A.01.02_Scope_of_Work.docx

Blanket Purchase Agreement (BPA) Between Joint Base Lewis-McChord Health Contracting Cell (JBLM-HCC) Scope of Work

1. AUTHORITY.

This agreement is established in accordance with FAR 13.303, Blanket Purchase Agreements (BPA. It will be reviewed by the Contracting Officer at least once annually prior to the anniversary of the effective date, and revised to conform to all requirements of Statutes, Executive Orders, or the Federal Acquisition Regulation as updates occur. Any revisions will be incorporated by modification to this BPA and agreed upon by the Contracting officer and the Contractors.

(2) DESCRIPTION OF AGREEMENT

The Contractor shall provide Various FDA-Approved Invasive Surgical Spinal Implants and Invasive Vascular products such as; Crescent Spacer Spinal Implant, CD Horizon Solera Spinal Implants, Vertex Spinal Implants, Infuse Bone Graft Implants, Vertex Select Reconstructions System, Allograft Tissue and Bone, Angio-Interventional, and Neuroradiological consumable supplies, tools and accessories for patient specific needs basis on the surgeons requirement. The commercial price listing will be incorporate into the Master Blanket Purchase Agreement.

The products are to support for the below following outlying medical treatment facilities (MTF):

Madigan Army Medical Center Departments (MAMC), Joint Base Lewis McChord, WA Bassett Army Community Hospital, Fort Wainwright AK, Evans Army Hospital, Fort Carson CO, Raymond W Bliss Army Health Center, Fort Huachuca AZ Irwin Army Hospital, Fort Riley KS, Gen Leonard Wood Army Hospital, Fort Leonard Wood, MO Munson Army Health Center, Fort Leavenworth KS, McAffee Army Health Clinic, White Sands Missile Range NM Weed Army Community Hospital, Fort Irwin, CA 92310

ALL PRODUCTS MUST BE FDA APPROVED, AND MEET THE SURGEON/PATIENT REQIREMENTS.

Master Blanket Purchase Agreements are being established to allow maximum flexibility and efficiency in the procurement of the provide Various FDA-Approved Invasive Surgical Spinal Implants and Invasive Vascular products such as; Crescent Spacer Spinal Implant, CD Horizon Solera Spinal Implants, Vertex Spinal Implants, Infuse Bone Graft Implants, Vertex Select Reconstructions System, Allograft Tissue and Bone, Angio-Interventional, and Neuroradiological consumable supplies, tools and accessories for patient specific needs basis on the surgeons requirement for outlying medical treatment facilities (MTF). A general competitive effort is made by the surgeon and attending team throughout the requirement review process which considers the applicability of products from various sources to determine the product that best meets the needs of the patient.

a. This agreement shall be in effect for a term of five (5) years starting on or about 18 Dec 2016 thru 17 Dec 2020. The Agreement terms and conditions may be renegotiated annually prior to the anniversary of the effective date of the agreement. Either party may terminate this agreement by giving thirty (30) days written notice.

b. The contractor submitted commercial product catalog and pricing (TO INCLUDE ALL APPLICABLE DISCOUNTS) is incorporated into this Agreement, and all BPA Calls shall utilize this pricing. Any updates or changes to the product catalogs or pricing must be approved by the Contracting Officer for incorporation into this Agreement. The Contractor must allow thirty (30) days for the revised catalog to be incorporated into the Agreement.

c. The Government may place BPA CALLs to fund the estimated expenditures for the entire year with one order, or may place multiple BPA CALLs during the year for limited periods. BPA CALLs will not cross fiscal years (except for required delivery time).

d. BPA calls will be issued by the Regional Health Contracting Office-Pacific (Provisional) Joint Base Lewis-McChord Health Contracting Cell(JBLM-HCC) located on 673 Woodland Square Loop SE Suite 101, Lacey WA 98503 , Regional Health Contracting Office - Central) and Southern Regional Health Contracting Office.

(3) EXTENT OF OBLIGATION

1. This Blanket Purchase Agreement (BPA) does not obligate any funds. This Blanket Purchase Agreement (BPA) does not obligate any funds and is not a binding contract. The Government will be obligated only to the extent that authorized BPA calls are actually made under this agreement. The medical treatment facility (MTF) will order surgical spinal implants products, and other instrumental consumable related supplies for patient specific needs basis on the surgeon requirement will be responsible for payment of any obligation via Government Credit Card or DFAS Indy (GEFEBS) code HQ0490, which invoicing is submitted into the into Invoicing, Receipt, Acceptance and Property Transfer (iRAPT) – formerly known as WAWF.

Purchase Limitation:

BPA Call Limit- $25,000.00 (if placed via Government Purchase Card) BPA Call Limit - $150K (ordered through the Contracting Office) BPA Master Dollar Limit=$7,000,000.00 (for life of Agreement)

(4) ORDERING PROCEDURES

This contract uses a CLIN structure that allows the purchase of all items within the scope of the items covered by this contract. The quantity and types of items needed for those medical treatments and emergencies vary over time based on patient needs. Each BPA CALL will be funded between $25,000.00 to $150,000.00 depending on payment method, and allow the facility to place telephonic orders for specific requirements/emergencies against that BPA CALL until the funds are depleted. This also allows for procurement of new items as technology advances without the need to modify the contract to include them. The products are to support for the below following Outlying medical treatment facilities (MTF):

Madigan Army Medical Center Departments (MAMC), Joint Base Lewis McChord, WA Bassett Army Community Hospital, Fort Wainwright AK, Evans Army Hospital, Fort Carson CO, Raymond W Bliss Army Health Center, Fort Huachuca AZ Irwin Army Hospital, Fort Riley KS, Gen Leonard Wood Army Hospital, Fort Leonard Wood, MO Munson Army Health Center, Fort Leavenworth KS, McAffee Army Health Clinic, White Sands Missile Range NM Weed Army Community Hospital, Fort Irwin, CA 92310

As requirements occur that meet the surgeon/ patient requirement for the medical treatment facilities, they (MTFs) will rotate contacting the various BPA holders for these products, and depending on the availability and delivery time of the products, will schedule deliveries accordingly.

(5) Individuals Authorized to Schedule Deliveries under the BPA

a. Each BPA Call paid by DFAS Indy will identify the names of the individuals authorized to schedule deliveries under this Agreement. Only authorized Government employees who have been specifically named by the Contracting Officer may schedule deliveries under this agreement. STRICT COMPLIANCE WITH THIS STIPULATION IS IMPERATIVE.

b. The Contracting Officer will provide the BPA holder and the Contractor a written notification of the appointed authorized ordering individuals for calls under payment terms by Government Credit Card.

c. The medical treatment facility designated individuals authorized responsibilities and requirements:

1. You are responsible for creating a GFEBS purchase request (PR) and routing the PR to Resource Management (RM) for funding. RM reviews the PR and conducts their L4 process to route the funded PR to Joint Base Lewis-McChord Health Contracting Cell (JBLM-HCC), NOTE – Funded PR cannot exceed $150,000.00 and must state payment by DFAS Indy in the funding line.

2. You shall use an authorized BPA GPC to schedule deliveries against the BPA Call up to $25,000 per delivery. Deliveries will be scheduled by, outlying medical treatment facilities (MTFs), and a call number will be associated with each delivery. Invoices shall reflect BPA number and Call number.

3. You are require to submit a itemize price listing for each GFEBS purchase request (PR) for a BPA Call be issued. You are require to submit a itemize price listing with the GFEBS purchase request (PR) on the products you are anticipating of purchasing under that BPA Call. The products MUST match what is ordered off the price listing in the BPA Call.

4. When the BPA cardholder creates a GPC BPA order through U.S. Banks Access Online, the following general information blocks must be additionally filled out:

1. Under “Document #”, insert BPA Number, w/o dashes, e.g., W91YU012A1234

1. Under “Authorization Number”, insert BPA Call Number + your internal control number/ordering sequence, e.g., 0001-001

5. JBLM-HCC issues a BPA Call and provides you with the funded BPA Call document with a call number. You shall use an authorized BPA Call to schedule deliveries. Deliveries will be scheduled by medical treatment facility (MTF), and a call number will be associated with each delivery. Invoices shall reflect BPA number and Call number.

6. You shall maintain a detailed log of delivery requests scheduled and decrement funding on their call each time a delivery request is scheduled. In minimum, for audit purposes, the log shall include delivery date, item number, nomenclature, quantity $ amount, and BPA Call number.

1. Monthly Report:

The medical treatment facility (MTF) designated appointed individual shall submit bpa call itemized invoice usage report to their contracting officer monthly or upon expiration the bpa call. The monthly call itemized invoice usage report shall list delivery date, item number, nomenclature, quantity $ amount, and BPA Call number for each delivery request scheduled against the BPA Call that month.

1. Orders will be placed telephonically to: _______________________ or _________________________ referencing Account Number: _____________________.

(6) DELIVERY TICKETS/PACKAGING

a. All packing lists (delivery tickets) shall contain the following information:

(7) SHIPPING

The contractor ship directly to the below medical treatment facility address indicated in the ship to block of the BPA calls for the medical treatment facility (MTF):

Overnight Deliveries will be shipped via Federal Express or UPS Services on or around 10:30 am in the event that immediate delivery is required.

Freight shall be inclusive to unit pricing and added to each invoice, if applicable. F. O. B Destination.

a. The contractor shall submit a separate invoice for each BPA call. The invoice shall include the following information below:

The contractor shall submit invoices for bpa calls in the Invoicing, Receipt, Acceptance and Property Transfer (iRAPT) – formerly known as WAWF formerly known as WAWF).

(8) PAYMENT METHOLOGY (Government- Wide Purchase Card (GPC)

a. Contractors that will be paid by Government credit card (GPC). The current Government credit card is VISA. All costs associated with the use of the credit card i.e. transaction fees, must be included in the price for the appropriate CLIN. See also FAR 52.232-36.

Invoices shall itemize implant products items used, showing the price for each product and the number utilized. If transportation charges are not included in the cost of the products, it must be prepaid and added to the invoice as a separate item. Invoice and credit card charges shall reflect the Blanket Purchase Agreement number and four digit call number.

Invoices need to be submitted to the outlying medical treatment facilities (MTF) addresses indicated in the ship to block of the BPA calls for the payment:

Credit card charges shall not be processed until the invoice has been certified and the cardholder has authorized payment. Payment amount MUST be based on actual surgery usage.

(9) PAYMENT METHOLOGY (Invoicing, Receipt, Acceptance and Property Transfer (iRAPT) – formerly known as WAWF).

a. The contractor will be required to submit an invoice and receiving report (COMBO) into Invoicing, Receipt, Acceptance and Property Transfer (iRAPT) – formerly known as WAWF for each BPA call delivery. Invoicing must show quantity amounts at 1$ each and will be subtracted from overall BPA call order amount. (i.e. billing for $250.00 will show as 250ea @ $1).

Instructions for submitting iRAPT invoices below:

Invoicing, Receipt, Acceptance and Property Transfer (iRAPT) – formerly known as WAWF iRAPT is the authorized method to electronically process vendor request for payment. This application allows DOD vendors to submit and track Invoices and Receipt/Acceptance documents electronically. Contractor shall (i) register to use iRAPT at https://wawf.eb.mil and (ii) ensure an electronic business point of contract (POC) is designated in the System for Award Management at https://www.sam.gov within ten (10) calendar days after award of this contract/order.

iRAPT Instructions:

Questions concerning payments should be directed to the Defense Finance and Accounting Service (DFAS) location listed in Block 18a of your purchase order/contract. Please have your purchase order/contract number ready when calling about payments.

You can easily access payment and receipt information using the DFAS web site at http://www.dfas.mil/money/vendor . Your purchase order/contract number or invoice number will be required to inquire status of your payment.

DFAS POC: Vendor Pay (DFAS-INDY VP GFEBS), CODE: HQ0490

8899 E 56TH STREET

INDIANAPOLIS IN

Phone: 888-332-7366 OPTION 1 OR (317) 212-0300

The following codes and information will be required to assure successful flow of iRAPT documents.

Foreign Vendors will submit banking information in the Comments Tab of the iRAPT invoice.

TYPE OF DOCUMENT [X the appropriate block]

___ Invoice (Contractor Only)

_____Invoice and Receiving Report (COMBO)410. X__Invoice and Receiving Report (COMBO) **ONCE THE WAWF INVOICE IS SUBMITTED, NOTIFY THE POINT OF CONTACT AT THE OUTLYING MEDICAL FACILITES SO THE PAYMENT CAN BE PROCESSED IMMEDIATELY.

____ Invoice ___ Invoice as 2-in-1 (Services Only)

___ Receiving Report (Government Only)

CAGE CODE: SEE BLOCK 9 OF DD 1155

ISSUE BY DODAAC: SEE BLOCK 6 OF DD 1155

ADMIN BY DODAAC: SEE BLOCK 7 OF DD 1155

INSPECT BY DODAAC: SEE BLOCK 6 OF DD 1155

ACCEPT BY DODAAC: SEE BLOCK 6 OF DD 1155

SHIP TO DODAAC: SEE BLOCK 6 OF DD 1155

PAYMENT OFFICE FISCAL STATION CODE: SEE BLOCK PAYMENT WILL BE MADE BY OF DD 1155

When submitting invoices via (IRAPT), the contractor shall ensure that the Receiver and the Acceptor are notified that an invoice is pending by initially loading their email addresses in the record for the contract and selecting them for notification each time an invoice is submitted. Email addresses for the following positions will be provided apart from this clause at the time distribution of the contract is made:

INSPECTOR:

ACCEPTOR:

RECEIVING OFFICE POC:

ADMINISTRATOR: CONTRACTING OFFICER:

PRIMARY ALT CONTACT:

For more information contact: SEE ISSUE BLOCK 6 OF DD 1155 FOR THE CONTRACT SPECIALIST AND BLOCK 24 OF DD 1155 FOR THE CONTRACTING OFFICER/ORDER OFFICER.

Any modification requests must be in writing and submitted to: ADMIN DODAAC.

10. CUSTOMER SERVICE

a. Contractor shall ensure that all local or toll free customer service numbers are updated periodically to each know Government point of contact and the Contracting Office. In addition, Contactors shall assign an account manager to the order to ensure customer satisfaction. BPA call orders can be fax or via email to Contractor.

b. The contractor shall provide authorized Sales Representatives for each outlying medical treatment facilities (MTF) are listed below:

Madigan Army Medical Center Departments (MAMC), Account number: ____________________ Tacoma, WA 98431

Bassett Army Community Hospital, Fort Wainwright AK, Account number: ____________________ 1060 Gaffney Road #7400 Fort Wainwright, AK 99703-7400

Evans Army Hospital, Fort Carson CO, Account number: ____________________ 7500 Cochran Circle Fort Carson, CO 80913-4604

Raymond W Bliss Army Health Center, Fort Huachuca AZ Account number: ____________________ 45001 Winrow Drive Fort Huachuca, AZ 85613-7040

Irwin Army Hospital, Fort Riley KS Account number: ____________________ 600 Caisson Hill Road Fort Riley, KS 6642-5037

Gen Leonard Wood Army Hospital, Fort Leonard Wood MO, Account number: ____________________ 126 Missouri avenue Fort Leonard Wood, MO 65473-8952

Munson Army Health Center, Fort Leavenworth KS, Account number: ____________________ 550 Pope Avenue Fort Leavenworth, KS 66027-2332

William Beaumont Army Medical Center, El Paso TX, Account number: ____________________ 5005 North Piedras Street El Paso, TX 79920-5001

MacAfee Army Health Clinic, White Sands Missile Range NM Account number: ____________________ Bldg 530 Rock Island Avenue White Sands Missile Range, NM 8802-5220

Weed Army Community Hospital, Fort Irwin, CA 92310 Account number: ____________________ PBO/Material Receiving Point Bldg 178 Inner Loop Fort Irwin CA 92310-9986

c. The contractor shall provide authorized Sales Representatives for each medical treatment facility (MTF) as listed below:

Madigan Healthcare System Departments (MAMC), Joint Base Lewis-McChord, Name Phone Email

Bassett Army Community Hospital, Fort Wainwright AK, Name Phone Email

Evans Army Hospital, Fort Carson CO, Name Phone Email

Raymond W Bliss Army Health Center, Fort Huachuca AZ

Name Phone Email

Irwin Army Hospital, Fort Riley KS, Name Phone Email

Gen Leonard Wood Army Hospital, Fort Leonard Wood MO, Name Phone Email

Munson Army Health Center, Fort Leavenworth KS, Name Phone Email

William Beaumont Army Medical Center, El Paso TX, Name Phone Email

McAffee Army Health Clinic, White Sands Missile Range NM

Name Phone Email

Weed Army Community Hospital, Fort Irwin, CA 92310, Name Phone Email

The BPA holder’s Government Representative is:

Name Phone Email

The BPA holder’s Billing/Accounting Representative is:

Name Phone Email

The contractor shall ensure that all customer service numbers are updated periodically to the outlying MTF facility and the Contracting Office.

(11) WARRANTY PROVISIONS/RETURNS

Return Policy: Due to the nature of the Medical Products being procured under this agreement, the BPA HOLDER shall ensure that all deliverables are in compliance with Medical and FDA Regulations. The contractor/Sales Representative shall provide a replacement immediately if a deliverable is determined unsatisfactory in accordance with Medical Standards. A return evaluation number must be obtained prior to returning any product and should be used on the shipping label and on any correspondence in the package. All returned products shall be credited to the applicable account number and bpa call number.

(12) PROMOTION

The contractor agrees it shall not advertise the use of this BPA in such a manner as to state or imply that the medical treatment facility (MTF) endorse a product, project, or commercial product line.

NOTE: HIPPA –PHI clause is only applicable if representatives from the Contractor are involved in the actual surgeries being performed.

(13) Non-DHA HIPAA BAA (7 July 2014)

HCAA Local Clause 5001 - Non-Defense Health Agency (Non-DHA) Health Insurance Portability and Accountability Act (HIPAA) Business Associate Agreement (BAA) (7 July 2014)

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 BAA between the signatory parties for purposes of the HIPAA and the “HITECH Act” amendments thereof, as implemented by the HIPAA Rules and DoD HIPAA Issuances (both defined below). The parties are a DoD Military Health System (MHS) component, acting as a HIPAA covered entity, and a DoD contractor, acting as a HIPAA business associate. The HIPAA Rules require BAAs between covered entities and business associates. Implementing this BAA requirement, the applicable DoD HIPAA Issuance (DoD 6025.18-R, paragraph C3.4.1.3) provides that requirements applicable to business associates must be incorporated (or incorporated by reference) into the contract or agreement between the parties.

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

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

—Business Associate shall generally have the same meaning as the term “business associate” in the DoD HIPAA Issuances, and in reference to this BAA, shall mean [insert name of Business Associate signatory to this BAA].

—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 MHS component signatory to this BAA].

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

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

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

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

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

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

I. Obligations and Activities of Business Associate

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

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

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

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

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

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

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

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

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

II. Permitted Uses and Disclosures by Business Associate

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

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

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

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

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

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

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

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

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

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

IV. Permissible Requests by Covered Entity

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

V. Breach Response

(a) In general.

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

If the DHA Privacy Office determines that a breach is an HHS Breach, then the Business Associate shall comply with both the HIPAA Breach Rule and DoD Privacy Act Issuances, as directed by the DHA Privacy Office, regardless of whether the breach occurs at DHA or at one of the Service components. If the DHA Privacy Office determines that the breach does not constitute an HHS Breach, then the Business Associate shall comply with DoD Privacy Act Issuances, as directed by the applicable Service-Level Privacy Office. The Business Associate shall contact the Covered Entity for guidance when the incident is not an HHS Breach.

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

(b) Government Reporting Provisions

The Business Associate shall report the breach within one hour of discovery to the Covered Entity and to the US Computer Emergency Readiness Team (US CERT) -the 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.

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 -Covered Entity and the applicable Service-Level Privacy Office, if requested by either. Business Associate questions about US-CERT reporting shall be directed to the Covered Entity or Service-Level Privacy Office, not the US-CERT office.

The additional US Army and the US Army Medical Command (MEDCOM) reporting requirements are addressed in the PII Breach Reporting and Notification Policy. The latest version of this policy can be obtained from the Covered Entity or the MEDCOM Privacy Act/Freedom of Information Act (FOIA) Office at: usarmy.jbsa.medcom.list.medcom-foia-users@mail.mil . 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.

When a Breach Report initially submitted is incomplete or incorrect due to unavailable information, or when significant developments require an update, the Business Associate shall submit a revised form or forms, stating the updated status and previous report date(s) and showing any revisions or additions in red text. Examples of updated information the Business Associate shall report include, but are not limited to: confirmation on the exact data elements involved, the root cause of the incident, and any mitigation actions to include, sanctions, training, incident containment, follow-up, etc. The Business Associate shall submit these report updates promptly after the new information becomes available. Prompt reporting of updates is required to allow the 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 Report. 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.

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

(c) Individual Notification Provisions

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

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

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

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

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

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

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

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

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

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

(b) Effect of Termination.

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

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

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

VII. Miscellaneous

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

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