N0018320Q0001_BUNNELL.docx

N0018320Q0001

Section A - Solicitation/Contract Form

**This is notification of a pending Sole Source Award to Bunnell Infant Care Life Pulse Ventilators and Patient Boxes**

VENDOR: Bunnell Incorporated

EMAIL:

Naval Medical Center Contracting:

POC: Christopher Ward Phone: 757-953-3412 Fax: 757-953-5738 Email: christopher.s.ward1.civ@mail.mil

Vendor to reference contract number (PO#) ****** on all inquiries including invoices and shipping documents.

Product/Services for:

Naval Medical Center Portsmouth

POC:

Phone:

Email:

Payment will be paid ***** In Arrears; Please Select 1 option

Monthly -- Payment in arrears after 30 days

Quarterly -- Payment in arrears

Semi Anuually -- Payment in arrears 2x a year

Annually -- Payment in arrears after 1 year of service

Note: Vendor will be required to provide billing electronically via the WAWF Electronic Invoicing Method per Section G of this RFQ. For additional information, a review of the following web sites may be required: Websites: https://wawf.eb.mil http://wawftraining Email: usn.detrick.navmedlogcomftdmd.list.nmlc-wawf@mail.mil

PROMPT PAYMENT: For Prompt Payment Act purposes, this contract is:

Subject to the 7-calendar day constructive acceptance period. This contract is subject to the Availability of funds clause 52.232-18 listed in full text in the Clause section of this contract.

Section B - Supplies or Services and Prices

Bunnell Life Pulse Ventilator Maintenanc

FFP

Bunnell to provide preventative maintenance and service on all componets of the Life Pulse Ventilators and Patient Boxes every 2,000.00 operating hours or a minimum once a year

**See Performance Work Statement and Equipment List for Details** FOB: Destination

MILSTRIP: N0018320RC34002

PURCHASE REQUEST NUMBER: N0018320RC34002

PSC CD: J065

NET AMT

Section C - Descriptions and Specifications

PERFORMANCE WORK STATEMENT

This contract shall provide full maintenance services for the listed equipment to include any accessories. This contract shall provide corrective repairs and preventive maintenance. It shall include systems, system components, and their assembly parts (i.e.: contractor responsible for total maintenance of entire system). All maintenance provisions shall apply to hardware, firmware, and software, as appropriate, unless otherwise stated.

1. General

a. The Contractor shall comply with HIPAA and DoD Business Associate Agreement as applicable to the performance of this contract.

b. OEM Bunnell shall be fully qualified as the Original Equipment Manufacturer (OEM) in the repair of all equipment listed within this contract. 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.

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. The Contractor will provide the name and phone number of a Government point of contact within 5 business days after receipt of award. A Contractor’s 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. The Contractor Point of Contact (POC). The Contractor shall provide in writing the name and telephone number of a primary and alternate English-speaking individual to act as their representative for the scheduling and coordination of service calls, and to be responsible for the coordination of the contract with the Government. The contractor shall provide contact information within 5 business days after contract award. In the event a replacement is made, the contractor shall provide the replacement’s contact information within 5 business days

3. Government furnished property, Materials and Services.

a. 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 operate the system in accordance with the instruction manual provided by the OEM.

c. 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. OEM Bunnell 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. OEM Bunnell 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 with Next Day Air at no additional cost to the Government. If Next Day is not available, then contractor shall ship by the next fastest means.

b. OEM Bunnell 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. OEM Bunnell 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 OEM Bunnell.

e. All replacement parts shall be new and certified as OEM replacement parts. In the event that new parts are not available, the COR must approve the use of rebuilt parts and sub-assemblies prior to ordering and installing. The use of rebuilt parts is 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. OEM Bunnell 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.

6. Contractor Report Requirements.

a. OEM Bunnell shall provide to NMCP a full service report within two (2) days after completion of all service performed. The service report shall include, but not be limited to: equipment description (model, serial number, equipment control number) detailed description of the service(s) performed, replacement part(s) information (part number, nomenclature, and whether the part is new/used/reconditioned), the completion date and time, 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”. The tag shall contain: the date when next service is required.

7. Contractor Responsibility.

a. OEM Bunnell shall be responsible for the repair/replacement of damaged Government owned equipment and property due to the negligence of the Contractor or his representatives.

All such replacement or repair shall be at the Contractor’s expense and shall be inspected to the satisfaction of the KO or appointed representative.

8. Preventive Maintenance Services.

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

b. The preventive maintenance shall be performed in accordance with an annual graduated maintenance plan developed between the Contractor and the BIOMED department prior to commencement of the Fiscal Year.

OEM Bunnell shall schedule and complete preventive maintenance services as near as possible to the 15th . FEBRUARY

c. During each scheduled preventive maintenance performed during the Base and each Option Year, the Contractor shall replace all worn or defective parts as required to complete the preventive maintenance.

d. All test equipment used in the performance of this contract must be calibrated (if required / as required by manufacture of test equipment) and shall be in compliance with Joint Commission on Accreditation of Healthcare Organizations (JCAHO), Original Equipment Manufacturer (OEM) and Federal Drug Administration (FDA) standards as required by Bureau of Medicine and Surgery (BUMED) Equipment Management Manual NAVMED P-5132 (CH-1, rev.1-2008).

9. Corrective Maintenance

a. Government request for corrective maintenance will be placed by BME, to the Contractor’s POC.

b. OEM Bunnell shall assign a unique Log/Reference Number to each Government request for Corrective Maintenance.

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

d. OEM Bunnell pricing shall be inclusive of all cost including parts, and shipping, with Bunnell paying shipping of loaner devices to hospital, and paying to return hospital’s equipment.

Government agrees to pay for return of it’s devices to Bunnell, and return of loaner devices to Bunnell.

f. OEM Bunnell 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. The repair of equipment cannot be performed at the Government site as OEM Bunnell does not provide this service. Bunnell shall provide a detailed description and quantities to NMCP of all equipment to be shipped to and from the location in which maintenance is performed. A Description shall include manufacturer’s serial numbers 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.

11. Equipment Modification Upgrades

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

b. The OEM Bunnell shall determine the requirement for 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 OEM Bunnell.

d. OEM Bunnell 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. OEM Bunnell shall immediately, but not later than 24 consecutive hours after discovery, notify NMCP, in writing, of the existence or the development of any defects in, or repair required to the scheduled equipment, which the OEM Bunnell considers they are not responsible for under the terms of this contract. The Contractor shall state why this existence or development is not within scope.

1. Schedule of Maintenance and Service

Preventive maintenance on all components of the LifePulse® Ventilator and Patient Box should be completed every 2,000 Operating Hours, or a Minimum of Once a Year.

Preventive maintenance and routine service will be provided for a period of one or more years from the date of this agreement as indicated by the number of years of coverage specified in Section VIII.

1. Maintenance To Be Provided

1. Calibration of the:

Ventilator and/or Patient Box

1. Physical Inspection and replacement, if necessary, of components including but not limited to the following:

Inspect Ventilator Exterior Inspect Ventilator Interior Replace Input Gas Filter Inspect / Replace PVC Gas Pathway Tubing Inspect / Replace Humidifier PBC Contact Pins Inspect / Replace Gas Check Valve Inspect / Clean Pulse Width Modulation Valves Inspect / Clean Fan Filter Inspect Humidifier Door Latch Inspect / Align Humidifier Door Inspect Wiring Harness, Cables, and terminations

Inspect Patient Box Exterior Inspect Patient Box Interior Inspect Patient Box Cable assembly Inspect Patient Box Solenoid assembly Replace Solenoid Assembly Isolator, Stand-Offs Service and Lubricate Solenoid Assembly Bearings Inspect Patient Box Transducer PCB assembly

1. Verification Testing, Calibration, and replacement, if necessary, of components including but not limited to the following:

Ventilator Processor Functionality Verification Front Panel Controls Verification Ventilator Driver Functionality Verification Airway Pressure Calibration Servo Pressure Calibration Humidifier Processor Functionality Verification Cartridge / Circuit Temperature Calibration Ventilator Display Driver / Display LED Functionality Verification Ventilator Alarms Functionality Verification Water Pump Operational Verification Input Gas Pressure Switch Calibration Ventilator Operational Verification

Patient Box Pinch Valve Head Alignment Verification Patient Box Pinch Gap Verification / Adjustment Patient Box Pinch Pressure Verification / Adjustment Patient Box Purge Valve Operational Verification Patient Box Transducer PCB assembly Airway Pressure Calibration Patient Box Operational Verification

1. Routine Service

Bunnell will repair and replace without charge any non-working parts or components that fail from routine operation during the term of this contract. In the event such repairs and replacements are necessitated by negligence, misuse or abuse of the Equipment by anyone other than Bunnell or its employees, the cost of such repair and replacement will be bore by the Owner.

1. Pre-Contract Inspection

Prior to Bunnell’s honoring the terms and conditions of the Agreement, Bunnell will perform an inspection of the Equipment to determine its operational condition. The Owner agrees to bear the cost of repairs necessary to correct any operating faults of the Equipment, unless the Equipment is currently under warranty. If it is not currently under warranty, such repairs, even if covered under Section II above, will be borne by the Owner if in the opinion of Bunnell and its employees the unit will not operate according to its published specifications without the repairs.

1. Loaner Equipment

Bunnell Incorporated will provide a loaner for use by the hospital while preventive maintenance or service is being performed on the Equipment described in Section XVI. The loaner unit will be provided at no charge to the hospital, provided that the following conditions are strictly adhered to:

0. Prior to maintenance: the unit to receive preventive maintenance or service must be received at Bunnell Incorporated within five (5) working days of receipt, by the hospital, of the loaner unit.

0. After maintenance: the loaner unit must be received at Bunnell Incorporated within 5 working days of receipt, by the hospital, of the hospital’s refurbished unit.

The hospital agrees that, if it fails to comply with the conditions stated above, it will pay Bunnell Incorporated a rental fee for the loaner unit in the amount equal to the current rental structure at the time of the loan, beginning with the date the loaner was shipped to the hospital; including return shipping charges.

1. Freight charges and Handling

Bunnell Incorporated will pay for the cost of shipping:

0. The loaner unit to the Owner, and

0. The serviced unit to the Owner.

The Owner will pay for the costs of shipping:

0. The Owner’s unit to Bunnell Incorporated, and

0. The loaner unit to Bunnell Incorporated.

All shipments are to be made in a Bunnell authorized shipping carton via next day air or an equivalent service. The use of surface transportation is not recommended and may result in damage.

1. Cost

The hospital agrees to pay $3,360 per ventilator (HFV) and $330 per Patient Box (PB) for one year of coverage for the services described in Sections II and III. The Owner further agrees to pay any and all rental charges which may arise as a result of failure to return units to Bunnell Incorporated as described in Sections VI, VII, and VIII.

Payment or a purchase order must accompany the unit being returned for pre-contract certification.

Product Covered

Bunnell Incorporated agrees to provide preventive maintenance and service, as described above, on:

Total HFVs: A 8 Total PBs: B 14

Number of year’s coverage: 1

Beginning on 1 January 2020 and ending 31 December 2020 (To be completed by Bunnell)

Section E - Inspection and Acceptance

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLAUSES INCORPORATED BY REFERENCE

Section F - Deliveries or Performance

DELIVERY INFORMATION

31-DEC-2020

RECEIVING OFFICER

54 LEWIS MINOR STREET

BLDG. 250

PORTSMOUTH VA 23708-2297

757-953-5770 FOB: Destination N00183

Section G - Contract Administration Data

CLAUSES INCORPORATED BY FULL TEXT

252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (DEC 2018)

(a) Definitions. As used in this clause—

“Department of Defense Activity Address Code (DoDAAC)” is a six position code that uniquely identifies a unit, activity, or organization.

“Document type” means the type of payment request or receiving report available for creation in Wide Area WorkFlow (WAWF).

“Local processing office (LPO)” is the office responsible for payment certification when payment certification is done external to the entitlement system.

“Payment request” and “receiving report” are defined in the clause at 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(b) Electronic invoicing. The WAWF system provides the method to electronically process vendor payment requests and receiving reports, as authorized by Defense Federal Acquisition Regulation Supplement (DFARS) 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(c) WAWF access. To access WAWF, the Contractor shall—

(1) Have a designated electronic business point of contact in the System for Award Management at https://www.sam.gov; and

(2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration available at this web site.

(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training Course and use the Practice Training Site before submitting payment requests through WAWF. Both can be accessed by selecting the “Web Based Training” link on the WAWF home page at https://wawf.eb.mil/.

(e) WAWF methods of document submission. Document submissions may be via web entry, Electronic Data Interchange, or File Transfer Protocol.

(f) WAWF payment instructions. The Contractor shall use the following information when submitting payment requests and receiving reports in WAWF for this contract or task or delivery order:

(1) Document type. The Contractor shall submit payment requests using the following document type(s):

(i) For cost-type line items, including labor-hour or time-and-materials, submit a cost voucher.

(ii) For fixed price line items—

(A) That require shipment of a deliverable, submit the invoice and receiving report specified by the Contracting Officer.

(Contracting Officer: Insert applicable invoice and receiving report document type(s) for fixed price line items that require shipment of a deliverable.)

(B) For services that do not require shipment of a deliverable, submit either the Invoice 2in1, which meets the requirements for the invoice and receiving report, or the applicable invoice and receiving report, as specified by the Contracting Officer.

(Contracting Officer: Insert either “Invoice 2in1” or the applicable invoice and receiving report document type(s) for fixed price line items for services.)

(iii) For customary progress payments based on costs incurred, submit a progress payment request.

(iv) For performance based payments, submit a performance based payment request.

(v) For commercial item financing, submit a commercial item financing request.

(2) Fast Pay requests are only permitted when Federal Acquisition Regulation (FAR) 52.213-1 is included in the contract.

[Note: The Contractor may use a WAWF “combo” document type to create some combinations of invoice and receiving report in one step.]

(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*

(*Contracting Officer: Insert applicable DoDAAC information. If multiple ship to/acceptance locations apply, insert “See Schedule” or “Not applicable.”) (**Contracting Officer: If the contract provides for progress payments or performance-based payments, insert the DoDAAC for the contract administration office assigned the functions under FAR 42.302(a)(13).)

(4) Payment request. The Contractor shall ensure a payment request includes documentation appropriate to the type of payment request in accordance with the payment clause, contract financing clause, or Federal Acquisition Regulation 52.216-7, Allowable Cost and Payment, as applicable.

(5) Receiving report. The Contractor shall ensure a receiving report meets the requirements of DFARS Appendix F.

(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.

(Contracting Officer: Insert applicable information or “Not applicable.”)

(2) Contact the WAWF helpdesk at 866-618-5988, if assistance is needed.

(End of clause)

Section H - Special Contract Requirements

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) D, Automatic Data Processing and Telecommunications, IT and Telecom- Telecommunications Transmission (D304) and Internet (D322) ONLY;

(5) S, Utilities ONLY;

(6) V, Freight and Shipping ONLY.

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 October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year. Contractors may direct questions to the help desk, linked at https://www.ecmra.mil.

(End of Text)

PRIVACY AND SECURITY OF PROTECTED HEALTH INFORMATION

1. Introduction

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

a. Definitions. As used in this clause generally refer to the Code of Federal Regulations (CFR) definition unless a more specific provision exists in DoD 6025.18-R or DoD 8580.02.

(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 Department of Health and Human Services or his/her designee.

(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, DoD 6025.18-R or DoD 8580.02 if done by the Government. The additional requirements of Title XIII of the HITECH Act that relate to privacy and that are made applicable with respect to covered entities shall also be applicable to Business Associate.

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, DoD 6025.18-R and DoD 8580.02) if done by the Government, except for providing Data Aggregation services to the Government and for management and administrative activities of the Business Associate as otherwise permitted by this clause.

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 DoD 6025.18-R, DoD 8580.02, Privacy Rule or Security Rule means the section currently in effect or as amended, and for which compliance is required.

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

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

VENDORMATE

Vendormate Credentialing Requirement Naval Medical Center, Portsmouth (NMCP) has instituted a Credentialing Program which is designed to streamline the collection and management of key information regarding the regulatory and compliance status as well as business operations of our suppliers.

The program requires all vendors and their representatives to register in order to gain base access to NMCP. One nominal annual credentialing fee covers your company as well as all representatives of your company that interact with NMCP.

The price ranges from $25 to $250 per year depending on your company’s risk profile and is paid directly to our partner, Vendormate Credentialing. It is imperative that each representative registers individually to maintain their personal credentials and ensure ongoing base access to our facility.

A Federal Tax Identification Number and a credit card are required to complete the initial registration. Additional representatives only need the Federal Tax Identification Number.

Register for Vendormate Credentialing at https://nmcp.vendormate.com.

For technical questions, go to https://ghx.com/customer-care.

Kiosks are located on the first and second floor entrances of Building two (2). Your representatives who visit NMCP may be required to sign in electronically to obtain an identification badge. With a valid appointment and current credentials, your representative will be able to print a single-use badge that is to be worn throughout the visit to any NMCP facility. Badges are required for all vendors on premises.

Please note that GHX Vendormate Credentialing is in addition to RapidGate for Base Access. Vendors are required to register for both programs in order to come onboard the NMCP base.

Section I - Contract Clauses

CLAUSES INCORPORATED BY FULL TEXT

52.203-18 PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE CERTAIN INTERNAL CONFIDENTIALITY AGREEMENTS OR STATEMENTS--REPRESENTATION (JAN 2017)

(a) Definition. As used in this provision-- Internal confidentiality agreement or statement, subcontract, and subcontractor, are defined in the clause at 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements.

(b) 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 funds appropriated (or otherwise made available) 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.

(c) The prohibition in paragraph (b) 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.

(d) 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 Office of the Inspector General).

(End of provision)

52.203-19 PROHIBITION ON REQUIRING CERTAIN INTERNAL CONFIDENTIALITY AGREEMENTS OR STATEMENTS (JAN 2017)

(a) Definitions. As used in this clause-- Internal confidentiality agreement or statement means a confidentiality agreement or any other written statement that the contractor requires any of its employees or subcontractors to sign regarding nondisclosure of contractor information, except that it does not include confidentiality agreements arising out of civil litigation or confidentiality agreements that contractor employees or subcontractors sign at the behest of a Federal agency.

Subcontract means any contract as defined in subpart 2.1 entered into by a subcontractor to furnish supplies or services for performance of a prime contract or a subcontract. It includes but is not limited to purchase orders, and changes and modifications to purchase orders.

Subcontractor means any supplier, distributor, vendor, or firm (including a consultant) that furnishes supplies or services to or for a prime contractor or another subcontractor.

(b) The Contractor shall 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 Office of the Inspector General).

(c) The Contractor shall notify current employees and subcontractors that prohibitions and restrictions of any preexisting internal confidentiality agreements or statements covered by this clause, to the extent that such prohibitions and restrictions are inconsistent with the prohibitions of this clause, are no longer in effect.

(d) The prohibition in paragraph (b) of this clause 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.

(e) 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) use of funds appropriated (or otherwise made available) is prohibited, if the Government determines that the Contractor is not in compliance with the provisions of this clause.

(f) The Contractor shall include the substance of this clause, including this paragraph (f), in subcontracts under such contracts.

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS--COMMERCIAL ITEMS (AUG 2019)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L.