RFQ N0018320Q0087 BPA FOR SURGICAL SUPPLIES.docx

N0018320Q0087

Section A - Solicitation/Contract Form

SOLICITATION

Administrative Data

VENDOR TO COMPLETE THE FOLLOWING:

COMPANY NAME: ______________________

Vendor POC: ____________________

Vendor email: _________________________________

Naval Medical Center Portsmouth, VA Acquisition Office

Product/Services for: Naval Medical Center Portsmouth VA DSS/Main OR

620 John Paul Jones Circle Portsmouth VA 23708-2197

Vendor to reference RFQ Number: N00183-20-Q-0087 on all inquiries.

NOTE: Vendors must be registered in System for Award Manaagement (SAM) in order to receive government contracts. Failure to be registered or have an ACTIVE account in SAM will result in your offer being deemed as being non-responsive the website for SAM is https://www.sam.gov/portal/public/sam/.

PROMPT PAYMENT

For Prompt Payment Act Purposes, this contract is:

Subject to the 7-calender day constructive acceptance period.

Provide pricing, F.OB, delivery terms. Award based on best value as determined by price and technical acceptance. Provide brand name or equal. If providing equal, must provide technical documentation.

Include copy of published price list with quote. If published price list is too large to forward with quote, include cover page with effective dates and pages for the items. Include information showing past performance.

Note: Vendor will be required to provide billing electronically via the WAWF Electronic Invoicing Method. For additional information, a review of the following web sites may be required: websites: https://wawf.eb.mil or http://wawftraining Email: usn.detrick.navmedlogcomftdmd.list.nmlc-wawf@mail.mil

DISCOUNTS

The vendor's initial response to this RFQ should reflect the Vendors' best price including all allowable discounts that are available to the Federal Government. Please identify all discounts that are being offered as part of the vendor's quote submission. The government does not intend to go out for a best and final offer.

“AVAILABILITY OF FUNDS. Pursuant to Section I, Availability of Funds (FAR 52.232-18), of the contract, funds are not presently available for this contract. The Government’s obligation under this contract is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise until funds are made available to the Contracting Officer for this contract and until the Contractor receives notice of such availability, to be confirmed in writing to the Contracting Officer.”

Section B - Supplies or Services and Prices

CONSIGNMENT OF JOINT INSTRUMENTS

FFP

AND IMPLANTS SEE SECTION c FOR DETAILED LISTING OF CONSIGNMENT ITEMS AND QUANTITIES REQUIRED. PROVIDE PRICING FIR ITEMS TO BE PROVIDED IN THE CONSIGNMENT.

FOB: Destination

MILSTRIP: N0018320RCSUCA2

PURCHASE REQUEST NUMBER: N0018320RCSUCA2

PSC CD: 6515

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Section C - Descriptions and Specifications

DESCRIPTION AND SPECIFICATINS

“Name of Awardee” (hereinafter “vendor”) agrees to the following terms of Blanket Purchase Agreement (BPA) “number to be determined at time of award” with the Naval Medical Center, Portsmouth, VA NMCP). Both parties agree to the following terms:

(1) Consignment Agreement Program. A consignment agreement is an agreement under which a vendor provides an item to the Government with Reimbusement to be made if and when the Government uses the item. The parties intend to enter into a consignment agreement with the following terms and conditions:

(2) Initial Stocking Inventory; Modifications to Inventory Levels. Vendor shall provide NMCP with an initial inventory of consigned Total Joint Instruments & Implants products listed below. Stocking Inventory levels shall be based on good faith reasonable estimates of NMCP’s use of the products for a typical one-month period. During the term of this agreement, the parties may agree to modify levels of inventory for the product and/or additional cardiology products to more closely match NMCP’s then current actual need for products. Any agreement to increase stocking inventory levels shall be in accordance with vendor’s then current policies for establishing and revising stocking inventory levels. Vendor shall provide NMCP with new list of stocking inventory and modification to this BPA will be issued to reflect any products added (and such products shall then be included in the definition of “Products”) or the parties have agreed to modify the level of Products in the stocking inventory. The Stocking Inventory is as follows:

a. See all tables below

(3) Shipment of Products. Total Joint Insstruments and Inplants shall be sent via an overnight delivery service for next business day delivery. All other Products shall be sent for delivery within two business days. Vendor shall pay for shipping charges incurred for Products provided under this agreement.

(4) Title: Risk of Loss. Title to Products in the Stocking Inventory shall remain with vendor until removed from Stocking Inventory for use by NMCP. NMCP controls the Stocking Inventory, and therefor, NMCP bears the risk of loss and costs t replace Products in the Stocking Inventory in the event of sterilization expiration, loss or damage of Products.

(5) Ordering Replacement Products. NMCP shall order and pay for replacement Products in the Stocking Inventory as Products are used so that the Product levels remain consistent with the Stocking Inventory levels in the then current agreement. All such purchases and all payments for Products made under this agreement shall be as stated in this BPA agreement and be ordered against the current BPA call number. The replacement shall be the exact size of the product being replaced to maintain an exact consignment inventory.

(6) Tracking Audit. NMCP shall properly trace all Products in the Stocking Inventory and maintain all records and documentation by and/or consistent with applicable law and vendor. At least annually, representatives from vendor and NMCP shall meet at the location where NMCP maintains the Stocking Inventory to count the number of Products (by Product category) that NMCP has in inventory under this agreement. If the audit determines that the actual inventory of Products is less than the Stocking Inventory levels set out in this agreement, NMCP shall either: (a) order and pay for sufficient quantities of each Product to restore the Stocking Inventory to the Stocking Inventory levels; or (b) issue a purchase order and pay for the Products representing the shortfall and in such case, the Stocking Inventory levels will be reduced accordingly.

(7) Extent of obligation. The Government is obligated only to the extent of authorized purchases actually made under the BPA. This agreement may be terminated upon 30 days written notice by either party.

(8) Purchase limitation. The dollar limit for each call shall be $250,000.00.

(9) Period of performance.

(10) Individuals authorized to purchase under the BPA. The contracting officer will provide the contractor a list of individuals authorized to place orders under this agreement.

(11) Delivery tickets. All shipments under the agreement, except those for newspapers, magazines, or other periodicals, shall be accompanied by delivery tickets or sales slips that shall contain the following minimum information:

a. Name of supplier.

b. BPA number.

c. Date of purchase.

d. Purchase number.

e. Itemized list of supplies or services furnished.

f. Quantity, unit price, and extension of each item, less applicable discounts (unit prices and extensions need not be shown when incompatible with the use of automated systems, provided that the invoice is itemized to show this information).

g. Date of delivery or shipment.

(12) Invoices. A summary invoice shall be submitted at least monthly or upon expiration of this BPA, whichever occurs first, for all deliveries made during a billing period, identifying the delivery tickets covered therein, stating their total dollar value, and supported by receipt copies of the delivery tickets.

(13) Termination. This agreement may be terminated at any time upon 30 days’ advance written notice by either party to the other. Within 30 days’ after termination or expiration of this agreement, NMCP shall either: (a) return to vendor Returnable Products in the Stocking Inventory in the amounts not to exceed the Stocking Inventory levels and pay for the Products in the Stocking Inventory that are not Returnable; or (b) retain all or some of the Products and provide a purchase order and pay for the retained Products

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INSTRUMENT

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Contractor Unclassified Access to Federally Controlled Facilities, Sensitive Information, Information Technology (IT) Systems or Protected Health Information (Jan 2017)

Homeland Security Presidential Directive (HSPD)-12, requires government agencies to develop and implement Federal security standards for Federal employees and contractors. The Deputy Secretary of Defense Directive-Type Memorandum (DTM) 08-006 – “DoD Implementation of Homeland Security Presidential Directive – 12 (HSPD-12)” dated November 26, 2008 (or its subsequent DoD instruction) directs implementation of HSPD-12. This clause is in accordance with HSPD-12 and its implementing directives.

APPLICABILITY

This text applies to contractor employees requiring physical access to any area of a federally controlled base, facility or activity and/or requiring access to a DoN or DoD computer/network/system to perform certain unclassified sensitive duties. This clause also applies to contractor employees who access Privacy Act and Protected Health Information, provide support associated with fiduciary duties, or perform duties that have been identified as National Security Position, as advised by the command security manager. It is the responsibility of the responsible security officer of the command/facility where the work is performed to ensure compliance.

Each contractor employee providing services at a Navy Command under this contract is required to obtain a Department of Defense Common Access Card (DoD CAC). Additionally, depending on the level of computer/network access, the contract employee will require a successful investigation as detailed below.

ACCESS TO FEDERAL FACILITIES

Per HSPD-12 and implementing guidance, all contractor employees working at a federally controlled base, facility or activity under this clause will require a DoD CAC. When access to a base, facility or activity is required contractor employees shall in-process with the Command’s Security Manager upon arrival to the Command and shall out-process prior to their departure at the completion of the individual’s performance under the contract.

ACCESS TO DOD IT SYSTEMS

In accordance with SECNAV M-5510.30, contractor employees who require access to DoN or DoD networks are categorized as IT-I, IT-II, or IT-III. The IT-II level, defined in detail in SECNAV M-5510.30, includes positions which require access to information protected under the Privacy Act, to include Protected Health Information (PHI). All contractor employees under this contract who require access to Privacy Act protected information are therefore categorized no lower than IT-II. IT Levels are determined by the requiring activity’s Command Information Assurance Manager.

Contractor employees requiring privileged or IT-I level access, (when specified by the terms of the contract) require a Single Scope Background Investigation (SSBI) or T5 or T5R equivalent investigation , which is a higher level investigation than the National Agency Check with Law and Credit (NACLC)/T3/T3R described below. Due to the privileged system access, an investigation suitable for High Risk national security positions is required. Individuals who have access to system control, monitoring, or administration functions (e.g. system administrator, database administrator) require training and certification to Information Assurance Technical Level 1, and must be trained and certified on the Operating System or Computing Environment they are required to maintain.

Access to sensitive IT systems is contingent upon a favorably adjudicated background investigation. When access to IT systems is required for performance of the contractor employee’s duties, such employees shall in-process with the Navy Command’s Security Manager and Information Assurance Manager upon arrival to the Navy command and shall out-process prior to their departure at the completion of the individual’s performance under the contract. Completion and approval of a System Authorization Access Request Navy (SAAR-N) form is required for all individuals accessing Navy Information Technology resources. The decision to authorize access to a government IT system/network is inherently governmental. The contractor supervisor is not authorized to sign the SAAR-N; therefore, the government employee with knowledge of the system/network access required or the COR shall sign the SAAR-N as the “supervisor”.

The SAAR-N shall be forwarded to the Command’s Security Manager at least 30 days prior to the individual’s start date. Failure to provide the required documentation at least 30 days prior to the individual’s start date may result in delaying the individual’s start date.

When required to maintain access to required IT systems or networks, the contractor shall ensure that all employees requiring access complete annual Information Assurance (IA) training, and maintain a current requisite background investigation. The Contractor’s Security Representative shall contact the Command Security Manager for guidance when reinvestigations are required.

INTERIM ACCESS

The Command's Security Manager may authorize issuance of a DoD CAC and interim access to a DoN or DoD unclassified computer/network upon a favorable review of the investigative questionnaire and advance favorable fingerprint results. When the results of the investigation are received and a favorable determination is not made, the contractor employee working on the contract under interim access will be denied access to the computer network and this denial will not relieve the contractor of his/her responsibility to perform.

DENIAL OR TERMINATION OF ACCESS

The potential consequences of any requirement under this clause including denial or termination of physical or system access in no way relieves the contractor from the requirement to execute performance under the contract within the timeframes specified in the contract. Contractors shall plan ahead in processing their employees and subcontractor employees. The contractor shall insert this clause in all subcontracts when the subcontractor is permitted to have unclassified access to a federally controlled facility, federally-controlled information system/network and/or to government information, meaning information not authorized for public release.

CONTRACTOR’S SECURITY REPRESENTATIVE

The contractor shall designate an employee to serve as the Contractor’s Security Representative. Within three work days after contract award, the contractor shall provide to the requiring activity’s Security Manager and the Contracting Officer, in writing, the name, title, address and phone number for the Contractor’s Security Representative. The Contractor’s Security Representative shall be the primary point of contact on any security matter. The Contractor’s Security Representative shall not be replaced or removed without prior notice to the Contracting Officer and Command Security Manager.

BACKGROUND INVESTIGATION REQUIREMENTS AND SECURITY APPROVAL PROCESS FOR CONTRACTORS ASSIGNED TO NATIONAL SECURITY POSITIONS OR PERFORMING SENSITIVE DUTIES

Navy security policy requires that all positions be given a sensitivity value based on level of risk factors to ensure appropriate protective measures are applied. Contractor employees under this contract are recognized as Non-Critical Sensitive [ADP/IT-II] positions when the contract scope of work require physical access to a federally controlled base, facility or activity and/or requiring access to a DoD computer/network, to perform unclassified sensitive duties. This designation is also applied to contractor employees who access Privacy Act and Protected Health Information (PHI), provide support associated with fiduciary duties, or perform duties that have been identified as National Security Positions. At a minimum, each contractor employee must be a US citizen and have a favorably completed NACLC or T3 or T3R equivalent investigation to obtain a favorable determination for assignment to a non-critical sensitive or IT-II position. The investigation consists of a standard NAC and a FBI fingerprint check plus law enforcement checks and credit check. Each contractor employee filling a non-critical sensitive or IT-II position is required to complete:

· SF-86 Questionnaire for National Security Positions (or equivalent OPM investigative product)

· Two FD-258 Applicant Fingerprint Cards (or an electronic fingerprint submission)

· Original Signed Release Statements

Failure to provide the required documentation at least 30 days prior to the individual’s start date shall result in delaying the individual’s start date. Background investigations shall be reinitiated as required to ensure investigations remain current (not older than 10 years) throughout the contract performance period. The Contractor’s Security Representative shall contact the Command Security Manager for guidance when reinvestigations are required.

Regardless of their duties or IT access requirements ALL contractor employees shall in-process with the Command’s Security Manager upon arrival to the command and shall out-process prior to their departure at the completion of the individual’s performance under the contract. Employees requiring IT access shall also check-in and check-out with the Navy Command’s Information Assurance Manager. Completion and approval of a System Authorization Access Request Navy (SAAR-N) form is required for all individuals accessing Navy Information Technology resources. The SAAR-N shall be forwarded to the Navy Command’s Security Manager at least 30 days prior to the individual’s start date. Failure to provide the required documentation at least 30 days prior to the individual’s start date shall result in delaying the individual’s start date.

The contractor shall ensure that each contract employee requiring access to IT systems or networks complete annual Information Assurance (IA) training, and maintain a current requisite background investigation. Contractor employees shall accurately complete the required investigative forms prior to submission to the Command Security Manager. The Command’s Security Manager will review the submitted documentation for completeness prior to submitting it to the Office of Personnel Management (OPM); Potential suitability or security issues identified may render the contractor employee ineligible for the assignment. An unfavorable determination is final (subject to SF-86 appeal procedures) and such a determination does not relieve the contractor from meeting any contractual obligation under the contract. The Command’s Security Manager will forward the required forms to OPM for processing. Once the investigation is complete, the results will be forwarded by OPM to the DoD Central Adjudication Facility (CAF) for a determination.

If the contractor employee already possesses a current favorably adjudicated investigation, the contractor shall submit a Visit Authorization Request (VAR) via the Joint Personnel Adjudication System (JPAS) or a hard copy VAR directly from the contractor’s Security Representative. Although the contractor will take JPAS “Owning” role over the contractor employee, the Command will take JPAS "Servicing" role over the contractor employee during the hiring process and for the duration of assignment under that contract. The contractor shall include the IT Position Category per SECNAV M-5510.30 for each employee designated on a VAR. The VAR requires annual renewal for the duration of the employee’s performance under the contract.

Section E - Inspection and Acceptance

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLAUSES INCORPORATED BY REFERENCE

Section F - Deliveries or Performance

DELIVERY INFORMATION

30-JUN-2021

RECEIVING OFFICER

54 LEWIS MINOR STREET

BLDG. 250

PORTSMOUTH VA 23708-2297

757-953-5770

N00183

30-JUN-2022

N00183

30-JUN-2023

N00183

30-JUN-2024

N00183

30-JUN-2025

N00183

Section G - Contract Administration Data

Naval Medical Center Portsmouth (NMCP) Receiving Dock Hours of Operation:

NMCP Receiving Dock is open Monday through Friday 0700 to 1600 (7:00 a.m. to 4:00 p.m.), excluding federal holidays. Receiving personnel may be reached at 757-953-5770.

252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (DEC 2018)

(a) Definitions. As used in this clause—

“Department of Defense Activity Address Code (DoDAAC)” is a six position code that uniquely identifies a unit, activity, or organization.

“Document type” means the type of payment request or receiving report available for creation in Wide Area WorkFlow (WAWF).

“Local processing office (LPO)” is the office responsible for payment certification when payment certification is done external to the entitlement system.

“Payment request” and “receiving report” are defined in the clause at 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(b) Electronic invoicing. The WAWF system provides the method to electronically process vendor payment requests and receiving reports, as authorized by Defense Federal Acquisition Regulation Supplement (DFARS) 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(c) WAWF access. To access WAWF, the Contractor shall—

(1) Have a designated electronic business point of contact in the System for Award Management at https://www.sam.gov; and

(2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration available at this web site.

usn.detrick.navmedlogcomftdmd.list.nmlc-wawf@mail.mil

For additional questions contact: kelby.m.conley.ctr@mail.mil

(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training Course and use the Practice Training Site before submitting payment requests through WAWF. Both can be accessed by selecting the “Web Based Training” link on the WAWF home page at https://wawf.eb.mil/.

(e) WAWF methods of document submission. Document submissions may be via web entry, Electronic Data Interchange, or File Transfer Protocol.

(f) WAWF payment instructions. The Contractor shall use the following information when submitting payment requests and receiving reports in WAWF for this contract or task or delivery order:

(1) Document type. The Contractor shall submit payment requests using the following document type(s):

(i) For cost-type line items, including labor-hour or time-and-materials, submit a cost voucher.

(ii) For fixed price line items—

(A) That require shipment of a deliverable, submit the invoice and receiving report specified by the Contracting Officer.

____________COMBO FOR SUPPLIES________________________________________________

(Contracting Officer: Insert applicable invoice and receiving report document type(s) for fixed price line items that require shipment of a deliverable.)

(B) For services that do not require shipment of a deliverable, submit either the Invoice 2in1, which meets the requirements for the invoice and receiving report, or the applicable invoice and receiving report, as specified by the Contracting Officer.

(Contracting Officer: Insert either “Invoice 2in1” or the applicable invoice and receiving report document type(s) for fixed price line items for services.)

(iii) For customary progress payments based on costs incurred, submit a progress payment request.

(iv) For performance based payments, submit a performance based payment request.

(v) For commercial item financing, submit a commercial item financing request.

(2) Fast Pay requests are only permitted when Federal Acquisition Regulation (FAR) 52.213-1 is included in the contract.

[Note: The Contractor may use a WAWF “combo” document type to create some combinations of invoice and receiving report in one step.]

(3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in applicable fields in WAWF when creating payment requests and receiving reports in the system.

Routing Data Table*

(*Contracting Officer: Insert applicable DoDAAC information. If multiple ship to/acceptance locations apply, insert “See Schedule” or “Not applicable.”) (**Contracting Officer: If the contract provides for progress payments or performance-based payments, insert the DoDAAC for the contract administration office assigned the functions under FAR 42.302(a)(13).)

(4) Payment request. The Contractor shall ensure a payment request includes documentation appropriate to the type of payment request in accordance with the payment clause, contract financing clause, or Federal Acquisition Regulation 52.216-7, Allowable Cost and Payment, as applicable.

(5) Receiving report. The Contractor shall ensure a receiving report meets the requirements of DFARS Appendix F.

(g) WAWF point of contact.

(1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity’s WAWF point of contact.

_USN.DETRICK.NAVMEDLOGCOMFTDMD.LIST.NMLC-WAWF@MAIl.MIL___ (Contracting Officer: Insert applicable information or “Not applicable.”)

(2) Contact the WAWF helpdesk at 866-618-5988, if assistance is needed.

(End of clause)

Section H - Special Contract Requirements

BUSINESS ASSOCIATE AGREEMENT

Privacy, Access, Use, and Disclosure of Protected Health Information

1. Introduction. In accordance with 45 C.F.R. §§ 164.502(e)(2) and 164.504(e), and DoDM 6025.18, “Implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule in DoD Health Care Programs,” March 13, 2019, this document serves as a Business Associate Agreement (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 (1) a DoD Military Health System (MHS) component command such as a Navy Medicine Medical Treatment Facility (MTF) (Naval Medical center or Naval hospital), or special mission command (research, public health, other), acting as a HIPAA covered entity, and (2) another Federal or Government organization, civilian academic institution, or other civilian entity, acting as a HIPAA Business Associate (BA). The HIPAA Rules require BAAs between covered entities and BAs. Implementing this BAA requirement, the applicable DoD HIPAA issuances (DoDM 6025.18) provides that requirements applicable to BAs must be incorporated (or incorporated by reference) into the contract or agreement between the Parties.

2. Definitions:

a. Terms. 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 (DoDM6025.18-): Data aggregation, designated record set, disclosure, health care operations, individual, minimum necessary, notice of privacy practices, protected health information (PHI), required by law, secretary, security incident, subcontractor, unsecured PHI, and use.

b. 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.

c. BA. shall generally have the same meaning as the term “BA” in the DoD HIPAA issuances, and in reference to this BAA, shall mean the entity (another Government organization, civilian academic institution, or other civilian organization), entering into agreement with a Navy Medicine MTF or special mission command.

d. Agreement. means this BAA together with the documents or other arrangements under which the BA signatory performs services involving access to PHI on behalf of the MHS component signatory to this BAA.

e. 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 a Navy Medicine MTF or special mission command under the Bureau of Medicine and Surgery.

f. DHA Privacy Office. means the Defense Health Agency (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.

g. DoD HIPAA Issuances. means the DoD issuances implementing the HIPAA Rules in the DoD MHS. These issuances are DoDM 6025.18 Implementation of the HIPAA Privacy Rule in DoD Health Care Programs,” March 13, 2019; DoD Instruction 6025.18, Privacy of Individually Identifiable Health Information in DoD Health Care Programs of December 2009, and DoD Instruction 8580.02, Security of Individually Identifiable Health Information in DoD Health Care Programs of August 2015.

h. DoD Privacy Act Issuances. means the DoD issuances implementing the Privacy Act, which are DoD Directive 5400.11, DoD Privacy Program of 29 October 2014, and DoD 5400.11-R, Department of Defense Privacy Program of 8 May 2007.

i. HIPAA Rules. means, collectively, the HIPAA privacy, security, breach and enforcement rules, issued by the United States (US) Department of Health and Human Services (HHS) and codified at 45 C.F.R. §§ 160 and 164, Subpart E (Privacy), Subpart C (Security), Subpart D (Breach) and 45 C.F.R. § 160, Subparts C-D (Enforcement), as amended by the 2013 modifications to those Rules which implemented the “HITECH Act” provisions of Publication L. 111-5. See 78 Federal Regulation 5566-5702 of 25 January 2013 (with corrections at 78 Federal Regulation 32464 of 7 June 2013. Additional HIPAA rules regarding electronic transactions and code sets (45 C.F.R. § 162) are not addressed in this BAA and are not included in the term HIPAA Rules.

j. HHS Breach. means a breach that satisfies the HIPAA Breach Rule definition of “Breach” in 45 C.F.R. § 164.402.

k. 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.

3. Obligations and Activities of BA:

a. The BA shall not access, use, or disclose PHI other than as permitted or required by this Agreement, the controlling Memorandum of Understanding (MOU) or training affiliation agreement, or as required by law.

b. The BA 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, the controlling MOU, or law.

c. The BA shall report to the covered entity any Breach of which it becomes aware and shall proceed with breach response steps required by paragraph 7 (Breach Response) of this BAA. With respect to electronic PHI, the BA shall also respond to any security incident of which it becomes aware in accordance with any information assurance provisions of the Understanding. If at any point the BA becomes aware that a security incident involves a breach, the BA shall immediately initiate breach response as required by paragraph 7 (Breach Response) of this BAA.

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

e. The BA 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 C.F.R. § 164.524.

f. The BA shall make any amendment(s) to PHI in a designated record set as directed or agreed to by the covered entity pursuant to 45 C.F.R. § 164.526, or take other measures as necessary to satisfy covered entity’s obligations under 45 C.F.R. § 164.526.

g. The BA 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 C.F.R. § 164.528.

h. To the extent the BA is to carry out one or more of the covered entity’s obligation(s) under the HIPAA privacy rule, the BA shall comply with the requirements of HIPAA privacy rule that apply to the covered entity in the performance of such obligation(s).

i. The BA shall make its internal practices, books, and records available to the Secretary and the covered entity for purposes of audit and in determining compliance with the HIPAA Rules.

4. Permitted Uses and Disclosures…