E.01 W91YT22Q0083.pdf

SEE ADDENDUM

(No Collect Calls)

W91YTZ22Q0083 25-Jul-2022

b. TELEPHONE NUMBER

910-907-9310

8. OFFER DUE DATE/LOCAL TIME

10:00 AM 05 Aug 2022

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

CYNTHIA A. RICHARDSON-RHONE

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

1 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

0011708957

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 RHCO-ATLANTIC USAHCA

WOMACK ARMY MEDICAL CENTER

POC: LONNIE K. ROBINSON

BLDG 4-2817 REILLY RD

FORT BRAGG NC 28310

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 W36XTM 16. ADMINISTERED BY

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFPX

WOMACK ARMY HOSPITAL

WOMACK ARMY MEDICAL CENTER

2817 REILLY RD

FORT BRAGG NC 28310

TEL: FAX:

FAX:

TEL: 910-907-9303 SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

$35,000,000

NAICS:

621991

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 OF84

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.

W91YTZ22Q0083

Section SF 1449 - CONTINUATION SHEET

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0002 1 Each Contractor Manpower Report

FFP

CMR

FOB: Destination

PSC CD: 6515

NET AMT

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1 Job

BPA CATI PERIOPERATIVE BLOOD

FFP

FY22 BPA FOR CELL SAVER EQUIPMENT FOR SURGICAL PROCEDURES

AS NEEDED AT WOMACK ARMY MEDICAL CENTER, OPERATING

ROOM. THE CONTRACTOR SHALL BRING IN THE EQUIPMENT IN THE

DAY BEFORE SURGURY FOR INSPECTION BY MEDICAL

MAINTENANCE. POP:10 AUG 2022 THRU 9 AUG 2026 PAYMENT MADE

VIA WAWF/CREDIT CARD(for EMERGENCY CASES ONLY) CAROLINA

AUTOTRANSFUSION.

FOB: Destination

PURCHASE REQUEST NUMBER: 0011708957

PSC CD: 6515

NET AMT

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government 0002 Destination Government Destination Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 POP 10-AUG-2022 TO

09-AUG-2026

N/A WOMACK ARMY HOSPITAL

WOMACK ARMY MEDICAL CENTER

2817 REILLY RD

FORT BRAGG NC 28310

FOB: Destination

W36XTM

0002 N/A N/A N/A N/A

BPA AGREEMENT

BLANKET PURCHASE AGREEMENT

BLANKET PURCHASE AGREEMENT (BPA)

Between

TBD

And

UNITED STATES DEPARTMENT OF DEFENSE (DoD)

1. AUTHORITY. This agreement is established in accordance with Federal Acquisition Regulation (FAR) Part 13, Subpart 13.303, Blanket Purchase Agreements (BPAs). This BPA will be reviewed by the Contracting Officer at least once annually before the anniversary of the effective date, and revised to conform to all requirements of Statutes, Executive Orders, and the FAR. Revisions will be evidenced by a modification to the BPA.

2. DESCRIPTION OF AGREEMENT. TBD shall provide all supplies as per this agreement in Section B of the BPA Schedule (Supplies/ Services and Prices). To include any potential components manufactured/or distributed by the contractor. Supplies shall be provided in accordance with the terms and conditions of this agreement.

3. EVENT OF OBLIGATION. TBD is hereby incorporated into this BPA. The Government is obligated only to the extent of calls (orders) placed by authorized individuals and the purchase limitations of this BPA. Calls (orders) will be made by placing calls for services required. Payment will be made for actual services rendered.

4. PURCHASE LIMITATION. MIN: BPA Delivery Order Limit = $25,000.00 MAX: Master Dollar Limit = $98,314.42 for the life of the BPA.

POP: 10 August 22 – 9 Aug 2026

5. INDIVIDUALS AUTHORIZED TO PURCHASE UNDER THE BPA.

A listing of individuals authorized to place purchases/calls under this agreement shall be identified by Regional Health Contracting Office-Atlantic, Womack Army Medical Center Contracting Cell in writing to the contractor, and shall be identified by organization component, title and dollar limitation per call for each individual authorized to place purchases/calls.

Calls placed by individuals not on the list are not authorized and shall not be honored by the contractor. Services provided by the contractor in violation of this authorization will be treated as an unauthorized commitment and may result in termination of this agreement by the government. Changes in the list shall require the signature of the Administering Contracting Officer.

Authorized individuals to place orders/calls:

5. DELIVERY TICKETS. Payments for calls issued under this BPA will be made by iRAPT if applicable. All shipments under this BPA shall be accompanied by delivery ticket that contains the following information:

-Name of Supplier -BPA Number and Call Number -Date of Request -Request Number -Itemized List of Equipment, Supplies, Materials Furnished of each service -Quantity, Unit Price, and Extension of Each Item, Less Applicable Discounts -Date of Delivery of Shipment/Service -Individual Placing Order

6. NUMBERING OF PURCHASES/CALLS PLACED UNDER THIS AGREEMENT.

Orders shall be placed by authorized personnel as calls against this BPA via FAX, mail order, telephonically (with written follow-up) and/or Electronic Data Interchange (EDI).

7. INVOICES/PAYMENTS.

The contractor shall create a per shipment invoice for each call received. The invoice shall list all products received for this shipment. The contractor is expected to submit an invoice upon receipt of a BPA Call.

Invoice payments will be made via the iRAPT. See attachment.

Invoice billings will be generated and emailed or faxed to the authorized ordering individual upon completion of service. The billings are based upon the attached pricing list.

Prices for this BPA are set forth in the contractor's published price list which is attached to this BPA, and will be updated at least on an annual basis and/or as required by any equipment change, substitution or upgrade. Pricing shall be based on published catalog price-list and any discounts offered. Prices to the Government shall be as low as, or lower than, those charged to the contractor’s most favored customers for comparable quantities of similar items or services. Pricing information will be provided as an attachment to the BPA.

There are no funds available for this BPA. Funds will be made available and the government will only be obligated for payment upon issuance of valid order/call placed against this BPA. The Government is only obligated to the extent of authorized orders made against the BPA. There is no minimum monetary amount the Government is obligated to purchase under this BPA.

Invoice billings will be generated and emailed or faxed to the authorized ordering individual monthly. The billings are based upon the attached pricing list.

8. SHIPPING INSTRUCTIONS.

CONTRACT/ PURCHASE ORDER NUMBER: W91YTZ-22-A-TBD

DO NOT UNDER ANY CIRCUMSTANCES SHIP ITEMS TO ADDRESSES OTHER THAN THOSE

SPECIFIED HEREIN. TO DO SO IS IN VIOLATION OF THIS ORDER AND COST OF SHIPMENT TO

ADDRESS OTHER THAN THAT SPECIFIED IN THIS ORDER WILL NOT BE PAID UNLESS THE SHIP

TO/DELIVERY ADDRESS IS CHANGED BY MODIFICATION TO THE ORDER SIGNED BY A

CONTRACTING OFFICER.

SHIP TO THE FOLLOWING ADDRESS:

XR USA MED DEPT ACTV

WOMACK ARMY MEDICAL CENTER

BLDG 4-2817 REILLY ROAD

FT BRAGG NC 28310-5000

EXTERIOR OF ALL SHIPPING CARTONS MUST BE MARKED WITH CONTRACT/PURCHASE ORDER

NUMBER. IF YOU ARE “DROP SHIPPING” ENSURE YOUR SHIPPER COMPLIES WITH THESE

INSTRUCTIONS. CARTONS WITHOUT IDENTIFICATION WILL BE RETURNED “FREIGHT COLLECT”.

THE ADDRESS LISTED ABOVE IS THE PRIMARY DELIVERY POINT. HOWEVER, SHIPPING

INSTRUCTION MAY CHANGE DEPENDING ON WHEN, WHERE AND HOW THE OPERATING ROOM

REPRESENTATIVES NEEDS THE PRODUCTS DELIVERED. FOLLOW THE INSTRUCTIONS FOR THE

WAMC REPRESENTATIVE IN THE ORDER.

11. PRICING:

Pricing shall be established at the time of award of the BPA and updated annually and/or as required by any equipment change, substitution or upgrade. Pricing shall be based on published catalog price list and any discounts offered. Prices to the Government shall be as low as, or lower than, those charged to the contractor’s most favored customers for comparable quantities of similar items or services. Pricing information will be provided as an attachment to the BPA.

12. REVIEW: The Regional Health Contracting Office-Atlantic, Womack Army Medical Center, Fort Bragg, NC will review this blanket purchase agreement annually. Review may be conducted to ensure that prices for services are in accordance with the terms and conditions of this BPA and that proper procedure have been followed. This is called an internal review. The contractor will be contacted if there are any discrepancies.

13. Non-Defense Health Agency (Non-DHA) Health Insurance Portability and Accountability Act (HIPAA) Business Associate Agreement (BAA) (7 July 2014) Introduction In accordance with 45 CFR 164.502(e)(2) and 164.504(e) and paragraph C.3.4.1.3 of DoD 6025.18-R, “DoD Health Information Privacy Regulation,” January 24, 2003, this document serves as a BAA between the signatory parties for purposes of the HIPAA and the “HITECH Act” amendments thereof, as implemented by the HIPAA Rules and DoD HIPAA Issuances (both defined below). The parties are a DoD Military Health System (MHS) component, acting as a HIPAA covered entity, and a DoD contractor, acting as a HIPAA business associate. The HIPAA Rules require BAAs between covered entities and business associates. Implementing this BAA requirement, the applicable DoD HIPAA Issuance (DoD 6025.18-R, paragraph C3.4.1.3) provides that requirements applicable to business associates must be incorporated (or incorporated by reference) into the contract or agreement between the parties.

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

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

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

—Agreement means this BAA together with the documents and/or other arrangements under which the Business Associate signatory performs services involving access to PHI on behalf of the MHS component signatory to this

BAA.

—Covered Entity shall generally have the same meaning as the term “covered entity” in the DoD HIPAA Issuances, and in reference to this BAA, shall mean [insert name of MHS component signatory to this BAA].

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

(NCRMD).

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

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

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

—HIPAA Rules means, collectively, the HIPAA Privacy, Security, Breach and Enforcement Rules, issued by the U.S. Department of Health and Human Services (HHS) and codified at 45 CFR Part 160 and Part 164, Subpart E (Privacy), Subpart C (Security), Subpart D (Breach) and Part 160, Subparts C-D (Enforcement), as amended by the 2013 modifications to those Rules, implementing the “HITECH Act” provisions of Pub. L. 111-5. See 78 FR 5566-

5702 (Jan. 25, 2013) (with corrections at 78 FR 32464 (June 7, 2013)). Additional HIPAA rules regarding electronic transactions and code sets (45 CFR Part 162) are not addressed in this BAA and are not included in the term HIPAA Rules.

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

I. Obligations and Activities of Business Associate

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

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

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

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

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

CFR 164.524.

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

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

CFR 164.528.

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

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

II. Permitted Uses and Disclosures by Business Associate

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

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

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

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

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

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

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

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

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

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

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

V. Breach Response

(a) In general.

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

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

This Part V is designed to satisfy the DoD Privacy Act Issuances and the HIPAA Breach Rule as implemented by the DoD HIPAA Issuances. In general, for breach response, the Business Associate shall report the breach to the Covered Entity, assess the breach incident, notify affected individuals, and take mitigation actions as applicable.

Because DoD defines “breach” to include possible (suspected) as well as actual (confirmed) breaches, the Business Associate shall implement these breach response requirements immediately upon the Business Associate’s discovery of a possible breach.

(b) Government Reporting Provisions The Business Associate shall report the breach within one hour of discovery to the Covered Entity and to the US Computer Emergency Readiness Team (US CERT) -the other parties as deemed appropriate by the Covered Entity.

The Business Associate is deemed to have discovered a breach as of the time a breach (suspected or confirmed) is known, or by exercising reasonable diligence would have been known, to any person (other than the person committing it) who is an employee, officer or other agent of the Business Associate.

The Business Associate shall submit the US-CERT report using the online form at https://forms.us-cert.gov/report/.

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

The additional US Army and the US Army Medical Command (MEDCOM) reporting requirements are addressed in the PII Breach Reporting and Notification Policy. The latest version of this policy can be obtained from the Covered Entity or the MEDCOM Privacy Act/Freedom of Information Act (FOIA) Office at:

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

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

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

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

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

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

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

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

THEFT (438-4338); TTY: 1-866-653-4261.

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

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

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

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

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

VI. Termination

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

(b) Effect of Termination.

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

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

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

VII. Miscellaneous

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

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

(End of Clause)

14. 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.

IRAPT

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 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)

___ Invoice and Receiving Report (COMBO) ___X_ Invoice as 2-in-1 (Services Only) ____ Receiving Report (Government Only)

CAGE CODE: TBD

ISSUE BY DODAAC: W91YTZ

ADMIN BY DODAAC: W36XTM

INSPECT BY DODAAC: W36XTM

ACCEPT BY DODAAC: W36XTM

SHIP TO DODAAC: W36XTM

PAYMENT OFFICE FISCAL STATION CODE: HQ0490

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

INSPECTOR Primary: TBD Alternate: TBD ACCEPTOR Primary: TBD Alternate: TBD

RECEIVING OFFICE POC: TBD

Primary: TBD Alternate: TBD Additional Point of Contact: TBD

CONTRACT ADMINISTRATOR/ SPECIALIST: TBD

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

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

(End of clause)

PERFORMANCE WORK STATEMENT (PWS)

(h) Scope of Work. The Contractor shall provide the Autotransfusion Cell Saver® Elite®+ system that provides hospitals with an easy-to-use, reliable way to recover and deliver back a patient’s own high-quality blood during medium to high blood loss surgeries. Cell Saver Autotransfusion services collects the bloodshed, mix with an anticoagulant, filter and wash it, and then run it through a centrifuge before finally returning the blood to the patient.

The company has a Scientific Advisory Council of members covering Trauma/Critical Care, Cardiac Surgery, Anesthesiology and Cardiology to help guide product development and clinical research initiation. The Contractor shall provide all equipment and transportation necessary to supply Intra-operative Procedures and Critical Emergencies. In addition, the contractor will also provide a fully insured and professionally credentialed Auto-transfusionist who will not only provide intra-operative monitoring of the Cell Saver data but also be in constant communication with real–time, highly experienced supervising Nursing Staff who will oversee the interpretation of data for immediate alerts to surgeons/trauma team; in case of potential harm or compromise to the patient at Womack Army Medical Center (WAMC), Fort Bragg, NC 28310. A Company must also have local Contractors/Technicians/Auto-transfusionist and all associated Sub-contractors that can be available to respond upon notification in case of Emergency Surgeries or Traumas.

1.1 Specific Tasks. The contractor shall provide Womack Army Medical Center with The Cell Saver equipment and Contract Auto-transfusionist to perform the procedures. The contractor shall arrive prior to the start of the surgical procedure/ Trauma and remain present during the entirety of the procedure until the patient leaves the Operating room/ Emergency Room. The contractor shall provide scheduling support services 24/7. No minimum notice will be required. The client may, in the event of an emergency, cancel a scheduled procedure prior to the reported start time by telephone notice to the company. The quality and all components of the Cell Saver System contractor are Joint Commission, and AABB accredited and appropriate documentation will be provided to WAMC. The contractor will have 24 hrs. for scheduled procedure.

1.2 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 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 as directed by DHA, 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. Contractor must adhere to and comply with the requirements of AR 190‐13 and AR 680‐10.

2. Employees.

• The Government has the right to restrict any Contractor who is identified as a potential threat to the health, safety, security, general wellbeing or operational mission of the installation and its population.

• At the time of the proposal the Contractor shall provide a roster of personnel expected to perform services under this contract to the Contracting Officer at the post award conference. This personnel roster shall include the employee’s full name, badge number, licenses and certifications held.

• The Contractor shall not employ any person who is an employee of the United States Government if the employment of that person would create a conflict of interest.

• Contractor shall comply with all safety requirements, in accordance with Army Regulation (AR) 385-10, Occupational Safety Health Administration (OSHA) and Emergency Management (EM) 385-1-1.

• All personnel employed by the Contractor in the performance of this contract, or any representative of the Contractor entering the Government reservation, shall abide by all the regulations, policies, and procedures of the installation, which may be in effect during the contract period.

3. Network Access Requirements for U.S. Government Contracts. NA

4. Vehicle Registration N/A

4.1. All vehicles must be cleared for access using All American Access Gate.

5. Hours of Operation.

5.1. The contractor shall provide a 24-hour per day point of contact by name and telephone number, the government will provide a point of contact for the contractor.

5.2. The Contractor is required to make available the supplies and services at all times as they are needed for surgeries at the military treatment facility (MTF).

6. Safety Requirements.

6.1. Equipment Safety. Prior to any equipment being placed into operation for a scheduled procedure, the Contractor shall bring the equipment in the day before surgery for inspection and shall obtain a safety technical inspection from the Equipment Maintenance Section, Directorate of Logistics, Bldg. 4-2817, Womack Army Medical Center, Fort Bragg, NC 28310. The equipment requires a verification/ calibration, copies of the last service performed will be provided to the Equipment Maintenance Section. The Contractor is responsible and liable for ensuring this safety inspection takes place before surgery begins on a patient. The government is responsible and liable to follow-up that this equipment has been through the safety inspection before surgery. In performance of this contract it can be inspected by the COR at any time. If the equipment is at any time deemed unsafe or unserviceable by the COR, the Contractor shall remove equipment from the area immediately. The government is responsible for ensuring the Contractor at any tier is assuring equipment is used in a safe, responsible manner. The Contractor shall, in all cases, ensure any equipment used in the performance of this contract is in a safe and serviceable condition.

6.2. Personnel Safety. The Contractor and Sub-Contractors shall not leave equipment unattended while in use.

7. Definitions.

7.1. Contract Discrepancy Report. A report of the Government's surveillance of failure to meet the contract specifications by the Contractor.

7.2. Contracting Officer. A warranted individual appointed with the authority to obligate the government’s money.

7.3. Contracting Officer Representative (COR). An individual designated by the contracting officer to act as his/her representative to assist in administering a contract. The source and authority for a COR is the Contracting Officer and limitations of a COR are contained in the written letter of designation.

7.4. Door/Exit Alarm. Type of alarm from the infant abduction system which occurs when an active infant transmitter has come either too close to an open exit door or has passed through an open exit door.

7.5. Facility. Building or office – Real Property.

7.7. Government Property. All property owned by or leased to the Government or acquired by the Government under the terms of the contract. Government property includes both Government-furnished property and Contractor acquired property as defined in FAR 45.101.

7.8. Quality Assurance. Those actions taken by the Government to assure services meet the requirements of the

Performance Work Statement (PWS) and all other service outputs.

7.9. Quality Control. Those actions taken by a Contractor to control the performance of services so that they meet the requirements of the PWS.

7.10. Repair. Restoration of an item to a condition substantially equivalent to its original or designed capacity and efficiency, so that the item may be continuously utilized for its intended purpose.

7.11. Security Event. A security event will be a forced door, held door, unauthorized access level, unattended bag or package, cut band, door exit alarm, or any other type of event programmed into the system which will trigger or activate the access control/CCTV system.

7.12. Security Violation. A security violation or infraction is any breach of security regulations, requirements, procedures or guidelines, whether or not they compromise results.

8. Contractor Furnished Items and Services.

8.1. General. The Contractor shall furnish everything required to perform the requirement of this contract.

8.2. Repair Parts. The Contractor shall provide all repair parts required to maintain all systems in operational status.

9. Emergency Medical Services.

9.1. Medical services for Contractor and all associated Sub-Contractor personnel are the responsibility of the Contractor.