Attachment_1_AFMH_Scribes_PWS_08232018.docx

Contract Number TBD Appendix D – DoD Regulations/Manuals/Instructions/Directives

Contract Number TBD 8 May 2018

PERFORMANCE WORK STATEMENT

for

Air Force Medical Operations Agency

(AFMOA)

Air Force Medical Home (AFMH) Scribes

Solicitation/Contract Number: TBD

23 August 2018

TABLE OF CONTENTS

2.9. Conduct of Contractor Personnel 5

2.10. Personnel Staffing 5

5. GOVERNMENT FURNISHED PROPERTY 10

6. DELIVERABLES 10

7. APPENDICES

Contract Number TBD 17 Nov 2017

Solicitation/Contract Number: TBD 23 August 2018

PERFORMANCE WORK STATEMENT (PWS)

AIR FORCE MEDICAL HOME (AFMH) SCRIBES

1.0 DESCRIPTION OF SERVICES

1.1 Background.

The mission of the Air Force Medical Operations Agency (AFMOA/SGHC) Air Force Medical Home (AFMH) Branch is to identify gaps and develop processes, implementation plans, tools and training to align and promote AFMH goals, objectives and initiatives within Air Force Medical Service (AFMS) strategic plans. The team provides subject matter expertise for the following:

“Medical Home access, performance management, and other AFMOA Cells as applicable, advise and mentor 500 medical homes at 218 clinics in support of 2.6M beneficiaries, is the liaison for Better Care Strategic Objective A6, “Improve Access to Care” and is co-owner of Better Care Strategic Objective A5, and “Cultivate AFMH as a cornerstone of Safe, Quality and Trusted Care.”

The Medical Scribe Program is a pilot program in support of these AFMS strategic objectives and is intended to ensure quality documentation in the electronic health record (EHR), foster safer care, and improve clinical efficiency and access.

1.2 Scope. This is a non-personal requirement to provide Medical Scribe support to the following Military Treatment Facilities (MTFs): Shaw Air Force Base (AFB), SC; Joint Base San Antonio (JBSA) Randolph, TX; JBSA Lackland, TX and Maxwell AFB, AL specifically in the Family Health clinics located within these MTFs. The medical team for each MTF location consists of four physicians, with one scribe assigned to each physician. The Contractor shall provide transcription support directly to the clinics in support of AFMOA/SGHC’s effort to determine the viability of scribes for use across all 76 Air Force MTFs. The Office of Primary Responsibility (OPR) is AFMOA/SGHC/AFMH.

1.2.1 Contractor personnel shall ensure accurate and timely documentation of the medical chart as requested by the medical provider. Contractor personnel shall assist the provider by recording detailed information into the Electronic Medical Record (EMR) during the patient exam. Contractor personnel shall perform other related medical record or health documentation duties to increase provider effectiveness, efficiency, and productivity for improved patient flow and satisfaction.

1.2.2 The Government will neither supervise Contractor personnel nor control the method by which the Contractor personnel performs the required tasks. The Contractor is responsible to manage its personnel and to guard against all actions that are of the nature of personal services, or give the perception of personal services. Contractor shall notify the Contracting Officer (CO) immediately if any actions constitute, or are perceived to constitute personal services. These services shall not be used to perform work of a policy/decision making or management nature, i.e., inherently Governmental functions. All decisions relative to programs supported by the Contractor are the sole responsibility of the Government.

2.0 GENERAL INFORMATION

2.1 Contractor Identification. All Contractor/Subcontractor personnel shall identify themselves as Government Contractor personnel during all forms of communications such as business meetings, telephone conversations, electronic mail, attendance sheets, coordination documentations, reports, and the signature blocks utilized in all correspondence. If a contract requires Government workspace, the Contractor/Subcontractor personnel shall wear a picture identification badge and identify their workspace area with their name and company affiliation.

2.2 Contractor Training. The following courses, available through computer-based modules, are required annually unless otherwise noted:

2.2.1 Health Insurance Portability and Accountability Act (HIPAA) and Privacy Act Training.

2.2.2 Department of Defense (DoD) Information Assurance Awareness (IAA) Cyber Awareness Challenge.

2.2.3 Air Force (AF) Information Assurance (IA).

2.2.4 Environmental Management Systems (EMS) General Awareness Training. This is a one-time training requirement.

2.2.5 Security Administration. This is a one-time training requirement.

2.2.6 Operation Security (OPSEC) Awareness Training. This is a one-time training requirement.

2.3 Contractor/Government Communication. The Contractor shall designate a Focal Point to be the single point of contact for all Contractor and Government correspondence. The Focal Point shall provide clear and consistent written and verbal response to Government within 12 business hours of Government initiated communication (e.g., return phone calls, emails or other communication).

2.3.1 The Contractor’s Focal Point shall meet with the Government team at least quarterly for customer feedback.

The Government or the Contractor may request additional meetings as necessary. The Contracting Officer (CO), Contractor Focal Point, CORs or other designated Government representative will provide performance feedback to the Contractor. The Contractor shall provide minutes in accordance with (IAW) Contract Data Requirements List (CDRL) A001.

2.3.2 Monthly Status/Financial Report: The Contractor shall prepare and submit a monthly status/financial report identifying fill status, quarterly meetings and any issues. The Contractor shall provide the Monthly/Financial Report IAW CDRL A002.

2.4 Place of Performance. The work under this contract shall be performed at Shaw AFB, SC; Maxwell AFB, AL; JBSA Randolph, TX and JBSA Lackland, TX.

2.5 Travel Requirements. Travel is not required during the Period of Performance (PoP) of this contract.

2.6 Mission/Emergency Essential. None of the services listed in this PWS are mission/emergency essential.

2.7 Duty Hours. Normal duty hours range between 7:00 am and 6:00 pm, IAW the clinic providers’ schedule, Monday through Friday (excluding federal holidays and clinic closures). Work hours are subject to change and will be at the Clinical Manager’s discretion and approval. The Contractor shall adjust work days as necessary to insure each work week does not exceed 40 hours. No overtime is authorized.

2.8 Federal Holidays. Federal offices are closed on New Year’s Day, Martin Luther King Jr. Day, Presidents Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas Day.

2.8.1 Clinic Closures. The days when the clinics are closed are considered non-duty days and the Contractor shall not provide services during these days. The COR will notify the Contractor of any scheduled or unscheduled closures.

2.9 Conduct of Contractor Personnel. Contractors must conduct themselves with the highest degree of integrity and honesty. The CO or designated Government representative may require the Contractor to remove Contractor personnel from the job site. Removal from the premises shall not relieve the Contractor of the contract requirements.

2.9.1 Contractor personnel shall be responsible for obeying all parking and traffic regulations on Government installations.

2.9.2 Alcoholic beverages and illegal drugs on the job are prohibited.

2.9.3 There shall be no loud, profane or abusive language used on the job.

2.9.4 Contractor personnel shall present a neat, well-groomed, professional appearance and wear neat, clean, casual business attire clothing.

2.9.5 Contract personnel shall conduct themselves in an efficient and professional manner consistent with AFMOA and AFMH business standards.

2.10 Personnel Staffing. The Contractor shall accomplish, at a minimum, the following personnel staffing performance management outcomes:

2.10.1 Ensure position is filled to provide services within 30 days from the start of contract PoP.

2.10.2 Ensure continuation of services during personnel absences due to sickness, leave, and voluntary or involuntary termination from employment, minimally impact the Government and position vacancies do not exceed 20 calendar days.

2.10.3 The substitute/replacement personnel shall begin work no later than 20 calendar days after notification or immediately after departure of the incumbent personnel, whichever is earlier.

2.10.4 The Contractor shall promptly notify the CO and COR within five (5) calendar days of a projected vacancy exceeding 10 calendar days.

3. CONTRACT REQUIREMENTS

3.1 Medical Scribe Support Services. The Contractor shall perform on-site medical scribe administrative support services and other duties to include, but are not limited to:

3.1.1 Prepare and assemble medical record documentation/charts for physician(s).

3.1.2 During patient visit, capture and transcribe medical record documentation utilizing the EMR applications.

3.1.3 Ensure medical record compliance by self-documentation attestation to include: scribe name, medical provider’s name, MTF name, date and time of entry.

3.1.4 Document medical visits and procedures accurately and thoroughly as they are being performed by the physician, including but not limited to:

3.1.4.1 Document patient medical history and physical exam.

3.1.4.2 Transcribe the procedures and treatments performed by healthcare professionals, including nurses, physicians and physician assistants.

3.1.4.3 Print and code patient education and explanations of risks and benefits.

3.1.4.4 Provide physician-dictated diagnoses, prescriptions and instructions for patient or family members for self-care and follow-up.

3.1.5 Prepare referral letters as directed by the physician.

3.1.6 Prepare and send all documentation to physician for review and approval via authentication of detailed data entry and facility-specific procedures.

3.1.7 Identify mistakes or inconsistencies in medical documentation and check to correct the information in order to reduce errors.

3.1.8 Prepare a monthly workload report to summarize the status of provider assignments, encounters completed, and time spent documenting in the health record during the reporting period. The Contractor shall provide a Monthly Progress Report IAW CDRL A003.

3.1.9 Enter new patient information accurately in to EMRs file.

3.1.10 Enter orders into the EMR system.

3.1.11 Create and update exam templates in the EMR for the physician.

3.1.12 Ensure compliance with hospital/clinic and contract company policies, including those relating to HIPAA and The Joint Commission (TJC).

3.1.13 Regular and reliable attendance at assigned facility is required.

3.1.14 Perform other duties and tasks to improve provider productivity and clinic workflow. Examples include, but are not limited to, printing and providing home care provider documents and patient education information handouts.

3.1.15 Position may require work for more than one clinical team during a scheduled week. The clinic manager will coordinate all work schedules with the scribes.

3.1.16 Minimum Personnel Qualifications and Contractor Expectations: The Government reserves the right to validate appropriate education and experience requirements of all Contractor personnel. All Contractor personnel performing tasks related to this PWS shall meet the following minimum requirements:

3.1.16.1 The Contractor personnel shall have a minimum of two (2) years’ experience of providing medical scribe services as describes herein.

3.1.16.2 Ability to demonstrate knowledge of medical terminology and human anatomy.

3.1.16.3 Skilled in operating various medical record software and hardware, word-processing, and database software programs.

3.1.16.4 Ability to listen to complex medical information and summarize in a clear, complete, and concise fashion.

3.1.16.5 Ability to learn and appropriately apply basic medical terminologies and techniques taught.

3.1.16.6 Skilled in written and verbal communication.

3.1.16.7 Ability to observe and draft grammatically-correct narrative account of events accurately and cogently.

3.1.16.8 Ability to spell, proofread, and edit written documentation and medical records.

3.1.16.9 Keyboard proficiency of approximately 60 words/minute.

3.1.16.10 Ability to operate a personal computer and related software applications.

3.1.16.11 Ability in achieving attention to detail.

3.1.16.12 Ability to work in a dynamic, highly-stressful environment that routinely involves exposure to highly-sensitive personal medical information.

3.1.16.13 Shall possess organizational, problem-solving, and communication skills to articulate medical requirements to staff members, patients, families/care givers, and medical and non-medical staff in a professional and courteous way.

3.1.16.14 Below are physical requirements that shall be met by contractor personnel to successfully perform the essential functions of this PWS. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The contractor shall have the ability to:

3.1.16.14.1 Stand with mobility for extended periods of time.

3.1.16.14.2 Lift, hold, push and pull 20 pounds.

3.1.16.14.3 View computer monitors with close vision, color vision, depth perception and ability to adjust focus with good hand-eye coordination.

3.1.16.14.4 Read, write, comprehend through listening, and speak English.

3.1.16.14.5 Hear within normal range.

3.1.16.14.6 Operate a computer or laptop through proficient typing, clicking, and viewing a monitor for extended periods.

3.1.16.14.7 Handwrite legibly.

3.2 Security Requirements.

3.2.1 Security Clearance Requirements. All Contractor personnel shall have/obtain an active favorable Tier 1 (T1) or meet the requirements of DoDM 1000.13-M-VI, January 23, 2014. Costs and documentation required for security certification shall be the responsibility of the Contractor. The Contractor shall provide documentation received from the appropriate Government agency as to the verification of contract personnel’s Tier 1 certification. In case the certification has been requested, but not received, the Contractor may provide documentation on any Contractor personnel where certification has been requested. In the instance, the Contractor personnel will be able to begin work in areas that would not conflict with Government security issues. The COR shall be kept abreast of issues dealing with the Tier 1 certification. The Contractor’s security officer shall ensure timely notification of all hires to the Air Force Surgeon General’s Security Office located at the AFMOA/SGA, JBSA Lackland, TX; JBSA Randolph, TX; Shaw AFB, SC and Maxwell AFB, AL.

3.2.2 List of Contractor Personnel: The Contractor shall maintain a current listing of Contractor personnel. The list shall include Contractor personnel’s name, social security number, and level of security clearance. The list shall be validated and signed by the company Facility Security Officer (FSO) and provided to the COR and Information Security Program Manager (ISPM) at each performance site 30 calendar days prior to the service start date. Updated listings shall be provided when Contractor personnel’s status or information changes. A Visit Request for all Contractor personnel with security clearances is required to be sent through the Joint Personnel Adjudication System (JPAS), and must be updated at least annually. The Contractor shall notify the (ISPM) at each operating location before on-base performance of the service. The notification shall include:

3.2.2.1 Name, address, and telephone number of the company key management representatives.

3.2.2.2 The contract number and contracting agency.

3.2.2.3 The highest level of classified information to which personnel require access.

3.2.2.4 The location(s) of service performance and future performance, if known.

3.2.2.5 The date service performance begins.

3.2.2.6 Any change to information previously provided under this paragraph.

3.2.3 Local Area Network (LAN). All Contractor personnel requiring access to the Government unclassified computer network shall have a valid TIER 1 (TI) verified through Joint Personnel Adjudication System (JPAS). No Contractor personnel will be provided access to unclassified computer network or its inherent capabilities (i.e., internet access, electronic mail, file and print services, etc.) without a valid TIER 1 (TI). The Contractor personnel shall be aware of and abide by all Government regulations concerning the authorized use of the Government’s computer network including the restriction against using the network to recruit Government personnel or advertise job openings.

3.2.4 Non-Disclosure Agreement (NDA). All Contractor personnel shall provide a copy of the signed/dated NDA to the COR prior to beginning work. (Appendix D).

3.3 Contractor Manpower Reporting Requirements Application (CMRA). The Contractor shall report ALL Contractor labor hours (including subcontracted labor hours) required for performance of services provided under this contract for the Air Force and Army via a secure data collection site. The Contractor is required to completely fill in all required data fields at http://www.ecmra.mil. 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 at 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.

3.3.1 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.

3.3.2 User Manuals. Data for Air Force service requirements must be input at the Air Force CMRA link. However, user manuals for Government personnel and Contractors are available at the Army CMRA link http://www.ecmra.mil.

3.4 Quality Control Plan (QCP): The Contractor is responsible for Contract Management and Quality Control, not the Government. The Contractor shall submit a QCP (10) business days after contract award and maintain/update it thereafter.

3.5 Post-Award Meetings. The Government will host a post-award meeting with the Contractor within 30 calendar days after contract award. Telecon/teleconference is permissible for the post-award meeting. The purpose of the post-award meeting is to introduce the Contractor to the Government representatives (PM/COR). The Contractor shall also attend an Initial Contractor Performance Review 30 calendar days after the Contractor assumes full performance responsibilities (i.e., after completion of transition/mobilization) to ensure the Contractor has successfully started performance, completed transition, is fully operational, and is within the estimated cost, schedule, and performance parameters of the contract. The Contractor shall also attend a follow-up meeting 90 calendar days after contract award to assess status of performance.

3.6. Applicable Publications. Publications applicable to this requirement include, but are not limited to, those listed in Appendix B of this PWS.

3.6.1 Publications and forms are maintained and available electronically for Contractor download through the internet.

3.6.2 DoD Directives can be found at http://www.dtic.mil/whs/directives/index.html. Regulations are followed by a “---R” (e.g., DoD 6025.18-R) and can be located on the website by clicking on Publications instead of Directives.

4. PERFORMANCE OBJECTIVES

4.1. Services Summary (SS). The Contractor services requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service for each requirement. These thresholds are critical to mission success.

4.2. Services Summary Table.

Table 2 - PWS SS

OBJECTIVE

5. GOVERNMENT FURNISHED PROPERTY (GFP)

5.1 No GFP is being provided to the Contractor in support of this contract. The Government will provide the Contractor with the facilities, equipment, and information necessary to perform the tasks stipulated in this contract. Facilities include office space in unclassified work areas. Equipment includes computers (unclassified), desks, chairs, access to printers, unclassified networks, copy machines, telephones (secure, DSN, commercial access capabilities), basic office supplies, and Government vehicles, if necessary and available. These items are incidental to the place of performance and remain accountable to the Government. In addition, the Government shall require each individual Contractor personnel to sign hand receipts for all Information Technology Equipment (ITE) that they exclusively use (i.e., all equipment on their desks). This includes laptops for travel or out-of-office use, if required. Contractor personnel are not required to sign for multiple users ITE such as network equipment, network printers, and servers. Information includes all reference material or documentation required to perform. All facilities, equipment, and information used by the Contractor will remain the property of the Government and the Contractor shall return all facilities, equipment, and information to the COR or other designated representative upon the request of the Government or at the end of the contract period of performance.

6. DELIVERABLES

6.1. The Contractor shall submit all deliverables as specified in this PWS and Exhibit A, Contract Data Requirements List (CDRL).

6.1.1. All deliverables must be submitted electronically to the COR(s).

6.1.2. The COR may approve extensions to the delivery timeline based on magnitude and complexity of the document topic.

6.1.3. Provide informal reports by e-mail as requested by the COR.

Appendix A

ACRONYMS

Acronyms and Definitions

17 Nov 2017

APPENDIX B - Department of Defense (DoD) Regulations/Manuals/Instructions/Directives

*Most current version will apply*

The Air Force’s E-Publishing site (http://www.e-publishing.af.mil) will be used to obtain Air Force Instructions.

AIR FORCE INSTRUCTIONS (AFI)/MANUALS

*Most current version will apply*

APPENDIX C

BUSINESS ASSOCIATE AGREEMENT

This BAA can serve as a separate standalone agreement or may be used for new or existing contracts between the MTF and the business associate.

Business Associate Agreement

[USE FOR STANDALONE BAA ONLY] This Business Associate Agreement (this "Agreement") is entered into this ___ day of ________, _____ (the “Effective Date”) between [NAME OF MHS COVERED ENTITY] ("Covered Entity") and [NAME OF BUSINESS ASSOCIATE], a [type of business entity] ("Business Associate").

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 Personally Identifiable Information (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 [INSERT NAME OF BUSINESS ASSOCIATE].

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 [INSERT NAME OF MTF COMPONENT].

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 Personal Health Information (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 [MODIFY THIS SECTION IF THE PURPOSE OF THE AGREEMENT/CONTRACT IS FOR THE BA TO DEIDENTIFY PHI FOR THE CE].

(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 Contracting Officer (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 (if applicable) 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 their review, and for approval by the [REMOVE CO REFERENCES FOR STAND-ALONE AGMT] Contracting Officer, in consultation with the Covered Entity. Upon request, the Business Associate shall provide the Contracting 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 Contracting Office 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 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.) 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 [REMOVE CO REFERENCES FOR STAND-ALONE AGMT] Contracting Officer, in consultation with the Covered Entity will determine the appropriate level of support services.

(iii) 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 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.

(iv) 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 cybersecurity 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 [FOR STANDALONE INSERT, REPLACE WITH “this Agreement”].

(b) Effect of Termination.

(1) If this Agreement has records management requirements, the Business Associate shall handle such records in accordance with the records management requirements. If this Agreement does not have records management requirements, the records should be handled in accordance with paragraphs VI.(2) and (3) below.