Amendment to Combined Synopsis/Solicitation – Warranty & Maintenance Service
Notice Type: Amendment to Combined Synopsis/Solicitation
Posted Date:
Office Address:
Subject: Warranty & Maintenance Service
Classification Code: J - Maintenance, repair & rebuilding of equipment
Solicitation Number: N00183-16-T-0213
Contact:
Setaside: N/AN/A
Place of Performance (address):
Place of Performance (zipcode): 23708
Place of Performance Country: US
Description:
Section A - Solicitation/Contract Form CLAUSES INCORPORATED BY FULL TEXT
TIN: CAGE: DUNS:
Billing/Payment in Arrears.
Naval Medical Center Contracting POC: Harold Woodley Phone: 757-953-7276 Fax: 757-953-5006 Email: [email protected]
Product/Services for:
Vendor to reference RFQ number N00183-16-T-0213 on all inquires.
Reference:
PROMPT PAYMENT For Prompt Payment Act Purposes, this contract is: Subject to the 7-calender day constructive acceptance period.
"AVAILABILITY OF FUNDS. Pursuant to Section I, Availability of Funds (FAR 52.232-18), of the contract, funds are not presently available for this contract. The Government's obligation under this contract is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise until funds are made available to the Contracting Officer for this contract and until the Contractor receives notice of such availability, to be confirmed in writing to the Contracting Officer.
Note to vendors: * Government reserves the right to make award on an "all-or-none" basis. * Award to be best value based upon past performance and lowest price technically acceptable.
Section B - Supplies or Services and Prices
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 4 Quarter (Time) Warranty and Maintenance Service FFP Nomenclature: Medical Simulator Manufacturer: Simbionix
FOB: Destination MILSTRIP: N0018317RQBT004 PURCHASE REQUEST NUMBER: N0018317RQRT004
NET AMT
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0002 4 Quarter (Time) Warranty and Maintenance Service FFP Nomenclature: Medical Simulator Manufacturer: Simbionix
FOB: Destination MILSTRIP: N0018317RQBT004 PURCHASE REQUEST NUMBER: N0018317RQRT004
NET AMT
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0003 4 Quarter (Time) Warranty and Maintenance Service FFP Nomenclature: Medical Simulator Manufacturer: Simbionix
FOB: Destination MILSTRIP: N0018317RQBT004 PURCHASE REQUEST NUMBER: N0018317RQRT004
NET AMT
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0004 4 Quarter (Time) Warranty and Maintenance Service FFP Nomenclature: Medical Simulator Manufacturer: Simbionix
FOB: Destination MILSTRIP: N0018317RQBT004 PURCHASE REQUEST NUMBER: N0018317RQRT004
NET AMT
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0005 4 Quarter (Time) Warranty and Maintenance Service FFP Nomenclature: Medical Simulator Manufacturer: Simbionix
FOB: Destination MILSTRIP: N0018317RQBT004 PURCHASE REQUEST NUMBER: N0018317RQRT004
NET AMT
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0006 4 Quarter (Time) Warranty and Maintenance Service FFP Nomenclature: Medical Simulator Manufacturer: Simbionix
FOB: Destination MILSTRIP: N0018317RQBT004 PURCHASE REQUEST NUMBER: N0018317RQRT004
NET AMT
Section C - Descriptions and Specifications
CLAUSES INCORPORATED BY FULL TEXT
SUP 5252.204-9400 Contractor Unclassified Access to Federally Controlled Facilities, Sensitive Information, Information Technology (IT) Systems or Protected Health Information (
Homeland Security Presidential Directive (HSPD)-12, requires government agencies to develop and implement Federal security standards for Federal employees and contractors. The Deputy Secretary of Defense Directive-Type Memorandum (DTM) 08-006 - "DoD Implementation of Homeland Security Presidential Directive - 12 (HSPD-12)" dated
APPLICABILITY This clause applies to contractor employees requiring physical access to any area of a federally controlled base, facility or activity and/or requiring access to a DoN or
Each contractor employee providing services at a Navy Command under this contract is required to obtain a
ACCESS TO FEDERAL FACILITIES Per HSPD-12 and implementing guidance, all contractor employees working at a federally controlled base, facility or activity under this clause will require a DoD CAC. When access to a base, facility or activity is required contractor employees shall in-process with the Navy Command's Security Manager upon arrival to the Navy Command and shall out-process prior to their departure at the completion of the individual's performance under the contract.
ACCESS TO DOD IT SYSTEMS In accordance with SECNAV M-5510.30, contractor employees who require access to DoN or
Access to sensitive IT systems is contingent upon a favorably adjudicated background investigation. When access to IT systems is required for performance of the contractor employee's duties, such employees shall in-process with the Navy Command's Security Manager and Information Assurance Manager upon arrival to the
The SAAR-N shall be forwarded to the Navy Command's Security Manager at least 30 days prior to the individual's start date. Failure to provide the required documentation at least 30 days prior to the individual's start date may result in delaying the individual's start date.
When required to maintain access to required IT systems or networks, the contractor shall ensure that all employees requiring access complete annual Information Assurance (IA) training, and maintain a current requisite background investigation. The Contractor's Security Representative shall contact the Command Security Manager for guidance when reinvestigations are required.
INTERIM ACCESS The Navy Command' s Security Manager may authorize issuance of a DoD CAC and interim access to a DoN or
DENIAL OR TERMINATION OF ACCESS The potential consequences of any requirement under this clause including denial or termination of physical or system access in no way relieves the contractor from the requirement to execute performance under the contract within the timeframes specified in the contract. Contractors shall plan ahead in processing their employees and subcontractor employees. The contractor shall insert this clause in all subcontracts when the subcontractor is permitted to have unclassified access to a federally controlled facility, federally-controlled information system/network and/or to government information, meaning information not authorized for public release.
CONTRACTOR'S SECURITY REPRESENTATIVE The contractor shall designate an employee to serve as the Contractor's Security Representative. Within three work days after contract award, the contractor shall provide to the requiring activity's Security Manager and the Contracting Officer, in writing, the name, title, address and phone number for the Contractor's Security Representative. The Contractor's Security Representative shall be the primary point of contact on any security matter. The Contractor's Security Representative shall not be replaced or removed without prior notice to the Contracting Officer and Command Security Manager.
BACKGROUND INVESTIGATION REQUIREMENTS AND SECURITY APPROVAL PROCESS FOR CONTRACTORS ASSIGNED TO NATIONAL SECURITY POSITIONS OR PERFORMING SENSITIVE DUTIES Navy security policy requires that all positions be given a sensitivity value based on level of risk factors to ensure appropriate protective measures are applied.
* SF-86 Questionnaire for National Security Positions (or equivalent OPM investigative product) * Two FD-258 Applicant Fingerprint Cards (or an electronic fingerprint submission) * Original Signed Release Statements
Failure to provide the required documentation at least 30 days prior to the individual's start date shall result in delaying the individual's start date. Background investigations shall be reinitiated as required to ensure investigations remain current (not older than 10 years) throughout the contract performance period. The Contractor's Security Representative shall contact the Command Security Manager for guidance when reinvestigations are required.
Regardless of their duties or IT access requirements ALL contractor employees shall in-process with the Navy Command's Security Manager upon arrival to the
The contractor shall ensure that each contract employee requiring access to IT systems or networks complete annual Information Assurance (IA) training, and maintain a current requisite background investigation. Contractor employees shall accurately complete the required investigative forms prior to submission to the Navy Command Security Manager. The Navy Command's Security Manager will review the submitted documentation for completeness prior to submitting it to the
If the contractor employee already possesses a current favorably adjudicated investigation, the contractor shall submit a Visit Authorization Request (VAR) via the Joint Personnel Adjudication System (JPAS) or a hard copy VAR directly from the contractor's Security Representative. Although the contractor will take JPAS "Owning" role over the contractor employee, the Navy Command will take JPAS "Servicing" role over the contractor employee during the hiring process and for the duration of assignment under that contract. The contractor shall include the IT Position Category per SECNAV M-5510.30 for each employee designated on a VAR. The VAR requires annual renewal for the duration of the employee's performance under the contract.
BACKGROUND INVESTIGATION REQUIREMENTS AND SECURITY APPROVAL PROCESS FOR CONTRACTORS ASSIGNED TO OR PERFORMING NON-SENSITIVE DUTIES Contractor employee whose work is unclassified and non-sensitive (e.g., performing certain duties such as lawn maintenance, vendor services, etc ...) and who require physical access to publicly accessible areas to perform those duties shall meet the following minimum requirements:
* Must be either a US citizen or a US permanent resident with a minimum of 3 years legal residency in
To be considered for a favorable trustworthiness determination, the Contractor's Security Representative must submit for all employees each of the following:
* SF-85 Questionnaire for Non-Sensitive Positions * Two FD-258 Applicant Fingerprint Cards (or an electronic fingerprint submission) * Original Signed Release Statements
The contractor shall ensure each individual employee has a current favorably completed National Agency Check with Written Inquiries (NACI) or ensure successful
Failure to provide the required documentation at least 30 days prior to the individual's start date may result in delaying the individual's start date.
* Consult with your Command Security Manager and Information Assurance Manager for local policy when IT-III (non-sensitive) access is required for non-US citizens outside
DESCRIPTION/SPECIFICATION/WORK STATEMENT
1. Vendor must be able to provide full contract support immediately upon award of a resulting order. Vendor will provide full maintenance support for the items listed in Section B and all support items / components. This contract shall provide for maintenance services which include on-site corrective repairs, normal working hour coverage (
2 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 qualified / authorized by the OEM (IE: Certified Agent of the OEM) in the repair of all equipment listed within this contract. Certification of the OEM must be current (within 2 years) at all times prior to contract award and throughout contract period. Contractor and its employees shall maintain qualifications throughout entire contract period. In the event that a sub-contractor is used for this requirement, the sub-contractor must be a Certified Agent of the OEM. Qualification includes but not limited to the certification of all repair persons and repair facilities by the OEM as being trained / qualified to perform required repairs. The Government shall maintain the right to seek proof of qualification prior to award and anytime during contract period of performance. Additionally contractor must have ready access to parts inventory of OEM replacement parts. All replacement parts must be authorized / certified for use by the OEM. All Contractor employees must be qualified / authorized by the OEM (Certified OEM Technician) in the repair of all equipment listed within this contract. Certification of the OEM must be current (within 2 years) at all times prior to contract award and throughout contract period. Performance of maintenance or repair by persons that do not hold current OEM qualifications will not be allowed. Qualification includes but not limited to the certification of all repair persons / technicians and by the OEM (or OEM approved facility) as being trained / qualified to perform required repairs. Contractor must have direct access to current OEM publications and technical data including data detailing maintenance / operation oddities (IE: OEM Equipment History Data Base and
3. 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 manufacturers (OEM's) specifications.
d. Equipment and associated components shall be serviced as listed on: DD Form 1155, "Order for Supplies or Services".
e.
4. 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 whichever occurs first. All non-apparent / hidden discrepancies, must be identified no later than 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.
5. 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.
6. 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. Vendor is not responsible for consumable items.
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.
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. Replacement parts must maintain the integrity of system / equipment certification to include compliance with any UL, AMA, JACHO, Manufactures Certifications or any other certifications as they apply.
f. The Contractor must include software revisions and updates (field service changes), which are required due to
Specific Tasks.
7. 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. (Biomedical Engineering located in Build-250 1st floor; 757-953-5336). 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 Desk (Bldg 2, 2nd Floor) 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, 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.
8. 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.
9. 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 Manufacturers (OEM) recommendations.
b. The preventive maintenance visit shall be performed during the time mutually agreed upon between the Government and the Contractor.
(The Government Fiscal Year runs: October through September). The Contractor shall make a best effort to schedule and complete preventive maintenance services prior to the 15th of the selected month, but no later than the last day of the 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
10. Corrective Maintenance
a. Normal Working Hour Maintenance Coverage Maintenance Coverage will be Monday through Friday, between
b. 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.
c. 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.
e. 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.
f. 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
g. 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.
11. 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 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.
12. 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.
13. 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:
CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY 0001 Destination Government Destination Government 0002 Destination Government Destination Government 0003 Destination Government Destination Government 0004 Destination Government Destination Government 0005 Destination Government Destination Government 0006 Destination Government Destination Government Section F - Deliveries or Performance
DELIVERY INFORMATION
CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC 0001 POP
CLAUSES INCORPORATED BY REFERENCE
52.242-15 Stop-Work Order
CLAUSES INCORPORATED BY FULL TEXT
252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (
2 IN 1 SERVICES ONLY ----------------------------------------------------------------------- (2) Inspection/acceptance location. The Contractor shall select the following inspection/acceptance location(s) in WAWF, as specified by the contracting officer. DESTINATION / DESTINATION ----------------------------------------------------------------------- (3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in applicable fields in WAWF when creating payment requests and receiving reports in the system.
Routing Data Table*
(4) Payment request and supporting documentation. The Contractor shall ensure a payment request includes appropriate contract line item and subline item descriptions of the work performed or supplies delivered, unit price/cost per unit, fee (if applicable), and all relevant back-up documentation, as defined in DFARS Appendix F, (e.g. timesheets) in support of each payment request. (5) WAWF email notifications. The Contractor shall enter the email address identified below in the "Send Additional Email Notifications" field of WAWF once a document is submitted in the system.
WAWF Acceptor/COR Email Address: [email protected] -----------------------------------------------------------------------
(g) WAWF point of contact.
(1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity's WAWF point of contact. [email protected] -----------------------------------------------------------------------
(2) For technical WAWF help, contact the WAWF helpdesk at 866-618-5988. (End of clause)
Section H - Special Contract Requirements
CLAUSES INCORPORATED BY FULL TEXT
NMCARS 5237.102-90 Enterprise-wide Contractor Manpower Reporting Application (ECMRA) The contractor shall report contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the [NAMED COMPONENT] via a secure data collection site. Contracted services excluded from reporting are based on Product Service Codes (PSCs). The excluded PSCs are: (1) W, Lease/Rental of Equipment; (2) X, Lease/Rental of Facilities; (3) Y, Construction of Structures and Facilities; (4) S, Utilities ONLY; (5) V,
PRIVACY AND SECURITY OF PROTECTED HEALTH INFORMATION
1. Introduction
In accordance with
a. Definitions. As used in this clause generally refer to the Code of Federal Regulations (CFR) definition unless a more specific provision exists in
(1) HITECH Act shall mean the Health Information Technology for Economic and Clinical Health Act included in the American Recovery and Reinvestment Act of 2009.
(2) 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).
(3) Privacy Rule means the Standards for Privacy of Individually Identifiable Health Information at 45 CFR part 160 and part 164, subparts A and E.
(4) 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 Business Associate from or on behalf of the Government pursuant to the Contract.
(5) Electronic Protected Health Information has the same meaning as the term "electronic protected health information" in 45 CFR 160.103.
(6) Required by Law has the same meaning as the term "required by law" in 45 CFR 164.103.
(7) Secretary means the Secretary of the
(8) Security Incident will have the same meaning as the term "security incident" in 45 CFR 164.304, limited to the information created or received by Business Associate from or on behalf of Covered Entity.
(9) Security Rule means the Health Insurance Reform: Security Standards at 45 CFR part 160, 162 and part 164, subpart C.
(10) Terms used, but not otherwise defined, in this Clause shall have the same meaning as those terms in 45 CFR 160.103, 160.502, 164.103, 164.304, and 164.501.
b. The Business Associate 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 Business Associate shall use appropriate safeguards to maintain the privacy of the Protected Health Information and to prevent use or disclosure of the Protected Health Information other than as provided for by this Contract.
d. The HIPAA Security administrative, physical, and technical safeguards in 45 CFR 164.308, 164.310, and 164.312, and the requirements for policies and procedures and documentation in 45 CFR 164.316 shall apply to Business Associate. The additional requirements of Title XIII of the HITECH Act that relate to the security and that are made applicable with respect to covered entities shall also be applicable to Business Associate. The Business Associate 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 Business Associate shall, at their own expense, take action to mitigate, to the extent practicable, any harmful effect that is known to the Business Associate of a use or disclosure of Protected Health Information by the Business Associate in violation of the requirements of this Clause. These mitigation actions will include as a minimum those listed in the TMA Breach Notification Standard Operating Procedure (SOP), which is available at: http://www.tricare.mil/tmaprivacy/breach.cfm
f. The Business Associate shall report to the Government any security incident involving protected health information of which it becomes aware.
g. The Business Associate shall report to the Government any use or disclosure of the Protected Health Information not provided for by this Contract of which the Business Associate becomes aware.
h. The Business Associate shall ensure that any agent, including a sub Business Associate, to whom it provides Protected Health Information received from, or created or received by the Business Associate, on behalf of the Government, agrees to the same restrictions and conditions that apply through this Contract to the Business Associate with respect to such information.
i. The Business Associate shall ensure that any agent, including a subBusiness Associate, to whom it provides electronic Protected Health Information, agrees to implement reasonable and appropriate safeguards to protect it.
j. The Business Associate 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 Business Associate 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 Business Associate 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 Business Associate, 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 Business Associate 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 Business Associate 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.
2. General Use and Disclosure Provisions
Except as otherwise limited in this Clause, the Business Associate 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,
3. Specific Use and Disclosure Provisions
a. Except as otherwise limited in this Clause, the Business Associate may use Protected Health Information for the proper management and administration of the Business Associate or to carry out the legal responsibilities of the Business Associate. b. Except as otherwise limited in this Clause, the Business Associate may disclose Protected Health Information for the proper management and administration of the Business Associate, provided that disclosures are required by law, or the Business Associate 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 Business Associate 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 Business Associate 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. Business Associate may use Protected Health Information to report violations of law to appropriate Federal and State authorities, consistent with 45 CFR 164.502(j)(1).
4. Obligations of the Government
Provisions for the Government to Inform the Business Associate of Privacy Practices and Restrictions
a. The Government shall provide the Business Associate with the notice of privacy practices that the Government produces in accordance with 45 CFR 164.520.
b. The Government shall provide the Business Associate with any changes in, or revocation of, permission by Individual to use or disclose Protected Health Information, if such changes affect the Business Associate's permitted or required uses and disclosures.
c. The Government shall notify the Business Associate 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.
5. Permissible Requests by the Government
The Government shall not request the Business Associate 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,
6. Termination
a. Termination. A breach by the Business Associate of this clause, may subject the Business Associate 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 Business Associate shall return or destroy all Protected Health Information received from the Government, or created or received by the Business Associate on behalf of the Government. This provision shall apply to Protected Health Information that agents of the Business Associate may come in contact. The Business Associate shall retain no copies of the Protected Health Information.
(3) If this contract does not have records management provisions and the Business Associate determines that returning or destroying the Protected Health Information is infeasible, the Business Associate shall provide to the Government notification of the conditions that make return or destruction infeasible. Upon mutual agreement of the Government and the Business Associate that return or destruction of Protected Health Information is infeasible, the Business Associate 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 Business Associate maintains such Protected Health Information.
7. Miscellaneous
a. Regulatory References. A reference in this Clause to a section in
c. Interpretation. Any ambiguity in this Clause shall be resolved in favor of a meaning that permits the Government to comply with
CLAUSES INCORPORATED BY REFERENCE
52.203-3 Gratuities
CLAUSES INCORPORATED BY FULL TEXT
52.219-6 NOTICE OF TOTAL SMALL BUSINESS SET-ASIDE (
(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
(End of clause)
52.232-18 AVAILABILITY OF FUNDS (
Funds are not presently available for this contract. The Government's obligation under this contract is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise until funds are made available to the Contracting Officer for this contract and until the Contractor receives notice of such availability, to be confirmed in writing by the Contracting Officer.
(End of clause)
52.232-39 UNENFORCEABILITY OF UNAUTHORIZED OBLIGATIONS (
(a) Except as stated in paragraph (b) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:
(1) Any such clause is unenforceable against the Government.
(2) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an "I agree'' click box or other comparable mechanism (e.g., "click-wrap'' or "browse-wrap'' agreements), execution does not bind the Government or any Government authorized end user to such clause.
(3) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.
(b) Paragraph (a) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.
(End of clause)
52.252-2 CLAUSES INCORPORATED BY REFERENCE (
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):
FAR Clauses http://acquisition.gov/comp/far/index.htm
DFAR Clauses http://www.acq.osd.mil/dpap/dars/dfars/index.htm
(End of clause)
252.203-7999 PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE CERTAIN INTERNAL CONFIDENTIALITY AGREEMENTS (DEVIATION 2015-O0010)(
252.204-7006 BILLING INSTRUCTIONS (
When submitting a request for payment, the Contractor shall--
(a) Identify the contract line item(s) on the payment request that reasonably reflect contract work performance; and
(b) Separately identify a payment amount for each contract line item included in the payment request.
(End of clause)
252.232-7001 DISPOSITION OF PAYMENTS (
Payment will be by a dual payee
(End of clause) Section K - Representations, Certifications and Other Statements of Offerors
CLAUSES INCORPORATED BY REFERENCE
52.225-18 Place of Manufacture
CLAUSES INCORPORATED BY FULL TEXT
52.204-3 TAXPAYER IDENTIFICATION (
(a) Definitions.
Common parent, as used in this provision, means that corporate entity that owns or controls an affiliated group of corporations that files its Federal income tax returns on a consolidated basis, and of which the offeror is a member.
Taxpayer Identification Number (TIN), as used in this provision, means the number required by the
(b) All offerors must submit the information required in paragraphs (d) through (f) of this provision to comply with debt collection requirements of 31 U.S.C. 7701(c) and 3325(d), reporting requirements of 26 U.S.C. 6041, 6041A, and 6050M, and implementing regulations issued by the
(c) The TIN may be used by the Government to collect and report on any delinquent amounts arising out of the offeror's relationship with the Government (31 U.S.C. 7701(c)(3)). If the resulting contract is subject to the payment reporting requirements described in FAR 4.904, the TIN provided hereunder may be matched with
(d) Taxpayer Identification Number (TIN).
___ TIN:.--------------------------------------------------------
___ TIN has been applied for.
___ TIN is not required because:
___ Offeror is a nonresident alien, foreign corporation, or foreign partnership that does not have income effectively connected with the conduct of a trade or business in
___ Offeror is an agency or instrumentality of a foreign government;
___ Offeror is an agency or instrumentality of the Federal Government.
(e) Type of organization.
___ Sole proprietorship;
___ Partnership;
___ Corporate entity (not tax-exempt);
___ Corporate entity (tax-exempt);
___ Government entity (Federal, State, or local);
___ Foreign government;
___ International organization per 26 CFR 1.6049-4;
___ Other--------------------------------------------------------
(f) Common parent.
___ Offeror is not owned or controlled by a common parent as defined in paragraph (a) of this provision.
___ Name and TIN of common parent:
Name-------------------------------------------------------------------
TIN--------------------------------------------------------------------
(End of provision)
52.204-20 Predecessor of Offeror (
(a) Definitions. As used in this provision-- Commercial and Government Entity (CAGE) code means--
(1) An identifier assigned to entities located in
52.222-25 AFFIRMATIVE ACTION COMPLIANCE (
The offeror represents that
(a) [ ] it has developed and has on file, [ ] has not developed and does not have on file, at each establishment, affirmative action programs required by the rules and regulations of the Secretary of Labor (41 CFR 60-1 and 60-2), or
(b) [ ] has not previously had contracts subject to the written affirmative action programs requirement of the rules and regulations of the Secretary of Labor.
(End of provision)
252.204-7007 ALTERNATE A, ANNUAL REPRESENTATIONS AND CERTIFICATIONS (
Substitute the following paragraphs (d) and (e) for paragraph (d) of the provision at FAR 52.204-8: (d)(1) The following representations or certifications in the System for Award Management (SAM) database are applicable to this solicitation as indicated: (i) 252.209-7003,
(iv) 252.225-7042, Authorization to Perform. Applies to all solicitations when performance will be wholly or in part in a foreign country.
(v) 252.225-7049, Prohibition on Acquisition of Commercial Satellite Services from Certain Foreign Entities--Representations. Applies to solicitations for the acquisition of commercial satellite services.
(vi) 252.225-7050, Disclosure of Ownership or Control by the Government of a Country that is a State Sponsor of Terrorism. Applies to all solicitations expected to result in contracts of
(ix) 252.247-7022, Representation of Extent of Transportation by Sea. Applies to all solicitations except those for direct purchase of ocean transportation services or those with an anticipated value at or below the simplified acquisition threshold. (2) The following representations or certifications in SAM are applicable to this solicitation as indicated by the Contracting Officer: [Contracting Officer check as appropriate.] ____ (i) 252.209-7002, Disclosure of Ownership or Control by a Foreign Government. ____ (ii) 252.225-7000, Buy American--Balance of Payments Program Certificate. ____ (iii) 252.225-7020, Trade Agreements Certificate. ____ Use with Alternate I. ____ (iv) 252.225-7031, Secondary Arab Boycott of
____ Use with Alternate IV.
____ Use with Alternate V. (e) The offeror has completed the annual representations and certifications electronically via the SAM Web site at https://www.acquisition.gov/. After reviewing the SAM database information, the offeror verifies by submission of the offer that the representations and certifications currently posted electronically that apply to this solicitation as indicated in FAR 52.204-8(c) and paragraph (d) of this provision have been entered or updated within the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer, and are incorporated in this offer by reference (see FAR 4.1201); except for the changes identified below ____ [offeror to insert changes, identifying change by provision number, title, date]. These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.
FAR/DFARS Clause # Title Date Change
Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications located in the SAM database.
(End of provision)
Section L - Instructions, Conditions and Notices to Bidders
CLAUSES INCORPORATED BY REFERENCE
52.204-16 Commercial and Government Entity Code Reporting
CLAUSES INCORPORATED BY FULL TEXT
52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (
This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):
(End of provision)
SECTION SF 30 BLOCK 14 CONTINUATION PAGE SUMMARY OF CHANGES
SECTION A - SOLICITATION/CONTRACT FORM The required response date/time has changed from
SECTION B - SUPPLIES OR SERVICES AND PRICES
To:
Nomenclature: Medical SimulatorManufacturer: Simbionix
To:
Nomenclature: Medical SimulatorManufacturer: Simbionix
To:
Nomenclature: Medical SimulatorManufacturer: Simbionix
To:
Nomenclature: Medical SimulatorManufacturer: Simbionix
To:
Nomenclature: Medical SimulatorManufacturer: Simbionix
To:
Nomenclature: Medical SimulatorManufacturer: Simbionix
(End of Summary of Changes)
Link/URL: https://www.fbo.gov/spg/DON/BUMED/N00183/N00183-16-T-0213/listing.html
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