Combined_Synopsis_Solicitation.docx

N62645-15-R-1022

This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR 12.6, Streamlined Procedures for Evaluation and Solicitation of Commercial Items and FAR 13.5 Test Program for Certain Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. It is the contractor’s responsibility to be familiar with the applicable FAR and DFARS clauses and provisions. The FAR and DFARS clauses may be accessed in full text at this address: http://farsite.hill.af.mil/

The NAICS code is 541990 with a business size standard of $15 Million. This is a total small business set-aside.

This Request for Proposal (RFP) is on behalf of the Navy Drug Screening Laboratory (NDSL) Great Lakes. This requirement is for a non-personal laboratory support services contract.

The solicitation number is N62645-15-R-1022.

This solicitation will result in one firm fixed price contract with a five year period of performance (a one-year base period and four one-year option periods). The estimated Period of Performance shall be from 01 November 2015 – 31 October 2020.

Proposal Submission Proposals are due by 21 September 2015 by 02:00 PM Local Time. Proposals shall be submitted in accordance with the Instructions to Offeror of this request.

Laboratory Support Services

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Laboratory Support Services at NDSL Great Lakes FOB: Destination

MILSTRIP: N6884916RCSA003

PURCHASE REQUEST NUMBER: N6884916RCSA003

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Laboratory Support Services at NDSL Great Lakes FOB: Destination

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PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT FOR

NAVY DRUG SCREENING LABORATORY

GREAT LAKES, IL 60088-2952 (5780)

Mission:

To deter illicit drug use and promote safety and operational readiness in the armed forces by providing scientifically valid and legally defensible test results for selected drugs of abuse and drug metabolites in urine specimens to our customers in an accurate and efficient manner.

Vision:

To be a recognized center of excellence among forensic drug testing laboratories through

· exceptional customer service

· accurate test results

· timely test results

· an upwardly-mobile, expert workforce

· advancing the frontiers of drug testing capabilities with research and development.

1.0 DESCRIPTION OF SERVICE

The contractor shall provide the services of laboratory specimen processing in accordance with the provisions listed below. The Place of Performance is the Navy Drug Screening Laboratory Great Lakes located in Great Lakes Ill 60088-2952.

1.1 GENERAL RESPONSIBILITIES

1.1.1. SPECIMEN PROCESSING SERVICES – Initial Testing Technician

Estimate of Batches Per Day: 1 FTE will perform 4 batches per day (min some people do 4 or 5) * 240 Working Days *6persons =6720 Batches

1.1.2 DRUG SCREENING SUPPORT SERVICES - Quality Control Technician

3.0. GOVERNMENT FURNISHED/PROVIDED EQUIPMENT

3.1.1 The government shall provide all facilities, Local Area Network Access (LAN) (Required training on site will be required after the contractor is hired. and supplies necessary to perform services in this PWS. This does not include prescription safety glasses. All items furnished to the contractor are for official use only for this contract.

QASP:

TASK/

DELIVERABLE

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful, and informative data and information.

Contractor’s technical performance meets all contract requirements.

Problems that are encountered are minor in nature, and are as follows:

· does not cause a delay in schedule;

· does not cause costs to increase;

· involves minimal effort to fix; and

· does not affect overall contractor performance

All matters shall be resolved in a satisfactory and timely manner.

100% Inspection

Are study reports complete and compliant with various government regulations?

Assignment of performance rating and criteria:

Excellent Performance meets all and exceeds contract requirements. Performance delivered with no required re-performance/rework; problems that are encountered are minor and resolved in a highly effective manner.

Acceptable Performance and deliverables meet all contract requirements. Performance delivered with no re-performance/rework; problems that are encountered are minor and resolved in a satisfactory manner.

Unacceptable Many contract requirements not met.

Re-performances or reworks required. Substantial problems were encountered and were resolved in a less than satisfactory manner.

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful, and informative data and information.

Contractor’s technical performance meets all contract requirements.

Problems that are encountered are minor in nature, and are as follows:

· does not cause a delay in schedule;

· does not cause costs to increase;

· involves minimal effort to fix; and

· does not affect overall contractor performance

All matters shall be resolved in a satisfactory and timely manner.

100% Inspection

Is the contractor meeting established timeframes?

Assignment of performance rating and criteria:

Excellent Performance meets all and exceeds contract requirements. Performance delivered with no required re-performance/rework; problems that are encountered are minor and resolved in a highly effective manner.

Acceptable Performance and deliverables meet all contract requirements. Performance delivered with no re-performance/rework; problems that are encountered are minor and resolved in a satisfactory manner.

Unacceptable

Re-performances or reworks required. Substantial problems were encountered and were resolved in a less than satisfactory manner.

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful, and informative data and information.

Contractor’s technical performance meets all contract requirements. Problems that are encountered are minor in nature, and are as follows:

· does not cause a delay in schedule;

· does not cause costs to increase;

· involves minimal effort to fix; and

· does not affect overall contractor performance

All matters shall be resolved in a satisfactory and timely manner.

Periodic Inspection and Customer Complaint

What is the governments overall satisfaction with the contractor?

Assignment of performance rating and criteria:

Excellent Performance meets all and exceeds contract requirements. Performance delivered with no required re-performance/rework; problems that are encountered are minor and resolved in a highly effective manner.

Acceptable Performance and deliverables meet all contract requirements. Performance delivered with no re-performance/rework; problems that are encountered are minor and resolved in a satisfactory manner.

Unacceptable

Re-performances or reworks required. Substantial problems were encountered and were resolved in a less than satisfactory manner.

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

DELIVERY INFORMATION

31-OCT-2016

2500 RODGERS STREET, BLDG 5501

GREAT LAKES IL 60088-2952

(847) 688-2045 X 112

N68849

31-OCT-2017

N68849

31-OCT-2018

N68849

31-OCT-2019

N68849

31-OCT-2020

N68849

CONTRACT ADMINISTRATION

1. CONTRACTING OFFICER’S REPRESENTATIVE

The Contracting Officer’s Representative (COR), (TBD), is hereby designated the Contracting Officer’s Representative for the purpose of conducting all technical liaison duties with the contractor. Such technical representative is not authorized to direct or consent to any deviation from the specifications, scope of work and/or terms and conditions of this contract. Accordingly, no deviations thereto may be made without the prior written approval of the Contracting Officer. Refer to Attachment 2 Contract Administration Plan (CAP) for additional information.

2. CONTRACTS POINT OF CONTACT

(a) The Contracting Officer is the only person authorized to approve changes in any of the requirements of this contract and, notwithstanding provisions contained elsewhere in this contract, the said authority remains solely with the Contracting Officer. In the event the Contractor effects any change at the direction of any person other than the Contracting Officer, the change will be considered to have been made without the authority to do so and no adjustment will be made in the contract price to cover any increase in charges incurred as a result thereof.

(b) The name and address of the Contract Specialist who is the point of contact prior to and after award is:

Naval Medical Logistics Command ATTN: Amanda E. Rutten 693 Neiman Street Fort Detrick, MD 21702

(301) 619-3969 Email: Amanda.E.Rutten.civ@mail.mil

3. COMMUNICATIONS

(a) Except as specified in paragraph (b) below, no order, statement, or conduct of Government personnel who visit the contractor's facility or in any other manner communicate with contractor personnel during the performance of this contract shall constitute a change under the "Changes" clause of this contract.

(b) The contractor shall not comply with any order, direction or request of Government personnel unless it is issued in writing and signed by the Contracting Officer, or is pursuant to specific authority otherwise included as a part of this contract.

(c) The Contracting Officer is the only person authorized to approve changes in any of the requirements of this contract and, notwithstanding provisions contained elsewhere in this contract, the said authority remains solely the Contracting Officer's. In the event the contractor effects any change at the direction of any person other than the Contracting Officer, the change will be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in charges incurred as a result thereof.

SPECIAL CONTRACT REQUIREMENTS

GENERAL INFORMATION

Dress/Appearance. The contractor shall present a clean and neat appearance. The contractor shall not permit employees to wear cut off shorts, clothing with tears, revealing clothing or clothing with obscene/ inflammatory designs, slogans, or remarks. The contractor shall wear appropriate clothes suited for their job.

Smoking, Eating and Drinking. The contractor shall be permitted to smoke, eat and drink, only in designated areas.

Base Regulations. The contractor shall be acquainted with and obey all Government regulations as posted, while on the Naval Station Great Lakes and those provided by NDSL.

PERFORMANCE BY FOREIGN NATIONALS OR FOREIGN OWNERSHIP, CONTROL OR INFLUENCE (FOCI) ORGANIZATIONS

In accordance with 8 U.S.C.1324a, it is unlawful to hire for employment in the U.S. an individual without verifying that individual’s employment authorization. 8 CFR 274a.2 VERIFICATION OF EMPLOYMENT ELIGIBILITY identifies the official documents that establish employment eligibility.

Prior to performance of work by a foreign national as a result of this contract, the employer shall provide the Contracting Officer the name of the foreign national and identify the type of form(s) produced for verification of employment status.

Should the foreign national’s performance require access to DoD facilities, the employer shall coordinate with the sponsor providing access, in order to submit the following:

1. Individual’s Name

1. Date/place of birth

1. Citizenship

1. Date and Location of the Visit

1. Purpose of the Visit

1. Passport Number

1. Employer’s Verification of Work Authorization

This information shall be forwarded to the Contracting Officer at least thirty days prior to the visit taking place. Failure to provide this information within this time frame may prevent the individual(s) from entry into the DoD facilities.

The offeror shall disclose if the company (or individual) is a FOCI organization. A FOCI organization includes sole proprietorships, partnerships, and corporations, and the divisions and subsidiaries of the corporation where: (a) 51% or more of the controlling (voting) stock is foreign-owned; or (b) parent organization is incorporated or otherwise charted in a country foreign to the U.S.; and (c) the organization is not performing a state function (any organization performing a state function falls under IPO authority). A division or subsidiary of an organization having a location in the U.S. is still considered a FOCI organization if the parent corporation is a FOCI organization. A university, college, or not-for-profit organization that is chartered, incorporated, or otherwise called into being in a country foreign to the U.S. and not performing a state function is a FOCI organization. A FOCI person is a non-U.S. citizen. Resident aliens are considered FOCI persons for licensing and technology transfer purposes. Approval by the U.S. Trade Representative may be required prior to executing a contract with a FOCI organization or person.

PRIVACY ACT AND HIPAA

The contractor shall ensure that all Protected Health Information (PHI) is protected in accordance with the Privacy Act of 1974 and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) mandated safeguards to ensure confidentiality of health information. All contractor personnel are required to complete HIPAA training within one (1) year prior to the provision of services under this contract. Contractor personnel must complete HIPAA refresher training annually.

AUTHORIZED CHANGES ONLY BY THE CONTRACTING OFFICER

(a) Except as specified in paragraph (b) below, no order, statement, or conduct of Government personnel who visit the contractor’s facilities or in any other manner communicates with contractor personnel during the performance of this contract shall constitute a change under the “Changes” clause of this contract.

(b) The contractor shall not comply with any order, direction or request of Government personnel unless it is issued in writing and signed by the Contracting Officer, or is pursuant to specific authority otherwise included as a part of this contract.

(c) The Contracting Officer is the only person authorized to approve changes in any of the requirements of this contract and notwithstanding provisions contained elsewhere in this contract, the said authority remains solely the Contracting Officer’s. In the event the contractor effects any change at the direction of any person other than the Contracting Officer, the change will be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in charges incurred as a result thereof.

CONTRACTOR'S PROPOSAL

Performance of this contract by the contractor shall be conducted and performed in accordance with detailed obligations to which the contractor committed itself in Proposal dated (To be filled in at contract award) in response to NMLC Solicitation No. (To be filled in at contract award).

ENVIRONMENTAL AND ENERGY CONSERVATION OBJECTIVES

If performance of any work under this contract is required at a Government facility, the Contractor shall contact the appropriate office and code with cognizance over safety and environmental requirement prior to performance of ANY work under this contract. The office having overall governance concerning safety is as follows:

Safety Officer/Industrial Hygiene Officer

Contractors are responsible for following all safety and health related State and Federal statutes and corresponding State, Federal and/or Department of Defense regulations protecting the environment, contractor employees, and persons who live and work in and around contractor and/or federal facilities.

STANDARD LIABILITY INSURANCE

The following types of insurance are required in accordance with the clause entitled, FAR 52.228-5, Insurance--Work on a Government Installation and shall be maintained in the minimum amounts shown:

(a) Comprehensive General Liability: $ N/A per person and $500,000 per accident for bodily injury.

(b) Automobile Insurance: $200,000 per person and $500,000 per accident for bodily injury and $20,000 per accident for property damage.

(c) Standard Workman’s Compensation and Employer’s Liability Insurance (or, where maritime employment is involved, Longshoremen’s and Harbor Worker’s Compensation Insurance) in the minimum amount of $100,000.

(d) Aircraft public and passenger liability: $N/A per person and $ N/A per occurrence for bodily injury, other than passenger liability; $ N/A per occurrence for property damage. Passenger bodily injury liability limits of $N/A per passenger, multiplied by the number of seats or number of passengers, whichever is greater.

ORGANIZATIONAL CONFLICT OF INTEREST (JAN 1992) (NAVSUP)

This clause provides examples of certain organizational conflicts of interest which are prescribed by Federal Acquisition Regulation Subpart 9.5. The two (2) underlying principles which this clause seeks to avoid are preventing the existence of conflicting roles that might bias a contractor's judgment and preventing unfair competitive advantage. The following subsections prescribe certain limitations on contracting as the means of avoiding, neutralizing or mitigating organizational conflicts of interest.

If, under this contract, the contractor will provide systems engineering and technical direction for a system, but does not have overall contractual responsibility for its development, integration, assembly, checkout or production, the contractor shall not be awarded a subsequent contract to supply the system or any of its major components, or to act as consultant to a supplier of any system, subsystem, or major component utilized for or in connection with any item or other matter that is (directly or indirectly) the subject of the systems engineering and technical direction. The term of this prohibition shall endure for the entire period of this contract and for two (2) years thereafter.

If, under this contract, the contractor will prepare and furnish complete specifications covering nondevelopmental items, to be used in a competitive acquisition, the contractor shall not be permitted to furnish these items, either as a prime or subcontractor. The term of this prohibition shall endure for the entire period of this contract performance and for either two (2) years thereafter or the duration of the initial production contract whichever is longer. This rule shall not apply to contractors who furnish specifications or data at Government request or to situations in which contractors act as Government representatives to help Government agencies prepare, refine or coordinate specifications, provided this assistance is supervised and controlled by Government representatives.

If, under this contract, the contractor will prepare or assist in preparing a work statement to be used in competitively acquiring a system or services, the contractor shall not supply the system, its major components, or the service unless the contractor is the sole source, the contractor has participated in the development and design work, or more than one contractor has been involved in preparing the work statement.

The term of this prohibition shall endure for entire period of this contract performance and for two (2) years thereafter.

If, under this contract, the contractor will provide technical evaluation of products or advisory and assistance services, the contractor shall not provide such services if the services relate to the contractor's own or a competitor's products or services unless proper safeguards are established to ensure objectivity.

If, under this contract, the contractor gains access to proprietary or source selection information of other companies in performing advisory assistance services for the Government, the contractor agrees to protect this information from unauthorized use or disclosure and to refrain from using the information for any purpose other than that for which it was furnished. A separate agreement shall be entered into between the contractor and the company whose proprietary information is the subject of this restriction. A copy of this agreement shall be provided to the Contracting Officer. Any OCI Mitigation Plan between the contractor and the Government does not give authorization for a contractor being in possession of another company’s proprietary or sensitive information.

STATION/BASE REGULATIONS

The contractor and its employees and subcontractors shall become familiar with and obey station/base regulations, including fire, traffic, and security regulations. Personnel working at the station/base shall keep within the limits of the work (and avenues of ingress and egress), and shall not enter restricted areas unless required to do so and are cleared for such entry. Any contractor’s equipment shall be marked for identification.

PRIVATELY-OWNED VEHICLE OPERATION

(a) Privately-Owned Vehicle (POV) Permits: Contractor personnel using POVs on DoD installations shall have proper operating licenses and permits for entry onto the installations. All vehicles, private or contractor-owned, shall comply with the vehicle operation regulations that govern installations. All vehicles are subject to search while on DoD installations. Only licensed contractor personnel shall operate vehicles on DoD installations. Vehicles shall be operated in accordance with local and state laws as well as installation specific traffic regulations.

(b) Privately-Owned Vehicle (POV) Parking: The contractor shall utilize on-station POV parking in authorized areas. The Government reserves the right to change parking arrangements at any time.

(c) Traffic Accident Report Requirements: The contractor shall report to Base Security, within one hour, any traffic accident involving contractor personnel that occurs on base, whether in the performance of this PWS or commuting in their POVs, IAW OPNAVINST 5102.1 series, OPNAVINST 5100.23 series, and other applicable local instructions. The contractor shall supply a copy of any on-base traffic accident report to the COR within five workdays after occurrence. The contractor shall also provide the COR a copy of any report of an off-base traffic accident that involves contractor personnel in the performance of this PWS within five workdays after occurrence.

(d) Fines, Fees, Point Assessment and Other Costs: The contractor shall pay all fines, fees, point assessment, and other costs associated with traffic violations, parking violations, or accidents that occur in the performance of work under this contract.

NOTICE TO CONTRACTOR OF CERTAIN DRUG DETECTION PROCEDURES

Pursuant to Department of Defense and Military Service policy applicable to both Government and contractor personnel, measures will be taken to prevent the introduction and utilization of illegal drugs and related paraphernalia into Government Work areas.

In furtherance of these drug control policies, unannounced periodic inspections of the following nature may be conducted by installation security authorities:

1. Routine inspections of contractor occupied work spaces.

1. Random inspections of vehicles on entry or exit from the installation, with drug detection dog teams as available, to eliminate them as a safe haven for storage of or trafficking in illegal drugs.

1. Random inspections of personal possessions on entry or exit from the installation.

When there is a probable cause to believe that a contractor employee working at a Government installation has been engaged in use, possession or trafficking of drugs, the installation authorities may detain the employee until the employee can be removed from the installation, or can be released to the local authorities having jurisdiction. When the Government discovers illegal drugs and related paraphernalia in the course of an inspection of a vehicle operated by a contractor employee, the vehicle may be detained until it can be turned over to local authorities having jurisdiction and the employee’s installation driving privileges may be suspended, revoked, or denied.

Trafficking in illegal drug and related paraphernalia by a contract employee while on a Government vessel or installation may lead to possible withdrawal or downgrading of security clearance, suspension or revocation of clinical privileges for employees working at an MTF, and/or referral for prosecution by appropriate law enforcement authorities.

The contractor is responsible for the conduct of employees performing work under this contract and is, therefore, responsible to assure that employees are notified of these provisions prior to assignment.

The removal of contractor personnel from a Government vessel or installation as a result of drug offenses shall not be a cause for excusable delay, nor shall such action be deemed a basis for an equitable adjustment to price, delivery or other provisions of this contract.

OCCUPATIONAL SAFETY AND HEALTH REQUIREMENTS

(a) If performance of any work under this contract is required at a Government facility, the contractor shall contact the appropriate office and code with cognizance over safety and environmental requirement prior to performance of any work under this contract.

(b) Contractors are responsible for following all safety and health related State and Federal statutes and corresponding State, Federal and/or Department of Defense regulations (e.g., NOSCINST 5100.5C, Occupational Safety and Health Manual) protecting the environment, contractor employees, and persons who live and work in and around contractor and/or federal facilities.

(c) Contractors shall monitor its employees and ensure that they are following safety regulations particular to the work areas. Contractors shall ensure that its employees:

(1) Wear appropriate safety equipment and clothing;

(2) Are familiar with all relevant emergency procedures should an accident occur; and

(3) Have access to a telephone and telephone numbers for the Government facility where the work is performed.

(d) This contract may require the contractor to handle hazardous materials, which material safety data sheets will be provided.

(e) Accidents: The contractor is solely responsible for compliance of all safety regulations of employees while working on Government facilities. All accidents which may arise out of, or in connection with, performance of services required hereunder which result in injury, death, or property damage, shall be reported in writing to the Contracting Officer and COR within twenty-four hours of such occurrence. Reports shall provide full details of the accident, including statements from witnesses. The fore-going procedures shall also apply to any claim made by a third party against the contractor as a result of any accident that occurs in connection with performance under this contract.

GOVERNMENT INSTALLATION WORK SCHEDULE

(a) The Government facility operates from 7:00 AM to 5:00 PM, Monday through Friday. Core operating hours are 9:00 AM to 3:00 PM.

(b) The Federal Holidays applicable to this contract are: New Year’s Day, Martin Luther King’s Birthday, President’s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran’s Day, Thanksgiving Day, and Christmas Day.

(c) In the event that the contractor is prevented from performance as the result of an Executive Order or an administrative leave determination (e.g., weather related closing, delayed opening or early closure) that applies to the Government facility, such time may be charged to the contract as a direct cost provided such charges are consistent with the contractor’s accounting practices. In the event that any of the above holidays occur on a Saturday or Sunday, then such holiday shall be observed as they are by the assigned Government employees at the Government facility.

(d) If the Government facility allows a flexible workweek for its Government employees, applicable on-site contractor personnel shall perform in consonance with those flexible workweek arrangements for the department(s) supported.

ELECTRONIC TRANSMISSION OF PROPRIETARY DATA

The contractor shall be fully capable and willing to electronically transmit proprietary data to the Government. This data may consist of contract deliverables or pricing data required for proposal evaluation. Any software required by the Government to receive the contractor-transmitted proprietary data that the Government does not already possess shall be provided by the contractor at no cost to the Government.

CONTRACTOR PERSONNEL IDENTIFICATION

Contractor employees shall identify themselves as contractor personnel by introducing themselves or being introduced as contractor personnel and displaying distinguishing badges or other visible identification for meetings with Government personnel. Contractor personnel shall also appropriately identify themselves as contractor employees in telephone conversations and in formal and informal written correspondence. When working at Government facilities, distinguishing badges or other visible identification shall be displayed by contractor personnel.

Contractor personnel, while performing in a Contractor capacity, are prohibited from using their retired or reserve component military rank or title in written or verbal communications associated with the contract under which they provide services.

STANDARDS OF CONDUCT

Contractor employees providing support to the Government shall conduct themselves in a professional, businesslike manner adhering to high ethical standards. Contractor employees must follow the Standards of Ethical Conduct for Employees of the Executive Branch (Codified in 5 C.F.R. Part 2635 and as amended at 76 FR 38547) and local command policy in addition to the standards of conduct policies of the contractor. The Government will not tolerate unethical behavior and behavior that reflects poorly upon the Government, its mission, and its operations. If a contractor employee is uncertain whether contemplated acts or conduct may violate the Standards of Ethical Conduct for Employees of the Executive Branch or local command policy, the contractor employee must contact the Contracting Officer Representative (COR) before engaging in such acts or conduct. CORs will seek advice on ethics issues from their ethics counselor.

BUSINESS ASSOCIATE AGREEMENT

This Business Associate Agreement (BAA) incorporates HIPAA/HITECH Act requirements under the HHS Final Omnibus Rule (78 FR 5566, published 25 Jan 2013), effective 23 Sep 2013. This BAA is for use by MHS components outside of DHA.

Business Associate Agreement

Introduction

In accordance with 45 CFR 164.502(e)(2) and 164.504(e) and paragraph C.3.4.1.3 of DoD 6025.18-R, “DoD Health Information Privacy Regulation,” January 24, 2003, this document serves as a business associate agreement (BAA) between the signatory parties for purposes of the Health Insurance Portability and Accountability Act (HIPAA) and the “HITECH Act” amendments thereof, as implemented by the HIPAA Rules and DoD HIPAA Issuances (both defined below). The parties are a DoD Military Health System (MHS) component, acting as a HIPAA covered entity, and a DoD contractor, acting as a HIPAA business associate. The HIPAA Rules require BAAs between covered entities and business associates. Implementing this BAA requirement, the applicable DoD HIPAA Issuance (DoD 6025.18-R, paragraph C3.4.1.3) provides that requirements applicable to business associates must be incorporated (or incorporated by reference) into the contract or agreement between the parties.

(a) Catchall Definition. 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: Data Aggregation, Designated Record Set, Disclosure, Health Care Operations, Individual, Minimum Necessary, Notice of Privacy Practices (NoPP), Protected Health Information (PHI), Required By Law, Secretary, Security Incident, Subcontractor, Unsecured Protected Health Information, and Use.

Breach means actual or possible loss of control, unauthorized disclosure of or unauthorized access to PHI or other PII (which may include, but is not limited to PHI), where 12 Nov 2013 Page 2 of 10 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.

Business Associate shall generally have the same meaning as the term “business associate” in the DoD HIPAA Issuances, and in reference to this BAA, shall mean the contractor.

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

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 the Government facility(s) and office(s) that are supported under this contract.

DHA Privacy Office means the 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 (NCRMD).

DoD HIPAA Issuances means the DoD issuances implementing the HIPAA Rules in the DoD Military Health System (MHS). These issuances are DoD 6025.18-R (2003), DoDI 6025.18 (2009), and DoD 8580.02-R (2007).

DoD Privacy Act Issuances means the DoD issuances implementing the Privacy Act, which are DoDD 5400.11 (2007) and DoD 5400.11-R (2007).

HHS Breach means a breach that satisfies the HIPAA Breach Rule definition of breach in 45 CFR 164.402.

HIPAA Rules means, collectively, the HIPAA Privacy, Security, Breach and Enforcement Rules, issued by the U.S. Department of Health and Human Services (HHS) and codified at 45 CFR Part 160 and Part 164, Subpart E (Privacy), Subpart C (Security), Subpart D (Breach) and Part 160, Subparts C-D (Enforcement), as amended by the 2013 modifications to those Rules, implementing the “HITECH Act” provisions of Pub. L. 111-5. See 78 FR 5566-5702 (Jan. 25, 2013) (with corrections at 78 FR 32464 (June 7, 2013)). Additional HIPAA rules regarding electronic transactions and code sets (45 CFR Part 162) are not addressed in this BAA and are not included in the term HIPAA Rules.

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.

I. Obligations and Activities of Business Associate

(a) The Business Associate shall not use or disclose PHI other than as permitted or required by the Agreement or as required by law.

(b) The Business Associate 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 the Agreement.

(c) The Business Associate shall report to Covered Entity any Breach of which it becomes aware, and shall proceed with breach response steps as required by Part V of this BAA. With respect to electronic PHI, the Business Associate shall also respond to any security incident of which it becomes aware in accordance with any Information Assurance provisions of the Agreement. If at any point the Business Associate becomes aware that a security incident involves a Breach, the Business Associate shall immediately initiate breach response as required by part V of this BAA.

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

(e) The Business Associate 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 CFR 164.524.

(f) The Business Associate shall make any amendment(s) to PHI in a Designated Record Set as directed or agreed to by the Covered Entity pursuant to 45 CFR 164.526, or take other measures as necessary to satisfy Covered Entity’s obligations under 45 CFR 164.526.

(g) The Business Associate 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 CFR 164.528.

(h) To the extent the Business Associate is to carry out one or more of Covered Entity's obligation(s) under the HIPAA Privacy Rule, the Business Associate shall comply with the requirements of HIPAA Privacy Rule that apply to the Covered Entity in the performance of such obligation(s); and

(i) The Business Associate shall make its internal practices, books, and records available to the Secretary for purposes of determining compliance with the HIPAA Rules.

II. Permitted Uses and Disclosures by Business Associate

(a) The Business Associate may only use or disclose PHI as necessary to perform the services set forth in the Agreement or as required by law. The Business Associate is not permitted to de-identify PHI under DoD HIPAA issuances or the corresponding 45 CFR 164.514(a)-(c), nor is it permitted to use or disclose de-identified PHI, except as provided by the Agreement or directed by the Covered Entity.

(b) The Business Associate 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 Business Associate shall not use or disclose PHI in a manner that would…