PERFORMANCE_WORK_STATEMENT.docx

PERFORMANCE WORK STATEMENT

FOR

AIR FORCE MEDICAL SERVICE

TELERADIOLOGY SERVICE

AT

EGLIN AFB, FLORIDA

DECEMBER 2018

Table of Contents

1.0 SECTION I: DESCRIPTION OF SERVICES

1.1 SCOPE OF WORK

1.2 SPECIFIC TASKS FOR TELERADIOLOGY SERVICES:

2.0 SECTION II: SERVICE SUMMARY

2.1 Performance objectives

3.5 Interface system

3.6 DICOM transmission station

4.0 SECTION IV: GENERAL INFORMATION

4.1 CONTRACTOR FURNISHED PROPERTY

4.2 Contractor Personnel

4.3 Continuity of services/ replacement staff

1.0. DESCRIPTION OF SERVICES:

1.0.1 The contractor shall provide (NON-PERSONAL) professional diagnostic radiological interpretations and reports by a board certified radiologist for 96 MDG, Eglin Air Force Base, FL called for under this service contract. Services shall be performed at the contractor's facility.

1.1. SCOPE OF WORK: Services shall include professional preliminary and final interpretation as well as specific consultation as needed. The services provided in this contract will be utilized to supplement Air Force radiologists. Examinations include basic film, ultrasound, and nuclear medicine, cross sectional imaging (Magnetic Resonance Imaging - MRI and Computerized Tomography - CT).

1.2. SPECIFIC TASKS FOR TELERADIOLOGY SERVICES:

1.2.1. The radiologist shall provide diagnostic interpretations and interpretations of radiological examinations performed by Government personnel and provide further diagnostic consultation that relates to diagnostic imaging, upon request, to the other members of the medical staff. "Examinations", as referred to herein consists of individual patient examinations, which may include preliminary and final interpretation of one or more images. Further diagnostic telephone consultation may be required upon request of the user. The services shall consist of, but are not limited to, those set forth below:

1.2.1.1. Diagnostic Plain Film

1.2.1.2. Ultrasound

1.2.1.3. Nuclear Medicine

1.2.1.4. Cross Sectional Imaging: Magnetic Resonance Imaging (MRI) and Computerized Tomography (CT)

1.2.2. The contractor must provide preliminary diagnostic reporting within I hour of receipt of the transmitted images for all studies. Final interpretations must be provided within 24 hours of receipt of transmitted images.

1.2.3. The name of the interpreting radiologist shall be clearly noted on all interpretive reports.

1.2.4. In case of failed electronic communication, an interpretive report can be faxed to the user. Contractor shall be available telephonically until restoration of electronic communications.

1.2.5. The contractor must have and/or maintain all applicable information security clearances and authorizations required to establish connection and maintain connection to the Air Force network:

1.2.5.1. The contractor must demonstrate DoD Information Assurance Certification and Accreditation Process (DIACAP) certification/interim clearance for all electronic systems required to interface with the Air Force network. Contractor must submit evidence of DIACAP compliance at the time of submission of proposal and maintain such Certification throughout the course of contract execution. The DIACAP process is described in Appendix D.

1.2.5.2. Prior to beginning to provide any services under this agreement, Contractor shall obtain all applicable government required authorizations to have a Virtual Private Network (VPN)/Business-to-Business connection (B2B) to the Air Force Computer Network System. This shall include an Authorization to Connect (ATC). The contractor shall provide a valid ATC within 3 days of contract award (if possessed) or submit a completed application for ATC and B2B within 14 calendar days after award of contract.

1.2.5.3. Contractor must employ electronic systems which have the ability to interface directly with the Department of Defense Composite Healthcare System (CHCS) by HL7 interface/BHIE adapter from their work site to directly transcribe interpretations into the patient record. The contractor must have computer hardware that is capable of receiving Digital Imaging and Communications in Medicine (DICOM) compliant images from the MOFMC.

1.2.6. Contractor shall provide personnel who qualify for all applicable security clearance requirements to maintain access to the Air Force network. Submission of required security clearance documents shall be performed within 7 days of contract award.

1.2.7. The contractor’s physicians shall provide written or telephonic advice and professional opinions upon request by the MOFMC. Although participation in MOFMC committees (Professional Staff Meetings, Executive Committee of the Medical Staff, Credentials Function, etc.) by contractor’s radiologist is not routinely required the contractor agrees to make the credentialed radiologists available in support of the various boards and committees within the MOFMC if a particular event should require. Such a request will be provided through the contract administrator to the contractor at least 7 days in advance if a contractor’s radiologist participation is required.

1.2.8. CREDENTIAL REVIEW

1.2.8.1. All physicians providing service under the provision of this contract shall have current ACR Board Certification.

1.2.8.2. The contractor shall submit all credentialing documentation to the Credential Office within 14 calendar days after award of contract for initial contractor personnel and 30 working days prior to performance of services by replacement contract personnel. Any incident that may impact the continued privileging of a physician shall be brought to the attention of the CO and 96MDG credentialing staff as soon as validated.

1.2.8.3. Credentialing and Privileging Process

1.2.8.3.1. Physicians will not provide any patient care until credentialing process is complete.

1.2.8.3.2. Contractor shall complete a privilege application, as well as provide evidence of professional training and experience, board certification status, and current unrestricted Florida state licensure to the Credential Office for each physician who desires to work under this agreement. Documentation of currency in interpretation of modalities may also be requested.

1.2.8.3.3. Notify the 96 MDG Credentialing Department of any changes to the Centralized Credentials Quality Assurance System (CCQAPS) data, to include addresses or work unit.

1.2.8.3.4. Report any voluntary or involuntary relinquishment of licensure or registration to practice or voluntary relinquishment of privileges within 7 working days and explain reason by completing a form letter.

1.2.8.3.5. Complete a statement of health indicating any significant medical or mental condition, which has previously interfered, or may currently interfere with or limit ability to practice medical care.

1.2.8.3.6. All contract providers shall maintain malpractice insurance compliant with applicable state and federal licensing authority at the expense of the contractor/provider.

2.0. SERVICES SUMMARY

Performance Objective

PWS Ref

Performance Threshold

and 100% for final interpretation in evaluating for major discrepancies leading to changes in patient care

3.0 GOVERNMENT FURNISHED PROPERTY AND SERVICES

3.1. The Government will perform and transmit all study images electronically to the contactor for diagnostic radiological interpretations along with any clinical information available to the radiologic technologist.

3.2. All digital images and accompanied data shall remain the property of, and subject to the' exclusive control of the U.S. Government. All related reports, images, and documents prepared by the contractor for diagnostic imaging interpretation and support in fulfillment of this contract will become the property of the U.S. Government.

3.3. A fax number will be provided to the contractor within 3 calendar days after award.

3.4. The Government Hospital Info System (HIS) is using CHCS (Composite Health Care System) and AGFA PACS that has the ability to transmit DICOM images directly from the PACS system and the modalities.

3.5. The Government is currently using the HL-7 interface system which the contractor may utilize for directing final reports directly into the Hospital Information System at no cost to the Government.

3.6. The Government permits the contractor to place an approved DICOM send station behind the Government's firewall in order to facilitate a central point of DICOM transfer once an ATC is issued.

4.0 GENERAL INFORMATION

4.1. CONTRACTOR FURNISHED PROPERTY: This is not intended to be a comprehensive list of all contractor furnished property, it covers the core components that are possibly involved in a complete personnel equipment, and service solution. The contractor is required to assess the full extent of support necessary to provide the required services, equipment, and/or personnel for this contract. Compliance with the elements of this section are only relevant to the extent it is applicable to this contract.

4.1.1. The contractor shall be required to obtain Virtual Private Network (VPN) access to connect to the Government Local Access Network (LAN) and must communicate with the network, DICOM, and HL7.

4.1.2. The contractor shall be responsible for network connectivity to access from their database location to the Government computer systems for the transference of interpretations.

4.1.3. The contractor shall ensure compliance with the electronic data security requirements as required under the Health Insurance Portability Act (HIPAA), see appendix B.

4.1.4. Computer hardware utilized for viewing images shall be capable of resolution display quality in accordance with the ACR-AAPM-SDM Technical Standard for Electronic Practice or Medical Imaging, 20 September 2012 (or current edition). See: http://www.acr.org//media/AF1480BOF9S842E7B163F09FICE00977.pdf The contractor will maintain all other applicable standards described in this document.

4.1.5. Maintenance of computer hardware to ensure capability and submission of those maintenance records if requested by the Government.

4.2. CONTRACTOR PERSONNEL Radiologists assigned by the contractor to provide the official interpretation of images transmitted by Teleradiology must maintain licensure appropriate necessary to deliver radiologic service. Physicians providing services under this contract must be privileged by the guidelines set by the Joint Commission

(JC) and Air Force Instructions prior to execution of service and maintain their credentials while providing service. The contractor shall ensure professional liability coverage is in place in accordance with jurisdictional requirement of the state in which services are being performed.

4.2.1. The contractor shall ensure that all contractor personnel providing services under this contract are able to read, write and speak English fluently.

4.2.2. No work shall be performed outside of the United States.

4.2.3. After receipt of contract award, the contractor shall furnish a list of qualified radiologists, including name and telephone number, scheduled to perform services during the performance of this contract.

4.2.4. After receipt of contract award, the contractor shall provide the name and telephone number of an individual to act as his/her representative.

4.2.4.1. The designated representative shall be responsible for the administration and coordination of this contract with the Government Monday through Friday 7:30 a.m. to 5:00 p.m., Central Time.

4.2.4.2. The contractor's representative shall not be a radiologist providing the service under this contract. Duties shall include, but are not limited to: -

4.2.4.2.1. Ensure interpretations and reporting are accomplished in a timely manner, see section 1.2.

4.2.4.2.2. Meet with Government personnel to discuss performance on a quarterly basis or as needed.

4.2.5. Contractor personnel shall not release medical information under any circumstance, but shall refer all requests for patient/hospital information to the 96 MDG QAP.

4.2.6. The contractor shall communicate any problems encountered during the performance of the contract to the CO, who will seek a timely resolution of the problem.

4.2.7. Contractor shall be required to furnish interpretation and consultation services 24 hours a day 7 days per week including weekends and holidays. The contractor may faxed reports for stat and preliminary studies prior to the final report being entered into the HIS within the prescribe 24 hours. In addition, contractor shall be available for telephone consultation.

4.3. CONTINUITY OF SERVICES/REPLACEMENTSTAFF. The contractor shall ensure sufficient staffing and resources to provide all required services and support throughout the term of the contract.

4.4. RELATIONSHIP OF THE PARTIES. This is a non-personal service contract. Contract personnel are not subject to the supervision and control of a Government officer or personnel [FAR 37.104(a)(l)(ii)]. Rather, contractor personnel perform their duties IAW specific tasks outlined in the PWS. Supervisory functions such as hiring, directing, counseling, and firing of contractor personnel are not performed by the Government. The contracted personnel who furnish services under this contract are subject to Government technical oversight of the services provided. The Government retains the right to reject services for' contractual nonperformance.

4.5. FORMAL EDUCATION. Physicians providing services under this contract shall have completed residency at an institute recognized to provide such credentials in the United States.

4.6. LICENSURE/REGISTRATION. Contract personnel must maintain an active license or authorizing document from the state in which they are conducting the services under this contract.

4.7. CERTIFICATION. The provider shall have national approved and current board certification in the specialty area in which he/she provides clinical services.

4.8. EXPERIENCE. The radiologists shall have been continuously employed in the practice of diagnostic radiology or in training for 24 months within the last 36 months. ·

4.9. RECORDS. The contractor shall segregate the Government-owned data from other contractor-held data to include actual patient information. Upon completion of this contract, all contractor-held data (regardless of media) received, created, maintained or provided in the performance of the statement of work shall be turned over to the Government or signed document stating that files have been erased/destroyed and the means utilized to do so.

4.10. RELEASE OF MEDICAL INFORMATION. The Contractor shall release medical information obtained during the course of this contract to Military Treatment Facility (MTF) staff involved in the care and treatment of that individual patient only in accordance with Appendix B.

4.11. SECURITY. The Contractor is responsible for maintaining the security of patient information in accordance with HIPAA guidelines. Unauthorized access to Contractor controlled data will be reported to the CO and 96MDG QAP immediately. See Appendix B.

4.12. PROCEDURE GUIDANCE. Contractor shall perform procedures compatible with the medical facility's operating capacity and equipment. New medical procedures/services shall not be introduced without prior recommendation to, and approval of the Contracting Officer.

4.13. COMMUNICATION. Contractor personnel shall maintain open and professional communication with members of the MTF staff. Complaints validated by the Chief of Diagnostic Imaging Services shall be reported in writing to the QAP to the Contracting Officer and Contractor for action. Failure of the Contractor to correct validated complaints will be considered a failure to perform.

4.14. DOCUMENTATION. Contractor personnel shall prepare all documentation to meet or exceed established standards of the 96MD0, to include, but not limited to, timeliness, accuracy, content and signature.

4.15. QUALITY ASSURANCE/CONTROL

4.15.1. The Government shall monitor the contractor's performance of this contract using quality assurance procedures established by the 96MDG and pursuant to the Inspection Services Clause. Additionally, the contractor's performance is subject to scheduled and unscheduled review.

4.15.2. The contractor shall have an internal quality control procedure, which shall ensure the contractor's performance/medical care evaluation will be at a level commensurate with standards of the medical profession and the American College of Radiology. Accuracy for preliminary interpretation shall be 98% and 100% for final interpretations in evaluating for major discrepancies that would result in a change to a patients care plan.

4.15.3. The 96 MDG shall maintain a record-keeping system that monitors the contractor's performance by exams interpreted for the purpose of payment verification.

4.15.4. Teleradiology Quality Control: a test image, such as the Society of Motion Picture and Television Engineers (SMPTE) test pattern shall be transmitted, archived, retrieved and displayed at least weekly, to test the overall operation of the system under conditions that simulate the normal operation of the system. The contractor shall maintain written documentation of the test performance and results. Failures of this QC test shall result in cessation of Teleradiology services until technical problems have been successfully resolved.

5.0 SECTION IV: APPENDICES & EXHIBITS

A. Acronyms & Abbreviations list B. HIPAA Business Associate Agreement C. Historical Data D. DIACAP Process

APPENDIX A GENERAL DEFINITIONS

As used throughout this Performance Work Statement, the following terms shall have the meaning set forth below:

I.I. Composite Health Care System (CHCS) - DOD mandated Health Information System (HIS) that also serves as the Radiology Information System (RIS)

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

1.3. Healthcare Insurance Portability and Accountability Act (HIPAA) - Establishes national standards for electronic health care transactions and national identifiers for providers, health plans, and employers. It also addressed the security and privacy of health data.

1.4. Quality Assurance (QA) - Those actions taken by the Government to check services to determine if they meet the requirements of The Joint Commission (TJC), Department of Defense, individual Medical Treatment Facilities Quality Assurance and Risk Management Programs and ensure that the contractor personnel comply with the terms and conditions of the agreement.

1.5. Quality Assurance Personnel (QAP)-A Government personnel selected and designated in writing by the contracting officer to act as his/her designated representative in administering a contract.

1.6. Quality Control (QC) - Those actions taken by the contractor to control the production of goods and services so that they meet the requirements of the agreement. This includes those actions taken by the contractor to ensure quality patient care and clinical performance, resolving identified problems, and reporting information to the Contracting Officer.

Arrival Services. Services performed to prepare for and properly park transient aircraft in an assigned parking area.

APPENDIX B HIPAA Business Associate Agreement

This Business Associate Agreement (this "Agreement") is entered into this xx day of XXX, 2014 between 96 MDG, Eglin AFB, FL (11Covered Entity") and XXX, a Profit Corporation ("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. I.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 (Contractor's Name).

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 96 MDG.

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 5400.11-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)(l)(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 Jaw. 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 agreement 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

(I) 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 n 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, 10 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 ccrt.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-ccrt.gov/pgp/cmuil.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 he directed to the Installation Privacy Act Officer or MTF HJPAA 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 lo make timely and accurate determinations on reports to HHS us 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. 1hc 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 over d Ent ty 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 Covered Entity. Upon request, the Business Associate shall provide the 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 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); ITY: 1-866-653-4261.

(D) A brief description of what the covered entity involved is doing lo 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 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 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.

(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 IO 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 PIJ/PHJ. 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 this agreement.

(b) Effect of Termination.

(I) 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 Vl.(2) and (3) below. If this Agreement has provisions for transfer of records and PII/PHI to a successor Business Associate, or if the Covered Entity gives directions for such transfer, the Business Associate shall handle such records and information in accordance with such Agreement provisions or the Covered Entity's direction.

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

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

VII. Notices. Any notices to be given hereunder will be made in the most expedient manner, via e-mail, facsimile, U.S. Mail, or express courier to such party's address given below.

Attn:

Title:

Company:

Address:

Eglin AFB, FL 32542

Phone:

Fax:

E-mail:

With a copy to:

Name:

Company:

Address:

Bldg. 260, Ste 130

Eglin AFB, FL 32542

Phone:

Fax:

Fax:

Email:

Each party named above may change its address and that of its representative for notice by the giving of notice thereof in the manner provided in this subsection.

VIII. Miscellaneous

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

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

(c) Counterparts; Facsimiles. This Agreement may be executed in any number of counterparts, each of which shall be deemed an original. The parties acknowledge and agree that faxed and/or electronically affixed signatures shall act as original signatures that bind each faxing, or electronically affixing, signatory to the terms and provisions of this Agreement. Delivery of an executed counterpart of this Agreement by facsimile or electronic mail shall be equally effective as delivery of a manually executed counterpart.

(d) Entire Agreement; Amendment. This Agreement embodies the entire understanding between the parties pertaining to the subject matter contained in it; supersedes any and all prior negotiations, correspondence, understandings, or agreements of the parties with respect to its subject matter; and may be waived, altered, amended, modified, revised or repealed, in whole or in part, only on the written consent of the parties to this Agreement.

APPENDIX C HISTORICAL DATA (Yearly Average)

I. Diagnostic Plain Film Studies: 1000

2. Ultrasound Studies: 1000

3. Nuclear Medicine Studies: l 0

4. Cross Sectional Imaging Studies MRI: l0

5. Cross Sectional Imaging Studies CT: 2200

6. Fluoroscopy Studies: 10

NDAA SECTION 8101

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the [NAMED COMPONENT) via a secure data collection site. The contractor is required to completely fill in all required data fields at http://www.ecmrn.mil. Reporting inputs will be for the labor executed during the period of performance for each Government fiscal year (FY), which runs l October through 30 September. While inputs may he 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."

*Reporting Period: Contractors are required to input data by 31 October of each year. However. due to the delayed implementation, input of FY 12 data is required by 31 Mar 13.

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 arc associated with the direct labor hours and direct labor dollars. At no time will any data be released to the public with the contract name and contract number associated with the data.

User Manuals: Data for Air Force service requirements must be input at the Air Force CMRA link.

APPENDIX D DIACAP PROCESS

What is DIACAP?

The DoD Information Assurance Certification and Accreditation Process (DIACAP) is a dynamic, information assurance (IA) certification and accreditation (C&A) process that supports the net-centric, Global Information Grid (GIG)-based environment by:

• Identifying, implementing, and managing IA controls

The core activities of the DIACAP are consistent with DoDD 8500.01E, DoDI 8500.2, DoDI 8580.l, the acquisition life cycle requirements of DoDD 5000.1 and DoDI 5000.2, FISMA security requirements, Appendix M of 0MB Al 30, industry best practices, and lessons learned.

DoDI 85 I0.0I cancels the DoD Information Technology Security Certification and Accreditation Process (DITSCAP) (defined in DoDI 5200.40 and DoD 8510.1-M) and the DIACAP Interim Guidance.

DIACAP Activities

The DIACAP defines the following activities for the certification and accreditation of a specific DoD Information…