Attachment_1_-_Neuro-Monitoring_Performance_Work_Statement_(PWS)_3_July_2019.pdf

PERFORMANCE WORK STATEMENT

INTRAOPERATIVE NEUROPHYSIOLOGIC MONITORING

David Grant Medical Center

Travis AFB, CA

Period of Performance: 01 October 19 - 30 September 24

15 July 2019

Table of Contents

Section Title Page(s)

1 Description of Services 3-4

2 Management 4

3 Services Summary 5-5

4 Government Furnished Equipment/Property 5

5. Health Requirements 5-8

6. Protection of Information 8-17

1. DESCRIPTION OF SERVICES. The contractor shall provide non-personal services for Intraoperative Neurophysiological Monitoring (IONM) to patients at David Grant Medical Center (DGMC), Travis AFB, CA also referred to as the MTF (Medical Treatment Facility). The contractor shall provide qualified personnel, and management to perform Neurophysiologic Monitoring services at DGMC as defined in the performance work statement.

1.2. The contractor shall abide by medical treatment facility (MTF) rules, regulations and by-laws, including applicable standard operating procedures established by the MTF. The quality of care shall meet or exceed all recognized standards established by The Joint Commission (TJC).

1.3. A certificate in Neurophysiologic Intraoperative Monitoring (CNIM) through the American Board of Registration of Electroencephalographic and Evoked Potential Technologists (ABRET), or certification from the American Board of Neurophysiologic Monitoring (ABNM).

1.4. The contractor shall provide the following services:

1.4.1. Anatomical and prep direction of pad/myotome placement on patient.

1.4.2. Set up and self-testing of equipment and leads.

1.4.3. Direction in use of equipment and diagnostic features interoperatively for the entire length of procedure.

1.4.4. Technical infomal action affecting the interpretation of data.

1.4.5. Monitor the patient and defer interpretation to the Staff Surgeon.

1.4.6. Keep the Surgeon and Anesthesiologist informed at all times during a procedure of the patients neurophysiological status.

1.4.7. Provide an in-service training, regarding contractor’s system to the MTF operating room staff every six months.

1.4.8. Intraoperative neurophysiological monitoring incorporating various neurodiagnostic modalities including but not limited to: evoked potentials, electromyography, electroencephalograms and pulse oximetry. Services shall be available 24 hours a day, 7 days a week and fees will include patient preparation, set actual monitoring and supplies to provide the services, Except for those items listed as Government Provided.

1.4.9. During surgery, the intraoperative neurophysiological monitoring (IONM) is to identify deleterious changes in the conduction of electrical impulses through the spinal cord and/or related neural structures.

1.4.10. Neuro technologist is responsible for equipment set-up, recording and evaluation of data. Neuro technologist will and report abnormal findings in the sensory and/or motor systems in patients during the surgical procedure.

1.4.11. DGMC staff physicians may request neurodiagnostic studies to be performed on DGMC patients that may include but are not limited to evoked potentials, nerve conduction tests and electroencephalograms.

1.5. Scheduling Protocol

1.5.1. The request for intraoperative monitoring services will originate from the DGMC surgeon's office or operating room. A call to schedule intraoperative monitoring for upcoming surgery is placed to the contractor’s office. The scheduled surgery date and time is provided to determine services availability. Once availability has been determined, the patient's name requesting surgeon's name, hospital and procedure is noted to reserve monitoring services. A patient information form is then completed and submitted to the vendor. This form shall include all the pertinent patient information, patient name & social security number.

1.5.2. For routine cases, the contractor will be notified at least 48 hours in advance of a case requirement. The contractor will be in place at the MTF at least two hours before the scheduled surgery.

The technical representative shall be in place at the MTF for emergency unscheduled surgeries within 2 hours after placement of call.

1.5.3. The contractor will provide a local phone number or a toll free number for placement of calls on a 24-hour basis to include method for cancellation. Scheduled intraoperative neurophysiological monitoring services may be cancelled twenty-four (24) hours in advance of the scheduled start time.

Cancellation may be delivered via telephone or facsimile, or other means, dependent on vendor’s required procedures.

1.5.4. The Government may provide a place for storage of contractor’s equipment however will not be held liable for loss or damage. The contractor will be responsible for the upkeep and maintenance contractor owned equipment. Disposables will be ordered as needed for surgical cases and delivered to the MTF within two days from placement of call. The contractor will provide a local phone number or a toll free number for placement of calls on a 24-hour basis to include method for cancellation.

2. MANAGEMENT

2.1. The Contractor shall appoint a primary Point of Contact (POC)/Site Lead to be responsible for the performance of the work, handling customer complaints, ensuring 60th Medical Group training is completed to include providing for contractor staff needs, (i.e. questions regarding timesheet preparation, time off requests, personnel issues, etc.). The POC and an alternate shall be designated in writing to the Contracting Officer and have the authority to act for the Contractor on all contracting matters relating to daily operation of this contract, to include solving 60th Medical Group complaints regarding contracted personnel performance issues. The POC or alternate shall be available during normal duty hours to meet with Medical Logistics Personnel, 60th Medical Group Staff and the Contracting Officer’s Representative (COR) and the FRED to discuss and resolve problems.

2.2. In the event of an adverse action, the Contracting Officer (CO) shall be notified by the COR as soon as possible when the necessity to exercise such authority becomes apparent. The COR will also provide the Contracting Officer with a written statement advising the contractor of an adverse action involving a health care provider, a brief statement of the basis for the action to provide the contractor sufficient information in order to make employment substitution decision as necessary, and if required, the final outcome of the adverse action process. The written notice will be marked by government as covered by 10 USC 1102. No other information pertaining to the adverse action will be released without 60th Medical Group/CC permission.

2.3. The COR/FRED performs surveillance according to the Quality Assurance Surveillance Plan (QASP) and provides documentation of surveillance observations to the CO monthly. The COR also certifies acceptance of service and calculates unacceptable service prescribed by the CO. The CO acts as the principal business advisor and principle agent for the Government. The CO informs the contractor of the duties and limitations.

3. SERVICES SUMMARY. The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success. Reports/Deliverables:

4. GOVERNMENT FURNISHED EQUIPMENT /PROPERTY (GFE)

4.1. The Government will provide general supplies: Medical and non-medical supplies commonly

Performance Objective Ref Performance Threshold

1. Effectively monitors the ongoing operation of the patient and network.

Para: 1.2;

1.4.2; 1.4.6

100% of the time.

2. Routinely provides effective resolution of problems and correction of operating system/software malfunctions.

Para: 2.1 Create trouble ticket for problems if can’t resolve at local level and dispatch to tier level support 98% of the time.

3. Conducts effective analysis of network usage, user complaints, and traffic interruptions.

Para: 2.1;

2.2

Responses are accurate, current and tailored to the individual needs and resolution of traffic interruptions are met 98% of the time.

4. Relays adverse activity involving equipment or services through proper channels.

Para: 2.1;

2.2; 2.3

100% of the time used in the facility for the care and management of patients or services. Commonly used supplies are those routinely stocked by the MTF. The Government will provide motor strip grids (Ix8) for brain mapping, when brain mapping is required.

5. HEALTH REQUIREMENTS

5.1. In accordance with AFI 48-105 and AFJI 48-110, all HCWs shall follow the methods for controlling and preventing disease as described in the American Public Health Association publication, Control of Communicable Diseases (CDC) Manual and the Centers for Disease Control and Prevention publications, Morbidity and Mortality Weekly Report (MMWR) and its supplements. The contractor shall maintain workforce health qualifications as published in the most recent guidelines from these publications throughout the life of the contract, and therefore comply with TJC, OSHA, and Center for Disease Control (CDC) health record requirements.

5.2. Prior to placement, assignment or commencement of duties in the MTF, contracted Health Care Workers will be current on all immunizations and laboratory requirements listed below. Compliance with immunization and laboratory requirements as specified is a condition of employment. Contract Health Care Workers are also required, as a condition of employment, to enroll in the MTF's Medical Employee Health Program administered by the Office of Public Health.

5.3. Religious and philosophical objections (or refusals) will not be accepted, nor will they be accommodated by the MTF for contract personnel. Requests for medical exemptions must be reviewed and approved by the MTF’s Allergy & Immunizations Clinic Chief Physician and the Public Health Officer in Charge. Approved medical exemptions must be renewed annually, be accompanied by sufficient medical documentation from a licensed board certified physician, and documented in ASIMS MEHP module. Insufficient, lack of, illegitimate, or misrepresentation of medical documentation shall result in disapproval of the exemption request. Failure to produce viable documentation within 15 duty days, or upon receipt of Public Health Notice of Workplace Exclusion for noncompliance with Medical Hospital Employee Health (MEHP) requirements, will result contract healthcare worker dismissal, and employment termination.

5.4. Contracted Health Care Workers shall provide proof of all immunizations, and when required documented laboratory evidence of immunity from the following diseases:

MEHP Immunization / Screening Requirement Presumptive evidence of immunity to measles, mumps and rubella includes any of the following

Measles, Mumps, Rubella (German Measles)

NOTE:

1. If a HCW does not have up-to-date blood test evidence with documentation of the complete series of 2 Measles, Mumps, and Rubella vaccinations or a positive titer for all 3 components, the HCW will require a MMR panel vaccination.

2. If the HCW’s titer result is determined as either negative or equivocal the HCW will require two doses of the MMR vaccine.

1. Written documentation of vaccination with 2 doses of live measles, mumps, and rubella or MMR vaccine administered at least 28 days apart OR

2. Laboratory evidence of immunity (Positive “Convalescent” Measles, Mumps and Rubella immunoglobulin G (IgG) in the blood; equivocal results should be considered negative) OR

3. Laboratory confirmation in the HCWs record that the HCW had measles, mumps and rubella disease (Positive “Acute” Measles, Mumps, and Rubella immunoglobulin M (IgM) in the blood

OR 4.

Birth before 1957 (The majority of persons born before 1957 are likely to have been infected naturally and may be presumed immune)

Tuberculosis (TB) Screening NOTE: HCWs with a baseline positive or newly positive test result for M. tuberculosis infection (i.e., TST or BAMT) or documentation of treatment for LTBI or TB disease should receive one chest radiograph result to exclude TB disease (or an interpretable copy within a reasonable time frame, such as 6 months).

1. Two-step tuberculin skin test (TST) for M. tuberculosis (BAMT)) that was performed within the previous 12 months

OR 2.

An approved blood assays for M.

tuberculosis (BAMT)) that was performed within the previous 12 months

Varicella (Chicken Pox) All HCWs require proof of varicella immunity. Evidence of immunity includes

1. Written documentation of vaccination with 2 doses of varicella vaccine OR

2. Laboratory evidence of immunity or laboratory confirmation of disease OR

3. Diagnosis or verification of a history of varicella disease by a health-care provider

OR

4. Diagnosis or verification of a history of Herpes Zoster by a health-care provider

Tetanus, Diptheria and Pertussis (Tdap). All HCWs, regardless of age, will receive a one-time dose of the Combined Tetanus, Diphtheria and Pertussis (Tdap) vaccine if not previously vaccinated. HCWs will receive Td boosters every 10 years thereafter.

Influenza Immunization against seasonal influenza each year is required unless there is a documented medical contraindication.

Hepatitis B Virus (HBV) Vaccine and Immunity NOTE: All high-risk(1) and exposure-prone(2) HCWs who do not have a protective concentration of anti-HBs (>10 mIU/mL) after completion of the second vaccination series (i.e., after receiving a total of 6 doses) will be tested for Hepatitis B surface antigen (HBsAg) and Hepatitis B core antibody (anti-HBc) to determine infection status.

Completion of three doses of hepatitis B vaccine and serologic testing for Hepatitis B surface antibody (anti-HBs) within 30- 60 days after completion of the three dose vaccination series is required for all HCWs with direct patient care duties.

(1) High-risk personnel: Personnel who have direct contact with patients or blood/body fluids, and are at ongoing risk for injuries with sharp instruments/needlesticks.

(2) Exposure-prone personnel: Medical and dental providers, nurses, and technicians who perform invasive procedures with sharp instruments in a poorly visualized or highly confined anatomic site, as defined by the most current CDC guidelines. All exposure-prone personnel are also high-risk.

5.5. Preventative, Prophylactic, and Follow-Up Procedures. The HCW shall ensure that he/she is in compliance with preventive, prophylactic and follow-up procedures, as well as infection control and employee health program procedures, as established by the MTF.

6. PROTECTION OF INFORMATION

6.1 Dissemination of Information/Publishing: There shall be no dissemination or publication, except within and between the Contractor and any subcontractors who have a need to know, of information developed under this contract or contained in the reports to be furnished pursuant to this contract without prior written approval of the PKO. DHA approval for publication will require provisions which protect the intellectual property and patent rights of both DHA and the Contractor.

6.2. Personally Identifiable Information (PII), Protected Health Information (PHI) and Federal Information Laws: The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all government data. The Contractor shall also ensure the confidentiality, integrity, and availability of government data in compliance with all applicable laws and regulations, including data breach reporting and response requirements, IAW Defense Federal Regulation Supplement (DFARS) Subpart 224.1 (Protection of Individual Privacy), which incorporates by reference current versions DoDD 5400.11, “DoD Privacy Program,” and DoD 5400.11-R, “DoD Privacy Program.” The Contractor shall also comply with federal laws relating to freedom of information and records management. The Contractor shall analyze any breach of PII/PHI for which it is responsible under the terms of this contract under both the Privacy Act and HIPAA, if applicable, to determine the appropriate course of action under each requirement, if any.

6.3. In accordance with 45 CFR 164.502(e)(2) and 164.504(e) and paragraph C.3.4.1.3 of DoD 6025.18- R, “DoD Health Information Privacy Regulation,” January 24, 2003, this document serves as a business associate agreement (BAA) between the signatory parties for purposes of the Health Insurance Portability and Accountability Act (HIPAA) and the “HITECH Act” amendments thereof, as implemented by the HIPAA Rules and DoD HIPAA Issuances (both defined below). The parties are a DoD Military Health System (MHS) component, acting as a HIPAA covered entity, and a DoD contractor, acting as a HIPAA business associate. The HIPAA Rules require BAAs between covered entities and business associates.

Implementing this BAA requirement, the applicable DoD HIPAA Issuance (DoD 6025.18-R, paragraph C3.4.1.3) provides that requirements applicable to business associates must be incorporated (or incorporated by reference) into the contract or agreement between the parties.

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

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

Business Associate shall generally have the same meaning as the term “business associate” in the DoD HIPAA Issuances, and in reference to this BAA, shall mean the contract holder.

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

Covered Entity shall generally have the same meaning as the term “covered entity” in the DoD HIPAA Issuances, and in reference to this BAA, shall mean David Grant Medical Center, Travis AFB, CA.

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

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

DoD Privacy Act Issuances means the DoD issuances implementing the Privacy Act, which are DoDD

5400.11 (2007) and DoD 5400.11-R (2007).

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

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

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

I. Obligations and Activities of Business Associate

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

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

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

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

(e) The Business Associate shall make available PHI in a Designated Record Set, to the Covered Entity or, as directed by the Covered Entity, to an Individual, as necessary to satisfy the Covered Entity obligations under 45 CFR 164.524 and corresponding DoD HIPAA Issuances.

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

(g) The Business Associate shall maintain and make available the information required to provide an accounting of disclosures to the Covered Entity or an individual as necessary to satisfy the Covered Entity’s obligations under 45 CFR 164.528 and corresponding DoD HIPAA Issuances.

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

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

II. Permitted Uses and Disclosures by Business Associate

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

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

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

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

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

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

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

(a) The Covered Entity shall notify the Business Associate of any limitation(s) in the notice of privacy practices of the Covered Entity under 45 CFR 164.520 and the corresponding provision of the DoD HIPAA Issuances, to the extent that such limitation may affect Business Associate’s use or disclosure of

PHI.

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

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

IV. Permissible Requests by Covered Entity

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

V. Breach Response

(a) In general.

(1) In the event of a breach of PII/PHI held by the Business Associate, the Business Associate shall report the breach to the Covered Entity in accordance with Section VII, assess the breach incident, take mitigation actions as applicable, and notify affected individuals, as directed by the Covered Entity.

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

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

(b) Government Reporting Provisions

(1) If the Covered Entity determines that a breach is an HHS Breach, then the Business Associate shall comply with both the HIPAA Breach Rule and DoD Privacy Act Issuances, as directed by the Covered Entity, regardless of where the breach occurs.. If the Covered Entity determines that the breach does not constitute an HHS Breach, then the Business Associate shall comply with DoD Privacy Act Issuances, as directed by the applicable Service-Level Privacy Office.

(2) This Part V is designed to satisfy the DoD Privacy Act Issuances and the HIPAA Breach Rule as implemented by the DoD HIPAA Issuances. In general, for breach response, the Business Associate shall report the breach to the Covered Entity, assess the breach incident, notify affected individuals, and take mitigation actions as applicable. Because DoD defines “breach” to include possible (suspected) as well as actual (confirmed) breaches, the Business Associate shall implement these breach response requirements immediately upon the Business Associate’s discovery of a possible breach.

(3) The following provisions of Part V set forth the Business Associate’s Privacy Act and HIPAA breach response requirements for all breaches, including but not limited to HHS breaches.

(i) The Business Associate shall report the breach within one hour of discovery to the US Computer Emergency Readiness Team (US CERT), and, within 24 hours of discovery, to the Covered Entity, and to other parties as deemed appropriate by the Covered Entity. The Business Associate is deemed to have discovered a breach as of the time a breach (suspected or confirmed) is known, or by exercising reasonable diligence would have been known, to any person (other than the person committing it) who is an employee, officer or other agent of the Business Associate.

(ii) The Business Associate shall submit the US-CERT report using the online form at https://forms.us-cert.gov/report/. Before submission to US-CERT, the Business Associate shall save a copy of the on-line report. After submission, the Business Associate shall record the US-CERT Reporting Number. Although only limited information about the breach may be available as of the one hour deadline for submission, the Business Associate shall submit the US-CERT report by the deadline. The Business Associate shall e-mail updated information as it is obtained, following the instructions at http://www.us-cert.gov/pgp/email.html. The Business Associate shall provide a copy of the initial or updated US-CERT report to the Installation Privacy Act Officer, MTF HIPAA Privacy Officer, and the Contracting Officer (if applicable), if requested. Business Associate questions about US-CERT reporting shall be directed to the Installation Privacy Act Officer or MTF HIPAA Privacy Officer, not the US-CERT office.

(iii) The Business Associate shall comply with the Breach Timeline and Notification Flow Chart processes attached to this Agreement, to include the timelines established for completing the DD Form 2959 and the HIPAA Privacy Incident Report.

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

(i) When a Breach Report Form initially submitted is incomplete or incorrect due to unavailable information, or when significant developments require an update, the Business Associate shall submit a revised form or forms, stating the updated status and previous report date(s) and showing any revisions or additions in red text. Examples of updated information the Business Associate shall report include, but are not limited to: confirmation on the exact data elements involved, the root cause of the incident, and any mitigation actions to include, sanctions, training, incident containment, and follow-up. The Business Associate shall submit these report updates within three (3) business days after the new information becomes available. Prompt reporting of updates is required to allow the Covered Entity to make timely final determinations on any subsequent notifications or reports. The Business Associate shall provide updates to the same parties as required for the initial Breach Reporting Form. The Business Associate is responsible for reporting all information needed by the Covered Entity to make timely and accurate determinations on reports to HHS as required by the HHS Breach Rule and reports to the Defense Privacy and Civil Liberties Office as required by DoD Privacy Act Issuances.

(ii) In the event the Business Associate is uncertain on how to apply the above requirements, the Business Associate shall consult with the Covered Entity and Contracting Officer (if applicable) when determinations on applying the above requirements are needed.

(c) Individual Notification Provisions

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

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

(A) The individual(s) must be advised of what specific data was involved. It is insufficient to simply state that PII has been lost. Where names, Social Security Numbers (SSNs) or truncated SSNs, and Dates of

Birth (DOBs) are involved, it is critical to advise the individual that these data elements potentially have been breached.

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

(C) The individual(s) must be informed of what protective actions the Business Associate is taking or the individual can take to mitigate against potential future harm. The notice must refer the individual to the current Federal Trade Commission (FTC) web site pages on identity theft and the FTC’s Identity Theft Hotline, toll-free: 1-877-ID-THEFT (438-4338); TTY: 1-866-653-4261.

(D) A brief description of what the covered entity involved is doing to investigate the breach, to mitigate harm to individuals, and to protect against any further breaches; and

(E) Contact procedures for individuals to ask questions or learn additional information, which shall include a toll-free telephone number, an e-mail address, Web site, or postal address

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

(iii) Business Associates shall ensure any envelope containing written notifications to affected individuals are clearly labeled to alert the recipient to the importance of its contents, e.g., “Important information – do not destroy,” and that the envelope is marked with the identity of the Business Associate and/or subcontractor organization that suffered the breach. The letter must also include contact information for a designated POC to include, phone number, e-mail address, and postal address.

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

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

VI. Termination

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

(b) Effect of Termination.

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

(2) If this Agreement does not have records management requirements, except as provided in the following paragraph (3), upon termination of this Agreement, for any reason, the Business Associate shall return or destroy all PHI received from the Covered Entity, or created or received by the Business Associate on behalf of the Covered Entity that the Business Associate still maintains in any form. This provision shall apply to PHI that is in the possession of subcontractors or agents of the Business Associate. The Business Associate shall retain no copies of the PHI.

(3) If this Agreement does not have records management provisions and the Business Associate determines that returning or destroying the PHI is infeasible, the Business Associate shall provide to the Covered Entity notification of the conditions that make return or destruction infeasible. Upon mutual agreement of the Covered Entity and the Business Associate that return or destruction of PHI is infeasible, the Business Associate shall extend the protections of this Agreement to such PHI and limit further uses and disclosures of such PHI to those purposes that make the return or destruction infeasible, for so long as the Business Associate maintains such PHI.

VII. Notices. Any notices to be given hereunder will be made in the most expedient manner, via e-mail, facsimile, U.S. Mail, or express courier to contract holder and the Contracting Officer as recorded on the contract.

VIII. Miscellaneous

(a) Survival. The obligations of Business Associate under the “Effect of Termination” provision of this BAA shall survive the termination of this Agreement.

(b) Interpretation. Any ambiguity in this Agreement shall be resolved in favor of a meaning that permits the Covered Entity and the Business Associate to comply with the HIPAA Rules and the DoD HIPAA Issuances.

>End of HIPAA<

7. Records Management: When creating and maintaining official Government records, the Contractor shall comply with all federal requirements established by 44 United States Code (USC), 41 USC, 36 Code of Federal Regulations, Department of Defense Administrative Instruction No. 15 (DoD AI-15), “Records Management, Administrative Procedures and Records Disposition Schedules,” and Chapter 2 of the TRICARE Operations Manual.

8. Freedom of Information Act (FOIA) Office: DHA Freedom of Information (FOIA) procedures require a written request under the Act to be addressed to the FOIA Officer, DHA, 16401 East Centretech Parkway, Aurora, Colorado 80011-9066. The request 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. No more than ten working days shall elapse after a request has been received by the Freedom of Information Officer before notification is sent that the request has been granted or denied.

The administrative time limit for responding to FOIA requests does not begin until the request is received by DHA.

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 IAW previously established criteria. All other requests from the public for release of DHA records and, specifically, all requests that reference the Freedom of Information Act shall be immediately forwarded to DHA, ATTENTION: Freedom of Information Officer, for appropriate action. Direct contact, including interim replies, between DHA contractors and such requestors is not authorized. The Contractor shall process requests by individuals for access to records about themselves under the Privacy Act procedures when those procedures are more advantageous to the requestor.