N0018318Q0117.docx

N0018318Q0117

Section A - Solicitation/Contract Form

CONTRACT INFORMATION

VENDOR TO COMPLETE THE FOLLOWING:

POINTS FO CONTACT

Naval Medical Center Portsmouth Points of Contact:

Name: Shannon Caldow Phone: 757-953-5056 Fax: 757-953- 5738 E-Mail: shannon.m.caldow.civ@mail.mil

REQUEST FOR QUOTE INFORMATION & EVALUATUION FACTORS

Vendor to reference Request for Quotation (RFQ) Number N0018318Q0117 on all correspondence relating to this RFQ

The government will make an award based on an “All or None” evaluation and/or based on the “Best Value” proposed for this requirement. All factors and required documents are listed in Section M of this RFQ. Failure to provide all requested information/documents will deem your proposal to be non-responsive.

PAYMENT INFORMATION

Payment in Arrears (Check One): Monthly Quarterly Semi-Annually Annually *Please ensure that quoted price matches the choice above

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

Maintenance OR Tables

FFP

Service to be performed in accordance with Performance Work Statement in Section C.

Department: CID FOB: Destination

MILSTRIP: N0018319RC4V015

PURCHASE REQUEST NUMBER: N0018319RC4V015

PSC CD: J065

NET AMT

Maintenance OR Tables

Service to be performed in accordance with Performance Work Statement in Section C.

Department: LABOR & DELIVERY (L&D) FOB: Destination

PURCHASE REQUEST NUMBER: N0018319RCLD001

NET AMT

Maintenance OR Tables

Service to be performed in accordance with Performance Work Statement in Section C.

Department: PLASTIC SURGERY O/P FOB: Destination

PURCHASE REQUEST NUMBER: N0018319RCPL002

NET AMT

Maintenance OR Tables

Service to be performed in accordance with Performance Work Statement in Section C.

Department: EMERGENCY ROOM DEPARTMENT FOB: Destination

PURCHASE REQUEST NUMBER: N0018319RCER001

NET AMT

Maintenance OR Tables

Service to be performed in accordance with Performance Work Statement in Section C.

Department: MAIN OPERATING ROOM (MOR) FOB: Destination

PURCHASE REQUEST NUMBER: N0018319RCSU007

NET AMT

Maintenance OR Tables

Service to be performed in accordance with Performance Work Statement in Section C.

Department: AMBULATORY SURGERY (ASC) FOB: Destination

MILSTRIP: N0018319RC9E011

PURCHASE REQUEST NUMBER: N0018319RC9E011

NET AMT

FFP

Service to be performed in accordance with Performance Work Statement in Section C.

Department: CID FOB: Destination

MILSTRIP: N0018319RC4V015

NET AMT

FFP

Service to be performed in accordance with Performance Work Statement in Section C.

Department: LABOR & DELIVERY (L&D) FOB: Destination

NET AMT

FFP

Service to be performed in accordance with Performance Work Statement in Section C.

Department: PLASTIC SURGERY O/P

NET AMT

FFP

Service to be performed in accordance with Performance Work Statement in Section C.

Department: EMERGENCY ROOM DEPARTMENT

NET AMT

FFP

Service to be performed in accordance with Performance Work Statement in Section C.

Department: MAIN OPERATING ROOM (MOR)

NET AMT

FFP

Service to be performed in accordance with Performance Work Statement in Section C.

Department: AMBULATORY SURGERY (ASC)

NET AMT

FFP

Service to be performed in accordance with Performance Work Statement in Section C.

Department: CID

NET AMT

FFP

Service to be performed in accordance with Performance Work Statement in Section C.

Department: LABOR & DELIVERY (L&D)

NET AMT

FFP

Service to be performed in accordance with Performance Work Statement in Section C.

Department: PLASTIC SURGERY O/P

NET AMT

FFP

Service to be performed in accordance with Performance Work Statement in Section C.

Department: EMERGENCY ROOM DEPARTMENT

NET AMT

FFP

Service to be performed in accordance with Performance Work Statement in Section C.

Department: MAIN OPERATING ROOM (MOR)

NET AMT

FFP

Service to be performed in accordance with Performance Work Statement in Section C.

Department: AMBULATORY SURGERY (ASC)

NET AMT

Section C - Descriptions and Specifications

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT

MAINTENANCE SERVICE AGREEMENT – OPERATING TABLES

This contract shall provide full maintenance services 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 (8:00 A.M. to 4:30 P.M. Monday through Friday excluding Federal holidays) and 24-hour emergency service and routine preventive maintenance services to Department of Defense owned equipment. It shall include all systems, subsystem components, and assemblies, (i.e.: contractor responsible for total maintenance of entire system). All maintenance provisions shall apply to hardware, firmware, and software, as appropriate, unless otherwise stated. Selected vendor must provide technical assistance and telephone support 24 hours a day, 7 days per week.

1. General

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

b. The Contractor shall be fully qualified / authorized by the Original Equipment Manufacturer (OEM) in the repair of all equipment listed within this contract. Contractor shall maintain current 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.

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

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

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

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

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

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, the designated POC for Biomedical Engineering (See Section A) must approve the use of rebuilt parts and sub-assemblies prior to ordering and installing. Uses of rebuilt parts 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 prior to departure. (Biomedical Engineering located in Building-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 duty Biomedical Engineer (BME) via cell phone 757-544-4506 to provide status of service performed, including PMs and corrective maintenance.

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, 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. The 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 from BME.

8. Preventive Maintenance Services.

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

b. The Contractor shall schedule and complete preventive maintenance services prior to the 15th of the selected month.

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

9. Corrective Maintenance

a. Normal Working Hour Maintenance Coverage Maintenance Coverage will be Monday through Friday, between 8:00 A.M. to 4:30 P.M. A contractor Service Tech shall respond via telephone within 2 hours after receipt of trouble call, and provide on-site service no later than the close of business (4:30 pm) on the next business day. Equipment shall be operational within 48 hours.

b. Government request for corrective maintenance will be placed by BME, to the Contractor’s POC listed above. 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:

· Provide instruction in determining operator error

· Determine the most likely cause of the problem

· Determine if resolution of the problem requires the dispatch of a FSE

· 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.

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 will be required to sign a Government form accepting responsibility for the Government equipment. The Contractor shall provide a detailed description and quantities of items to be removed. Description shall include manufacturer’s serial numbers and equipment control number (ECN). 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. In the event that that contractor determines the equipment must be moved to an alternate location for repair, the Contractor is responsible for transporting the equipment to the alternate location and returning the repair equipment back to the Government site.

11. Equipment Modification Upgrades

a. The Contractor shall only incorporate OEM specified modifications, alterations and upgrades. Approval shall be obtained from BME COR 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 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. The Contractor shall state why this existence or development is not within scope.

PERIODS OF PERFORMANCE

Base Year Period of Performance: 01 October 2018 – 30 September 2019 Option Year 1 Period of Performance: 01 October 2019 – 30 September 2020 Option Year 2 Period of Performance: 01 October 2020 – 30 September 2021

EQUIPMENT LIST

Option Year 1 Cost

Option Year 2 Cost

Option Year 1 Cost

Option Year 2 Cost

Option Year 1 Cost

Option Year 2 Cost

Option Year 1 Cost

Option Year 2 Cost

Option Year 1 Cost

Option Year 2 Cost

Option Year 1 Cost

Option Year 2 Cost

CONTRACTOR UNCLASSIFIED ACCESS

Contractor Unclassified Access to Federally Controlled Facilities, Sensitive Information, Information Technology (IT) Systems or Protected Health Information (Jan 2017)

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 November 26, 2008 (or its subsequent DoD instruction) directs implementation of HSPD-12. This clause is in accordance with HSPD-12 and its implementing directives.

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 DoD computer/network/system to perform certain unclassified sensitive duties. This clause also applies to contractor employees who access Privacy Act and Protected Health Information, provide support associated with fiduciary duties, or perform duties that have been identified as National Security Position, as advised by the command security manager. It is the responsibility of the responsible security officer of the command/facility where the work is performed to ensure compliance.

Each contractor employee providing services at a Navy Command under this contract is required to obtain a Department of Defense Common Access Card (DoD CAC). Additionally, depending on the level of computer/network access, the contract employee will require a successful investigation as detailed below.

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 DoD networks are categorized as IT-I, IT-II, or IT-III. The IT-II level, defined in detail in SECNAV M-5510.30, includes positions which require access to information protected under the Privacy Act, to include Protected Health Information (PHI). All contractor employees under this contract who require access to Privacy Act protected information are therefore categorized no lower than IT-II. IT Levels are determined by the requiring activity’s Command Information Assurance Manager.

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 Navy command and shall out-process prior to their departure at the completion of the individual’s performance under the contract. Completion and approval of a System Authorization Access Request Navy (SAAR-N) form is required for all individuals accessing Navy Information Technology resources. The decision to authorize access to a government IT system/network is inherently governmental. The contractor supervisor is not authorized to sign the SAAR-N; therefore, the government employee with knowledge of the system/network access required or the COR shall sign the SAAR-N as the “supervisor”.

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 DoD unclassified computer/network upon a favorable review of the investigative questionnaire and advance favorable fingerprint results. When the results of the investigation are received and a favorable determination is not made, the contractor employee working on the contract under interim access will be denied access to the computer network and this denial will not relieve the contractor of his/her responsibility to perform.

DENIAL OR TERMINATION OF ACCESS

The potential consequences of any requirement under this clause including denial or termination of physical or system access in no way relieves the contractor from the requirement to execute performance under the contract within the timeframes specified in the contract. Contractors shall plan ahead in processing their employees and subcontractor employees. The contractor shall insert this clause in all subcontracts when the subcontractor is permitted to have unclassified access to a federally controlled facility, federally-controlled information system/network and/or to government information, meaning information not authorized for public release.

CONTRACTOR’S SECURITY REPRESENTATIVE

The contractor shall designate an employee to serve as the Contractor’s Security Representative. Within three work days after contract award, the contractor shall provide to the requiring activity’s Security Manager and the Contracting Officer, in writing, the name, title, address and phone number for the Contractor’s Security Representative. The Contractor’s Security Representative shall be the primary point of contact on any security matter. The Contractor’s Security Representative shall not be replaced or removed without prior notice to the Contracting Officer and Command Security Manager.

BACKGROUND INVESTIGATION REQUIREMENTS AND SECURITY APPROVAL PROCESS FOR CONTRACTORS ASSIGNED TO NATIONAL SECURITY POSITIONS OR PERFORMING SENSITIVE DUTIES

Navy security policy requires that all positions be given a sensitivity value based on level of risk factors to ensure appropriate protective measures are applied. Contractor employees under this contract are recognized as Non-Critical Sensitive [ADP/IT-II] positions when the contract scope of work require physical access to a federally controlled base, facility or activity and/or requiring access to a DoD computer/network, to perform unclassified sensitive duties. This designation is also applied to contractor employees who access Privacy Act and Protected Health Information (PHI), provide support associated with fiduciary duties, or perform duties that have been identified as National Security Positions. At a minimum, each contractor employee must be a US citizen and have a favorably completed NACLC or T3 or T3R equivalent investigation to obtain a favorable determination for assignment to a non-critical sensitive or IT-II position. The investigation consists of a standard NAC and a FBI fingerprint check plus law enforcement checks and credit check. Each contractor employee filling a non-critical sensitive or IT-II position is required to complete:

· 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 System Authorization Access Request Navy (SAAR-N) form is required for all individuals accessing Navy Information Technology resources. The SAAR-N shall be forwarded to the Navy Command’s Security Manager at least 30 days prior to the individual’s start date. Failure to provide the required documentation at least 30 days prior to the individual’s start date shall result in delaying the individual’s start date.

The contractor shall ensure that each contract employee requiring access to IT systems or networks complete annual Information Assurance (IA) training, and maintain a current requisite background investigation. Contractor employees shall accurately complete the required investigative forms prior to submission to the Command Security Manager. The Command’s Security Manager will review the submitted documentation for completeness prior to submitting it to the Office of Personnel Management (OPM); Potential suitability or security issues identified may render the contractor employee ineligible for the assignment. An unfavorable determination is final (subject to SF-86 appeal procedures) and such a determination does not relieve the contractor from meeting any contractual obligation under the contract. The Command’s Security Manager will forward the required forms to OPM for processing. Once the investigation is complete, the results will be forwarded by OPM to the DoD Central Adjudication Facility (CAF) for a determination.

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.

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

30-SEP-2019

BIOMEDICAL ENGINEERING

54 LEWIS MINOR STREET

BLDG. 250

PORTSMOUTH VA 23708-2297

757-953-5336

N00183

30-SEP-2019

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30-SEP-2019

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30-SEP-2019

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30-SEP-2019

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30-SEP-2019

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30-SEP-2020

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30-SEP-2020

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30-SEP-2020

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30-SEP-2020

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30-SEP-2020

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30-SEP-2020

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30-SEP-2021

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30-SEP-2021

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30-SEP-2021

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30-SEP-2021

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30-SEP-2021

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30-SEP-2021

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NMCP DOCK HOURS

Naval Medical Center Portsmouth (NMCP) Receiving Dock Hours of Operation:

NMCP Receiving Dock is open Monday through Friday 0700 to 1600 (7:00 a.m. to 4:00 p.m.), excluding federal holidays. Receiving personnel may be reached at 757-953-5770.

Section G - Contract Administration Data

Section H - Special Contract Requirements

PRIVACY & SECURITY OF PHI

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…