SOLICITATION NOTICE
65 -- MAMMOTOME CONTROL MODULE & HOLSTER SERVICE MAINTENANCE
- Notice Date
- 9/19/2009
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 339113
— Surgical Appliance and Supplies Manufacturing
- Contracting Office
- Southeast Regional Contracting Office, ATTN: MCAA SE, Building 39706, Fort Gordon, GA 30905-5650
- ZIP Code
- 30905-5650
- Solicitation Number
- W91YTV10TM504
- Response Due
- 9/24/2009
- Archive Date
- 11/23/2009
- Point of Contact
- Marian Jones-Millwood, 706-787-0296
- E-Mail Address
-
Southeast Regional Contracting Office
(marian.jones-millwood@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- This is a Combined Synopsis/Solicitation for commercial items prepared in accordance with the format in 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. The solicitation number is W91YTV-10-T-M504. This acquisition is issued as a Request for Quote - RFQ. The North American Industry Classification System Code - NAICS for this procurement is 339113; the Standard Industrial Classification Code is 3842; and the small business size standard is 500.Purchase requisition W34GMS90969504. The US Army Medical Command Southeast Region has a requirement for a MAMMOTOME CONTROL MODULE & HOLSTER SERVICE MAINTENANCE in accordance with the below Performance Based Work Statement for BLANCHFIELD ARMY COMMUNITY HOSPITAL, FORT CAMPBELL, KENTUCKY. Performance Based Work Statement GENERAL This contract shall provide for maintenance services which include on site remedial repairs, emergency repairs and routine preventive maintenance services to the government owned equipment listed at TE-1. Maintenance services will be accomplished five days per week during normal duty hours 0730 to 1600 hours excluding legal public holidays. This equipment is located at Blanchfield Army Community Hospital, Fort Campbell, KY. It shall include all systems, subsystems components, and assemblies which were part of the original system purchased. All subsequent maintenance provisions shall apply to hardware, firmware, and software as appropriate, unless otherwise stated. 1.1. Technical Exhibit-1 - Equipment List a. Nomenclature: MAMMOTOME CONTROL MODULE Manufacturer: ETHICON ENDO-SURGERY INC Model Number: MCMEXT Serial Number: 1200916 ECN Number: E3579 b. Nomenclature: MAMMOTOME HOLSTER Manufacturer: ETHICON ENDO-SURGERY INC. Model Number: MHOEXT Serial Number: GST010920 ECN Number: N/A 1.2. BACKGROUND INFORMATION 1.2.1. The Contractor shall comply with Federal, State and local laws and regulations applicable to the performance of this contract. 1.2.2. The Contractor shall not accept any instructions issued by any person other than the Contracting Officer, or the Contracting Officer's Representative - COR acting within the limits of their authority. 1.3. PERSONNEL 1.3.1. Program Manager: The Contractor will provide, in writing, the name and phone number of a Program Manager within ten calendar days of the award of the contract. The Program Manager will be a qualified and experienced manager to oversee the personnel assigned to perform the maintenance services. The contractor's Program Manager will correspond with the Contracting Officer's Representative - COR on a regular basis to discuss any problems that the contractor or contractor's personnel may be experiencing during the performance of this contract. Unresolved problems will be referred to the contracting officer for resolution. 1.3.2. Contractor Service Personnel - CSP: CSP will be English speaking and required to show documentation of Original Manufacturer Certification Training -OEM. All Subcontractors performing work for primary contractor will meet all specifications and standards that apply to CSP under this agreement. CSP will maintain clean and neat appearance and will wear an identification badge at all times when performing services at the Government site. Identification badges will be worn in a clearly visible area of the outer garment. The COR will furnish this badge. Due to conflict of interest, the contractor will not employ a current DOD employee, military or civilian to provide services under this contract. 1.3.3. Government Point of Contact - POC. The COR will be the Government's POC. The COR will be designated in writing to the Contractor and the scope of authority will be set forth therein. SFC Matthew S. Alexander, NCOIC, Equipment Management Branch, Blanchfield Army Community Hospital - BACH, Fort Campbell, KY -FTCKY will be the Contracting Officers Representative - COR. Contractor shall respond only to calls from COR or a designated representative from the Medical Maintenance Branch. 1.4. PHYSICAL SECURITY 1.4.1. The Government will not be responsible in any way for damage to the Contractors supplies, materials, equipment and property or to contractors personnel personal belongings that are damaged or destroyed by fire, theft, accident or other disaster. 1.4.2. Contractor personnel or any representative of the contractor entering Ft. Campbell shall abide by all security regulations and shall be subject to security checks. When entering post, contractor personnel must have vehicle registration, drivers license and proof of insurance. 1.5. QUALITY CONTROL - The contractor shall be responsible for ensuring that the quality of service and materials provided under this contract meet or exceed the Performance Work Statement. 1.6. QUALITY ASSURANCE - Upon completion of work, an acceptance inspection will be conducted bythe COR and the equipment user to ensure all services are satisfactory and completed. 1.7. PERFORMANCE MEASURES 1.7.1. Performance is considered acceptable when requested loaner equipment is received the next business day. 1.8. ACRONYMS AND DEFINITIONS 1.8.1. Contracting Officer -KO. A person duly appointed with the authority to enter into and administer contracts on behalf of the U.S. Government. 1.8.2. Contracting Officers Representative - COR. A Government employee selected and designated in writing by the KO to act as their authorized representative in administering a contract. The Government POC or their designated representative at the equipment work site has the authority to request services and performance of the contractor against his contract. 1.8.3. Contractor Service Personnel - CSP. 1. A person who is authorized by the Contractor to perform maintenance - corrective and/or preventive services on the equipment specified. These personnel must be fully qualified. 2. Successfully completed a formalized training program, for the equipment specified. 3. Has a minimum of two year experience, with respect to scheduled and remedial maintenance on the equipment listed at TE-1. 1.8.4. Preventive Maintenance - PM. Maintaining equipment in a satisfactory operating condition in accordance with the manufacturers standards and specifications by providing systematic inspection, detection, and correction of incipient failures either before they occur or before they develop into major defects. For purposes of this contract, it includes the installation of any manufacturers Field Modification Instructions - FMI kits applicable to this unit. 1.8.5. Downtime: Anytime during the MTFs normal patient schedule day when the equipment is not operable due to breakdown, under repair, or fails to perform according to specifications, and is deemed unsafe for patient care. Downtime for remedial repairs is calculated from the time the service is requested by the Government, until the CSP verifies acceptance of work completed with the COR. The time accrued as downtime will only be during those hours identified below as normal duty hours. Scheduled routine preventive maintenance and calibrations shall not be considered downtime. Also, minor failures with ancillary components which do not affect system availability shall not be considered in determining downtime. 1.8.6. Response Time: The Contractor is responsible for providing telephonic technical assistance within two (2) hours of notification of the equipment failure. If the assistance provided does not correct the equipment failure/problems the contractor's technical representative will be on site to initiate corrective action within 24 hours or the following normal duty day. 1.8.7. Remedial/Routine Repair: An action required due to a malfunction, minor or major. The service includes inspection, testing/troubleshooting and all actions necessary to return the item to a fully serviceable state. Included are those calibrations and test which are incidental to a repair action. 1.8.8. Replacement Part: A component or module of the existing system or approved upgraded/modified system requiring replacement through a fault developed through normal use or normal wear and tear. Replacement parts do not include consumable supplies. 1.8.9. Scheduled Services: Those services routinely performed on a scheduled basis at set intervals. Three categories of scheduled services are preventive maintenance, calibration, and safety testing. Preventive maintenance shall include, but need not be limited to, the following when applicable: 1. Cleaning of equipment. 2. Reviewing the operating system software diagnostics to ensure that the system is operating to the manufacturers specifications. 3. Calibrating and lubricating the equipment. 4. Performing remedial maintenance of non-emergent nature. 5. Testing and replacing faulty and worn parts and/or parts which are likely to become faulty, fail or become worn. 6. Inspecting all high voltage cables and bushings and replacement of dielectric as necessary. 7. Measuring and adjusting and calibrating as necessary for optimal image quality. 8. Inspecting and replacing where indicated, electric wiring and cables for wear and fraying. 9. Returning equipment to the operating condition. 10. Providing documentation of services performed. 1.8.10. Service Completion Date: The date and hour the COR accepts the work as completed and signs the Contractors service report. 1.8.11. Normal Duty Day. From 7:30am 4:00pm, Monday through Friday, excluding the legal public holidays. Legal Public Holiday. Holidays in each calendar year identified as follows: New Years Day, January 1 Martin Luther Kings Birthday, 3rd Monday in January Washingtons Birthday, 3rd Monday in February Memorial Day, last Monday in May Independence Day, July 4 Labor Day, 1st Monday in September Columbus Day, 2nd Monday in October Veterans Day, November 11 Thanksgiving Day, 4th Thursday in November Christmas Day, December 25 Those holidays falling on a Saturday will be observed on the preceding Friday. Those falling on Sunday will be observed on the following Monday. 1.8.12. Weekend: The period beginning at 5:00 pm on Friday and ending at 7:30 am the following Monday. 1.9. GOVERNMENT FURNISHED PROPERTY, MATERIALS AND SERVICES 1.9.1. 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 the need for remedial maintenance. The Contractor agrees to leave the equipment in good operating condition at the expiration of this contract. The Contractor will be obligated to perform any work under this contract to accomplish this. During the final week of this contract, a final inspection of the equipment will be made by the Government. Any correction of deficiencies noted at that inspection will represent the final requirement to be performed by the Contractor under this contract. Government and Contractor representatives at each site will perform a pre-maintenance inspection at the onset of the contract. Any equipment found to be inoperable during this joint pre-maintenance inspection will be repaired using a separate purchase instrument. 1.9.2. Government property and materials made available to the Contractor under the terms of this contract shall be for use only in the performance of this contract. 1.9.3. The Government will make available to the Contractor the equipment scheduled for servicing at such time and duration as required by the Contractor and coordinated with the COR. 1.9.4. The Contractor Service Personnel shall park in the appropriately designated parking areas as determined by the COR. The Government will not invalidate or make reimbursement for parking violations of the Contractor under this contract. Violations of the Government's site regulations and policies may result in citation answerable in the United States Federal District Court, not a local, state or municipal court. 1.9.5. The Government will furnish expendable supplies, i.e., film, chemicals consumed during normal procedural sequence and necessary for the completion of the required maintenance services. Expendable supplies will only be provided for work accomplished at the Government site. 1.9.6. The Government will provide the Contractor with all government forms and make available all government publications referenced in this contract when not normally available to the public or the Contractor. 1.9.7. The Contractor shall not be responsible for delays encountered due to the non-availability of Government furnished materials. The time allowed for the completion of remedial repairs will be extended to equal the amount of time delayed due to the Government caused delays. 1.9.8. 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. 1.9.9. The Government will operate the system in accordance with the instruction manual provided by the OEM. 1.9.10. The Government will not be responsible for 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. 1.10. CONTRACTOR FURNISHED PROPERTY AND MATERIAL 1.10.1. Only the material referenced in section 3 above will be furnished by the Government. All other material required in the performance of this contract shall be furnished by the Contractor. 1.10.2. 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. 1.10.3. Replacement Parts. 1. The Contractor shall have ready access to unique and/or high mortality replacement parts. All parts supplied shall be compatible with the existing system. 2. The Contractor shall replace all worn or defective parts necessary to restore the equipment to the original operational condition as specified by the OEM. 3. Contractor installed replacement parts shall become the property of the Government and the replaced malfunctioning part shall become the property of the Contractor. 4. 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. 5. The Contractor shall use only new or warranted replacement parts where the quality is equal to or better than the OEM's original part. When discrepancies occur, the Government will make the final determination on whether a replacement part is of equal or better quality. 6. The Contractor must include software revisions and upgrades - field service changes - which are required due to a manufacturer announced safety - hazard and FDA recall as part of the contract at no additional cost to the Government. 1.11. SPECIFIC TASKS 1.11.1. On-site Repair/Preventive Maintenance Inspections: Contractor's representative shall report and sign in to the Medical Maintenance Branch, Bldg. 650 BACH prior to commencing services during the normal duty day 07:30a.m. to 4 p.m.. During other than normal duty hours, contractors representative shall coordinate maintenance services with the Medical Maintenance On-Call Technician. The On-Call Technician can be reached by contacting the Administrative Officer of the Day - AOD, Bldg, 650, BACH, and FTCKY. The Government and the contractor will exchange hazard communication information before the commencement of any services. The contractor will comply with all pertinent OSHA, National Fire Protection Association -NFPA and Joint Commission - JC requirements and standards in performing maintenance services. When CSP are performing services within the Medical Treatment Facility they will comply with the fire evacuation plan. 1.11.2. Equipment Modification/Alteration/Upgrades: The Contractor will perform only Original Equipment Manufacture - OEM specified modifications, alterations and upgrades. Approval will be obtained from the COR prior to the installation of any modification, alteration or upgrade. The Contractor will perform or cause to be performed all OEM field modifications and safety alert inspections. The Contractor will maintain contact with the OEM to determine the requirement for field modifications and to ensure accomplishment of these field modifications in accordance with the time schedule set forth by the OEM. Minor or routine OEM Software upgrades will be made known to the COR by the Contractor as they are made available by the manufacturer and implementation will be coordinated with the COR. 1.11.3. Vehicle operation: CSP operating motor vehicles on federal property will possess an operator's license for the category of vehicle being operated and auto insurance as required by regulations/laws governing said federal property. CSP will park in the appropriately designated parking areas as determined by the COR. The Government will not invalidate or make reimbursement for parking violations of the Contractor under any condition. 1.11.4. Documentation of Services: Contractor's representative, upon completion of any calibration, will affix and/or update Medical Equipment Verification/Certification Label DD Form 2163. Forms will be provided by the Medical Maintenance Branch upon request. Upon completion of services, a written service report shall be provided to the COR or the On-Call Technician. The service report shall provide detailed information regarding the service provided, the cause of equipment malfunctions and corrective action taken to include the time required to complete the work, price of labor (hourly rate) and a list of parts replaced with a price for each part. In the event all information is not available to the contractors representative when the services are performed, the initial service report shall include all information stated above except price. The Contractor shall provide the balance of the required information in writing to the COR, Medical Maintenance Branch, Bldg. 650 Joel Dr., BACH, FTCKY, 42223-5349, within five business days. 1.12. Contractor Responsibility. 1.12.1. The Contractor shall be responsible for all items of Government equipment throughout the period they are under his control. 1.12.2. The Contractor shall be responsible for any damages to Government owned equipment and property and shall replace or repair any property damaged due to a fault of the Contractor or his representatives. All such replacement or repair shall be at the Contractor's expense and approved by the KO. 1.12.3. The Contractor shall ensure all areas where equipment is serviced on site are left in a clean, neat, safe, and orderly condition. To prevent safety hazards, no equipment shall be left pulled out or apart upon Contractor departure from the work site. Equipment being repaired shall be safely secured at all times. 1.12.4. The Contractor is not responsible for service required due to Government misuse or abuse, or damage to the system or its components when it has been determined that the damage resulted from an act of God. The Contractor has four hours to make this determination and submit it to the COR for resolution. 1.12.5. Full service agreement includes service, parts and loaner if necessary on the Mammotome Control Module and one Holster, unlimited service calls during the normal duty hours 7:30am to 4:00pm Monday to Friday. It also includes all parts, components, labor, and travel associated therewith, excluding consumables such as fibers, delivery systems and sliders. 1.12.6. On-site coverage will be 7:00 AM to 7:00 PM, seven days a week. 1.12.7. Provide all labor, all travel, expenses and all parts for an unlimited number of on-demand service visits and telephone support calls around the clock. 1.12.8. All product hardware enhancements will be included at no additional charge. 1.13. Scheduled Services. 1.13.1. The Contractor shall, at a minimum, perform all scheduled services as prescribed by the OEM using a detailed services checklist. The completed checklist will be provided to the Government with the Contractor's service report. 1.13.2. The Contractor shall perform schedules services for other than peak patient examination times determined by the COR at each site. 1.13.3. The Contractor shall confirm scheduled dates with the COR at least five working days prior to performing scheduled services. 1.13.4. The Contractor shall affix or update a DD Form 2163, Medical Equipment Verification/Certification label, upon completion of each calibration. The DD Form 2163 shall be affixed to the system as directed by the COR. 1.14. Remedial Repairs. 1.14.1. Government requests for remedial repairs will be placed by the COR to the Contractor's POC. Remedial Maintenance shall be made available during normal duty hours associated with each site. 1.14.2. The Contractor's response to requests for remedial repairs may include telephone consultation between the equipment user/operator and the CSP. The purpose of this telephone consultation shall be: 1. to 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 CSP; and 4. to identify replacement parts likely to be required in order to return the equipment to the original operational condition as specified by the OEM. 1.14.3. The Contractor shall provide service manuals, specifications, schematic diagrams, and parts lists for all equipment included in this contract. 1.15. Removal of Government Property. 1.15.1. Only equipment requiring major disassembly, major overhaul, or repair by replacement shall normally be removed from the Government site. 1.15.2. Whenever the repair of equipment cannot be performed at the Government site as determined by the Contractor, the Contractor shall notify the COR. who will make arrangements for the Contractor to remove the item to the Contractor's designated site. The Contractor may be required to sign a Government form accepting responsibility for the Government equipment. 1.15.3. 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. 1.16. Service beyond the Scope of the Contract. 1.16.1. The Contractor shall immediately, but not later than 24 consecutive hours after discovery, notify the COR 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. 1.16.2. At the same time of the notification, the Contractor shall furnish the COR with a 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 instrument. 2.0 BUSINESS TO BUSINESS GENERAL SECURITY REQUIREMENTS. 2.1. General Security Requirements. The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all Government data, to ensure the confidentiality, integrity, and availability of government data. As a minimum, this shall include provisions for personnel security, electronic security and physical security as listed in the sections that follow. 2.2. Personnel Security. 2.2.1. The contractor shall comply with DoD Directive 8500.1, Information Assurance, DoD Instruction 8500.2, Information Assurance Implementation, DoD Directive 5400.11, DoD Privacy Program, DoD 6025.18-R, DoD Health Information Privacy Regulation, DoD 5200.2-R, Personnel Security Program Requirements. AR25-1, Army Knowledge Management and Information Technology, AR25-2 Information Assurance. and local regulations as deemed appropriate by the activity Information Assurance personnel. 2.2.2. Contractor responsibilities for ensuring personnel security include, but are not limited to, meeting the following requirements: 2.2.3. Follow the Army guidelines for submittal of Automated Data Processor/Information Technology background investigations and ensure all contractor personnel are designated as ADP/IT-I, ADP/IT-II, or ADP/IT-III where their duties meet the criteria of the position sensitivity designations outlined in AR25-2. 2.2.4. Initiate, maintain, and document personnel security investigations appropriate to the individuals responsibilities and required access to Information Systems within the logical boundaries of the facility LAN. 2.2.5. Immediately report to the Blanchfield Army Community Hospital Security Office Mr. Randy Washington and deny access to any automated information system, network, or information if a contractor employee filling a sensitive position receives an unfavorable adjudication, if information that would result in an unfavorable adjudication becomes available, or if directed to do so by the appropriate government representative for any reason. 2.2.6. Ensure that all contractor personnel receive information assurance training before being granted access to DoD AISs/networks and information. 2.3. Electronic Security. 2.3.1. Contractor Information Systems /networks that are involved in the operation of systems in support of Blanchfield Army Community Hospital shall operate in accordance with controlling laws, regulations, DoD, Army, and local policy. 2.3.2. Certification & Accreditation requirements apply to all DoD and contractors IS/networks that receive process, display, store or transmit DoD information. The contractor shall comply with the C&A process for safeguarding IS. Certification is the determination of the appropriate level of protection required for IS/networks. Certification also includes a comprehensive evaluation of the technical and non-technical security features and countermeasures required for each system/network. 2.3.3. Accreditation is the formal approval by the government to operate the contractors IS/networks in a particular security mode using a prescribed set of safeguards at an acceptable level of risk. In addition, accreditation allows IS/networks to operate within the given operational environment with stated interconnections; and with appropriate level of protection for the specified period. 2.3.4. The contractor shall comply with C&A requirements, as specified by the government that meet appropriate DoD Information Assurance requirements. The C&A requirements shall be met before the contractors system is authorized to access DoD data or interconnect with any DoD IS/network that receives, processes, stores, displays or transmits DoD data. The contractor shall ensure the proper contractor support staff is available to participate in all phases of the C&A process. They include, but are not limited to: 1. Attending and supporting C&A meetings with the government 2. Supporting/conducting the vulnerability mitigation process 3. Supporting the C&A Team during system security testing 2.3.5. Contractors must confirm that there is/networks are locked down prior to initiating testing. 2.3.6. Conformation of system lock down shall be agreed upon during the definition of the C&A boundary and be signed and documented as part of the System Security Authorization Agreement. 2.3.7. Locking down the system means that there shall be no changes made to the configuration of the system -within the C&A boundary during the C&A process 2.3.8. Any re-configuration or change in the system during the C&A testing process will require a re-baselining of the system and documentation of system changes. 2.3.9. IA mitigation strategies include security updates, service packs, and changes to operating procedures as physical and cyber vulnerabilities are detected. Operating system, routers, servers, development platforms and the application being delivered to the government shall be in compliance with all known applicable Department of Defense Computer Emergency Response Team Alert, Bulletin, and Technical Advisory Notices published during the past 36 months. 2.3.10. Disposing of Electronic Media. Vendors shall follow the DoD standards, procedures, and use approved products to dispose of unclassified hard drives and other electronic media, as appropriate, in accordance with DoD Memorandum - Disposition of Unclassified Computer Hard Drives, June 4, 2001. Vendors are required to also follow DoD guidance on sanitization of other internal and external media components in DODI 8500.2 Information Assurance Implementation, 6 Feb 2003 - see PECS-1 in enclosure 4 Attachment 5 and DoD 5220.22-M Industrial Security Program Operating Manual NISPOM, - Chapter 8. 2.3.11. Information Assurance Vulnerability Management. The contractor shall implement an information assurance vulnerability management program for all AIS and corresponding subnets that are connected to or intermittently connect to Army networks. The program shall meet the scope and intent of AR25-2 and Insert MTF Name IA policies to provide protection against known threats and vulnerabilities. Compliance with Army IAVM alerts and bulleting is required for these systems, and shall be completed within the specified timeframe. 2.4. Information Systems / Networks Physical Security. 2.4.1. The contractor shall employ physical security safeguards for IS/Networks involved in processing or storage of Government Data to prevent the unauthorized access, disclosure, modification, destruction, use, etc., and to otherwise protect the confidentiality and ensure use conforms with DoD regulations. In addition, the contractor will support a Physical Security Audit performed by the Government of the contractor's internal information management infrastructure. The MHS Physical Security Audit Matrix is available at: http://www.tricare.osd.mil/tmis_new/Policy/PSA_Matrix_%20012304%200930%20clean%20version.xls. The contractor shall correct any deficiencies identified by the Government of the contractor's physical security posture. 2.5. Special Requirements for Protected Health Information. 2.5.1. Whenever a contract is awarded that requires the vendor to collect, use, copy, access or store Protected Health Information in commercial office space, the contractors must: 2.5.2. Notify the Blanchfield Army Community Hospital Mr/Ms. Gloria Davis-HIPAA Security Manager. 2.5.3. Follow all DUA and DoD requirements for secure disposal, destruction, and/or sanitization of all equipment that contained PHI. 3.0 PRIVACY AND SECURITY OF PROTECTED HEALTH INFORMATION INTRODUCTION 3.1.1. IAW DOD 6025.18R Department of Defense Health Information Privacy Regulation 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 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 DOD 6025.18R, as amended. Additional requirements will be addressed when implemented. 3.2. Definitions. As used in this clause generally refer to the Code of Federal Regulations definition unless a more specific provision exists in DOD 6025.18R. 3.2.1. Individual has the same meaning as the term individual in 45 CFR 164.501 and 164.103 and shall include a person who qualifies as a personal representative in accordance with 45 CFR 164.502 g. 3.2.2. Privacy Rule means the Standards for Privacy of Individually Identifiable Health Information at 45 CFR part 160 and part 164, subparts A and E. 3.2.3. Protected Health Information has the same meaning as the term protected health information in 45 CFR 164.501, limited to the information created or received by The Contractor from or on behalf of The Government. 3.2.4. Electronic Protected Health Information has the same meaning as the term electronic protected health information in 45 CFR 160.103. 3.2.5. Required by Law has the same meaning as the term required by law in 45 CFR 164.501 and 164.103. 3.2.6. Secretary means the Secretary of the Department of Health and Human Services or his/her designee. 3.2.7. Security Rule means the Health Insurance Reform: Security Standards at 45 CFR part 160, 162 and part 164, subpart C. 3.2.8. Terms used, but not otherwise defined, in this Agreement shall have the same meaning as those terms in 45 CFR 160.103, 164.501 and 164.304. 3.3. Contractors Responsibilities: 3.3.1. The Contractor agrees to not use or further disclose Protected Health Information other than as permitted or required by the Contract or as Required by Law. 3.3.2. The Contractor agrees to use appropriate safeguards to prevent use or disclosure of the Protected Health Information other than as provided for by this Contract. 3.3.3. 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. 3.3.4. 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 Contract. 3.3.5. The Contractor agrees to report to the Government any security incident involving protected health information of which it becomes aware. 3.3.6. The Contractor agrees to 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 of. 3.3.7. The Contractor agrees to 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. 3.3.8. The Contractor agrees to 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 The Contractor agrees to provide access, at the request of the Government, and in the time and manner 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. 3.3.9. The Contractor agrees to make any amendments 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 or an Individual, and in the time and manner designated by the Government. 3.3.10. The Contractor agrees to 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 designated by the Government or the Secretary, for purposes of the Secretary determining the Governments compliance with the Privacy Rule. 3.3.11. The Contractor agrees to 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. 3.3.12. The Contractor agrees to provide to the Government or an Individual, in time and manner 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. 3.4. General Use and Disclosure Provisions Except as otherwise limited in this Agreement, 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 Privacy Rule, the Security Rule or DOD 6025.18R if done by the Government. 3.5. Specific Use and Disclosure Provisions 3.5.1. Except as otherwise limited in this Agreement, 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. 3.5.2. Except as otherwise limited in this Agreement, 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. 3.5.3. Except as otherwise limited in this Agreement, 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. 3.5.4. Contractor may use Protected Health Information to report violations of law to appropriate Federal and State authorities, consistent with 45 CFR 164.502j,1. 3.6. Obligations of the Government 3.6.1. Provisions for the Government to Inform the Contractor of Privacy Practices and Restrictions 3.6.2. Upon request the Government shall provide the Contractor with the notice of privacy practices that the Government produces in accordance with 45 CFR 164.520, as well as any changes to such notice. 3.6.3. 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. 3.6.4. 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. 3.6.5. 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 Privacy Rule 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. 3.7. Termination 3.7.1. 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. 3.7.2. 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. 3.7.3. 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. 3.8. Miscellaneous 3.8.1. Regulatory References. A reference in this Clause to a section in DOD 6025.18R, Privacy Rule or Security Rule means the section as in effect or as amended, and for which compliance is required. 3.8.2. 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. 3.8.3. Interpretation. Any ambiguity in this Clause shall be resolved in favor of a meaning that permits the Government to comply with DOD 6025.18R, Privacy Rule or Security Rule. End of Performance Work Statement TERM: BASE YEAR PLUS FOUR ONE YEAR OPTIONS, Subject to the availability of funds. Base Year commence 01 OCTOBER 2009 THROUGH 30 SEPTEMBER 2010. 0001 MAMMOTOME CONTROL MODULE & HOLSTER SERVICE MAINTENANCE;Unit of Issue: Each; BASE YEAR: 01 OCTOBER 2009 THROUGH 30 SEPTEMBER 2010. UNIT PRICE $__________, TOTAL COST $__________ 1001 MAMMOTOME CONTROL MODULE & HOLSTER SERVICE MAINTENANCE;Unit of Issue: Each; First Option Year: 01 OCTOBER 2010 THROUGH 30 SEPTEMBER 2011. UNIT PRICE $__________, TOTAL COST $__________ 2001 MAMMOTOME CONTROL MODULE & HOLSTER SERVICE MAINTENANCE;Unit of Issue: Each; Second Option Year: 01 OCTOBER 2011 THROUGH 30 SEPTEMBER 2012. UNIT PRICE $__________, TOTAL COST $__________ 3001 MAMMOTOME CONTROL MODULE & HOLSTER SERVICE MAINTENANCE;Unit of Issue: Each; Third Option Year: 01 OCTOBER 2012 THROUGH 30 SEPTEMBER 2013. UNIT PRICE $__________, TOTAL COST $__________ UNIT PRICE $__________, TOTAL COST $__________; 4001 MAMMOTOME CONTROL MODULE & HOLSTER SERVICE MAINTENANCE;Unit of Issue: Each; Fourth Option Year: 01 OCTOBER 2013 THROUGH 30 SEPTEMBER 2014.. UNIT PRICE $__________, TOTAL COST $__________; Quote all or none. Shipping method is FOB Destination. The Government anticipates awarding a single award for this requirement. To be delivered to: Blanchfield Army Community Hospital, Ms. Genera Shannon, Property Management Branch PBO, Bldg. 650, Level 1 Joel Drive, Fort Campbell, Kentucky 42223-1498. The Government will award a contract to the responsible offer whose offer conforming to the solicitation will be the most advantageous to the Government, price and other factors considers. The following FAR Clauses and provisions in their latest editions apply to this solicitation. FAR 52.212-1, Instructions to Offerors-Commercial; FAR 52.212-5, Evaluation Commercial Items; FAR 52.232-18 Availability of Funds; FAR 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition; FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items; FAR 52.219-6, Notice of Small Business; FAR 52.222-3, Convict Labor; FAR 52.222-19, Child Labor Cooperation with Authorities and Remedies; FAR 52.222-21, Prohibition of Segregated Facilities; FAR 52.222-26, Equal Opportunity, FAR 52.222-35; FAR 52.222-36; FAR 52.222-37, Employment Reports on Disabled Veterans and Veterans of the Vietnam Era -38 U.S.C. 4212; FAR 52.237-2 Protection of Government Building, Equipment and Vegetation; FAR 52.232-19 Availability of Funds for next Fiscal Year; FAR 52.222-3 ; FAR 52.225-1; FAR 52.225-13; FAR 52.232-33, Payment by Electronic Funds Transfer-Central Contractor Registration; FAR 52.252-1 Solicitation Provisions Incorporated by Reference, FEB 1998; DFAR Clause 252.232-7003, Electronic Submission of Payment Request, JAN 2004; and DFAR Clause 252.204-7004 Alt A, Required Central Contractor Registration Alternate A, NOV 2003; FAR 52.217-8, Option to Extend Services; FAR 52.217-9, Option to Extend the Term of the Contract; FAR 52.237-3, Continuity of Services; all of which apply to this solicitation. Full text of provisions and clauses may be accessed electronically at the following address: http://www.arnet.gov/far. The submitted offer must include the following: a completed copy of the provisions at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items. All offerors must be registered in the Central Contractor Registration prior to award, and lack of registration shall make an offer ineligible for award. Evaluation: Lowest Priced, Technically Acceptable. Offerors may obtain information on registration and annual confirmation requirements by calling 1-888-227-2423 or via Internet at http://www.ccr.gov/. Quotes are being requested and a written solicitation will not be issued. Paper copies of this solicitation will not be issued and telephone requests or FAX requests for the solicitation will not be accepted. All responsible sources should submit quotes to M. Jones-Millwood via fax at 706-787-6573 or e-mail: Marian.Jones-Millwood@us.army.mil by 1:00 P.M., EST Thursday, September 24, 2009.
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