TMDE PWS.pdf

PERFORMANCE WORK STATEMENT

TEST MEASUREMENT AND DIAGNOSTIC EQUIPMENT

GENERAL LEONARD WOOD ARMY COMMUNITY

HOSPITAL

FORT LEONARD WOOD, MISSOURI 65473-1317

1. SCOPE OF WORK: Contractor shall provide service for all Test Measurement and Diagnostic Equipment (TMDE) quoted. This includes unlimited telephonic assistance, inspections, preventive maintenance, calibration, and scheduled parts replacement for all TMDE. The equipment will be identified as property of General Leonard Wood Army Community Hospital (GLWACH), 4430 Missouri Avenue, Fort Leonard Wood, Missouri, 65473.

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, Clinical Engineering Section, Health Technology Management (HTM) Branch at (573) 596-0482.

1.1.2. All scheduled services shall go through the Clinical Engineering Section, Health Technology Management Branch.

1.1.3. Only a representative of the Clinical Engineering Section, Health Technology Management Branch will make all requests for services.

1.2. PERSONNEL: Individuals who have demonstrated knowledge and competence in the service of listed TMDE identified shall perform on this contract.

1.2.l. The contractor shall ensure supplied technicians are fully trained as authorized for all equipment by reputable manufacturers of listed TMDE agreement specific or have 2 years of maintenance experience in the calibration of like equipment.

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

2.0 Reserved

3. GOVERNMENT FURNISHED PROPERTY AND SERVICES: On a government authorized, case-by-case basis, the contractor may use the government Clinical Engineering shop in order to expedite services with the approval of the Maintenance Manager.

4. SPECIFIC TASKS TO BE PERFORMED:

4.1. Services, labor, parts and materials. The contractor shall provide services, labor, parts, and materiel necessary to cause serviced equipment to be in proper working condition in accordance with the Original Equipment Manufacturers (OEM's) specifications at the completion of each service call.

4.2. For Service and Return. Upon completion of services, a written service report shall accompany the equipment being returned. The service report shall provide detailed information regarding the status of the equipment and any 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 prices for each part.

4.3. For On-site Services:

(a) Services are to be performed during the month(s) of March through February.

Contractor shall respond within 48-hours, during normal duty hours of 8:00 AM and 4:00 PM excluding Federal Public Holidays.

(b) Contractor's service representative shall report in person or telephonically notify the Maintenance Manager, Building No. 310, 4430 Missouri Avenue, Clinical Engineering Section, HTM, Telephone No. 573-596- 0482 prior to commencing services during normal duty operating hours of 8:00 AM and 4:00 PM.

(c) The government and the contractor's service representative shall exchange any hazard communication information before the commencement of any Service.

(d) When required, the contractor's service representative will comply with the Office of Safety and Health Administration lockout/tag out standards while performing maintenance on equipment.

(e) Upon completion of services by the contractor's service representative, a written service report shall be provided to the maintenance manager. The service report shall provide detailed information regarding the status upon completion of the service. 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.

(f) 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 maintenance manager no later than 10 days after services are completed.

(g) In the event of calibration, after performing Calibration/Verification/Certification services, the contractor's service representative will affix a calibration label stating at minimum;

serial number of equipment, date service performed, date next service due and if there are any limitations on the equipment.

(h) Contractor must furnish all software upgrades issued by the equipment manufacturer.

(i) Required forms and extracts from pertinent directives will be furnished to the contractor's service representative by the government.

(j) If the contractor1s calibration equipment produces a printed summary of the calibration procedure used, attach the printed summary to the service report.

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, Health Technology

Management (HTM) Branch will first evaluate any equipment condition and facilitate scheduled services (screening process).

4.5.1. The contractor shall perform routine service between 8:00 AM and 4:00 PM Monday through Friday, excluding Legal Public Holidays. Contractor will report when scheduled to conduct scheduled service. If unforeseen circumstances (weather, technician issues, vehicle issues) arise the contractor will make immediate contact with the HTM manager or contracting specialist for Clinical Engineering and make on contingency plan for service.

4.6. Badges. Contractor's representative shall report to Clinical Engineering, 4430 Missouri Avenue, room no. 034, General Leonard Wood Army Community Hospital, telephone (573)596-0482, prior to commencing services during normal operating hours (8:00 AM to 4:00 PM). Also, contractor will be escorted to get a visitor badge from the hospital security office located on the 6th floor upon arrival and return the badge upon departure.

4.7. Service reports. Upon completion of services, a written service report will be provided to the Clinical Engineering manager, or the government medical equipment repairer assigned to the service call.

4.7.1. The service report shall indicate the Contract Number, service performed (e.g., INSP, PM, CAL, SPR), 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. 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, Medical Equipment Branch, not later than l 0 days after services are completed. The remaining information should be mailed to: Commander, USA Medical Department Activity, ATTN:

MCXP-LOG-EMM, HTM Service Reports, 4430 Missouri Avenue, Box 1259, Ft. Leonard Wood, MO 65473-9098 or faxed to 573-596-1786. This address is not to be used for any purpose other than as stated in the paragraph.

4.7.3. Contractor shall provide a copy of the invoice to the Chief, Clinical Engineering Section, Health Technology Management Branch, for verification of services performed.

This is in addition to the requirements of block 13 of the DD Form 1155, Order for Supplies or Services. The copy of the invoice can be mailed to Commander, USA Medical Department Activity, and ATTN: MCXP-LOG-EMM, 4430 Missouri Avenue, Box 1259, Ft. Leonard Wood, MO 65473-9098 or faxed to 573-596-1786, ATTN: Service Report.

4.8. The contractor shall be responsible for all items of government equipment throughout the period they are under their 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 service shall be secured at all times.

4.10. If the contractor determines that the item being serviced is uneconomically repairable, the Chief, Clinical Engineering Section, Health Technology Management Branch shall be notified. The Chief, Clinical Engineering Section, Health Technology Management Branch, GLWACH will determine economic reparability in accordance with the Defense Health Agency Directives.

5. Reserved

6.0. 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.

6.1. Not Used..

6.2. 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 10 days 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: Level I Antiterrorism Awareness Training (jten.mil)

6.2b. 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 (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.

6.3 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 Gate Information and Access Control :: FORT LEONARD WOOD (army.mil) . 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.

6.4. IWatch Training. Within 10 calendar days of Task Order award and within 10 days of new Contractor employees commencing work on this Task Order, all Contractor and sub-contractor http://cdsetrain.dtic.m/ https://jkodirect.jten.mil/pdf/atl1/launch.html https://home.army.mil/wood/index.php/Garrison/DES/physical-security/access-control https://home.army.mil/wood/index.php/Garrison/DES/physical-security/access-control employees shall review the FLW Directorate of Emergency Services (DES) web link for iWatch training located at iWATCH Fort Leonard Wood :: FORT LEONARD WOOD (army.mil) . 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.

6.5. 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 Cyber Training Login (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.

The COR or KO will coordinate with the requiring activity Information Assurance Support Officer or ATCTS Folder Manager to input contractor information into the ATCTS and verify compliance.

6.6. Not Used

6.7. For contracts that require OPSEC Training. Per AR 530‐1, Operations Security, the contractor employees must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter.

6.8. For IA/IT training. All contractor employees and associated subcontractor employees must complete the DoD IA awareness training before issuance of network access and annually thereafter. All contractor employees working IA/IT functions must comply with DoD and Army training requirements in DoDD 8570.01, DoD 8570.01‐M and AR 25‐2 within six months of appointment to IA/IT functions.

6.9. For IA/IT certification. Per DoD 8570.01‐M , DFARS 252.239.7001 and AR 25‐2, the contractor employees supporting IA/IT functions shall be appropriately certified upon contract award. The baseline certification as stipulated in DoD 8570.01‐M must be completed upon contract award.

PERFORMANCE REQUIREMENT SUMMARY MATRIX (PRS).

A. OBJECTIVE: The contractor shall provide maintenance and repair services for medical equipment located at General Leonard Wood Army Community Hospital; Missouri as listed in the contract’s Performance Work Statement.

B. PERFORMANCE MEASUREMENT OBJECTIVE: The key area(s) of the Contractor’s performance that will be evaluated during the term of the contract. The PWS reference will be provided for each performance measurement objective.

C. ASSESSMENT METHOD: Contractor performance is inspected and evaluated on key areas of performance as shown in paragraph F. below.

D. METHODS OF SURVEILLANCE. The following Methods of Surveillance may be utilized in monitoring the Contractors’ performance:

• 100% Inspection will be reserved for the highest risk areas where consequence of failure may affect life or limb, or there is likelihood of mission failure https://home.army.mil/wood/index.php/Garrison/DES/iwatch http://www.wood.anny.mil/LEC/iWatch/iWatch.htm https://cs.signal.army.mil/login.asp

• Random Sampling Will be used when a service is performed on a frequent basis and a statistically valid sample can be selected for audit. This is most appropriate method for frequently recurring tasks

• Periodic Inspection Will be used when planned sampling of a service is at a specific predetermined date and time. This is most appropriate for tasks that occur infrequently, yet on a scheduled basis

• Customer Feedback. Not a valid method of surveillance, but a good indicator of areas where surveillance should be conducted or intensified. The DA Form 5477, Customer Complaint Record, will be placed at convenient locations for the end user of these services, and made available to document/record all complaints. The acceptor will collect the Customer Complaints each surveillance cycle and investigate for validity ASAP.

The following procedures will be followed when a complaint is received.

• The acceptor will investigate to determine the validity of the complaint

• If the complaint is determined to be invalid, the acceptor will inform the person who submitted the complaint of the reason(s) as soon as practical

• A Customer Complaint Log will be used to document each validated customer complaint.

E. ACCEPTABLE QUALITY LEVEL (AQL): The degree to which the Government will allow the Contractor’s key areas of performance to vary; the variance from the standard that the Contractor is allowed and the grading/ measurement associated with deviation from the specific performance standard.

F. KEY AREAS OF PERFORMANCE:

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

REQUIRED

SERVICE

REFERENCE

PARAGRAPH

STANDARD

ACCEPTABLE

QUALITY

LEVEL (AQL)

METHOD OF

SURVEILLANCE

Specific tasks to be performed. PWS para.

4.1

Contract shall include services, labor, parts and materiel necessary for equipment in working condition according to the OEM’s specs.

100% 100% Inspection

On-site services. PWS para 4.3.(a)

Contractor shall respond within 48-hours, during normal duty hours of 8:00am to 4:00pm excluding federal

100% Periodic Inspection

REQUIRED

SERVICE

REFERENCE

PARAGRAPH

STANDARD

ACCEPTABLE

QUALITY

LEVEL (AQL)

METHOD OF

SURVEILLANCE

holidays.

Modifications and upgrades. PWS 4.4

Contractor shall perform OEM specified modifications and software upgrades without charge to the Government.

98% Periodic Inspection

Service reports. PWS para. 4.7

Contractor shall provide a service report at the conclusion of each service.

98% Periodic Inspection

STANDARD MEASUREMENT PAST PERFORMANCE ASSESSMENT

99% to 100% Excellent Document Past Performance Assessment Report, paying 96% to 98% Very Good particular attention to performance that exceeds 95% Satisfactory the standard.

91% to 94% Marginal 90% or Less Unsatisfactory

(END OF PERFORMANCE WORK STATEMENT)

SUPPLEMENT TO THE PERFORMANCE WORK STATEMENT

1. GOVERNMENT HOLIDAYS

The following Government Holidays are observed:

New Year’s Day, 1 January Martin Luther King Jr.’s Birthday, 3rd Monday in January President’s Day, 3rd Monday in February Memorial Day, Last Monday in May Juneteenth Day, 19 June Independence Day, 4 July Labor Day, 1st Monday in September Columbus Day, 2nd Monday in October Veteran’s Day, 11 November Thanksgiving Day, 4th Thursday in November Christmas Day, 25 December

Any of the above holidays falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. Any holidays that are declared by Presidential

Executive Order shall be observed in the same manner as the holidays listed above. If the area in which a contractor is scheduled to perform maintenance is closed due to a holiday declared by an Executive Order and the contractor is not required to report in, contractor shall service equipment on the available day staff will be present. Closures of the installation due to inclement weather or other such acts of God shall be handled in the same manner.

2. Invoicing and Payment

The contractor shall submit monthly, in arrears, itemized invoices in accordance with DFARS 252.232- 7003 & 252.232-7006, for services rendered under this contract. Information regarding Wide Area Workflow is available on the Internet at https://piee.eb.mil

3. TOBACCO FREE MEDICAL CAMPUS (TFMC)

The Contractor shall ensure that all contract personnel comply with the U.S. Army Medical Command and MTF smoking policies while performing services under this contract. Smoking restrictions will apply at any location or building where health care activities are performed under this contract.

In accordance with Army Regulation 600-63, paragraph 7-3, 14 April 2015; Operations Order 15-48 (Army Medical Command (MEDCOM) Tobacco Free Living – USAMEDCOM), 8 May 2015; and any Operations Order, regulation or other instruction implementing, defining or otherwise addressing the Tobacco Free Medical Campus (TFMC) on any military installation or DoD-controlled location, Contractor personnel are prohibited from using any tobacco product on or within any TFMC while performing under this contract. TFMCs are established at each installation or DoD-controlled location and include: (1) any property or non-residential building that is operated, maintained or assigned to support medical activities, including but not limited to, hospitals, medical laboratories, outpatient clinics (including medical, dental, and veterinary facilities), or aid stations operating for the primary purpose of delivering medical care and services for DOD eligible beneficiaries and /or meeting the mission of the Army Medical Command; (2) all other facilities in which medical activities or administration take place, to include HQ MEDCOM and Defense Health Headquarters; (3) all internal roadways, sidewalks and parking lots; and

(4) all sidewalks, parking lots and grounds external but adjacent to the building or related to the migratory corridors surrounding the medical facility. The contractor shall obtain from the COR any orders, regulations, instructions or other documents implementing, defining or otherwise addressing the TFMC for any given installation or DoD-controlled location where contractor personnel may perform under this contract and shall instruct contractor personnel on the TFMC limitations for installations or DoD-controlled locations where they may perform under this contract.

4. EXCLUSION FROM PARTICIPATION IN FEDERAL HEALTH CARE PROGRAM

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

1. The Contractor shall not employ or contract with any individual or entity (hereinafter collectively referred to as “person”) to provide items or services that will be included in invoices submitted to the Government under this contract if such person is listed on the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) List of Excluded Individuals and Entities (LEIE) or the TRICARE Sanctioned Provider List. The Government is legally prohibited from paying for provision of items or services by such persons. The prohibition extends to services beyond direct patient care, such as services of persons in executive or leadership roles and administrative and management services, whether or not such services are billed separately. The LEIE may be found at h ttp://oig.hhs.gov/fraud/exclusions.asp, and the TRICARE Sanctioned Provider list at h ttp://www.health.mil/Military-Health-Topics/Access-Cost-Quality-and-Safety/Quality-And-Safety-of- H ealthcare/Program-Integrity/Sanctioned-Providers. The LEIE and TRICARE Sanctioned Provider List are hereinafter collectively referred to as “the Lists.”

2. Prior to start of contract performance, the Contractor shall (a) query the Lists to determine whether the https://piee.eb.mil/ http://www.health.mil/Military-Health-Topics/Access-Cost-Quality-and-Safety/Quality-And-Safety-of-name of any person the Contractor employs or contracts with to provide services or items for which payment may be made under this contract appears on the Lists, and (b) certify to the Contracting Officer that the Contractor has queried the Lists and no such names appear on either of the Lists.

3. During performance of the contract, and prior to persons other than those whose names were queried in accordance with paragraph 2, above, (hereinafter “new persons”) providing services or items under the contract, the Contractor shall (a) query the Lists as in paragraph 2, and (b) certify to the Contracting Officer that the names of such new persons do not appear on either of the Lists.

4. The Contractor is advised that during performance of the contract, MTF personnel will perform a recurrent recheck of the names of contractor personnel working in the MTF against the Lists, as specified in OTSG/MEDCOM Policy Memo 15-037. The Government will notify the Contractor in the event any contractor personnel working in the MTF appear on either of the Lists.

5. Should any person providing items or services under the contract appear on either of the Lists at any time during contract performance, the Contractor shall (a) in cases where the Contractor identified the person, notify the Contracting Officer, and (b) promptly remove that person from the contract.

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

7. The Contractor is further advised that, in accordance with Civil Monetary Penalties Law [CMP] (codified at 42 USC § 1320a- 7a):There are steep civil monetary penalties associated with billing the Government for providing items or services by a person on either of the Lists, and with failing to return to the Government any overpayments received for provision of such items or services.

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

HHS OIG has issued a Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs with additional information on the CMP. The Special Advisory Bulletin may be found at h ttp://oig.hhs.gov/exclusions/files/sab-05092013.pdf.

5. Sexual Assault Prevention & Response Program (SAPR)

1. The DoD's goal is to provide a culture free of sexual assault through an environment of prevention, education, training, response capability, victim support, reporting procedures, and appropriate accountability that enhances the safety and well being of all persons covered by the DoD Directive. The DHA is one (1) of the agencies of the DoD, and as such follows the directives, instructions, and guidance of the DoD.

2. All contract personnel will comply with the Department of Defense Directive (DoDD) 6495.01, SAPR Program. More information is available via the following weblink: www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodd/649501p.pdf

6. Personally Identifiable Information, Protected Health Information, and Federal Information Requirements (Revised 10/27/2020)

General Requirements Overview - Personally Identifiable Information (PII), Protected Health Information (PHI) and Federal Information Laws

1.This Section addresses the Contractor’s requirements under The Privacy Act of 1974 (Privacy Act), The Freedom of Information Act (FOIA), and The Health Insurance Portability and Accountability Act (HIPAA) as set forth in applicable statutes, implementing regulations and Department of Defense (DoD) issuances. In general, the Contractor shall comply with the specific requirements set forth in this Section and elsewhere in this Contract. The Contractor shall also comply with requirements relating to records management as described herein.

http://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodd/649501p.pdf

This Contract incorporates by reference the federal regulations and DoD issuances referred to in this Section. If any authority is amended or replaced, the changed requirement is effective when it is incorporated under contract change procedures. Where a federal regulation and any DoD issuance govern the same subject matter, the Contractor shall first follow the more specific DoD implementation unless the DoD issuance does not address or is unclear on that matter. DoD issuances are available at http://www.dtic.mil/whs/directives.

For purposes of this Section, the following definitions apply.

DoD Privacy Act Issuances means the DoD issuances implementing the Privacy Act, which are DoDI 5400.11, DoD Privacy and Civil Liberties Programs, January 29, 2019 and DoDI 5400.11- R, Department of Defense Privacy Program, May 14, 2007.

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 Code of Federal Regulations (CFR) Part 160 and Part 164, Subpart E (Privacy), Subpart C (Security), Subpart D (Breach) and Part 160, Subparts C-E (Enforcement), as amended.

Additional HIPAA rules regarding electronic transactions and code sets (45 CFR Part 162) are not addressed in this Section and are not included in the term HIPAA Rules.

DoD HIPAA Issuances means the DoD issuances implementing the HIPAA Rules in the DoD Military Health System (MHS). These issuances are DoDM 6025.18, “Implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule in DoD Health Care Programs,” March 13, 2019, DoDI 6025.18, Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule Compliance in DoD Health Care Programs, March 13, 2019, and DoDI 8580.02, Security of Individually Identifiable Health Information in DoD Health Care Programs, August. 12, 2015.

Defense Health Agency (DHA) Privacy Office is the DHA Privacy and Civil Liberties Office. The DHA Privacy Office Chief is the HIPAA Privacy and Security Officer for DHA.

2. Records Management When creating and maintaining official government records, the Contractor shall comply with all federal requirements established by 44 United States Code (U.S.C.) Chapters 21, 29, 31, 33 and 35, and by 36 CFR, Chapter XII, Subchapter B – Records Management. The Contractor shall also comply with DoD Administrative Instruction No. 15 (DoD AI-15), “OSD Records and Information Management Program” (May 3, 2013) and Records Management requirements outlined in the current TRICARE Operations Manual (TOM).

3. Freedom of Information Act (FOIA) The Contractor shall comply with the following procedures if it receives a FOIA request and immediately contact the DHA FOIA Officer for evaluation/action:

The Contractor shall inform beneficiaries that DHA FOIA procedures require a written request preferably sent via the National FOIA Portal at: www.FOIA.gov. However, requesters may also submit requests via email at DHA.FOIA@mail.mil; or via postal delivery addressed to the DHA Freedom of Information Service Center, 7700 Arlington Boulevard, Suite 5101, Falls Church, Virginia 22042-5101. All FOIA requests shall describe the desired record as completely as possible to facilitate its retrieval from files and to reduce search fees which may be borne by the requestor. Contract and/or Modification numbers must be included in all FOIA requests seeking DHA procurement records. Although the administrative time limit to grant or deny a request (ten working days after receipt) does not begin until the request is received by DHA, the Contractor shall act as quickly as possible and respond to DHA within ten working days.

http://www.dtic.mil/whs/directives http://www.foia.gov/ mailto:DHA.FOIA@mail.mil

In response to requests received by the Contractor for the release of information, unclassified information, documents and forms which were previously provided to the public as part of routine services shall continue to be made available in accordance with previously established criteria. All other requests from the public for release of DHA records and, specifically, all requests that reference FOIA shall be immediately forwarded to DHA, ATTENTION: Freedom of Information Officer, for appropriate action.

Direct contact, including interim replies, between TRICARE contractors and such requestors is not authorized. The Contractor shall process requests by individuals for access to records about themselves in accordance with directions from the DHA Freedom of Information Service Center. If such a requestor specifically makes the request under the Privacy Act or does not make clear whether the request is made under FOIA or the Privacy Act, the Contractor shall process the request in accordance with directions from the DHA Privacy Office. If requestor specifically seeks PHI under HIPAA, the Contractor shall follow paragraph 8.1.6, relating to individual rights of access to PHI.

4. Systems of Records In order to meet the requirements of the Privacy Act and the DoD Privacy Act Issuances, the Contractor shall identify to the DHA Contracting Officer (CO) systems of records that are or will be maintained or operated for DHA where records of PII collected from individuals are maintained and specifically retrieved using a personal identifier. Upon identification of such systems to the CO, and prior to the lawful operation of such systems, the Contractor shall coordinate with the DHA Privacy Office to complete systems of records notices (SORNs) for submission and publication in the Federal Register as coordinated by the Defense Privacy, Civil Liberties, and Transparency Division, and as required by the DoD Privacy Act Issuances.

Following proper SORN publication and Government confirmation of Contractor authority to operate the applicable system(s), the Contractor shall also comply with the additional systems of records and SORN guidance, in coordination with the DHA Privacy Office, regarding periodic system review, amendments, alterations, or deletions set forth by the DoD Privacy Act Issuances, Office of Management and Budget (OMB) Memorandum 99-05, Attachment B, OMB Circular A-130, and Privacy Act of 1974 requirements applicable to contractors operating systems of records on behalf of federal agencies. The Contractor shall promptly advise the DHA Privacy Office of changes in systems of records or their use that may require a change in the SORN.

5. Privacy Impact Assessment (PIA)

If DHA data is stored on a Contractor owned system, a PIA is required from the Contractor.

6. Data Sharing Agreement (DSA)

6.1 (Applies if contract requirements involve the use of DHA data (including PII/PHI, a limited data set, or de-identified data)

The Contractor shall consult with the DHA Privacy Office to determine if the Contractor must obtain a DSA or Data Use Agreement (DUA), when DHA data will be accessed, used, disclosed or stored, to perform the requirements of this Contract.

The Contractor shall comply with the permitted uses established in a DSA/DUA to prevent the unauthorized use and/or disclosure of any PII/PHI, in accordance with the HIPAA Rules and DoD HIPAA Issuances. Likewise, the Contractor shall comply with the DoD Privacy Act Issuances.

Prior to using any data involving PHI for research purposes, as defined by HIPAA, the Contractor must gain approval from the DHA Privacy Board. Thus, the Contractor shall comply with DHA Privacy Board requests for additional documentation.

To begin the DSA request process, the Contractor shall submit a DSA Application (DSAA) to the DHA Privacy Office. Upon approval, the requestor shall enter into one of the following agreements, depending http://www.defenselink.mil/privacy/documents/pa1974.pdf mailto:DHA.PrivacyAct@mail.mil http://www.tricare.mil/tma/privacy/Templates.aspx on the data involved DSA for De-Identified Data DSA for PHI DSA for PII Without PHI DUA for Limited Data Set DSAs executed for contract support will expire after 1 year or at the end of the contract option year, whichever comes first. If the contractual use of DHA data will continue after the DSA expiration date, the Contractor shall submit a DSA Renewal Request template to the Privacy Office; however, if the DSA will not be renewed, the Contractor shall close the DSA by providing a Certificate of Data Disposition (CDD) to the DHA Privacy Office.

6.2 (Applies if contract requirements may include human subject research)

This Contract incorporates by reference the Protection of Human Subject Research clause in the Defense Federal Acquisition Regulation Supplement (DFARS) at 48 CFR 252.235-7004. A separate DFARS provision, 48 CFR 235.072(e), requires that the clause be incorporated in contracts that include or may include research involving human subjects in accordance with 32 CFR 219, DoDI 3216.02, and 10 U.S.C.

980, including research that meets exemption criteria under 32 CFR 219.101(b), the clause applies to solicitations and contracts awarded by any DoD component, regardless of mission or funding Program Element Code. Thus, in the event a contractor participates in a study or demonstration project or other activity that involves human subject research, then the contractor shall comply with Protection of Human Subject Research clause. COs may not determine whether an activity is exempt from human subject research requirements. If contractor activity appears to involve human subject research, then the contractor shall consult the DHA Privacy Office, which may contact the Research Regulatory Oversight Office in the Office of the Under Secretary of Defense for Personnel and Readiness (OUSD(P&R)).

7. Privacy Act and HIPAA Training

The Contractor shall ensure that its entire staff, including subcontractors and consultants that perform work on this Contract receive training on the Privacy Act, HIPAA, and the federal regulations on confidentiality of substance use disorder patient records, 42 CFR Part 2. Refer to FAR 52.224-3 regarding specific requirements for Privacy Training appropriate to the Contractor’s scope of involvement with DHA’s PHI and its regulatory responsibilities as either a Covered Entity, or Business Associate.

The Contractor shall ensure all employees and subcontractors supply a certificate of all training completion to the Contracting Officer’s Representative (COR) within 30 days of being assigned and on an annual basis based on the trainee’s birth month thereafter.

8. HIPAA Business Associate Provisions

8.1 Business Associate – General Provisions

The Contractor meets the definition of Business Associate, and DHA meets the definition of a covered entity under the HIPAA Rules and the DoD HIPAA Issuances. Therefore, a Business Associate Agreement (BAA) between the Contractor and DHA is required to comply with the HIPAA Rules and the DoD HIPAA Issuances. The contractor shall use the DoD BAA, which shall be used by all organizational entities within the DoD, referred to collectively as the “DoD Components”, located at, https://www.health.mil/Military-Health-Topics/Privacy-and-Civil- Liberties/Privacy-Contract- Language/HIPAA-Compliant-Business-Associate-Agreement-for-the-MHS. b.i. and (3)b.ii

9. Breach Response

[This paragraph 9 is inoperative, and all references herein to “paragraph 9” shall be deemed to refer to the https://www.health.mil/Military-Health-Topics/Privacy-and-Civil-Liberties/Privacy-Contract-Language/HIPAA-Compliant-Business-Associate-Agreement-for-the-MHS https://www.health.mil/Military-Health-Topics/Privacy-and-Civil-Liberties/Privacy-Contract-Language/HIPAA-Compliant-Business-Associate-Agreement-for-the-MHS https://www.health.mil/Military-Health-Topics/Privacy-and-Civil-Liberties/Privacy-Contract-Language/HIPAA-Compliant-Business-Associate-Agreement-for-the-MHS https://www.health.mil/Military-Health-Topics/Privacy-and-Civil-Liberties/Privacy-Contract-Language/HIPAA-Compliant-Business-Associate-Agreement-for-the-MHS

TOM breach responses provisions, if the contract incorporates the TOM by reference

9.1 Definitions Related to Breach response

9.1.2 Breach means a loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where: (1) a person other than an authorized user accesses or potentially accesses PII; or (2) an authorized user accesses or potentially accesses PII for an other than authorized purpose. The foregoing definition is based on the definition of breach in DoDM 6025.18. Breaches are classified as either possible or confirmed (see the following two definitions) and as either cyber or non-cyber (i.e., involving either electronic PII/PHI or paper/oral PII/PHI).

9.1.3 A possible breach is an incident where the possibility of unauthorized access is suspected (or should be suspected) and has not been ruled out. For example, if a laptop containing PII/PHI is lost, and the contractor does not initially know whether or not the PII/PHI was encrypted, then the incident must initially be classified as a possible breach, because it is impossible to rule out the possibility of unauthorized access to the PII/PHI. In contrast, that possibility can be ruled out immediately, and a possible breach has not occurred, when misdirected postal mail is returned unopened in its original packaging. However, if the intended recipient informs the contractor that an expected package has not been received, then a possible breach exists until and unless the unopened package is returned to the contractor.

In determining whether unauthorized access should be suspected, the contractor shall consider at least the following factors:

How the event was discovered;

Did the information stay within the covered entity’s control;

Was the information actually accessed/viewed; and Ability to ensure containment (e.g., recovered, destroyed, or deleted).

9.1.4 A confirmed breach is an incident in which it is known that unauthorized access could occur. For example, if a laptop containing PII/PHI is lost and the contractor knows that the PII/PHI is unencrypted, then the contractor should classify and report the incident as a confirmed breach, because unauthorized access could occur due to the lack of encryption (the contractor knows this even without knowing whether or not unauthorized access to the PII/PHI has actually occurred). If the laptop is subsequently recovered and forensic investigation reveals that files containing PII/PHI were never accessed, then the possibility of unauthorized access can be ruled out, and the contractor should re-classify the incident as a non-breach incident.

9.1.5 A HHS breach is an incident that satisfies the definition of breach in Section 164.402 of the HIPAA Breach Rule. The text of the HHS definition states:

Breach means the acquisition, access, use, or disclosure of PHI in a manner not permitted under subpart E of this part [i.e. the HIPAA Privacy Rule] which compromises the security or privacy of the PHI.

HHS breach excludes:

Any unintentional acquisition, access, or use of PHI by a workforce member or person acting under the authority of a DoD covered entity or a business associate, if such acquisition, access, or use was made in good faith and within the scope of authority and does not result in further use or disclosure in a manner not permitted under the HIPAA Privacy Rule.

Any inadvertent disclosure by a person who is authorized to access PHI at a DoD covered entity or business associate to another person authorized to access PHI at the same DoD covered entity or business associate, or organized health care arrangement in which the DoD covered entity participates, and the information received as a result of such disclosure is not further used or disclosed in a manner not permitted the HIPAA Privacy Rule.

A disclosure of PHI where a DoD covered entity or business associate has a good faith belief that an unauthorized person to whom the disclosure was made would not reasonably have been able to retain such information.

Except as provided in this definition, an acquisition, access, use, or disclosure of PHI in a manner not permitted under this issuance is presumed to be a breach unless the DoD covered entity or business associate, as applicable, demonstrates that there is a low probability that the PHI has been compromised based on a risk assessment of at least the following factors:

The nature and extent of the PHI involved, including the types of identifiers and the likelihood of re-identification;

The unauthorized person who used the PHI or to whom the disclosure was made;

Whether the PHI was actually acquired or viewed; and The extent to which the risk to the PHI has been mitigated.

9.1.6 A cybersecurity incident is a violation or imminent threat of violation of computer security policies, acceptable use policies, or standard security practices, with respect to electronic PII/PHI. A cybersecurity incident may or may not involve a breach of PII/PHI. For example, a malware infection would be a possible breach if it could cause unauthorized access to PII/PHI. However, if the malware only affects data integrity or availability (not confidentiality), then a non-breach cybersecurity incident has occurred.

9.2 General

9.2.1 The breach response requirements shall be followed for all unauthorized use or disclosure of information regardless of whether the information is PHI or solely PII.

9.2.2 Because DoD defines “breach” to include possible (suspected), as well as actual (confirmed) breaches, the Contractor shall implement these breach response requirements immediately upon the Contractor’s discovery of a possible breach. These procedures focus on the first two steps (breach identification and reporting) of a comprehensive breach response program, but also require addressing the remaining steps: containment, mitigation (which includes individual notification), eradication, recovery, and follow-up.

9.2.3 The contractor shall establish internal processes for carrying out the procedures set forth below.

These processes shall assign responsibility for investigating, classifying, reporting and otherwise responding to breaches and cybersecurity incidents. The contractor should consult with the DHA Privacy Office where guidance is needed, such as when the contractor is uncertain whether a discovered breach is the contractor’s responsibility (e.g., if the contractor discovers a breach not caused by the contractor), or how the contractor is to classify an incident (breach vs. non-breach, confirmed vs. possible, cyber vs. non-cyber). Under no circumstances will a contractor delay reporting a confirmed or possible breach to the DHA Privacy Office beyond the 24-hour deadline.. In conjunction with its initial investigation, the contractor shall immediately take steps to minimize any impact from the occurrence, proceed with further investigation of any relevant details (such as root causes, vulnerabilities exploited), and initiate further breach response steps.

9.2.4 In the event of a cybersecurity incident not involving a PII/PHI breach, the contractor shall follow applicable DoD cybersecurity and NIST requirements, which include United States- Computer Emergency Readiness Team (US-CERT) reporting (see paragraph 9.3). If at any point a contractor finds that a cybersecurity incident involves a PII/PHI breach (possible or confirmed), the contractor shall immediately initiate the reporting procedures set forth below. The contractor shall also continue to follow any required cybersecurity incident response procedures and other applicable DoD cybersecurity requirements.

9.2.5 Contractors shall require subcontractors who discover a possible breach or cybersecurity incident to initiate the incident response requirements herein by reporting the incident to the contractor immediately after discovery. The time of that report to the contractor shall trigger the contractor’s DHA Privacy Office reporting deadline (24 hours) under paragraph 9.3.2. If a cybersecurity incident is involved, the contractor’s deadline for US-CERT reporting (1 hour) runs from the time the incident is confirmed. The contractor shall require the subcontractor to cooperate as necessary to meet these deadlines, maintain records, and otherwise enable the contractor to complete the breach response requirements herein.

Alternatively, the contractor and subcontractor may agree that the subcontractor shall report directly to US- CERT and the DHA Privacy Office, and that the subcontractor shall be responsible for completing the response process, provided that such agreement requires the subcontractor to inform the contractor of the incident and the subsequent response actions.

9.2.6 Contractors shall maintain records of all breach and cybersecurity incident investigations, regardless of the outcome. Investigations identifying unauthorized disclosures must be logged for HIPAA and Privacy Act disclosure accounting purposes, whether or not individual notification is required under the HIPAA Breach Rule.

9.2.7 Contractors, when acting as HIPAA-covered entities, and not as business associates, are not subject to the breach response requirements herein. However, such contractors are subject to both the HIPAA Breach Rule (applicable to them in their capacity as covered entities) and DoD cybersecurity requirements (applicable to them in their capacity as DoD contractors).

9.3 Reporting Provisions

9.3.1 Immediately upon discovery of a possible or confirmed breach or cybersecurity incident, the contractor shall initiate an investigation. If the incident involves electronic PII/PHI, and if the investigation finds a confirmed breach or cybersecurity incident, the contractor shall report it, within 1 hour of confirmation, to the US-CERT Incident Reporting System at https://forms.us- cert.gov/report/, as required by the Department of Homeland Security (DHS).

Note: DHS no longer requires US-CERT reporting of non-cyber breaches or unconfirmed electronic breaches. However, DHS permits US-CERT reporting of unconfirmed cyber-related incidents on a voluntary basis.