B08 Combined Synopsis Solicitation W91YTZ24R0046 8-16-2024.pdf

Document Type: Combined Solicitation/ Synopsis

Date: 16 August 2024

Subject: Sterilizer Preventive Maintenance and Repair

Solicitation Number: W91YTZ24R0046

Response Date: 30 August 2024 at 12:00 PM EDT

Point of Contact: jessie.g.hart.civ@health.mil

Set-Aside: 100% small business set aside

Delivery Location: KACC, Ft. Meade, MD

Delivery Date: 20 September 2024

NAICS Code: 811210 Electronic and Precision Equipment Repair and Maintenance

Size Standard: $34,000,000

Contracting Office Address

Department of the Army

US Army Medical Command

Army Health Contracting Activity

Medical Readiness Contracting Office - East

9275 Doerr Rd. Bldg. 1221

Fort Belvoir, VA 22060-5505

The Medical Readiness Contracting Office – East, Belvoir Health Contracting Cell intends to solicit and award a Firm-Fixed Price contract with a period of performance of one (1) base year plus four (4) option years for a total of up to five years. Services will be provided in support of Kimbrough Ambulatory Care Center (KACC), Fort Meade, MD for preventative maintenance and repair services for sterilizing units and medical instrument washers.

The Contractor shall provide supplies to include, but not be limited to, all equipment, tools, accessories, and installation necessary to perform services under this contract. See CLIN structure and performance work statement below:

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This solicitation number W91YTZ24R0046 is issued as a request for quote (RFQ). This is a 100% small business set-aside requirement. The NAICS Code is 811210 Electronic and Precision Equipment Repair and Maintenance.

The Small Business Size Standard is $34,000,000.

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2020-06.

Interested persons may identify their interest and capability to respond to the requirement and submit proposals. Provide your Unique

Entity ID (UEI); CAGE code; tax ID number; and proposal for evaluation purposes.

All quotes received after the date of publication of this synopsis and prior to the due date and time will be considered by the

Government.

Submit quotes via email ONLY to Jessie Hart at jessie.g.hart.civ@health.mil no later than 30 August 2024 @ 12:00 PM EST. No telephonic requests will be honored.

Clauses and provisions throughout this solicitation can be viewed by accessing website www.acquisition.gov. FAR provision 52.212-1

[Instructions to Offerors Commercial Items] applies to this acquisition to include the following addenda: All offerors are cautioned that if selected for award, they must be registered in the System for Award Management (SAM) program. The SAM can be accessed via the internet at https://www.sam.gov/portal/public/SAM/. Confirmation of SAM registration will be validated prior to awarding a contract.

The provision at FAR 52.212-2, Evaluation – Commercial Items and any addendums to this provision apply to this acquisition. The clause at FAR 52.212-5 (DEVIATION 2018-O0021) (SEP 2018), Contract Terms and Conditions to Implement Statutes or Executive

Orders – Commercial Items applies to this acquisition.

The following provisions in their latest editions apply to this solicitation.

https://www.sam.gov/portal/public/SAM/

SEE ADDENDUM

(No Collect Calls)

W91YTZ24R0046 16-Aug-2024

b. TELEPHONE NUMBER

240-608-2357

8. OFFER DUE DATE/LOCAL TIME

12:00 PM 30 Aug 2024

5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA – FAR (48 CFR) 53.212

(TYPE OR PRINT)

(SIGNATURE OF CONTRACTING OFFICER)

ADDENDA X ARE

26. TOTAL AWARD AMOUNT (For Gov t. Use Only )

23.

CODE 10. THIS ACQUISITION IS

SUCH ADDRESS IN OFFER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT

BELOW IS CHECKED

TELEPHONE NO.

W91YTZ9. ISSUED BY

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a. UNLESS BLOCK

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

JESSIE G. HART

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NUMBER

(TYPE OR PRINT)

30b. NAME AND TITLE OF SIGNER 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a.UNITED STATES OF AMERICA

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1. 52.212-4. FAR 52.212-3. 52.212-5 ARE ATTACHED.X

25. ACCOUNTING AND APPROPRIATION DATA

1. REQUISITION NUMBER

20.

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

0012134603

ARE NOT ATTACHED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

. YOUR OFFER ON SOLICITATION

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

% FOR:SET ASIDE:UNRESTRICTED OR X

SMALL BUSINESSX

17a.CONTRACTOR/ CODE FACILITY

OFFEROR CODE

W40M MRCO EAST

MEDICAL READINESS CONTR OFFICE EAST

9275 DOERR ROAD BLDG 1221

FORT BELVOIR VA 22060-5580

18a. PAYMENT WILL BE MADE BY CODE

RATED ORDER UNDER

DPAS (15 CFR 700)

13a. THIS CONTRACT IS A

13b. RATING

CODE15. DELIVER TO CODE HT0873 16. ADMINISTERED BY

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFPX

KIMBROUGH AMB CC MEADE - MM

FOR POP SEE LINE ITEM

5TH ST

BLDG 2484

FORT GEORGE G MEADE MD 20755-5000

TEL: 301-677-8800 FAX:

FAX:

TEL: 703-545-6700

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

$34,000,000

NAICS:

811210

X

OFFER DATED

29. AWARD OF CONTRACT: REF.

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

EMAIL:

TEL:

31c. DATE SIGNED

SEE SCHEDULE

SCHEDULE OF SUPPLIES/ SERVICESITEM NO. QUANTITY UNIT UNIT PRICE AMOUNT

24.22.21.19.

WOMEN-OWNED SMALL BUSINESS (WOSB)

ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

(CONTINUED)

PAGE 2 OF69

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED: ______________________________________________________

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32c. DATE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f . TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

37. CHECK NUMBER

FINALPARTIALCOMPLETE

36. PAYMENT35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER

FINAL

33. SHIP NUMBER

PARTIAL

38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER 40. PAID BY

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42c. DATE REC'D (YY/MM/DD) 42d. TOTAL CONTAINERS

STANDARD FORM 1449 (REV. 2/2012) BACK

Prescribed by GSA – FAR (48 CFR) 53.212

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

SEE SCHEDULE

20.

SCHEDULE OF SUPPLIES/ SERVICES

21.

QUANTITY UNIT

22. 23.

UNIT PRICE

24.

AMOUNT

19.

ITEM NO.

W91YTZ24R0046

Section SF 1449 - CONTINUATION SHEET

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 4 Quarter

BASE YEAR-STERIS

FFP

SUSTAINMENT TECHNOLOGIES - STERIS PM, CAL, REPAIR SERVICE

BASE YEAR 20 SEPTEMBER 2024 TO 19 SEPTEMBER 2025.

FOB: Destination

PURCHASE REQUEST NUMBER: 0012134603

PSC CD: J065

NET AMT

1001 4 Quarter

OPTION OPTION PERIOD 1 - STERIS

FFP

SUSTAINMENT TECHNOLOGIES - STERIS PM, CAL, REPAIR SERVICE

OPTION PERIOD 1, POP: 20 SEPTEMBER 2025 TO 19 SEPTEMBER 2026

FOB: Destination

2001 4 Quarter

OPTION OPTION PERIOD 2 -STERIS

FFP

SUSTAINMENT TECHNOLOGIES - STERIS PM, CAL, REPAIR SERVICE

OPTION PERIOD 2, POP: 20 SEPTEMBER 2026 TO 19 SEPTEMBER 2027

FOB: Destination

3001 4 Quarter

OPTION OPTION PERIOD 3 -STERIS

FFP

SUSTAINMENT TECHNOLOGIES - STERIS PM, CAL, REPAIR SERVICE

OPTION PERIOD 3, POP: 20 SEPTEMBER 2027 TO 19 SEPTEMBER 2028

FOB: Destination

4001 4 Quarter

OPTION OPTION PERIOD 4 -STERIS

FFP

SUSTAINMENT TECHNOLOGIES - STERIS PM, CAL, REPAIR SERVICE

OPTION PERIOD 4, POP: 20 SEPTEMBER 2028 TO 19 SEPTEMBER 2029

FOB: Destination

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT

1. SCOPE OF WORK: The contractor will provide preventive maintenance and repair services of Steris Sterilizers at the Fort Meade Medical Activity (MEDDAC), Kimbrough Ambulatory Care Center, Fort Meade, MD, Epes

Dental Clinic, 8472 Simonds St, Fort Meade, MD, and Rader Army Health Clinic, 401 Carpenter Rd, Fort Myer, VA.

2. GENERAL REQUIREMENT: This is contract to provide preventive maintenance and repair services of Steris

Sterilizers at the Fort Meade Medical Activity (MEDDAC).

Epes Dental Clinic, 8472 Simonds St, Fort Meade, MD 20755

Model Description Serial Number

AMSCO 400 Sterilizing Unit, Steam 03345515-33

V120 Century Sterilizing Unit, Steam 0131105-18

AMSCO 2532 Washer, Labware/ Surgical 3617017016

Rader Army Health Clinic, 401 Carpenter Rd, Fort Myer, VA 22211

AMSCO 400 Sterilizing Unit, Steam 032592001

Kimbrough Ambulatory Care Center, 2480 Llewellyn Ave, Fort George G Meade, MD 20755

VPRO MAX Sterilizing Unit, Germicidal Gas, Gaseous Plasma 030062313

Repair technicians must:

Be Steris trained Field Service Engineers

Utilize Steris designed and developed software

Utilize Steris parts and equipment

3. REMOVAL OF EQUIPMENT: N/A

4. UTILITIES: The government will furnish the contractor all reasonable amounts of electrical power and other utilities necessary to perform the above services called for under this contract.

5. SPECIAL WORKING CONDITIONS: N/A.

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

New Year's Day 1 January

Martin Luther King's Birthday Third Monday in January

President's Day Third Monday in February

Memorial Day Last Monday in May

Juneteenth 19 June

Independence Day 4 July

Labor Day First Monday in September

Columbus Day Second Monday in October

Veteran's Day 11 November

Thanksgiving Day Fourth Thursday in November

Christmas Day 25 December

7. DELIVERABLES.

7.1. The Contractor shall submit reports to the COR and/or the Contracting Officer as requested.

7.2. The Office of the Assistant Secretary of the Army (Manpower & Reserve Affairs): This requirement does not apply to this contract

8. SECURITY REQUIREMENTS. The Military Treatment Facilities (MTF)s are restricted access military installations. Base access at controlled gates will require registration to include a background database search. 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 military installation, will not be able to perform services at the facility.

9. CONTRACTOR HCP FURNISHED SUPPLIES/SERVICES.

9.1. SERVICES.

9.1.1. 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.

9.1.2. Point of Contact. The primary point of contact for any coordination that is required can be reached at (301)

677-8005.

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). A CAC is not required for this service.

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.

PERFORMANCE

OBJECTIVE

PERFORMANCE

STANDARD

REF PWS METHOD OF

ASSESSMENT

Designate a point of contact prior to start date of the contract

Written notification must be received by the KO and

COR prior to start date of contract. 100%

Para 1.8.1.3. Written notification to KO

Comply with Security

Requirements.

Comply initially and as required 100% of the time.

General Section

Para 1.9.

COR maintain log.

Comply with Specific

Tasks.

Comply at least 99% of the time.

Attachment 1 COR maintain log.

Combating Trafficking in persons (awareness training)

100% compliance (zero tolerance) regarding trafficking in persons policy

FAR 52.222-50 and FAR

22.1703

COR documentation and program review. Any non-compliance must be brought to the immediate attention of the KO

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 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.

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 .

CLAUSES INCORPORATED BY REFERENCE

52.203-11 Certification And Disclosure Regarding Payments To

Influence Certain Federal Transactions

SEP 2007

52.204-7 System for Award Management OCT 2018

52.204-9 Personal Identity Verification of Contractor Personnel JAN 2011

52.204-16 Commercial and Government Entity Code Reporting AUG 2020

52.204-17 Ownership or Control of Offeror AUG 2020

52.204-23 Prohibition on Contracting for Hardware, Software, and

Services Developed or Provided by Kaspersky Lab Covered

Entities

DEC 2023

52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment

NOV 2021

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

52.209-6 Protecting the Government's Interest When Subcontracting

With Contractors Debarred, Suspended, or Proposed for

Debarment

NOV 2021

52.212-1 Instructions to Offerors--Commercial Products and

Commercial Services

SEP 2023

52.212-4 Contract Terms and Conditions--Commercial Products and

Commercial Services

NOV 2023

52.219-6 Notice Of Total Small Business Set-Aside NOV 2020

52.222-3 Convict Labor JUN 2003

52.222-21 Prohibition Of Segregated Facilities APR 2015

52.222-43 Fair Labor Standards Act And Service Contract Labor

Standards - Price Adjustment (Multiple Year And Option

Contracts)

AUG 2018

52.222-50 Combating Trafficking in Persons NOV 2021

52.222-51 Exemption from Application of the Service Contract Labor

Standards to Contracts for Maintenance, Calibration, or

Repair of Certain Equipment--Requirements

MAY 2014

52.223-1 Biobased Product Certification MAY 2024

52.223-2 Reporting of Biobased Products Under Service and

Construction Contracts.

MAY 2024

52.223-5 Pollution Prevention and Right-to-Know Information MAY 2024

52.225-13 Restrictions on Certain Foreign Purchases FEB 2021

52.225-25 Prohibition on Contracting with Entities Engaging in Certain

Activities or Transactions Relating to Iran-- Representation and Certifications.

JUN 2020

52.232-33 Payment by Electronic Funds Transfer--System for Award

Management

OCT 2018

52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

MAR 2023

52.233-3 Protest After Award AUG 1996

52.233-4 Applicable Law for Breach of Contract Claim OCT 2004

52.237-2 Protection Of Government Buildings, Equipment, And

Vegetation

APR 1984

52.237-3 Continuity Of Services JAN 1991

252.201-7000 Contracting Officer's Representative DEC 1991

252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7002 Requirement to Inform Employees of Whistleblower Rights DEC 2022

252.204-7003 Control Of Government Personnel Work Product APR 1992

252.204-7004 Antiterrorism Awareness Training for Contractors JAN 2023

252.204-7016 Covered Defense Telecommunications Equipment or Services

-- Representation

DEC 2019

252.204-7017 Prohibition on the Acquisition of Covered Defense

Telecommunications Equipment or Services -- Representation

MAY 2021

252.204-7018 Prohibition on the Acquisition of Covered Defense

Telecommunications Equipment or Services

JAN 2023

252.204-7019 Notice of NIST SP 800-171 DoD Assessment Requirements NOV 2023

252.223-7008 Prohibition of Hexavalent Chromium JAN 2023

252.225-7048 Export-Controlled Items JUN 2013

252.232-7003 Electronic Submission of Payment Requests and Receiving

Reports

DEC 2018

252.232-7010 Levies on Contract Payments DEC 2006

252.243-7001 Pricing Of Contract Modifications DEC 1991

CLAUSES INCORPORATED BY FULL TEXT

52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it "does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument" in paragraph (c)(1) in the provision at 52.204-26, Covered Telecommunications Equipment or Services--

Representation, or in paragraph (v)(2)(i) of the provision at 52.212-3, Offeror Representations and Certifications-

Commercial Products and Commercial Services. The Offeror shall not complete the representation in paragraph

(d)(2) of this provision if the Offeror has represented that it "does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services" in paragraph (c)(2) of the provision at 52.204-26, or in paragraph (v)(2)(ii) of the provision at 52.212-3.

(a) Definitions. As used in this provision-

Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause

52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or

Equipment.

(b) Prohibition.

(1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.

115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.

115-232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract or extending or renewing a contract with an entity that uses any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system.