COMBINED_SYNOPSIS_SOLICITATION__3_65.pdf

N62645-15-R-1023

Section SF 1449 - CONTINUATION SHEET

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 2 Each Heart-Lung Bypass Unit

FFP

DEVICE CODE: 11-969; S5 3-Pump console (includes:Timer, power supply, emergency power supply, electronic and power supply pack and mast system);

P/N: 48-30-00

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 48-30-00

PURCHASE REQUEST NUMBER: N0025915RCD0772

ADDITIONAL MARKINGS: ACN: N00259-17P001

NET AMT

0002 2 Each Cable holding and organizing system

FFP

P/N: 45-09-10

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 45-09-10

0003 2 Each Cable holding and organizing system

FFP

P/N: 45-09-11

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 45-09-11

0004 2 Each Cap for fast clamp (6 pes.)

FFP

P/N: 43-42-61

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 43-42-61

0005 2 Each Single roller pump

FFP

P/N: 10-80-00

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 10-80-00

0006 4 Each Double roller pump

FFP

P/N: 10-85-00

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 10-85-00

0007 8 Each Tubing insert, 1/8”x1/16”, Violet

FFP

P/N: 10-86-55

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 10-86-55

0008 6 Each Pump Tray for RP 150

FFP

P/N: 10-84-60

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 10-84-60

0009 2 Each Mast roller pump 150

FFP

(inc. mast mountable pump and control panel); P/N: 50-80-00

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 50-80-00

0010 2 Each Mast extension pole

FFP

P/N: 50-45-15

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 50-45-15

0011 4 Each Tubing Gate

FFP

P/N:10-81-30

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 10-81-30

0012 2 Each Variolock CP inserts (2) 1:1 SILVER

FFP

P/N: 10-61-91

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 10-61-91

0013 2 Each Tubing Variolock 4:1 SILVER

FFP

P/N: 10-61-94

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 10-61-94

0014 2 Each 4-slot system Panel

FFP

P/N: 28-95-00

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 28-95-00

0015 8 Each Display Module

FFP

P/N: 28-95-10

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 28-95-10

0016 2 Each Pressure sensor module (2 channel)

FFP

P/N: 22-20-20

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 22-20-20

0017 2 Each Temperature sensor module

FFP

(4 channels) for YSI probes; P/N: 20-30-20

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 20-30-20

0018 2 Each Level Sensor (incl. 23-27-40, 23-27-41)

FFP

P/N: 23-40-00

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 23-40-00

0019 2 Each Holder

FFP

(required for Level Sensor II 23-27-40); P/N: 75-521-548

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 75-521-548

0020 2 Each Mounting pads, Level sensor II

FFP

P/N: 23-27-60

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 23-27-60

0021 2 Each 3/8" Bubble sensor module

FFP

w/420 mm holder, incl. (23-07-50, 23-26-96, 23-45-20 and 96-06-10); P/N: 23-45-

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 23-45-00

0022 2 Each Tubing insert, metal, 3/8 X 3/32, BLUE

FFP

P/N: 10-07-48

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 10-07-48

0023 2 Each ¼” Bubble sensor module

FFP

w/420mm holder, inc. (23-07-40, 23-45-20 and 96-06-10); P/N: 23-45-01

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 23-45-01

0024 2 Each Tubing insert, metal, 1/4 X 1/16, RED

FFP

P/N: 10-07-45

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 10-07-45

0025 2 Each Crosstray 3 position W/Power Outlet

FFP

P/N: 48-31-19

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 48-31-19

0026 2 Each Sechrist Blender

FFP

(incl. 050-350-100 & 050-350-200); P/N: 050-350-000

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 050-350-000

0027 2 Each Heater-Cooler System 3T (110V -60Hz)

FFP

P/N: 16-02-85

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 16-02-85

0028 2 Each 3T Connection Cable to S5/C5

FFP

P/N: 45-12-16

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 45-12-16

0029 2 Each Tubing insert, Plastic ¼” x 1/16”, RED

FFP

P/N: 10-07-20

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 10-07-20

0030 2 Each Tubing insert, Plastic 1/8” x 1/16”, VIO

FFP

P/N: 10-07-27

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 10-07-27

0031 2 Each CP5 system

FFP

P/N: 60-00-60

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 60-00-60

0032 2 Each ERC Clamp

FFP

P/N: 60-05-60

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

MFR PART NR: 60-05-60

0033 1 Lot

SHIPPING

COST

The Contractor shall not ship, and the Government will assume no increase in liability, if the costs will exceed the specified estimated amount without first obtaining a contract modification to cover the additional costs.

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

ESTIMATED COST

0034 2 Each

SERVICE MANUAL

FFP

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

0035 2 Each

USER MANUAL

FFP

FOB: Destination

BRAND NAME/SOLE SOURCE: BN

MILSTRIP: N0025915RCD0772

OTHER CONTRACTING REQUIREMENTS

All Department of the Navy (DON) information systems as defined in Department of Defense Directive (DoDD)

8500.1 shall be certified and accredited (C&A) for operation. C&A is attained via the Defense Information

Assurance Certification and Accreditation Process (DIACAP) and is applicable to all DON-owned or controlled information systems that receive, process, store, display or transmit Department of Defense (DoD) information, regardless of Mission Assurance Category (MAC) classification or sensitivity, except, per DoDD 8500.1 Paragraph

2.3; IT that is considered Platform Information Technology (PIT). Regardless of whether the system or device is considered PIT or whether it is determined that it requires a full accreditation, the following DIACAP artifacts shall be included with your proposal; System Identification Profile (SIP), DIACAP Implementation Profile (DIP), and

Plan of Actions and Milestones (POA&M). A template has been included with this solicitation and is referred to as the Medical Device Risk Assessment (MDRA). Completion of this form in its entirety will satisfy the requirement for the SIP, DIP and POA&M.

The contractor shall establish appropriate administrative, technical, and physical safeguards to protect all government data, to ensure the confidentiality, integrity, and availability of government data under their control. At a minimum, this shall include provisions for personnel, electronic, and physical security.

Navy PIT Designation

Certain medical technologies may be designated as PIT by the Navy Operational Designated Accrediting Authority

(ODAA); however the PIT designation itself does not constitute an Approval to Operate (ATO). The PIT system will require a PIT Risk Analysis (PRA). The DIACAP SIP, DIP, POA&M and Risk Analysis documents are required in order to complete a PRA. Contractors will be required to scan the PIT system for vulnerabilities prior to delivery.

According to DoDD 85001, Paragraph E2.1.16.4; PIT refers to computer resources, both hardware and software, that are physically part of, dedicated to, or essential in real time to the mission performance of special-purpose systems. Medical technologies, and specifically medical imaging and monitoring systems are considered special-purpose mission technologies according to this definition.

The PIT designation issued by the ODAA may be used by the Program Manager (PM) to complete a

PRA in order to prove compliance with C&A requirements, but is cautioned that the appropriate IA controls must still be built into the IT to comply with acquisition requirements. The contractor shall work with Navy Program Managers to ensure their systems meet these requirements.

The Contractor will be required to propose an acceptable approach to selecting IA controls starting from the baseline set on DoD Instruction 8500.2 B, commensurate with the system’s Mission

Assurance Category (MAC) and Confidentiality Level. For medical devices and systems the MAC level assigned is typically MAC III sensitive.

If the system or device is determined to be PIT, the Contractor shall support Navy Medicine IA representatives in creation of the PIT designation request packages to include all relevant configuration, software and IA data. The following documents will assist is creating the PIT designation request package;

1. Digital Imaging and Communications in Medicine (DICOM) Conformance

Statement (if applicable)

2. Food and Drug Administration (FDA) Certification (510k)

3. Integrating the Healthcare Enterprise (IHE) Integration Statement

4. International Organization for Standardization (ISO) Statement (if applicable)

5. Manufacturer Disclosure Statement for Medical Device Security (MDS2)

6. A full system diagram to include any PIT to PIT or other interconnections

DIACAP

For those systems that do not meet the requirements for designation as PIT, the contractor shall comply with

DIACAP requirements as specified by the DoD that meet appropriate DoD and Navy IA requirements. The contractor shall initiate the process by providing the required documentation necessary to receive an ATO. The contractor shall make their device or system delivered against this contract available for C&A testing and initiate the process well in advance of a contract delivery order. The requirements shall be met before the contractor's system is authorized to access DoD data or interconnect with any DoD network that receives, processes, stores, displays or transmits DoD data. An ATO, at a minimum, will be required before a device or system is installed. The contractor shall ensure that the proper contractor support staff is available to participate in all phases of the DIACAP process.

They include but are not limited to;

Completing and maintaining all documentation necessary to obtain an ATO.

Attending and supporting DIACAP and C&A meetings with Navy IA representatives.

Supporting/conducting the vulnerability mitigation process to comply with IA controls listed in DoD

Instruction 8500.2.

Supporting the C&A Team during system security testing.

Contractors must confirm that their systems are locked down prior to initiating C&A testing.

Post-Accreditation Review

An annual IA review shall be conducted that comprehensively evaluates existing policies and processes to ensure procedural consistency and that the IS continues to operate in the manner to which it was accredited. The annual review process should account for the analysis of projected policy needs, and produce a plan for development or implementation of new policies or processes.

Personnel Security and User Access Control

The contractor shall comply with DoDD 8500.1, “Information Assurance (IA)”, DoD Instruction (DODI) 8500.2

“Information Assurance (IA) Implementation”, DoDD 5400.11, “DoD Privacy Program”, DoD 6025.18-R, DoD

Health Information Privacy Regulation and DoD 5200.2-R, “Personnel Security Program Requirements”.

Contractor responsibilities for ensuring personnel security include, but are not limited to meeting the following requirements:

Follow the Privacy Office guidelines for submittal of IT security clearances and ensure all contractor personnel are designated as IT-I, IT-II or IT-III where their duties meet the criteria of the position sensitivity designations.

Because of the unique circumstances presented by DoD and DON networks, personnel security requirements shall be followed to ensure appropriate precautions are taken prior to allowing vendor personnel access to the network.

Any vendor personnel that will be accessing the medical device/system while installed on the hospital network will be required to have a National Agency Check (NAC) completed. Typically, this requires an investigation to support a “Public Trust Position” and requires the person(s) to complete and submit a Standard Form 85P (SF85P), Questionnaire for Public Trust Positions, via the Electronic Personnel Security Questionnaire (EPSQ). Questions relating to SF85Ps and the EPSQ process may be directed to 1-888-282-7682 or online at http://www.dss.mil/index.htm. Contractor personnel accessing equipment connected to the hospital network will be required to complete a System Authorization Access Request-Navy (SAAR-N) (form OPNAV 5239/14). Copies of this form can be obtained from the Navy PACS Office. Additionally, contractor personnel are required to complete the annual DoD IA training requirements.

The contractor shall initiate, maintain and document personnel security investigations appropriate to the individual’s responsibilities and required access to Sensitive Information (SI).

Immediately report to the appropriate Navy POC and deny access to any automated information system (AIS), network, or information if a contractor employee filling a sensitive position receives an unfavorable adjudication, if information that would result in an unfavorable adjudication becomes available, or if directed to do so by the appropriate Navy representative for security reasons.

Ensure that all contractor personnel receive IA training before being granted access to DoD AIS’s.

Access to the medical devices will be limited to authorized users as determined by local policy. Vendors whose systems do not yet meet the requirement for CAC authentication must indicate their willingness to do so, and offer a timeline for compliance.

Operating Systems

To ensure that medical systems attain data confidentiality, integrity, and availability levels consistent with best industry practices, the use of current Operating Systems (OS) is highly recommended. Therefore preference may be given to systems that employ modern operating systems, including closed source, open source, or proprietary. Medical systems will employ whenever possible, operating systems that are fully supported by the manufacturer and are commercially available.

Domain Name System Realm/Directory Services

Contractor will be required to provide technical evidence, if applicable, whether client/server topology based medical systems can integrate with Directory Services and support LDAP authentication.

Local Privileged and Administrative User/Local System Accounts

Contractor shall create a single local user account with administrative/root level privileges for purposes of conducting system repairs and maintenance only. This account shall be separate and distinct from the built-in local administrative/root account provided by the Operating System and shall comply with DoD policy. All factors required to complete successful identification, authentication and authorization against the built-in local Administrative/Root level account shall be provided to the MTF Biomedical Engineering Department.

Complete administrative system rights shall be provided to the government System Administrator for the purpose of conducting device vulnerability scans as needed.

Navy Business to Business (B2B) Gateway http://www.dss.mil/index.htm

All contractor systems that will communicate with DON systems will interconnect through the established Military

Health System (MHS) Business to Business (B2B) gateway. For all Web applications, contractors will connect to the

DISA-established Web DMZ.

Contractors will connect to the B2B gateway via a contractor procured Internet Service Provider (ISP) connection and assume all responsibilities for establishing and maintaining their connectivity to the

B2B gateway. This will include acquiring and maintaining the circuit to the B2B gateway and acquiring a FIPS-140-2 Virtual Private Network (VPN)/Firewall device compatible with the MHS

VPN device. Maintenance and repair of contractor procured VPN equipment shall be the responsibility of the contractor.

Contractors shall configure their network to support access to government systems (e.g., configure ports and protocols for access).

Contractors shall provide full time connections to a TIER1 or TIER2 ISP. Dial-up ISP connections are not acceptable.

Contractors will comply with DoD guidance regarding allowable ports, protocols and risk mitigation strategies

Prior to accessing DON, all contractors will be required to complete a DISA Form 2875 System

Authorization Access Request form (SAAR) and submit it to NMLC, Code 03, Imaging Informatics Division for processing. The contractor will be required to complete applicable DoD IA training.

IPv6

The proposed system shall be Internet Protocol version 6 (IPv6) capable or the vendor must provide a detailed project, migration or planning documentation to show when the proposed system shall be IPv6 capable.

Minimum IPv6 capabilities include:

Conformant with the IPv6 standards profile contained in the DoD IT Standards Registry (DISR);

Maintaining interoperability in heterogeneous environments with IPv4;

Commitment to upgrade as the IPv6 standard evolves;

Availability of vendor IPv6 technical support.

The contractor must be able to demonstrate or provide documentation to prove that their product is IPv6 capable. As described in the DISR IPv6 standards profile, application vendors are expected to scan and test their code for IPv6 compliance and provide a letter of compliance indicating to what degree they comply. The letter shall be in vendor format and describe the standards used for testing and the results of the scans. IPv6 'capable' is defined as having the capability of receiving, processing and forwarding IPv6 packets and/or interfacing with other IPv6 capable systems/devices and in a manner similar to IPv4. In order to demonstrate IPv6 compliance, the vendor should submit the following documentation:

Provide a diagram showing IPv6 core configuration, to include IPv6 addressing, internal network connectivity and topology, external network connectivity, and IPv6 traffic flow;

Submit a list of core components to include vendor/manufacturer IPv6 compliance;

Submit a report that illustrates testing of IPv6 compliance, to include test scripting, logs and results.

Information Assurance Vulnerability Management (IAVM)

IAVM is focused on maintaining a secure platform as new vulnerabilities and exploits are discovered and released through various software developers and security agencies. The core tool of successful IAVM is the Information

Assurance Vulnerability Alert (IAVA). The DoD releases IAVAs for local action on the various platforms across the enterprise network. Each Navy Healthcare Facility is responsible for managing their local network. Most DoD

IAVAs originate from a real world event such as a patch release or vulnerability notification from a software vendor

(e.g. Windows or Sun patch release), or a US-CERT released from the CERT Coordination Center at Carnegie

Mellon University. To have an effective IAVM program, vendors must be proactive in monitoring emerging threats.

Some recommended sources for IAVM support are:

General Vulnerability alerts, all platforms: http://www.cert.org/nav/index_red.html

Microsoft security resources: http://www.microsoft.com/technet/security/bulletin/notify.mspx

SUN Microsystems Security resources: http://sunsolve.sun.com/pub-cgi/show.pl?target=security/sec

As part of the IAVM program, the contractor shall provide a primary and secondary point of contact for compliance actions. The point of contact shall provide, upon receipt of a vulnerability message, an acknowledgement of that receipt. The vendor shall thoroughly test all mitigations for the vulnerability, and upon applying the mitigation to the system, report compliance. Receipt and compliance messages shall occur within the stipulated time window, as stated in the vulnerability message or other official notification.

Any vendor interested in meeting this requirement shall have a documented process to demonstrate an organizational culture embracing security throughout the system lifecycle. The processes shall clearly demonstrate security’s role in the product development phase, and the processes the vendor employs to react to vulnerabilities, validate required patches, communicate status and required actions to their customers, and the follow up service support to address patch implementation.

Health Insurance Portability and Accountability Act (HIPAA)

The contractor shall comply with the HIPAA Act of 1996 (Public Law 104-191) requirements, specifically the administrative simplification provision s of the law and the associated rules and regulations published by the

Secretary, Health and Human Services (HHS). This includes the Standards for Electronic Transactions, the

Standards for Privacy of Individually Identifiable Health Information and the Security Standards.

Business Associate Agreement

In accordance with DoD 6025.18-R “Department of Defense Health Information Privacy Regulation” the Contractor meets the definition of Business Associate. Therefore, a Business Associate Agreement is required to comply with both the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security regulations. This clause serves as that agreement whereby the Contractor agrees to abide by all applicable HIPAA Privacy and Security requirements regarding health information as defined in this clause, and DoD 6025.18-R and DoD 8580.02-R, as amended. Additional requirements will be addressed when implemented.

(a) Definitions. As used in this clause generally refer to the Code of Federal Regulations (CFR) definition unless a more specific provision exists in DODI 6025.18-R.

Individual has the same meaning as the term ``individual'' in 45 CFR 164.501 and 164.103 and shall include a person who qualifies as a personal representative in accordance with 45 CFR 164.502(g).

Privacy Rule means the Standards for Privacy of Individually Identifiable Health Information at 45 CFR part 160 and part 164, subparts A and E.

Protected Health Information has the same meaning as the term ``protected health information'' in 45 CFR

164.501, limited to the information created or received by The Contractor from or on behalf of The Government.

Electronic Protected Health Information has the same meaning as the term “electronic protected health information” in 45 CFR 160.103.

Required by Law has the same meaning as the term ``required by law'' in 45 CFR 164.501 and 164.103.

Secretary means the Secretary of the Department of Health and Human Services or his/her designee.

http://www.cert.org/nav/index_red.html http://www.microsoft.com/technet/security/bulletin/notify.mspx http://sunsolve.sun.com/pub-cgi/show.pl?target=security/sec

Security Rule means the Health Insurance Reform: Security Standards at 45 CFR part 160, 162 and part

164, subpart C.

Terms used, but not otherwise defined, in this Clause shall have the same meaning as those terms in 45 CFR

160.103, 164.501 and 164.304.

(b) The Contractor shall not use or further disclose Protected Health Information other than as permitted or required by the Contract or as Required by Law.

(c) The Contractor shall use appropriate safeguards to prevent use or disclosure of the Protected Health

Information other than as provided for by this Contract.

(d) The Contractor shall use administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity, and availability of the electronic protected health information that it creates, receives, maintains, or transmits in the execution of this Contract.

(e) The Contractor shall mitigate, to the extent practicable, any harmful effect that is known to the

Contractor of a use or disclosure of Protected Health Information by the Contractor in violation of the requirements of this Contract.

(f) The Contractor shall report to the Government any security incident involving protected health information of which it becomes aware.

(g) The Contractor shall report to the Government any use or disclosure of the Protected Health

Information not provided for by this Contract of which the Contractor becomes aware of.

(h) The Contractor shall ensure that any agent, including a subcontractor, to whom it provides Protected

Health Information received from, or created or received by the Contractor on behalf of the Government agrees to the same restrictions and conditions that apply through this Contract to the Contractor with respect to such information.

(i) The Contractor shall ensure that any agent, including a subcontractor, to whom it provides electronic

Protected Health Information, agrees to implement reasonable and appropriate safeguards to protect it.

(j) The Contractor shall provide access, at the request of the Government, and in the time and manner designated by the Government to Protected Health Information in a Designated Record Set, to the Government or, as directed by the Government, to an Individual in order to meet the requirements under 45 CFR 164.524.

(k) The Contractor shall make any amendment(s) to Protected Health Information in a Designated Record

Set that the Government directs or agrees to pursuant to 45 CFR 164.526 at the request of the Government or an

Individual, and in the time and manner designated by the Government.

(l) The Contractor shall make internal practices, books, and records relating to the use and disclosure of

Protected Health Information received from, or created or received by the Contractor on behalf of, the Government, available to the Government, or at the request of the Government to the Secretary, in a time and manner designated by the Government or the Secretary, for purposes of the Secretary determining the Government’s compliance with the Privacy Rule.

(m) The Contractor shall document such disclosures of Protected Health Information and information related to such disclosures as would be required for the Government to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528.

(n) The Contractor shall provide to the Government or an Individual, in time and manner designated by the

Government, information collected in accordance with this Clause of the Contract, to permit the Government to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528.

General Use and Disclosure Provisions

Except as otherwise limited in this Clause, the Contractor may use or disclose Protected Health Information on behalf of, or to provide services to, the Government for treatment, payment, or healthcare operations purposes, in accordance with the specific use and disclosure provisions below, if such use or disclosure of Protected Health

Information would not violate the Privacy Rule, the Security Rule, DoD 6025.18-R or DoD 8580.02-R if done by the Government.

Specific Use and Disclosure Provisions

(a) Except as otherwise limited in this Clause, the Contractor may use Protected Health Information for the proper management and administration of the Contractor or to carry out the legal responsibilities of the Contractor.

(b) Except as otherwise limited in this Clause, the Contractor may disclose Protected Health Information for the proper management and administration of the Contractor, provided that disclosures are required by law, or the Contractor obtains reasonable assurances from the person to whom the information is disclosed that it will remain confidential and used or further disclosed only as required by law or for the purpose for which it was disclosed to the person, and the person notifies the Contractor of any instances of which it is aware in which the confidentiality of the information has been breached.

(c) Except as otherwise limited in this Clause, the Contractor may use Protected Health Information to provide Data Aggregation services to the Government as permitted by 45 CFR 164.504(e)(2)(i)(B).

(d) Contractor may use Protected Health Information to report violations of law to appropriate Federal and

State authorities, consistent with 45 CFR 164.502(j)(1).

Obligations of the Government

Provisions for the Government to Inform the Contractor of Privacy Practices and Restrictions

(a) Upon request the Government shall provide the Contractor with the notice of privacy practices that the

Government produces in accordance with 45 CFR 164.520, as well as any changes to such notice.

(b) The Government shall provide the Contractor with any changes in, or revocation of, permission by

Individual to use or disclose Protected Health Information, if such changes affect the Contractor's permitted or required uses and disclosures.

(c) The Government shall notify the Contractor of any restriction to the use or disclosure of Protected

Health Information that the Government has agreed to in accordance with 45 CFR 164.522.

Permissible Requests by the Government

The Government shall not request the Contractor to use or disclose Protected Health Information in any manner that would not be permissible under the Privacy Rule if done by the Government, except for providing Data

Aggregation services to the Government and for management and administrative activities of the Contractor as otherwise permitted by this clause.

Termination

(a) Termination. A breach by the Contractor of this clause, may subject the Contractor to termination under any applicable default or termination provision of this Contract.

(b) Effect of Termination.

(1) If this contract has records management requirements, the records subject to the Clause should be handled in accordance with the records management requirements. If this contract does not have records management requirements, the records should be handled in accordance with paragraphs (2) and (3) below

(2) If this contract does not have records management requirements, except as provided in paragraph (3) of this section, upon termination of this Contract, for any reason, the Contractor shall return or destroy all Protected Health Information received from the Government, or created or received by the Contractor on behalf of the Government. This provision shall apply to Protected Health Information that is in the possession of subcontractors or agents of the Contractor. The Contractor shall retain no copies of the Protected Health

Information.

(3) If this contract does not have records management provisions and the Contractor determines that returning or destroying the Protected Health Information is infeasible, the Contractor shall provide to the

Government notification of the conditions that make return or destruction infeasible. Upon mutual agreement of the

Government and the Contractor that return or destruction of Protected Health Information is infeasible, the

Contractor shall extend the protections of this Contract to such Protected Health Information and limit further uses and disclosures of such Protected Health Information to those purposes that make the return or destruction infeasible, for so long as the Contractor maintains such Protected Health Information.

Miscellaneous

(a) Regulatory References. A reference in this Clause to a section in DoD 6025.18-R, DoD 8580.02-R, Privacy Rule or Security Rule means the section as in effect or as amended, and for which compliance is required.

(b) Survival. The respective rights and obligations of Business Associate under the ``Effect of Termination'' provision of this Clause shall survive the termination of this Contract.

(c) Interpretation. Any ambiguity in this Clause shall be resolved in favor of a meaning that permits the

Government to comply with DoD 6025.18-R, DoD 8580.02-R, Privacy Rule or Security Rule

References:

Public Law 107-347, E-Government Act, December 2002; Title III, Federal Information Security

Management Act.

Public Law 100-235, Computer Security Act of 1987

National Institute for Standards and Technology Special Publication 800-70, Security Configuration

Checklists Program for IT Products – Guidance for Checklist Users and Developers, May 2005

CNSSI 4012, National Information Assurance Training Standard for Senior System Managers, June 2004

CNSSI 4013, National Information Assurance Training Standard for System Administrators, March 2004

CNSSI 4015, National Training Standard for System Certifiers, December 2000

DoDD 8100.01, Global Information Grid (GIG) Overarching Policy, 19 September 2002

DoDD 8500.01E, Information Assurance, 24 October 2002

DoDI 5000.2, Operation of the Defense Acquisition System, 12 May 03

DoDI 5200.1-R, Information Security Program, January 1997

DoDI 8500.2, Information Assurance (IA) Implementation, 6 February 2003

DoDI 8510.01, Department of Defense Information Assurance Certification and Accreditation Process

(DIACAP), 28 November 2007

DoD 8570.01-M, Information Assurance Workforce Improvement Program, 19 December 2005

CJCSI 3170.01F, Joint Capabilities Integration and Development System, 1 May 2007

CJCSI 6211.02B, Defense Information System Network (DISN): Policy, Responsibilities and Processes, 30

Aug 06

CJCSI 6212.01B, Interoperability and Supportability of National Security Systems, and Information

Technology Systems, 8 May 2000

CJCSM 3170.01C, Operation of the Joint Capabilities Integration and Development System, 1 May 2007

CJCSM 6510.01, Defense-in-Depth: Information Assurance (IA) and Computer Network Defense (CND), 8 March 2006

DISA Enclave Security Technical Implementation Guide, Version 4, Release 2

DON-CIO Memo 0-10, 26 Apr 2010 – Information Assurance Policy for Platform Information Technology

TRICARE Systems Manual 7950.1-M

SECNAV M-5239.1 Department of the Navy Information Assurance Program

Department of the Navy DIACAP Handbook, Version 1.0

DoD IPv6 Standard Profiles for IPv6 Capable Products – Supplemental Guidance v3.0.

Federal Acquisition Regulation parts 7, 11, 12, and 39

Defense Information Systems Agency (DISA) – http://www.disa.mil

Military Health System Help Desk - http://www.mhs-helpdesk.com

Department of the Navy IT resource - http://www.DONCIO.navy.mil/policy.aspx

ADMINISTRATIVE INFORMATION

THE POINT OF CONTACT FOR ADMINISTRATIVE CONCERNS FOR THIS ORDER AT NAVAL MEDICAL

LOGISTICS COMMAND, 693 NEIMAN STREET, FORT DETRICK, MD 21702 IS DEBORAH HAGAN VIA

EMAIL AT DEBORAH.L.HAGAN.CIV@MAIL.MIL.

If available please provide all operator and service manual on some form of electronic media.

CONTRACTOR SUPPORT

NOTICE: NAVY USE OF SUPPORT CONTRACTOR FOR CONTRACT CLOSEOUT FUNCTIONS

Naval Medical Logistics Command uses two private contractors in support of the contract closeout process. Those companies are Contracting Resources Group (CRG) of Federal Hill, MD, doing business under the authority of the

Small Business Administration’s 8(a) program, and the Ability One Program, doing business under the authority of the Javits-Wagner O’Day Act(41 U.S.C. § 47).

The contract closeout process includes activities such as processing deobligation modifications, obtaining contractor and requiring activity concurrence, preparing the DD-Form 1594 (Contract Completion Statement), and preparing closed files for archiving. Support contractors may perform additional administrative duties, including filing and processing simple administrative modifications. Performing these functions require the contractor employees to have access to the contract file. Therefore, information you provide to the Government or information already in the possession of the Government may be viewed by these support contractors in the course of performing contract close-out functions. The information that may be made available to the contractor may include pricing and technical proposals and performance information.

Naval Medical Logistics Command has signed Non-Disclosure Agreements with each support contractor employee and has required both contractors to provide a Conflict of interest Mitigation Plan to ensure these employees are firewalled from all business development activity.

By submission of an offer in response to this solicitation, the offeror and its subcontractors consent to access of their business sensitive/confidential or proprietary data by the Government’s support contractor personnel in order to perform close out services.

http://www.mhs-helpdesk.com/ http://www.doncio.navy.mil/policy.aspx mailto:DEBORAH.L.HAGAN.CIV@MAIL.MIL

INSTRUCTIONS TO OFFERORS

This section specifies the format and content that offerors shall use in this solicitation. Offerors shall submit a response that is legible and comprehensive enough to provide the basis for a sound evaluation by the Government.

Any proposal which does not provide, as a minimum, that which is required in the solicitation may be determined to be substantially incomplete and not warrant any further consideration.

Questions

All questions must be submitted in writing via email no later than 25 August 2015 by 10:00 am local time.

Questions must be sent via EMAIL to Deborah.L.Hagan.civ@mail.mil , SUBJECT: N62645-15-R-1023.

Answers to questions will be addressed and sent out via amendment as soon as possible after the deadline for questions has closed. In the event multiple questions address the same issue, the Government reserves the right to answer a representative question that best exemplifies the issue. Please submit only one set of questions per company.

NO telephonic questions will be accepted.

Response Submission

Responses must be submitted via email no later than 14 September 2015 by 10:00 am local time. Responses must be sent via EMAIL as a MS Word, MS Excel or Adobe PDF attachments to Deborah.L.Hagan.civ@mail.mil, SUBJECT: N62645-15-R-1023.

Individual emails shall not be more than 10MB.

All responses shall provide the following company details:

Complete company name and address

Company Point of Contact (POC)

Email

Phone Number

CAGE Code

DUNS number

Place of Manufacture

Responses received in conjuction with solicitation number N62645-15-R-1023 represents offerors concurrence with all terms and conditions herein.

Incomplete responses may not be considered. To be considered for award, responses must contain the following information:

Technical Approach

The Offerors shall include information to enable the evaluation of the proposed system and its conformance to the specified brand name by part number, manufacturer and description.

The Offerors shall complete the Medical Device Cybersecurity Assessment located at http://www.med.navy.mil/sites/nmlc/Pages/DBU-RFP.aspx

Price

Offerors shall provide pricing for all line items and a total contract price (all line items).

Offerors shall provide acknowledgement of the solicitation and all amendments.

The proposed price will be evaluated by the Government and must be determined to be fair and reasonable for award.

Other Admininstrative Instructions mailto:Deborah.L.Hagan.civ@mail.mil mailto:Deborah.L.Hagan.civ@mail.mil http://www.med.navy.mil/sites/nmlc/Pages/DBU-RFP.aspx

Offerors shall complete and submit DFARS Provision 252.209-7992 Representation by corporations regarding an unpaid delinquent tax liability or a felony conviction under any federal law—Fiscal Year 2015

Appropriations (Deviation 2015-OO0005) (DEC 2014).

Offerors shall be registered in the System for Award Management (SAM) database at time of award.

Registration is free and can be completed on-line at https://www.sam.gov/portal/public/SAM/.

BASIS FOR AWARD

This requirement will be evaluated as a Lowest Price Technically Acceptable (LPTA) requirement. Award will be made on the basis of the lowest evaluated price of proposals that meet or exceed the non-price factors. The

Government anticipates award of a firm fixed price (FFP) contract.

The Government intends to evaluate proposals and award a contract without discussions, but reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government reserves the right to make no award as a result of this solicitation.

Technical Approach Evaluation Factors

The Offeror with the lowest overall proposed price and determined technically acceptable will receive an award and no further offers will be evaluated.

Conformance to Essential Characteristics

Evaluation shall include the ability to meet the brand name of this requirement. Offerors not meeting all requirements will not be further considered for award unless there are no other technically acceptable

Offerors.

Conformance to IA Requirements

The government will evaluate the capability of the proposed system to meet the Information Assurance

(IA) requirements for the Department of Navy. This evaluation will be based on the information provided in the completed IA documentation. See “Technical” under “Instructions to Offerors”; Medical Device

Cybersecurity Assessment.

Price Evaluation Factors

Reasonableness: The degree to which the Offeror’s total proposed price represents a fair and reasonable price, including any additional components that must be purchased to make the system fully functional.

Completeness: Offeror’s have included pricing for all line items, are registered in SAM at time of award and have provided acknowledgement of all amendments.

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

0003 Destination Government Destination Government

0004 Destination Government Destination Government

0005 Destination Government Destination Government

0006 Destination Government Destination Government

0007 Destination Government Destination Government https://www.sam.gov/portal/public/SAM/

0008 Destination Government Destination Government

0009 Destination Government Destination Government

0010 Destination Government Destination Government

0011 Destination Government Destination Government

0012 Destination Government Destination Government

0013 Destination Government Destination Government

0014 Destination Government Destination Government

0015 Destination Government Destination Government

0016 Destination Government Destination Government

0017 Destination Government Destination Government

0018 Destination Government Destination Government

0019 Destination Government Destination Government

0020 Destination Government Destination Government

0021 Destination Government Destination Government

0022 Destination Government Destination Government

0023 Destination Government Destination Government

0024 Destination Government Destination Government

0025 Destination Government Destination Government

0026 Destination Government Destination Government

0027 Destination Government Destination Government

0028 Destination Government Destination Government

0029 Destination Government Destination Government

0030 Destination Government Destination Government

0031 Destination Government Destination Government

0032 Destination Government Destination Government

0033 Destination Government Destination Government

0034 Destination Government Destination Government

0035 Destination Government Destination Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC

0001 28-SEP-2015 2 NAVAL MEDICAL CENTER SAN DIEGO

JESSE LOFTUS

RECEIVING LOADING DOCK 1

34800 BOB WILSON DRIVE

SAN DIEGO CA 92134-5000

619-532-5752

N00259

0002 28-SEP-2015 2 (SAME AS PREVIOUS LOCATION)

0003 28-SEP-2015 2 (SAME AS PREVIOUS LOCATION)

0004 28-SEP-2015 2 (SAME AS PREVIOUS LOCATION)

0005 28-SEP-2015 2 (SAME AS PREVIOUS LOCATION)

0006 28-SEP-2015 4 (SAME AS PREVIOUS LOCATION)

0007 28-SEP-2015 8 (SAME AS PREVIOUS LOCATION)

0008 28-SEP-2015 6 (SAME AS PREVIOUS LOCATION)

0009 28-SEP-2015 2 (SAME AS PREVIOUS LOCATION)

0010 28-SEP-2015 2 (SAME AS PREVIOUS LOCATION)

0011 28-SEP-2015 4 (SAME AS PREVIOUS LOCATION)

0012 28-SEP-2015 2 (SAME AS PREVIOUS LOCATION)

0013 28-SEP-2015 2 (SAME AS PREVIOUS LOCATION)

0014 28-SEP-2015 2 (SAME AS PREVIOUS LOCATION)

0015 28-SEP-2015 8 (SAME AS PREVIOUS LOCATION)

0016 28-SEP-2015 2 (SAME AS PREVIOUS LOCATION)

0017 28-SEP-2015 2 (SAME AS PREVIOUS LOCATION)

0018 28-SEP-2015 2 (SAME AS PREVIOUS LOCATION)

0019 28-SEP-2015 2 (SAME AS PREVIOUS LOCATION)

0020 28-SEP-2015 2 (SAME AS PREVIOUS LOCATION)

0021 28-SEP-2015 2 (SAME AS PREVIOUS LOCATION)

0022 28-SEP-2015 2 (SAME AS PREVIOUS LOCATION)

0023 28-SEP-2015 2 (SAME AS PREVIOUS LOCATION)

0024 28-SEP-2015 2 (SAME AS PREVIOUS LOCATION)

0025 28-SEP-2015 2 (SAME AS PREVIOUS LOCATION)

0026 28-SEP-2015 2 (SAME AS PREVIOUS LOCATION)

0027 28-SEP-2015 2 (SAME AS PREVIOUS LOCATION)

0028 28-SEP-2015 2 (SAME AS PREVIOUS LOCATION)

0029 28-SEP-2015 2 (SAME AS PREVIOUS LOCATION)

0030 28-SEP-2015 2 (SAME AS PREVIOUS LOCATION)

0031 28-SEP-2015 2 (SAME AS PREVIOUS LOCATION)

0032 28-SEP-2015 2 (SAME AS PREVIOUS LOCATION)

0033 28-SEP-2015 1 (SAME AS PREVIOUS LOCATION)

0034 28-SEP-2015 2 (SAME AS PREVIOUS LOCATION)

0035 28-SEP-2015 2 (SAME AS PREVIOUS LOCATION)

CLAUSES INCORPORATED BY REFERENCE

52.203-3 Gratuities APR 1984

52.204-7 System for Award Management JUL 2013

52.204-13 System for Award Management Maintenance JUL 2013

52.209-7 Information Regarding Responsibility Matters JUL 2013

52.212-1 Instructions to Offerors--Commercial Items APR 2014

52.212-4 Contract Terms and Conditions--Commercial Items MAY 2015

52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

DEC 2013

52.247-34 F.O.B. Destination NOV 1991

252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7002 Requirement to Inform Employees of Whistleblower Rights SEP 2013

252.203-7005 Representation Relating to Compensation of Former DoD

Officials

NOV 2011

252.204-7003 Control Of Government Personnel Work Product APR 1992

252.204-7012 Safeguarding of Unclassified Controlled Technical

Information

NOV 2013

252.204-7015 Disclosure of Information to Litigation Support Contractors FEB 2014

252.222-7007 Representation Regarding Combating Trafficking in Persons JAN 2015

252.223-7008 Prohibition of Hexavalent Chromium JUN 2013

252.225-7001 Buy American And Balance Of Payments Program-- Basic

(Nov 2014)

NOV 2014

252.225-7012 Preference For Certain Domestic Commodities FEB 2013

252.232-7003 Electronic Submission of Payment Requests and Receiving

Reports

JUN 2012

252.232-7010 Levies on Contract Payments DEC 2006

252.243-7001 Pricing Of Contract Modifications DEC 1991

252.243-7002 Requests for Equitable Adjustment DEC 2012

252.244-7000 Subcontracts for Commercial Items JUN 2013

252.246-7006 Warranty Tracking of Serialized Items JUN 2011

252.247-7023 Transportation of Supplies by Sea APR 2014

CLAUSES INCORPORATED BY FULL TEXT

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL ITEMS (MAR 2015)

ALTERNATE I (OCT 2014)

The offeror shall complete only paragraphs (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) Web site accessed through http://www.acquisition.gov . If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (p) of this provision.

(a) Definitions. As used in this provision--

“Economically disadvantaged women-owned small business (EDWOSB) concern” means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

“Forced or indentured child labor” means all work or service—

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

http://www.acquisition.gov/

“Highest-level owner” means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

“Immediate owner” means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following: Ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

“Inverted domestic corporation,” means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

“Manufactured end product” means any end product in product and service codes (PSCs) 1000-9999, except—

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

“Place of manufacture” means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

“Restricted business operations” means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military…