Solicitation.doc

Section SF 1449 - CONTINUATION SHEET

INFORMATION SHEET

FIRM-FIXED PRICE AWARD

THIS IS A FULL & OPEN COMPETITION SOLICITATION

ALL VENDORS ARE TO COMPLETE THE BELOW AND SUBMIT

WITH THEIR PROPOSAL/QUOTE PACKAGE

ALL VENDORS ARE REQUIRED TO HAVE AN ACTIVE REGISTRATION IN www.sams.gov

VENDOR NAME: _________________________________________________

CAGE CODE: _________________________

DUNS NUMBER: _________________________

VENDOR POC: _________________________________________________

PHONE: _________________________

EMAIL: _________________________

GSA SCHEDULE NO (IF APPLICABLE): _________________________

EXPIRE DATE: _________________________

MIN/MAX: _________________________

PRODUCT/SERVICES FOR: THE COMPREHENSIVE INDUSTRIAL HYGIENE LABORATORY, NAVY ENVIRONMENTAL AND PREVENTATIVE MEDICINE UNIT TWO, NORFOLK, VA

CUSTOMER TECHNICAL POC WILL BE PROVIDED AT AWARD.

NAVY MEDICINE EAST CONTRACTING OFFICE

POC: KLOH-ANN DEROSIN

PHONE: 757‐953‐9106

EMAIL: Kloh-ann.c.derosin.civ@mail.mil NOTE: Vendor is 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 Prompt Payment: For Prompt Payment Act Purposes, this contract is: Subject to the 7‐ Calendar Day Constructive Acceptance Period. Payment in Arrears.

Responses must address technical factors identified in FAR Clause 52.212-2, Evaluation –Commercial items (Oct 2014)

Laboratory Gases and Cylinder Rental

FFP

Laboratory Gases and Cylinder Rental

Base Year: Period of Performance: 01 March 2019 – 29 February 2020

NET AMT

0001AA

Argon

Argon, Ultra High Purity Grade, Size-180 - 230 PSI, Type-Dewar

Base Yr: Period of Performance: 01 March 2019 – 29 February 2020

FOB: Destination

PSC CD: 6830

NET AMT

0001AB

Helium

Helium, Ultra High Purity Grade, Size 300 Cylinder

Base Yr: Period of Performance: 01 March 2019 – 29 February 2020

NET AMT

0001AC

Helium, Size 80 Cylinder

Helium, Ultra High Purity Grade, Size 80 Cylinder

Base Yr: Period of Performance: 01 March 2019 – 29 February 2020

NET AMT

0001AD

Hydrogen, Size 300 Cylinder

Hydrogen, High Purity Grade, Size 300 Cylinder

Base Yr: Period of Performance: 01 March 2019 – 29 February 2020

NET AMT

0001AE

Nitrogen, Size 300 Cylinder

Nitrogen, Ultra High Purity, Size 300 Cylinder

Base Yr: Period of Performance: 01 March 2019 – 29 February 2020

NET AMT

0001AF

Cylinder Lease

Cylinder Lease

Base Yr: Period of Performance: 01 March 2019 – 29 February 2020

NET AMT

0001AG

Dewar Lease

Dewar Lease

Base Yr: Period of Performance: 01 March 2019 – 29 February 2020

NET AMT

0001AH

Expedited Delivery Fee

Expedited Delivery Fee

Base Yr: Period of Performance: 01 March 2019 – 29 February 2020

NET AMT

0001AJ

Delivery Charge (If Required)

Delivery Charge (If Required)

If you do not require a delivery charge, please indicate “NO CHARGE”

Base Yr: Period of Performance: 01 March 2019 – 29 February 2020

NET AMT

FFP

Option Yr 1: Period of Performance: 01 March 2020 – 28 February 2021

NET AMT

1001AA

FFP

Argon, Ultra High Purity Grade, Size-180 – 230 PSI, Type-Dewar

Option Yr 1: Period of Performance: 01 March 2020 – 28 February 2021

NET AMT

1001AB

FFP

Helium, Ultra High Purity Grade, Size 300 Cylinder

Option Yr 1: Period of Performance: 01 March 2020 – 28 February 2021

NET AMT

1001AC

FFP

Helium, Ultra High Purity Grade, Size 80 Cylinder

Option Yr 1: Period of Performance: 01 March 2020 – 28 February 2021

NET AMT

1001AD

FFP

Hydrogen, High Purity Grade, Size 300 Cylinder

Option Yr 1: Period of Performance: 01 March 2019 – 29 February 2020

NET AMT

1001AE

FFP

Nitrogen, Ultra High Purity, Size 300 Cylinder

Option Yr 1: Period of Performance: 01 March 2020 – 28 February 2021

NET AMT

1001AF

FFP

Cylinder Lease

Option Yr 1: Period of Performance: 01 March 2020 – 28 February 2021

NET AMT

1001AG

Option Yr 1: Period of Performance: 01 March 2020 – 28 February 2021

NET AMT

1001AH

FFP

Expedited Delivery Fee

Option Yr 1: Period of Performance: 01 March 2020 – 28 February 2021

NET AMT

1001AJ

FFP

Delivery Charge (If Required)

If you do not require a delivery charge, please indicate “NO CHARGE”

Option Yr 1: Period of Performance: 01 March 2020 – 28 February 2021

NET AMT

FFP

Option Yr 2: Period of Performance: 01 March 2021 – 28 February 2022

NET AMT

2001AA

FFP

Argon, Ultra High Purity Grade, Size-180 – 230 PSI, Type-Dewar

Option Yr 2: Period of Performance: 01 March 2021 – 28 February 2022

NET AMT

2001AB

FFP

Helium, Ultra High Purity Grade, Size 300 Cylinder

Option Yr 2: Period of Performance: 01 March 2021 – 28 February 2022

NET AMT

2001AC

FFP

Helium, Ultra High Purity Grade, Size 80 Cylinder

Option Yr 2: Period of Performance: 01 March 2021 – 28 February 2022

NET AMT

2001AD

FFP

Hydrogen, High Purity Grade, Size 300 Cylinder

Option Yr 2: Period of Performance: 01 March 2021 – 28 February 2022

NET AMT

2001AE

FFP

Nitrogen, Ultra High Purity, Size 300 Cylinder

Option Yr 2: Period of Performance: 01 March 2021 – 28 February 2022

NET AMT

2001AF

FFP

Cylinder Lease

Option Yr 2: Period of Performance: 01 March 2021 – 28 February 2022

NET AMT

2001AG

Option Yr 2: Period of Performance: 01 March 2021 – 28 February 2022

NET AMT

2001AH

FFP

Expedited Delivery Fee

Option Yr 2: Period of Performance: 01 March 2021 – 28 February 2022

NET AMT

2001AJ

FFP

Delivery Charge (If Required)

If you do not require a delivery charge, please indicate “NO CHARGE”

Option Yr 2: Period of Performance: 01 March 2021 – 28 February 2022

NET AMT

FFP

Option Yr 3: Period of Performance: 01 March 2022 – 28 February 2023

NET AMT

3001AA

FFP

Argon, Ultra High Purity Grade, Size-180 – 230 PSI, Type-Dewar

Option Yr 3: Period of Performance: 01 March 2022 – 28 February 2023

NET AMT

3001AB

FFP

Helium, Ultra High Purity Grade, Size 300 Cylinder

Option Yr 3: Period of Performance: 01 March 2022 – 28 February 2023

NET AMT

3001AC

FFP

Helium, Ultra High Purity Grade, Size 80 Cylinder

Option Yr 3: Period of Performance: 01 March 2022 – 28 February 2023

NET AMT

3001AD

FFP

Hydrogen, High Purity Grade, Size 300 Cylinder

Option Yr 3: Period of Performance: 01 March 2022 – 28 February 2023

NET AMT

3001AE

FFP

Nitrogen, Ultra High Purity, Size 300 Cylinder

Option Yr 3: Period of Performance: 01 March 2022 – 28 February 2023

NET AMT

3001AF

FFP

Cylinder Lease

Option Yr 3: Period of Performance: 01 March 2022 – 28 February 2023

NET AMT

3001AG

Option Yr 3: Period of Performance: 01 March 2022 – 28 February 2023

NET AMT

3001AH

FFP

Expedited Delivery Fee

Option Yr 3: Period of Performance: 01 March 2022 – 28 February 2023

NET AMT

3001AJ

FFP

Delivery Charge (If Required)

If you do not require a delivery charge, please indicate “NO CHARGE”

Option Yr 3: Period of Performance: 01 March 2022 – 28 February 2023

NET AMT

FFP

Option Yr 4: Period of Performance: 01 March 2023 – 29 February 2024

NET AMT

4001AA

FFP

Argon, Ultra High Purity Grade, Size-180 – 230 PSI, Type-Dewar

Option Yr 4: Period of Performance: 01 March 2023 – 29 February 2024

NET AMT

4001AB

FFP

Helium, Ultra High Purity Grade, Size 300 Cylinder

Option Yr 4: Period of Performance: 01 March 2023 – 29 February 2024

NET AMT

4001AC

FFP

Helium, Ultra High Purity Grade, Size 80 Cylinder

Option Yr 4: Period of Performance: 01 March 2023 – 29 February 2024

NET AMT

4001AD

FFP

Hydrogen, High Purity Grade, Size 300 Cylinder

Option Yr 4: Period of Performance: 01 March 2023 – 29 February 2024

NET AMT

4001AE

FFP

Nitrogen, Ultra High Purity, Size 300 Cylinder

Option Yr 4: Period of Performance: 01 March 2023 – 29 February 2024

NET AMT

4001AF

FFP

Cylinder Lease

Option Yr 4: Period of Performance: 01 March 2023 – 29 February 2024

NET AMT

4001AG

Option Yr 4: Period of Performance: 01 March 2023 – 29 February 2024

NET AMT

4001AH

FFP

Expedited Delivery Fee

Option Yr 4: Period of Performance: 01 March 2023 – 29 February 2024

NET AMT

4001AJ

FFP

Delivery Charge (If Required)

If you do not require a delivery charge, please indicate “NO CHARGE”

Option Yr 4: Period of Performance: 01 March 2023 – 28 February 2024

NET AMT

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

DELIVERY INFORMATION

KIMBERLY TERNEUS-FISCHER

1285 WEST D STREET BLDG U-238

NORFOLK VA 23511-3394

757-953-6562

N63117

N63117

N63117

N63117

N63117

N63117

N63117

N63117

N63117

KIMBERLY TERNEUS-FISCHER

1285 WEST D STREET BLDG U-238

NORFOLK VA 23511-3394

757-953-6562

N63117

N63117

N63117

N63117

N63117

N63117

N63117

N63117

N63117

KIMBERLY TERNEUS-FISCHER

1285 WEST D STREET BLDG U-238

NORFOLK VA 23511-3394

757-953-6562

N63117

N63117

N63117

N63117

N63117

N63117

N63117

N63117

N63117

KIMBERLY TERNEUS-FISCHER

1285 WEST D STREET BLDG U-238

NORFOLK VA 23511-3394

757-953-6562

N63117

N63117

N63117

N63117

N63117

N63117

N63117

N63117

N63117

KIMBERLY TERNEUS-FISCHER

1285 WEST D STREET BLDG U-238

NORFOLK VA 23511-3394

757-953-6562

N63117

N63117

N63117

N63117

N63117

N63117

N63117

N63117

N63117

STATEMENT OF WORK

Scope: The Comprehensive Industrial Hygiene Laboratory (CIHL) at the Navy Environmental and Preventive Medicine Unit TWO provides analytical services in the areas of industrial hygiene for the analysis of air, toxic propriety products and performance of toxicological testing to evaluate worker exposure to hazardous materials. CIHL analyzes over 18,000 samples annually for different analytics using a variety of instrumentation such Ion Chromatography, Atomic Absorption Spectrometry-Graphite Furnace, High Performance Liquid Chromatography, and Gas Chromatography that utilize the noted goods. The lack of any of these goods will create a work stoppage producing a backlog and increased turn-around-times for the customers.

Purpose: To ensure required goods are available and delivered by the contractor in a timely manner, in better than good condition cylinders and dewars, and high quality rating as specified by amount and timeline of deliveries below.

Requirements: The requirements are to provide the products as specified below in a timely manner, as specified by each type, in better than good cylinders and dewars when applicable, and high quality rating of each good. The cylinders and dewars will be on a lease program that will be paid for at the start of the contract for the first full year.

1. Routine goods as stated above, shall be received/delivered within a forty-eight hours. Emergency requests will be received within 24 hours.

2. Notification to contractor will be performed via telephone or email for routine and emergency needs/requirements of goods.

3. Emergency or unexpected needs of goods will be notified to contractor via email and response shall be within a twenty-four (24) hour period.

4. Inoperable, and unfilled cylinders and dewars will be rectified or replaced immediately within the same day or by the next business day before noon.

5. All goods shall be of high quality or ultra-high purity standard as identified in the table above. Any impure, contaminated, and dirty cylinder and Dewar must be rectified or replaced immediately within the same day or by the next business day before noon.

6. CIHL shall be notified of deliveries in a timely manner via telephone/email. All goods shall be delivered during regular working hours of 0700 to 1600 for which time a CIHL personnel shall be available for all deliveries. No deliveries of goods shall be done outside regular working hours and without the presence of CIHL personnel.

7. The contractor shall make the necessary arrangements to enter the facility independently. CIHL personnel will not escort the contractor to deliver goods.

Contract Length: The contract agreement will be for a period of one full year (12 months) and four (4) subsequent option years from the designated start date. The period of performance listed below is tentative:

Contractor Responsibilities: The contractor shall be responsible for the scheduling of cylinders pickup and delivery, optimum conditions of all cylinders and dewars used to provide goods and the scheduling of good deliveries to accommodate CIHL needs. The contractor may provide as needed required accessories at current market cost which shall be billed to a separate CLIN.

The following goods shall be provided at the following location in the Comprehensive Industrial Hygiene Laboratory, Navy Environmental and Preventive Medicine Unit TWO, 1285 West D St BLDG U 238, Norfolk VA 23511.

CLAUSES INCORPORATED BY REFERENCE

CLAUSES INCORPORATED BY FULL TEXT

52.212-2 EVALUATION--COMMERCIAL ITEMS (OCT 2014)

Award will be made using Lowest Price Technically Acceptable evaluation criteria. Award will be made to the offeror that proposes the lowest priced offer with a technically acceptable approach and acceptable past performance. Technical acceptability will be determined through an evaluation of the offeror’s technical proposal.

Except for communications conducted for the purpose of minor clarification, the Government intends to evaluate proposals and award a contract without discussions. Therefore, each initial offer should contain the offeror's best terms from a technical and price standpoint. However, the Government reserves the right to conduct discussions if it is later determined by the Contracting Officer to be necessary.

EVALUATION FACTORS. The following factors below will be evaluated:

FACTOR 1. TECHNICAL MERIT: Technical factors reflected below must be met and stated in the offeror’s proposal. Technical merit ratings reflect the Government’s confidence in each offeror’s ability, as demonstrated in its proposal, to perform the requirements stated in the solicitation. Failure to submit a technical proposal or clearly address the technical factors will result in an “Unacceptable” rating. To receive consideration for award, a rating of “Acceptable” must be achieved for all technical factors.

1. Technical Merit shall be assessed based on the evaluation of the following technical factors:

a. The contractor’s approach to meet the requirements of the Statement of Work (SOW).

b. The supplies and or equipment must be certified for use in U.S. hospitals adhering to UL and JACHO requirements as required.

Please ensure that each proposal demonstrates a clear understanding of the SOW and all applicable requirements and please provide documentation that can be evaluated for Technical capability.

The following adjectival ratings will be used in evaluating each offeror’s technical proposal.

Technical Acceptable/Unacceptable Ratings

FACTOR 2. PAST PERFORMANCE: The offeror’s performance will be rated in terms of acceptability. A performance rating of acceptable or unacceptable will be assigned dependent upon the evaluator’s assessment of the level of confidence in the offeror’s performance record. Past Performance will be evaluated based on assessments of the performance under current and prior contracts for the last five years.

The information which will be used for evaluation will be obtained from the Past Performance Questionnaires submitted, Past Performance Information Retrieval System (PPIRS) www.ppirs.gov, FAPIIS, CPAR, and any other sources. The Government may reject a proposal if it is found that any information that has a negative impact on the offeror’s past performance record has been deleted, misrepresented, or withheld. Past performance surveys should be based upon performance of like services to those in this solicitation.

If adverse past and present performance information is obtained, the respective point of contact may be contacted to obtain additional information about the circumstances surrounding the situation. Offerors will be given an opportunity to address unfavorable reports of past and present performance to which the offeror has not had a previous opportunity to respond. The offeror's response, or lack thereof, will be taken into consideration.

The following adjectival ratings will be used in evaluating each offeror’s past performance proposal.

Past Performance Evaluation Ratings

Note: In the case of an offeror without a record of relevant past performance or for whom information on past performance is not available or so sparse that no meaningful past performance rating can be reasonably assigned, the offeror may not be evaluated favorably or unfavorably on past performance (see FAR 15.305 (a)(2)(iv)). Therefore, the offeror shall be determined to have unknown past performance. In the context of acceptability/unacceptability, “unknown” shall be considered “acceptable.”

FACTOR 3. PRICE: The purpose of the price factor is to determine if the proposed price is fair and reasonable. In no event will the Government make an award against an offer that the Government does not find to be fair and reasonably priced.

The pricing criteria used for evaluation are completeness, price reasonableness, and Total Evaluated Price (TEP).

1. Completeness - The Government will review the pricing submissions for completeness and compliance with FAR 52.212-1 of this solicitation. Incomplete price submissions may not be evaluated and the quotation may be eliminated from the competition.

2. Price Reasonableness - The offerors price proposal will be evaluated using one or more of the techniques defined in FAR 13.106-3(a). Generally, adequate price competition will satisfy the criteria of price reasonableness.

3. Total Evaluated Price (TEP) – The TEP will be calculated as the sum of the offeror’s proposed prices for the base year and all option periods. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the options.

(End of provision)

52.213-3 NOTICE TO SUPPLIER (APR 1984)

This is a firm order ONLY if your price does not exceed the maximum line item or total price in the Schedule. Submit invoices to the Contracting Officer. If you cannot perform in exact accordance with this order, WITHHOLD PERFORMANCE and notify the Contracting Officer immediately, giving your quotation.

(End of clause)

52.217-7 OPTION FOR INCREASED QUANTITY--SEPARATELY PRICED LINE ITEM (MAR 1989)

The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor prior to expiration of contract. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree.

(End of clause)

52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor prior to expiration of the contract, provided that the Government gives the Contractor a preliminary written notice of its intent to extend prior to expiration of the contract. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 60.

(End of clause)

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

FAR Clauses https://acquisition.gov/browsefar

DFAR Clauses https://www.acq.osd.mil/dpap/dars/dfarspgi/current/

(End of clause)

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.

INVOICE AND RECEIVING REPORT COMBO

(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.

N/A

(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.

Provided at Award

(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

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

(End of clause)

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 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.

5252.204-9400 SUP 5252.204-9400 Contractor Unclassified Access to Federally Controlled Facilities, Sensitive Information, Information Technology (IT) Systems or Protected Health Information (July 2013)

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 clause applies to…