Performance_Work_Statement.pdf

PERFORMANCE WORK STATEMENT

1. This is a non-personal service to provide full, on-site maintenance service on the Hologic mammographic units located in Radiology at William Beaumont Army Medical Center (WBAMC), El Paso, Texas. Contractor shall furnish all parts, labor, equipment, materials, travel, and transportation to perform all scheduled and unscheduled maintenance for the equipment listed below:

a. Radiographic Mammographic Unit - ECN: 028210, SN:81410100441, Site ID: 81009199437, MFR: Hologic Model: ASY-01966

b. R2 Digital CAD ECN: 028645, SN: C2516, MFR: Hologic Model: ASY-02354

2. CONTRACTOR REQUIREMENTS:

2.1. Contractor shall provide only technically qualified technicians who are formally trained on the above equipment. Service personnel must have a good working knowledge of the equipment.

2.2. Contractor provides a plan for service coverage if less than two (2) personnel are trained on the equipment. The plan describes and ensures the Government is not without service support for more than one day (i.e., coverage during technician illnesses, vacations, terminations, and /or strikes).

2.3. Contractor shall obtain the most current legal editions of the original equipment manufacturer (OEM) literature or approved copies.

2.4. Contractor shall furnish and install only OEM repair parts and OEM recommended substitution/ modifications, as required to ensure proper and safe operation of the equipment.

2.5. Contractor shall have knowledge of, furnish and install all OEM sponsored modifications at no additional charge. This includes all the OEM published Equipment Changed Orders (ECO) and Fielded Change Orders (FCO). Mandatory modifications include equipment upgrades or enhancements to equipment design, and changes necessary for operator and patient safety. Manufacturer sponsored modifications are made as hardware/software updates/ corrections becoming available from the manufacturer. In addition, the Government may request the Contractor to install said OEM sponsored modification in the event that the Government obtained knowledge of ECO or FCO before the Contractor.

Contractor shall make all ECO and FCO modifications in a timely manner, but in no case shall it exceed sixty (60) calendar days after ECO or FCO is announced by the OEM. All such modifications shall be made so as not to interfere with the Government’s operation. If such modification is not possible during normal duty hours, the Contractor shall do the modifications outside of normal duty hours (overtime) at no additional cost the Government

2.6. If the Contractor is unable to repair the unit and subcontracts out to a third party, the Contractor will not stop the third party in the middle of the repair job and will not charge the Government for the subcontracted labor.

3. MAINTENANCE TIME FRAMES: The Contractor shall provide one (1) preventive maintenance (PM) and one (1) annual calibration verification check (CVC). The Contractor shall perform CVC in conjunction with the preventive maintenance services. Services during the time frame will include one (1) electrical safety current leakage test to determine the amount of electrical current electrical leakage to the case of the unit. All services performed are documented and indicated on the service ticket upon completion of services as follows:

3.1. Calibration: CA with the time spent.

3.2. Preventive Maintenance INSP is inspection with the time spent, the electrical safety test is considered to be part of this process.

3.3. Scheduled Parts Replacement SPR with the time, name, and part numbers with cost of parts replaced.

4. SCHEDULED SERVICES:

4.1. For base year, the Contractor shall perform the schedule preventive maintenance (PM) inspection within 3 weeks after the award of the contract.

4.2. For all option years, one Preventive Maintenance services. (PM) inspection.

4.3. The Contractor shall complete all required scheduled services within four (4) working days after starting each scheduled services.

4.4. The Contractor shall coordinate with the Contracting Officer Representative (COR), to ensure access to the equipment to be serviced, no later than the 4th working day of the month scheduled for service.

5. UNSCHEDULED SERVICES:

5.1. All repairs must be accomplished and the unit fully operational within three (3) working days of telephonic notification of a malfunction. These days are Monday through Friday, excluding all Government holidays. All equipment is repaired to meet manufacturers specifications at all times.

5.2. The Contractor shall respond telephonically within four (4) hours during normal duty hours days and within six (6) hours after normal duty hours/or weekends/holidays.

5.3. Delays caused by the Government must be immediately communicated to the COR and will not counted against the repair completion time frame.

5.4. If parts are required and are not in stock with the original equipment manufacturer, authorized sales representative, or repair parts supply outlets, an allowable delay will be determined by the COR and subsequent ship time will not exceed two days.

5.5. The Contractor shall provide for all replacements of worn and/or defective parts necessary to restore the equipment to 100% operational condition as specified by the OEM.

5.6. HOURS OF OPERATION: Medical Maintenance Branch, WBAMC, office hours 7:30 A.M. thru 4:30 P.M., MST, Monday thru Friday

6. SERVICE REPORTS: Upon completion of services, a service report shall be provided to the COR.

This report is initiated by the Contractor at the completion of each repair and at the minimum will include:

6.1. Contractor’s name

6.2. Contract number

6.3. Name of technician performing the repair (full printed and signed name)

6.4. Number of hours expended on each and associated Contractor’s hourly rate. Hours are in tenths and rounded up to the nearest tenth of an hour. Example 1.1 is one hour and six minutes.

6.5 Part number and listed cost of each repair part used

6.6 Equipment Control Number and serial number of equipment being repaired.

7. GOVERNMENT FURNISHED PROPERTY AND MATERIALS: The COR will provide the contractor access to the equipment covered under the contract.

8. CONTRACTOR FURNISHED PROPERTY:

8.1 All materials, other than those materials specified as Government furnished, required in the performance of this contract shall be furnished by the Contractor.

8.2 Availability of manufacturer’s service literature needed in the performance of the contract will be Contractor’s responsibility and will remain Contractor owned at the termination of the contract.

8.3 Equipment maintenance performance under the contract includes the unlimited replacement of defective repair parts.

8.4 Contractor shall notify the COR immediately when parts required to accomplish a maintenance service are not available from the original manufacturer, authorized sales representative, or other repair parts supply outlets.

8.5 The Government shall not be responsible for any damages or loss of Contractor supplies, materials, or equipment.

8.6 The Government shall not be responsible for any damages or loss of the Contractor’s personal belongings, or those of the Contractor’s employees, due to fire, theft, accidents or other causes

9. PERSONS AUTHORIZED TO PLACE SERVICE CALLS: The Government’s COR, as well as those authorized to give instructions, place service calls, or request updates status, are listed below No instructions will be accepted by any one other than the people listed below or the Contracting Officer. One of the persons listed below will call and leave their name and number and the Contractor will return the call, or come directly to the COR in room 3K4 of the Bradley Building to verify the call prior to initiating any action.

Chief, Medical Maintenance Branch (CW3 William J. Sexton) (915) 742-2705

COR, Contract Service - (Patricia Batzel) (915) 742-2721

10. SCOPE OF WORK:

10.1 Qualified Technician shall report to the Medical Maintenance Branch, Bradley Building, Room 3K4, and sign-in the Contractor’s Log by indicating company name, individuals name, time of arrival, and destination. When departing WBAMC, the technician must exist through Medical Maintenance and provide the service report with applicable information.

10.2 The performance of all services shall meet or exceed the specifications of the original equipment manufacturer.

10.3 The Contractor is not responsible for the maintenance of equipment listed when damage resulted from act of God, or Government neglect/misuse/abuse, or when services from other than the Contractor’s personnel have been performed.

10.4 The Contractor shall provide unlimited unscheduled maintenance services for the equipment covered under the contract.

10.5 The Contractor shall perform scheduled preventive maintenance inspection one (1) time per year and calibrated/verification/certification as needed.

10.6 The Contractor shall establish and follow a procedural checklist when performing scheduled services.

Any updates shall be supplied to the COR.

10.7 The Contractor shall comply with applicable federal, state, and local laws and regulations.

10.8 The Contractor shall ensure that all maintenance services meet or exceed accreditation requirements/standards of the Joint Commission on Accreditation of Healthcare Organizations.

10.9 Upon completion of each repair or service, the Contractor shall provide the COR with a Service Report not later than 48 hours following the performance of each maintenance service.

10.10 The Contractor shall have available or have reasonable access to all repair parts to maintain the equipment. At no time during the contract period shall the equipment remain inoperative more than four

(4) consecutive working days following initial on-site visit. Delays caused by Government will not be counted as contractor “down time” for the purpose of this requirement.

10.11 Repair services shall continue uninterrupted until the equipment is fully operational. If the Contractor determines that additional parts are required, services will resume as soon as parts become available.

10.12 When it is questionable as to whether a malfunction exists with the Contractor maintained equipment or the Government’s utilities (i.e., water, air, electricity). The COR shall notify the Government’s maintenance representative and establish an arrival time when said representative will arrive at the job site within 30 minutes or less upon notification by COR. The Contractor’s maintenance representative shall remain at the site, if not, the Contractor’s maintenance representative is allowed to depart the site and return at a time which coincides with the arrival of the Government’s maintenance representative. The utilities will be tested; it will then be determined what failed (the utility or the equipment). Should it be determined that the Contractor maintained equipment malfunctioned, the Government shall be reimbursed by the Contractor for the added costs for chargeable maintenance time spent testing utilities.

11. REPLACEMENT REPAIR PARTS:

11.1 The Contractor shall have and maintain an adequate inventory of repair parts to service the equipment listed herein and satisfactory sources of supply for such parts as may be needed in the performance of this contract. Inventory of available parts shall be readily available and be verifiable by the Government if so desired at any time. The Contractor shall ensure 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.

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

11.3 Parts which have been replaced with Contractor furnished parts shall become the property of the Contractor. Parts once placed in a system or sub-system becomes the property of the Government.

11.4 The Contractor shall replace all worn, failed, or doubtful components and parts at no further cost or charge to the Government. Replacement parts shall be of like or current design to minimize system depreciation and obsolescence. Where statistical data of the manufacturer indicated the failure point is approaching for any component, such component, such component may be repaired or replaced in advance to prevent a system failure.

12. CONTRACTOR PERSONNEL:

12.1 The Contractor shall provide technically qualified technicians to accomplish all maintenance services required by the contract. Repair technician must have received formal training presented by the OEM specific or similar to make and model of equipment listed herein within the last 24 month or received a combination of formal training presented by the OEM specific or similar to the make and model of equipment listed herein, and has had repair experience on this equipment within last 12 months. The

Contractor’s service representative will be factory trained and have a minimum of two years of experience working on the contracted equipment.

12.2 The Contractor shall designate a Point of Contact (POC) for the contract. The Contractor’s POC shall be authorized to discuss with the COR, any and all maintenance services required by the contract and ensure response to requests for performance of the contract. The POC shall have the authority to make decision for the Contractor. The Contracting Officer or the COR shall be notified immediately whenever the POC changes. Contractor’s POC shall be submitted no later than 10 days after award of contract, and shall included as a minimum name, title, and telephone number.

12.3 The Contractor shall not hire off-duty Government employees who serve as inspector or COR’s in their Government position, or any other persons whose employment would result in a conflict of interest.

12.4 The Contractor shall provide each employee an identification badge which shall be displayed on their outer garment at all time when on duty. The badge shall include, at a minimum, the employee’s name, current picture, the Contractor’s name, and title identification.

13. SAFETY:

13.1 When the Contractor leaves on-site location where maintenance services are being performed, the site shall be left in a clean, neat, and orderly condition ensuring the hospital staff and patients are not subjected to any safety hazards, including but not limited to, expose wiring, open circuit panels, or tripping hazards.

13.2 Equipment which is left unserviceable at the end of normal duty hours or until performance can be resumed, will be identified by the Contractor attaching DD Form 1577 (TAG) to the equipment in plain view of hospital staff. The COR will be informed personally or in writing of the equipment status prior to the Contractor leaving the work site.

14. ANTITERRORISM/OPERATIONS SECURITY (AT/OPSEC) REQUIREMENTS.

14.1 AT Level I training. This standard language is for contractor employees with an area of performance within an 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 60 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 65 calendar days after completion of training by all employees and subcontractor personnel. AT level I awareness training is available at the following website: http://jko.jten.mil

14.2 Access and general protection/security policy and procedures. This standard language is for contractor employees with an 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 of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) 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.

14.3 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.

14.4 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 60 calendar days of contract award and within 60 calendar days of new employees commencing performance with the results reported to the COR NLT 65 calendar days after contract award.

15. APPLICABLE PUBLICATION AND FORMS - Publications documents and forms applicable to this PWS are listed below. The Contractor is required to comply with these directives. Supplements or amendments may be issued during the life of the contract and will be considered to be in full force and effective immediately upon receipt by the Contractor. If compliance with such supplements and amendments changes the contract cost, it shall be a change within the meaning of the “Changes” clauses of the contract.

AR 40-5 Preventive Medicine

AR 40-61, Medical Logistics Policies and Procedures

SB8-75-11 Supplement to AR 40-61

TB MED 7, Maintenance Expenditure Limits for Medical Equipment

TB MED 750-1, Operating Guide for Medical Equipment Maintenance

16. OTHER PUBLICATIONS – The following publications will be acquired by the Contractor for his use at his own expense. These publications are other than Army publications which establish guidelines for administering adequate healthcare services. When a conflict between these publications and Army publications arises, the publication which is more restrictive will be followed.

Joint Commission of Accreditation of Healthcare Organization Manual (Current edition)

National Fire Protection Association (NFPA) 99, Health Facilities Handbook, (Current edition).

National Fire Protection Association (NFPA) 101, Life Safety Code, (Current edition).

17. DOCUMENTATION FORMS – No Contractor developed forms will be used except those used as a Service Report.

The forms listed below will be provided to the Contractor by the Government for use in the performance of this contract.

DD Form 1577, Warning Tag.

18. DEFINITIONS: Terms used throughout this contract have the following meaning:

18.1 CALIBRATION/VERIFICATION/CERTIFICATION (CVC) – The comparison of a system or device of unverified accuracy to measure system or device of known accuracy to detect and correct deviations from required performance specifications/standards. Required performance specification/standards are detailed within the original manufacturer’s service literature/manuals and Federal publications.

18.2 Contracting Officer’s Representative (COR): A government employee selected and designated in writing by the contracting officer to act as his/her designated representative in administering a contract/task order.

18.3 MAINTENANCE SERVICE – An action taken to keep equipment in a serviceable condition in accordance with original equipment manufacturer’s specifications. It includes the systemic care, inspection, service, repair, testing of equipment, and repair parts.

18.4 ORIGINAL EQUIPMENT MANUFACTURER (OEM).

18.5 ON-SITE MAINTENANCE SERVICE – Scheduled and unscheduled maintenance performed at the Government’s facility and location where the equipment is utilized in the treatment and care of patients.

18.6 SCHEDULED SERVICES – Periodic maintenance services to medical equipment at Government prescribed times during the contract period. These services includes PM and CVC.

18.7 PREVENTIVE MAINTENANCE (PM) – A systematic scheduled inspection of equipment per the original manufacturer’s literature/service manual. Preventive maintenance includes, but is not limited lubrication, cleaning, inspections, functional tests and adjustments.

18.8 TEST, MEASUREMENT, AND DIAGNOSTIC REQUIREMENT (TMDE).

An instrument or device, the accuracy of which is directly traceable to the National Bureau of Standards, natural physical constant, or material with known performance characteristics, which is used to provide maintenance services on equipment listed in this contract.

18.9 UNSCHEDULED SERVICES – A repair service performed on an as required basis when an equipment item or system fails to perform as specified by the original equipment manufacturer. These are commonly referred to as repairs.

19. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP): Government Quality Assessment and Improvement (QA&I): The government will monitor the contractor’s performance under this contract using the quality and improvement procedures established by William Beaumont Army Medical Center and pursuant to the Inspection of Services Clause. Additionally the contractor’s performance is subject to schedule and unscheduled review by quality assessment personnel as defined by the Quality Assurance Surveillance Plan. The following minimum Performance Requirements Summary (PRS) applies. The Government may modify inspection methods in accordance with site specific requirements:

PERFORMANCE

OBJECT

PERFORMANCE

STANDARD

REFERENCE

METHOD OF

ASSESSMENT

Reporting Requirements

Ensure that all technicians report to the Bradley Bldg, Room 3K4.

Para 9.1

Verify (COR) Log Book

Field Service Reports

Ensure the Field Service Report (FSR) - is provided to the COR upon completion of PM or repair.

Para. 5

Confirm FSR is provided to the

COR.

Scheduled/Unscheduled PM’s and Repairs

All repairs must be accomplished and the unit fully operational within 3 working days.

Para 4.1 & 5

Confirm all repairs are completed.

RANGE RATING

(91-100) Exceptional

(81-90) Very Good

(71-80) Satisfactory

(61-70) Marginal

(less than 61) Unsatisfactory

20. 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 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.

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

21. Contractor Manpower Reporting (CMR).

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.

22. NON-DEFENSE HEALTH AGENCY (NON-DHA) HEALTH INSURANCE PORTABILITY AND

ACCOUNTABILITY ACT (HIPAA) 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…