Sigma Knee Revision System

1 This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation: quotes are being requested and a written solicitation will not be issued. Solicitation number W91YTZ19Q0064 is issued as a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2005-95 and Defense Federal Acquisition Supplement Publication (DPN) 20161222. This acquisition is issued on an UNRESTRICTED FULL AND OPEN basis under NAICS code 339113 and size standard is 750. The Government anticipates awarding a single award issued as Firm Fixed Price. The requirement of this solicitation is to provide a one-time buy for a Sigma Total Knee Revision for Eisenhower Army Medical Center, Fort Gordon, GA. All responsible sources may submit a quotation which shall be considered by the agency. Quotes are due by 27 November 2018 at 12:00 pm EST. Questions must be submitted via email no later than 26 November 2018 at 12:00 pm EST. Quotes and questions shall be submitted via email to contact@example.gov. This is a brand name or equal solicitation. The brand name is Sigma Knee Revision System. If submitting an "or equal" quote, the offer must comply with the Addendum to FAR 52.212-1 and FAR 52.211-6, Brand Name or Equal. ITEM NO 0001. Sigma Knee Revision System QTY: 1 UNIT: EACH UNIT PRICE: TOTAL: Delivery Address Eisenhower Army Medical Center 300 Hospital Road Fort Gordon, GA 30905 SOLICITATION PROVISIONS 52.212-1 -- INSTRUCTIONS TO OFFERORS -- COMMERCIAL ITEMS (JAN 2017) Addendum to 52.212-1 Para (b) Submission of Offers: The following supplements this paragraph with respect to the information and documents required for submission in response to this solicitation. All responsible offerors must submit: -Technical Description of items being offered (see note) -Clin/Item Number Pricing (filled out) -Company's Dunn and Bradstreet number (DUNS) -CAGE code -Delivery Time -Company Contact Information, for evaluation purposes. 2 -Fill out and return 52.212-3 Alt I (Registration in SAM can be substituted for FAR 52.212-3 Alt I. The information in SAM must be current and complete before an award can bemade. Contractor shall not have any Active Exclusion Record in SAM. NOTE: If providing an "equal" item(s), comply with FAR Provision 52.211-6, Brand Name or Equal. Explain in detail how the proposed items will meet the salient characteristics of the items as specified here in the solicitation. Offerors shall demonstrate that the product proposed complies with the technical requirements described in the salient characteristics via the submission of a written capability statement, product literature, or other materials, with their offer. Offerors shall cross-reference their product to its "equal" in the solicitation via the use of part numbers or another methodology that clearly identifies what the submitted product is "equal" to. Offerors shall ensure their proposed quantities result in the same number of items required, as identified in the solicitation. Salient Characteristics: Performance 1 each Sigma Knee Revision and Instrumentation or equivalent with vendor rep available in the operating room during patient specific surgery scheduled for 4 December 2018. The SIGMA High Performance Partial Knee is a unique system comprised of unicondylar and patellofemoral implants and a full range of state-of-the-art instruments to perform both of these procedures. The system's implants are designed to treat degenerative joint disease one compartment at a time: medial uni, lateral uni and patellofemoral. This allows the surgeon to replace only the affected compartment, leaving healthy bone, cartilage and ligaments intact. The modularity of the system addresses one of the main reasons for early intervention revision, disease progression. Because of the ability to maintain the ACL with this system, normal kinematics in activities of daily living can be achieved. The uni components are designed for patients who require a higher than normal degree of flexion, providing support up to 155 degrees. The combination of a highly polished cobalt chrome tray with a moderately cross linked polyethylene insert is designed to help reduce backside wear. The system is complemented by High Performance instruments offering precision, efficiency and accuracy. The surgical technique using these instruments is robust and reproducible, taking only the amount of bone necessary, preserving bone and soft tissue (m) The non-FAR Part 12 discretionary FAR, DFARS, AFARS, and MEDCOM provisions included herein are incorporated into this solicitation either by reference or in full text. If incorporated by reference, see provision 52.252-1 for locations where full text can be obtained.(End of Provision) 52.209-2 -- PROHIBITION ON CONTRACTING WITH INVERTED DOMESTIC CORPORATIONS - REPRESENTATIONS (NOV 2015) 52.209-11 - REPRESENTATION BY CORPORATIONS REGARDING DELINQUENT TAX LIABILITY OR A FELONY CONVICTION UNDER ANY FEDERAL LAW (FEB 2016) 52.209-12 - CERTIFICATION REGARDING TAX MATTERS (FEB 2016) 52.211-6 -- BRAND NAME OR EQUAL (AUG 1999) 52.214-34 - SUBMISSION OF OFFERS IN THE ENGLISH LANGUAGE (APR 1991) 52.222-56 - CERTIFICATION REGARDING TRAFFICKING IN PERSONS COMPLIANCE PLAN (MAR 2015) 52.225-25 -- PROHIBITION ON ENGAGING IN SANCTIONED ACTIVITIES RELATING TO IRAN-CERTIFICATION (OCT 2015) 3 52.252-1 -- SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998); http://farsite.hill.af.mil/ 52.252-5 -- AUTHORIZED DEVIATIONS IN PROVISIONS (APR 1984) (Insert "DoD FAR Supplement (48 CFR Chapter 2)" in paragraph (b)) 252.203-7005 -- REPRESENTATION RELATING TO COMPENSATION OF FORMER DOD OFFICIALS (NOV 2011) 252.204-7004 - ALTERNATE A, SYSTEM FOR AWARD MANAGEMENT (FEB 2014) 252.204-7008 - COMPLIANCE WITH SAFEGUARDING COVERED DEFENSE INFORMATION CONTROLS (DEVIATION 2016-O0001)(OCT 2015) 252.204-7011 -- ALTERNATIVE LINE-ITEM STRUCTURE (SEP 2011) (See Clins) 252.215-7007 -- NOTICE OF INTENT TO RESOLICIT (JUN 2012) 252.215-7008 -- ONLY ONE OFFER (OCT 2013) 252.222-7007 - REPRESENTATION REGARDING COMBATING TRAFFICKING IN PERSONS (JAN 2015) 252.225-7050 -- DISCLOSURE OF OWNERSHIP OR CONTROL BY THE GOVERNMENT OF A COUNTRY THAT IS A STATE SPONSOR OF TERRORISM (DEC 2014) 252.247-7022 -- REPRESENTATION OF EXTENT OF TRANSPORTATION BY SEA (AUG 1992) (End of Addendum to 52.212-1) 52.212-2 -- EVALUATION -- COMMERCIAL ITEMS (OCT 2014) Addendum to 52.212-2 The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: Lowest Price Technically Accepted (LPTA). Award may be made without discussions with offerors (except communications conducted for the purpose of minor clarification). Therefore, each initial offer should contain the offeror's best terms from a technical and pricestandpoint. However, the Government reserves the right to conduct discussions if it is later determined by the contracting officer to be necessary. Paragraph (a) is hereby replaced with the following: (a). The Government will award a Firm-Fixed-Price contract resulting from this solicitation, to the responsible offer conforming to the solicitation that is lowest price technical acceptability. The following factors shall be used to evaluate offers: 1.In Accordance with Brand Name or Equal FAR 52.211-6. Sigma KneeRevision to be considered for award, offers of "equal" products, including "equal" products of the brand name manufacturer, must - a.Meet the salient physical, functional, or performance characteristicspecified below and in this solicitation; b.Clearly identify the itemby- (i)Brand name, if any; and 4 (ii)Make or model numberc.Include descriptive literature such as illustrations, drawings, or a clear reference to previous furnished descriptive data or information available to the Contracting Officer; and clearly describe any modification the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modification.d.Product Quality: Provide evidence for the quality of product.e.Warranty for product detailing length of service coverage,parts covered must be included.f.Price will be evaluated for fairness and reasonability in terms of:(i)That the prices are consistent with and reflect the proposed requirement.(ii)Pricing will be evaluated for fair and reasonable in terms of the Government's requirements. The Government is interested in proposals that meet the requirements with acceptable risk, at the lowest price technically acceptable.g.Quoters shall submit quotes to Gordon Health Contracting Cell Office to arrive no later than 12:00 PM eastern standard time on 27 November, 2018. Quotes can be submitted via email contact@example.gov. Mailed and faxed submissions are acceptable. h.Evaluation Process: All quotes will be evaluated on overallproduct quality, warranty, service repair and price. Must meetthe functional characteristics referenced. The award decisionwill be based on the Lowest Price Acceptable. (End of Addendum to 52.212-2) 52.212-3 -- OFFEROR REPRESENTATIONS AND CERTIFICATIONS -- COMMERCIAL ITEMS (MAR 2015) ALTERNATE I (OCT 2014) CONTRACT CLAUSES 52.212-4 -- CONTRACT TERMS AND CONDITIONS -- COMMERCIAL ITEMS (JAN 2017) Addendum to 52.212-4 The following policy applies only if the contractor will be on the Government installation for more than thirty (30) days. (v)Policy for Reporting Incidents of Sexual Assault and Sexual Harassment under theSexual Assault Prevention and Response Program (SHARP). The contractor shall comply with OTSG/MEDCOM Policy Memo 13-062, Policy for ReportingIncidents of Sexual Assault and Sexual Harassment under the Sexual Assault Preventionand Response Program (SHARP), 12 Nov 2013. The SHARP reporting requirements applyonly to knowledge obtained by contractor personnel while performing services under this 5 contract. The contractor shall require all Contract Service Providers (CSP) with knowledge of an incident of sexual assault occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the contractor who shall immediately (within 24 hours) report the incident in writing to the government's COR. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals. The contractor shall require all CSPs with knowledge of an incident of sexual harassment occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the contractor who shall immediately (within 24 hours) report the incident in writing to the government's COR. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals. (w)The non-FAR Part 12 discretionary FAR, DFARS, AFARS, and LOCAL clausesincluded herein are incorporated into this contract either by reference or in full text. Ifincorporated by reference, see clause 52.252-2 for locations where full text can be found.Also, the full text of a clause may be accessed electronically at this/these address(es): http://farsite.hill.af.mil/https://acquisition.gov/far/index.html 52.204-10 -- REPORTING EXECUTIVE COMPENSATION AND FIRST-TIER SUBCONTRACT AWARDS (OCT 2016) 52.204-21 - BASIC SAFEGUARDING OF COVERED CONTRACTOR INFORMATION SYSTEMS (JUN 2016) 52.209-6 -- PROTECTING THE GOVERNMENT'S INTEREST WHEN SUBCONTRACTING WITH CONTRACTORS DEBARRED, SUSPENDED, OR PROPOSED FOR DEBARMENT (OCT 2015) 52.219-4 -- NOTICE OF PRICE EVALUATION PERFERENCE FOR HUBZONE SMALL BUSINESS CONCERNS (OCT 2014) 52.219-6 - NOTICE OF TOTAL SMALL BUSINESS SET-ASIDE (NOV 2011) 52.222-19 -- CHILD LABOR-COOPERATION WITH AUTHORITIES AND REMEDIES (JAN 2014) 52.222-21 -- PROHIBITION OF SEGREGATED FACILITIES (APR 2015) (EEO) 52.222-26-EQUAL OPPPRTUNITY (APR 2015) 52.222-50 -- COMBATING TRAFFICKING IN PERSONS (MAR 2015) 52.223-3 - HAZARDOUS MATERIAL IDENTIFICATION AND MATERIAL SAFETY DATA (JAN 1997) 52.223-5 -- POLLUTION PREVENTION AND RIGHT-TO-KNOW INFORMATION (MAY 2011) 52.223-18 -- ENCOURAGING CONTRACTOR POLICIES TO BAN TEXT MESSAGING WHILE DRIVING (AUG 2011) 52.225-13 -- RESTRICTIONS ON CERTAIN FOREIGN PURCHASES (JUN 2008) 52.232-33 -- PAYMENT BY ELECTRONIC FUNDS TRANSFER-SYSTEM FOR AWARD MANAGEMENT (JUL 2013) 52.232-39 -- UNENFORCEABILITY OF UNAUTHORIZED OBLIGATIONS (JUN 2013) 52.232-40 -- PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS (DEC 2013) 52.233-3 -- PROTEST AFTER AWARD (AUG 1996) 6 52.233-4 -- APPLICABLE LAW FOR BREACH OF CONTRACT CLAIM (OCT 2004) 52.237-2 -- PROTECTION OF GOVERNMENT BUILDINGS, EQUIPMENT, AND VEGETATION (APR 1984) 252.203-7000 -- REQUIREMENTS RELATING TO COMPENSATION OF FORMER DOD OFFICIALS (SEP 2011) 252.203-7002 -- REQUIREMENT TO INFORM EMPLOYEES OF WHISTLEBLOWER RIGHTS (SEP 2013) 252.204-7003 -- CONTROL OF GOVERNMENT PERSONNEL WORK PRODUCT (APR 1992) 252.225-7036 - BUY AMERICAN-FREE TRADE AGREEMENTS-BALANCE OF PAYMENTS PROGRAM (AUG 2016) 252.225-7048 -- EXPORT CONTROLLED ITEMS (JUN 2013) 252.232-7003 -- ELECTRONIC SUBMISSION OF PAYMENT REQUESTS AND RECEIVING REPORTS (JUN 2012) 252.232-7006 -- WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (MAY 2013) 252.232-7010 -- LEVIES ON CONTRACT PAYMENTS (DEC 2006) 52.209-10 -- PROHIBITION ON CONTRACTING WITH INVERTED DOMESTIC CORPORATIONS (DEC 2014) 52.219-28 -- POST-AWARD SMALL BUSINESS PROGRAM REREPRESENTATION (JUL 2013) 52.252-2 -- CLAUSES INCORPORATED BY REFERENCE (FEB 1998) 52.252-6 -- AUTHORIZED DEVIATIONS IN CLAUSES (APR 1984) (Insert "DoD FAR Supplement (48 CFR Chapter 2)" in paragraph (b)) 252.203-7999 -- PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE CERTAIN INTERNAL CONFIDENTIALITY AGREEMEMNTS (DEVIATION 2015- O0010) (FEB 2015) 252.204-7012 -- SAFEGUARDING OF UNCLASSIFIED CONTROLLED TECHNICAL INFORMATION (OCT 2016) 252.204 - 7015 - DISCLOSURE OF INFORMATION TO LITIGATION SUPPORT CONTRACTORS (MAY 2016) 252.211-7003 -- ITEM UNIQUE IDENTIFICATION AND VALUATION (DEC 2013) 252.244-7000 -- SUBCONTRACTS FOR COMMERCIAL ITEMS (JUN 2013) 252.247-7023 - TRANSPORTATION OF SUPPLIES BY SEA - BASIC (APR 2014) 52.212-5 -- CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS - COMMERCIAL ITEMS (JAN 2017) (DEVIATION 2013-O0019) iRAPT 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. 7 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 (ContractorOnly) _X Invoice and Receiving Report (COMBO) Invoice as 2-in-1 (ServicesOnly) Receiving Report (GovernmentOnly) CAGE CODE: ISSUE BY DODAAC: W91YTZ ADMIN BY DODAAC: W91YTZ INSPECT BY DODAAC: W33XTF ACCEPT BY DODAAC: W33XTF SHIP TO DODAAC: W33XTF PAYMENT OFFICE FISCAL STATION CODE: HQ0490 EMAIL POINTS OF CONTACT LISTING: (Use Group e-mail accounts if applicable) INSPECTORPrimary: Alternate:_______ ACCEPTORPrimary: Alternate: ____ RECEIVING OFFICE POC:Primary: Alternate: CONTRACT ADMINISTRATOR/ SPECIALIST:Raymond E. Hulse, contact@example.gov , DSN: 773 Comm: +1 (555) 000-0000 CONTRACTING OFFICER: Francine Brown, Contracting Officer, (706) 787- 1409, contact@example.gov . ADDITIONAL CONTACT: Gordon Health Contracting Cell 43 Central Hospital Court, Bldg 332 Fort Gordon, GA 30905 Any modification requests must be in writing and submitted to: ADMIN DODAAC. HIPPA 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 usedin this BAA shall have the same meaning as those terms in the DoD HIPAA Rules: DataAggregation, 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 ProtectedHealth Information, and Use. -Breach means actual or possible loss of control, unauthorized disclosure of or 8 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 BusinessAssociate (a)The Business Associate shall not use or disclose PHI other than as permitted orrequired by the Agreement or as required by law. (b)The Business Associate shall use appropriate safeguards, and comply with the DoDHIPAA Ruleswith respect to electronic PHI, to prevent use or disclosure of PHI other thanas provided for by the Agreement. (c)The Business Associate shall report to Covered Entity any Breach of which it becomesaware, 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 securityincident of which it becomes aware in accordance with any Information Assurance 9 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 thisBAA. (d)In accordance with 45 CFR 164.502(e)(1)(ii)) and 164.308(b)(2), respectively), asapplicable, the Business Associate shall ensure that any subcontractors that create,receive, maintain, or transmit PHI on behalf of the Business Associate agree to the samerestrictions, conditions, and requirements that apply to the Business Associate withrespect to such PHI. (e)The Business Associate shall make available PHI in a Designated Record Set, to theCovered Entityor, as directed by the Covered Entity, to an Individual, as necessary tosatisfy the Covered Entity obligations under 45 CFR164.524. (f)The Business Associate shall make any amendment(s) to PHI in a Designated RecordSet as directed or agreed to by the Covered Entity pursuant to 45 CFR 164.526, or takeother measures as necessary to satisfyCovered Entity's obligations under 45 CFR164.526. (g)The Business Associate shall maintain and make available the information required toprovide an accounting of disclosures to the Covered Entity or an individual as necessary tosatisfy the Covered Entity's obligations under 45 CFR164.528. (h)To the extent the Business Associate is to carry out one or more of Covered Entity'sobligation(s) under the HIPAA Privacy Rule, the Business Associate shall comply with therequirements of HIPAA Privacy Rule that apply to the Covered Entity in the performance ofsuch obligation(s); and (i)The Business Associate shall make its internal practices, books, and records availableto theSecretary 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 theservices set forth in the Agreement or as required by law. The Business Associate is notpermitted to de-identify PHI under DoD HIPAA issuances or the corresponding 45 CFR164.514(a)-(c), nor is it permitted to use or disclose de- identified PHI, except as providedby the Agreement or directed by the Covered Entity. The Business Associate agrees touse, disclose and request PHI only in accordance with the HIPAA Privacy Rule "minimumnecessary" standard and corresponding DHA policies and procedures as stated in theDoD HIPAAIssuances. (b)The Business Associate shall not use or disclose PHI in a manner that would violate theDoD HIPAA Issuances or HIPAA Privacy Rules if done by the Covered Entity, except usesand disclosures for the Business Associate's own management and administration andlegal responsibilities or for data aggregation services as set forth in the following threeparagraphs. (c)Except as otherwise limited in the Agreement, the Business Associate may use PHIfor the proper management and administration of the Business Associate or to carry outthe legal responsibilities of the Business Associate. The foregoing authority to use PHIdoes not apply to disclosure of PHI, which is covered in the next paragraph. (d)Except as otherwise limited in the Agreement, the Business Associate may disclosePHI for the proper management and administration of the Business Associate or to carryout the legal responsibilities of the Business Associate, provided that disclosures arerequired by law, or the Business Associate obtains reasonable assurances from the 10 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 beenbreached. (e)Except as otherwise limited in the Agreement, the Business Associate may use PHIto provide Data Aggregation services relating to the Covered Entity's health careoperations. III.Provisions for Covered Entity to Inform Business Associate of Privacy Practices andRestrictions (a)The Covered Entity shall provide the Business Associate with the notice of privacypractices that the Covered Entity produces in accordance with 45 CFR 164.520 and thecorresponding provision of the DoD HIPAA Issuances. (b)The Covered Entity shall notify the Business Associate of any changes in, orrevocation of, the permission by an Individual to use or disclose his or her PHI, to theextent that such changes affect the Business Associate's use or disclosure ofPHI. (c)The Covered Entity shall notify the Business Associate of any restriction on the use ordisclosure of PHI that the Covered Entity has agreed to or is required to abide by under 45CFR 164.522, to the extent that such changes may affect the Business Associate's use ordisclosure of PHI. IV.Permissible Requests by CoveredEntity 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.BreachResponse (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. 11 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 ReportingProvisions 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 CoveredEntity 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: contact@example.gov . 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 informatio...