A.09.03_Solicitation_Amendment_2_Released.pdf

W40M USA HLTH CONTRACTING ACT

SOUTHERN REG CONTR OFC

POC: SHERYL EGANS

3551 ROGER BROOK DR BLDG 3600

FORT SAM HOUSTON TX 78234-6200

0011012905-0001

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

A. The purpose of this amendment 0002 is three-fold: 1) To add a Statement of Work, 2) Change CLIN 0005 w arranty period to read from "3 year w arranty" to read "2 year w arranty", and 3) To extend the offeror due date for receipt of proposals.

B. See Summary of Changes.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 17

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 06-Jun-2017

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X W81K00-17-T-0223

X 9B. DATED (SEE ITEM 11)

08-May-2017

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer X is extended, is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

07-Jun-2017

CODE

W40M USA HLTH CONTRACTING ACT

SOUTHERN REG CONTR OFC

3551 ROGER BROOK DR BLDG 3600

FORT SAM HOUSTON TX 78234-6200

W81K00 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W81K00

FACILITY CODECODE

EMAIL:TEL:

W81K00-17-T-0223

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SOLICITATION/CONTRACT FORM

The required response date/time has changed from 16-May-2017 10:00 AM to 13-Jun-2017 10:00 AM.

SUPPLIES OR SERVICES AND PRICES

CLIN 0005

The CLIN description has changed from 3 year warranty on all products assoc w/ to 2 year warranty on all products assoc w/.

The CLIN extended description has changed from:

3 year warranty on all products assoc w/ device

To:

2 year warranty on all products assoc w/ devices. Service, maintenance, and training provided IAW attached Statement of Work..

The following have been added by full text:

STATEMENT OF WORK

Statement of Work

This is a requirement for purchase, installation, recurring training, maintenance service and repairs, for 35 Vascutherm 5 ice/DVT devices (including various wraps) at General Leonard Wood Army Community Hospital (GLWACH), 4430 Missouri Avenue, Fort Leonard Wood, Missouri, 65473.

BACKGROUND:

General Leonard Wood ACH is working to meet and improve standard of care for patients in the in-patient and out-patient settings. Deep Vein Thrombosis compression therapy and thermal therapy is necessary in both areas of patient care. Thermal therapy (cold/hot) when used immediately post-operatively improves patient outcomes such as patient mobility, reduction of patient pain medication, and reduction of swelling thus aiding a much faster recovery.

1.0 SCOPE OF WORK

Contractor shall provide all labor, supplies, tools, material, transportation, parts, and equipment to perform Installation, Training, Preventive Maintenance (PM), Calibration/Verification/ Certification (CVC) and repairs (by repair exchange if necessary), to maintain the Government-Owned, Vascutherm 5 ice/DVT systems. This includes unlimited telephonic assistance and unlimited on-site maintenance repairs. The equipment is located Intensive Care Unit, Mother Baby Unit, Post Anesthesia Care Unit, Emergency Room, Operating Room and Medical Surgical Ward on various floors and rooms in General Leonard Wood Army Community Hospital (GLWACH), 4430 Missouri Avenue, Fort Leonard Wood, Missouri, 65473.

Work to be performed:

Delivery and initial setup Initial and quarterly training to staff at each setup location Phone consultation and clinical onsite support Repair and maintenance coordination

1.1. POINT OF CONTACT: At the start of the contract, the Contractor shall have a contract representative and alternate responsible for scheduling and coordination of service calls. The name and phone number of the designated individual and alternate shall be provided to the Chief, Equipment Management Branch at (xxx) xxx-xxxx.

1.1.2. All scheduled services shall go through the Clinical Engineering Section.

1.1.3. Only a representative of the Clinical Engineering Section will make all requests for repairs.

1.2. PERSONNEL: Individuals who have demonstrated knowledge and competence in the repair of equipment identified shall perform on this Contract.

1.2.1. The Contractor shall ensure repair technicians have attended training on the specific model of contract equipment or have 3 years of maintenance experience.

1.2.2. While on duty, contractor employees shall maintain a neat, well-groomed appearance.

1.2.3 The Contractor shall request a visitor’s pass for each one year duration of each contract period of performance in order to access the Fort Leonard Wood military installation. Visit https://vcc1.icmvcc.com/im3500/Registration.aspx for additional information. List one of the following as the point of contact: Work Order Clerk, NCOIC or Chief of Clinical Engineering @ xxx-xxx-xxxx.

2.0 DEFINITIONS:

2.1. CALIBRATION/VERIFICATION/CERTIFICATION (CVC): Systematic procedure as defined by the OEM’s specifications for defined operation. Ensures equipment operates within all OEM’s parameters for maximum performance and patient quality of care.

2.2. GLWACH: General Leonard Wood Army Community Hospital.

2.3. LEGAL PUBLIC HOLIDAYS:

New Years Day, January 1 Martin Luther King's Birthday, 3rd Monday in January Washington's Birthday, 3rd Monday in February Memorial Day, last Monday in May Independence Day, July 4 Labor Day, 1st Monday in September Columbus Day, 2nd Monday in October Veteran's Day, November 11 Thanksgiving Day, 4th Thursday in November Christmas Day, December 25

2.4. OEM: Original Equipment Manufacturer.

2.5. PREVENTIVE MAINTENANCE (PM): Maintaining equipment in accordance with the EOM’s standards and providing systematic inspection, detection, and correction of incipient failures either before they occur or before they develop into major defects.

2.6. QUALITY CONTROL: Contractor’s actions to control and ensure contract compliance.

2.7. MD/MDS: Medical Device and/or Medical Device Systems.

3.0 GOVERNMENT FURNISHED PROPERTY AND SERVICES:

3.1. The Government will provide expendables such as reagents, sample cups, pipette tips, wooden sticks, printer paper, and any other consumables routinely used during the course of normal machine operation and use.

3.2. On a Government authorized, case-by-case basis, the Contractor may use the Government medical equipment maintenance shop in order to expedite repairs.

4.0 SPECIFIC TASKS TO BE PERFORMED:

4.1. Services, labor, parts and materials. The Contractor shall provide services, labor, parts, and materiel necessary to cause subject equipment to be in proper working condition in accordance with the OEM's specifications at the completion of each service call.

4.1.1. Contractor shall use only OEM new or OEM refurbished repair parts.

4.2. Preventive Maintenance and Calibration. Preventive Maintenance (PM) and Calibration shall be in accordance with the OEM’s checklist. The Contractor shall schedule the PM and Calibration at 6 month intervals (November and May) and coordinate the scheduled date with Clinical Engineering Section and notify the NCOIC or Shop Foreman of Clinical Engineering Section at (573) 596-0482.

4.2.1. The Contractor shall perform PM in accordance with the OEM’s checklist.

4.2.2. Upon completion of calibration, the Contractor shall affix a DD Form 2163 (Medical Equipment Calibration/Verification/ Certification) to the control panel of the equipment in plain view. If the form is already present, it will be replaced.

4.3. Work shall be performed at GLWACH. Equipment shall not be removed from site unless approved by the Government. This includes obtaining prior authorization for repair exchanges through the clinical engineering section.

4.3.1. The Contractor shall complete repairs within the time frames indicated (See para 4.5.1).

4.3.2. Only equipment requiring a major disassembly or major overhaul shall be removed from the customer’s site.

4.3.3. The Contractor shall not remove equipment without proper documentation. Proper documentation will be a Temporary Hand Receipt (DA Form 3161) prepared in accordance with DA Pamphlet 710-2-1.

The DA Form 3161 will include the following statement: "The Contractor,_(Contractor name)______ has been authorized to remove the item as described on this form for repair and return." The DA Form 3161 will be the Contractor's authorization to remove the item from GLWACH to his facility for repair and return.

4.4. Modifications and upgrades. The Contractor shall perform OEM specified modifications and software upgrades with the consent of and without charge to the Government. Resultant Contractor must have direct contact with the OEM to accomplish field modifications to equipment in accordance with the time schedule set forth by the OEM. All modifications and upgrades will be documented in the government owned operator and service literature.

4.5. Service calls. The GLWACH Clinical Engineering Section will first evaluate any equipment malfunction and facilitate repairs (screening process). If a service call is necessary, the Contractor shall provide unlimited service calls. Only the Clinical Engineering Section will determine if the required maintenance service is emergency or routine.

4.5.1. The Contractor shall perform routine and emergency maintenance services 24 hours a day, 7 days per week, excluding Legal Public Holidays. Any services provided outside normal business hours (0730-1600, M-F) must be authorized by the Chief, Equipment Management Branch.

4.5.1.2. Contractor response time shall be within 48 clock hours after telephonic notification excluding weekends and Legal Public Holidays.

4.5.2. Repair completion time for repair service shall not be more than 96 clock hours after telephonic notification excluding weekends and Legal Public Holidays.

4.6. Badges. Contractor's representative shall report to the information desk to sign for a contractor’s authorization badge, 4430 Missouri Avenue, main lobby, General Leonard Wood Army Community Hospital, telephone number (xxx) xxx-xxxx. The service representative will obtain a badge before reporting to service area.

4.7. Service reports. Upon completion of services by the contractor’s service representative, a written service report shall be provided to the clinical engineering staff. The service report shall provide detailed information regarding the cause of the MD/MDS malfunction and corrective action taken. Include, at a minimum, the time required to complete the work, price of labor (hourly rate), and a list of parts replaced with part numbers and prices for each part. Emailed reports are acceptable. Email reports to: usarmy.leonardwood.medcom-glwach.list.med-maint@mail.mil. In the event all information is not available to the contractor's service representative when services are performed, the initial service report shall include all available information. The contractor shall provide the balance of the required information to the clinical engineering manager no later than 48 clock hours after services are completed.

4.7.1. The service report shall indicate the Contract Number, service performed (e.g., PM and/or repair), provide detailed information regarding the cause of equipment malfunction, corrective action taken, to include the time required to complete the work. The service report shall also include the estimated price of labor (hourly labor rate); a list of parts replaced with price for each part, the unit Site ID and ECN number, and the name of the technician performing the service.

4.7.2. On weekends and after normal duty hours, service tickets shall be given to the Government AOD/SDNCO, at the front desk of the hospital.

4.7.3. In the event that all information is not available to contractor's representative when services are performed, the initial service report shall include all information available. Contractor shall provide the balance of the required information in writing to the Chief, Equipment Management Branch, not later than 10 days after services are completed.

4.8. The Contractor shall be responsible for all items of Government equipment throughout the period they are under his control. The Contractor shall be responsible for any contractor-caused damage to Government-owned property and shall replace or repair at the contractor’s expense. The Contracting Officer will approve replacements or repairs.

4.9. The Contractor shall ensure all areas where equipment is serviced on-site are left in a clean, neat, safe, and orderly condition. To prevent safety hazards, no equipment shall be left pulled out or apart at the end of the workday. All equipment under repair shall be secured at all times.

4.10. If the Contractor determines that the item being serviced is uneconomically repairable, the Chief, Equipment Management Branch shall be notified. The Chief, Equipment Management Branch, GLWACH will determine economic reparability in accordance with US Army Directives.

4.11. The government and the contractor’s service representative will exchange hazard communication information before the commencement of any repair. When required, the contractor’s service representative will comply with the Office of Safety and Health Administration (OSHA) lockout/tag-out standards while performing maintenance on

MD/MDS.

5. 0 APPLICABLE DIRECTIVES/DOCUMENTS:

5.1. Documents applicable to this PWS are listed below and all Army publications and forms will be available from the Chief, Equipment Management Branch upon request.

5.2. ARMY REGULATIONS:

AR 40-61 Medical Logistics Policies and Procedures AR 190-13 Army Physical Security Program AR 190-51 Security of Army Property at Unit and Installation Level

5.3. ARMY PAMPHLET:

DA Pam 710-2-1 Using Unit Supply System Manual Procedures

5.4. FORMS:

DD Form 1150 Request for Issue or Turn-In DD from 2163 Medical Equipment Calibration/Verification

5.5. OTHER REGULATORY DOCUMENTS:

[Unnumbered] Standards for the Joint Commission on Accreditation of Healthcare Organizations

6.0 INVOICE AND PAYMENT INFORMATION:

6.1 Payment will be made by Defense Finance and Accounting Service, (DFAS Indianapolis, Army Vendor Pay) (address in Block 18a), in the arrears , after receipt of services, or by previously scheduled payments as identified in the contract schedule herein. Contractor submits their 2n1 invoice in the Wide Area Workflow system for payment.

(See Wide-Area Workflow Clause in schedule), The Government Point of Contact (GPOC) shall verify for acceptance to be submitted to DFAS Indianapolis, IN. Government payment will only be authorized for services actually rendered. ADVANCE PAYMENTS ARE NOT AUTHORIZED.

7.0 Performance Requirements Summary

The following minimum Performance Requirement Summary applies. The Government may modify inspection methods in accordance with site specific requirements.

Required Services

(Tasks) Performance

Standards Acceptable Quality

Levels Methods of Surveillance

Incentive (Positive and/or Negative)

(impact on Contractor Payments)

Delivery & Install of all equipment with coordination with Logistics division

100% delivery & installation completion

100% Medical Maintenance Division coordination

Full payment will be processed when delivery & installation are complete and accepted by Medical Maintenance.

Provide training on purchased equipment

Provide initial training at each

100% Contract COR Full payment will be processed when initial install location and reoccurring scheduled training installation is completed.

Provide all labor, parts and shipping to perform preventative maintenance and repairs (by exchange if necessary)

Unlimited telephonic assistance, unlimited on-site maintenance repairs and (if required) exchange of broken equipment)

100% Medical Maintenance Division coordination

Contractor Deficiency Reports will be filled for non-performance

8.0 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 the following:

(1) Contracting Office, Contracting Officer, Contract, Government Point of Contact (GPOC);

(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).

As part of its submission, the contractor will also provide the estimated total cost (if any) incurred to comply with this reporting requirement. This cost will be reflected on a separate line item and can be invoiced upon completion of the report.

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.

The following information is provided for the Contractor’s use in completing the above report:

Predominant Federal Service Code: J065 Unit Identification Code for the Army Requiring Activity: W1MLAA

9.0 OPERATIONAL SECURITY (OPSEC)

9.0. OPSEC Training. New Contractors shall complete Level I OPSEC training within 30 calendar days of their reporting for duty. All Contractors with CAC access will complete training online in APEQS, all others can complete the training located at http://cdsetrain.dtic.mil/opsec/index.htm. (IAW AR 530-1). For contracts that cross fiscal years, or for contracts with option years, all Contractor personnel shall complete annual OPSEC awareness training. Course certificates shall be provided to the COR within five calendar days of completion.

9.1. Anti-terrorism (AT) Level I Training. All contractor employees, to include sub-contractor employees, requiring access to army installations, facilities, and controlled access areas shall complete AT Level I awareness training within 24 hours after starting performance under this contract or effective date of incorporation of this requirement into the contract whichever is applicable. The contractor shall submit certificates of completion for each affected contract employee and subcontractor employee, to the COR or to the KO within five calendar days after completion of training by all contractor/subcontractor personnel. AT level I awareness training is available at the following website: https://atlevel1.dtic.mil/at

9.2 ACCESS AND GENERAL PROTECTION/SECURITY POLICY AND PROCEDURES. All Contractor and sub-contractor personnel performing tasks on this PWS shall comply with applicable installation, facility and area commander installation/facility access and local security policies and procedures which will be provided to the Contractor by a Government representative within five working days of Task Order award. Contractor shall provide all information required for background checks to meet installation access requirements as performed by the installation Provost Marshal Office, Director of Emergency Services or Security Office. Requesting Contractor shall submit request for installation pass to the COR or KO at https://vcc1.icmvcc.com/im3500/. Contractor personnel shall 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 the base contract to this task order, should the Force Protection Condition (FPCON) at any facility or installation change, the Government may require changes in Contractor security matters or processes.

9.3. iWatch Training. Within 10 calendar days of Task Order award and within 24 hours of new Contractor employees commencing work on this Task Order, all Contractor and sub-contractor employees shall review the FLW Directorate of Emergency Services (DES) web link for iWatch training located at http://www.wood.army.mil/LEC/iWatch/iWatch.htm. This locally developed training will inform employees of the types of behavior to watch for and how to report suspicious activity. Suspicious activity shall be reported to the COR or KO.

9.4. Information Assurance (IA) Awareness Training. All Contractor and sub-contractor personnel requiring network access to Government information systems shall successfully complete DoD IA Awareness training available at https://ia.signal.army.mil prior to accessing systems and annually thereafter. Training certificates shall be provided to the COR immediately upon completion. CAC issued Contractor employees will be registered in the Army Training Certification Tracking System (ATCTS) by the organization’s Information Assurance Officer prior to commencement of work and shall sign the acceptable use policy in accordance with Army Regulation 25-2, Para.

3-3.

CMR ITEM REQUIREMENTS:

1. Contracting Office / Contracting Officer, Technical Point of Contact

Regional Health Command, Central (RHCO-C) Contracting Office

2. Contract Number

3. Beginning/Ending Dates covered

4. Contractor Name, Address, Phone Number, email, & POC

5. Estimated Direct Labor Hours (including sub-contractors)

6. Estimated direct labor dollars paid this reporting period (including sub-contractor

7. Total Payments (including sub-contractor)

8. Federal Service Code J065

9. Army’s Organizational UIC W1MLAA

10. Location of Work 65473

11. Deployment/Contingency None

12. Number of Contractor/Sub-contractor Employees deployed in theater None

SUPPLEMENT TO PWS

1. SEXUAL HARASSMENT/ASSAULT RESPONSE AND PREVENTION

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.

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 the MTF. 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.

2. HEALTH INSURANCE PORTABILTY AND ACCOUNTABILITY

Non-Defense Health Agency (Non-DHA) Health Insurance Portability and Accountability Act (HIPAA) Business Associate Agreement (BAA) (7 July 2014)

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

(a) Catchall Definition. Except as provided otherwise in this BAA, the following terms used in this BAA shall have the same meaning as those terms in the DoD HIPAA Rules: Data Aggregation, Designated Record Set, Disclosure, Health Care Operations, Individual, Minimum Necessary, Notice of Privacy Practices (NoPP), Protected Health Information (PHI), Required By Law, Secretary, Security Incident, Subcontractor, Unsecured Protected Health Information, and Use.

—Breach means actual or possible loss of control, unauthorized disclosure of or unauthorized access to PHI or other PII (which may include, but is not limited to PHI), where persons other than authorized users gain access or potential access to such information for any purpose other than authorized purposes, where one or more individuals will be adversely affected. The foregoing definition is based on the definition of breach in DoD Privacy Act Issuances as defined herein.

—Business Associate shall generally have the same meaning as the term “business associate” in the DoD HIPAA Issuances, and in reference to this BAA, shall mean [insert name of Business Associate signatory to this BAA].

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

BAA.

—Covered Entity shall generally have the same meaning as the term “covered entity” in the DoD HIPAA Issuances, and in reference to this BAA, shall mean [insert name of MHS component signatory to this BAA].

—DHA Privacy Office means the DHA Privacy and Civil Liberties Office. The DHA Privacy Office Director is the HIPAA Privacy and Security Officer for DHA, including the National Capital Region Medical Directorate

(NCRMD).

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

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

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

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

—Service-Level Privacy Office means one or more offices within the military services (Army, Navy, or Air Force) with oversight authority over Privacy Act and HIPAA privacy compliance.

I. Obligations and Activities of Business Associate

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

(b) The Business Associate shall use appropriate safeguards, and comply with the DoD HIPAA Rules with respect to electronic PHI, to prevent use or disclosure of PHI other than as provided for by the Agreement.

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

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

(e) The Business Associate shall make available PHI in a Designated Record Set, to the Covered Entity or, as directed by the Covered Entity, to an Individual, as necessary to satisfy the Covered Entity obligations under 45

CFR 164.524.

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

(g) The Business Associate shall maintain and make available the information required to provide an accounting of disclosures to the Covered Entity or an individual as necessary to satisfy the Covered Entity’s obligations under 45

CFR 164.528.

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

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

II. Permitted Uses and Disclosures by Business Associate

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

(b) The Business Associate agrees to use, disclose and request PHI only in accordance with the HIPAA Privacy Rule “minimum necessary” standard and corresponding DHA policies and procedures as stated in the DoD HIPAA Issuances.

(c) The Business Associate shall not use or disclose PHI in a manner that would violate the DoD HIPAA Issuances or HIPAA Privacy Rules if done by the Covered Entity, except uses and disclosures for the Business Associate’s own management and administration and legal responsibilities or for data aggregation services as set forth in the following three paragraphs.

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

(e) Except as otherwise limited in the Agreement, the Business Associate may disclose PHI for the proper management and administration of the Business Associate or to carry out the legal responsibilities of the Business Associate, provided that disclosures are required by law, or the Business Associate obtains reasonable assurances from the person to whom the PHI is disclosed that it will remain confidential and used or further disclosed only as required by law or for the purposes for which it was disclosed to the person, and the person notifies the Business Associate of any instances of which it is aware in which the confidentiality of the information has been breached.

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

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

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

(b) The Covered Entity shall notify the Business Associate of any changes in, or revocation of, the permission by an Individual to use or disclose his or her PHI, to the extent that such changes affect the Business Associate’s use or disclosure of PHI.

(c) The Covered Entity shall notify the Business Associate of any restriction on the use or disclosure of PHI that the Covered Entity has agreed to or is required to abide by under 45 CFR 164.522, to the extent that such changes may affect the Business Associate’s use or disclosure of PHI.

IV. Permissible Requests by Covered Entity The Covered Entity shall not request the Business Associate to use or disclose PHI in any manner that would not be permissible under the HIPAA Privacy Rule or any applicable Government regulations (including without limitation, DoD HIPAA Issuances) if done by the Covered Entity, except for providing Data Aggregation services to the Covered Entity and for management and administrative activities of the Business Associate as otherwise permitted by this BAA.

V. Breach Response

(a) In general.

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

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

This Part V is designed to satisfy the DoD Privacy Act Issuances and the HIPAA Breach Rule as implemented by the DoD HIPAA Issuances. In general, for breach response, the Business Associate shall report the breach to the Covered Entity, assess the breach incident, notify affected individuals, and take mitigation actions as applicable.

Because DoD defines “breach” to include possible (suspected) as well as actual (confirmed) breaches, the Business

Associate shall implement these breach response requirements immediately upon the Business Associate’s discovery of a possible breach.

(b) Government Reporting Provisions The Business Associate shall report the breach within one hour of discovery to the Covered Entity and to the US Computer Emergency Readiness Team (US CERT) -the other parties as deemed appropriate by the Covered Entity.

The Business Associate is deemed to have discovered a breach as of the time a breach (suspected or confirmed) is known, or by exercising reasonable diligence would have been known, to any person (other than the person committing it) who is an employee, officer or other agent of the Business Associate.

The Business Associate shall submit the US-CERT report using the online form at https://forms.us-cert.gov/report/.

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

The additional US Army and the US Army Medical Command (MEDCOM) reporting requirements are addressed in the PII Breach Reporting and Notification Policy. The latest version of this policy can be obtained from the Covered Entity or the MEDCOM Privacy Act/Freedom of Information Act (FOIA) Office at:

usarmy.jbsa.medcom.list.medcom-foia-users@mail.mil . If multiple beneficiaries are affected by a single event or related set of events, then a single reportable breach may be deemed to have occurred, depending on the circumstances. The Business Associate shall inform the Covered Entity as soon as possible if it believes that “single event” breach response is appropriate; the Covered Entity will determine how the Business Associate shall proceed and, if appropriate, consolidate separately reported breaches for purposes of Business Associate report updates, beneficiary notification, and mitigation.

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

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

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

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

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

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

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

THEFT (438-4338); TTY: 1-866-653-4261.

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

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

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

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

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

VI. Termination

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

(b) Effect of Termination.

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

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