Shredding_PERFORMANCE WORK STATEMENT Final.docx

PERFORMANCE WORK STATEMENT

0. General. This requirement is for record Storage support and Shredding services for Dwight D. Eisenhower Army Medical Center, Fort Gordon, GA.

1.2 Scope. The records storage contract will store media records (paper, diskettes, tapes, videotapes, CD Rom’s, X-Rays, micrographic and electronic records), to include classified documents - designated as confidential - to include privacy/protected- protected health information/ personally identifiable information (PHI/PII) adhering to HIPAA rules; and on-site shredding- approximately 1,500 units per year for destruction. Records are also destroyed and retired to Federal Records Center AMEDD Records Processing Center, St. Louis, MO. The service agreement shall comply with standard Army regulatory requirements described in AR 25-400-2 and Air Force regulatory requirements described in AFI 33-322, and National Archives and Records Administration.

1.3. Requirements. The contractor shall pick up, store, retrieve, re-file, destroy, and ship records to other Federal Records Centers. The contractor shall have a climate controlled secured storage facility that houses media records (paper, diskettes, tapes, videotapes, CD Rom’s, X-Rays, micrographic and electronic records). The facility is required to store classified documents in a separate and secured type of environment that meet regulatory requirements. Approximately 760- 1.2 cubic feet (or equivalent) cartons for storage, number of cartons will fluctuate based on storage and destruction. Due to the 24-hour mission of Dwight D. Eisenhower, a customer service phone number must be available 24 hours a day, 7 days a week. A trained representative of the vendor must be able to physically respond to the site within 2 hours of notice who can provide in-services, answer questions, and assist with troubleshooting within the hours of 8:00 am to 8:00 pm EST, Monday through Friday, excluding Holidays with average response time of eight (8) business hours.

1.4. Training. Contractor personnel performing work under this contract shall maintain the level of security (public trust) required for the life of the contract.

1.4.1 All contractor employees performing work on site shall report to the Security office and obtain vendor credentials for the duration of the work. Contractor employees shall always wear their badge credentials while on site.

1.4.2 Access and general protection/security policy and procedures. This standard language is for contractor employees with an area of performance within a DHA controlled installation, facility, or area. Contractor and all associated sub-contractors’ employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DOD, DHHQ 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.

1.4.2.1. 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), 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.

1.4.3 The contractor shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This 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 15 calendar days of new contract employees' commencing performance, with the results reported to the COR no later than 45 calendar days after contract award.

1.4.4 All contractor employees with access to a government information system must be registered in the ATCTS (Army Training Certification Tracking System) at commencement of services and must successfully complete the DoD Information Assurance Awareness training prior to access to the information system and then annually thereafter.

1.4.5 AT level 1 (general) all contractor employees requiring access to Army installations, facilities, or 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 applies. The contractor shall submit certificates of completion for each affected contractor employee to the COR (or to the contracting officer, if a COR is not assigned) within 15 calendar days after completion of training by all employees and subcontractor personnel.

1.4.6 For contracts that require a formal OPSEC program. The contractor shall develop an OPSEC Standing Operating Procedure (SOP)/Plan within 90 calendar days of contract award, to be reviewed and approved by the responsible Government OPSEC officer. This plan will include a process to identify critical information, where it is located, who is responsible for it, how to protect it and why it needs to be protected. The contractor shall implement OPSEC measures as ordered by the commander. In addition, the contractor shall have an identified certified Level II OPSEC coordinator per DHA-AI 5200.03.

1.4.7 For Cyber Awareness (Information Assurance (IA)/information Technology (IT) training. All contractor employees and associated subcontractor employees must complete the DoD Cyber Awareness training before issuance of network access and annually thereafter. All contractor employees working IA/IT functions must comply with DoD requirements DoD 8570.01 and DoD 8570.01-M within six months of appointment to IA/IT functions. DoD Cyber Awareness Challenge Training is available at the following website:

https://jkodirect.jten.mil/Atlas2/page/login/Login.jsf?ORG=NAVSEA , DOD Course US1364-22 DOD Cyber Awareness Challenge 2022.

1.4.8 For Cyber (Information assurance (IA)/information technology (IT) certification. Per DoD 8570.01-M , DFARS 252.239.7001, 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.

1.4.9 Controlled Unclassified Information (CUI). Include DFARS clause 252.204-7012, which requires the contractor to comply with NIST 800-171. Also include DFARS provision 252.204-2019 into solicitations. Acquisition officials should follow procedures outlined in DFARS 204.73 and verify vendors have an adequate NIST SP 800-171 summary assessment score within the Supplier Performance Risk System (within PIEE). If the score doesn't show a medium- or high-level assessment with a score of 110 or better (as described in the "NIST SP 800-171 DoD Assessment Methodology"), include clause 252.204-7020 and obtain the vendor's "system security plan" and "plan of action" for NIST SP 800-171 verification and assurance by Army security officials.

1.4.10 Threat Awareness Reporting Program. For all contractors with security clearances. Per DHA-AI 097, Insider Threat Program, contractor employees must receive annual Insider Threat Awareness training within 30 days of initial employment, and refresher training annually either through instructor-led or computer-based.

1.5. Support. Due to the 24- hour mission of Dwight D. Eisenhower, a customer service phone number must be provided 24 hours a day, 7 days a week for support. A trained representative of the vendor must be able to physically respond to the site within 2 hours of notice who can provide in-services, answer questions, and assist with troubleshooting. Online ordering via the internet, telephone, fax and or email is required to allow a quick and easy access for all the records stored in the facility. Local point(s) of contract and phone numbers are required for quick response and assistance. A wide variety of shapes and sizes of cartons should be provided to adequately protect documents outlined in the contract.

1.6. Delivery & Pick-Up. The contractor shall pickup and/deliver cartons between the hours 8:00 AM – 3:30 PM. Monday through Friday, except on government holidays. Timeframes will be coordinated with the COR.

1.7. Receiving and Entry of Records for Storage. The contractor shall scan the records by bar-coding, assigning a location and capturing the descriptive information from service provider documentation (Standard Form 135, Records Receipt and Transmittal). The contractor shall furnish the service provider with barcode labels and transmittal forms. The service provider shall complete one transmittal form for each new carton to be stored at the facility with the information required to property index the records. The service provider shall enter the customer identification number on the barcode label. The service provider shall affix the barcode to each carton in the area marked Accession Number. The service provider shall place a copy of the transmittal form inside the first carton and on top of each carton for each shipment. The service provider shall contact the contractor for pickup and transport to the contractor’s facility. The contractor shall match the bar-coding on the transmittal with their corresponding cartons. The contractor shall furnish a listing of all the records received and entered their system to the service provider. The contractor shall retrieve the cartons when requested by the service provider. The service provider shall provide the contractor with the barcode and box number of the carton to be retrieved by email and/or by telephone. The contractor shall provide delivery service directly to the customer requesting the carton(s) and pickup for re-file of the carton(s). The contractor shall provide delivery service based on mission requirement needs as needed basis (immediate/rush delivery, within 2 hours and/or next day delivery). Upon pickup of the carton for re-file, the service provider shall re-file the carton in the same storage location as retrieved.

1.8. Destruction of Records. The contractor shall destroy records in either one of two ways: Recycling and Secure Shredding. The contractor shall destroy records in the facility, on-call, offsite and/or onsite. The contractor will pick up and transport from the location site and/or by utilization of the state-of-art- mobile shredding vehicles at the customer’s site(s). The contractor will furnish the security console and/or gallon cart container(s) to house the material until time of destruction. Operational requirements need to be available to modify from time-to-time, regarding container, pickup-up volumes and similar matters. An additional requirement is to retrieve and permanently withdraw records from storage.

1.9. Invoicing. A monthly invoice is required (a separate and a consolidated invoice for each customer) which identifies the invoice date, invoice number(s), customer number, contract line-item number, lists each type of transaction, the total quantity of each type of transaction, and the total amount. A separate detailed billing transaction report is required listing the same items mentioned above, but to include the order number, order date, the customer who requested the transaction, the description of the transaction, the storage date, the quantity, the unit, the rate and total amount for each line entry. Once the invoice has been approved, it must be submitted into WAWF as a 2-in-1 invoice. This contract will be a pay-per-use contract. The government shall only pay for services rendered.

PERFORMANCE MEASUREMENTS

2.1. Outcome. The contractor shall provide Dwight D. Eisenhower Army Medical Center with hardware and software maintenance including delivery, pick-up, training, maintenance, 24/7 technical support, and a vendor representative.

2.2. Standards. Acceptable measures include: the pick-up of all media records within 24 hours after notification, on-going and continuous services, 24/7 availability of technical support and pick-up within 24 hours after notification. Other performance factors, which may be monitored and are not quantified by numerical measurements include: the Contractor’s relationship with hospital staff/government personnel and accurate and timely invoicing.

2.3. How measured. The Contracting Officer’s Representative and or Technical Representative will monitor contractor performance by verifying timely delivery and pick-up; Monitor Computerized reporting includes an inventory, with supplemental reporting as requested, activity reports, preliminary destruction and destruction listings, on-site visit reporting and any periodic and special reporting requirements needed by the customer to track and manage records; Verify the availability of technical support and the vendor representative; Monitor invoices received and the general business relationship between the Contractor’s staff and Government personnel; Conduct an audit/reviewing room for an internal review of records by the customer. This service includes retrieval of records along with documentation for each record retrieved and storage of the records within this area until the process is completed by the customer; Monitor retrieval, packing, labeling and shipping records to other agencies and/or federal record centers, utilizing the required GSA standard box for letter and/or legal records; Ensure that a Disaster Recovery Plan is in place.

SPECIFIC TASK

2.4. The Contractor shall provide services during the normal working hours from 8:00 a.m. to 3:30 p.m. Monday through Friday.

2.4.1 Contractor shall insure that drivers comply with all standards applicable to the installation.

2.4.2 Customer may require a 2 hour notice escorted pickup from record storage area.

2.4.3 Customer may require short notice to shred within the Fort Gordon area.

2.4.4 A monthly Invoice is required with a separate detailed billing transaction listing description.

SUPPLEMENT TO THE PERFORMANCE WORK STATEMENT

1. GOVERNMENT HOLIDAYS

The following Government Holidays are observed:

New Year’s Day Martin Luther King Jr.’s Birthday President’s Day Memorial Day Juneteenth Day Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day

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)

a. 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.”

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

c. 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.

d. 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.

e. 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.

f. 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.

g. 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 HARASSMENT/ASSAULT RESPONSE AND PREVENTION

Sexual Harassment/Assault Response and Prevention (SHARP) Program. The contractor shall comply with Sexual Harassment/Assault Response and Prevention (SHARP) Program, The SHARP reporting requirements apply only to knowledge obtained by contractor personnel while performing services under this contract.

The contractor shall require all contract personnel 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 of gaining knowledge of the incident) report the incident in writing to the Government's COR. This reporting policy also applies to sexual harassment incidents involving Government personnel that occur on the contractor’s owned or leased facility under this contract. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals, when the incidents occur on a Government facility or a Government leased facility.

The contractor shall require all contract personnel 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.

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

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.

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.

1. 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.

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 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 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. Thus, if a contractor is uncertain whether a possible cyber-related incident should be treated as confirmed and thus reportable, the contractor may voluntarily report the incident.

Before submission to US-CERT, the contractor shall save a copy of the on-line report. After submitting the report, the contractor shall record the US-CERT incident reporting number, which shall be included in the initial report to the DHA Privacy Office as described in paragraph 9.3.2.

Note: Regardless of whether or not an incident is confirmed as a breach, the contractor must also investigate whether or not the incident impacts data integrity or availability of PII/PHI. If such impact is confirmed, then the incident is reportable to US-CERT as a cybersecurity incident. For guidance on investigating the impact on data integrity and availability, refer to DoD cybersecurity and NIST guidance.

The contractor shall provide any updates to the initial US-CERT report by email to soc@us- cert.gov, with the Reporting Number in the subject line. The contractor shall provide a copy of the initial or updated US-CERT report to the DHA Privacy Office if requested. Contractor questions about US-CERT reporting shall be directed to the DHA Privacy Office, not the US-CERT office.

9.3.2 In addition to US-CERT reporting, the contractor shall report to the DHA Privacy Office by submitting the form specified below within 24 hours of discovery of a breach (possible or confirmed), unless the breach falls within a category that the Privacy Office has determined to be not reportable. This 24-hour period runs from the time of discovery, unlike the 1 hour US- CERT reporting period, which runs from the time a cybersecurity incident is confirmed. Thus, depending on the time period needed to confirm, the report to the DHA Privacy Office may be due either before or after the US-CERT report.

The breach report form required within the 24-hour deadline shall be sent by e-mail to: DHA.PrivacyOfficer@mail.mil. The contractor shall also e-mail the report to the CO, the COR and its usual point of contact at the applicable Program Office. Encryption is not required, because reports and notices shall not contain PII/PHI. If electronic mail is not available, telephone notification is also acceptable (at 703-275-6363), but all notifications and reports delivered telephonically must be confirmed in writing as soon as technically feasible.

Contractors shall prepare the breach reports required within the 24-hour deadline by completing the Breach Reporting Department of Defense Form DD 2959 (Breach of PII Report), available at https://www.esd.whs.mil/Portals/54/Documents/DD/forms/dd/dd2959.pdf. For non-cyber incidents without a US-CERT number, the contractor shall assign an internal tracking number and include that number in Box 1.e of the DD Form 2959. The contractor shall coordinate with the DHA Privacy Office for subsequent action, such as beneficiary notification, and mitigation. The contractor must promptly update the DD Form 2959 as new information becomes available.

When a Breach Report Form initially submitted is incomplete or incorrect due to unavailable information, or when significant developments require an update, the Contractor shall submit a revised form or forms promptly after the new information becomes available, stating the updated status and previous report date(s) and showing any revisions or additions in red text. The Contractor shall provide updates to the same parties as required for the initial Breach Report Form.

9.4 Individual Notification Provisions

9.4.1 If the DHA Privacy Office determines that individual notification is required, the Contractor shall provide written notification to beneficiaries affected by the breach as soon as possible, but no later than 10 working days after the breach is discovered and the identities and addresses of the beneficiaries are ascertained. The 10 day period begins when the Contractor is able to determine the identities (including addresses) of the beneficiaries whose records were impacted. If notification cannot be accomplished within 10 working days, the contractor shall notify the DHA Privacy Office.

9.4.2 The Contractor’s proposed notification to be issued to the affected beneficiaries shall be submitted to the DHA Privacy Office for approval. The notification to beneficiaries shall include, at a minimum, the following:

Specific data elements, Basic facts and circumstances, Recommended precautions the beneficiary can take, Federal Trade Commission (FTC) identity theft hotline information, and Any mitigation support services offered, such as credit monitoring.

Contractors shall…