Draft PWS Infectious Blood Donor Testing.docx

Blood Donor Infectious Disease Testing

PERFORMANCE WORK STATEMENT

1. GENERAL. This is a nonpersonal services contract to provide blood donor testing services and blood bank reference lab testing. The government will not exercise any supervision or control over the contractor employees performing services herein. Such employees shall be accountable solely to the contractor who, in turn, is responsible to the government.

1.1. SCOPE. The contractor shall provide all required facilities, personnel, services, transportation, materials, equipment, and supplies required to provide blood donor testing services in support of the U.S. Army. Use of this contract will be limited to those agencies identified. No other federal agencies will be considered at this time.

1.1.1. All tests shall be executed at the contractor’s premises, or within the contractor's network of laboratories (affiliate or qualified subcontractor). Contractor referrals to a secondary (subcontractor) laboratory shall be kept to a minimum for control and uniformity purposes. Contractor shall have a plan to ensure no delay or stoppage of service in case of a national emergency (example 9/11).

1.1.2. All testing shall be in accordance with the Food and Drug Administration (FDA) regulations for the manufacturing of transfusable blood products and for blood bank reference lab testing. The standard test panel shall include at a minimum: ABO/Rh, Antibody screen, Antibody Identification , STS, HBsAg, HBcAb, HCV, HIV 1 and 2, HTLV 1 and 2, Chagas/ T.cruzi. The Nucleic Acid Test (NAT) panel shall include at a minimum: WNV NAT, HIV NAT, HCV NAT and HBV NAT (see Section 2.2 for explanation of acronyms), Babesia NAT. The confirmatory testing shall consist of individually run tests: HBsAg Neutralization, HCV confirmatory, HBV confirmatory , HIV 1 and HIV 2 confirmatory, HTLV I/II confirmatory, and Syphiliis (TP-PA) confirmatory. HLA 1 & 2 upon request. All tests included in the standard blood donor testing and confirmation testing required by the Sullivan Memorial Blood Center and reference lab testing for Transfusion services, Martin Army Community Hospital, Fort Benning, GA (will be preformed IAW Code of Federal Regulation, Title 21 (CFR) and applicable industrial standards).

1.2. CONTRACTOR RESPONSIBILITY.

1.2.1. The contractor shall ensure all employees under this contract who will be interacting with government personnel (i.e., contractor representative, customer service personnel, data entry/specimen processing technician, and courier) are able to read, write, and speak English fluently, with sufficient clarity, to effectively communicate.

1.2.2. The contractor shall ensure each laboratory possesses all legally-required license(s), certification(s), and accreditation(s) in accordance with Federal statutes and implementing regulations as well as those of the State in which the laboratory is located. The contractor shall ensure any subcontractors performing services hereunder shall meet the same requirements as the prime contractor. Proof of the above required certification(s), accreditation(s), license(s), etc., shall be provided to the BDCs IAW the FDA regulations.

1.2.3. The contractor shall ensure its employees have the ability to perform the applicable duties consistent with their license and certification. The contractor shall ensure all laboratory testing staff complies with minimum Federal, State, and local law qualifications/requirements. The contractor shall ensure all employees comply with applicable State regulations regarding their certification or registry, or license for the State in which the contractor’s testing facility is located.

1.2.4. The contractor shall ensure all testing and supervisory personnel at all contractor-owned, affiliate, or subcontracted laboratories assigned to work under this contract meet and maintain the applicable personnel qualifications set forth under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations.

1.2.5. The contractor shall submit a copy of the professional certification and/or licensure of the corporate Laboratory Director and/or Medical Director to the Contracting Officer Representative (COR) within 10 working days after contract award. The contractor shall also submit copies of all certifications/licenses for the Technical Supervisors of the primary contractor’s laboratory.

1.2.6. CONTRACTOR PERSONNEL.

1.2.6.1. Contractor Representative. The contractor shall designate and submit, in writing, within 10 working days after award, the name of a full-time contractor representative and alternate. The written designation shall be submitted to the contracting officer and the COR as identified on contract. The contractor shall also provide the telephone, pager, cell phone and facsimile numbers and email address for the designated full-time contractor representative and alternate.

1.2.6.1.1. The contractor shall ensure the contractor representative is available telephonically, or in person by appointment, as needed, for troubleshooting, servicing, introducing new tests, etc. During non-duty hours, the contractor representative shall be accessible on a cell phone or pager.

1.2.6.1.2. The contractor shall ensure the contractor representative is available telephonically, or in person by appointment, to meet, as necessary, with the COR, as identified on contract or task order, to discuss immediate administrative, technical issues, and problem areas the customers may be experiencing in the field. During non-duty hours, the contractor representative shall be accessible on a cell phone or pager number.

1.2.6.2. Customer Services. The contractor shall provide customer service which shall be accessible by toll-free telephone service 24 hours per day, 7 days per week to assist Government staff in tracking test results, modifying test requests, obtaining information regarding specimen requirements, and other applicable related issues/problems that may arise in the performance of work under this contract. The contractor shall provide toll-free number(s) as applicable to each task order.

1.2.6.3. The contractor shall provide testing service 7 days a week.

1.2.6.3.1. The contractor shall provide all necessary instructions for shipping and supplies for biologic specimens to be transported from the blood donor centers submitting test requests under this contract to the contractor.

1.2.6.3.2. The primary result reporting will be by secure e-mail to the representatives of the blood donor centers. Results must be e-mailed upon completion of the testing and verification of results for accuracy within a 24 hour period following receipt of the specimens. Contractor shall inform the COR of any delay in test results within the 24-hour period via e-mail or secure fax. Repeat positive results for initially reactive and failed run sample shall be available within 48 hours of receipt of donor specimens. The contractor shall provide additional confirmatory testing for donor specimens that are initially reactive for donor specimens that are initially reactive for Hepatitis B Surface Antigen, Hepatitis B Virus Core, Human T- Lymphotropic Viruses Type I & II , Human Immunodeficiency Virus 1 & 2, Hepatitis C Virus, and Treponema Pallidum (Syphilis) as required by regulatory and service agencies.

The additional confirmatory testing results shall be available within 5 to 10 business days to the blood donor centers via e- mail or secure fax. Confirmation test results will be available based upon the requirements established by the specific testing procedure. Original hard copy results must be sent to the representatives of the blood donor centers by courier or mail. Facsimile will be utilized as a back-up to e-mail. A list of email addresses will be provided by the representatives of the blood donor centers within 10 working days after award to the contractor to provide results electronically through email. Original test results will be mailed to the following addresses:

a. Infectiuos Disease Testing and Confirmation results:

Sullivan Memorial Blood Center

b. Reference laboratory Testing:

Martin Army Community Hospital

1.2.6.3.3. The contractor shall bring any errors or discrepancies to the attention of the representatives of the blood donor centers immediately upon discovery. The names of authorized representatives of blood donor center personnel will be provided, in writing, by the government within 10 working days after award of the contract, to the contractor and updated as necessary throughout the contract period.

0. PERFORMANCE QUALITY.

1.3.1. CONTRACTOR QUALITY CONTROL (QC) PROGRAM. The contractor shall provide a copy of its existing Quality Control System within 10 working days after award of the contract. Any changes made after award of contract shall be submitted to the COR and to the contracting officer for government’s review and approval prior to implementation.

1.3.1.1. The contractor shall maintain QC System records that are complete and reliable.

1.3.1.2. A progress meeting shall be held by telephone within 60 calendar days after contract start date between the COR and the contractor to discuss any issues.

1.3.1.3. The contractor shall perform external proficiency testing surveys as required by CLIA for all regulated analytes. The contractor shall provide the COR a listing of external proficiency surveys that the laboratory participates in accordance with CLIA. Survey results and statistical reviews for specific laboratory specialties shall be provided to COR or designee upon request.

1.3.1.4. The contractor shall operate a quality control program as required by FDA; Current CLIA requirements are located at the Health Care Financing Administration’s website: http://www.phppo.cdc.gov/CLIA. Upon request of the COR , the contractor shall provide documentation of quality assurance policies, quality control results for assays, on-going calculations of quality control performance (coefficient of variation, mean and standard deviation), monthly Levy-Jennings graphs, and documentation of appropriate analyzer maintenance. Upon request, the contractor shall provide verification results for assays of non-regulated analytes, and analytes for which proficiency testing does not currently exist.

1.3.1.5. All test methods shall be FDA approved for blood donor testing. Any non-FDA approved method being performed shall have a documented validation plan. Upon request, the validation plan and validation results shall be made available to the COR or designee. All instrumentation and testing methods, standard operating procedures must be validated prior to implementation and use by the contractor providing blood donor testing IAW FDA requirements.

1.3.1.6. The contractor shall ensure that subcontracted laboratories comply with and meet all accreditations/certifications as the prime contractor.

1.3.2. Government Performance Requirements Summary (PRS). The government will monitor the contractor’s performance under this contract, in part using specimen pick times, result turn-around times, percentage of discrepant results and by selected inspections or audits of the contractor’s own written instructions and procedures.

1.3.3 The contractor shall notify the Contracting Officer immediately, in writing, upon its loss of any required certification, accreditation, or licensure.

1.4. SAFETY REQUIREMENTS. The contractor shall:

1.4.1. Maintain safety and health standards consistent with the requirements set forth by the Occupational, Health, and Safety Administration (OSHA), and the Center for Disease Control (CDC) and Prevention.

1.5. SECURITY REQUIREMENTS.

1.5.1. Physical Security.

1.5.1.1. All contractor employees performing work on a government facility shall observe and comply with all local rules and regulation prescribed by the installation and other federal authorities concerning fire, safety, sanitation, security and possession of firearms or other lethal weapons. No contractor employee shall be permitted on the installation when his/her presence would be detrimental to the security of the installation.

1.5.1.2. The contractor shall obtain all local, State and Federal government licenses, passes and permits necessary to enter the government installation to include motor vehicle registration and insurance as required.

1.5.2. Information Security. The computer system shall be processing and transferring data that is classified as Sensitive But Unclassified (SBU) and shall have the appropriate security features. Electronic transmission of identifiable patient information shall be in compliance with requirements of the Privacy Act and Health Insurance Portability and Accountability Act (HIPAA). The following security requirements are in addition to the DoD, U.S. Army, or other government agency basic policy of initial and periodic security training, and the need for physical controls to protect hardware.

1.5.2.1. Neither the contractor, nor any of its employees, shall disclose or cause to be disseminated any information concerning military activity operations.

1.5.2.2. Neither the contractor, nor any of its employees, shall disclose private medical information concerning patients to third parties other than those personnel designated by the Government at each Submitting Activity to receive patient results. Results shall be handled as private medical records in accordance with DA Pam 25-51, Privacy Act Requirements for Medical Records Systems.

1.5.2.3. All inquiries, comments or complaints pertaining to patient information or government information, arising from any matter observed, experienced, or discovered as a result of, or in connection with, the performance of this contract shall be directed to the COR for resolution.

2. DEFINITIONS/ACRONYMS.

2.1. DEFINITIONS.

2.1.1. CONTRACTOR. The term as used in this contract refers to both the prime and subcontractors.

2.1.2. CONTRACTING OFFICER. A person with authority to enter into, administer, or terminate contracts, and make related determinations and findings on behalf of the Government. Note: The only individual who can legally bind the Government.

2.1.3. CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the Contracting Officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.4. C-2 SECURITY REQUIREMENTS. These are found in the National Security Agency “Orange Book” (DoD 5200.28-STD, DoD Trusted Computer System Evaluation Criteria). Basically, computer system processing is sensitive, but unclassified information, and shall have the appropriate security features. The following security requirements are in addition to the U.S. Army’s basic policy of initial and periodic security training and the need for physical controls to protect hardware. For example:

. Discretionary Access Control; (access control lists).

. Object Reuse; (hard drives/diskettes shall be wiped clean of information before turned in to supply for transfer back to the contractor).

. Identification and Authentication (user ID and passwords to use the system).

. Audit (the system shall have audit trail capability).

. Operational Assurance (protection from external interference or tampering).

. Accreditation (signed by a designated accreditation authority).

2.1.5. DEFECTIVE SERVICE. A unit of service which contains one or more defects, or noncompliance with specified requirements.

2.1.6. ETIOLOGIC AGENT. Infectious agents as defined by 42 CFR Part 72.

2.1.7. QUALITY ASSURANCE. The Government procedures used to verify that services being performed by the contractor are performed according to acceptable standards.

2.1.8. QUALITY ASSURANCE PROGRAM (QAP). All necessary measures taken by the Government to assure that the quality of an end product or service shall meet contract requirements.

2.1.9. SHIPPING FORM. Form(s) used to initiate shipping actions.

2.1.10. SPECIMEN. A quantity of human blood, serum, tissue, excreta, patient body fluid, or environmental specimen provided for test purposes.

2.1.11. SUBCONTRACTOR. One that enters into a subcontract and assumes some of the obligations of the primary contractor.

2.1.12. SUBMITTING ACTIVITY. Any Government activity submitting specimens under this contract.

2.1.13. TRANSFER TUBE. Any tube used to collect, transport, transship, and store samples under terms of the PWS .

2.2. ACRONYMS.

Title 21 CFR, Parts 210-211, Food and Drug Administration: Drug (210-211), Biological Products 600,680, (600-680)

ATTACHMENTS/TECHNICAL EXHIBITS LIST:

Attachment A – Performance Requirement Summary

PERFORMANCE REQUIREMENTS SUMMARY

TESTING OF BLOOD SERVICES

ARMED SERVICES BLOOD PROGRAM OFFICE

Performance Requirements Performance Standards Performance Indicator Performance Level (AQL)

END OF THE PERFORMANCE WORK STATEMENT

SUPPLEMENT TO THE PERFORMANCE WORK STATEMENT

The following Government Holidays are observed:

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

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, in arrears, itemized invoices in accordance with DFARS 252.232-7003 & 252.232-7006, for services rendered under this contract. Invoices must be submitted no more than 30 days after the completion of the annual period of performance. 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. 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.