Performance Work Statement.pdf

Performance Work Statement Cassette Engraver – General Data Co. Inc.

Evans Army Community Hospital Fort Carson, Colorado

GENERAL.

1. DESCRIPTION OF WORK: Evans Army Community Hospital (EACH), Fort Carson, Colorado has a requirement for an on-site maintenance service contract. The contractor shall provide their Maintenance Service Contract to include all resources, labor, travel, transportation, parts, materials, equipment, and management necessary to keep the medical equipment in good operating condition and to perform all scheduled and unscheduled maintenance of the equipment listed in Table 1. This non-personal services maintenance contract shall cover the repair, PM, calibration, and exchange services according to the Manufacturer’s specifications for the equipment listed in Table 1.

Table 1 - Equipment List

ECN NOMENCLATURE MANUFACTURER NAMEPLATE

MODEL

SERIAL

NUMBER

Service

Description 065646 Laser Aimer (Laser

Cassette Marker) General Data Co.

Inc.

CL-01

652001Q462009 Onsite Repair

1.1. This contract is a NON-PERSONAL SERVICES contract under which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the government and its employees.

1.2. The inspection and acceptance point for all services rendered under this contract will be by the Contracting Officer’s Representative (COR). The performance by the contractor technician, the quality of services rendered, and any documentation or written material in support of same, shall be subject to continuous inspection, surveillance and review for acceptance by the COR or designated representative. Other performance evaluation factors will be monitored that are not quantified by numerical measurements, Contractor technician relationship with hospital staff/Government contracting personnel and compliance with hospital policy and procedures.

2. Contractor Requirements.

2.1. Contractor will provide only technically qualified System technicians who are factory trained and certified to perform maintenance on the equipment in Table 1 and have a minimum of two years of experience working on the contracted equipment. Service personnel must have a good working knowledge of the equipment.

2.2. The Contractor shall only install System Hardware, Firmware and Software to ensure compliance with the manufacturer’s specifications to the General Data Co. Inc., Cassette Engraver.

2.3. The Contractor shall only install System firmware and software upgrades as necessary to keep up with annual improvements and Evans Army Community Hospital expansions, to ensure that the General Data Co. Inc., Cassette Engraver is running according to manufacturer’s specifications.

2.4. 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.

3. Administrative.

3.1. Reports. The Contractor shall submit reports to the COR or Contracting Officer as requested for use in monitoring Contractor performance. Such reports may include, but are not limited to, a service report as identified in paragraph 7.8.

3.2. Safety. The Contractor shall ensure its personnel comply with all installation and MTF safety regulations. Such regulations include, but are not limited to, general safety, fire prevention, and waste disposal. Copies of these regulations are on file in the medical activity safety office or may be obtained through the COR. The use of cellular phones and 2-way radios is expressly forbidden in all Medical Treatment Facilities and Health Clinics.

3.3. Security.

3.3.1. The Contractor shall ensure its personnel comply with the local installation requirements for vehicle registration and operation on the military facility. Any vehicle operated by contract personnel on the military installation must have the minimum liability coverage required by the state in which the performance is located.

3.3.2. The Contractor shall ensure its personnel comply with installation and MTF personnel identification and access requirements. The Contractor is responsible for absences due to expired identification and access documents.

3.4. Antiterrorism/Operations Security (AT/OPSEC) Requirements.

3.4.1. Antiterrorism (AT) Level I Training. This provision/contract text 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 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee, to the COR or to the contracting officer, if a COR is not assigned, within 30 calendar days after completion of training by all employees and subcontractor personnel. AT level I awareness training is available at the following website https://jko.jten.mil/courses/atl1/launch.html.

3.4.2. Access and General Protection/Security Policy and Procedures. This standard language text is for contractor employees with an area of performance within an Army controlled installation, facility or area. Contractor and all associated sub-contractors employees shall comply with applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative). The contractor shall also provide all information required for background checks to meet installation 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 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.

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

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

3.5. Hours of Operation. Medical Maintenance Branch, EACH, office hours 7:00 A.M. thru 4:00 P.M., MST, Monday thru Friday. Overtime hours are not allowed, in accordance with the contract. Thus, the contractor is not allowed to work overtime hours, if service is required, after normal business hours.

3.6. Software upgrades. All software upgrades, corrective in nature, or which enhance equipment features shall be at no-cost to the government.

3.7. Contractor shall provide all documentation required to meet all regulatory compliance testing procedures.

https://jko.jten.mil/courses/atl1/launch.html

3.8. Invoices and Payment Information.

Payment will be made by Defense Finance and Accounting Service, (DFAS Indianapolis), Indianapolis, IN (address in Block 18a), after receipt of services. Contractor submits their 2-N-1 invoice in the Wide Area Workflow (WAWF) system for payment. The Contracting Officer’s Representative (COR) shall verify for acceptance to be submit to DFAS Indianapolis. Government Payment will only be authorized for services actually rendered. Advance payments under this contract are not authorized.

4. Contractor Conduct.

4.1. The Contractor is responsible for the conduct of his/her employees. All services shall be provided in accordance with established standards, principles, and ethics of the profession and applicable professional specialty organizations, and shall ensure the highest regard to patient dignity.

4.2. The Contractor shall ensure that its personnel comply with MTF policies regarding personal appearance and conduct.

4.3. Inquiries. Contractor shall ensure that its personnel do not respond to any media inquiries. Any inquiries from the media shall be immediately relayed to the COR, who will relay them to the MTF Commander. There shall be no interviews, comments, or any other response without the knowledge and approval of the MTF Commander. Other than routine inquiries from external agencies, all other inquiries and complaints shall be brought to the attention of the Government.

4.4. Smoking. The Contractor shall ensure its personnel shall comply with the MTF smoking policy.

4.5. Complaints. Complaints will be validated by the COR and be reported in writing to the Contracting Officer and the Contractor for action, if it constitutes a failure to perform, as determined by the Government. The Contractor shall have no more than one substantiated complaints for each period of performance.

4.6. Contractor Representation. The Contractor shall designate a Point of Contact (POC) for the contract. The Contractor’s POC shall be the only authorized representative of contractor 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 promptly whenever the POC changes. Contractor’s POC shall be submitted no later than 10 days after award of contract, and shall include as a minimum name, title, and telephone number.

5. Government /Contractor Furnished Property.

5.1. Government. The COR will provide the contractor access to the equipment covered under the contract.

6. Contractor.

6.1. The Contractor shall provide each employee an identification badge which shall be displayed on their outer garment at all times when responding to a service call at EACH. The badge shall include, as a minimum, the employee’s name, current picture, the Contractor’s name, and title identification.

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

6.3. 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. The Contractor shall obtain the currently available literature of the original equipment manufacturer (OEM).

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

6.5. Contractor shall notify the COR when replacement parts are needed to complete service are not available.

6.6. The Government will not be responsible for any damages or loss of Contractor supplies, materials, or equipment nor is the Government responsible for any damages or loss of the Contractor employees’ personal belongings, due to fire, theft, accidents or other causes.

6.7. The contractor shall report immediately to the Government Point of Contact, or the Chief of Equipment Management Branch, all accidents which may arise out of or in connection with the performance of services required within the scope of this contract.

7. Scope of Work.

7.1. The Contractor employee is required to check-in Room 0705 (Service Level) Medical Maintenance Office, to check in with the COR, OIC, NCOIC, or Shop Foreman before proceeding to complete the service repair work.

7.2. Persons Authorized to Make Calls. Only those people listed below and the Contracting Officer are authorized to give the Contractor instructions, place service calls, or request updates status. The Government representative or COR will call and leave their name and number. The Contractor will return the call or come directly to the Medical Maintenance Branch to verify instructions prior to initiating any action.

Primary POC: Bill Morawe, Electronics Biomed Technician, 719-524-5291 Alternate POC: Janpatrick Barroga, Contracting Officers Representative, 719-524-3651 Officer in Charge: Steven Mercer, Chief, Medical Maintenance, 719-526-7252 Non-Commission in Officer in Charge: SSG Anthony Boheler, 719-526-3599 Shop Foreman: SSG Jessica Quiroz, 719-526-7202

7.3. Any service performed without the prior approval of one of the individuals above shall be at no cost to the Government.

7.4. Maintenance Time Frames.

7.4.1. The Contractor shall provide one preventive maintenance (PM) and calibration verification check (CVC). If OEM standard requires more than one PM this will be covered by the Contractor at no additional cost. Services during the time frame will include one electrical safety current leakage test to determine the amount of electrical current electrical leakage to the case of the unit and these tasks shall be performed together. All services performed are documented and indicated on the service ticket upon completion of services as follows:

7.4.1.1. Calibration. CA with the time spent.

7.4.1.2. Preventive Maintenance Inspection (PMI) is inspection with the time spent, the electrical safety test is a part of this process.

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

7.5. Services Required and Specific Tasks.

7.5.1. Scheduled Services.

7.5.1.1. One PM annually for the life of the contract starting at the time of award and at the beginning of each option period. More than one PM might be required depending on the OEM standards and will be covered under this contract.

7.5.1.2. The Contractor shall complete all required scheduled services within four working days after starting each scheduled services.

7.5.1.3. No later than the fifth day of the month for scheduled services, the Contractor shall coordinate with the Medical Maintenance Branch and the end-users, ensuring access to the equipment to be serviced.

7.5.1.3.1. Includes any additional scheduled preventive maintenance repairs to the medical equipment.

7.5.1.3.2. Upon completion of PM on the equipment, the contractor or bio med technician shall update the affixed DD Form 2163, Medical Equipment Verification/Certification Sticker according to TB 38-750-2.

7.6. Unscheduled Services.

7.7.1. Contractor shall use reasonable efforts to provide on-site services with a response time not to exceed two business days after telephonic notification of a malfunction if contractor is unable to provide services via telephone support. These days are Monday through Friday, excluding all Government holidays. All equipment is repaired to meet manufacturers specifications in accordance with contractor's policies and procedures at all times.

7.7.2. The Contractor shall use reasonable efforts to respond telephonically within four hours during normal duty hour’s days and within six hours after normal duty hours.

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

7.7.4. If parts are required and are not in stock with the contractor or original equipment manufacturer, an allowable delay will be determined by the COR.

7.7.5. The Contractor shall provide for all replacements of worn and/or defective parts that contractor has determined have failed under proper use as necessary to restore the equipment to 100% operational condition as specified by the OEM.

7.7.6. Contractor is required to be available and respond to the needs of EACH within 24 hours of being called. The Contractor should be able or willing to be present if required.

7.8. Service Reports.

7.8.1. Upon completion of services, a service report shall be provided to the COR and Medical Maintenance prior to the contractor technician’s departure. In the event all information is not available when services are performed, the initial service report shall include all available information. The contractor shall provide the balance of the required information no later than 48 hours after services are completed. This report is initiated by the Contractor at the completion of each repair and at the minimum will include:

7.8.1. Contractor’s name

7.8.2. Contract number

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

7.8.4. 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.

7.8.5. Part number and listed cost of each repair part used.

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

7.8.7. Detailed information regarding the equipment malfunction and corrective action taken and preventive maintenance and calibrations standards checked.

8. Other Required Tasks.

8.1. Contractor shall report to the Medical Maintenance Branch, Building 7500, Room 0705, and sign-in the Contractor’s Log by indicating company name, individuals name, time of arrival, and destination. When departing EACH, the contractor technician must exit through Medical Maintenance and provide the service report as required above.

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

8.3. 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.

8.4. Delays caused by Government will not be counted as contractor “down time” for the purpose of this requirement.

8.5. Contractor shall furnish and install only OEM replacement parts or OEM recommended substitution/ modifications, as approved by the Medical Maintenance Branch as required ensuring proper and safe operation of the equipment. The Contractor shall provide technical assistance; install firmware/hardware/software updates as required by the manufacturer.

8.6. The Contractor shall perform scheduled preventive maintenance inspection and CVC one time per year or per OEM standards/specifications. When CVC services are complete, the Contractor shall affix a DD Form 2163 to the equipment; update the current form, when appropriate, as specified 750-1. The COR shall determine where on the equipment the DD Form will be affixed.

8.7. The Contractor shall establish and follow a procedural checklist when performing scheduled services. Any updates shall be supplied to the COR.

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

8.9. The contractor shall use reasonable efforts to continue uninterrupted until the equipment is operational.

Equipment which is left unserviceable at the end of normal duty hours or until performance can be resumed, will be identified by the Contractor notifying the Medical Maintenance technician, POC or the COR and the hospital staff/end users. If the Contractor determines that additional parts are required, services will resume as soon as parts become available. The COR will be informed personally or in writing of the equipment status prior to the Contractor leaving the work site.

8.10. If a malfunction exists with the Contractor maintained equipment or the Government’s utilities (i.e., water, air, electricity), the contractor’s maintenance representative will be notified. The Contractor’s maintenance representative and the Government’s maintenance representative will test the utilities and will determine whether the utility or the equipment failed. If it is determined that the equipment failed, the contractor shall perform maintenance services immediately.

8.11. Contractor personnel shall leave job site in the same condition as found upon arrival.

9. REPLACMENT PARTS:

9.1. The Contractor shall replace all worn, failed, or defective parts at no additional cost to the Government.

9.2. The Contractor shall have and maintain an adequate inventory of repair parts to service the equipment listed herein and as may be needed in the performance of this contract. The Contractor shall maintain a backup inventory of spare parts so that any spare parts can be delivered to the site within the time frames established, if the spare part is not available from the local contractor inventory.

9.3. Replacement 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.

9.4. 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.

10. APPLICABLE FORMS AND PUBLICATIONS: Publications documents and forms applicable to this PWS are listed below. The Contractor shall use reasonable efforts 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, scope or purpose, it shall be a change within the meaning of the “Changes” clauses of the contract.

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

DD Form 2163, Medical Equipment Verification/Certification

10.2. PUBLICATIONS. Army publications shall be made available to the Contractor during the period of the contract. These publications are located in the Medical Maintenance Branch, EACH.

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

10.3. 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)

11. Sexual Assault Prevention and Response Program.

11.1. 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.

11.2. The contractor shall require all HCP(s) 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.

11.3. The contractor shall require all HCP(s) 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.

11.4. 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 MEDCOM on an every other month basis by contacting (210) 221-6118 for class date/time and availability. 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.asp1.

11.5. The Contractor shall notify its employees of the United States Government's zero tolerance policy described in paragraph (b) of FAR clause 52.222-50 “Combating Trafficking in Persons” and the actions that will be taken against employees for violations of this policy.

12. CONTRACT MANPOWER REPORTING

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://www.sam.gov. The required information includes:

a. Contracting Office, KO, COR http://www.atsc.army.mil/tadlp/delivery/alms.asp1

b. Contract number, including task and delivery order number

c. Beginning and ending dates covered by reporting period

d. Contractor name, address, phone number, e-mail address, identity of contractor employee entering data

e. Estimated direct labor hours (including subcontractor)

f. Estimated direct labor dollars paid this reporting period (including subcontractor)

g. Total payments (including subcontractor)

h. Predominant Federal Service Code (FSC) reflecting services provided by contractor (and separate predominant

FSC for each subcontractor if different)

i. Contractual 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)

j. Locations where contractor and subcontractors 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)

k. Presence of deployment or contingency contract language

l. Number of contractor and subcontractor employees deployed in theater this reporting period (by country)

The 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 COR by the 5th working day of November of each government fiscal year whether or not they have completed this report. If the COR is unavailable, the contractor will notify the KO.

13. HCAA Local Clause 5001 - 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 Evans Army Community Hospital.

—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 Evans Army Community Hospital.

—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 https://forms.us-cert.gov/report/ http://www.us-cert.gov/pgp/email.html mailto:usarmy.jbsa.medcom.list.medcom-foia-users@mail.mil 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…