Representative (COR) or Government Inspector when the worksheet is complete. The affected employee will then be scheduled by the government for two or more appointments to complete the security package. If at any point after submission of the security worksheet, disqualifying information is discovered or developed, the government reserves the right to deny entry to restricted/controlled areas. In this instance the Contracting Officer will notify the contractor of the denial. That individual will not be allowed to perform duties requiring access to restricted/controlled areas.

Upon receipt of a favorable investigation results and authorization by the appropriate commander, the contractor member will receive appropriate entry credentials for access to restricted/controlled areas, unless disqualifying information is subsequently discovered. In this instance access will be revoked. The NACI adjudication process normally takes 2 to 5 months after submission of the package.

3.3.15. Weapons, Firearms, and Ammunition. Contractor employees are prohibited from possessing weapons, firearms, or ammunition, on themselves or within their contractor-owned vehicle or privately-owned vehicle while on JBSA San Antonio.

3.4. Contractor Manpower Reporting Application (CMRA): The Contractor shall report ALL

Contractor labor hours (including Sub-Contractor labor hours) required for performance of services provided under this contract via a secure data collection site. The contractor is required to completely fill in all required data fields at http://www.ecmra.mil.

http://www.opm.gov/forms/pdf_fill/SF85P.pdf http://www.ecmra.mil/

3.4.1. Reporting inputs will be for the labor executed during the period of performance for each Government fiscal year (FY), which runs 1 October through 30 September.

While inputs may be reported any time during the FY, all data shall be reported no later than 31 October of each calendar year. Contractors may direct questions to the CMRA help desk.

3.4.2. Uses and Safeguarding of Information: Information from the secure web site is considered to be proprietary in nature when the contract number and Contractor identity are associated with the direct labor hours and direct labor dollars. At no time will any data be released to the public with the Contractor name and contract number associated with the data.

3.4.3. User Manual: Data for Air Force service requirements must be input at the Air Force

CMRA link. However, user manuals for Government personnel and Contractor are available at the Army CMRA link at http://www.ecmra.mil. Once at the web site, click the Department of Air Force CMRA link, to log-in or to initially set-up a user account.

3.5. Quality Control. The Contractor shall be responsible for quality control for all work accomplished during the performance of the contract. The Contractor shall provide a Quality Control Plan (QCP) within 10 days of Contract Award or Notice of Award to ensure the requirements in this PWS are met. As a minimum, the Contractor shall develop quality control procedures that address the areas identified in paragraph 7, Service Summary.

3.5.1. Quality Assurance. The government will conduct monthly contractor performance evaluations. The Contracting Officer Representative (COR) will monitor performance to ensure services are received and are acceptable. The COR will correspond with an assigned Functional Requirements Evaluator Designee (FRED) to assist in monitoring schedule compliance (days/hours worked) and inspecting work performance. The COR will then, evaluate the Contractors performance in accordance with the government's Quality Assurance Surveillance Plan (QASP) developed for this requirement.

4. Qualifications, Education and Experience Requirements.

4.1. Degree/ /Education:

• Minimum of a Bachelor’s degree, and

• Diabetes Care and Educating Specialist (DCES) Certification (formerly known as

Certified Diabetes Educator)

4.2. Qualifications/Certifications

• Licensure within discipline as designated by the National Certification Board for Diabetes Educators (NCBDE) (nursing preferred) http://www.ecmra.mil/

• Eligibility for certification: Minimum of 2 years professional practice experience in discipline. Minimum of 1000 hours providing diabetes education

• Continuing education requirement to maintain Diabetes Care and Education Specialist (DCES) credentialing with 75 diabetes-related continuing education (CE) over 5 year certification period

• Possess and maintain an active current, valid, and unrestricted license from a US jurisdiction before practicing independently within the defined scope of practice for their specialty

4.3. Experience:

• Minimum of 2 years professional practice experience in nursing discipline

• Minimum of 1000 hours providing diabetes education

• One year of experience as a DCES or in the specialty area identified within the last 36 months

• Managed an American Diabetes Association (ADA)/American Association of Diabetes

Educators (AADE) or any other recognized Diabetes-Self Management Education and Support Services Program within last 5 years

4.4. Other Qualifications Necessary:

• Knowledge of computer operations

• Proficiency in the use of basic word processing, data entry, and automated medical records.

• Development of Professional Education Programs

• Technology Training. Accounts and systems access requirements include Armed Forces

Health Longitudinal Technology Application (AHLTA), Composite Health Care System (CHCS), VAVMC, Air Force Knowledge Exchange, Tri-Care-on-line (TOL) secure messaging, Microsoft Office (Word, Excel, PowerPoint, Publisher), or any new system that supersedes current system

The contractor shall, without additional expense to the Government, be responsible for obtaining any necessary licenses and certifications, to comply with any applicable Federal and State laws, codes, and regulations, in connection with the performance of the type of services required by this contract.

4.5. Federal Holidays: The Medical Treatment Facility (MTF) will observe the following federal holidays in addition to any family/goals/planned closure days.

Holiday Projected Date

* Should the official holiday fall on a Saturday then the observed holiday is the previous Friday before.

** Should the official holiday fall on Sunday then the observed holiday is the following Monday.

4.6. Contractor Personnel (CP) may be scheduled to work on AETC Family/Down days. The CP will be notified by the Government at least 14 days prior to the AETC Family/Down Days if the CP will be required to work during this time and a Government employee is present to verify hours and services performed.

4.7. CP performing under this contract shall abide by the provisions of MDWI 41-101 Medical

Expense and Performance Reporting System (MEPRS), (Paragraph 2.1.3.). The contractor shall provide documentation or records of units worked through Wide Area Work Flow

(WAWF).

4.8. Services performed under this contract have been determined not to be essential for performance during crisis declared by the National Command Authority.

5. Core Duties and Responsibilities. In collaboration with the VA PM the individual will:

• Function as the Diabetes Self-Management Education and Support (DSMES) subject matter expert. In addition:

5.1. Ensure the DSMES curriculum meets current National Standards, as well as, American

Diabetes Association ADA Standards. Additionally:

• Participate in weekly, telephonic/online, collaboration meetings with the VA PM.

• Travel (up to 2 times) during fiscal year (not to exceed 5 days each time) to a location within the contiguous 48 United States as determined by the JIF Working Group.

• Participate in 2-4, telephonic/online, leadership meetings per month as scheduled.

• Participate, telephonic/online/in-person, in scheduled Working Group meetings.

• Submit/Present Poster or General Session at National Professional or Military Conference during summer 2020 (date dependent on acceptance to conference agenda).

New Year's Day January 1 Martin Luther King Jr's Birthday 3rd Monday in January President’s Day 3rd Monday in February Memorial Day Last Monday in May Independence Day July 4 Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veterans' Day November 11 Thanksgiving Day 4th Thursday in November Christmas Day December 25

• Submit application for program recognition to the ADA no later than (NLT) May 31, 2020. Application should define patient population, initially and update annually.

• Establish Advisory Council meeting at least annually.

5.2. Review and update curriculum at least annually

5.3. Identify and complete Continuing Quality Improvement (CQI) Project annually. In addition, collect the following data each quarter from the facilitators beginning in January 2020 for annual ADA reports:

• Patient Demographics, Satisfaction and Clinical and Behavioral Outcomes

• Provider Satisfaction.

• Identified issues using the VAVMC.

5.4. Develop a Professional Education Program to train DoD and VA Providers as

Faculty/Facilitators in their respective DSMES patient populations via the VAVMC.

5.5. Recruitment. Recruit at least three (3) facilitators each quarter from all DoD services, including:

• Mentoring and training recruited facilitators as they initiate their respective programs to be able to assist participants in developing an avatar, navigate the VAVMC, etc.

• Provide quarterly, Train the Facilitator Training (TFT) within the VAVMC beginning

January 2020. Prospective timing of training will be January 2020, March 2020, June 2020, and September 2020.

5.6. Facilitator Mentoring. Consistently communicate and treat facilitators in a courteous, tactful, and respectful manner. In addition:

• Handle facilitator’s conflicts and problems constructively and appropriately.

• Establishes productive working relationships with peers, and other colleagues.

• Mentor facilitators to provide the DSMES services to include, but not limited to:

o Understanding and sensitivity of the individual needs, beliefs, and/or expectations of patients with various backgrounds o Being respectful toward patients’ values and practices resulting in overall patient satisfaction and comfort level o Conduct education sessions utilizing all modules.

o Collect demographics and outcome data o Coordinate at least 1 synchronous (virtual classroom) DSMES event per quarter, 2-5 patients o Ensure documentation of all patient encounters in AHLTA with appropriate coding per DoD policy o Collect and provide the following data each quarter to the DoD and VA DSMES

SMEs beginning January 2020:

Patient demographics, satisfaction, clinical and behavioral outcomes Provider satisfaction Identified issues utilizing VA VMC

6. Place of performance: The contractor shall provide a DSMES SME to assist the DoD in meeting obligations for the JIF Initiative to provide DSMES via the VAVMC platform. The work to be performed under this contract will be performed is predominately tele-work within the VAVMC, utilizing Government provided equipment. The contractor shall be responsible for safeguarding all issued equipment, information and property provided by the government.

6.1. Prior to telework commencing, the employee must have a suitable workspace, utilities adequate for installing equipment and a general work environment that is free from interruptions and provides reasonable security and protection of state property and information.

6.2. Initial Contractor Training will be provided within 30 days of hiring in the use of the following electronic medical records: AHLTA, CHCS, VAVMC, Air Force Knowledge Exchange, Relay Health (secure messaging), Health Insurance Portability and Accountability Act (HIPAA) training (AFI 33-332), Information Awareness/Cybersecurity training, or any new system that supersedes these systems. Training will be conducted at Wilford Hall Ambulatory Surgical Center (WHASC) in San Antonio, TX.

6.3. Contractor Travel: Contractor will be required to travel CONUS (contiguous 48 United

States) during the performance of this contract to attend meetings and training. The contractor may be required to travel to off-site training locations in support of this PWS.

Contractor will be authorized travel expenses IAW FAR 31.205-46 and the limitation of funds specified in this contract. All travel requires Government approval/authorization and notification to the COR.

7. Service Summary.

P.O. # Performance Objective (PO)

PWS

Para graph Performance

Threshold (Per FTE)

1.

Application for ADA program recognition NLT May 31, 2020 5.1 100%

2.

Participate in Working Group meetings as scheduled via telephonic/online/in-person platform. 5.1. >90%

3.

Recruit and train at least 3 DoD MTF facilitators per quarter 5.5 >90%

4.

Mentor each facilitator to provide at least 1 DSMES session per quarter and data collection 5.6 >85%

8. List of Appendices

1. Appendix A: Referenced Publications

2. Appendix B. HIPAA Business Associate Agreement (BAA) 10/17/2019

Appendix A: Referenced Publications

AFGMAFI44-102, Medical Care Management Jan 2017 AFMAN 33-363, Management of Records AFI 16-1404, Air Force Information Security Program AFPD 48-1, Aerospace Medicine Enterprise

AFI 31-218, Motor Vehicle Traffic Supervision AFI 31-501, Personnel Security Program Management AFI 33-332, Air Force Privacy and Civil Liberties Program AFI 33-322, Records Management Program AFI 40-102, Tobacco Free Living AFI 44-102, Medical Care Management AFI 44-119, Medical Quality Operation AFI 48-105, Surveillance, Prevention and Control of Diseases and Condition of Public Health or Military Significance AFI 48-122, Deployment Health AFI 48-1233, Medical Examination and Standards AFI 48-127, Occupational Noise and Hearing Conservation Program AFI48-149, Flight and Operational Medicine Program AFI48-307 Vol 1, En Route Care and Aeromedical Evacuation Medical Operations AFI 71-101 Vo1 1, Criminal Investigation AFI 71-101, Vol 2, Protect Service Matters

DoD Directive 5200.2-R, DoD Personnel Security Program DoDI 1402.5 Criminal History Background Checks on Individual in Child Care Services (Enclosure 5)

MDWI 36-2601, Human Resources Development MDWI 41-101, Medical Expense and Performances Reporting Systems (MEPRS)

AETC-I 36-2909, Recruiting, Education, Accession and Training Standards of Conduct AFI 33-332, Air Force Privacy and Civil Liberties Program HIPPA

Appendix B. HIPAA Business Associate Agreement (BAA) 10/17/2019

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 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 Personnel.

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 San Antonio medical MTFs.

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/or 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 this 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 this 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 this 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, and corresponding DoD HIPAA Issuances, 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 and corresponding DoD HIPAA Issuances.

(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, and corresponding DoD HIPAA Issuances.

(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 and corresponding DoD HIPAA Issuances.

(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 the 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 only use or disclose PHI as necessary to perform the services set forth in this 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 this 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 this 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 this 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 this 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 notify the Business Associate of any limitation(s) in the notice of privacy practices of the Covered Entity under 45 CFR 164.520 and the corresponding provision of the DoD HIPAA Issuances, to the extent that such limitation may affect Business Associate’s use or disclosure of PHI.

(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 and the corresponding DoD HIPAA Issuances, 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.

(1) In the event of a breach of PII/PHI held by the Business Associate, the Business Associate shall report the breach to the Covered Entity in accordance with Section VII, assess the breach incident, take mitigation actions as applicable, and notify affected individuals, as directed by the Covered Entity.

(2) The Business Associate shall coordinate all investigation actions with the Covered Entity, and at a minimum, 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.

(3) 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.

(b) Government Reporting Provisions

(1) If the Covered Entity 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 Covered Entity, regardless of where the breach occurs. If the Covered Entity 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.

(2) 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.

(3) 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.

(i) 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 Covered Entity, and to other parties as deemed appropriate by the Covered Entity.

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.

(ii) 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 Installation Privacy Act Officer, MTF HIPAA Privacy Officer, and the CO (if applicable), if requested. Business Associate questions about US-CERT reporting shall be directed to the Installation Privacy Act Officer or MTF HIPAA Privacy Officer, not the US- CERT office.

(iii) The Business Associate shall comply with the Breach Timeline and Notification

Flow Chart processes attached to this Agreement, to include the timelines established for completing the DD Form 2959 and the HIPAA Privacy Incident Report.

(4) 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 Covered Entity as soon as possible if it believes that “single event” breach response is appropriate; the Covered Entity 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.

(i) 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, and follow-up. The Business Associate shall submit these report updates within three (3) business days after the new information becomes available.

Prompt reporting of updates is required to allow the Covered Entity 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 Covered Entity 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.

(ii) In the event the Business Associate is uncertain on how to apply the above requirements, the Business Associate shall consult with the Covered Entity and Contracting Officer when determinations on applying the above requirements are needed.

(c) Individual Notification Provisions

(i) If the Covered Entity 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.

(ii) 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 VII, for review, and for approval by the Contracting Officer, in consultation with the Covered Entity. Upon request, the Business Associate shall provide the Contraction Officer and Covered Entity 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 PO or Covered Entity. The Business Associate’s notification to the individuals, at a minimum, shall include the following:

(A) 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.

(B) 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.

(C) 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.

(D) A brief description of what the covered entity involved is doing to investigate the breach, to mitigate harm to individuals, and to protect against any further breaches;

and

(E) Contact procedures for individuals to ask questions or learn additional information, which shall include a toll-free telephone number, an e-mail address, Web site, or postal address

(F) 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. The Contracting Officer, in consultation with the Covered Entity will determine the appropriate level of support services.

(i) 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., “Important information – do not destroy,” 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, e-mail address, and postal address.

(ii) 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 Covered Entity, 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 the Covered Entity approval.

(d) 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 forth here. 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 underlying Contract.

(b) Effect of Termination.

(1) If this Agreement has records management requirements, the Business Associate shall handle such records in…