DRAFT_PWS.doc

PERFORMANCE WORK STATEMENT

Haemonetics® ACP®215 Automated Cell Processor Units

1. General:

Contractor shall provide scheduled and unscheduled maintenance to include parts, labor on the Haemonetics® ACP®215 Automated Cell Processor units located in the Robertson Blood Bank Center within C. R. Darnall Army Medical Center (CRDAMC), Fort Hood, Texas.

EQUIPMENT LIST:

ECN #’S

SN #’S

33567

10E162

33568

09A340

33569

10E163 33570

09A339

33571

09A338

33572

09J113

33573

09F161

33574

09J112

2. Scope of Work:

2.1. The contractor shall provide all necessary trained experienced personnel, labor, tools, diagnostic equipment and software, material, supplies, transportation, parts and equipment, excluding expendable items to perform service maintenance, repair and support of the Haemonetics® ACP®215 Automated Cell Processor units. Service shall consist of one (1) yearly preventive maintenance (PM) and unlimited repair calls for the Haemonetics® ACP®215 Automated Cell Processor units necessitated by the equipment’s failure during normal usage and the failure is not the result of an intervening external cause. Haemonetics® 24/7 Technical Assistance phone number must be made available to the CRDAMC Medical Maintenance Department.

2.2. Normal Duty Hours: Monday through Friday 7:30 am. to 4:30 p.m., excluding national holidays and weekends.

2.3. Upon arrival contractor shall report or telephonically notify the Medical Maintenance Branch Government Point of Contact (GPOC) or Non-Commissioned Officer in Charge (NCOIC), (254) 288-8810 or (254) 553-9288 CRDAMC BLDG 36065 Room 40-251 Fort Hood TX 76544.

2.4. After Duty Hours: Contractor shall report to the Administrative Officer of the Day (AOD) at the front desk of the hospital to be escorted to the appropriate work area. There are no authorized overtime hours.

3. Personnel Qualifications:

The contractor shall provide documentation that the field service engineers/technicians (FSE/FST) are qualified and manufacture trained on the Haemonetics® ACP®215 Automated Cell Processor units. In addition to this training, the technicians must have proof of two years of working experience, effective with the current date. Upon request, the contractor prior to service commencing shall present documented proof of successful completion of such training.

4. Contract Representative (POC).

The contractor shall provide in writing on the contract start date, the name and telephone number of a primary and alternate individual to act as their representative to be responsible for the coordination of the contract with the government. The contractor’s designated representative shall be the point of contact with the government and shall have the authority to act or make decisions for the contractor on all matters pertaining to the contract. The contracting officer shall be notified in writing within 40 hours to equal five business days, whenever changes are made.

5. Quality Control:

5.1. The contractor shall establish and maintain a Quality Control Plan to ensure that the quality of service and material provided meet or exceed the specifications, terms and conditions of the contract. All repairs or modifications that are made shall be in compliance with the Original Equipment Manufacturers (OEM) specification and Food and Drug Administration guidance.

5.2. The government will establish and maintain a Quality Assurance (QA) Plan to ensure that the quality of service is being provided and meet and exceed the specifications, terms and conditions of the contract.

6. Definitions:

6.1. Scheduled Maintenance: The scheduled care and servicing of equipment for the purpose of the equipment in a serviceable condition in accordance with the manufacturer’s specifications.

6.2. Unscheduled Maintenance: Repair action necessary to return the equipment to a totally operational condition as it was designed to operate in accordance with the manufacturer’s specifications.

6.3. Quality Control Plan: The contractors’ written plan describes how he will ensure the performance of the services required by the contract are met or exceeded. At a minimum, the contractor’s Quality Control Plan will include:

a. Method for acquiring acceptable replacement parts.

b. Inspection intervals and a copy of the checklist to be used by the contractors QA Inspector.

6.4. Replacement Part: A component or module of the existing system or approved upgraded/modified system requiring replacement through a fault developed through normal use or normal wear and tear. Replacement parts do not include consumable supplies. Replacement parts include components that are installed solely for cosmetic appearance i.e. cowlings, molding, keyboard keypads (when the key designation is work off), etc.

7. Government Furnished Services:

7.1. Equipment: The equipment covered under this contract will be made available to the contractor for the purpose of scheduled or unscheduled service. The contractor shall obtain CRDAMC Medical Maintenance approval for the time and duration of the service to be conducted and shipping instructions.

7.2. Property: The contractor shall not use property provided by the government for any purpose other than in the performance of this contract.

7.3. Utilities: Reasonable amounts of electric power and other utilities will be provided to the contractor to perform required services. The contractor is responsible for conserving utilities while working on the installation.

7.4. Contractor Furnished: Only the property and services referenced in paragraph 7.1 and 7.2 will be provided to the contractor to perform required services. All other property and services required in the performance of this contract shall be furnished and held by the contractor. For example:

7.4.1. Tools

7.4.2. Test equipment

7.4.3. Current service manuals with guaranteed ability to provide product updates, guaranteed to provide factory mandated instrument modifications, schematics, wiring diagrams and troubleshooting guides (failure to provide product updates or factory mandated modifications may constitute grounds for contract termination).

7.4.4. All other items necessary to perform service such as common hardware, connectors, tubing and etc.

8. Replacement Parts:

8.1. The contractor shall have ready access to OEM brand name only unique and/or high mortality replacement parts. All parts and supplies shall be compatible and OEM products for the Haemonetics® ACP®215 Automated Cell Processor units.

8.2. All replacement parts shall become the property of the government and the replaced malfunctioning part shall become the property of the contractor.

8.3. Freight, postage and storage charges associated with shipment and receipt of replacement parts and the return of work or defective parts shall be the responsibility of the contractor.

8.4. The contractor shall use only new or government pre-approved reconditioned parts for which the quality is equal to or better than the OEM’s original part. Any parts provided by the contractors that are considered by the OEM to be substandard may be replaced at the contractor’s cost. When discrepancies occur, the contracting officer will make the final determination about whether a replacement part is of equal or better quality.

8.5. The contractor shall provide all replacements and service necessary to restore the equipment to 100% operational condition as specified by the OEM and the equipment shall be restored to fully mission capable and operational within 40 hours (to equal five business days).

9. Coordination for scheduled and unscheduled services:

9.1. Preventive maintenance shall be performed in accordance with the manufacturer’s specifications during the specified month. The contractor shall coordinate 15 days in advance with the GPOC or NCOIC, Medical Maintenance Branch, (254) 288-8810 or (254) 553-9822 for preventive maintenance, certification, and calibration. The service technician shall provide online/internet support (IF APPLICABLE) within twenty-four (24) hours of notification. Government request for remedial repairs will be placed telephonically by the GPOC or his/her designated representative to the contractor’s POC.

The contractor’s response to requests for remedial repairs may include a telephone consultation between the equipment user/operator or Government’s Service Technician and a contractor’s FSE/FST Technical Assistance Agent. The purpose of this telephone consultation shall be:

9.2. To determine the most likely cause of the problem.

9.3. To determine if resolution of the problem requires the dispatch of a FSE/FST once determination has been made that a contractor’s FSE/FST is required on site. The contractor’s FSE/FST shall have 24 hours (to equal three business days) to be on-site from the time of notification by the contracting officer to the contractor and restored fully mission capable and operational within 40 hours (to equal five business days).

9.4. To identify replacement parts if any likely to be required in order to return the equipment to 100% operational condition as specified by the OEM.

9.5. The Government and the contractor will exchange hazard communication information before the commencement of any repair.

9.6. When required, the contractor will comply with the OSHA lockout/tag-out standard while performing maintenance on electrical equipment.

10. Scheduled/Unscheduled Maintenance documentation:

10.1. All scheduled and unscheduled maintenance shall be documented on a service report. This form will be furnished upon completion of service within five working days to the Medical Maintenance Branch NCOIC/GPOC via email tammytha.d.scott.civ@mail.mil.

10.2. In the event all information is not available to the contractor's service representative when services are performed, the initial service report shall include all available information. The contractor shall provide the balance of the required information to the clinical engineering manager no later than 40 hours to equal five business days after services are completed.

10.3. Service Reports:

The contractor shall prepare a service report for each job performed. During duty hours, the service reports will be authenticated with the Medical Maintenance Branch during normal duty hours and with the AOD after normal duty hours. The service reports shall include the following information as a minimum:

1. Government contract number

2. Equipment identification data

3. System nomenclature, room number, location, model and serial number

4. Purpose of service (scheduled service or unscheduled service call)

5. Start date/time and completion date/time

6. Description of defect and corrective action taken

7. List of parts and cost. Total cost of service to include labor and parts

8. Explanations of any deferred or delayed repair action with an estimated get well date.

10.4. Calibration Documentation; All calibration services shall be documented by the contractor on the service report and a government supplied DD 2163 Calibration/Verification Certification label is attached to the medication management system if needed. The verification shall be affixed to the units with the service date, initials and date next service due annotated. If the contractor does not have labels, the medical maintenance shop will furnish the government form DD 2163 Verification/Certification.

10.5. Maintenance Logs: A maintenance log will be maintained with the service technician for the system. The log will be documented for any service performed. The log will remain on-site with each system.

10.6. Scheduled Maintenance documentation: All scheduled maintenance shall be documented on a service contract. This form will be furnished upon completion of service to the Medical Maintenance Branch NCOIC.

11. Equipment Modification/Alteration/Upgrades:

11.1. The contractor shall perform/incorporate only OEM specified modifications, alterations, and upgrades. Approval shall be obtained from the GPOC prior to the contractor’s installation of the modification, alteration, or upgrade.

11.2. The contractor shall perform or cause to be performed all OEM field modifications and safety alert inspections.

11.3. The OEM shall determine the requirement for field modifications and to ensure accomplishment of these field modifications are in accordance with the time schedule set forth by the OEM.

11.4. The contractor will make known to the GPOC of minor or routine OEM software upgrades when they become available by the manufacturer.

11.5. Hardware and software changes not supported by the OEM are not authorized.

12. Contractor Reporting Requirements:

During normal duty hours, the contractor’s FSE/FST shall notify the GPOC in person upon arrival at the government site and again prior to departure. Contractor representative shall sign in and out at the Medical Maintenance Branch, room 40-251, basement, Building 36065. In the event that the contractor performs authorized service beyond the normal duty hours, he shall sign-in and out with the AOD at the information desk located on the main floor in the front lobby. There are no authorized overtime hours.

13. Repair Parts:

13.1. Replacement parts used in the performance of this contract shall be OEM, new or approved government reconditioned, however, Government approved reconditioned repair parts shall be the only reconditioned repair parts allowed for performance of services under this contract.

13.2. The contractor shall have and maintain an adequate inventory of repair parts at their immediate disposal to service the Haemonetics® ACP®215 Automated Cell Processor equipment listed herein and as may be needed in the performance of this contract. The contractor shall maintain a backup inventory of spare parts so that any spare parts can be delivered to the site within the time frames established, if the spare part is not available from the local contractor inventory.

14. Services beyond the scope of the performance work statement:

The contractor shall immediately, but not later than 24 consecutive hours after discovery, notify the GPOC (in writing) of the existence or development of any defects in/or repairs required to the equipment covered under this contract especially which the contractor considers they are not responsible under the terms of the contract. At the same time of the notification, the contractor shall furnish the contracting officer with a written estimate of the cost to make the necessary repairs.

15. Conduct of Personnel:

The Contracting Officer may require the contractor to remove from the job site any employee working under this contract for reasons of misconduct, security, or found to be or suspected to be under the influence of alcohol, drugs or other incapacitating agent. Contractor employees shall be subject to dismissal from the premises upon determination by the Contracting Officer that such action is necessary and in the interest of the Government. In accordance with applicable directives and 18 U.S.C. 1382 (1972), the Installation Commander has the authority to bar individuals from the installation. The removal from the job site or dismissal from the premises shall not relieve the contractor of the requirement to provide sufficient personnel to perform the services as required by this work statement.

16. Identification Badge:

Contractor personnel shall wear a vendor identification badge at all times when performing services at the Government site. Identification badges shall be worn in a clearly visible area of the FSE/FST outer garment. The badge will be furnished at the Medical Maintenance Branch during duty hours and by the AOD after duty hours.

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

The following minimum Quality Assurance Plan applies. The Government may modify inspection methods in accordance with site specific requirements.

CONTRACTOR MANPOWER REPORTING

"ACCOUNTING FOR CONTRACT SERVICES-The Office of the Assistant Secretary of the Army (Manpower & Reserve Affairs) operates and maintains a secure Army data collection site where the contractor will report ALL contractor manpower (including subcontractor manpower) required for performance of this contract. The contractor is required to completely fill in all the information in the format using the following web address “https://cmra.army.mil.” The required information includes: (1) Contracting Office, Contracting Officer, Contracting Officer’s Technical Representative; (2) Contract number, including task and delivery order number; (3) Beginning and ending dates covered by reporting period; (4) Contractor name, address, phone number, e-mail address, identity of contractor employee entering data; (5) Estimated direct labor hours (including sub-contractor); (6) Estimated direct labor dollars paid this reporting period (including sub-contractor); (7) Total payments (including sub-contractor); (8) Predominant Federal Service Code (FSC) reflecting services provided by contractor (and separate predominant FSC for each sub-contractor if different); (9) Organizational title associated with the Unit Identification Code (UIC) for the Army Requiring Activity (the Army Requiring Activity is responsible for providing the contractor with its UIC for the purposes of reporting this information); (10) Locations where contractor and sub-contractors perform the work (specified by zip code in the United States and nearest City, Country, when in an overseas location, using standardized nomenclature provided on website); (11) Presence of deployment or contingency contract language, and, (12) Number of contractor and sub-contractor employees deployed in theater this reporting period (by country). (13) As part of its submission, the contractor will also provide the estimated total cost (if any) incurred to comply with this reporting requirement. Reporting period will be the period of performance not to exceed 12 months ending September 30 of each government fiscal year and must be reported by 31 October of each calendar year. The contractor shall notify the Contracting Officer’s Representative (COR) by the 5th working day of November whether or not they have completed this report. If the COR is unavailable, the contractor will notify the Contracting Officer."

SUPPLEMENT TO THE PERFORMANCE WORK STATEMENT

1. GOVERNMENT HOLIDAYS

The following Government Holidays are observed:

New Year’s Day, January 1

Martin Luther King, Jr.’s Birthday, 3rd Monday in January

President’s Day, 3rd Monday in February

Memorial Day, Last Monday in May

Independence Day, July 4

Labor Day, 1st Monday in September

Columbus Day, 2nd Monday in October

Veteran’s Day, November 11

Thanksgiving Day, 4th Thursday in November

Christmas Day, December 25

Note: Any of the above holidays falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. Any holidays that are declared by Presidential Executive Order shall be observed in the same manner as the holidays listed above. If the area in which a contract employee is scheduled to work is closed due to a holiday declared by an Executive Order and the employee is not required to report in, payment will not be made for those hours. Closures of the installation due to inclement weather or other such acts of God shall be handled in the same manner.

2. INVOICING AND PAYMENT MONTHLY

The contractor shall submit once yearly after yearly PM, in arrears, itemized invoices in accordance with DFARS 252.232-7003, for services rendered under this contract. Information regarding IRAPT is available on the Internet at https://wawf.eb.mil/. Payment will be made by Defense Finance and Accounting Service, (DFAS Indianapolis), Indianapolis, IN (address in Block 18a), after receipt of services. Contractor submits their 2-n-1 invoice in the IRAPT Invoicing, Receipt, Acceptance and Property Transfer (iRAPT) – formerly known as WAWF system for payment. The Contracting Officer’s Representative (COR) shall verify for acceptance to be submit to DFAS Indianapolis. Government Payment will only be authorized for services actually rendered. Advance payments under this contract are not authorized.

3. ANTITERRORISM/OPERATIONS SECURITY:

3.1. AT Level I training. This standard language is for contractor employees with an area of performance within on Army controlled installation, facility or area. All contractor employees, to include subcontractor employees, requiring access Army installations, facilities and controlled access areas shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date or incorporation of this requirement into the contract, whichever is applicable. The contractor shall submit certificates or completion for each affected contractor employee and subcontractor employee, to the COR or to the contracting officer, Jr a COR is not assigned, within 30 calendar days after completion or training by all employees and subcontractor personnel. AT level I awareness training is available at the following website: http://jko.jten.mil

3.2. Access and general protection/security policy and procedures. This standard language is for contractor employees with on area of performance within Army controlled installation, facility, or area. Contractor and all associated sub-contractors employees shall provide all Information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director or Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204·9, Personal Identity Verification or Contractor Personnel) as directed by DOD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause or this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

3.3. For contractors that do not require CAC, but require access to a DoD facility or installation. Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

3.4. iWATCH Training. This standard language is for contractor employees with an area of performance within an Army controlled installation, facility or area. The contractor and all associated sub-contractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This local developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 30 calendar days of the results reported to the COR NLT 30 calendar days after contract award.

3.5. Threat Awareness Reporting Program. For all contractors with security clearances. Per AR 381-12 Threat Awareness and Reporting Program (TARP), contractor employees must receive annual TARP training by a Cl agent or other trainer as specified in 2-4b.

4. SEXUAL ASSAULT PREVENTION AND RESPONSE PROGRAM (SHARP):

The contractor shall comply with OTSG/MEDCOM Policy Memo 13-062, Policy for Reporting Incidents of Sexual Assault and Sexual Harassment under the Sexual Assault Prevention and Response Program (SHARP), 12 Nov 2013. The SHARP reporting requirements apply only to knowledge obtained by contractor personnel while performing services under this contract.

The contractor shall require all Contract Service Providers (CSP) with knowledge of an incident of sexual assault occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the contractor who shall immediately (within 24 hours) report the incident in writing to the government's COR. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals.

The contractor shall require all CSPs with knowledge of an incident of sexual harassment occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the contractor who shall immediately (within 24 hours) report the incident in writing to the government's COR. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals.

4.1 Government Unique Training: The contractor shall ensure all service providers receive Sexual Harassment/Assault Response and Prevention (SHARP) training not later than 60 calendar days after contractor personnel begins performance under this contract. Training can be obtained either online or in person. Contractor personnel can attend SHARP training provided by Carl R. Darnall Army medical Center, Fort Hood, Texas. If the employee has an AKO account, they can access online the Team Bound Self Study course through Army Learning Management System (ALMS) at http://www.atsc.army.mil/tadlp/delivery/alms.asp

4.2. Advisory Publications: Army Regulation 600-20, Army Command Policy, 20 Sep 2012

4.3. Government Unique Training

The contractor shall ensure all service providers receive Sexual Harassment/Assault Response and Prevention (SHARP) training not later than 60 calendar days after contractor personnel begins performance under this contract. Training can be obtained either online or in person. Contractor personnel can attend SHARP training provided by Carl R. Darnall Army Medical Center, Fort Hood, TX. If the employee has an AKO account, they can access online the Team Bound Self Study course through Army Learning Management System (ALMS) at http://www.atsc.army.mil/tadlp/delivery/alms.asp

4.4. Advisory Publications

Army Regulation 600-20, Army Command Policy, 20 Sep 2012

OTSG/MEDCOM Policy Memo 13-062, Policy for Reporting Incidents of Sexual Assault and Sexual Harassment under the Sexual Assault Prevention and Responses Program (SHARP), 12 Nov 2013

5. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA) NON-DEFENSE HEALTH AGENCY (NON-DHA) BUSINESS ASSOCIATE AGREEMENT (BAA) (7 JULY 2014)

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 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 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 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 [insert name of Business Associate signatory to this BAA].

—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 [insert name of MHS component signatory to this BAA].

—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 violate the DoD HIPAA Issuances or HIPAA Privacy Rules if done by the Covered Entity, except uses and disclosures for the Business Associate’s own management and administration and legal responsibilities or for data aggregation services as set forth in the following three paragraphs.

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

(e) Except as otherwise limited in the Agreement, the Business Associate may disclose PHI for the proper management and administration of the Business Associate or to carry out the legal responsibilities of the Business Associate, provided that disclosures are required by law, or the Business Associate 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 Business Associate of any instances of which it is aware in which the confidentiality of the information has been breached.

(f) Except as otherwise limited in the Agreement, the Business Associate may use PHI to provide Data Aggregation services relating to the Covered Entity’s health care operations.

III. Provisions for Covered Entity to Inform Business Associate of Privacy Practices and Restrictions

(a) The Covered Entity shall provide the Business Associate with the notice of privacy practices that the Covered Entity produces in accordance with 45 CFR 164.520 and the corresponding provision of the DoD HIPAA Issuances.

(b) The Covered Entity shall notify the Business Associate 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 Business Associate’s use or disclosure of PHI.

(c) The Covered Entity shall notify the Business Associate 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 CFR 164.522, to the extent that such changes may affect the Business Associate’s use or disclosure of PHI.

IV. Permissible Requests by Covered Entity

The Covered Entity shall not request the Business Associate 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 Business Associate as otherwise permitted by this BAA.

V. Breach Response

(a) In general.

In the event of a breach of PII/PHI held by the Business Associate, the Business Associate shall follow the breach response requirements set forth in this Part V, which is designed to satisfy both the Privacy Act and HIPAA as applicable. If a breach involves PII without PHI, then the Business Associate shall comply with DoD Privacy Act Issuance breach response requirements only; if a breach involves PHI (a subset of PII), then the Business Associate shall comply with both Privacy Act and HIPAA breach response requirements. A breach involving PHI may or may not constitute an HHS Breach. If a breach is not an HHS Breach, then the Business Associate has no HIPAA breach response obligations. In such cases, the Business Associate must still comply with breach response requirements under the DoD Privacy Act Issuances.

If the DHA Privacy Office determines that a breach is an HHS Breach, then the Business Associate shall comply with both the HIPAA Breach Rule and DoD Privacy Act Issuances, as directed by the DHA Privacy Office, regardless of whether the breach occurs at DHA or at one of the Service components. If the DHA Privacy Office determines that the breach does not constitute an HHS Breach, then the Business Associate shall comply with DoD Privacy Act Issuances, as directed by the applicable Service-Level Privacy Office. The Business Associate shall contact the Covered Entity for guidance when the incident is not an HHS Breach.

This Part V is designed to satisfy the DoD Privacy Act Issuances and the HIPAA Breach Rule as implemented by the DoD HIPAA Issuances. In general, for breach response, the Business Associate shall report the breach to the Covered Entity, assess the breach incident, notify affected individuals, and take mitigation actions as applicable. Because DoD defines “breach” to include possible (suspected) as well as actual (confirmed) breaches, the Business Associate shall implement these breach response requirements immediately upon the Business Associate’s discovery of a possible breach.

(b) Government Reporting Provisions

The Business Associate shall report the breach within one hour of discovery to the Covered Entity and to the US

Computer Emergency Readiness Team (US CERT) -the other parties as deemed appropriate by the Covered Entity. The Business Associate 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 Business Associate.

The Business Associate shall submit the US-CERT report using the online form at https://forms.us-cert.gov/report/. Before submission to US-CERT, the Business Associate shall save a copy of the on-line report. After submission, the Business Associate shall record the US-CERT Reporting Number. Although only limited information about the breach may be available as of the one hour deadline for submission, the Business Associate shall submit the US-CERT report by the deadline. The Business Associate shall e-mail updated information as it is obtained, following the instructions at http://www.us-cert.gov/pgp/email.html. The Business Associate shall provide a copy of the initial or updated US-CERT report to the -Covered Entity and the applicable Service-Level Privacy Office, if requested by either. Business Associate questions about US-CERT reporting shall be directed to the Covered Entity or Service-Level Privacy Office, not the US-CERT office.

The additional US Army and the US Army Medical Command (MEDCOM) reporting requirements are addressed in the PII Breach Reporting and Notification Policy. The latest version of this policy can be obtained from the Covered Entity or the MEDCOM Privacy Act/Freedom of Information Act (FOIA) Office at: usarmy.jbsa.medcom.list.medcom-foia-users@mail.mil. 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 circumstances. The Business Associate shall inform the Covered Entity as soon as possible if it believes that “single event” breach response is appropriate; the Covered Entity will determine how the Business Associate shall proceed and, if appropriate, consolidate separately reported breaches for purposes of Business Associate report updates, beneficiary notification, and mitigation.

When a Breach Report initially submitted is incomplete or incorrect due to unavailable information, or when significant developments require an update, the Business Associate shall submit a revised form or forms, stating the updated status and previous report date(s) and showing any revisions or additions in red text. Examples of updated information the Business Associate shall report include, but are not limited to: confirmation on the exact data elements involved, the root cause of the incident, and any mitigation actions to include, sanctions, training, incident containment, follow-up, etc. The Business Associate shall submit these report updates promptly after the new information becomes available. Prompt reporting of updates is required to allow the Covered Entity to make timely final determinations on any subsequent notifications or reports. The Business Associate shall provide updates to the same parties as required for the initial Breach Report. The Business Associate is responsible for reporting all information needed by the Covered Entity to make timely and accurate determinations on reports to HHS as required by the HHS Breach Rule and reports to the Defense Privacy and Civil Liberties Office as required by DoD Privacy Act Issuances.

In the event the Business Associate is uncertain on how to apply the above requirements, the Business Associate shall consult with the Covered Entity (or the Service-Level Privacy Office, which will consult with the DHA Privacy Office as appropriate) when determinations on applying the above requirements are needed.

(c) Individual Notification Provisions

If the DHA Privacy Office determines that individual notification is required, the Business Associate shall provide written notification to individuals affected by the breach as soon as possible, but no later than 10 working days after the breach is discovered and the identities of the individuals are ascertained. The 10 day period begins when the Business Associate is able to determine the identities (including addresses) of the individuals whose records were impacted.

The Business Associate’s proposed notification to be issued to the affected individuals shall be submitted to the parties to which reports are submitted under paragraph V (a) for their review, and for approval by the DHA Privacy Office. Upon request, the Business Associate shall provide the DHA Privacy Office with the final text of the notification letter sent to the affected individuals. If different groups of affected individuals receive different notification letters, then the Business Associate shall provide the text of the letter for each group. (PII shall not be included with the text of the letter(s) provided.) Copies of further correspondence with affected individuals need not be provided unless requested by the Privacy Office. The Business Associate’s notification to the individuals, at a minimum, shall include the following:

—The individual(s) must be advised of what specific data was involved. It is insufficient to simply state that PII has been lost. Where names, Social Security Numbers (SSNs) or truncated SSNs, and Dates of Birth (DOBs) are involved, it is critical to advise the individual that these data elements potentially have been breached.

—The individual(s) must be informed of the facts and circumstances surrounding the breach. The description should be sufficiently detailed so that the individual clearly understands how the breach occurred.

—The individual(s) must be informed of what protective actions the Business Associate is taking or the individual can take to mitigate against potential future harm. The notice must refer the individual to the current Federal Trade Commission (FTC) web site pages on identity theft and the FTC’s Identity Theft Hotline, toll-free: 1-877-ID-THEFT (438-4338); TTY: 1-866-653-4261.

—The individual(s) must also be informed of any mitigation support services (e.g., one year of free credit monitoring, identification of fraud expense coverage for affected individuals, provision of credit freezes, etc.) that the Business Associate may offer affected individuals, the process to follow to obtain those services and the period of time the services will be made available, and contact information (including a phone number, either direct or toll-free, e-mail address and postal address) for obtaining more information.

Business Associates shall ensure any envelope containing written notifications to affected individuals are clearly labeled to alert the recipient to the importance of its contents, e.g., “Data Breach Information Enclosed,” and that the envelope is marked with the identity of the Business Associate and/or subcontractor organization that suffered the breach. The letter must also include contact information for a designated POC to include, phone number, email address, and postal address.

If the Business Associate determines that it cannot readily identify, or will be unable to reach, some affected individuals within the 10 day period after discovering the breach, the Business Associate shall so indicate in the initial or updated Breach Report. Within the 10 day period, the Business Associate shall provide the approved notification to those individuals who can be reached. Other individuals must be notified within 10 days after their identities and addresses are ascertained. The Business Associate shall consult with the DHA Privacy Office, which will determine which media notice is most likely to reach the population not otherwise identified or reached. The Business Associate shall issue a generalized media notice(s) to that population in accordance with Privacy Office approval.

The Business Associate shall, at no cost to the government, bear any costs associated with a breach of PII/PHI that the Business Associate has caused or is otherwise responsible for addressing.

Breaches are not to be confused with security incidents (often referred to as cyber security incidents when electronic information is involved), which may or may not involve a breach of PII/PHI. In the event of a security incident not involving a PII/PHI breach, the Business Associate shall follow applicable DoD Information Assurance requirements under its Agreement. If at any point the Business Associate finds that a cyber-security incident involves a PII/PHI breach (suspected or confirmed), the Business Associate shall immediately initiate the breach response procedures set forth here. The Business Associate shall also continue to follow any required cyber security incident response procedures to the extent needed to address security issues, as determined by DoD/DHA.

VI. Termination

(a) Termination. Noncompliance by the Business Associate (or any of its staff, agents, or subcontractors) with any requirement in this BAA may subject the Business Associate to termination under any applicable default or other termination provision of the Agreement.

(b) Effect of Termination.

(1) If the Agreement has records management requirements, the Business Associate shall handle such records in accordance with the records management requirements. If the Agreement does not have records management requirements, the records should be handled in accordance with paragraphs (2) and (3) below. If the Agreement has provisions for transfer of records and PII/PHI to a successor Business Associate, or if DHA gives directions for such transfer, the Business Associate shall handle such records and information in accordance with such Agreement provisions or DHA direction.

(2) If the Agreement does not have records management requirements, except as provided in the following paragraph (3), upon termination of the Agreement, for any reason, the Business Associate shall return or destroy all PHI received from the Covered Entity, or created or received by the Business Associate on…