N00183-12-T-0264.doc

Section A - Solicitation/Contract Form

CONTRACTOR SHALL PROVIDE THE FOLLOWING:

1. A copy of your service or supply price sheet for all items quoted in Section B. If you do not have a price sheet, please provide the cost to procure the equipment new.

2. If the items/service you are quoting are on your GSA/FSS contract, please provide the following information:

GSA Contract #:

FSS Group/Class/Part: ______________________________

FSS SIN:

Single or Multiple Award Contract ______________________

Expiration Date:

Contract Minimum Dollar Amount:

Contract Maximum Dollar Amount:

3. Contractor identification and point of contact information:

CAGE CODE:

DUNS:

TIN:

Vendor Point of Contact:

Phone:

Vendor E-Mail:

Fax:

4. Contractor’s preferred invoice for payment schedule. Note that payment will be in arrears. Example: if you select “Annually” you will not receive payment until the end of the period of performance date.

(Please “x” one) Payment in Arrears: __Monthly __Quarterly __Semi-Annually __Annually

SOLICITATION EVALUATION AND AWARD INFORMATION:

Contractor shall be required to provide billing electronically via the WAWF Electronic Invoicing Method per Section G of this RFQ. For additional information, visit the following web sites: https://wawf.eb.mil http://wawftraining and/or Email: wawf@nmlc.med.navy.mil Prompt Payment: For Prompt Payment Act purposes, this contract is subject to the 7 calendar-day constructive acceptance period.

EVALUATION: Based on total price and best value for the Government.

NOTE: The Government reserves the right to make an award based on “All or None”. A multiple award contract may be issued for order for supplies.

Section B - Supplies or Services and Prices

Maintenance and Repair Services - FY12

FFP

Contractor shall provide GOLD preventive maintenance and repair services, hardware and software, for (2) Hologic InSight 2 Fluoroscans, SN: 09-0610-12 and 09-1108-08, located at the Naval Health Clinic, Annapolis, MD, in accordance with Section C, Statement of Work. Quoted price shall be inclusive of all cost including labor, material, repair parts, preventive maintenance, replacement parts including glassware X-ray tube/HVPS assembly and image intensifier, replacement of any worn items, transportation, travel and shipping.

Base Year - POP: 22 Jun 2012 - 21 Jun 2013

FOB: Destination

MILSTRIP: N0016212RC0R203

PURCHASE REQUEST NUMBER: N0016212RC0R203

NET AMT

FFP

Contractor shall provide GOLD preventive maintenance and repair services, hardware and software, for (2) Hologic InSight 2 Fluoroscans, SN: 09-0610-12 and 09-1108-08, located at the Naval Health Clinic, Annapolis, MD, in accordance with Section C, Statement of Work. Quoted price shall be inclusive of all cost including labor, material, repair parts, preventive maintenance, replacement parts including glassware X-ray tube/HVPS assembly and image intensifier, replacement of any worn items, transportation, travel and shipping.

Option Year I - POP: 22 Jun 2013 - 21 Jun 2014

FOB: Destination

NET AMT

FFP

Contractor shall provide GOLD preventive maintenance and repair services, hardware and software, for (2) Hologic InSight 2 Fluoroscans, SN: 09-0610-12 and 09-1108-08, located at the Naval Health Clinic, Annapolis, MD, in accordance with Section C, Statement of Work. Quoted price shall be inclusive of all cost including labor, material, repair parts, preventive maintenance, replacement parts including glassware X-ray tube/HVPS assembly and image intensifier, replacement of any worn items, transportation, travel and shipping.

Option Year II - POP: 22 Jun 2014 - 21 Jun 2015

NET AMT

FFP

Contractor shall provide GOLD preventive maintenance and repair services, hardware and software, for (2) Hologic InSight 2 Fluoroscans, SN: 09-0610-12 and 09-1108-08, located at the Naval Health Clinic, Annapolis, MD, in accordance with Section C, Statement of Work. Quoted price shall be inclusive of all cost including labor, material, repair parts, preventive maintenance, replacement parts including glassware X-ray tube/HVPS assembly and image intensifier, replacement of any worn items, transportation, travel and shipping.

Option Year III - POP: 22 Jun 2015 - 21 Jun 2016

NET AMT

FFP

Contractor shall provide GOLD preventive maintenance and repair services, hardware and software, for (2) Hologic InSight 2 Fluoroscans, SN: 09-0610-12 and 09-1108-08, located at the Naval Health Clinic, Annapolis, MD, in accordance with Section C, Statement of Work. Quoted price shall be inclusive of all cost including labor, material, repair parts, preventive maintenance, replacement parts including glassware X-ray tube/HVPS assembly and image intensifier, replacement of any worn items, transportation, travel and shipping.

Option Year IV - POP: 22 Jun 2016 - 21 Jun 2017

NET AMT

Section C - Descriptions and Specifications

Statement of Work

Contractor shall provide GOLD preventive maintenance and repair services, hardware and software, for (2) Hologic InSight 2 Fluoroscans located at the Naval Health Clinic, Annapolis, MD, starting 22 Jun 2012. Services shall include on-site corrective repairs, normal working hour coverage (8:00 A.M. to 5:00 P.M. Monday through Friday excluding Federal holidays) and 24-hour emergency service, labor, material, repair parts, preventive maintenance, all replacement parts including glassware X-ray tube/HVPS assembly and image intensifier, replacement of any worn items, transportation, travel and shipping for Department of Defense owned equipment, as listed in Section B. Services shall also include all systems, subsystem components, and assemblies, (i.e.: contractor responsible for total maintenance of entire system). All maintenance provisions shall apply to hardware, firmware, and software, as appropriate, unless otherwise stated. All replacement and repair parts shall be manufactured by the Original Equipment Manufacturer (OEM) Hologic, Inc. Substituted replacement and repair parts ARE NOT acceptable.

1. General

a. The Contractor shall comply with Federal, State, and Local Laws, plus any Federal Regulations as applicable to the performance of this contract.

b. The Contractor shall not accept any instructions issued by any person employed by the U. S. Government, other than: the Contracting Officer (KO), or Biomedical Engineering Division (BME), all acting within the limits of their authority.

c. The Contractor shall be fully qualified, with at least 20 hours of certified training in the repair of all equipment listed in Section B. Contractor shall maintain current (within 2 years) qualifications throughout the entire contract period. Qualification includes, but not limited to, the certification of all repair persons and repair facilities by the OEM and training by independent schools authorized by the OEM. The Government maintains the right to seek proof of qualifications anytime during contract period of performance.

IN ORDER TO BE CONSIDERED FOR CONTRACT AWARD, CONTRACTOR SHALL PROVIDE CURRENT (WITHIN 2 YEARS) CERTIFIED TRAINING CERTIFICATE(S) WITH YOUR QUOTE ON OR BEFORE THE REQUEST FOR QUOTATION CLOSE DATE. CERTIFICATE SHALL STATE THE NUMBER OF TRANING HOURS/DAYS. THIS REQUIREMENT MAY BE WAIVED IF YOUR COMPANY PREVIOUSLY PROVIDED MAINTENANCE SERVICES FOR THE EQUIPMENT LISTED IN SECTION B (WITHIN THE PAST 2 YEARS) AND RECEIVED A FAVORABLE PAST PERFORMANCE EVALUATION FOR SERVICES RENDERED. CONTRACTOR SHALL PROVIDE REQUESTED CERTIFICATES OR REQUEST A WAIVER TWO DAYS BEFORE RFQ CLOSE DATE IN ORDER TO BE CONSIDERED FOR CONTRACT AWARD.

2. Scope of Work

a. The Contractor shall provide trained, experienced, English speaking personnel, labor, tools, diagnostic equipment, software, test phantoms, material, supplies, transportation, parts and equipment necessary to perform Preventive Maintenance (PM), Calibration (CAL), Safety testing (ST) and corrective maintenance.

b. The Contractor shall provide telephonic communications with the Government to discuss technical matters relating to the performance of this contract. A systems operator will be made available to answer technical questions regarding system operations and applications.

c. Equipment listed in this contract will be maintained to meet the original equipment manufacturer’s (OEM’s) specifications.

d. Equipment and associated components shall be serviced as listed in Section B.

e. The Contractor Point of Contact (POC). The Contractor shall provide in writing the name and telephone number of a primary and alternate English-speaking individual to act as their representative for the scheduling and coordination of service calls, and to be responsible for the coordination of the contract with the Government.

3. Government furnished property, Materials and Services.

a. The Contractor representative(s) at each site is encouraged to request a pre-maintenance inspection prior to the onset of the contract. As all apparent discrepancies must be identified upon submittal of quote, any and all claims must be received within 30 days of contract award or prior to contract start which ever occurs first. All non-apparent / hidden discrepancies, must be identified no later that the first scheduled preventative maintenance. Any claims resulting from hidden defects must be received within 30 days of first scheduled preventative maintenance. Any equipment found to be inoperable during this pre-maintenance inspection would be repaired using a separate purchase order. The cost of repairs shall not exceed contractor’s normal retail rate for required repairs. The government certifies that the equipment to be maintained under this contract will be in good operating condition on the effective date of this contract. For the purpose of this contract, the clause, “good operating condition” means the conditions necessary for the equipment to function as intended without corrective maintenance. The Contractor agrees to leave the equipment in good operating condition at the expiration of this contract. During the final week of this contract, the Government will make final inspection of the equipment. Any correction of deficiencies noted during this inspection shall be resolved prior to contract end. The Government reserves the right to request the repair (at no additional cost to the Government) of items identified with latten defects after contract termination, when it has been determined that defects either are a result of contractor’s performance or should have been discovered during normal performance of work under this contract.

b. The government will be responsible for maintaining the proper environment, including utilities and site requirements necessary for the system to function properly as specified by the OEM.

c. The Government will operate the system in accordance with the instruction manual provided by the OEM.

d. The Government will not be responsible for the damage or loss due to fire, theft, accident, or other disaster of Contractor supplies, materials, or for the personal belongings brought onto Government property by Contractor’s personnel.

4. Contractor Furnished Property and Material.

a. The Contractor shall provide all service literature, reference publications, laptop computers and diagnostic software to be used by the contractor service technicians and as required for the completion of the services in accordance with this contract.

5. Replacement Parts.

a. The Contractor shall have ready access to unique and/or high mortality replacement parts. All parts supplied shall be compatible with the existing system. In the event that replacements parts are required to be shipped. Shipping shall be performed in the fastest reasonable means possible (i.e., next day air) at no additional cost to the Government.

b. The Contractor shall at their expense, replace all worn or defective parts necessary to restore the equipment to 100% operational condition as specified by the OEM.

c. Contractor installed replacement parts shall become the property of the Government and the replaced malfunctioning part shall become the property of the Contractor. Replaced items shall be properly disposed of at no additional cost to the Government (contractor to pay all “environmental fees” where required).

d. Freight, postage, and storage charges associated with shipment and receipt of replacement parts, and the return of parts shall be the responsibility of the Contractor.

e. All replacement parts shall be new and certified as OEM replacement parts. In the event that new parts are not available, rebuilt parts and sub-assemblies are allowed provided that they are warranted to be free of defects for a period of time that meets or exceeds warranties of similar replacement parts. The contractor shall specifically annotate on the final Field Service report the use and identification of rebuilt parts and the period of warranty. When discrepancies occur, the Government will make the final determination on whether a replacement part is of equal or better quality.

f. The Contractor must include software revisions and updates (field service changes), which are required due to FDA, or manufacturer announced safety-hazard recall, to include FDA Year 2000 Compliance Directive, as part of the contract at no additional cost to the Government. Updates shall be performed as soon as possible after release, but no later than the first scheduled Preventative Maintenance Inspection after release. For any updates that have been identified as critical, or required for the proper operation of equipment by the OEM, contractor shall provide installation within 30 days of release regardless of Preventative Maintenance Schedules.

Specific Tasks.

6. Contractor Report Requirements.

a. During normal duty hours, Contracted Field Service Engineer (FSE) personnel shall check-in with the Biomedical Engineering Division upon arrival at the Government site and again prior to departure. Naval Health Clinic Annapolis Biomedical Rpair, 250 Wood RD, Bldg 275. Annapolis, MD 21402, (410) 293-1177). The Contractor FSEs shall personally notify Biomedical Engineering (BME) of problems that result in the equipment being left disabled upon their departure. After normal duty hours, Contractor FSE’s shall notify the Officer of the Day and the systems operator designated by BME.

b. The Contractor shall provide to BME a full service report within two (2) days after completion of all service performed. The service report shall include, but not be limited to: contract number, equipment description (model, serial number, equipment control number) contractor’s log number, detailed description of the service(s) performed, replacement part(s) information (part number, part value, nomenclature, unit price, manufacturer, if not OEM, and whether the part is new/used/reconditioned), the completion date and time, man-hours expended and the hourly rate normally charged for the type of service performed, model and serial numbers, and the name of the FSE performing the service. In the event that agents / sub-contractor’s are used in the performance of repairs, said agent shall be identified on the service report by company name and contact information (i.e., telephone number). Additionally contractor will be required to affix a tag on equipment upon the completion of a preventative maintenance inspection. Tag may either be a “sticker” or “hanging tag”. As a minimum the tag shall contain: the name of the contractor, technician performing inspection and date of inspection legibly printed.

7. Contractor Responsibility.

a. The Contractor shall be responsible for the repair/replacement of damaged Government owned equipment and property due to the negligence of the Contractor or his representatives. All such replacement or repair shall be at the Contractor’s expense and shall be inspected to the satisfaction of the KO or appointed representative.

8. Preventive Maintenance Services.

a. In accordance with Naval Medical Logistics Command (NAVMEDLOGCOM) Risk Assessment Criteria, preventive maintenance shall be performed one (1) time per year in accordance with the Original Equipment Manufactures (OEM) recommendations.

b. The Government shall select the months in which preventive maintenance services are to be performed. The preventive maintenance visits shall be performed during the following months: January and June.

(The Government Fiscal Year runs: October through September). The Contractor shall schedule and complete preventive maintenance services prior to the 15th of the selected month.

c. All test equipment used in the performance of this contract must be calibrated (if required / as required by manufacture of test equipment) and shall be in compliance with Joint Commission on Accreditation of Healthcare Organizations (JCAHO), Original Equipment Manufacturer (OEM) and Federal Drug Administration (FDA) standards as required.

9. Corrective Maintenance

a. Normal Working Hour Maintenance Coverage

Maintenance Coverage will be Monday through Friday, between 8:00 A.M. to 4:30 P.M. A contractor Service Tech shall respond via telephone within 2 hours after receipt of trouble call, and provide on-site service no later than the close of business (4:30 pm) on the next business day. Equipment shall be operational within 48 hours. The Government reserves the right to deduct from the Contractor’s payment an amount not to exceed the hourly rate of $50.00 per hour for each hour the Contractor fails to respond, as specified in the contract.

a. In the event that emergency service outside the normal working hours are required by the Government, additional work shall be billable to the Government at published commercial rates, and negotiated and approved by a Contracting Officer prior to services rendered.

b. Government request for corrective maintenance will be placed by BME, to the Contractor’s POC. Corrective Maintenance shall be completed during the hours specified in the contract.

c. The Contractor shall assign a unique Log/Reference Number to each Government request for corrective Maintenance.

d. Contractor’s response to requests for service may include telephone consultation with the equipment user/operator and a Contractor FSE. Telephone consultation shall: 1) provide instruction in determining operator error; 2) to determine the most likely cause of the problem; 3) to determine if resolution of the problem requires the dispatch of a FSE; and 4) to identify replacement parts likely to be required in order to return the equipment to 100% operational condition as specified by the OEM.

e. Contractor’s pricing shall be inclusive of all cost including parts, labor, travel and shipping, unless otherwise indicated. Any/all exclusions are listed as follows:

No Exclusions

f. The Contractor shall have his/her own service manuals, specifications, schematic diagrams, and parts lists to assist in the evaluation/repair of all equipment included in this contract.

10. Removal of Government Property

a. Whenever the repair of equipment cannot be performed at the Government site as determined by the Contractor, the Contractor shall notify BME who will make arrangements for the Contractor to remove the item (i.e. obtain property pass for material) to the Contractor’s designated site. The Contractor may be required to sign a Government form accepting responsibility for the Government equipment. The Contractor shall provide a detailed description of removed items. For associated items / accessories, contractor to provide a detailed description and quantities of items to be removed. Description to include as a minimum manufacturers serial numbers and equipment control number (ECN) of all equipment / items removed. In the event that items / sub-assemblies / accessories are repaired via “Repair by Replacement” a detailed description of replaced items is to be included upon return of repaired components.

b. All charges resulting from a Contractor determined requirement to transport Government owned property, covered by this contract, to and from an alternate repair location shall be the responsibility of the Contractor.

11. Equipment Modification Upgrades

a. The Contractor shall only incorporate OEM specified modifications, alterations and upgrades. Approval shall be obtained from BME prior to the Contractor installation of any modification, alteration, or upgrades.

b. The Contractor shall maintain contact with the OEM to determine the requirement for field modifications and to ensure accomplishment of these modifications in accordance with the time schedule set forth by the OEM.

c. The Government shall not alter the system without prior notification to the Contractor.

d. The contractor at no additional cost shall provide software updates to the Government. Installation of updates will be left to the discretion of the Government. All supplied software is to be warranted current and free of defects such as viruses.

12. Service Beyond the Scope of the Contract

a. The Contractor shall immediately, but not later than 24 consecutive hours after discovery, notify BME, in writing, of the existence or the development of any defects in, or repair required to the scheduled equipment, which the Contractor considers they are not responsible for under the terms of this contract.

b. At the same time of the notification, the Contractor shall furnish BME with written estimate of the cost to make the necessary repairs. Repairs considered by the Contracting Officer to be outside the scope of this contract shall not be covered under this contract, but shall be ordered under a separate purchase order.

Section E - Inspection and Acceptance

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

Section F - Deliveries or Performance

DELIVERY INFORMATION

21-JUN-2013

RECEIVING OFFICER

250 WOOD ROAD

ANNAPOLIS MD 21402

N00162

21-JUN-2014

N00162

21-JUN-2015

N00162

21-JUN-2016

N00162

21-JUN-2017

N00162

CLAUSES INCORPORATED BY REFERENCE

Section G - Contract Administration Data

WAWF – INVOICE INSTRUCTIONS AND PAYMENT INFORMATION FOR SERVICES

Invoices rendered under this Contract shall be submitted electronically through Wide Area Work Flow – Receipt and Acceptance (WAWF):

The vendor shall self-register at the web site https://wawf.eb.mil. Vendor training is available on the internet at http://wawftraining.com.

Select the 2-in-1 Invoice within WAWF as the invoice type. The 2-in-1 Invoice prepares the Material Inspection and Receiving Report, DD Form 250, and invoice in one document.

Back up documentation (such as service tickets, etc.) can be included and attached to the invoice in WAWF.

Attachments created in any Microsoft Office product are attachable to the invoice in WAWF.

The following information regarding Naval Medical Center Portsmouth and Naval Hospital Camp Lejeune is provided for completion of the invoice in WAWF:

Issuing Office DODAAC: N00183 Admin DODAAC: N00183 Acceptor/Ship to DODAAC: N00162

LPO DODAAC: N00162

Pay DODAAC: HQ0248 The contractor shall submit invoices for payment per contract terms.

The Government shall process invoices for payment per contract terms.

For more information on Wide Area Workflow, please contact the Wide Area Workflow Implementation Team at wawf@med.navy.mil.

Section H - Special Contract Requirements

CLAUSES INCORPORATED BY FULL TEXT

INFORMATION ONLY: This document has been designated for posting to the Navy Electronic Commerce Online (NECO) at http://www.neco.navy.mil

Section I - Contract Clauses

CLAUSES INCORPORATED BY REFERENCE

CLAUSES INCORPORATED BY FULL TEXT

52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 15 days prior to contract expiration date.

(End of clause)

52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 15 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 21 Jun 2017.

(End of clause)

52.219-6 NOTICE OF TOTAL SMALL BUSINESS SET-ASIDE (NOV 2011)

(a) Definition.

"Small business concern," as used in this clause, means a concern, including its affiliates, that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the size standards in this solicitation.

(b) Applicability. This clause applies only to--

(1) Contracts that have been totally set aside or reserved for small business concerns; and

(2) Orders set aside for small business concerns under multiple-award contracts as described in 8.405-5 and 16.505(b)(2)(i)(F).

(c) General. (1) Offers are solicited only from small business concerns. Offers received from concerns that are not small business concerns shall be considered nonresponsive and will be rejected.

(2) Any award resulting from this solicitation will be made to a small business concern.

(d) Agreement. A small business concern submitting an offer in its own name shall furnish, in performing the contract, only end items manufactured or produced by small business concerns in the United States or its outlying areas. If this procurement is processed under simplified acquisition procedures and the total amount of this contract does not exceed $25,000, a small business concern may furnish the product of any domestic firm. This paragraph does not apply to construction or service contracts.

(End of clause)

52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984)

Funds are not presently available for performance under this contract beyond 21 Jun 2013 . The Government's obligation for performance of this contract beyond that date 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 for performance under this contract beyond 21 Jun 2013, until funds are made available to the Contracting Officer for performance and until the Contractor receives notice of availability, to be confirmed in writing by the Contracting Officer.

(End of clause)

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.arnet.gov/far

(End of clause)

Department of Defense Business Associate Agreement Introduction

In accordance with DoD 6025.18-R “Department of Defense Health Information Privacy Regulation,” January 24, 2003, the Contractor meets the definition of Business Associate. Therefore, a Business Associate Agreement is required to comply with both the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security regulations. This clause serves as that agreement whereby the Contractor agrees to abide by all applicable HIPAA Privacy and Security requirements regarding health information as defined in this clause, and in DoD 6025.18-R and DoD 8580.02-R, as amended. Additional requirements will be addressed when implemented.

(a) Definitions. As used in this clause generally refer to the Code of

Federal Regulations (CFR) definition unless a more specific provision exists in DoD 6025.18-R or DoD 8580.02-R.

Individual has the same meaning as the term “individual” in 45 CFR

160.103 and shall include a person who qualifies as a personal representative in accordance with 45 CFR 164.502(g).

Privacy Rule means the Standards for Privacy of Individually Identifiable Health Information at 45 CFR part 160 and part 164, subparts A and E.

Protected Health Information has the same meaning as the term

“protected health information” in 45 CFR 160.103, limited to the information created or received by the Contractor from or on behalf of the Government pursuant to the Contract.

Electronic Protected Health Information has the same meaning as the term “electronic protected health information” in 45 CFR 160.103.

Required by Law has the same meaning as the term “required by law” in 45 CFR 164.103.

Secretary means the Secretary of the Department of Health and Human Services or his/her designee.

Security Rule means the Health Insurance Reform: Security Standards at

45 CFR part 160, 162 and part 164, subpart C.

Terms used, but not otherwise defined, in this Clause shall have the same meaning as those terms in 45 CFR 160.103, 164.501 and 164.304.

(b) The Contractor shall not use or further disclose Protected Health

Information other than as permitted or required by the Contract or as Required by Law.

(c) The Contractor shall use appropriate safeguards to prevent use or disclosure of the Protected Health Information other than as provided for by this Contract.

(d) The Contractor agrees to use administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity, and availability of the electronic protected health information that it creates, receives, maintains, or transmits in the execution of this Contract.

(e) The Contractor agrees to mitigate, to the extent practicable, any harmful effect that is known to the Contractor of a use or disclosure of Protected Health Information by the Contractor in violation of the requirements of this Clause.

(f) The Contractor shall report to the Government any security incident involving protected health information of which it becomes aware.

(g) The Contractor shall report to the Government any use or disclosure of the Protected Health Information not provided for by this Contract of which the Contractor becomes aware.

(h) The Contractor shall ensure that any agent, including a subcontractor, to whom it provides Protected Health Information received from, or created or received by the Contractor, on behalf of the Government, agrees to the same restrictions and conditions that apply through this Contract to the Contractor with respect to such information.

(i) The Contractor shall ensure that any agent, including a subcontractor, to whom it provides electronic Protected Health Information, agrees to implement reasonable and appropriate safeguards to protect it.

(j) The Contractor shall provide access, at the request of the Government, and in the time and manner reasonably designated by the Government to Protected Health Information in a Designated Record Set, to the Government or, as directed by the Government, to an Individual in order to meet the requirements under 45 CFR 164.524.

(k) The Contractor shall make any amendment(s) to Protected Health

Information in a Designated Record Set that the Government directs or agrees to pursuant to 45 CFR 164.526 at the request of the Government, and in the time and manner reasonably designated by the Government.

(l) The Contractor shall make internal practices, books, and records relating to the use and disclosure of Protected Health Information received from, or created or received by the Contractor, on behalf of the Government, available to the Government, or at the request of the Government to the Secretary, in a time and manner reasonably designated by the Government or the Secretary, for purposes of the Secretary determining the Government’s compliance with the Privacy Rule.

(m) The Contractor shall document such disclosures of Protected

Health Information and information related to such disclosures as would be required for the Government to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528.

(n) The Contractor shall provide to the Government or an Individual, in time and manner reasonably designated by the Government, information collected in accordance with this Clause of the Contract, to permit the Government to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528.

General Use and Disclosure Provisions

Except as otherwise limited in this Clause, the Contractor may use or disclose Protected Health Information on behalf of, or to provide services to, the

Government for treatment, payment, or healthcare operations purposes, in accordance with the specific use and disclosure provisions below, if such use or disclosure of Protected Health Information would not violate the HIPAA Privacy Rule, the HIPAA Security Rule, DoD 6025.18-R or DoD 8580.02-R if done by the Government.

Specific Use and Disclosure Provisions

(a) Except as otherwise limited in this Clause, the Contractor may use

Protected Health Information for the proper management and administration of the Contractor or to carry out the legal responsibilities of the Contractor.

(b) Except as otherwise limited in this Clause, the Contractor may disclose Protected Health Information for the proper management and administration of the Contractor, provided that disclosures are required by law, or the Contractor obtains reasonable assurances from the person to whom the information is disclosed that it will remain confidential and used or further disclosed only as required by law or for the purpose for which it was disclosed to the person, and the person notifies the Contractor of any instances of which it is aware in which the confidentiality of the information has been breached.

(c) Except as otherwise limited in this Clause, the Contractor may use

Protected Health Information to provide Data Aggregation services to the

Government as permitted by 45 CFR 164.504(e)(2)(i)(B).

(d) Contractor may use Protected Health Information to report violations of law to appropriate Federal and State authorities, consistent with 45 CFR 164.502(j)(1).

Obligations of the Government

Provisions for the Government to Inform the Contractor of Privacy Practices and Restrictions

(a) The Government shall provide the Contractor with the notice of privacy practices that the Government produces in accordance with 45 CFR 164.520.

(b) The Government shall provide the Contractor with any changes in, or revocation of, permission by Individual to use or disclose Protected Health

Information, if such changes affect the Contractor’s permitted or required uses and disclosures.

(c) The Government shall notify the Contractor of any restriction to the use or disclosure of Protected Health Information that the Government has agreed to in accordance with 45 CFR 164.522.

Permissible Requests by the Government

The Government shall not request the Contractor to use or disclose

Protected Health Information in any manner that would not be permissible under the HIPAA Privacy Rule, the HIPAA Security Rule, or any applicable Government regulations (including without limitation, DoD 6025.18-R and DoD 8580.02-R) if done by the Government, except for providing Data Aggregation services to the Government and for management and administrative activities of the Contractor as otherwise permitted by this clause.

Termination

(a) Termination. A breach by the Contractor of this clause, may subject the

Contractor to termination under any applicable default or termination provision of this Contract.

(b) Effect of Termination.

(1) If this contract has records management requirements, the records subject to the Clause should be handled in accordance with the records management requirements. If this contract does not have records management requirements, the records should be handled in accordance with paragraphs (2) and (3) below

(2) If this contract does not have records management requirements, except as provided in paragraph (3) of this section, upon termination of this Contract, for any reason, the Contractor shall return or destroy all Protected Health Information received from the Government, or created or received by the Contractor on behalf of the Government. This provision shall apply to Protected Health Information that is in the possession of subcontractors or agents of the Contractor. The Contractor shall retain no copies of the Protected Health Information.

(3) If this contract does not have records management provisions and the Contractor determines that returning or destroying the Protected Health

Information is infeasible, the Contractor shall provide to the Government notification of the conditions that make return or destruction infeasible. Upon mutual agreement of the Government and the Contractor that return or destruction of Protected Health Information is infeasible, the Contractor shall extend the protections of this Contract to such Protected Health Information and limit further uses and disclosures of such Protected Health Information to those purposes that make the return or destruction infeasible, for so long as the Contractor maintains such Protected Health Information.

Miscellaneous

(a) Regulatory References. A reference in this Clause to a section in DoD 6025.18-R, DoD 8580.02-R, Privacy Rule or Security Rule means the section currently in effect or as amended, and for which compliance is required.

(b) Survival. The respective rights and obligations of Business Associate under the “Effect of Termination” provision of this Clause shall survive the termination of this Contract.

(c) Interpretation. Any ambiguity in this Clause shall be resolved in favor of a meaning that permits the Government to comply with DoD 6025.18-R, DoD 8580.02-R, the HIPAA Privacy Rule or the HIPAA Security Rule.

Section L - Instructions, Conditions and Notices to Bidders

CLAUSES INCORPORATED BY REFERENCE

Section M - Evaluation Factors for Award

CLAUSES INCORPORATED BY REFERENCE