N0018321Q0001 AMENDED.docx

N0018321Q0001

Section A - Solicitation/Contract Form

SECTION A

VENDOR TO COMPLETE THE FOLLOWING:

Vendor Name: ____________________________________________________

Vendor Point of Contact:

Vendor Address: __________________________________________________

Vendor Phone:

Vendor Fax:

Vendor E-Mail:

Tax ID Number:

CAGE:

DUNS:

Vendor to reference Open Market Quote N0018321Q0001 on all correspondence relating to this RFQ.

Naval Medical Center Portsmouth Contracting Point of Contact:

Melissa Peregrino E-Mail: melissa.peregrino-white.civ@mail.mil (questions via e-mail only)

Payment in Arrears (Check One): ___ Monthly ___ Quarterly ___Semi-Annually ___Annually

Note: Vendor will be required to provide billing electronically via the WAWF Electronic Invoicing Method. For additional information, a review of the following web sites may be required: https://wawf.eb.mil http://wawftraining Email: wawf@med.navy.mil

PROMPT PAYMENT: For Prompt Payment Act purposes, this contract is:

Subject to the 7-calendar day constructive acceptance period.

Government reserves the right to make award based on the “Lowest Price Technically Acceptable” proposed for this requirement. Vendors will be evaluated based on the following factors:

1. Technical

2. Pricing

Vendor to provide technical capability, proof of pricing (i.e., past invoices) containing the items specified herein.

Section B - Supplies or Services and Prices

Digitek DC1550 Labels for FY21

FFP

Item # 4805601 W0215 21 200001 - W0215 21 200900 3 rolls = 300 labels per roll See Section C for Minimum Requirements FOB: Destination

PURCHASE REQUEST NUMBER: 0011511462

PSC CD: 3611

NET AMT

Digitek DC1550 Labels for FY21

FFP

Item # 4805601 W0215 21 000001 - W0215 21 006300 21 rolls = 300 labels per roll See Section C for Minimum Requirements FOB: Destination

PURCHASE REQUEST NUMBER: 0011511462

NET AMT

FFP

Item # 4805601 W0215 22 200001 - W0215 22 200900 3 rolls = 300 labels per roll See Section C for Minimum Requirements FOB: Destination

NET AMT

FFP

Item # 4805601 W0215 22 000001 - W0215 22 006300 21 rolls = 300 labels per roll See Section C for Minimum Requirements

NET AMT

FFP

Item # 4805601 W0215 23 200001 - W0215 23 200900 3 rolls = 300 labels per roll See Section C for Minimum Requirements

NET AMT

FFP

Item # 4805601 W0215 23 000001 - W0215 23 006300 21 rolls = 300 labels per roll See Section C for Minimum Requirements

NET AMT

FFP

Item # 4805601 W0215 24 200001 - W0215 24 200900 3 rolls = 300 labels per roll See Section C for Minimum Requirements

NET AMT

FFP

Item # 4805601 W0215 24 000001 - W0215 24 006300 21 rolls = 300 labels per roll See Section C for Minimum Requirements

NET AMT

FFP

Item # 4805601 W0215 25 200001 - W0215 25 200900 3 rolls = 300 labels per roll See Section C for Minimum Requirements

NET AMT

FFP

Item # 4805601 W0215 25 000001 - W0215 25 006300 21 rolls = 300 labels per roll See Section C for Minimum Requirements

NET AMT

Section C - Descriptions and Specifications

SECTION C

Statement of Work & Salient Characteristics

1. Vendor to ship a total of 24 rolls (300 tags/roll) each of Digitek DC 1550 Tags with the series of numbers for each fiscal year (FY) listed below, to be shipped at a rate as specified in Section F. The selected vendor must be able to supply items detailed in Section B in a new ready to use condition. As a minimum:

a. Per AABB (regulatory agency) standards:

1) Labels need to be created and maintained within the document control system to ensure that the label is correct, meets regulatory requirements, and is current. Changes to labels (including source) must be managed in a controlled process (changes to source of supplier because supplier qualification is tightly regulated)

b. Labels must comply with the following FDA and AABB documents:

1) “Guideline for the Uniform Labeling of Blood and Blood Components”

2) “International Society of Blood Transfusion (ISBT) 128 3.0.0”

3) “United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128”

c. Adhesives must be approved by the FDA: “only those substances that are FDA approved as ‘indirect food additives’ may be used in adhesives and coating components for labels placed on the base label. Labels must also be scratch resistant, maintain adherence to blood bag and specimen tubes during freezing, refrigeration, condensation, when thoroughly soaked, and any combination of these temperatures or environments.

d. Labels must abide by National regulatory requirements when selecting labels and establishing labeling policies.

e. All blood components shall be labeled with a bar-coded label.

f. Each component must bear a unique DIN that can be traced back to the blood donor. Vendor must be able to print individual DINs per tag in a sequential order specified by the customer.

g. Individual tags must measure 3.75” x 6.5”. Each tag must contain 8 large (0.750”) barcodes, 12 small (0.400”) barcode labels, 5 specimen tube (1.650”) barcoded labels. Colored circles and bag logos must rotate through each tag. Manufacturer must QA/QC DIN tags for acceptability and adherence to regulatory and customer standards prior to shipment.

2. Numbers series for each year:

a. Base Year – FY21 (to be delivered on or before 09 November 2020)

1) CLIN 1001 – W0215 21 200001 – W0215 21 200900

2) CLIN 1002 – W0215 21 000001 – W0215 21 006300

b. Option Year I – FY22 (to be delivered on or before 01 November 2021)

1) CLIN 2001 – W0215 22 200001 – W0215 22 200900

2) CLIN 2002 – W0215 22 000001 – W0215 22 006300

c. Option Year II – FY23 (to be delivered on or before 01 November 2022)

1) CLIN 3001 – W0215 23 200001 – W0215 23 200900

2) CLIN 3002 – W0215 23 000001 – W0215 23 006300

d. Option Year III – FY24 (to be delivered on or before 01 November 2023)

1) CLIN 4001 – W0215 24 200001 – W0215 24 200900

1) CLIN 4002 – W0215 24 000001 – W0215 24 006300

e. Option Year IV – FY25 (to be delivered on or before 01 November 2024)

1) CLIN 5001 – W0215 25 200001 – W0215 25 200900

2) CLIN 5002 – W0215 25 000001 – W0215 25 006300

REQUEST THE FOLLOWING INFORMATION FOR REQUEST FOR QUOTES (RFQ):

Requirement to be awarded on a Brand Name or Equal basis. Technical evaluation of vendor’s quote will consist of technical capability to provide and perform product specifications and price.

Items on this RFQ are manufactured by Computype for Naval Medical Center, Portsmouth, Virginia. Quotes should reflect pricing on all items for consideration.

Please provide government and destination pricing. If freight charges apply, indicate if charges will be “per shipment” or “single one-time charge”. Item must be warranted against manufacturer’s defects for a period of no less than 12 months and warranty to provide no cost parts, labor, travel and shipment of parts. All requested items are to be delivered as soon as possible after receipt of award.

Refrigerated, frozen, or hazardous material must be indicated as such and a copy of the Material Safety Data Sheet (MSDS) must be supplied for any hazardous material. Specify any special handling instructions.

Bids should be received by e-mail on or before the closing date. For further information, please contact:

Melissa Peregrino E-mail: melissa.peregrino-white.civ@mail.mil

Section E - Inspection and Acceptance

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLAUSES INCORPORATED BY REFERENCE

Section F - Deliveries or Performance

SECTION F

Naval Medical Center Portsmouth (NMCP) Receiving Dock Hours of Operation:

NMCP Receiving Dock is open Monday through Friday 0700 to 1600 (7:00 a.m. to 4:00 p.m.), excluding federal holidays. Receiving personnel may be reached at 757-953-5770.

DELIVERY INFORMATION

DFAS INDIANAPOLIS (GFEBS) 21001

8899 E. 56 TH STREET

INDIANAPOLIS IN 46249-3120

INDIANAPOLIS IN 46249-3120

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HT0242

HT0242

HT0242

HT0242

HT0242

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CLAUSES INCORPORATED BY FULL TEXT

52.211-17 DELIVERY OF EXCESS QUANTITIES (SEP 1989)

The Contractor is responsible for the delivery of each item quantity within allowable variations, if any. If the Contractor delivers and the Government receives quantities of any item in excess of the quantity called for (after considering any allowable variation in quantity), such excess quantities will be treated as being delivered for the convenience of the Contractor. The Government may retain such excess quantities up to $250 in value without compensating the Contractor therefor, and the Contractor waives all right, title, or interests therein. Quantities in excess of $250 will, at the option of the Government, either be returned at the Contractor's expense or retained and paid for by the Government at the contract unit price.

Section G - Contract Administration Data

252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (DEC 2018)

(a) Definitions. As used in this clause—

“Department of Defense Activity Address Code (DoDAAC)” is a six position code that uniquely identifies a unit, activity, or organization.

“Document type” means the type of payment request or receiving report available for creation in Wide Area WorkFlow (WAWF).

“Local processing office (LPO)” is the office responsible for payment certification when payment certification is done external to the entitlement system.

“Payment request” and “receiving report” are defined in the clause at 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(b) Electronic invoicing. The WAWF system provides the method to electronically process vendor payment requests and receiving reports, as authorized by Defense Federal Acquisition Regulation Supplement (DFARS) 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(c) WAWF access. To access WAWF, the Contractor shall—

(1) Have a designated electronic business point of contact in the System for Award Management at https://www.sam.gov; and

(2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration available at this web site.

(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training Course and use the Practice Training Site before submitting payment requests through WAWF. Both can be accessed by selecting the “Web Based Training” link on the WAWF home page at https://wawf.eb.mil/.

(e) WAWF methods of document submission. Document submissions may be via web entry, Electronic Data Interchange, or File Transfer Protocol.

(f) WAWF payment instructions. The Contractor shall use the following information when submitting payment requests and receiving reports in WAWF for this contract or task or delivery order:

(1) Document type. The Contractor shall submit payment requests using the following document type(s):

(i) For cost-type line items, including labor-hour or time-and-materials, submit a cost voucher.

(ii) For fixed price line items—

(A) That require shipment of a deliverable, submit the invoice and receiving report specified by the Contracting Officer.

(Contracting Officer: Insert applicable invoice and receiving report document type(s) for fixed price line items that require shipment of a deliverable.)

(B) For services that do not require shipment of a deliverable, submit either the Invoice 2in1, which meets the requirements for the invoice and receiving report, or the applicable invoice and receiving report, as specified by the Contracting Officer.

(Contracting Officer: Insert either “Invoice 2in1” or the applicable invoice and receiving report document type(s) for fixed price line items for services.)

(iii) For customary progress payments based on costs incurred, submit a progress payment request.

(iv) For performance based payments, submit a performance based payment request.

(v) For commercial item financing, submit a commercial item financing request.

(2) Fast Pay requests are only permitted when Federal Acquisition Regulation (FAR) 52.213-1 is included in the contract.

[Note: The Contractor may use a WAWF “combo” document type to create some combinations of invoice and receiving report in one step.]

(3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in applicable fields in WAWF when creating payment requests and receiving reports in the system.

Routing Data Table*

(*Contracting Officer: Insert applicable DoDAAC information. If multiple ship to/acceptance locations apply, insert “See Schedule” or “Not applicable.”) (**Contracting Officer: If the contract provides for progress payments or performance-based payments, insert the DoDAAC for the contract administration office assigned the functions under FAR 42.302(a)(13).)

(4) Payment request. The Contractor shall ensure a payment request includes documentation appropriate to the type of payment request in accordance with the payment clause, contract financing clause, or Federal Acquisition Regulation 52.216-7, Allowable Cost and Payment, as applicable.

(5) Receiving report. The Contractor shall ensure a receiving report meets the requirements of DFARS Appendix F.

(g) WAWF point of contact.

(1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity’s WAWF point of contact.

(Contracting Officer: Insert applicable information or “Not applicable.”)

(2) Contact the WAWF helpdesk at 866-618-5988, if assistance is needed.

(End of clause)

Section H - Special Contract Requirements

SECTION H

Base Access (NMCP)

Commander, Navy Installations Command (CNIC), has established the Navy Commercial Access Control System (NCACS), a standardized process for granting unescorted access privileges to vendors, contractors, suppliers and service providers not otherwise entitled to the issuance of a Common Access Card (CAC) who seek access to and can provide justification to enter Navy installations and facilities. Vendors visiting Naval Medical Center Portsmouth (NMCP) may obtain daily passes directly from Naval Station Norfolk (NSN) Pass and ID office, located at NSN (Bldg CD-9), 9040 Hampton Blvd, Norfolk, Virginia, 23505, by submitting identification credentials for verification and undergoing a criminal screening/ background check. Alternatively, if the vendor so chooses, it may voluntarily elect to obtain long-term credentials through enrollment, registration, background vetting, screening, issuance of credentials, and electronic validation of credentials at its own cost through one of the designated independent contractor NCACS service providers. Credentials will be issued every five years and access privileges will be reviewed / renewed on an annual basis. The costs incurred to obtain Navy installation access of any kind are not reimbursable, and the price(s) paid for obtaining long-term NCACS credentials will not be approved as a direct cost of this contract. Further information regarding NCACS can be found at http://cnic.navy.mil/CNIC_HQ_Site/index.htm.

BUSINESS ASSOCIATE AGREEMENT

Privacy, Access, Use, and Disclosure of Protected Health Information

1. Introduction. In accordance with 45 C.F.R. §§ 164.502(e)(2) and 164.504(e), and DoDM 6025.18, “Implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule in DoD Health Care Programs,” March 13, 2019, this document serves as a Business Associate Agreement (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 (1) a DoD Military Health System (MHS) component command such as a Navy Medicine Medical Treatment Facility (MTF) (Naval Medical center or Naval hospital), or special mission command (research, public health, other), acting as a HIPAA covered entity, and (2) another Federal or Government organization, civilian academic institution, or other civilian entity, acting as a HIPAA Business Associate (BA). The HIPAA Rules require BAAs between covered entities and BAs. Implementing this BAA requirement, the applicable DoD HIPAA issuances (DoDM 6025.18) provides that requirements applicable to BAs must be incorporated (or incorporated by reference) into the contract or agreement between the Parties.

2. Definitions:

a. Terms. 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 (DoDM6025.18-): Data aggregation, designated record set, disclosure, health care operations, individual, minimum necessary, notice of privacy practices, protected health information (PHI), required by law, secretary, security incident, subcontractor, unsecured PHI, and use.

b. Breach. means actual or possible loss of control, unauthorized disclosure of or unauthorized access to PHI or other Personally Identifiable Information (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.

c. BA. shall generally have the same meaning as the term “BA” in the DoD HIPAA issuances, and in reference to this BAA, shall mean the entity (another Government organization, civilian academic institution, or other civilian organization), entering into agreement with a Navy Medicine MTF or special mission command.

d. Agreement. means this BAA together with the documents or other arrangements under which the BA signatory performs services involving access to PHI on behalf of the MHS component signatory to this BAA.

e. 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 a Navy Medicine MTF or special mission command under the Bureau of Medicine and Surgery.

f. DHA Privacy Office. means the Defense Health Agency (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.

g. DoD HIPAA Issuances. means the DoD issuances implementing the HIPAA Rules in the DoD MHS. These issuances are DoDM 6025.18 Implementation of the HIPAA Privacy Rule in DoD Health Care Programs,” March 13, 2019; DoD Instruction 6025.18, Privacy of Individually Identifiable Health Information in DoD Health Care Programs of December 2009, and DoD Instruction 8580.02, Security of Individually Identifiable Health Information in DoD Health Care Programs of August 2015.

h. DoD Privacy Act Issuances. means the DoD issuances implementing the Privacy Act, which are DoD Directive 5400.11, DoD Privacy Program of 29 October 2014, and DoD 5400.11-R, Department of Defense Privacy Program of 8 May 2007.

i. HIPAA Rules. means, collectively, the HIPAA privacy, security, breach and enforcement rules, issued by the United States (US) Department of Health and Human Services (HHS) and codified at 45 C.F.R. §§ 160 and 164, Subpart E (Privacy), Subpart C (Security), Subpart D (Breach) and 45 C.F.R. § 160, Subparts C-D (Enforcement), as amended by the 2013 modifications to those Rules which implemented the “HITECH Act” provisions of Publication L. 111-5. See 78 Federal Regulation 5566-5702 of 25 January 2013 (with corrections at 78 Federal Regulation 32464 of 7 June 2013. Additional HIPAA rules regarding electronic transactions and code sets (45 C.F.R. § 162) are not addressed in this BAA and are not included in the term HIPAA Rules.

j. HHS Breach. means a breach that satisfies the HIPAA Breach Rule definition of “Breach” in 45 C.F.R. § 164.402.

k. 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.

3. Obligations and Activities of BA:

a. The BA shall not access, use, or disclose PHI other than as permitted or required by this Agreement, the controlling Memorandum of Understanding (MOU) or training affiliation agreement, or as required by law.

b. The BA shall use appropriate safeguards and comply with the DoD HIPAA Rules with respect to electronic PHI to prevent use or disclosure of PHI other than as provided for by this Agreement, the controlling MOU, or law.

c. The BA shall report to the covered entity any Breach of which it becomes aware and shall proceed with breach response steps required by paragraph 7 (Breach Response) of this BAA. With respect to electronic PHI, the BA shall also respond to any security incident of which it becomes aware in accordance with any information assurance provisions of the Understanding. If at any point the BA becomes aware that a security incident involves a breach, the BA shall immediately initiate breach response as required by paragraph 7 (Breach Response) of this BAA.

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

e. The BA 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 C.F.R. § 164.524.

f. The BA shall make any amendment(s) to PHI in a designated record set as directed or agreed to by the covered entity pursuant to 45 C.F.R. § 164.526, or take other measures as necessary to satisfy covered entity’s obligations under 45 C.F.R. § 164.526.

g. The BA 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 C.F.R. § 164.528.

h. To the extent the BA is to carry out one or more of the covered entity’s obligation(s) under the HIPAA privacy rule, the BA shall comply with the requirements of HIPAA privacy rule that apply to the covered entity in the performance of such obligation(s).

i. The BA shall make its internal practices, books, and records available to the Secretary and the covered entity for purposes of audit and in determining compliance with the HIPAA Rules.

4. Permitted Uses and Disclosures by BA:

a. The BA may only use or disclose PHI as necessary to perform the services set forth in the Understanding or as required by law. The BA is not permitted to de-identify PHI under DoD HIPAA issuances or the corresponding 45 C.F.R. § 164.514(a) through (c), nor is it permitted to use or disclose de-identified PHI except as provided by the Understanding or directed by the covered entity.

b. The BA 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 BA 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 BA’s own management and administration and legal responsibilities or for data aggregation services as set forth in the following three paragraphs:

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

(2) Except as otherwise limited in the Understanding, the BA may disclose PHI for the proper management and administration of the BA or to carry out the legal responsibilities of the BA, provided that disclosures are required by law, or the BA 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 BA of any instances of which it is aware in which the confidentiality of the information has been breached.

(3) Except as otherwise limited in the Understanding, the BA may use PHI to provide Data Aggregation services relating to the covered entity’s health care operations.

5. Provisions for Covered Entity to Inform BA of Privacy Practices and Restrictions:

a. The covered entity shall provide the BA with the notice of privacy practices that the covered entity produces in accordance with 45 C.F.R.§ 164.520 and the corresponding provision of the DoD HIPAA issuances (DoDM 6025.18).

b. The covered entity shall notify the BA 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 BA’s use or disclosure of PHI.

c. The covered entity shall notify the BA 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 C.F.R. § 164.522, to the extent that such changes may affect the BA’s use or disclosure of PHI.

6. Permissible Requests by Covered Entity. The covered entity shall not request the BA 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 BA as otherwise permitted by this BAA.

7. Breach Response:

a. General. Breach Response is designed to satisfy the DoD Privacy Act issuances and the HIPAA Breach Rule as implemented by the DoD HIPAA issuances. In general, the BA shall report the breach to the covered entity, assess the breach incident, notify affected individuals, and take mitigating actions, as applicable. Because DoD defines “Breach” to include possible (suspected) as well as actual (confirmed) breaches, the BA shall implement these breach response requirements immediately upon the BA’s discovery of a possible breach. The following provisions set forth the BA’s Privacy Act and HIPAA breach response requirements for all breaches, including but not limited to HHS breaches (defined below). In the event of a breach of PII or PHI held by the BA, the BA shall follow the breach response requirements set forth under paragraphs 7, 8, and 9 of this BAA, which are designed to satisfy both the Privacy Act and HIPAA, as applicable.

(1) If a breach involves PII without PHI, then the BA shall comply with DoD Privacy Act issuance breach response requirements only.

(2) If a breach involves PHI (a subset of PII), then the BA shall comply with both Privacy Act and HIPAA breach response requirements.

(3) If a breach involves PHI, it may or may not constitute an HHS Breach. If a breach is not an HHS Breach, then the BA has no HIPAA breach response obligations. In such cases, the BA must still comply with breach response requirements under the DoD Privacy Act issuances.

b. HHS Breach. If the DHA Privacy Office determines that a breach is an HHS Breach, then the BA shall comply with both the HIPAA Breach Rule and DoD Privacy Act issuances, as directed by the DHA Privacy Office, regardless of where the breach occurs.

c. Non-HHS Breach. If the DHA Privacy Office determines that the breach does not constitute an HHS Breach, then the BA shall comply with DoD Privacy Act issuances, as directed by the applicable Service-Level Privacy Office.

d. Service-Level Privacy Office Point of Contact (POC). Brian Martin, who may be reached at Comm: 904-542-3559, DSN: 312-942-3559, or via E-mail: brian.k.martin4.civ@mail.mil, or usn.ncr.bumedfchava.list.bumed-pii-rpt@mail.mil.

8. Breach Reporting Provisions:

a. The BA shall report the breach within 1 business day of discovery to the US Computer Emergency Readiness Team (US-CERT) and within 24 hours of discovery to the DHA Privacy Office and the other Parties set forth below. The BA 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 BA.

b. The BA shall submit the US-CERT report using the online form at https://forms.us-cert.gov/report. Before submission to US-CERT, the BA shall save a copy of the on-line report. After submission, the BA shall record the US-CERT Reporting Number. Although only limited information about the breach may be available as of the 1 hour deadline for submission, the BA shall submit the US-CERT report by the deadline. The BA shall e-mail updated information as it is obtained, following the instructions at: http://www.us-cert.gov/pgp/email.html. The BA shall provide a copy of the initial or updated US-CERT report to the DHA Privacy Office and the applicable Service-Level Privacy Office, if requested by either.

BA questions about US-CERT reporting shall be directed to the DHA or Service-Level Privacy Office, not the US-CERT office.

c. The BA report due within 24 hours shall be submitted by completing the New Breach Reporting Form DD 2959 at the Breach Response page on the DHA Privacy Office web site and emailing that form to, as applicable, the DHA Privacy Office, the Service-Level Privacy Office, the Contracting Officer (CO) and Contracting Officer’s Representative (COR) (if the Understanding is not a contract, delete these references to the CO and COR), and the BA’s DoD POC unless the POC specifies another addressee for breach reporting. Encryption is not required, because Breach Report Forms should not contain PII or PHI. The email address for notices to the DHA Privacy Office is provided at the Privacy Office web site breach response page. If electronic mail is not available, telephone notification is also acceptable, but all notifications and reports delivered telephonically must be confirmed by email as soon as technically feasible.

d. 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 BA shall inform the DHA Privacy Office as soon as possible if it believes that “single event” breach response is appropriate; the DHA Privacy Office will determine how the BA shall proceed and, if appropriate, consolidate separately reported breaches for purposes of BA report updates, beneficiary notification, and mitigation.

e. When a Breach Report Form initially submitted is incomplete or incorrect due to unavailable information, or when significant developments require an update, the BA 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 BA shall report include, but are not limited to:

(1) Confirmation on the exact data elements involved.

(2) Root cause of the incident.

(3) Any mitigation actions to include, sanctions, training, incident containment, follow-up, etc. The BA shall submit these report updates promptly after the new information becomes available. Prompt reporting of updates is required to allow the DHA Privacy Office to make timely final determinations on any subsequent notifications or reports. The BA shall provide updates to the same Parties as required for the initial Breach Reporting Form. The BA is responsible for reporting all information needed by the DHA Privacy Office 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.

f. In the event the BA is uncertain on how to apply the above requirements, the BA shall consult with the DHA privacy office or service-level privacy office when determinations on applying the above requirements are needed.

9. Breach - Individual Notification Provisions:

a. Determine if Notification is Required. If the DHA Privacy Office determines that individual notification is required, the BA shall provide written notification to individuals affected by the breach as soon as possible, but no later than 60 working days after the breach is discovered and the identities of the individuals ascertained. The 60-day period begins when the BA is able to determine the identities (including addresses) of the individuals whose records were impacted.

b. Draft Proposed Notification. The BA’s proposed notification to be issued to the affected individuals shall be submitted to the Parties to which reports are submitted under paragraph 7 (breach response) for their review and for approval by the DHA Privacy Office. Upon request, the BA 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 BA 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 BA’s notification to the individuals, at a minimum, shall include the following:

(1) Identify PII Lost. 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 are involved, it is critical to advise the individual that these data elements potentially have been breached.

(2) Inform. The affected 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.

(3) Protective Actions. The affected individual(s) must be informed of what protective actions the BA 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.

(4) Credit Monitoring. The individual(s) must also be informed of any mitigating support services (e.g., 1 year of free credit monitoring, identification of fraud expense coverage for affected individuals, provision of credit freezes, etc.) that the BA may offer affected individuals, the process to follow to obtain those services, 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.

(5) Labeling. BAs 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 BA 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.

c. Notification within 60 Days. If the BA determines that it cannot readily identify, or will be unable to reach, some affected individuals within the 60-day period after discovering the breach, the BA shall so indicate in the initial or updated Breach Report Form. Within the 10-day period, the BA shall provide the approved notification to those individuals who can be reached. Other individuals must be notified within 60 days after identities and addresses are ascertained. The BA 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 BA shall issue a generalized media notice(s) to that population in accordance with Privacy Office approval.

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

e. Security Incident versus Breach. 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 or PHI. In the event of a security incident not involving a PII or PHI breach, the BA shall follow applicable DoD Information Assurance requirements under its Understanding. If at any point the BA finds that a cyber security incident involves a PII or PHI breach (suspected or confirmed), the BA shall immediately initiate the breach response procedures set forth herein. The BA 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.

10. Termination:

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

b. Effect of Termination.

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

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

(3) If the Understanding does not have records management provisions and the BA determines that returning or destroying the PHI is infeasible, the BA 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 BA that return or destruction of PHI is infeasible, the BA shall extend the protections of the Understanding 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 BA maintains such PHI.

11. Miscellaneous:

a. Survival. The obligations of BA under the “Effect of Termination” provision of this BAA shall survive the termination of the Understanding.

b. Interpretation. Any ambiguity in the Understanding shall be resolved in favor of a meaning that permits the covered entity and the BA to comply with HIPAA and the DoD HIPAA Rules.

NMCARS 5237.102-90 Enterprise-wide Contractor Manpower Reporting Application (ECMRA) The contractor shall report contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the NAVAL MEDICAL CENTER PORTSMOUTH via a secure data collection site. Contracted services excluded from reporting are based on Product Service Codes (PSCs). The excluded PSCs are:

(1) W, Lease/Rental of Equipment;

(2) X, Lease/Rental of Facilities;

(3) Y, Construction of Structures and Facilities;

(4) D, Automatic Data Processing and Telecommunications, IT and Telecom- Telecommunications Transmission (D304) and Internet (D322) ONLY;

(5) S, Utilities ONLY;

(6) V, Freight and Shipping ONLY.

The contractor is required to completely fill in all required data fields using the following web address https://www.ecmra.mil.

Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year. Contractors may direct questions to the help desk, linked at https://www.ecmra.mil.

(End of Text)

Section I - Contract Clauses

52.203-18 PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE CERTAIN INTERNAL CONFIDENTIALITY AGREEMENTS OR STATEMENTS--REPRESENTATION (JAN 2017)

(a) Definition. As used in this provision-- Internal confidentiality agreement or statement, subcontract, and subcontractor, are defined in the clause at 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements.

(b) In accordance with section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions), Government agencies are not permitted to use funds appropriated (or otherwise made available) for contracts with an entity that requires employees or subcontractors of such entity seeking to report waste, fraud, or abuse to sign internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information.

(c) The prohibition in paragraph (b) of this provision does not contravene requirements applicable to Standard Form 312, (Classified Information Nondisclosure Agreement), Form 4414 (Sensitive Compartmented Information Nondisclosure Agreement), or any other form issued by a Federal department or agency governing the nondisclosure of classified information.

(d) Representation. By submission of its offer, the Offeror represents that it will not require its employees or subcontractors to sign or comply with internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting waste, fraud, or abuse related to the performance of a Government contract to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information (e.g., agency Office of the Inspector General).

(End of provision)

52.203-19 PROHIBITION ON REQUIRING CERTAIN INTERNAL CONFIDENTIALITY AGREEMENTS OR STATEMENTS (JAN 2017)

(a) Definitions. As used in this clause-- Internal confidentiality agreement or statement means a confidentiality agreement or any other written statement that the contractor requires any of its employees or subcontractors to sign regarding nondisclosure of contractor information, except that it does not include confidentiality agreements arising out of civil litigation or confidentiality agreements that contractor employees or subcontractors sign at the behest of a Federal agency.

Subcontract means any contract as defined in subpart 2.1 entered into by a subcontractor to furnish supplies or services for performance of a prime contract or a subcontract. It includes but is not limited to purchase orders, and changes and modifications to purchase orders.

Subcontractor means any supplier, distributor, vendor, or firm (including a consultant) that furnishes supplies or services to or for a prime contractor or another subcontractor.

(b) The Contractor shall not require its employees or subcontractors to sign or comply with internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting waste, fraud, or abuse related to the performance of a Government contract to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information (e.g., agency Office of the Inspector General).

(c) The…