Attachment PWS Medical Warehouse Technician1.0.pdf

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Medical Warehouse Technician Spangdahlem Air Base
Solicitation number
FA560625QA066
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This Performance Work Statement (PWS) is for Medical Warehouse Technician services at Spangdahlem Air Base, Germany, covering a base year and four option years from 30 September 2025 to 29 September 2030. The contract requires two full-time equivalent (FTE) Medical Material Technicians who will perform seven key duties: receiving shipments, verifying and scanning inventory, storing and rotating medical materials, issuing/shipping items, conducting inventories, operating material handling equipment, and maintaining records. Technicians must have a high school diploma or GED, complete Basic Life Support Training, and be categorized as low-risk medical employees.

The contract is a non-personal service, firm-fixed-price agreement for the 52 Medical Group at Spangdahlem Air Base. Technicians will work standard business hours (0730-1630 Monday through Friday), wear steel-toe boots, maintain a professional appearance, and comply with medical employee health program requirements. This includes mandatory vaccinations, health screenings, and adherence to HIPAA regulations. The government will provide workspace, computer equipment, administrative support, and required training, while the contractor is responsible for ensuring employee qualifications, health compliance, and performance of warehouse logistics tasks.

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Attachment 1 PWS Medical Material - 28 August 2025_.pdf PDF

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PERFORMANCE WORK STATEMENT

FOR

MEDICAL WAREHOUSE TECHNICIAN

Non-Personal Service

SPANGDAHLEM AIR BASE, GERMANY

28 August 2025

Table of Contents

Subject Part

1. General Information 1

2. Definitions and Acronyms 2

3. Government Furnished Property and Services 3

4. Medical Employee Health Program Requirements (Attachment I) 4

5. Health Insurance Portability and Accountability Act (HIPAA) 5 Business Associate Agreement (BAA) (Attachment II)

PERFORMANCE WORK STATEMENT (PWS)

MEDICAL WAREHOUSE TECHNICIAN

PART 1

GENERAL INFORMATION

1. GENERAL: This is a non-personal services contract to provide warehouse support services to the Medical Logistics Flight as described in this Performance Work Statement at the 52 Medical Group Unit 3865, APO, AE 09126, Medical Treatment Facility (MTF). The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the contractor who, in turn is responsible to the Government.

1.1 Description of Services/Introduction: The contractor shall provide all personnel, transportation, supervision, and other items necessary required to perform services as a warehouse technician for military treatment facilities (MTFs). Additionally, the contractor monitors, manages and reports on services for higher management and develops plans to improve timeliness and accuracy rates, service availability, and overall MTF performance and compliance.

1.2 Objective: To procure 2 each FTE (1,912 hours) Medical Material Technician who will perform the following duties:

Duty 1: Performs a broad range of standard receiving assignments. Verifies shipments. Matches specific item ID by name, stock number, letter, code, quantity, or unit of issue on containers. Unloads incoming shipments, scan bar codes, or keys receipt information into automated record system.

Duty 2: Performs a broad range of standard storage assignments. Stores, stacks, palletizes, and/or rotates items considering their use, size, shape, quantity, and special handling requirements. Matches, checks, and compares data on storage instruments with materials to be stored against materials already in storage locations.

Duty 3: Performs tasks involved in issuing/shipping items. Selects and assembles items based on priority, type of material, mode of transportation, destination, and type of transaction.

Duty 4: Assists in accomplishing inventories by counting items and properly completing tally listings and other inventory documents.

Duty 5: Operates automated material handling and identification equipment to include mobile stock selectors and electromechanical automated equipment such as high rise automated storage and retrieval vehicles, to move, stack and unstack, load and unload, bin, and position material.

Duty 6: Performs material handling duties, including the use of tools and other equipment, in a safe manner, utilizing safety practices and procedures, and complying with established safety rules and regulations.

Duty 7: Maintains records and documents

1.4 Scope: The contractor shall provide support services within the Medical Logistics Flight as described in this Performance Work Statement at the 52 Medical Group Unit 3865, APO, AE 09126, MTF.

1.5 Period of Performance: The period of performance shall be for one (1) Base Year of 12 months and four (4) Option Year of 12 months. The Period of Performance reads as follows:

Base Year 30 September 2025 - 29 September 2026

Option Year I 30 September 2026 - 29 September 2027

Option Year II 30 September 2027 – 29 September 2028

Option Year III 30 September 2028 – 29 September 2029

Option Year IV 30 September 2029 – 29 September 2030

1.6 Holidays: There are eleven (11) U.S. federal holidays each year. They are New Year’s Day (observed 1 January), Martin Luther King, Jr’s Birthday (observed the third Monday in January), President’s Day (observed the third Monday in May), Memorial Day (observed the last Monday in May),Juneteenth (observed 19 June) Independence Day (observed 4 July), Labor Day (observed the first Monday in September), Columbus Day (observed the second Monday in October), Veterans Day (observed 11 November), Thanksgiving Day (observed the fourth Thursday in November), and Christmas Day (observed 25 December). If New Year’s Day, Independence Day, Veterans Day or Christmas Day falls on a Saturday, it is observed on Friday; if it falls on Sunday it is observed on Monday.

1.6.1 All US Federal Holidays that the contractor is not present in the facility are non-chargeable to theU.S.

Government and will not be reimbursed to the contractor.

1.6.2 Hours of Operation: The Contractor is responsible for conducting business between the hours of 0730-1630 Monday through Friday, or as negotiated with the MTF, equal to 40 hours per week. U.S. Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, presidential closings or similar Government directed facility closings are non-reimbursable. The Contractor is also allowed to take a one hour lunch break, non- chargeable, during the previously identified duty hours. The contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the contractor shall keep in mind that the stability and continuity of the workforce are essential.

1.7 Place of Performance: The work to be performed under this contract will be performed at 52 Medical Group and outlying its locations.

1.8 Type of Contract: The Government will award a Firm-Fixed-Price Contract.

1.9 Security Requirements: Contractor needs to provide a copy of Criminal History Background Check (CHBC) to the Government.

1.9.1 Physical Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use. At the close of each work period, Government facilities, equipment, and materials shall be secured.

1.9.2 Identification of Contractor Employees: All contract personnel attending meetings, answering Government telephones, and working in other situations in which their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed. The contractor personnel will be required to obtain and wear badges in the performance of this service.

1.9.3 Data Rights: The Government has unlimited rights to all documents/material produced under this contract.

All documents and materials, to include the source codes of any software produced under this contract, shall be Government owned and are the property of the Government with all rights and privileges of ownership/copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the contractor without written permission from the CO. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

1.9.3.1 Uses and Safeguarding of Information: Information from the secure web site is considered to be proprietary in nature when the contract number and contractor identity are associated with the direct labor hours and direct labor dollars. At no time will any data be released to the public with the contractor name and contract number associated with the data.

1.10 Personnel Requirements:

1.10.1 English Language Requirement: Personnel shall read, understand, speak and write English.

1.10.2 Education and Training: The personnel performing this duty shall meet the following requirements:

1.10.2.1 High School diploma or General Educational Development (GED) equivalency.

1.10.2.2 Completed and maintains Basic Life Support Training as required and provided by the MTF.

1.10.2.3 Medical Employee Health category: Low Risk.

1.11 Dress and Appearance:

1.11.1. Clothing: While on duty, contract personnel shall be neat and clean, well-groomed and dressed appropriately. Contract personnel’s clothing shall fit correctly to provide a professional, modest appearance in keeping with the normally accepted community standards of dress for the work being performed. In all cases, clothing shall be neat and clean. This includes being free from visible dirt and stains. It is the expectation of the employees to dress in a business attire of a casual nature. Additionally, the Contractor must wear steel toe boots at all times during the duty hours.

1.11.2. Facial Hair (including beards, mustaches and sideburns): Facial hair shall be controlled (restrained) or trimmed.

1.11.3. It shall not interfere with safe work practices, look unkempt or unclean.

PART 2

DEFINITIONS & ACRONYMS

2. DEFINITIONS AND ACRONYMS:

2.1 DEFINITIONS:

2.1.1 CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime.

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

2.1.3 DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement.

2.1.4 MEDICAL TREATMENT FACILITY (MTF). Air Force hospitals or clinics, including all activities providing outpatient and/or in-patient health care services for authorized personnel.

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

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

2.1.7 WORK DAY. The number of hours per day the contractor provides services in accordance with the contract.

2.1.8 WORK WEEK. Monday through Friday, unless specified otherwise.

2.2 ACRONYMS:

AAAHC Accreditation Association of Ambulatory Health Care

AHLTA Armed Forces Health Longitudinal Technology

Application DD250 Department of Defense Form 250 (Receiving

Report)

DD254 Department of Defense Contract Security Requirement List

DOD Department of Defense

FAR Federal Acquisition Regulation

HIPAA Health Insurance Portability and Accountability Act of 1996

MEHP Medical Employee Health Program

CO Contracting Officer

PWS Performance Work Statement

QA Quality Assurance

QAP Quality Assurance Program

TE Technical Exhibit

PART 3

GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

3. GOVERNMENT FURNISHED ITEMS AND SERVICES:

3.1 General: The Government shall provide the following equipment and supplies listed.

3.2 Equipment: The Government shall furnish desk, workspace, computer equipment, necessary software, required network access and connectivity, telephone, utilities, fax, reproduction services, office supplies, and parking.

3.3 Forms: The MTF shall provide required Government forms used in the performance of services.

3.4 Services:

3.4.1 Administrative Support: Contract personnel will be authorized to use all administrative support available to Government employees. This will include but not be limited to copy machines, telefax machines, medical library, installation distribution, Class-A telephone lines and Defense Switching Network (DSN) lines. Contract personnel shall be authorized CHCS, AHLTA, TRICARE Online, EWRAS, ADS and computer access only to complete assigned tasks. Contractor’s use of CHCS, other electronic systems, and a computer system is limited to official government business.

3.4.2 Housekeeping: The Government, as part of the MTF housekeeping contract, will provide routine housekeeping.

3.4.3 Government Orientation/Training: The Government will provide training on Government provided forms and equipment, universal precautions, initial orientation and continuing orientation. Participates in continuing education programs to update and/or maintain skills and knowledge to meet annual requirements. Participates in evaluation of the quality and effectiveness of activities and services of the unit.

3.4.3.1 The Government will provide training to the contracting employee.

3.4.3.2 The contractor’s staff shall have functioning knowledge of The Joint Commission (JC), Health Insurance Portability and Accountability Act (HIPAA), DoD Health Information Privacy Regulation (DoD 6025.18-R) the Privacy Act, and DoD Privacy Program (DoD 5400.11-R). All Contractor staff that access Government IT systems shall be trained in security awareness, protection of Government sensitive and privacy information and their responsibility and consequences before access is authorized.

3.5 Records, Files, Documents, and Work Papers: All records, files and documents provided by the government remain Government property. The Quality Assurance Personnel (QAP) will provide guidance to the contract personnel who shall maintain and dispose of these records, files, and documents in accordance with the Privacy Act of 1974, the Health Insurance Portability and Accountability Act (HIPAA) of 1996, and AFI 41-210 when handling patient information. Patient information shall not be disclosed or revealed to unauthorized personnel.

PART 4 ATTACHMENT I

MEDICAL EMPOLYEE HEALTH PROGRAM (MEHP) REQUIRMENTS

1. MEHP enrollment

Public Health will in-process all HealthCare Workers (HCWs) including contractors into the Aeromedical Services Information Management System (ASIMS) MEHP module and will ensure HCWs receive or have received all general requirements based on their risk categories with 10 days of starting work.

Contract personnel providing services under this contract shall receive a pre-employment physical examination prior to commencement of work. This certification shall state the date on which the examination was completed, the doctor’s name that performed the examination, and a statement concerning the physical health of the individual. The health certificate shall state that the contract employee is cleared to work without restrictions. The certification shall contain a signed statement by the examining physician stating that the employee is free of any contagious diseases.

2. General Requirements based on risk category:

HCWs to include contractors are required to have the following as a condition of employment:

2.1. Risk categories: All HCWs are assigned a CDC Exposure Risk Category in ASIMS (low-risk, high-risk or exposure-prone) upon in-processing, based on job duties. The assigned risk category dictates initial and ongoing MEHP requirements.

2.1.1. Low-risk personnel are those with minimal risk of exposure to patient blood/bodily fluids

2.1.2. High-risk personnel are those working in or under the jurisdiction of AF MTFs and Guard and Reserve medical units, who have direct contact with patients or blood/bodily fluids, and are at ongoing risk for injures with sharp instruments/needle sticks.

2.1.3. Exposure-prone personnel are those medical and dental providers, nurses, and technicians who perform invasive procedures, defined by the CDC as “surgical entry into tissues, cavities or organs or repair of major traumatic injuries associated with operating or delivery room, emergency department, or outpatient setting (dental and physician), cardiac catheterization and angiographic procedures; vaginal/cesarean delivery or other invasive obstetric procedure where bleeding occurs; or manipulation, cutting or removal MDGI 48-113, 29 January 2009 Certified Current and Essential as of 8 Nov 2017 5 of any oral or perioral tissues, including tooth structure, during which bleeding occurs or the potential for bleeding exists. All exposure prone personnel are also high risk.

Requirement Low Risk HBV Hep B vaccine series Influenza Vaccinate annually (HN HCWs and contractors: highly encouraged but not mandatory) MMR MMR vaccine series or (+) Ab titer Tdap/Td Booster every 10 yrs. (Tdap requires only a one-time dose) Varicella Varicella vaccine or (+) Ab titer COVID-19 Fully vaccinated/boosted TST/QFT Baseline (2-step TST or one time QFT) HIV screening : Active Duty (AD) every 2 yrs., Civilian/Contractor: n/a

Requirement High Risk HBV Hep B vaccine series and (+) HBsAb titer Influenza Vaccinate annually (HN HCWs and contractors: highly encouraged but not mandatory) MMR MMR vaccine series or (+) Ab titer Tdap/Td Booster every 10 yrs. (Tdap requires only a one-time dose) Varicella Varicella vaccine or (+) Ab titer COVID-19 Fully vaccinated/boosted

HIV screening AD every 2 yrs., Civilian/Contractor: optional

Requirement Exposure Prone HBV Hep B vaccine series and (+) HBsAb titer, HBsAg titer if (-) HBsAb Influenza Vaccinate annually (HN HCWs and contractors: highly encouraged but not mandatory) MMR MMR vaccine series or (+) Ab titer Tdap/Td Booster every 10 yrs. (Tdap requires only a one-time dose) Varicella Varicella vaccine or (+) Ab titer COVID-19 Fully vaccinated/boosted

HIV screening AD every 2 yrs., Civilian/Contractor: optional

2.2. Requirements

2.2.1. Tuberculosis screening is required prior to employment and at periodic frequencies based on the local TB risk assessment and exposure to active TB cases. All HCWs must accomplish or present documentation of a two-step tuberculin skin test (TST) or an approved blood assay for TB screening (QFT), or documentation of the BCG vaccination.

2.2.3. Measles, Mumps and Rubella (MMR) immunity or documentation of two MMR vaccinations is required for all HCWs.

2.2.4. Varicella immunity or documentation of two varicella vaccinations is required for all AD, contractor, and civilian HCWs. Vaccine non-responders will be documented in ASIMS after the vaccination series has been accomplished twice.

2.2.5. Influenza vaccination is required for all AD members, contractors and civilian HCWs who provide direct patient care. HCWs who provide direct patient care can reasonably be interpreted to include any worker whose daily activities include contact with patients or involve work in common areas or clinic/hospital rooms where patients are likely to be present (e.g., clerical staff who interact with patients, food service personnel, and cleaning or janitorial staff).

Influenza vaccination is highly encouraged but not mandatory for HN employees.

2.2.6. Hepatitis B vaccination is required for all AD HCWs, but can be declined by civilians/contractors categorized as low risk personnel Hepatitis B Vaccine Consent/Declination. High risk and exposure prone HCWs will be tested for anti-HBs within 30-60 days after completion of the three dose vaccine series. All personnel who do not develop protective immunity will complete a second three dose vaccine series and be tested for anti-HBs. It is not recommended for non-responders to receive more than two vaccination series.

2.2.7. COVID-19 vaccination in compliance with current definition of “fully vaccinated” to include any required boosters is mandatory for all HCWs.

2.2.8. HIV screening for all AD members is required every 2 years IAW AFI 44-178. HIV screening is offered to high risk and exposure prone civilian and contracted HCWs, and consent for testing should be documented using the HIV Antibody Testing Consent Form for Non-AD (Attachment 4).

2.2.9. HCWs infected with a blood borne pathogen will be evaluated for duty restrictions. In general, they will not perform invasive procedures until disease resolution and non-infectivity status can be verified.

2.3. Expenses/responsibilities

No medical tests, immunizations or procedures required by the contract shall be performed by the Government unless the provider is an eligible beneficiary. Vaccinations may differ depending upon performance location. Expenses for all required tests, immunizations and/or procedures shall be borne by the contractor or contracting employee, not the Government. It is the contractor’s responsibility to ensure the contracting employee has all required immunizations and has knowledge of health precautions for the respective country.

2.4. Protocols for handling occupationally related illnesses and injuries:

All contract personnel providing services under this contract, who experience a parenteral (e.g., needle stick or cut) or mucous membrane exposure (e.g., splash to the mouth or eye) to blood or bloody body fluids, shall receive prompt treatment. The employee may choose to either seek care through the medical treatment facility (MTF) or the civilian sector IAW AFI 41-210 TRICARE Operations and Patient Administration Functions.

The MTF will evaluate the source of exposure for risk of Hepatitis B, Hepatitis-C, and Human Immunodeficiency Virus (HIV) and will provide a report of the findings to the contractor and the contracting employee.

It shall be the contractor’s responsibility to provide appropriate treatment as needed to possibly include Tetanus- Diphtheria booster, or Hepatitis-B Immune Globulin. The contractor shall be responsible for providing the employee with initial testing and if the source of exposure was unknown, positive, or considered at high risk for HIV infection, follow-up testing 3, 6, and 12 months after exposure. In the event of a confirmed or highly suspected parenteral exposure to HIV, the contractor shall ensure that the employee receives appropriate counseling and is referred immediately to a private infectious disease specialist for consideration of any post-exposure or experimental therapy.

The Government may require the contractor to provide evidence of the status of treatment and testing of the employee.

MDGI 48-113 MEDICAL EMPLOYEE HEALTH PROGRAM

PART 5 ATTACHMENT II

This BAA can serve as a separate standalone agreement or may be used for new or existing contracts between the MTF and the business associate. If this BAA is used as a separate standalone agreement and as part of an underlying Contract, there are several identified references to Contracting Officers (COs) throughout the BAA that need to be removed. This BAA is NOT to be used in contracts for access to MHS-wide data or components of DHA. Contact the DHA Procurement Directorate at ContractPolicyDivision@dha.mil. for applicable contract language and guidance.

Business Associate Agreement

[USE FOR STANDALONE BAA ONLY] This Business Associate Agreement (this "Agreement") is entered into this day of , (the “Effective Date”) between [NAME OF MHS COVERED ENTITY] ("Covered Entity") and [NAME OF BUSINESS ASSOCIATE], a [type of business entity] ("Business Associate").

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 business associate agreement (BAA) between the signatory parties for purposes of the Health Insurance Portability and Accountability Act (HIPAA) and the “HITECH Act” amendments thereof, as implemented by the HIPAA Rules and DoD HIPAA Issuances (both defined below). The parties are a DoD Military Health System (MHS) component, acting as a HIPAA covered entity, and a DoD contractor, acting as a HIPAA business associate. The HIPAA Rules require BAAs between covered entities and business associates.

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

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

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

Business Associate shall generally have the same meaning as the term “business associate” in the DoD HIPAA Issuances, and in reference to this BAA, shall mean [INSERT NAME OF BUSINESS

ASSOCIATE].

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 MTF COMPONENT].

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

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

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

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

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

HIPAA Rules means, collectively, the HIPAA Privacy, Security, Breach and Enforcement Rules, issued by the U.S. Department of Health and Human Services (HHS) and codified at 45 CFR Part 160 and Part 164, Subpart E (Privacy), Subpart C (Security), Subpart D (Breach) and Part 160, Subparts C-D (Enforcement), as amended by the 2013 modifications to those Rules, implementing the “HITECH Act” provisions of Pub.

L. 111-5. See 78 FR 5566-5702 (Jan. 25, 2013) (with corrections at 78 FR 32464 (June 7, 2013)).

Additional HIPAA rules regarding electronic transactions and code sets (45 CFR Part 162) are not addressed in this BAA and are not included in the term HIPAA Rules.

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

I. Obligations and Activities of Business Associate

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

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

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

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

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

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

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

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

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

II. Permitted Uses and Disclosures by Business Associate

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

THIS SECTION IF THE PURPOSE OF THE AGREEMENT/CONTRACT IS FOR THE BA TO

DEIDENTIFY PHI FOR THE CE].

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

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

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

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

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

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

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

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

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

IV. Permissible Requests by Covered Entity

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

V. Breach Response

(a) In general.

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

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

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

(b) Government Reporting Provisions

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

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

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

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

(ii) The Business Associate shall submit the US-CERT report using the online form at https://forms.us-cert.gov/report/. Before submission to US-CERT, the Business Associate shall save a copy of the on-line report. After submission, the Business Associate shall record the US-CERT Reporting Number. Although only limited information about the breach may be available as of the one hour deadline for submission, the Business Associate shall submit the US-CERT report by the deadline. The Business Associate shall e-mail updated information as it is obtained, following the instructions at http://www.us-cert.gov/pgp/email.html.

The Business Associate shall provide a copy of the initial or updated US-CERT report to the Installation Privacy Act Officer, MTF HIPAA Privacy Officer, and the Contracting Officer (if applicable), if requested.

Business Associate questions about US-CERT reporting shall be directed to the Installation Privacy Act Officer or MTF HIPAA Privacy Officer, not the US-CERT office.

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

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

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

(ii) In the event the Business Associate is uncertain on how to apply the above requirements, the Business

Associate shall consult with the Covered Entity and Contracting Officer (if applicable) when determinations on applying the above requirements are needed.

(c) Individual Notification Provisions

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

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

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

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

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

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

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

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

The [REMOVE CO REFERENCES FOR STAND-ALONE AGMT] Contracting Officer, in consultation with the Covered Entity will determine the appropriate level of support services.

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

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

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

VI. Termination

(a) Termination. Noncompliance by the Business Associate (or any of its staff, agents, or subcontractors) with any requirement in this BAA may subject the Business Associate to termination under any applicable default or other termination provision of the underlying Contract [FOR STANDALONE INSERT, REPLACE WITH “this Agreement”].

(b) Effect of Termination.

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

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

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

VII. Notices. Any notices to be given hereunder will be made in the most expedient manner, via e-mail, facsimile, U.S. Mail, or express courier to such party’s address given below.

If to the Business Associate: If to the Covered Entity:

Attn: Attn:

Title: Title: MTF HIPAA Privacy Officer Company: Unit:

Address: Address:

Phone: Phone:

Fax: Fax:

E-mail: E-mail:

With a copy to:

Name: Name:

Company: Title: Contracting Officer Address: Address:

Phone: Phone:

Fax: Fax:

Email: Email:

Each party named above may change its address and that of its representative for notice by the giving of notice thereof in the manner provided in this subsection.

VIII. Miscellaneous

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

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

[USE FOR STANDALONE BAA ONLY] (c) Counterparts; Facsimiles. This Agreement may be executed in any number of counterparts, each of which shall be deemed an original. The parties acknowledge and agree that faxed and/or electronically affixed signatures shall act as original signatures that bind each faxing, or electronically affixing, signatory to the terms and provisions of this Agreement.

Delivery of an executed counterpart of this Agreement by facsimile or electronic mail shall be equally effective as delivery of a manually executed counterpart.

[USE FOR STANDALONE BAA ONLY] (d) Entire Agreement; Amendment. This Agreement embodies the entire understanding between the parties pertaining to the subject matter contained in it;

supersedes any and all prior negotiations, correspondence, understandings, or agreements of the parties with respect to its subject matter; and may be waived, altered, amended, modified, revised or repealed, in whole or in part, only on the written consent of the parties to this Agreement.

[USE FOR STANDALONE BAA ONLY] IN WITNESS WHEREOF, the parties have executed this Agreement as of the Effective Date.

[USE FOR STANDALONE BAA ONLY]

BUSINESS ASSOCIATE: COVERED ENTITY:

Signature: Signature:

Print name: Print name:

Title: Title:

Date: Date:

File details come from the government source that posted it. Updated .