RFQ 20Q00142 glucose strips and controls.docx

N0018320Q0142

Section A - Solicitation/Contract Form

VENDOR TO COMPLETE THE FOLLOWING:

Vendor Name: ___________

CAGE:

DUNS:

TIN:

Vendor Point of Contact:

Vendor Address: __________________________________________________

Vendor Phone:

Vendor Fax:

Vendor E-Mail:

Vendor to reference Open Market Quote N0018320Q0142 on all correspondence relating to this RFQ.

Naval Medical Center Portsmouth Contracting Point of Contact:

Lahonda Carter-Graves E-Mail: LAHONDA.R.CARTER-GRAVES.civ@mail.mil (questions via e-mail only)

Payment in Arrears (Check One): ___ Monthly ___ Quarterly ___Semi-Annually ___Annually

Note: Payment for all supplies/services will be in arrears. Vendor may choose to invoice monthly, quarterly, semi-annually or annually. Invoice shall be submitted on or after the selected period of performance end date. (i.e., if annually is selected, vendor will not receive payment until the end of the period of performance date). Invoice payments are made Net 30 days upon certification in WAWF.

Note: Vendor will be required to provide billing electronically via the WAWF Electronic Invoicing Method. For additional information, a review of the following web sites may be required: 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.

Government reserves the right to make award based on the “Best Value” proposed for this requirement. Vendors will be evaluated based on the factors listed below (in order of importance).

1. Technical Capability

2. Past Performance

3. Pricing

Vendor MUST include information for the evaluation factors above, meet minimum requirements in Section C and proof of pricing, i.e., past invoices.

Pursuant to FAR 52.232-18 – AVALIABILITY 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.

NOTE TO BIDDERS:

Vendor required to quote bid as stated.

The government will make the award based on “all or none” determination and/or based on a “Best Value” determination.

Best Value evaluation factors are technical capability (ability to provide items as specified), delivery, price and past performance with each factor weighted equally. A contractor with superior past performance history for contracts the same or similar to the scope and magnitude of the items/services described by this solicitation may be given 1st consideration. In addition, priority consideration will be given to federal supply schedule holders quoting items under GSA/FSS contracts. The government reserves the right to eliminate quotes, without discussion that are deemed technically unacceptable. Technically unacceptable offers are not eligible for contract award.

Section B - Supplies or Services and Prices

STATSTRIP GLUCOSE STRIPS

FFP

42214 STATSTRIPS (1.800 TEST STRIPS/CASE)

SHIP 12 CASES ON 1 OCT 2020 AND 12 CASES EACH QUARTER

1 JAN, 1 APR, AND 1 JUL

FOB: Destination

PURCHASE REQUEST NUMBER: 0011519790

PSC CD: 6515

NET AMT

STATSTRIP GLUCOSE STRIPS

FFP

41741 CONTROL SOLUTION 1 STAT STRIP (1 BOTTLE PER PACKAGE)

SHIP 75 BOTTLES ON OCT 1 2021 AND 12 CASES EACH QUARTER

1 JAN, 1 APR, AND 1 JUL

SEND MOST RECENT PRODUCED PRODUCT FOR LONGEST USAGE.

FOB: Destination

NET AMT

FFP

42214 STATSTRIPS (1.800 TEST STRIPS/CASE)

SHIP 12 CASES ON oct1 202 AND 12 CASES EACH QUARTER

1 JAN, 1 APR, AND 1 JUL

NET AMT

FFP

42214 STATSTRIPS (1.800 TEST STRIPS/CASE)

SHIP 12 CASES ON 1 OCT 2922 AND 12 CASES EACH QUARTER

1 JAN, 1 APR, AND 1 JUL

NET AMT

FFP

42214 STATSTRIPS (1.800 TEST STRIPS/CASE)

SHIP 12 CASES ON1 OCT 2023 AND 12 CASES EACH QUARTER

1 JAN, 1 APR, AND 1 JUL

NET AMT

FFP

42214 STATSTRIPS (1.800 TEST STRIPS/CASE)

SHIP 12 CASES ON1 OCT 2024 AND 12 CASES EACH QUARTER

1 JAN, 1 APR, AND 1 JUL

NET AMT

FFP

41741 CONTROL SOLUTION 1 STAT STRIP (1 BOTTLE PER PACKAGE)

SHIP 75 BOTTLES ON OCT 1 2021 AND 12 CASES EACH QUARTER

1 JAN, 1 APR, AND 1 JUL

SEND MOST RECENT PRODUCED PRODUCT FOR LONGEST USAGE.

NET AMT

FFP

41741 CONTROL SOLUTION 1 STAT STRIP (1 BOTTLE PER PACKAGE)

SHIP 75 BOTTLES ON OCT 1 2022 AND 12 CASES EACH QUARTER

1 JAN, 1 APR, AND 1 JUL

SEND MOST RECENT PRODUCED PRODUCT FOR LONGEST USAGE.

NET AMT

FFP

41741 CONTROL SOLUTION 1 STAT STRIP (1 BOTTLE PER PACKAGE)

SHIP 75 BOTTLES ON OCT 1 2023 AND 12 CASES EACH QUARTER

1 JAN, 1 APR, AND 1 JUL

SEND MOST RECENT PRODUCED PRODUCT FOR LONGEST USAGE.

NET AMT

FFP

41741 CONTROL SOLUTION 1 STAT STRIP (1 BOTTLE PER PACKAGE)

SHIP 75 BOTTLES ON OCT 1 2024 AND 12 CASES EACH QUARTER

1 JAN, 1 APR, AND 1 JUL

SEND MOST RECENT PRODUCED PRODUCT FOR LONGEST USAGE.

NET AMT

Section C - Descriptions and Specifications

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT (PWS)

Nova biomedical – Nova biomedical stat strip consumables Naval Medical Center Portsmouth

PART 1

SCOPE OF WORK

GENERAL: This is a non-personal services contract for Nova biomedical. The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

Description of Services/Introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform actions that have been acquired in the Data Innovations account as defined in this PWS except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract.

Background: Nova biomedical is the only supplier of the reagents (consumables) for the Nova stat strip glucose meters. The Nova stat strip meters are in the process of verification within the laboratory Point of Care Department. This allows the NMCP Laboratory to stay within CAP compliance.

Objectives: Basic services include:

· Provide Nova Stat strip glucose strips

· Provide Nova Stat strip control and linearity solutions.

Scope: The contractor shall accomplish all services that are listed within the performance work statement.

Period of Performance: The period of performance shall be for one (1) Base Year. The Period of Performance reads as follows:

GENERAL INFORMATION

Recognized Holidays: The contractor is not required to perform services on Federal Holidays.

Hours of Operation: The contractor is responsible for conducting business, between the hours of 7:00 am – 7:00 pm Monday thru Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. The Contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential.

Place of Performance: The work to be performed under this contract will be performed at the contractor facility.

PHYSICAL Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use.

Contracting Officer Representative (COR): The COR will be identified by COR Appointment letter. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract: perform inspections necessary in connection with contract performance: maintain written and oral communications with the Contractor concerning technical aspects of the contract: issue written interpretations of technical requirements; including Government drawings; designs; specifications; monitor Contractor's performance and notify both the KO and Contractor of any deficiencies; coordinate availability of government furnished property, and provide site entry of Contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the contract

Identification of Contractor Employees: All contract personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.

PART 2

DEFINITIONS & ACRONYMS

DEFINITIONS AND ACRONYMS:

DEFINITIONS:

CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime.

CONTRACTING OFFICER (KO). A person with authority to enter into, administer, and/or terminate contracts, and make related determinations and findings on behalf of the government. This is the only individual who can legally bind the government.

CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement.

DELIVERABLE. Anything that can be physically delivered, but may include non-manufactured things such as meeting minutes or reports.

KEY PERSONNEL. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

QUALITY ASSURANCE. The government procedures to verify that services being performed by the Contractor are performed according to acceptable standards.

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

QUALITY CONTROL. All necessary measures taken by the Contractor to assure that the quality of an end product or service meet contract requirements.

SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

WORK DAY. The number of hours per day the Contractor provides services in accordance with the contract.

WORK WEEK. Monday through Friday, unless specified otherwise.

ACRONYMS:

PART 3

CONTRACTOR FURNISHED ITEMS AND SPECIFIC TASKS

CONTRACTOR RESPONSIBILITIES AND SPECIFIC TASKS:

Basic Services. Vendor shall provide software, software license, maintenance and technical support on the Alere Informatics Rals Data Software systems.

Vendor’s price shall be inclusive of all cost including labor, materials, shipping, royalties and software license fees.

Vendor shall provide support during normal work hours of 8:00 am – 5:00 pm (EST) Monday – Friday except Federal Holidays.

Vendor shall provide all software maintenance releases as soon as possible after release but no later than 14 days after release.

Supplied, software / license shall be provided free of all additional royalties or other charges.

All supplied software shall be certified free of malicious codes / damaging properties such as viruses, Trojan horses, worms, spyware etc.

NMCP recognizes that the use of all supplied software is for the sole use of NMCP. NMCP agrees not to share, sell, copy, lease or assign supplied software without the expressed permission of vendor.

NMCP shall make all attempts to preserve the proprietary nature of all supplied software. Vendor shall take all reasonable measures to safeguard any and all NMCP file data. (i.e. vendor shall not share any medical records / data collected by supplied software) All technical support personnel must be adequately trained and knowledgeable of supplied software.

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:

Section F - Deliveries or Performance

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.

DELIVERY INFORMATION

DFAS INDIANAPOLIS (GFEBS) 21001

8899 E. 56 TH STREET

INDIANAPOLIS IN 46249-3120

INDIANAPOLIS IN 46249-3120

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CLAUSES INCORPORATED BY REFERENCE

CLAUSES INCORPORATED BY FULL TEXT

52.211-17 DELIVERY OF EXCESS QUANTITIES (SEP 1989)

The Contractor is responsible for the delivery of each item quantity within allowable variations, if any. If the Contractor delivers and the Government receives quantities of any item in excess of the quantity called for (after considering any allowable variation in quantity), such excess quantities will be treated as being delivered for the convenience of the Contractor. The Government may retain such excess quantities up to $250 in value without compensating the Contractor therefor, and the Contractor waives all right, title, or interests therein. Quantities in excess of $250 will, at the option of the Government, either be returned at the Contractor's expense or retained and paid for by the Government at the contract unit price.

Section G - Contract Administration Data

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.

usn.detrick.navmedlogcomftdmd.list.nmlc-wawf@mail.mil

For additional questions contact: kelby.m.conley.ctr@mail.mil

(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.

____________COMBO FOR SUPPLIES________________________________________________

(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.

_USN.DETRICK.NAVMEDLOGCOMFTDMD.LIST.NMLC-WAWF@MAIl.MIL___ (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

BUSINESS ASSOCIATE AGREEMENT

Privacy, Access, Use, and Disclosure of Protected Health Information

1. Introduction. In accordance with 45 C.F.R. §§ 164.502(e)(2) and 164.504(e), and DoDM 6025.18, “Implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule in DoD Health Care Programs,” March 13, 2019, this document serves as a Business Associate Agreement (BAA) between the signatory Parties for purposes of the HIPAA and the “HITECH Act” amendments thereof, as implemented by the HIPAA Rules and DoD HIPAA issuances (both defined below). The Parties are (1) a DoD Military Health System (MHS) component command such as a Navy Medicine Medical Treatment Facility (MTF) (Naval Medical center or Naval hospital), or special mission command (research, public health, other), acting as a HIPAA covered entity, and (2) another Federal or Government organization, civilian academic institution, or other civilian entity, acting as a HIPAA Business Associate (BA). The HIPAA Rules require BAAs between covered entities and BAs. Implementing this BAA requirement, the applicable DoD HIPAA issuances (DoDM 6025.18) provides that requirements applicable to BAs must be incorporated (or incorporated by reference) into the contract or agreement between the Parties.

2. Definitions:

a. Terms. Except as provided otherwise in this BAA, the following terms used in this BAA shall have the same meaning as those terms in the DoD HIPAA Rules (DoDM6025.18-): Data aggregation, designated record set, disclosure, health care operations, individual, minimum necessary, notice of privacy practices, protected health information (PHI), required by law, secretary, security incident, subcontractor, unsecured PHI, and use.

b. Breach. means actual or possible loss of control, unauthorized disclosure of or unauthorized access to PHI or other Personally Identifiable Information (PII) (which may include, but is not limited to PHI), where persons other than authorized users gain access or potential access to such information for any purpose other than authorized purposes, where one or more individuals will be adversely affected. The foregoing definition is based on the definition of “Breach” in DoD Privacy Act issuances as defined herein.

c. BA. shall generally have the same meaning as the term “BA” in the DoD HIPAA issuances, and in reference to this BAA, shall mean the entity (another Government organization, civilian academic institution, or other civilian organization), entering into agreement with a Navy Medicine MTF or special mission command.

d. Agreement. means this BAA together with the documents or other arrangements under which the BA signatory performs services involving access to PHI on behalf of the MHS component signatory to this BAA.

e. Covered Entity. shall generally have the same meaning as the term “covered entity” in the DoD HIPAA issuances, and in reference to this BAA, shall mean a Navy Medicine MTF or special mission command under the Bureau of Medicine and Surgery.

f. DHA Privacy Office. means the Defense Health Agency (DHA) Privacy and Civil Liberties Office. The DHA Privacy Office Director is the HIPAA Privacy and Security Officer for DHA, including the National Capital Region Medical Directorate.

g. DoD HIPAA Issuances. means the DoD issuances implementing the HIPAA Rules in the DoD MHS. These issuances are DoDM 6025.18 Implementation of the HIPAA Privacy Rule in DoD Health Care Programs,” March 13, 2019; DoD Instruction 6025.18, Privacy of Individually Identifiable Health Information in DoD Health Care Programs of December 2009, and DoD Instruction 8580.02, Security of Individually Identifiable Health Information in DoD Health Care Programs of August 2015.

h. DoD Privacy Act Issuances. means the DoD issuances implementing the Privacy Act, which are DoD Directive 5400.11, DoD Privacy Program of 29 October 2014, and DoD 5400.11-R, Department of Defense Privacy Program of 8 May 2007.

i. HIPAA Rules. means, collectively, the HIPAA privacy, security, breach and enforcement rules, issued by the United States (US) Department of Health and Human Services (HHS) and codified at 45 C.F.R. §§ 160 and 164, Subpart E (Privacy), Subpart C (Security), Subpart D (Breach) and 45 C.F.R. § 160, Subparts C-D (Enforcement), as amended by the 2013 modifications to those Rules which implemented the “HITECH Act” provisions of Publication L. 111-5. See 78 Federal Regulation 5566-5702 of 25 January 2013 (with corrections at 78 Federal Regulation 32464 of 7 June 2013. Additional HIPAA rules regarding electronic transactions and code sets (45 C.F.R. § 162) are not addressed in this BAA and are not included in the term HIPAA Rules.

j. HHS Breach. means a breach that satisfies the HIPAA Breach Rule definition of “Breach” in 45 C.F.R. § 164.402.

k. Service-Level Privacy Office. means one or more offices within the military services (Army, Navy, or Air Force) with oversight authority over Privacy Act and HIPAA privacy compliance.

3. Obligations and Activities of BA:

a. The BA shall not access, use, or disclose PHI other than as permitted or required by this Agreement, the controlling Memorandum of Understanding (MOU) or training affiliation agreement, or as required by law.

b. The BA shall use appropriate safeguards and comply with the DoD HIPAA Rules with respect to electronic PHI to prevent use or disclosure of PHI other than as provided for by this Agreement, the controlling MOU, or law.

c. The BA shall report to the covered entity any Breach of which it becomes aware and shall proceed with breach response steps required by paragraph 7 (Breach Response) of this BAA. With respect to electronic PHI, the BA shall also respond to any security incident of which it becomes aware in accordance with any information assurance provisions of the Understanding. If at any point the BA becomes aware that a security incident involves a breach, the BA shall immediately initiate breach response as required by paragraph 7 (Breach Response) of this BAA.

d. In accordance with 45 C.F.R. §§ 164.502(e)(1)(ii)) and 164.308(b)(2), respectively, as applicable, the BA shall ensure that any entities that create, receive, maintain, or transmit PHI on behalf of the BA agree to the same restrictions, conditions, and requirements that apply to the BA with respect to such PHI.

e. The BA shall make available PHI in a designated record set, to the covered entity or, as directed by the covered entity, to an Individual, as necessary to satisfy the covered entity obligations under 45 C.F.R. § 164.524.

f. The BA shall make any amendment(s) to PHI in a designated record set as directed or agreed to by the covered entity pursuant to 45 C.F.R. § 164.526, or take other measures as necessary to satisfy covered entity’s obligations under 45 C.F.R. § 164.526.

g. The BA shall maintain and make available the information required to provide an accounting of disclosures to the covered entity or an individual as necessary to satisfy the covered entity’s obligations under 45 C.F.R. § 164.528.

h. To the extent the BA is to carry out one or more of the covered entity’s obligation(s) under the HIPAA privacy rule, the BA shall comply with the requirements of HIPAA privacy rule that apply to the covered entity in the performance of such obligation(s).

i. The BA shall make its internal practices, books, and records available to the Secretary and the covered entity for purposes of audit and in determining compliance with the HIPAA Rules.

4. Permitted Uses and Disclosures by BA:

a. The BA may only use or disclose PHI as necessary to perform the services set forth in the Understanding or as required by law. The BA is not permitted to de-identify PHI under DoD HIPAA issuances or the corresponding 45 C.F.R. § 164.514(a) through (c), nor is it permitted to use or disclose de-identified PHI except as provided by the Understanding or directed by the covered entity.

b. The BA agrees to use, disclose, and request PHI only in accordance with the HIPAA privacy rule “minimum necessary” standard and corresponding DHA policies and procedures as stated in the DoD HIPAA issuances.

c. The BA shall not use or disclose PHI in a manner that would violate the DoD HIPAA issuances or HIPAA privacy rules if done by the covered entity, except uses and disclosures for the BA’s own management and administration and legal responsibilities or for data aggregation services as set forth in the following three paragraphs:

(1) Except as otherwise limited in the understanding, the BA may use PHI for the proper management and administration of the BA or to carry out the legal responsibilities of the BA. The foregoing authority to use PHI does not apply to disclosure of PHI, which is covered in the next paragraph.

(2) Except as otherwise limited in the Understanding, the BA may disclose PHI for the proper management and administration of the BA or to carry out the legal responsibilities of the BA, provided that disclosures are required by law, or the BA obtains reasonable assurances from the person to whom the PHI is disclosed that it will remain confidential and used or further disclosed only as required by law or for the purposes for which it was disclosed to the person, and the person notifies the BA of any instances of which it is aware in which the confidentiality of the information has been breached.

(3) Except as otherwise limited in the Understanding, the BA may use PHI to provide Data Aggregation services relating to the covered entity’s health care operations.

5. Provisions for Covered Entity to Inform BA of Privacy Practices and Restrictions:

a. The covered entity shall provide the BA with the notice of privacy practices that the covered entity produces in accordance with 45 C.F.R.§ 164.520 and the corresponding provision of the DoD HIPAA issuances (DoDM 6025.18).

b. The covered entity shall notify the BA of any changes in, or revocation of, the permission by an Individual to use or disclose his or her PHI, to the extent that such changes affect the BA’s use or disclosure of PHI.

c. The covered entity shall notify the BA of any restriction on the use or disclosure of PHI that the covered entity has agreed to or is required to abide by under 45 C.F.R. § 164.522, to the extent that such changes may affect the BA’s use or disclosure of PHI.

6. Permissible Requests by Covered Entity. The covered entity shall not request the BA to use or disclose PHI in any manner that would not be permissible under the HIPAA privacy rule or any applicable Government regulations (including without limitation, DoD HIPAA issuances) if done by the covered entity, except for providing Data Aggregation services to the covered entity and for management and administrative activities of the BA as otherwise permitted by this BAA.

7. Breach Response:

a. General. Breach Response is designed to satisfy the DoD Privacy Act issuances and the HIPAA Breach Rule as implemented by the DoD HIPAA issuances. In general, the BA shall report the breach to the covered entity, assess the breach incident, notify affected individuals, and take mitigating actions, as applicable. Because DoD defines “Breach” to include possible (suspected) as well as actual (confirmed) breaches, the BA shall implement these breach response requirements immediately upon the BA’s discovery of a possible breach. The following provisions set forth the BA’s Privacy Act and HIPAA breach response requirements for all breaches, including but not limited to HHS breaches (defined below). In the event of a breach of PII or PHI held by the BA, the BA shall follow the breach response requirements set forth under paragraphs 7, 8, and 9 of this BAA, which are designed to satisfy both the Privacy Act and HIPAA, as applicable.

(1) If a breach involves PII without PHI, then the BA shall comply with DoD Privacy Act issuance breach response requirements only.

(2) If a breach involves PHI (a subset of PII), then the BA shall comply with both Privacy Act and HIPAA breach response requirements.

(3) If a breach involves PHI, it may or may not constitute an HHS Breach. If a breach is not an HHS Breach, then the BA has no HIPAA breach response obligations. In such cases, the BA must still comply with breach response requirements under the DoD Privacy Act issuances.

b. HHS Breach. If the DHA Privacy Office determines that a breach is an HHS Breach, then the BA shall comply with both the HIPAA Breach Rule and DoD Privacy Act issuances, as directed by the DHA Privacy Office, regardless of where the breach occurs.

c. Non-HHS Breach. If the DHA Privacy Office determines that the breach does not constitute an HHS Breach, then the BA shall comply with DoD Privacy Act issuances, as directed by the applicable Service-Level Privacy Office.

d. Service-Level Privacy Office Point of Contact (POC). Brian Martin, who may be reached at Comm: 904-542-3559, DSN: 312-942-3559, or via E-mail: brian.k.martin4.civ@mail.mil, or usn.ncr.bumedfchava.list.bumed-pii-rpt@mail.mil.

8. Breach Reporting Provisions:

a. The BA shall report the breach within 1 business day of discovery to the US Computer Emergency Readiness Team (US-CERT) and within 24 hours of discovery to the DHA Privacy Office and the other Parties set forth below. The BA is deemed to have discovered a breach as of the time a breach (suspected or confirmed) is known, or by exercising reasonable diligence would have been known, to any person (other than the person committing it) who is an employee, officer, or other agent of the BA.

b. The BA shall submit the US-CERT report using the online form at https://forms.us-cert.gov/report. Before submission to US-CERT, the BA shall save a copy of the on-line report. After submission, the BA shall record the US-CERT Reporting Number. Although only limited information about the breach may be available as of the 1 hour deadline for submission, the BA shall submit the US-CERT report by the deadline. The BA shall e-mail updated information as it is obtained, following the instructions at: http://www.us-cert.gov/pgp/email.html. The BA shall provide a copy of the initial or updated US-CERT report to the DHA Privacy Office and the applicable Service-Level Privacy Office, if requested by either.

BA questions about US-CERT reporting shall be directed to the DHA or Service-Level Privacy Office, not the US-CERT office.

c. The BA report due within 24 hours shall be submitted by completing the New Breach Reporting Form DD 2959 at the Breach Response page on the DHA Privacy Office web site and emailing that form to, as applicable, the DHA Privacy Office, the Service-Level Privacy Office, the Contracting Officer (CO) and Contracting Officer’s Representative (COR) (if the Understanding is not a contract, delete these references to the CO and COR), and the BA’s DoD POC unless the POC specifies another addressee for breach reporting. Encryption is not required, because Breach Report Forms should not contain PII or PHI. The email address for notices to the DHA Privacy Office is provided at the Privacy Office web site breach response page. If electronic mail is not available, telephone notification is also acceptable, but all notifications and reports delivered telephonically must be confirmed by email as soon as technically feasible.

d. If multiple beneficiaries are affected by a single event or related set of events, then a single reportable breach may be deemed to have occurred, depending on the…