STATEMENT OF WORK 2024.docx

STATEMENT OF WORK

USACAEL Blanket Purchase Agreement Allergen Extract Products and Related Ancillary Supplies

1. SCOPE OF WORK: The contractor shall provide allergen extract stock solutions for a wide variety of allergens, including but not limited to trees, grasses, weeds, molds, food, animals and miscellaneous antigens; vials, syringes and other related ancillary supplies as per specifications detailed in the itemized contract listing. Materials are to be provided to the United States Army Centralized Allergen Extract Laboratory, Department of the Army, Kimbrough Ambulatory Care Center, Fort Meade, MD. Allergen extract products are supplied for fulfillment of the critical Tri-service readiness support mission of the United States Army Centralized Allergen Extract Laboratory which encompasses the provision of quality assured and cost effective patient allergen extract vaccines, diagnostic testing allergens, delayed-type hypersensitivity antigens and related biologicals for the treatment of over 30,000 active duty soldiers, their beneficiaries and military retirees in over 500 medical treatment facilities worldwide (Army, Navy, Air Force, Veterans Administration Medical Centers and Public Health Service) on an annual basis. Approximately 95,000 – 100,000 vials of allergy patient treatment vaccines and diagnostic skin testing antigen products are processed and formulated annually.

2. DELIVERY LOCATION: All deliveries of procured allergen extract supplies and materials from the manufacturer placed under this contract are to be delivered to the United States Army Centralized Allergen Extract Laboratory, 9100 Brookville Road, Building 512, Forest Glen, Silver Spring, Maryland 20910.

3. PERIOD OF PERFORMANCE:

Base Period: 01 October 2022 through 31 March 2023

4. GENERAL REQUIREMENTS:

A. Contractor/Manufacturer:

1. The contractor/manufacturer must be approved and licensed by the FDA have no current outstanding violations with respect to appropriate FDA procedural and regulatory guidelines or policies.

2. The contractor/manufacturer’s facility will be compliant with USP regulations and recommended USP 797 guidelines. Manufacturer USP 797 adherence policies and procedures shall be made available to USACAEL upon request. Issues and concerns involving USP 797 guidelines will be addressed promptly.

3. The manufacturer/contractor shall supply the allergen extract products and ancillary supplies as specified with respect to concentrations and annual USACAEL volume usage requirements as detailed in the itemized contract listing.

4. A representative of the manufacturer/contractor’s medical or scientific affairs team will be available as a point of contract and for support to assist with technical, scientific and clinical inquiries that USACAEL has regarding allergen extract product concentrations and substitutions, species cross-reactivities, cut back dosing recommendations, expiration dating, potency and stability.

5. The FDA approved manufacturer/offeror will be the sole source provider for the listed allergen extract products and biological supplies for the duration of this contract because manufacturing processes and sources of raw materials differ among manufacturers; thereby the interchangeability of extracts from different manufacturers cannot be assured. There is potentially an increased risk of a systemic reaction if the immunotherapy extract is changed because of the possible variability in the composition and potency of allergen extracts. An allergen immunotherapy extract formulation is considered different from a clinical standpoint if there is any change in the constituents of the allergen immunotherapy extract products. Change would include differences in lot numbers, manufacturers, concentration and type of extract (aqueous vs. glycerinated or standardized vs. non-standardized).

B. Allergen Extract Product Specifications:

1. Weight per Volume items will be supplied in the desired 1:20 W/V, 1:10 W/V or 1:100 W/V concentrations as specified in the itemized contract listing for allergen extract products (trees, weeds, grasses, molds, miscellaneous antigens, foods and special processed antigens). If a 50 ml vial is not available, five 10 ml vials may be substituted. Species as noted and volume usag (vials) per year will also be provided as requested in the itemized allergen extract per Exhibit A/Product Listing.

2. The PNU/ml content shall be provided for requested Weight per Volume allergen extract products. The PNU/ml content shall be clearly labeled for all Alum-Precipitated slow release allergen extract products.

3. The mg/ml content shall be made available by the contractor upon request.

4. Stock allergen extract solutions will be provided as 50% glycerinated solution (G) or aqueous solutions (A) as requested by USACAEL and detailed in the itemized allergen extract via the Product Listing (see Exhibit A). New allergen extract products to be added to the inventory will be provided as requested and approved by USACAEL in aqueous or glycerinated solutions. (Concentrate stock solutions contain soluble extracts from source material, 0.5% sodium chloride and 0.54% sodium bicarbonate in water for injection or 50% glycerin. (Aqueous allergen extract solutions contain 0.4% phenol as a preservative. 50% glycerinated stock solutions contain 0.2% phenol).

5. Food items (Weight per Volume) are to be provided in 1:20 W/V or 1:10 W/V concentrated solutions as specified in the itemized listing for allergen extract products. If this is not possible for a specific food product, the highest available concentration will be acceptable. These items shall be supplied as 50% glycerinated solutions.

6. Standardized (BAU/ml and AU) allergen extract products to include cat, mite products and grass 50% glycerinated stock solutions must be provided in the following desired concentrations:

c. Grasses: Standardized grasses are to be supplied at a 100,000 BAU/ml concentration except for Bermuda which is available only at 10,000 BAU/ml.

7. All allergen extract products shall be labeled with the appropriate genus/species name as well as the common name of the product as applicable. All changes to the labelling of stock extract products to include nomenclature should be made known to USACAEL in an immediate manner before any deliveries with the labeling change occur.

8. All requested allergen extract stock solutions shall be provided in the appropriate vial sizes (10 ml, 50 ml) as specified in the itemized contract listing. Substitutions may be made if a vial size is not available, for example, five 10 ml vials may be substituted for a 50 ml vial of a particular allergen extract product if the 50 ml vial size of the product is not available.

9. Diluents shall be provided in the specified vial sizes. Annual volume requirements for diluent products are indicated in the itemized contract listing. Human Serum Albumin diluent may be substituted with 10% glycerosaline diluent if necessary or as requested.

a. Sterile albumin saline (HSA) diluent products (9 ml, 1.8 ml and 100 ml) contain 0.9% sodium chloride, 0.03% normal human serum albumin and 0.4% phenol as a preservative in water for injection.

b. Sterile phenol saline (normal saline) diluent products (9 ml and 100 ml) contain 0.9% sodium chloride and 0.4% phenol as preservative in distilled water.

c. Sterile 50% glycerin solution (100 ml) contains 50% glycerin, 0.09% sodium bicarbonate, and 0.166 sodium chloride in distilled water.

d. Sterile 10% glycerin solution contains 10% glycerin, 0.9% sodium chloride and 0.4% phenol.

10. Venom products shall be supplied in the appropriate vial sizes (5.5 ml or multi dose 10 ml) and mcg/ml concentrations as specified in the itemized contract listing.

11. Vial labels for stock allergen extract solutions will have bar coding capability to assist in capturing information (lot number, expiration dating, and item #).

C. Related Ancillary Supply Items:

1. Related ancillary supply items to include syringes, empty vials, vial caps, tamper proof seals, biohazard containers and jiffy bags are to be supplied in the desired annual amounts as specified in the detailed itemized contract listing.

2. Sterile empty vials and scratch dropper vials to include 10 ml empty vials, 30 ml empty vials, 50 ml empty vials and 5ml scratch dropper vials are to be supplied in the volume indicated as detailed in the itemized contract listing.

D. Allergen Extract Product Availability:

1. USACAEL must be notified immediately (upon receipt of supply order) as to the availability of an allergen extract product. Bio-equivalent or cross reacting species substitutions for an allergen extract product that is no longer available or discontinued, will be made in consultation with the manufacturer medical affairs team and technical representatives to prevent the risk of an adverse patient reaction and minimize interruptions to the patient’s treatment regimen, Cross-reactivity data or information will be made available upon request.

2. USACAEL must be notified for any allergen extract product that will have a shortened expiration dating (less than 1 year). These products will be sent upon the approval of USACAEL to assure they will be utilized in a timely fashion.

3. New allergen extract antigens and related ancillary supplies that are requested and may be supplied or added to the itemized contract listing, during the course of the contract (base year), shall be priced accordingly with respect to manufacturer pricing for current option year.

E. Ordering and Delivery (Invoices and Status):

USACAEL shall have the option to place orders electronically (ordering template preferred), by fax or by phone.

All products shall be shipped by the manufacturer in a timely manner- within one week of receipt of submitted USACAEL order. USACAEL must be notified immediately as to the availability of ordered products with respect to expected time of delivery. Back ordered items will be delivered as soon as possible by the contractor.

The contractor will notify USACAEL immediately as to the delivery status of ordered biologicals and supplies. Vial size substitutions shall be made at no extract charge to USACAEL.

Complete and accurate invoices are to be sent with all deliveries. Allergen Extract product information will be sent to include item lot numbers, expiration dating, PNU/ml designation and number of vials shipped.

An annual report (number of vials, total cost per item) for all allergen extract products ordered will be made available by the manufacturer upon request by USACAEL.

F. Contract Management and Coordination:

The contractor shall coordinate contract requirement changes through the appropriate USACAEL Contract Officer Representative.

5. LEGAL HOLIDAYS: The following legal holidays are observed by Kimbrough Ambulatory Care Center.

6. SECURITY REQUIREMENTS. The Medical Treatment Facilities (MTFs) are restricted access military installations. Contracted workers shall not begin performance until the complete documentation for a Personnel Background Investigation has been submitted, if applicable. An identification (ID) badge, the Common Access Card (CAC) and the vehicle registration will not be issued until complete documentation has been submitted to the appropriate Installation, MTF, or other Security Manager (s), as required at the facility. The CAC card is required for access to Government computer databases and also is presented to the security guards when entering the military installation. If a background investigation results in an unfavorable finding, the contracting officer will notify the contractor and the contract employee will not be granted access to the facility, will not be able to perform services at the facility, and must return all identification badges, CAC cards, and other items issued previously issued by the Government.

7. CONTRACTOR HCP FURNISHED SUPPLIES/SERVICES.

7.1. SERVICES.

7.1.1. The Contractor shall furnish all personnel and services to comply with the requirements of this contract, except where specifically identified as government-furnished supplies and services.

7.1.2. Point of Contact. Three 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.

PERFORMANCE WORK STATEMENT – ADDENDUM FOR

ANTI-TERRORISM/OPERATIONS SECURITY

Access and general protection/security policy and procedures. This standard language is for contractor employees with an area of performance within Army controlled installation, facility, or area. Contractor and all associated sub-contractors employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DOD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

For contractors requiring Common Access Card (CAC). Before CAC issuance, the contractor employee requires, at a minimum, a favorably adjudicated National Agency Check with Inquiries (NACI) or an equivalent or higher investigation in accordance with Army Directive 2014-05. The contractor employee will be issued a CAC only if duties involve one of the following: (1) Both physical access to a DoD facility and access, via logon, to DoD networks on-site or remotely; (2) Remote access, via logon, to a DoD network using DoD-approved remote access procedures; or (3) Physical access to multiple DoD facilities or multiple non-DoD federally controlled facilities on behalf of the DoD on a recurring basis for a period of 6 months or more. At the discretion of the sponsoring activity, an initial CAC may be issued based on a favorable review of the FBI fingerprint check and a successfully scheduled NACI at the Office of Personnel Management.

For contractors that do not require CAC, but require access to a DoD facility or installation. Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

Threat Awareness Reporting Program. For all contractors with security clearances. Per AR 381-12 Threat Awareness and Reporting Program (TARP), contractor employees must receive annual TARP training by a CI agent or other trainer as specified in 2-4b.

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

The following minimum Quality Assurance Surveillance Plan applies. The Government may modify inspection methods in accordance with site specific requirements.

SOW ATTACHMENT 01

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 accord ance 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.

(End of language)

SOW Attachment # 02

TOBACCO FREE MEDICAL CAMPUS (TFMC)

In accordance with Army Regulation 600-63, paragraph 7-3, 14 April 2015; Operations Order 15-48 (Army Medical Command (MEDCOM) Tobacco Free Living – USAMEDCOM), 8 May 2015; and any Operations Order, regulation or other instruction implementing, defining or otherwise addressing the Tobacco Free Medical Campus (TFMC) on any military installation or DoD-controlled location, Contractor personnel are prohibited from using any tobacco product on or within any TFMC while performing under this contract. TFMCs are established at each installation or DoD-controlled location and include: (1) any property or non-residential building that is operated, maintained or assigned to support medical activities, including but not limited to, hospitals, medical laboratories, outpatient clinics (including medical, dental, and veterinary facilities), or aid stations operating for the primary purpose of delivering medical care and services for DOD eligible beneficiaries and /or meeting the mission of the Army Medical Command; (2) all other facilities in which medical activities or administration take place, to include HQ MEDCOM and Defense Health Headquarters; (3) all internal roadways, sidewalks and parking lots; and (4) all sidewalks, parking lots and grounds external but adjacent to the building or related to the migratory corridors surrounding the medical facility. The Contractor shall obtain from the COR any orders, regulations, instructions or other documents implementing, defining or otherwise addressing the TFMC for any given installation or DoD-controlled location where Contractor personnel may perform under this contract and shall instruct Contractor personnel on the TFMC limitations for installations or DoD-controlled locations where they may perform under this contract.

SOW Attachment # 03

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

1. The Contractor shall not employ or contract with any individual or entity (hereinafter collectively referred to as “person”) to provide items or services that will be included in invoices submitted to the Government under this contract if such person is listed on the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) List of Excluded Individuals and Entities (LEIE) or the TRICARE Sanctioned Provider List. The Government is legally prohibited from paying for provision of items or services by such persons. The prohibition extends to services beyond direct patient care, such as services of persons in executive or leadership roles and administrative and management services, whether or not such services are billed separately. The LEIE may be found at 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.

SOW Attachment # 04

Allergen Pricing

2022 UNITED STATES ARMY ANTIGEN INVENTORY (6 MONTH BASE)

TREES (WEIGHT/VOLUME)

BASE YEAR

HICKORY, SHAGBARK

TOTAL

GRASSES (WEIGHT PER VOLUME)

BASE YEAR

TOTAL

GRASSES (BAU/ML) STANDARD

TOTAL

WEEDS (WEIGHT/VOLUME)

BASE YEAR

TOTAL

MOLDS (WEIGHT/VOLUME)

BASE YEAR

TOTAL

MISCELLANEOUS (WEIGHT/VOLUME)

BASE YEAR

TOTAL

CAT AND MITES (STRANDARD BAU AND AU)

BASE YEAR

TOTAL

FOOD ITEMS (WEIGHT PER VOLUME)