Stryker Power System Service
Notice Type: Combine Solicitation
Posted Date:
Office Address:
Subject: Stryker Power System Service
Classification Code: J - Maintenance, repair & rebuilding of equipment
Solicitation Number: N0018318Q0138
Contact:
Setaside: Total Small BusinessTotal Small Business
Place of Performance (address):
Place of Performance (zipcode): 23708
Place of Performance Country: US
Description:
Section A - Solicitation/Contract Form CONTRACTOR INFORMATION 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 N0018318Q0138 on all inquires.
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.
Vendor Note: 1. Government to award on an "all-or-none" basis. 2. Award to be best value for the Government based upon past performance and price. 3. Vendor's past performance shall include history of maintenance and service on the items listed in Section B of this solicitation.
Section B - Supplies or Services and Prices
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 12 Months Maintenance, service & repair FFP for Stryker Power System. See Section C for Performance Work Statement and for items. NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide
NET AMT
Section C - Descriptions and Specifications
PERFORMANCE WORK STATEMENT DESCRIPTION/SPECIFICATION/WORK STATEMENT
Statement of Work Selected 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 (
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 Original Equipment Manufacturer (OEM) in the repair of all equipment listed within this contract. Contractor shall maintain qualifications throughout entire contract period. 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. Qualifications must be current (within 2 years) The Government shall maintain the right to seek proof of qualification prior to award and anytime during contract period of performance.
2. Scope of Work
a. The Contractor shall provide trained, experienced, English speaking personnel, labor, tools, diagnostic equipment, software, test phantoms, material, supplies, transportation, parts and equipment necessary to perform Preventive Maintenance (PM), Calibration (CAL), Safety testing (ST) and corrective maintenance.
b. The Contractor shall provide telephonic communications with the Government to discuss technical matters relating to the performance of this contract. A systems operator will be made available to answer technical questions regarding system operations and applications.
c. Equipment listed in this contract will be maintained to meet the original equipment manufacturer's (OEM's) specifications.
d. Equipment and associated components shall be serviced as listed on: DD Form 1155, "Order for Supplies or Services".
e.
3. Government furnished property, Materials and Services.
a. The Contractor representative(s) at each site is encouraged to request a pre-maintenance inspection prior to the onset of the contract. As all apparent discrepancies must be identified upon submittal of quote, any and all claims must be received within 30 days of contract award or prior to contract start which ever occurs first. All non-apparent / hidden discrepancies, must be identified no later that the first scheduled preventative maintenance. Any claims resulting from hidden defects must be received within 30 days of first scheduled preventative maintenance. Any equipment found to be inoperable during this pre-maintenance inspection would be repaired using a separate purchase order. The cost of repairs shall not exceed contractor's normal retail rate for required repairs. The government certifies that the equipment to be maintained under this contract will be in good operating condition on the effective date of this contract. For the purpose of this contract, the clause, "good operating condition" means the conditions necessary for the equipment to function as intended without corrective maintenance. The Contractor agrees to leave the equipment in good operating condition at the expiration of this contract. During the final week of this contract, the Government will make final inspection of the equipment. Any correction of deficiencies noted during this inspection shall be resolved prior to contract end. The Government reserves the right to request the repair (at no additional cost to the Government) of items identified with latten defects after contract termination, when it has been determined that defects either are a result of contractor's performance or should have been discovered during normal performance of work under this contract.
b. The government will be responsible for maintaining the proper environment, including utilities and site requirements necessary for the system to function properly as specified by the OEM.
c. The Government will operate the system in accordance with the instruction manual provided by the OEM.
d. The Government will not be responsible for the damage or loss due to fire, theft, accident, or other disaster of Contractor supplies, materials, or for the personal belongings brought onto Government property by Contractor's personnel.
4. Contractor Furnished Property and Material.
a. The Contractor shall provide all service literature, reference publications, laptop computers and diagnostic software to be used by the contractor service technicians and as required for the completion of the services in accordance with this contract.
5. Replacement Parts.
a. The Contractor shall have ready access to unique and/or high mortality replacement parts. All parts supplied shall be compatible with the existing system. In the event that replacements parts are required to be shipped. Shipping shall be performed in the fastest reasonable means possible (i.e., next day air) at no additional cost to the Government.
b. The Contractor shall at their expense, replace all worn or defective parts necessary to restore the equipment to 100% operational condition as specified by the OEM.
c. Contractor installed replacement parts shall become the property of the Government and the replaced malfunctioning part shall become the property of the Contractor. Replaced items shall be properly disposed of at no additional cost to the Government (contractor to pay all "environmental fees" where required).
d. Freight, postage, and storage charges associated with shipment and receipt of replacement parts, and the return of parts shall be the responsibility of the Contractor.
e. All replacement parts shall be new and certified as OEM replacement parts. In the event that new parts are not available, rebuilt parts and sub-assemblies are allowed provided that they are warranted to be free of defects for a period of time that meets or exceeds warranties of similar replacement parts. The contractor shall specifically annotate on the final Field Service report the use and identification of rebuilt parts and the period of warranty. When discrepancies occur, the Government will make the final determination on whether a replacement part is of equal or better quality.
f. The Contractor must include software revisions and updates (field service changes), which are required due to FDA, or manufacturer announced safety-hazard recall, to include FDA Year 2000 Compliance Directive, as part of the contract at no additional cost to the Government. Updates shall be performed as soon as possible after release, but no later than the first scheduled Preventative Maintenance Inspection after release. For any updates that have been identified as critical, or required for the proper operation of equipment by the OEM, contractor shall provide installation within 30 days of release regardless of Preventative Maintenance Schedules.
Specific Tasks.
6. Contractor Report Requirements.
a. During normal duty hours, Contracted Field Service Engineer (FSE) personnel shall check-in with the Biomedical Engineering Division upon arrival at the Government site and again prior to departure. (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 and the hourly rate normally charged for the type of service performed, model and serial numbers, and the name of the FSE performing the service. In the event that agents / sub-contractor's are used in the performance of repairs, said agent shall be identified on the service report by company name and contact information (i.e., telephone number). Additionally contractor will be required to affix a tag on equipment upon the completion of a preventative maintenance inspection. Tag may either be a "sticker" or "hanging tag". As a minimum the tag shall contain: the name of the contractor, technician performing inspection and date of inspection legibly printed.
7. Contractor Responsibility.
a. The Contractor shall be responsible for the repair/replacement of damaged Government owned equipment and property due to the negligence of the Contractor or his representatives. All such replacement or repair shall be at the Contractor's expense and shall be inspected to the satisfaction of the KO or appointed representative.
8. Preventive Maintenance Services.
a. In accordance with Naval Medical Logistics Command (NAVMEDLOGCOM) Risk Assessment Criteria, preventive maintenance is not required but shall be performed at time of any major repair.
b. The Government shall select the months in which preventive maintenance services are to be performed. The preventive maintenance visits shall be performed during the following months: Not Required
(The Government Fiscal Year runs: October through September). The Contractor shall schedule and complete preventive maintenance services prior to the 15th of the selected month.
c. All test equipment used in the performance of this contract must be calibrated (if required / as required by manufacture of test equipment) and shall be in compliance with
9. Corrective Maintenance
a. Normal Working Hour Maintenance Coverage Maintenance Coverage will be Monday through Friday, between
a. In the event that emergency service outside the normal working hours are required by the Government, additional work shall be billable to the Government at published commercial rates, and negotiated and approved by a Contracting Officer prior to services rendered.
b. Government request for corrective maintenance will be placed by BME, to the Contractor's POC. Corrective Maintenance shall be completed during the hours specified in the contract.
c. The Contractor shall assign a unique Log/Reference Number to each Government request for corrective Maintenance.
d. Contractor's response to requests for service may include telephone consultation with the equipment user/operator and a Contractor FSE. Telephone consultation shall: 1) provide instruction in determining operator error; 2) to determine the most likely cause of the problem; 3) to determine if resolution of the problem requires the dispatch of a FSE; and 4) to identify replacement parts likely to be required in order to return the equipment to 100% operational condition as specified by the OEM.
e. Contractor's pricing shall be inclusive of all cost including parts, labor, travel and shipping, unless otherwise indicated. Any/all exclusions are listed as follows:
No Exclusions
f. The Contractor shall have his/her own service manuals, specifications, schematic diagrams, and parts lists to assist in the evaluation/repair of all equipment included in this contract.
10. Removal of Government Property
a. Whenever the repair of equipment cannot be performed at the Government site as determined by the Contractor, the Contractor shall notify BME who will make arrangements for the Contractor to remove the item to the Contractor's designated site. The Contractor may be required to sign a Government form accepting responsibility for the Government equipment. The Contractor shall provide a detailed description of removed items. For associated items / accessories, contractor to provide a detailed description and quantities of items to be removed. Description to include as a minimum manufacturers serial numbers and equipment control number (ECN) of all equipment / items removed. In the event that items / sub-assemblies / accessories are repaired via "Repair by Replacement" a detailed description of replaced items is to be included upon return of repaired components.
b. All charges resulting from a Contractor determined requirement to transport Government owned property, covered by this contract, to and from an alternate repair location shall be the responsibility of the Contractor.
11. Equipment Modification Upgrades
a. The Contractor shall only incorporate OEM specified modifications, alterations and upgrades. Approval shall be obtained from BME prior to the Contractor installation of any modification, alteration, or upgrades.
b. The Contractor shall maintain contact with the OEM to determine the requirement for field modifications and to ensure accomplishment of these modifications in accordance with the time schedule set forth by the OEM.
c. The Government shall not alter the system without prior notification to the Contractor.
d. The contractor at no additional cost shall provide software updates to the Government. Installation of updates will be left to the discretion of the Government. All supplied software is to be warranted current and free of defects such as viruses.
12. Service Beyond the Scope of the Contract
a. The Contractor shall immediately, but not later than 24 consecutive hours after discovery, notify BME, in writing, of the existence or the development of any defects in, or repair required to the scheduled equipment, which the Contractor considers they are not responsible for under the terms of this contract.
b. At the same time of the notification, the Contractor shall furnish BME with written estimate of the cost to make the necessary repairs. Repairs considered by the Contracting Officer to be outside the scope of this contract shall not be covered under this contract, but shall be ordered under a separate purchase order.
Stryker Instruments:
air Items Exhibit A - Section A Repair Items Exhibit A - Section A Product# Description Serial # Product# Description Serial # Main OR 6208-000-000 System 6 Sagittal Saw 0725406863 4300-000-000 Cordless Driver 3 1116013663 6208-000-000 System 6 Sagittal Saw 1121002943 4300-000-000 Cordless Driver 3 1116013713 6209-000-000 System 6 Precision 1122323513 4300-000-000 Cordless Driver 3 1116013673 6400-015-000 RemB Micro Drill 1114602363 5400-015-000 CORE
Product# Description Serial # Product# Description Serial # 5400-099-000 CORE U Driver 0430700533 5100-088-000 TPS Micro Driver 98050643 5400-099-000 CORE U Driver 0505300533 5400-015-000 CORE
Product# Description Serial # Product# Description Serial # 7110-120-000 Universal Charger 1312903193 7206-000-000 System 7 Recip Saw 1425208343 7110-120-000 Universal Charger 1315004973 7206-000-000 System 7 Recip Saw 1425208603 7110-120-000 Universal Charger 1315004983 7206-000-000 System 7 Recip Saw 1425804883 7110-120-000 Universal Charger 1315004993 7206-000-000 System 7 Recip Saw 1425804923 7110-120-000 Universal Charger 1315005003 7206-000-000 System 7 Recip Saw 1425804933 7110-120-000 Universal Charger 1315700443 7206-000-000 System 7 Recip Saw 1425804963 5400-015-000 CORE
Procare Instruments for ASC Department Drivers Core driver Rem B Driver Cordless Battery Driver (CD4) 1314201503 1315604933 0-814801233 1315503853 1315604863 0-412500283 1315604943 1310705773 0-530601113 0-321902023 1311402713 0-613511693 0-435501033 1120100793 0-427300953 Sagittal Saw Core Rem B 1314007443 1314211903 0815706383 1310105753 0-924600193 1314211913 0412600903 1314007453 0-600304993 1314007143 0-610903773 1310106003 1316817463 0-430602293 1310105763 1310105743 1310105993 1314211893 Oscillating Saw Core Rem B 1315000883 1215100143 1315401353 0-600907413 1315401273 0-713403363 1315401433 1315401423 1315401343 1315401293 1315401303 1114602023 1315401283 1315401443 1312601503 1315401453 1315401413 1315401263 1314908263 Reciprocating Saw Rem B 1309802043 1309802103 1307710293 1309802233 1309802213 1309802023 1309801933 1309802053 1309802033 1309801923 4609802223 1309801943 1309801913 Micro Drill Core Rem B 0-425704493 1316816293 0-716401363 1315002603 0-816103413 1316816353 0-920900823 1315002613 0-924601423 1319209033 0-920900843 1315002643 0-412500403 1316816363 0-816103403 1316816303 0-613512133 1316816313 0-523801293 1315002583 0-725704063 1316816373 0-610903833 1315002623 0-918900033 1316816323 1402402813 1316816283 0726015413 1315002633 0920900823 1316816253 0610903813 0920900863
CONTRACTOR UNCLASSIFIED ACCESS 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 text applies to contractor employees requiring physical access to any area of a federally controlled base, facility or activity and/or requiring access to a DoN or
ACCESS TO FEDERAL FACILITIES
Per HSPD-12 and implementing guidance, all contractor employees working at a federally controlled base, facility or activity under this clause will require a DoD CAC. When access to a base, facility or activity is required contractor employees shall in-process with the Command's Security Manager upon arrival to the Command and shall out-process prior to their departure at the completion of the individual's performance under the contract.
ACCESS TO DOD IT SYSTEMS
In accordance with SECNAV M-5510.30, contractor employees who require access to DoN or
Contractor employees requiring privileged or IT-I level access, (when specified by the terms of the contract) require a Single Scope Background Investigation (SSBI) or T5 or T5R equivalent investigation , which is a higher level investigation than the National Agency Check with Law and Credit (NACLC)/T3/T3R described below. Due to the privileged system access, an investigation suitable for High Risk national security positions is required. Individuals who have access to system control, monitoring, or administration functions (e.g. system administrator, database administrator) require training and certification to Information Assurance Technical Level 1, and must be trained and certified on the Operating System or Computing Environment they are required to maintain.
Access to sensitive IT systems is contingent upon a favorably adjudicated background investigation. When access to IT systems is required for performance of the contractor employee's duties, such employees shall in-process with the Navy Command's Security Manager and Information Assurance Manager upon arrival to the
The SAAR-N shall be forwarded to the Command's Security Manager at least 30 days prior to the individual's start date. Failure to provide the required documentation at least 30 days prior to the individual's start date may result in delaying the individual's start date. When required to maintain access to required IT systems or networks, the contractor shall ensure that all employees requiring access complete annual Information Assurance (IA) training, and maintain a current requisite background investigation. The Contractor's Security Representative shall contact the Command Security Manager for guidance when reinvestigations are required.
INTERIM ACCESS
The Command's Security Manager may authorize issuance of a DoD CAC and interim access to a DoN or
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
* SF-86 Questionnaire for National Security Positions (or equivalent OPM investigative product) * Two FD-258 Applicant Fingerprint Cards (or an electronic fingerprint submission) * Original Signed Release Statements
Failure to provide the required documentation at least 30 days prior to the individual's start date shall result in delaying the individual's start date. Background investigations shall be reinitiated as required to ensure investigations remain current (not older than 10 years) throughout the contract performance period. The Contractor's Security Representative shall contact the Command Security Manager for guidance when reinvestigations are required.
Regardless of their duties or IT access requirements ALL contractor employees shall in-process with the Command's Security Manager upon arrival to the command and shall out-process prior to their departure at the completion of the individual's performance under the contract. Employees requiring IT access shall also check-in and check-out with the Navy Command's Information Assurance Manager. Completion and approval of a
If the contractor employee already possesses a current favorably adjudicated investigation, the contractor shall submit a Visit Authorization Request (VAR) via the Joint Personnel Adjudication System (JPAS) or a hard copy VAR directly from the contractor's Security Representative. Although the contractor will take JPAS "Owning" role over the contractor employee, the Command will take JPAS "Servicing" role over the contractor employee during the hiring process and for the duration of assignment under that contract. The contractor shall include the IT Position Category per SECNAV M-5510.30 for each employee designated on a VAR. The VAR requires annual renewal for the duration of the employee's performance under the contract.
NMCARS 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
(1) W, Lease/Rental of Equipment; (2) X, Lease/Rental of Facilities; (3) Y, Construction of Structures and Facilities; (4) D,
The contractor is required to completely fill in all required data fields using the following web address https://www.ecmra.mil.
Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs
(End of Text) 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 Section F - Deliveries or Performance
DOCK DELIVERY Naval Medical Center Portsmouth (NMCP) Receiving
DELIVERY INFORMATION
CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC / CAGE 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 FOR SERVICES ----------------------------------------------------------------------- (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 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
PRIVACY & SECURITY OF PHI 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
BASE ACCESS Base Access (NMCP) Commander, Navy Installations Command (CNIC), has established the Navy Commercial Access Control System (NCACS), a standardized process for granting unescorted access privileges to vendors, contractors, suppliers and service providers not otherwise entitled to the issuance of a Common Access Card (CAC) who seek access to and can provide justification to enter
CLAUSES INCORPORATED BY REFERENCE
52.203-3 Gratuities
CLAUSES INCORPORATED BY FULL TEXT
52.203-18 PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE CERTAIN INTERNAL CONFIDENTIALITY AGREEMENTS OR STATEMENTS--REPRESENTATION (
(End of provision)
52.203-19 PROHIBITION ON REQUIRING CERTAIN INTERNAL CONFIDENTIALITY AGREEMENTS OR STATEMENTS (
(End of clause)
52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL ITEMS (
The offeror shall complete only paragraphs (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) Web site located at https://www.sam.gov/portal. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (u) of this provision. (a) Definitions. As used in this provision-- "Economically disadvantaged women-owned small business (EDWOSB) concern" means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of
___ ___
___ ___
[List as necessary] (3) The Government will evaluate offers in accordance with the policies and procedures of FAR Part 25. (g) (1) Buy American -- Free Trade Agreements -- Israeli Trade Act Certificate. (Applies only if the clause at FAR 52.225-3, Buy American -- Free Trade Agreements -- Israeli Trade Act, is included in this solicitation.) (i) The offeror certifies that each end product, except those listed in paragraph (g)(1)(ii) or (g)(1)(iii) of this provision, is a domestic end product and that for other than COTS items, the offeror has considered components of unknown origin to have been mined, produced, or manufactured outside
___ ___
___ ___
[List as necessary] (iii) The offeror shall list those supplies that are foreign end products (other than those listed in paragraph (g)(1)(ii) or this provision) as defined in the clause of this solicitation entitled "Buy American-Free Trade Agreements-Israeli Trade Act." The offeror shall list as other foreign end products those end products manufactured in
___ ___
___ ___
[List as necessary] (iv) The Government will evaluate offers in accordance with the policies and procedures of FAR Part 25. (2) Buy American-Free Trade Agreements-Israeli Trade Act Certificate, Alternate I. If Alternate I to the clause at FAR 52.225-3 is included in this solicitation, substitute the following paragraph (g)(1)(ii) for paragraph (g)(1)(ii) of the basic provision: (g)(1)(ii) The offeror certifies that the following supplies are Canadian end products as defined in the clause of this solicitation entitled "Buy American-Free Trade Agreements-Israeli Trade Act": Canadian End Products: Line Item No.: ___ [List as necessary] (3) Buy American-Free Trade Agreements-Israeli Trade Act Certificate, Alternate II. If Alternate II to the clause at FAR 52.225-3 is included in this solicitation, substitute the following paragraph (g)(1)(ii) for paragraph (g)(1)(ii) of the basic provision: (g)(1)(ii) The offeror certifies that the following supplies are Canadian end products or Israeli end products as defined in the clause of this solicitation entitled "Buy American--Free Trade Agreements--Israeli Trade Act'': Canadian or Israeli End Products: Line Item No.: Country of Origin: ___ ___
___ ___
___ ___
[List as necessary] (4) Buy American-Free Trade Agreements-Israeli Trade Act Certificate, Alternate III. If Alternate III to the clause at 52.225-3 is included in this solicitation, substitute the following paragraph (g)(1)(ii) for paragraph (g)(1)(ii) of the basic provision: (g)(1)(ii) The offeror certifies that the following supplies are Free Trade Agreement country end products (other than Bahrainian, Korean, Moroccan, Omani, Panamanian, or Peruvian end products) or Israeli end products as defined in the clause of this solicitation entitled "Buy American-Free Trade Agreements-Israeli Trade Act": Free Trade Agreement Country End Products (Other than Bahrainian, Korean, Moroccan, Omani, Panamanian, or Peruvian End Products) or Israeli End Products: Line Item No.: Country of Origin: ___ ___
___ ___
___ ___
[List as necessary] (5) Trade Agreements Certificate. (Applies only if the clause at FAR 52.225-5, Trade Agreements, is included in this solicitation.) (i) The offeror certifies that each end product, except those listed in paragraph (g)(5)(ii) of this provision, is a
___ ___
___ ___
[List as necessary] (iii) The Government will evaluate offers in accordance with the policies and procedures of FAR Part 25. For line items covered by the WTO GPA, the Government will evaluate offers of
___ ___
___ ___
(2) Certification. [If the Contracting Officer has identified end products and countries of origin in paragraph (i)(1) of this provision, then the offeror must certify to either (i)(2)(i) or (i)(2)(ii) by checking the appropriate block.] [ ___ ] (i) The offeror will not supply any end product listed in paragraph (i)(1) of this provision that was mined, produced, or manufactured in the corresponding country as listed for that product. [ ___ ] (ii) The offeror may supply an end product listed in paragraph (i)(1) of this provision that was mined, produced, or manufactured in the corresponding country as listed for that product. The offeror certifies that is has made a good faith effort to determine whether forced or indentured child labor was used to mine, produce, or manufacture any such end product furnished under this contract. On the basis of those efforts, the offeror certifies that it is not aware of any such use of child labor. (j) Place of manufacture. (Does not apply unless the solicitation is predominantly for the acquisition of manufactured end products.) For statistical purposes only, the offeror shall indicate whether the place of manufacture of the end products it expects to provide in response to this solicitation is predominantly- (1) [ ___ ] In
(1) The Offeror represents that it [ ___ ] has or [ ___ ] does not have an immediate owner. If the Offeror has more than one immediate owner (such as a joint venture), then the Offeror shall respond to paragraph (2) and if applicable, paragraph (3) of this provision for each participant in the joint venture.
(2) If the Offeror indicates "has" in paragraph (p)(1) of this provision, enter the following information: Immediate owner CAGE code: ____________________. Immediate owner legal name: _____________________. (Do not use a "doing business as" name) Is the immediate owner owned or controlled by another entity: ____ Yes or ____ No.
(3) If the Offeror indicates "yes" in paragraph (p)(2) of this provision, indicating that the immediate owner is owned or controlled by another entity, then enter the following information: Highest-level owner CAGE code: __________________. Highest-level owner legal name: ___________________. (Do not use a "doing business as" name)
(q) Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law.
(1) As required by sections 744 and 745 of Division E of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235), and similar provisions, if contained in subsequent appropriations acts, The Government will not enter into a contract with any corporation that-
(i) Has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, where the awarding agency is aware of the unpaid tax liability, unless an agency has considered suspension or debarment of the corporation and made a determination that suspension or debarment is not necessary to protect the interests of the Government; or
(ii) Was convicted of a felony criminal violation under any Federal law within the preceding 24 months, where the awarding agency is aware of the conviction, unless an agency has considered suspension or debarment of the corporation and made a determination that this action is not necessary to protect the interests of the Government.
(2) The Offeror represents that-
(i) It is ____ is not ____ a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability; and
(ii) It is ____ is not ____ a corporation that was convicted of a felony criminal violation under a Federal law within the preceding 24 months.
(r) Predecessor of Offeror. (Applies in all solicitations that include the provision at 52.204-16, Commercial and Government Entity Code Reporting.) (1) The Offeror represents that it [ ___ ] is or [ ___ ] is not a successor to a predecessor that held a Federal contract or grant within the last three years. (2) If the Offeror has indicated "is'' in paragraph (r)(1) of this provision, enter the following information for all predecessors that held a Federal contract or grant within the last three years (if more than one predecessor, list in reverse chronological order): Predecessor CAGE code: ____ (or mark "Unknown''). Predecessor legal name: ____. (Do not use a "doing business as'' name).
(t) Public Disclosure of Greenhouse Gas Emissions and Reduction Goals. Applies in all solicitations that require offerors to register in SAM (52.212-1(k)). (1) This representation shall be completed if the Offeror received
(u)(1) In accordance with section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions), Government agencies are not permitted to use appropriated (or otherwise made available) funds for contracts with an entity that requires employees or subcontractors of such entity seeking to report waste, fraud, or abuse to sign internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information.
(2) The prohibition in paragraph (u)(1) of this provision does not contravene requirements applicable to Standard Form 312 (Classified Information Nondisclosure Agreement), Form 4414 (Sensitive Compartmented Information Nondisclosure Agreement), or any other form issued by a Federal department or agency governing the nondisclosure of classified information.
(3) Representation. By submission of its offer, the Offeror represents that it will not require its employees or subcontractors to sign or comply with internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting waste, fraud, or abuse related to the performance of a Government contract to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information (e.g., agency
(End of provision)
52.219-28 POST-AWARD SMALL BUSINESS PROGRAM REREPRESENTATION (
(a) Definitions. As used in this clause--
Long-term contract means a contract of more than five years in duration, including options. However, the term does not include contracts that exceed five years in duration because the period of performance has been extended for a cumulative period not to exceed six months under the clause at 52.217-8, Option to Extend Services, or other appropriate authority.
Small business concern 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 criteria in 13 CFR part 121 and the size standard in paragraph (c) of this clause. Such a concern is "not dominant in its field of operation'' when it does not exercise a controlling or major influence on a national basis in a kind of business activity in which a number of business concerns are primarily engaged. In determining whether dominance exists, consideration shall be given to all appropriate factors, including volume of business, number of employees, financial resources, competitive status or position, ownership or control of materials, processes, patents, license agreements, facilities, sales territory, and nature of business activity.
(b) If the Contractor represented that it was a small business concern prior to award of this contract, the Contractor shall rerepresent its size status according to paragraph (e) of this clause or, if applicable, paragraph (g) of this clause, upon the occurrence of any of the following:
(1) Within 30 days after execution of a novation agreement or within 30 days after modification of the contract to include this clause, if the novation agreement was executed prior to inclusion of this clause in the contract.
(2) Within 30 days after a merger or acquisition that does not require a novation or within 30 days after modification of the contract to include this clause, if the merger or acquisition occurred prior to inclusion of this clause in the contract.
(3) For long-term contracts--
(i) Within 60 to 120 days prior to the end of the fifth year of the contract; and
(ii) Within 60 to 120 days prior to the date specified in the contract for exercising any option thereafter.
(c) The Contractor shall rerepresent its size status in accordance with the size standard in effect at the time of this rerepresentation that corresponds to the North American Industry Classification System (NAICS) code assigned to this contract. The small business size standard corresponding to this NAICS code can be found at http://www.sba.gov/content/table-small-business-size-standards.
(d) The small business size standard for a Contractor providing a product which it does not manufacture itself, for a contract other than a construction or service contract, is 500 employees.
(e) Except as provided in paragraph (g) of this clause, the Contractor shall make the representation required by paragraph (b) of this clause by validating or updating all its representations in the Representations and Certifications section of the System for Award Management (SAM) and its other data in SAM, as necessary, to ensure that they reflect the Contractor's current status. The Contractor shall notify the contracting office in writing within the timeframes specified in paragraph (b) of this clause that the data have been validated or updated, and provide the date of the validation or update.
(f) If the Contractor represented that it was other than a small business concern prior to award of this contract, the Contractor may, but is not required to, take the actions required by paragraphs (e) or (g) of this clause.
(g) If the Contractor does not have representations and certifications in SAM, or does not have a representation in SAM for the NAICS code applicable to this contract, the Contractor is required to complete the following rerepresentation and submit it to the contracting office, along with the contract number and the date on which the rerepresentation was completed:
The Contractor represents that it ( ) is, ( ) is not a small business concern under NAICS Code - assigned to contract number.
(Contractor to sign and date and insert authorized signer's name and title).
(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)
52.252-1 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)
52.252-2 CLAUSES INCORPORATED BY REFERENCE (
(End of clause)
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)
52.222-25 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) Section L - Instructions, Conditions and Notices to Bidders
CLAUSES INCORPORATED BY REFERENCE
52.214-34 Submission Of Offers In The English Language
Link/URL: https://www.fbo.gov/spg/DON/BUMED/N00183/N0018318Q0138/listing.html
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