FY26 Newborn Screening PWS.docx

PERFORMANCE WORK STATEMENT

Newborn Screening Services Womack Army Medical Center Fort Bragg, NC

1. 0. INTRODUCTION.

1.0.1. The Contractor shall provide health care support for Womack Army Medical Center, Fort Bragg, NC. The services will be of a nature and scope described in the paragraphs below. The Contractor HCP shall provide the non-personal services of Newborn Screening Services of the nature and scope described in this Performance Work Statement (PWS).

1.01.1. The Unit Price is a legislative mandated fee in the State of North Carolina and may be modified within thirty (30) day’s notice by the contractor, by amendment if the North Carolina General Assembly amends the new born screening fee by amending the General Statue 130-A-125(c).

1.0.1.2. The quality of care provided by the Contractor HCP shall be of a quality meeting or exceeding currently recognized national standards as established by the Joint Commission (JC). Contractor HCP shall give the highest regard to patient dignity and observe the precepts of the American Hospital Association’s Bill of Rights for Patients. The Contractor HCP shall abide by the Medical Treatment Facility (MTF) rules, regulations and by laws, including Medical Staff By laws, as well as applicable Army regulations governing such things as medical records.

1.1. GENERAL.

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

1.1.2. Responsibility and Procedures. If any suit or action is filed or any claim is made against the contract HCP, which occurred as a result of work performed by the HCP under this contract, the HCP shall immediately notify the contractor and the Contracting Officer and the chief of the appropriate services and promptly furnish them copies of all pertinent papers received.

1.1.3. The contractor and Contractor HCP shall cooperate with the government, without further compensation, in the processing, review, settlement, or defense of the suit, action, or claim; and authorize government representatives to settle or defend the claim and to represent the HCP in, or take charge of, any litigation involved in such an action. The Contractor HCP may, at the Contractor HCP’s own expense, participate in defense of such claim or litigation.

1.1.4. Confidentiality / HIPAA. The Contractor HCP shall abide by AR 40-3 and AR 40-66 concerning the nature of limited privileged communication between patient and health care provider for security and personnel reliability programs. The Contractor HCP shall abide by AR 40-66 concerning the confidentiality of patient records, as embodied in federal statutes including the Privacy Act of 1974 and the Drug and Alcohol Act, Public Law 92-129 and HIPAA. The Contractor HCP shall direct all requests for medical information on patients to the Chief, Patient Administration Division. The Contractor HCP shall not release any medical or personal information on a patient without first receiving written approval from the government. Government will provide the regulations upon request by the Contractor HCP.

1.2. SCOPE OF WORK: The Contractor shall provide qualified personnel, services, materials, equipment, supplies and facilities necessary to perform (See Attachment#1).

1.3. Sexual Harassment/Assault Response and Prevention (SHARP)

1.3.1. The contractor shall comply with OTSG/MEDCOM Policy Memo 13-062, Policy for Reporting Incidents of Sexual Assault and Sexual Harassment under the Sexual Assault Prevention and Response Program (SHARP), 12 Nov 2013. The SHARP reporting requirements apply only to knowledge obtained by contractor personnel while performing services under this contract.

1.3.2. The contractor shall require all Contract Service Providers (CSP) with knowledge of an incident of sexual assault occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the contractor who shall immediately (within 24 hours) report the incident in writing to the government's COR. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals.

1.3.3. The contractor shall require all CSPs 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.

1.4. STANDARDS OF PERFORMANCE.

1.4.1. Reserved.

1.5. HEALTH AND IMMUNIZATION REQUIREMENTS.

1.5.1. Reserved.

1.6. CONTRACTOR HCP FURNISHED SUPPLIES/SERVICES.

1.6.1. SERVICES.

1.6.1.1. The Contractor HCP shall furnish all personnel and services to comply with the requirements of this contract, except where specifically identified as government-furnished supplies and services (paragraph 1.18 and 1.19).

1.6.1.2. Certificates/licenses/training shall be maintained in a current status at all times while performing services under this contract. If at any time during the contract the Contractor HCP does not renew any of the required certifications/licenses prior to the expiration date. This expense shall be borne by the Contractor and will not excuse the Contractor from fulfilling the requirements under this contract.

1.6.1.3. Point of Contact. Seven calendar days prior to performance of services, the Contractor HCP shall designate, in writing, and provide to the Contracting Officer's Representative [COR] and Contracting Officer, the name, email address, and telephone number of the point of contact for all actions on this requirement.

1.7. Description and Specifications of Work to be performed. [See Attachment 1].

1.7.1. DELIVERABLES.

1.7.1. The Contractor shall submit reports to the COR and/or the Contracting Officer as requested for use in monitoring Contractor HCP performance.

1.7.2. RSVD

1.8. Sexual Harassment/Assault Response and Prevention (SHARP)

1.8.1. The contractor shall comply with OTSG/MEDCOM Policy Memo 13-062, Policy for Reporting Incidents of Sexual Assault and Sexual Harassment under the Sexual Assault Prevention and Response Program (SHARP), 12 Nov 2013. The SHARP reporting requirements apply only to knowledge obtained by contractor personnel while performing services under this contract.

1.8.2. The contractor shall require all Contract Service Providers (CSP) with knowledge of an incident of sexual assault occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the contractor who shall immediately (within 24 hours) report the incident in writing to the government's COR. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals.

1.8.2.1. The contractor shall require all CSPs 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.

2.0. DEFINITIONS AND ACRONYMS.

2.1. DEFINITIONS

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

CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the contracting officer to monitor contractor performance. 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.

CONTRACTOR. The term as used in this contract refers to the prime.

MILITARY TREATMENT FACILITIES (MTF): Military hospital or clinic.

PHYSICAL SECURITY. Actions that prevent the loss or damage of government property

QUALITY ASSURANCE. The government procedures to verify that services being performed by the Contractor are performed according to acceptable standards.

QUALITY CONTROL (QC): Those actions taken by the Contractor to control and ensure that performance of duties meet the requirements of the contract.

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

2.2. ACRONYMS.

3.0. ATTACHMENT/TECHNICAL EXHIBIT LIST.

ATTACHMENT 1– Description and Specifications of Work ATTACHMENT 2– Performance Requirement Summary (PRS)

ATTACHMENT #1 Description and Specifications of Work

1. Womack Army Medical Center (WAMC) staff will collect 5 blood samples from newborns at WAMC, dry the specimens and transport the specimens overnight to the Contractor with complete demographics using the Hearing Link to NC Department of Health and Human Services Form DHHS 3105 that contains the following information:

Newborn’s Medical Record Number, Newborn’s First and Last Name, Newborn’s birth date, Birth-time, Race, Sex, Birth weight in grams, Specimen date, Specimen time, Latino or Hispanic Origin; Type of Feeding; Mother’s First and Last name, Mother’s Maiden Name, Mother’s Social Security Number, Mother’s Mailing Address; Mothers Phone Number; Mothers County of Residence; Hospital Specimen submitter, Federal Tax Identification number, Physical Name and Federal tax Identification Number; current weight in grams, gestational age in weeks; NICU meconium ileus; multiple birth; and applicable RBC transfusion date and time.

2. Collection of Specimens by WAMC staff will occur with 24-48 hours following birth of the newborn and be transported to the State Laboratory of Public Health by overnight delivery means by the 3rd day.

3. The Contractor shall perform the following tests on the following blood samples:

Amino Acid Disorders

· Argininemia§

· Argininosuccinic aciduria*

· Benign hyperphenylalaninemia§

· Biopterin defect in cofactor biosynthesis§

· Biopterin defect in cofactor regeneration§

· Citrullinemia, type I*

· Citrullinemia, type II§

· Classic phenylketonuria*

· Homocystinuria*

· Hypermethioninemia§

· Maple syrup urine disorder*

· Tyrosinemia, type I*

· Tyrosinemia, type II§

· Tyrosinemia, type III§ Endocrine Disorders

· Primary Congenital Hypothyroidism*

· Congenital Adrenal Hyperplasia* Fatty Acid Oxidation Disorders

· Carnitine acylcarnitine translocase deficiency§

· Carnitine palmitoyltransferase type II deficiency§

· Carnitine uptake defect/Carnitine transport defect*

· Glutaric acidemia type II§

· Long-chain L-3 hydroxyacyl-CoA dehydrogenase deficiency*

· Medium-chain acyl-CoA dehydrogenase deficiency*

· Medium-chain ketoacyl-CoA thiolase deficiency§

· Short-chain acyl CoA dehydrogenase deficiency§

· Trifunctional protein deficiency*

· Very long-chain Acyl-CoA dehydrogenase deficiency* Hemoglobin Disorders

· S, βeta-thalassemia*

· S,C disease*

· S,S disease (Sickle cell anemia)*

· Various other hemoglobinopathies including§:

· Hemoglobin C disease§

· Hemoglobin E disease§

· Sickle/hemoglobin C disease (FSC, Hb S/C)§

· Sickle/hemoglobin E disease (FSE, Hb S/E)§

· Sickle/hemoglobin D disease (FSD, Hb D/D)§ Organic Acid Conditions

· 2-methylbutyrylglycinuria§

· 2-methyl-3-hydroxybutyric aciduria§

· 3-hydroxy-3-methyglutaric aciduria*

· 3-methylcrotonyl-CoA carboxylase deficiency*

· 3-methylglutaconic aciduria§

· β-ketothiolase deficiency*

· Glutaric acidemia type 1*

· Holocarboxylase synthase deficiency*

· Isobutyrylglycinuria§

· Isovaleric acidemia*

· Malonic acidemia§

· Methylmalonic acidemia, cobalamin disorders*

· Methylmalonic acidemia, methylmalonyl-CoA mutase*

· Methylmalonic acidemia with homocystinuria§

· Propionic acidemia* Other Conditions

· Biotinidase deficiency*

· Classic galactosemia*

· Critical congenital heart disease¥

· Cystic fibrosis*

· Galactoepimerase deficiency§

· Galactokinase deficiency§

· Hearing loss¥

· Severe combined immunodeficiency (SCID)*

· T-cell related lymphocyte deficiencies§

4. There are no charges for hearing test information- the State of North Carolina collects this information for demographic purposes only.

5. Patients with a confirmed diagnosis of Phenylketonurias (PK) may submit filter paper specimens to monitor compliance with diet therapy. There shall be no additional charge for this testing.

6. For those specimens collected in which the specimen is unsatisfactory for screening, the test will be repeated. WAMC will submit recollection specimens with no additional charges for services.

7. For instances of multiple births, above tests will be performed for each newborn.

8. The Contractor shall submit the results of those tests to WAMC to the submitter and healthcare provider as listed on the newborn screening filter form.

9. In cases of abnormal test results of the laboratory screening of the blood samples, the Contractor shall provide a report to WAMC requesting additional blood samples. WAMC will collect the repeat specimens and mail or fax to the Contractor. There shall be no additional charge for services.

RECEIVING REPORT PROCEDURES FOR RECEIVING ACTIVITY

The Contracting Officer's Representative (COR) is responsible for processing the Newborn Screening reports received from DHHS via USPS mail delivery to the Womack Mail Room. The COR will reconcile the DHHS reports against the reports received from the Department of Pathology. DHHS will not submit invoices in WAWF until notification from the COR that reconciliation has been complete and invoices are ready for payment.

Method of payment: WAWF - see WAWF clause located in the contract.

ATTACHMENT #2 PRS Performance Requirements Summary Matrix and Attachment 1 in the PWS includes performance standards. The Government shall use these standards to determine Contractor performance and shall compare Contractor performance to the Acceptable Quality Level (AQL).

Incentives.

The Government shall use past performance as incentives. Incentives shall be based on exceeding, meeting, or not meeting performance standards.

Other performance evaluation factors that will be monitored and documented in the Contractor’s performance records but cannot be quantified by numerical measurements:

Contractor providing personnel exceeding the minimum qualification standards

Performance above or below the standard, for above factors, will be documented in the Contractor’s Performance Assessment Reporting System (CPARS) for the reporting period.

PWS SUPPLEMENTAL INFO

CRIME CONTROL ACT OF 1990

No performance under this contract will be allowed without full compliance with the Crime Control Act of 1990 and the Department of the Army Circular 690-92-1, 15 November 1992, Criminal History Background Checks on Individuals in Child Care Services. Contractor shall ensure that proposed providers cooperate with and assist the Government in conducting any necessary background checks.

COMPLIANCE WITH CRIME CONTROL ACT OF 1990. This position requires the contractor to comply with Public Law 101-647 (Crime Control Act) and submit to a criminal history background check performed by the government. The contractor shall schedule an appointment with the Security & Intelligence Office, MTF within 3 working days after start of performance under this contract. The contractor will be fingerprinted and complete a Standard Form SF85-P. If the contract employee is in a position that requires access to Critical Sensitive or Classified Information the contract agency Facility Security Office (FSO) is responsible for ensuring that the employee has the required SECURITY clearance to include submitting a SF86 EPSQ questionnaire to DSS and obtaining the necessary SECURITY clearance level through Defense Investigative Security Clearance Office (DISCO) as prescribed by the National Industrial Security Program Operating Manual (NISPOM) The contractor shall be advised that a FAVORABLE report is needed as a condition of employment under Army Contracts. Until the final background checks are completed, line of sight restriction shall apply and access to classified or Critical Sensitive information will be denied until a final SECURITY clearance or an interim SECURITY clearance has been granted by DISCO and the appropriate security verification and visitation letter has been received by the MTF Security and Intelligence office. The security office will notify each department head when line of sight requirement can be lifted.

Contract employees who previously received a background check and do not have a two-year break in service must get verification from Security and Intelligence Office. All employees are required to have a record re-verification and internal record check at a minimum of every five years.

MOBILIZATION AND CONTINGENCY PLANNING

a. In the event of a general or limited mobilization of reserve forces or an emergency, which impacts upon contract performance, the contractor will be expected to promptly take whatever measures are needed to meet any new demands placed upon it. Such demands could require increases in Contractor-furnished property, as well as extended work hours and expansion of the contract work force.

b. To ensure that Government operations which depend upon the services provided hereunder can proceed with no or minimal disruption, the contractor shall during the life of this contract anticipate the possibility of a mobilization or similar emergency and the steps it will need to take to rapidly expand its contract capabilities to meet the emergency.

UNAUTHORIZED SERVICES.

The Contractor shall not undertake any action that will increase the price of the contract without the written approval of the Contracting Officer. Any such unauthorized action taken by the contractor or any Contractor employee, which might be construed to be approved by the Government, shall be the responsibility of the Contractor and shall be resolved by the Contractor at no expense to the Government. Third party claims resulting from such unauthorized actions shall also be resolved by the Contractor without expense to the Government.

Non-Defense Health Agency (Non-DHA) Health Insurance Portability and Accountability Act (HIPAA) Business Associate Agreement (BAA) (7 July 2014)

Introduction

In accordance with 45 CFR 164.502(e)(2) and 164.504(e) and paragraph C.3.4.1.3 of DoD 6025.18-R, “DoD Health Information Privacy Regulation,” January 24, 2003, this document serves as a BAA between the signatory parties for purposes of the HIPAA and the “HITECH Act” amendments thereof, as implemented by the HIPAA Rules and DoD HIPAA Issuances (both defined below). The parties are a DoD Military Health System (MHS) component, acting as a HIPAA covered entity, and a DoD contractor, acting as a HIPAA business associate. The HIPAA Rules require BAAs between covered entities and business associates. Implementing this BAA requirement, the applicable DoD HIPAA Issuance (DoD 6025.18-R, paragraph C3.4.1.3) provides that requirements applicable to business associates must be incorporated (or incorporated by reference) into the contract or agreement between the parties.

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

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

—Business Associate shall generally have the same meaning as the term “business associate” in the DoD HIPAA Issuances, and in reference to this BAA, shall mean [insert name of Business Associate signatory to this BAA].

—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 [insert name of MHS component signatory to this BAA].

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

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

—DoD Privacy Act Issuances means the DoD issuances implementing the Privacy Act, which are DoDD 5400.11 (2007) and DoD 5400.11-R (2007).

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

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

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

I. Obligations and Activities of Business Associate

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

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

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

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

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

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

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

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

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

II. Permitted Uses and Disclosures by Business Associate

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

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

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

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

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

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

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

(a) The Covered Entity shall provide the Business Associate with the notice of privacy practices that the Covered Entity produces in accordance with 45 CFR 164.520 and the corresponding provision of the DoD HIPAA Issuances.

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

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

IV. Permissible Requests by Covered Entity

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

V. Breach Response

(a) In general.

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

If the DHA Privacy Office determines that a breach is an HHS Breach, then the Business Associate shall comply with both the HIPAA Breach Rule and DoD Privacy Act Issuances, as directed by the DHA Privacy Office, regardless of whether the breach occurs at DHA or at one of the Service components. If the DHA Privacy Office determines that the breach does not constitute an HHS Breach, then the Business Associate shall comply with DoD Privacy Act Issuances, as directed by the applicable Service-Level Privacy Office. The Business Associate shall contact the Covered Entity for guidance when the incident is not an HHS Breach.

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

(b) Government Reporting Provisions

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

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

The additional US Army and the US Army Medical Command (MEDCOM) reporting requirements are addressed in the PII Breach Reporting and Notification Policy. The latest version of this policy can be obtained from the Covered Entity or the MEDCOM Privacy Act/Freedom of Information Act (FOIA) Office at: usarmy.jbsa.medcom.list.medcom-foia-users@mail.mil . If multiple beneficiaries are affected by a single event or related set of events, then a single reportable breach may be deemed to have occurred, depending on the circumstances. The Business Associate shall inform the Covered Entity as soon as possible if it believes that “single event” breach response is appropriate; the Covered Entity will determine how the Business Associate shall proceed and, if appropriate, consolidate separately reported breaches for purposes of Business Associate report updates, beneficiary notification, and mitigation.

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

In the event the Business Associate is uncertain on how to apply the above requirements, the Business Associate shall consult with the Covered Entity (or the Service-Level Privacy Office, which will consult with the DHA Privacy Office as appropriate) when determinations on applying the above requirements are needed.

(c) Individual Notification Provisions

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

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

—The individual(s) must be advised of what specific data was involved. It is insufficient to simply state that PII has been lost. Where names, Social Security Numbers (SSNs) or truncated SSNs, and Dates of Birth (DOBs) are involved, it is critical to advise the individual that these data elements potentially have been breached.

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

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

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

Business Associates shall ensure any envelope containing written notifications to affected individuals are clearly labeled to alert the recipient to the importance of its contents, e.g., “Data Breach Information Enclosed,” and that the envelope is marked with the identity of the Business Associate and/or subcontractor organization that suffered the breach. The letter must also include contact information for a designated POC to include, phone number, email address, and postal address.

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

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

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

VI. Termination

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

(b) Effect of Termination.

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

(2) If the Agreement does not have records management requirements, except as provided in the following paragraph (3), upon termination of the 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 the 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 the 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. Miscellaneous

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

(b) Interpretation. Any ambiguity in the 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 Rules.

(c) Termination by the Contractor. Notwithstanding anything to the contrary contained or incorporated herein whatsoever: The Contractor may terminate this contract at any time by providing the Government 120 days’ notice in writing. In that event, the Contractor shall complete all finished and unfinished deliverable items under this contract and shall accept additional Newborn Screenings until the 120th day even though that necessarily requires the Contractor to work one or more days beyond the 120th day. If this contract is terminated by the Contractor as provided in this section, the Government shall pay for services satisfactorily completed by the Contractor. Additionally, the Contractor may terminate this contract earlier than 120 days if the North Carolina General Assembly enacts legislation that makes the Contractor’s performance under this contract impossible or impracticable. In that event, the Contractor shall accept additional Newborn Screenings until the date on which such performance becomes impossible or impracticable or until the contract otherwise terminates according to its terms, whichever is shorter. Additionally, where the Contractor identifies a clause, provision, term, condition, or other language that would cause the Contractor, its employees, or subcontractors to violate North Carolina law as that law currently exists or may be hereafter amended; the Contractor must notify the Contracting Officer in writing of the conflict before not performing that aspect of the Contract. Provided, however, that the Contractor is excused from performance on matter(s) barred by North Carolina law until such matter(s) is/are resolved to the extent that the violation(s) is/are removed. If no resolution is achieved within thirty (30) days of the written notice, either of the parties may immediately terminate this contract without such being a breach. Under no circumstance will the Contractor be required to violate North Carolina law

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

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

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

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

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

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

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

7. The Contractor is further advised that, in accordance with Civil Monetary Penalties Law [CMP] (codified at 42 USC § 1320a-7a):

a. 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.

b. 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.

8. 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 http://oig.hhs.gov/exclusions/files/sab-05092013.pdf.

(End of Clause)

(END OF PWS)