A.09.03_W81K00-17-T-M044__Solicitation.pdf

SEE ADDENDUM

(No Collect Calls)

W81K00-17-T-M044

b. TELEPHONE NUMBER

210-221-3159

8. OFFER DUE DATE/LOCAL TIME

12:00 AM 15 Sep 2017

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 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.

W81K009. ISSUED BY

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

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

CALVIN L. BLUE

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

0 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1. 52.212-4. FAR 52.212-3. 52.212-5 ARE ATTACHED.

25. ACCOUNTING AND APPROPRIATION DATA

1. REQUISITION NUMBER

20.

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

PAGE 1 OF

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

0011017159

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 ORX

SMALL BUSINESS

17a.CONTRACTOR/ CODE FACILITY

OFFEROR CODE

W40M USA HLTH CONTRACTING ACT

SOUTHERN REG CONTR OFC

3551 ROGER BROOK DR BLDG 3600

FORT SAM HOUSTON TX 78234-6200

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 W81NWY 16. ADMINISTERED BY

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFPX

W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG 3600

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

TEL: 210-221-7928 FAX:

FAX:

TEL: SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

NAICS:

339113

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 OF

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.

W81K00-17-T-M044 Page 3 of 48

Section I – Contract Provisions

CLAUSES INCORPORATED BY REFERENCE

52.212-4 Contract Terms and Conditions--Commercial Items JAN 2017

ADDENDUM TO 52.212-4

(v) The contractor shall comply with OTSG/MEDCOM Policy Memo 13-062, Policy for Reporting

Incidents of Sexual Assault and Sexual Harassment under the Sexual Assault Prevention and

Response Program (SHARP), 12 Nov 2013. The SHARP reporting requirements apply only to knowledge obtained by contractor personnel while performing services under this contract.

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

The contractor shall require all CSPs with knowledge of an incident of sexual harassment occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the contractor who shall immediately (within

24 hours) report the incident in writing to the government's COR. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals.

The contractor shall ensure all service providers receive Sexual Harassment/Assault Response and

Prevention (SHARP) training not later than 60 calendar days after contractor personnel begin performance under this contract.

Training can be obtained either online or in person. Contractor personnel can attend SHARP training provided by MEDCOM on an every other month basis by contacting (210) 221-6118 for class date/time and availability. If the employee has an AKO account, they can access online the

Team Bound Self Study course through Army Learning Management System (ALMS) at http://www.atsc.army.mil/tadlp/delivery/alms.asp

Advisory publications

Army Regulation 600-20, Army Command Policy, 20 Sep 2012

OTSG/MEDCOM Policy Memo 13-062, Policy for Reporting Incidents of Sexual Assault and

Sexual Harassment under the Sexual Assault Prevention and Responses Program (SHARP), 12 Nov

(w) The non-FAR Part 12 discretionary FAR and DFARS clauses included herein are incorporated into this contract either by reference or in full text. If incorporated by reference, see clause 52.252-2 herein for locations where full text can be found.

(End of Addendum)

W81K00-17-T-M044 Page 4 of 48

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).

W81K00-17-T-M044 Page 5 of 48

—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.

W81K00-17-T-M044 Page 6 of 48

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

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

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

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

II. Permitted Uses and Disclosures by Business Associate

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

(b) The Business Associate agrees to use, disclose and request PHI only in accordance with the

HIPAA Privacy Rule “minimum necessary” standard and corresponding DHA policies and procedures as stated in the DoD HIPAA Issuances.

(c) The Business Associate shall not use or disclose PHI in a manner that would violate the DoD

HIPAA Issuances or HIPAA Privacy Rules if done by the Covered Entity, except uses and disclosures for the Business Associate’s own management and administration and legal responsibilities or for data aggregation services as set forth in the following three paragraphs.

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

(e) Except as otherwise limited in the Agreement, the Business Associate may disclose PHI for the proper management and administration of the Business Associate or to carry out the legal responsibilities of the Business Associate, provided that disclosures are required by law, or the Business Associate obtains reasonable assurances from the person to whom the PHI is disclosed that it will remain confidential and used or furtherdisclosed 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

W81K00-17-T-M044 Page 7 of 48 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.

W81K00-17-T-M044 Page 8 of 48

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 https://forms.us-cert.gov/report/ http://www.us-cert.gov/pgp/email.html mailto:usarmy.jbsa.medcom.list.medcom-foia-users@mail.mil mailto:usarmy.jbsa.medcom.list.medcom-foia-users@mail.mil

W81K00-17-T-M044 Page 9 of 48

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-

W81K00-17-T-M044 Page 10 of 48

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

W81K00-17-T-M044 Page 11 of 48 handle such records in accordance with the records management requirements. If the Agreement does not have records management requirements, the records should be handled in accordance with paragraphs (2) and (3) below. If the Agreement has provisions for transfer of records and

PII/PHI to a successor Business Associate, or if DHA gives directions for such transfer, the

Business Associate shall handle such records and information in accordance with such

Agreement provisions or DHA direction.

(2) If the Agreement does not have records management requirements, except as provided in the following paragraph (3), upon termination of the Agreement, for any reason, the Business

Associate shall return or destroy all PHI received from the Covered Entity, or created or received by the Business Associate on behalf of the Covered Entity that the Business Associate still maintains in any form. This provision shall apply to PHI that is in the possession of subcontractors or agents of the Business Associate. The Business Associate shall retain no copies of the PHI.

(3) If the Agreement does not have records management provisions and the Business Associate determines that returning or destroying the PHI is infeasible, the Business Associate shall provide to the Covered Entity notification of the conditions that make return or destruction infeasible. Upon mutual agreement of the Covered Entity and the Business Associate that return or destruction of PHI is infeasible, the Business

Associate shall extend the protections of the Agreement to such PHI and limit further uses and disclosures of such PHI to those purposes that make the return or destruction infeasible, for so long as the Business Associate maintains such PHI.

VII. Miscellaneous

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

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

DoD HIPAA Rules.

(End of Local Clause)

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-

W81K00-17-T-M044 Page 12 of 48

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.

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

W81K00-17-T-M044 Page 13 of 48

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.

ACCESS TO MEDICAL TREATMENT FACILITY (MTF).

1. Vehicle Registration. The MTFs are located on restricted access military installations. The

Contractor/contract employee shall comply with the local installation requirements for vehicle registration and operation on the military installation. Any vehicle operated by the contractor/contract employee in performance of this service must have the minimum liability coverage required by the state in which the installation is located. All contract employees must register their vehicles with the office responsible for vehicle registration to gain access onto the military installation. A valid driver’s license, government-furnished civilian identification, proof of insurance and current registration must be presented to the at the

Visitor Information Office located at the Main Gate, at which time a temporary vehicle pass will be issued.

2. All vehicles are subject to search. Contract employees may encounter long delays for vehicle inspection and identification checks upon entering and exiting the installation. The government will not reimburse the contractor for time spent at installation checkpoints. Contract employees should plan accordingly and report to work at their scheduled duty time, at their appointed place of duty within the MTF.

3. Access and General Protection/Security Policy and Procedures. This standard language text is for contractor employees with an area of performance within an Army controlled installation, facility or area.

Contractor and all associated sub-contractors employees shall comply with applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative). The contractor shall also provide all information required 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 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.

(End)

Invoicing, Receipt, Acceptance and Property Transfer (iRAPT) – formerly known as WAWF iRAPT is the authorized method to electronically process vendor request for payment. This application

W81K00-17-T-M044 Page 14 of 48 allows DOD vendors to submit and track Invoices and Receipt/Acceptance documents electronically.

Contractor shall (i) register to use iRAPT at https://wawf.eb.mil and (ii) ensure an electronic business point of contract (POC) is designated in the System for Award Management at https://www.sam.gov within ten

(10) calendar days after award of this contract/order.

iRAPT Instructions:

Questions concerning payments should be directed to the Defense Finance and Accounting Service (DFAS) location listed in Block 18a of your purchase order/contract. Please have your purchase order/contract number ready when calling about payments.

You can easily access payment and receipt information using the DFAS web site at http://www.dfas.mil/money/vendor . Your purchase order/contract number or invoice number will be required to inquire status of your payment.

The following codes and information will be required to assure successful flow of iRAPT documents.

Foreign Vendors will submit banking information in the Comments Tab of the iRAPT invoice.

TYPE OF DOCUMENT [X the appropriate block]

___ Invoice (Contractor Only)

__x_ Invoice and Receiving Report (COMBO)

___ Invoice as 2-in-1 (Services Only)

___ Receiving Report (Government Only)

CAGE CODE:

ISSUE BY DODAAC:W81K00

ADMIN BY DODAAC: W81K00

INSPECT BY DODAAC:

ACCEPT BY DODAAC:

SHIP TO DODAAC:

PAYMENT OFFICE FISCAL STATION CODE: 021001

EMAIL POINTS OF CONTACT LISTING: (Use Group e-mail accounts if applicable)

INSPECTOR Primary:

Alternate:

ACCEPTOR Primary:

RECEIVING OFFICE POC: Primary:

W81K00-17-T-M044 Page 15 of 48

CONTRACT ADMINISTRATOR/ SPECIALIST: calvin.l.blue.civ@mail.mil DSN:

Comm:210-539-8663 - Fax:

CONTRACTING OFFICER: See Block 31b on SF1449 for email address.

ADDITIONAL CONTACT:

Any modification requests must be in writing and submitted to:ADMIN DODAAC.

(End)

STATEMENT OF OBJECTIVES (SOO)

The Regional Health Contracting Office - Central has a requirement various orthopedic implants and supplies. When ordered, the orthopedic implant or supply item must pass a Technical Inspection performed by the regional healthcare facility’s orthopedic surgeon prior to being accepted for use by the

Government. The date/time of the procedure and case number will be provided to the vendor upon placement of an order. An order number shall be provided to the vendor by the Ordering Officer.

The government intends to award up to five (5) Blanket Purchase Agreements (BPA) to offers that are determined technically acceptable and offer a fair and reasonable price. BPA(s) will be established under Federal Acquisition Regulation (FAR) Part 12 and 13. BPA(s) issued as a result of this solicitation will have a single bulk call limit of up to $350,000.00 for a 6 months delivery period, with a maximum overall BPA limit of $7,000,000.00.

BPA calls/orders will be based on patient need and physician preference. The Medical Treatment

Facility (MTF) will schedule deliveries against the bulk call as needed based on a case by case basis.

Offerors are reminded that, in the event they receive a BPA, calls/orders are not guaranteed. Funds are not obligated on the BPA, but only on any issued calls/orders.

The anticipated period of performance is 1 October 2017 through 30 September 2022. The associated North American Industrial Classification System (NAICS) code for this procurement is 339113

– Surgical Appliance and Supplies Manufacturing, Size Standard: 750. This procurement is being conducted as a full and open competition.

Medical Treatment Facilities requiring orthopedic implants and supplies are listed below:

1) San Antonio Military Medical Center, Fort Sam Houston, TX

2) Carl R. Darnall Army Medical Center, Fort Hood, TX

3) Munson Army Health Center, Fort Leavenworth, KS

4) General Leonard Wood Army Community Hospital, Fort Leonard Wood, MO

5) Bayne-Jones Army Community Hospital, Fort Polk, LA

6) Irwin Army Community Hospital, Fort Riley, KS

7) Reynolds Army Community Hospital, Fort Sill, OK

8) Weed Army Community Hospital, Fort Irwin, CA

9) Raymond W. Bliss Army Health Center, Fort Huachuca, AZ

10) Evans Army Community Hospital, Fort Carson, CO

11) William Beaumont Army Medical Center, Fort Bliss, TX

W81K00-17-T-M044 Page 16 of 48

NOTE 1: The terms “offer” and “offeror” should be interpreted to mean the same as “quote” and “quoter” wherever they appear in the solicitation.

NOTE 2: A draft Blanket Purchase Agreement (BPA) is included with this solicitation as Attachment I.

All pertinent clauses are included in this draft BPA, and are not listed here. They are applicable to any

BPA that may result from this solicitation. Only provisions are included in this document.

NOTE 3: A price list template is included as Attachment III. Offerors may submit their own format, but should include as a minimum the headings/categories listed on the template.

SCOPE

The following points represent the Government’s requirements for the orthopedic implants and supplies.

An orthopedic implant is a device surgically placed into or onto the body designed to restore function by replacing or reinforcing a damaged structure. The medical implant is generally fabricated using stainless steel and titanium alloys for strength and the plastic coating that is done on it acts as an artificial cartilage.

Instrumentation availability for usage during surgical cases: Instrumentation must be made available 48 hours prior to surgical procedure and be picked up within 48 hours after procedure.

The government is seeking vendors that are capable of providing the orthopedic surgical implants and supplies for one or more of the following areas;

(a) Upper and/or lower extremities cases to include total joint replacement and sport medicine cases.

(b) Orthopedic implants and supplies for use in trauma and emergency surgical procedures which include multiple fractures of the hip and multiple fractures of the upper and lower extremities.

(c) Implantable implants and supplies/devices for orthopedic reconstruction.

A. SPECIFIC REQUIREMENTS: The requirements for the orthopedic implants and supplies item are:

1. Offered Products must be FDA and TAA compliant.

2. Must be able to provide clinical training (in-services) for surgeons and staff. An example of required training would consist of receiving training on the use of any new orthopedic implant or supply item based on the original equipment manufacturers instruction for use (IFU). (Offeror shall provide detailed information for any clinical training provided for offered products.)

3. Contractor shall provide procedures in the event of a recall for implants and supplies offered. If any product is recalled the contractor shall provide the dates of recall, a description of the preparations recalled, and the reasons for the recall. The contractor shall provide the corrective and preventive actions put into place for the recalls. (Offeror shall provide a detailed description of recall procedures for all offered products.)

4. Contractor shall provide a monthly report (summary) of all supplies invoiced under the BPA.

Information contained in the report shall include; Name of supplier, BPA number, Date of purchase, Purchase or case number, Itemized list of supplies furnished, Quantity, unit price, extension of each

W81K00-17-T-M044 Page 17 of 48 item, less applicable discounts, Date of delivery or shipment.

B. ORTHOPEDIC SURGERY/PROCEDURE

The listing below includes five (5) categories of orthopedic surgical procedures conducted within the

Regional Health Command - Central that requires orthopedic implants and supplies, along with specific examples of the orthopedic surgical procedures conducted under each category.

Lower Extremity Orthopedic Surgery

- TIBIA IM NAIL PLACEMENT

- PROXIMAL FEMUR

- LEG HAMSTRING REPAIR

- KNEE TKA

- KNEE ARTHROSCOPY

- EXTERNAL FIXATION APPLICATION

Foot and Ankle

- ORIF ULNA

- ORIF FOOT

- ORIF ANKLE

- NERVE BLOCK

- FOOT RECONSTRUCTION

- FOOT PINNING

- ANKLE LIGAMENT REPAIR

- ANKLE FUSION

Arm / Distal Radius Fixation Implants

- ORIF ULNA

- ORIF OLECRANON FRACTURE

- DISTAL RADIUS ORIF

- WRIST PERCUTANEOUS PINNING

- ORIF WRIST

Prosthetics - Elbow and Shoulder

- SHOULDER REVERSE ARTHROPLASTY

- SHOULDER TSA

Hip/Knee Arthroplasty Systems

- SHOULDER TSA

- HIP THA NON-CEMENTED

- HIP IM NAIL FIXATION

- HIP ARTHROPLASTY

- HIP HEMIARTHROPLASTY

W81K00-17-T-M044 Page 18 of 48

* ORIF - Open reduction and internal fixation

* TSA - Total shoulder arthroplasty

C. ORTHOPEDIC IMPLANT AND SUPPLY LIST

Attachment II – Cross Reference Product Matrix includes a sample list of orthopedic implants and supplies required. The implants and supplies listed contain a portion of the requirements of implants and supplies for the orthopedic surgeries listed in paragraph B of this solicitation. Vendors are encouraged to provide a comprehensive price list which includes all offered orthopedic implant and supply items as it relates to this requirement. Attachment III provides a template for vendor product and price listing.

52.212-1 Instructions to Offerors – Commercial Items OCT 2015

CLAUSES INCORPORATED BY FULL TEXT ADDENDUM

TO 52.212-1

Offeror shall submit the following:

1. Vendors shall submit their offers in three separate volumes. Volume I shall consist of the technical capability submittals. Volume II will consist of the pricing data. Volume III shall consist of the administrative submission. There shall be no pricing data included in Volume I or III. The combined response for Volume I shall not exceed 50 pages. Offeror shall mark and prepare each volume submitted in accordance with these instructions.

2. The following Factor(s) and sub-factor(s) will be used for evaluation purposes:

Volume I – Technical Capability

Factor 1 - Technical Capability - The technical offer shall be addressed in sufficient written detail for the

Government to determine if the offeror understands the technical aspects of the Government’s requirement. Statements that the offeror understands, can or will comply with all specifications, or statements paraphrasing the specifications of parts thereof, or phrases such as “standard procedures will be used” or “well-known techniques will be used” will be considered unacceptable. Insufficient explanations may result in your offer receiving an UNACCEPTABLE rating.

Sub-factor 1A – Specific Requirements – Offerors shall provide a detailed explanation as to how their orthopedic products meet each item listed in paragraph A of the “SPECIFIC REQUIREMENTS” section of this solicitation.

Sub-factor 1B – Orthopedic Surgical Category Identification – Offerors shall identify the category of orthopedic surgery that can be supported by the items provided on their price list. Offerors must use at least one of the surgical categories listed in paragraph B of the Statement of Objectives. Offerors may identify more than one orthopedic surgical category and may include other orthopedic surgical categories not listed in paragraph B, so long as at least one of the listed categories found in paragraph B is used. The category or categories must be stated on the price list. Offerors may use the template provided in

W81K00-17-T-M044 Page 19 of 48 attachment III or similar format when completing submittals for this sub-factor.

Sub-factor 1C –…