PWS_-_Stryker_Equipment_Maintenance.pdf

PERFORMANCE WORK STATEMENT

STRYKER EQUIPMENT MAINTENANCE SERVICES

CARL R. DARNALL ARMY MEDICAL CENTER, FORT HOOD, TEXAS

General:

Contractor shall provide scheduled and unscheduled maintenance to include parts, and labor on the Government-owned equipment located at Carl R. Darnall Army Medical

Center (CRDAMC), Building 36000, Room 0004, Fort Hood, Texas 76544.

1. Scope of Work:

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 repair support of the Government-owned equipment. Service shall consist of two preventive maintenance (PM) and unlimited repair calls for the Government-owned equipment.

2.1 Plan coverage includes for the Equipment all costs associated with: (1) Parts, Labor and Travel associated with scheduled Onsite visits by Service Technician for items listed in Exhibit A. (2) Parts and labor associated with repair of items listed in Exhibit

A. (3) Repair/Replace costs associated with accessories listed in Exhibit A. (4) Freight costs associated with shipments of repairs and loaners will be billed to CRDAMC.

2.2. Normal Duty Hours: Monday through Friday 8:00 am to 5:00 pm, excluding national holidays and weekends.

2.3. Contractor shall report upon arrival or telephonically notify the Medical

Maintenance Branch Contracting Officer’s Representative or NCOIC, CRDAMC Bldg.

36000 Room 0004.

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.

2. Personnel Qualifications:

The contractor shall provide documentation that the field service technicians are qualified and manufacture trained on the Government-owned equipment. In addition to this training, the technicians must have proof of two years of working experience, effective with the current date. The contractor prior to service commencing shall present documented proof of successful completion of such training.

3. 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 72 hours, whenever changes are made.

4. Quality Control:

4.1. 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 manufacturer’s specification and Food and Drug Administration guidance. Additionally, in the case where a part is sent to Stryker for repair and another part is returned in place of the part that was to be repaired, the contractor will coordinate and receive agreement from the Government, prior to the Government accepting a replacement part.

4.2. The government will establish and maintain a Quality Assurance Plan to ensure that the quality of service is being provided and meet and exceed the specifications.

5. Reserved:

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:

1. Method for acquiring acceptable replacement parts. See section 4. Quality

Control, 4.1., for process for Government accepting replacement parts.

2. 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.

6.5. OEM: Original Equipment Manufacturer.

7. Government Furnished:

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 Contracting Officer 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 in 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 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 is 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:

The contractor shall have ready access to unique and/or high mortality replacement parts. All parts supplies shall be compatible with the Government-owned equipment, as agreed to by the Government.

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

8.2. 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.

8.3. The contractor shall use only new or reconditioned parts for which the quality is equal to or better than the Original Equipment Manufacturer (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.

8.4. The contractor shall provide all replacements and service necessary to restore the equipment to 100% operational condition as specified by the OEM.

9. Coordination for scheduled and unscheduled services:

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 Contracting Officer’s Representative or NCOIC, Medical Maintenance

Branch, 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 contracting officer 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. The purpose of this telephone consultation shall be:

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

9.2. To determine if resolution of the problem requires the dispatch of a FSE once determination has been made that a contractor’s FSE is required on site. The contractor’s FSE shall have 48 hours to be on-site from the time of notification by the contracting officer to the contractor and restored fully operational within 72 hours.

9.3. 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.

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

9.5. When required, the contractor will comply with the OSHA lockout/tagout standard while performing maintenance on electrical equipment.

10. Scheduled/Unscheduled Maintenance documentation:

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/Contract Officer Representative via email

10.1 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.

10.2. Calibration Documentation; All calibration services shall be documented by the contractor on the service report and a 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.

10.3. Calibration Documentation of X-Ray systems; the contractor shall complete DD

Form 2164 in accordance with the instructions provided in TB 38-750-2. A continuation sheet shall be attached to the DD Form 2164 indicating the manufacturer, model, serial number and date of calibration expiration of all items of test and measurement equipment used to perform the calibration. Required forms and extracts from pertinent directives will be furnished to the contractor by the government.

10.4. 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 the system.

10.5. 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 contracting officer representative (COR) 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 contractor shall maintain contact with the OEM to 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 contracting officer representative 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 shall notify the contracting officer 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 0004, basement, Building 36000. In the event that the contractor performs service beyond the normal duty hours, he shall sign-in and out with the Administrative Officer of the Day

(AOD) at the information desk located on the main floor in the front lobby.

13. Repair Parts:

All repair parts shall meet exact manufacturer’s specifications and be the most current revision level. All parts shall be new or remanufactured by the manufacturer of the instruments.

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 COR (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. Security Requirements:

16.1. Contractor personnel or any representative of the contractor entering Fort Hood

Army Installation shall abide by all security regulations and shall be subject to security checks.

16.2. Contractor personnel and property shall be subject to search and seizure upon entering the confines of Fort Hood Army Installation and while on the installation in accordance with AR 190-13 (The Army Physical Security Program).

17. 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 Field Service Engineers (FSE’s) outer garment. The badge will be furnished at the Medical Maintenance Branch during duty hours and by the

Administrative Officer of the Day (AOD) after duty hours.

18. 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 subcontractor 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."

19. Sexual Assault and Sexual Harassment under the 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 https://cmra.army.mil/ 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.

PWS/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

PWS/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.

20. ANTITERRORISM/OPERATIONS SECURITY (Applies to all Contract Personnel):

Contractor and all associated sub-contractor's employees shall comply with applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative). The contractor shall also provide all information required for background checks to meet installation and

MTF access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or MTF Security Office. Contractor workforce must comply with all personal identity verification requirements as directed by DOD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of 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. The contractor is responsible for absence of contract HCPs due to expired identification and access documents.

All contractor employees, to include subcontractor employees, requiring access to

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 of incorporation of this requirement into the contract, whichever is applicable. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee, to the COR or to the contracting officer, if a

COR is not assigned, within 35 calendar days after completion of training by all http://www.atsc.army.mil/tadlp/delivery/alms.asp employees and subcontractor personnel. AT Level I awareness training is available at the following website: https://atlevell.dtic.mil/at iWATCH Training. The contractor and all associated sub-contractors shall brief all employees on the local iWATCH program. All HCPs will view the Match video on the CRDAMC PMO website. All HCPs must understand to contact 288-COPS if any suspicious activity is observed. This training shall be completed within 30 calendar days of contract award and within 30 calendar days of new employees commencing performance with the results reported to the COR NLT 30 calendar days after contract award.

Per AR 530-1, Operations Security, new contractor employees must complete Level I

OPSEC training within 30 calendar days of their reporting for duty. All contractor employees must complete annual OPSEC awareness training.

(IT) training. All contractor employees and associated sub-contractor employees must complete the DoD IA awareness training before issuance of network access and annually thereafter.

A criminal history background check shall be required for all HCPs under this contract. Provided personnel must agree to sign documentation allowing the government to conduct such checks as deemed required by the CRDAMC Personnel

Security Office.

21. Exclusion from Participation in Federal Health Care Programs (October 2015)

21.1. The Contractor shall not employ or contract with any individual or entity (hereinafter collectively referred to as “person”) to provide items or services that will be included in invoices submitted to the Government under this contract if such person is listed on the Department of

Health and Human Services (HHS) Office of the Inspector General (OIG) List of Excluded

Individuals and Entities (LEIE) or the TRICARE Sanctioned Provider List. The Government is legally prohibited from paying for provision of items or services by such persons. The prohibition extends to services beyond direct patient care, such as services of persons in executive or leadership roles and administrative and management services, whether or not such services are billed separately. The LEIE may be found at http://oig.hhs.gov/fraud/exclusions.asp, and the

TRICARE Sanctioned Provider list at http://www.health.mil/Military-Health-Topics/Access-

Cost-Quality-and-Safety/Quality-And-Safety-of-Healthcare/Program-Integrity/Sanctioned-

Providers. The LEIE and TRICARE Sanctioned Provider List are hereinafter collectively referred to as “the Lists.”

21.2. Prior to start of contract performance, the Contractor shall (a) query the Lists to determine whether the name of any person the Contractor employs or contracts with to provide services or items for which payment may be made under this contract appears on the Lists, and (b) certify to the Contracting Officer that the Contractor has queried the Lists and no such names appear on either of the Lists.

https://atlevell.dtic.mil/at

21.3. During performance of the contract, and prior to persons other than those whose names were queried in accordance with paragraph 2, above, (hereinafter “new persons”) providing services or items under the contract, the Contractor shall (a) query the Lists as in paragraph 2, and

(b) certify to the Contracting Officer that the names of such new persons do not appear on either of the Lists.

21.4. The Contractor is advised that during performance of the contract, MTF personnel will perform a recurrent recheck of the names of contractor personnel working in the MTF against the

Lists, as specified in OTSG/MEDCOM Policy Memo 15-037. The Government will notify the

Contractor in the event any contractor personnel working in the MTF appear on either of the

Lists.

21.5. Should any person providing items or services under the contract appear on either of the

Lists at any time during contract performance, the Contractor shall (a) in cases where the

Contractor identified the person, notify the Contracting Officer, and (b) promptly remove that person from the contract.

21.6. Violation of any aspect of the above paragraphs shall be considered a material breach of the contract and may result in termination of the contract.

21.7. The Contractor is further advised that, in accordance with Civil Monetary Penalties Law

[CMP] (codified at 42 USC § 1320a-7a):

a. There are steep civil monetary penalties associated with billing the Government for providing items or services by a person on either of the Lists, and with failing to return to the

Government any overpayments received for provision of such items or services.

b. Billing under the contract for provision of items or services by a person on either List may also result in exclusion of the person that employs or contracts with such person.

21.8. HHS OIG has issued a Special Advisory Bulletin on the Effect of Exclusion from

Participation in Federal Health Care Programs with additional information on the CMP. The

Special Advisory Bulletin may be found at http://oig.hhs.gov/exclusions/files/sab-05092013.pdf.

22. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT

Non-DHA HIPAA BAA (7 January 2014)

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

Defense Health Agency (DHA). This BAA can serve as a separate agreement or may be used to modify an existing contract or other agreement between the MHS component and the business associate. It is also appropriate for new contracts or agreements. In each case, the MHS component should consult with the Contracting

Officer or other POC and the Service-level privacy officials for completing and/or modifying this BAA as may be appropriate. At several points, bracketed language indicates where additional or different language may be needed, including specifics regarding breach response.

This BAA is NOT to be used in contracts for components of DHA. Those components should request contract language from the DHA Procurement Directorate. Contact

ContractPolicyDivision@dha.mil.

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

[replace with corresponding paragraph in the pending successor issuance, DoDI

6025.18, Enclosure 3, when published], 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) [replace with corresponding paragraph in the pending successor issuance, DoDI 6025.18, Enclosure 3, when published] 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].

mailto:ContractPolicyDivision@dha.mil

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). [These citations should be replaced with citations to the pending successor issuances when those are published.]

DoD Privacy Act Issuances means the DoD issuances implementing the

Privacy Act, which are DoDD 5400.11 (2007) and DoD 5400.11-R (2007). [The latter citation should be replaced with a citation to the pending successor issuance when it is published.]

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. [This definition may need tailoring to the service-specific organizational structure.]

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. [When the pending successor issuances are published, then the preceding sentence should begin as follows: “In accordance with DoDI 6025.18, Enclosure 3, paragraph ___, DoDI

8580.02, Enclosure 3, paragraph __, and 45 CFR 164.502(e)(1)(ii)) and

164.308(b)(2), as applicable, the Business Associate shall …”]

(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 hea lth 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. The following provisions of Part V set forth the Business Associate’s Privacy Act and HIPAA breach response requirements for all breaches, including but not limited to HHS breaches.

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:

https://forms.us-cert.gov/report/ http://www.us-cert.gov/pgp/email.html usarmy.jbsa.medcom.list.medcom-foia-users@mail.mil (I do not know if John has a mailbox for Privacy).

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 mailto:usarmy.jbsa.medcom.list.medcom-foia-users@mail.mil%20(I

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

Assu…