N6264518R0006.pdf

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CHEMISTRY ANALYZER
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N6264518R0006
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SEE ADDENDUM

(No Collect Calls)

N6264518R0006 09-Jan-2018

b. TELEPHONE NUMBER

301-619-1103

8. OFFER DUE DATE/LOCAL TIME

03:30 PM 10 Jan 2018

5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA – FAR (48 CFR) 53.212

(TYPE OR PRINT)

(SIGNATURE OF CONTRACTING OFFICER)

ADDENDA ARE

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

23.

CODE 10. THIS ACQUISITION IS

SUCH ADDRESS IN OFFER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT

BELOW IS CHECKED

TELEPHONE NO.

N626459. ISSUED BY

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

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

LETITIA R. SHIREY

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

(TYPE OR PRINT)

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

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

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

25. ACCOUNTING AND APPROPRIATION DATA

1. REQUISITION NUMBER

20.

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

N6809618RC05008

ARE NOT ATTACHED

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

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

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

. YOUR OFFER ON SOLICITATION

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

% FOR:SET ASIDE:UNRESTRICTED ORX

SMALL BUSINESS

17a.CONTRACTOR/ CODE FACILITY

OFFEROR CODE

NAVAL MEDICAL LOGISTICS COMMAND

693 NEIMAN STREET

FORT DETRICK MD 21702-9239

18a. PAYMENT WILL BE MADE BY CODE

RATED ORDER UNDER

DPAS (15 CFR 700)

13a. THIS CONTRACT IS A

13b. RATING

CODE15. DELIVER TO CODE N68096 16. ADMINISTERED BY

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

X SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFPX

NH GUAM

JOSEPH TRICE

MATERIALS MANAGEMENT

BLDG 1 L WING RM L103 FARENHOLD RD

AGANA HEIGHTS GU 96910

TEL: (671) 344-9221 FAX:

FAX:

TEL: (301) 619-9180 SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

1,000

NAICS:

334516

X

OFFER DATED

29. AWARD OF CONTRACT: REF.

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

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

EMAIL:

TEL:

31c. DATE SIGNED

SEE SCHEDULE

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

24.22.21.19.

WOMEN-OWNED SMALL BUSINESS (WOSB)

ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

(CONTINUED)

PAGE 2 OF71

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

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

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

REPRESENTATIVE

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

37. CHECK NUMBER

FINALPARTIALCOMPLETE

36. PAYMENT35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER

FINAL

33. SHIP NUMBER

PARTIAL

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

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

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

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

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

STANDARD FORM 1449 (REV. 2/2012) BACK

Prescribed by GSA – FAR (48 CFR) 53.212

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

SEE SCHEDULE

20.

SCHEDULE OF SUPPLIES/ SERVICES

21.

QUANTITY UNIT

22. 23.

UNIT PRICE

24.

AMOUNT

19.

ITEM NO.

Section SF 1449 - CONTINUATION SHEET

ADMINISTRATIVE INFORMATION

***NOTE: PROPOSALS ARE NOT BEING REQUESTED AS A RESULT OF THIS RFP***

The point of contact for administrative concerns for this order at Naval Medical Logistics Command, 693 Neiman Street, Fort Detrick, MD 21702 is Letitia Shirey, 301-619-1103, letitia.r.shirey.civ@mail.mil.

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 a proposal 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.

STATEMENT OF REQUIREMENTS

The Navy has a requirement for a 5-year Indefinite Delivery, Indefinite Quantity contract for a Chemistry/Immunoassay Analyzer that includes equipment, reagents, quality control, maintenance support, and consumable supplies for two (2) analyzers, laboratory, clinical chemistry/immunoassay [20-821] for U.S. Naval Hospital (USNH) Guam for a minimum guarantee value of $25,000. The systems shall be capable of performing a minimum throughput of 150 tests per hour. Sample and calibrator dilutions shall be performed automatically. The systems shall be capable of performing the following tests.

TEST TEST TEST

ACETAMINOPHEN CK-MB NT-PROBNP

ALBUMIN COCAINE OPIATE

ALCOHOL CREATINE PCP

ALKP CRP PHENYTOIN

ALT CSF PROTEIN PHOSPHORUS

AMMONIA DIGOXIN POTASSIUM

AMYLASE DIRECT HDL PSA

AMPHETAMINES DIRECT LDL SALICYLATE

AST DIRECT TIBC SODIUM

B-HCG, TOTAL FERRITIN T4, FREE

BARBITUATES GENTAMICIN THC

BENZODIAZAPINES GGT THEOPHYLINE

BILIRUBIN, TOTAL GLUCOSE TOBRAMYCIN

BUBC IRON TOTAL PROTEIN

BUN LACTATE TRANSFERRIN

CALCIUM LDH TRIGLYCERIDES

CARBAMAZEPINE LIPASE TROPONIN

CO2 LITHIUM TSH

CHLORIDE MAGNESIUM URIC ACID

CHOLESTEROL METHADONE URINE PROTEIN

CK, TOTAL MICROALBUMIN VALPROIC ACID

VANCOMYCIN

1. Equipment

a. The system shall not require an external water source for operation and shall not require major facility changes beyond electrical.

b. The system shall be capable of adding new third party tests.

c. The system shall be capable of utilizing the following sample types without the need for pre-treatments: serum, plasma, urine, cerebrospinal fluid (CSF).

d. The system shall be capable of pre-calibrating and storing at least 2 lots onboard the unit.

e. The system shall have sufficient onboard storage to accommodate daily workload at proper storage temperatures.

f. The system shall include a primary tube sampling system capable of handling 75 mm x 13 mm x 1000 mm x 13 mm standard test tube sizes, including pediatrics and micro containers.

g. The system shall complete STAT (urgent) requests in 60 minutes or less.

h. The system shall be capable of utilizing sample tube bar codes for accurate sample identification.

i. The system shall utilize the following operational types: batch, random access, discrete, and continuous random access.

j. The system shall be capable of maintaining calibration curves for all assays outlines above.

k. The system shall be capable of interfacing with the Composite Health Care

System (CHCS) laboratory information management system.

l. The system shall include programmable panels to accommodate in-house needs.

m. The system shall be capable of starting up without priming or washes.

n. The system shall be capable of external data storage in compliance with

Navy/Department of Defense (DoD) Information Assurance (IA) regulations.

o. The system shall include an uninterruptible power supply (UPS) that is compatible with all system components, is capable of conditioning the power to the system, and allows the system a minimum of 30 minutes run time after and during a power outage.

p. The power requirement is 220 VAC, 60 Hz, single phase.

2. Training and Support

a. System installation, validation, correlation, and onsite training is required.

b. Yearly on-sight training shall be provided for two (2) personnel and supervisor training will be offered to one (1) personnel each year.

c. On-site assistance during system validation shall be provided.

3. Reagent and Supply Delivery

a. All supplied items and reagents shall be certified for use with the equipment provided by the selected vendor.

b. All supplied items and reagents that require special handling (e.g. refrigeration, time sensitivity, immediate open, etc.) will be marked in an explicit manner with a label that is easily read, understandable, and a minimum of 3 inches x 3 inches (9 sq. inches). The label will be placed in three (3) or more locations on the container (top & two sides). Supplies or items that require refrigeration will have both the required Celsius and Fahrenheit temperature identified.

c. The contractor shall provide deliveries to the delivery point identified below:

U.S. Naval Hospital Guam Medical Laboratory Bldg #50 Farenholt Road Ste 1Y02 Agana Heights, Guam 96910

4. Maintenance

a. The Vendor Field Service Engineers shall be original equipment manufacturer (OEM) trained, experienced, and English-speaking personnel. The Vendor shall provide all labor, tools, diagnostic equipment, software, material, supplies, transportation, parts and equipment necessary to perform Preventive Maintenance (PM), Calibration (CAL), Safety Testing (ST), and corrective maintenance (CM).

b. The Vendor shall provide telephonic communications to discuss technical matters relating to the performance of this contract. An English-speaking systems operator shall be made available to answer technical questions regarding system operations and applications.

c. Equipment listed in this contract will be maintained to meet and retain the OEM’s specifications and/or equipment certification.

5. Preventive Maintenance Services

a. Normal Business Hour Maintenance Coverage will be Monday through Friday, between 8:00 A.M. to 5:00 P.M. local time in Guam. Vendor shall provide full-service preventive maintenance.

b. Preventive maintenance shall be performed in accordance with OEM recommendations.

c. Vendor shall perform preventive maintenance service checks during the base contract period at the OEM’s recommended intervals. Vendor will also perform preventive maintenance service checks during each option year at a date and time mutually agreed upon by the vendor and the Government.

d. All test equipment used in the performance of this contract shall be calibrated, as required by the OEM, and shall be in compliance with The Joint Commission (JC), OEM, the College of American Pathologist’s (CAP), and Food and Drug Administration (FDA), and National Institute for Standards and Technology (NIST) standards.

6. Corrective Maintenance

a. Vendor shall provide on-site corrective maintenance between the hours of 8:00 A.M.

and 5:00 P.M. Guam local time, Monday-Friday, to include unlimited service calls.

Telephonic support shall be available 24 hours per day, 7 days per week, 365 days a year, excluding Federal Government holidays, which are identified online at the following site: https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact-sheets/holidays-work-schedules-and-pay.

b. A vendor service technician shall respond via telephone within two (2) hours after receipt of trouble call, and provide on-site service within twenty four (24) hours.

Equipment shall be operational within 48 hours of the initial trouble call.

c. Government request for corrective maintenance will be placed by USNH Guam Biomedical Engineering Division (BIOMED) personnel, to the Vendor. Corrective maintenance shall be completed during the hours specified in the contract.

d. The vendor’s response to requests for service may include telephone consultation with the equipment user/operator and a Vendor Field Service Engineer (FSE).

Telephone consultation 1) shall provide instruction in determining operator error; 2) shall determine the most likely cause of the problem; 3) shall determine if resolution of the problem requires the dispatch of a Field Service Engineer (FSE); and 4) should identify replacement parts likely to be required to return the equipment to 100% operational condition as specified by the OEM.

e. The vendor’s pricing shall be inclusive of all costs including parts, consumables, labor, travel, and shipping.

f. The vendor FSE shall have his/her own service manuals, specifications, schematic diagrams, and parts lists to assist in the evaluation and repair of all equipment included in this contract.

7. Replacement Parts/Upgrades

a. The vendor shall have ready-access to unique and/or high mortality replacement parts. All parts supplied shall be compatible with the existing system. In the event that replacement parts are required to be shipped, shipping shall be performed in the fastest reasonable means possible at no additional cost to the Government.

b. The vendor shall replace all worn or defective parts necessary to restore the equipment to 100% operational condition as specified by the OEM.

c. Freight, postage, and storage charges associated with shipment and receipt of replacement parts and the return of parts shall be the responsibility of the vendor.

d. All replacement parts shall be new, non-refurbished, and certified as OEM replacement parts.

e. The vendor shall install software revisions, updates, and upgrades (field service changes) that are required by FDA- or manufacturer-announced safety hazards, alerts, or recalls, including the FDA Year 2000 (Y2K) Compliance Directive, as part of the contract at no additional cost to the Government. Updates, revisions, and upgrades shall be performed as soon as possible after release, no later than the first scheduled Preventative Maintenance inspection after release. For any updates that have been identified as critical or required for the proper operation of equipment by the OEM, the vendor shall provide installation within 30 days of release regardless of preventative maintenance schedules.

f. With approval from the Government, the vendor may perform hardware/software upgrades as they become available.

8. Government Furnished Property, Materials and Services

a. The Government will be responsible for maintaining the proper environment, including utilities and site requirements necessary for the system to function properly as specified by the OEM.

b. The Government will operate the system in accordance with the instruction manual provided by the OEM.

c. The Government will not be responsible for the damage or loss due to fire, theft, accident, or other disaster of Vendor supplies, materials, or for the personal belongings brought onto Government property by Vendor’s personnel.

9. Vendor Furnished Property and Material.

a. The vendor shall provide all service literature, reference publications, laptop computers, and diagnostic software to be used by the vendor FSE as required for the completion of the services in accordance with this contract.

10. Vendor Report Requirements.

a. During normal duty hours, vendor FSE personnel shall check-in with the Biomedical Engineering Division upon arrival at the Government site and again prior to departure. The vendor FSEs shall personally notify BIOMED personnel of problems that result in the equipment being left disabled upon their departure. If equipment is left disabled, a method of physical use prevention of the disabled equipment shall be implemented, and the disabled equipment shall be locked out with a letter of intent in compliance with OSHA regulation to prevent any patient hazards. After normal duty hours, vendor FSEs shall notify the Officer of the Day Desk and the Duty BIOMED personnel.

b. The vendor shall provide a full service report to BIOMED within two (2) days of completion of all services performed. Each service report shall at a minimum document the following data legibly, in complete detail, and in English:

i. Name of Vendor

ii. Contract Number

iii. Name of field service technician performing service

iv. Vendor log/control number

v. Date, time (beginning and ending), and hours on-site for service call

vi. Description of problem reported by user

vii. Equipment identification factors to include: manufacturer, make, model, serial number, and Facility Equipment Control Number (ECN)

viii. Itemized description of service performed to include: labor and travel costs, parts used, parts cost, parts number/nomenclature, part new or reconditioned, part manufacturer, and problem/corrective action taken or recommended

ix. Problem resolution or pending action

x. Reserved

xi. Signatures:

1. Field Service Technician performing services

2. BMET verifying service rendered (Identify Medical Treatment

Facility)

xii. In the event that agents / sub-vendors are used in the performance of repairs, said agent shall be identified on the service report by company name and contact information (i.e., telephone number)

11. Vendor Responsibility.

a. The vendor shall be responsible for the repair/replacement of damaged Government-owned equipment and property due to the negligence of the vendor or its representatives. All such replacement or repair shall be at the vendor's expense and shall be inspected to the satisfaction of the KO or appointed BIOMED representative.

12. Removal of Government Property

a. No equipment shall be removed without the approval of the Contracting Officer’s Representative and Materials Management Department of the Medical Treatment Facility (MTF). Property passes for equipment removal shall be obtained by the vendor via the Materials Management Department of the MTF. Any failure to obtain such passes which results in detainment or prosecution of vendor FSE personnel are the sole responsibility of the service vendor personnel.

b. The vendor shall provide a detailed description of removed items in writing on the vendor’s company letterhead. For associated items/accessories, the vendor will provide a detailed written description and quantities of items to be removed. This description will include, as a minimum, the manufacturer’s serial numbers and facility equipment control numbers (ECNs) of all equipment and/or items removed.

In the event that items/sub-assemblies/accessories are “repaired by replacement,” a detailed description of replaced items is to be included upon return of repaired components.

c. No additional charge shall be allowed for work performed off-site, or any additional time required. All charges resulting from a vendor-determined requirement to transport Government-owned property, covered by this contract, to and from an alternate repair location shall be the responsibility of the vendor. The vendor shall provide insurance coverage for damage to or loss of equipment while in vendor custody.

d. In regards to patient information confidentiality and privacy, all vendors shall not remove equipment containing patient information from the Government site. The equipment hard drive(s) and/or solid state drive(s) shall be removed at the MTF prior to removal. If hard drives are to be replaced, they shall be left at the MTF for disposal.

13. Service Beyond the Scope of the Contract

a. The vendor shall immediately, but no later than 24 consecutive hours after discovery, notify BIOMED in writing of the existence of or of the development of any defects in, or repair required to, the contracted equipment, for which the vendor considers they are not responsible under the terms of this contract.

b. At the same time of this written notification, the vendor shall furnish BIOMED with a written cost estimate to make the necessary repairs. Repairs considered by the Contracting Officer to be outside the scope of this contract shall not be covered under this contract, but shall be ordered under a separate purchase order.

RISK MANAGEMENT FRAMEWORK

Risk Management Framework

(RMF)

The contractor shall comply with RMF requirements, as specified by the Defense Health Agency (DHA) that meet appropriate DoD, DHA and Navy Cybersecurity requirements. The contractor shall initiate the process by providing the required documentation necessary to submit their system to the Authorizing Official (AO) for assessment and authorization (A&A) for all orders delivered against this contract. The requirements shall be met before the contractor's system is authorized to access DoD data or to interconnect with any DoD network or system that receives, processes, stores, displays or transmits DoD data. The contractor shall ensure the proper contractor support staff is available to participate in all phases of the RMF process. This includes, but is not limited to;

Attending and supporting RMF and A&A meetings with Navy and DHA cybersecurity representatives as required.

Support/conduct vulnerability mitigation to comply with cybersecurity controls listed in National Institute of Standards and Technology (NIST) Special Publication (SP) 800-53;

Security and Privacy Controls for Federal Information Systems and Organizations and DHA Administrative Instruction 77. In order for a system to be authorized, there shall be zero Category 1 findings.

Support the A&A Team during system security testing.

Once the system has been authorized, the contractor shall maintain an acceptable security baseline consistent with the authorization granted by the AO throughout the life of the system.

This includes ensuring that all vulnerabilities affecting the operating system, primary application, database and all third party software have validated and applied within 30 days.

Cybersecurity

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

The proposed system shall be capable of supporting the use of Defense Information

Systems Agency (DISA) approved antimalware applications. The Navy uses McAfee Host Based Security System (HBSS) as their solution. The vendor shall provide technical specifications that clearly demonstrate whether the proposed solution can integrate and support, either fully or partially the operation without performance degradation of the medical system/device. In cases where the operation of HBSS is not technically achievable, the vendor shall provide detailed justification and a Plan of Actions and Milestones (POA&M) describing steps towards compliance with this requirement.

The vendor must provide their Antivirus (AV) policy and a list of AV Exceptions (if applicable) to the NMLC prior to AV installation on the system/device. AV must be installed on all devices before they are placed on the Navy network.

Systems shall be configured in such a way to allow for the updating of malware definition signatures on a scheduled basis. Scanning shall encompass the entire system (file system, operating system, real-time processes), by default. In cases where scanning of the entire system may negatively affect its operation, the vendor shall provide a detailed list of exclusions with justifications.

Vulnerability Management

Vulnerability mitigation strategies include security updates, service packs, and changes to operating procedures as physical and cyber vulnerabilities are detected. Operating systems, servers, development platforms and the application being delivered to the Navy shall be in compliance with all known applicable guidelines. The vendor shall agree to be proactive in working with the Navy to mitigate new threats as they emerge.

All vendor validated and approved patches, up to and including the date of install, must be loaded on the system prior to system go-live. Security scans will be run during government acceptance testing. All Category I (CAT I) findings must be remediated prior to government acceptance of the system. A CAT I vulnerability is any vulnerability, the exploitation of which will, directly and immediately result in loss of Confidentiality, Availability, or Integrity. There shall be no more than 10 Category II (CAT II) findings at the time of government acceptance. CAT II vulnerabilities are any vulnerability, the exploitation of which has a potential to result in loss of Confidentiality, Availability, or Integrity.

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.

DHA Business to Business (B2B) Gateway. All contractor systems that will communicate with DON systems will interconnect through the established DHA Business to Business (B2B) gateway.

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 Virtual Private Network (VPN) device compatible with the DHA 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 DoD/DHA networks. All contractors will be required to complete a DISA Form 2875, System Authorization Access Request form (SAAR) and submit it to the Navy PACS Office for processing. Contractor personnel will be required to complete applicable DoD cybersecurity training.

IPv6

The proposed system shall be Internet Protocol version 6 (IPv6) capable or the vendor shall 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 shall be able to demonstrate or provide documentation to prove that their product is IPv6 capable

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

N6264518R0006

(HHS). This includes the Standards for Electronic Transactions, the Standards for Privacy of Individually Identifiable Health Information and the Security Standards.

Applicable References:

DoD Instruction 8510.01, Risk Management Framework (RMF) for DoD Information Technology (IT) NIST SP 800-37 Guide for Applying the Risk Management Framework to Federal Information Systems of February 2010, as amended NIST SP 800-53 Security and Privacy Controls for Federal Information Systems and Organizations, of 30 April 2013, as amended DoD Instruction 500.01 of 14 March 2014, DoD Cybersecurity DHA Administrative Instruction 77 of 28 May 2015 DoD Instruction 6025.18-R, DoD Health Information Privacy Regulation DoD Instruction 8580.02, Security of Individually Identifiable Health Information in DoD Health Care Programs

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

CHEMISTRY ANALYZER

FFP

FOR INSTRUMENTATION, REAGENTS, SUPPLIES, DISPOSABLES,

LOCATED AT NH GUAM POP: 1/15/18-1/14/19

ADDITIONAL MARKINGS: ATTN: JOSEPH TRICE; N68096-7305-5008; TP3;

N68096-180002

NET AMT

0001AA 2 Lot

CHEMISTRY ANALYZER

FFP

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FOB: Destination

MILSTRIP: N6809618RC05008

PURCHASE REQUEST NUMBER: N6809618RC05008

IMMUNOASSAY TESTS

FFP

FOR INSTRUMENTATION, REAGENTS, SUPPLIES, DISPOSABLES,

LOCATED LOCATED AT NH GUAM POP: 1/15/18-1/14/19

0002AA 2 Lot

IMMUNOASSAY TESTS

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PURCHASE REQUEST NUMBER: N6809618RC05008

CALIBRATORS, CONTROLS AND CONSUMABLES

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FOR INSTRUMENTATION, REAGENTS, SUPPLIES, DISPOSABLES,

LOCATED LOCATED AT NH GUAM POP: 1/15/18-1/14/19

0003AA 2 Lot

CALIBRATORS, CONTROLS AND CONSUMABLES

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SHIPPING

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GUAM POP: 1/15/18-1/14/19

0004AA 2 Lot

SHIPPING

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OPTION CHEMISTRY ANALYZER

FFP

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LOCATED AT NH GUAM POP: 1/15/19-1/14/20

1001AA 2 Lot

OPTION CHEMISTRY ANALYZER

FFP

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OPTION IMMUNOASSAY TESTS

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LOCATED LOCATED AT NH GUAM POP: 1/15/19-1/14/20

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OPTION CALIBRATORS, CONTROLS AND CONSUMABLES

FFP

FOR INSTRUMENTATION, REAGENTS, SUPPLIES, DISPOSABLES,

LOCATED LOCATED AT NH GUAM POP: 1/15/19-1/14/20

1003AA 2 Lot

OPTION CALIBRATORS, CONTROLS AND CONSUMABLES

FFP

THIS LINE FOR FUTURE FUNDING

FOB: Destination

OPTION SHIPPING

FFP

SHIPPING FOR REAGENT SUPPLIES, DISPOSABLES LOCATED AT NH

GUAM POP: 1/15/19-1/14/20

1004AA 2 Lot

OPTION SHIPPING

FFP

THIS LINE FOR FUTURE FUNDING

FOB: Destination

MILSTRIP: N6809618RC05008

OPTION CHEMISTRY ANALYZER

FFP

FOR INSTRUMENTATION, REAGENTS, SUPPLIES, DISPOSABLES,

LOCATED AT NH GUAM POP: 1/15/20-1/14/21

2001AA 2 Lot

OPTION CHEMISTRY ANALYZER

FFP

THIS LINE FOR FUTURE FUNDING

FOB: Destination

OPTION IMMUNOASSAY TESTS

FFP

FOR INSTRUMENTATION, REAGENTS, SUPPLIES, DISPOSABLES,

LOCATED LOCATED AT NH GUAM POP: 1/15/20-1/14/21

2002AA 2 Lot

OPTION IMMUNOASSAY TESTS

FFP

THIS LINE FOR FUTURE FUNDING

FOB: Destination

OPTION CALIBRATORS, CONTROLS AND CONSUMABLES

FFP

FOR INSTRUMENTATION, REAGENTS, SUPPLIES, DISPOSABLES,

LOCATED LOCATED AT NH GUAM POP: 1/15/20-1/14/21

2003AA 2 Lot

OPTION CALIBRATORS, CONTROLS AND CONSUMABLES

FFP

THIS LINE FOR FUTURE FUNDING

FOB: Destination

OPTION SHIPPING

FFP

SHIPPING FOR REAGENT SUPPLIES, DISPOSABLES LOCATED AT NH

GUAM POP: 1/15/20-1/14/21

2004AA 2 Lot

OPTION SHIPPING

FFP

THIS LINE FOR FUTURE FUNDING

FOB: Destination

MILSTRIP: N6809618RC05008

OPTION CHEMISTRY ANALYZER

FFP

FOR INSTRUMENTATION, REAGENTS, SUPPLIES, DISPOSABLES,

LOCATED AT NH GUAM POP: 1/15/21-1/14/22

3001AA 2 Lot

OPTION CHEMISTRY ANALYZER

FFP

THIS LINE FOR FUTURE FUNDING

FOB: Destination

OPTION IMMUNOASSAY TESTS

FFP

FOR INSTRUMENTATION, REAGENTS, SUPPLIES, DISPOSABLES,

LOCATED LOCATED AT NH GUAM POP: 1/15/21-1/14/22

3002AA 2 Lot

OPTION IMMUNOASSAY TESTS

FFP

THIS LINE FOR FUTURE FUNDING

FOB: Destination

OPTION CALIBRATORS, CONTROLS AND CONSUMABLES

FFP

FOR INSTRUMENTATION, REAGENTS, SUPPLIES, DISPOSABLES,

LOCATED LOCATED AT NH GUAM POP: 1/15/21-1/14/22

3003AA 2 Lot

OPTION CALIBRATORS, CONTROLS AND CONSUMABLES

FFP

THIS LINE FOR FUTURE FUNDING

FOB: Destination

OPTION SHIPPING

FFP

SHIPPING FOR REAGENT SUPPLIES, DISPOSABLES LOCATED AT NH

GUAM POP: 1/15/21-1/14/22

3004AA 2 Lot

OPTION SHIPPING

FFP

THIS LINE FOR FUTURE FUNDING

FOB: Destination

MILSTRIP: N6809618RC05008

OPTION CHEMISTRY ANALYZER

FFP

FOR INSTRUMENTATION, REAGENTS, SUPPLIES, DISPOSABLES,

LOCATED AT NH GUAM POP: 1/15/21-1/14/22

4001AA 2 Set

OPTION CHEMISTRY ANALYZER

FFP

THIS LINE FOR FUTURE FUNDING

FOB: Destination

OPTION IMMUNOASSAY TESTS

FFP

FOR INSTRUMENTATION, REAGENTS, SUPPLIES, DISPOSABLES,

LOCATED LOCATED AT NH GUAM POP: 1/15/22-1/14/23

4002AA 2 Lot

OPTION IMMUNOASSAY TESTS

FFP

THIS LINE FOR FUTURE FUNDING

FOB: Destination

OPTION CALIBRATORS, CONTROLS AND CONSUMABLES

FFP

FOR INSTRUMENTATION, REAGENTS, SUPPLIES, DISPOSABLES,

LOCATED LOCATED AT NH GUAM POP: 1/15/22-1/14/23

4003AA 2 Lot

OPTION CALIBRATORS, CONTROLS AND CONSUMABLES

FFP

THIS LINE FOR FUTURE FUNDING

FOB: Destination

OPTION SHIPPING

FFP

SHIPPING FOR REAGENT SUPPLIES, DISPOSABLES LOCATED AT NH

GUAM POP: 1/15/22-1/14/23

4004AA 2 Lot

OPTION SHIPPING

FFP

THIS LINE FOR FUTURE FUNDING

FOB: Destination

MILSTRIP: N6809618RC05008

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 N/A N/A N/A N/A 0001AA Destination Government Destination Government 0002 N/A N/A N/A N/A 0002AA Destination Government Destination Government 0003 N/A N/A N/A N/A 0003AA Destination Government Destination Government 0004 N/A N/A N/A N/A 0004AA Destination Government Destination Government 1001 N/A N/A N/A N/A 1001AA Destination Government Destination Government 1002 N/A N/A N/A N/A 1002AA Destination Government Destination Government 1003 N/A N/A N/A N/A 1003AA Destination Government Destination Government 1004 N/A N/A N/A N/A 1004AA Destination Government Destination Government 2001 N/A N/A N/A N/A 2001AA Destination Government Destination Government 2002 N/A N/A N/A N/A 2002AA Destination Government Destination Government 2003 N/A N/A N/A N/A 2003AA Destination Government Destination Government 2004 N/A N/A N/A N/A 2004AA Destination Government Destination Government 3001 N/A N/A N/A N/A 3001AA Destination Government Destination Government 3002 N/A N/A N/A N/A

3002AA Destination Government Destination Government 3003 N/A N/A N/A N/A 3003AA Destination Government Destination Government 3004 N/A N/A N/A N/A 3004AA Destination Government Destination Government 4001 N/A N/A N/A N/A 4001AA Destination Government Destination Government 4002 N/A N/A N/A N/A 4002AA Destination Government Destination Government 4003 N/A N/A N/A N/A 4003AA Destination Government Destination Government 4004 N/A N/A N/A N/A 4004AA Destination Government Destination Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 N/A N/A N/A N/A

0001AA POP 15-JAN-2018 TO

14-JAN-2019

N/A NH GUAM

JOSEPH TRICE

MATERIALS MANAGEMENT

BLDG 1 L WING RM L103 FARENHOLD

RD

AGANA HEIGHTS GU 96910

(671) 344-9221 FOB: Destination

N68096

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

0002AA POP 15-JAN-2018 TO

14-JAN-2019

N/A NH GUAM

JOSEPH TRICE

MATERIALS MANAGEMENT

BLDG 1 L WING RM L103 FARENHOLD

RD

AGANA HEIGHTS GU 96910

(671) 344-9221

0003 N/A N/A N/A N/A

0003AA POP 15-JAN-2018 TO

14-JAN-2019

N/A NH GUAM

JOSEPH TRICE

MATERIALS MANAGEMENT

BLDG 1 L WING RM L103 FARENHOLD

RD

AGANA HEIGHTS GU 96910

(671) 344-9221

0004 N/A N/A N/A N/A

0004AA POP 15-JAN-2018 TO

14-JAN-2019

N/A NH GUAM

JOSEPH TRICE

MATERIALS MANAGEMENT

BLDG 1 L WING RM L103 FARENHOLD

RD

AGANA HEIGHTS GU 96910

(671) 344-9221

1001 N/A N/A N/A N/A

1001AA POP 15-JAN-2019 TO

14-JAN-2020

N/A NH GUAM

JOSEPH TRICE

MATERIALS MANAGEMENT

BLDG 1 L WING RM L103 FARENHOLD

RD

AGANA HEIGHTS GU 96910

(671) 344-9221

1002 N/A N/A N/A N/A

1002AA POP 15-JAN-2019 TO

14-JAN-2020

N/A NH GUAM

JOSEPH TRICE

MATERIALS MANAGEMENT

BLDG 1 L WING RM L103 FARENHOLD

RD

AGANA HEIGHTS GU 96910

(671) 344-9221

1003 N/A N/A N/A N/A

1003AA POP 15-JAN-2019 TO

14-JAN-2020

N/A NH GUAM

JOSEPH TRICE

MATERIALS MANAGEMENT

BLDG 1 L WING RM L103 FARENHOLD

RD

AGANA HEIGHTS GU 96910

(671) 344-9221

1004 N/A N/A N/A N/A

1004AA POP 15-JAN-2018 TO

14-JAN-2019

N/A NH GUAM

JOSEPH TRICE

MATERIALS MANAGEMENT

BLDG 1 L WING RM L103 FARENHOLD

RD

AGANA HEIGHTS GU 96910

(671) 344-9221

2001 N/A N/A N/A N/A

2001AA POP 15-JAN-2020 TO

14-JAN-2021

N/A NH GUAM

JOSEPH TRICE

MATERIALS MANAGEMENT

BLDG 1 L WING RM L103 FARENHOLD

RD

AGANA HEIGHTS GU 96910

(671) 344-9221

2002 N/A N/A N/A N/A

2002AA POP 15-JAN-2020 TO

14-JAN-2021

N/A NH GUAM

JOSEPH TRICE

MATERIALS MANAGEMENT

BLDG 1 L WING RM L103 FARENHOLD

RD

AGANA HEIGHTS GU 96910

(671) 344-9221

2003 N/A N/A N/A N/A

2003AA POP 15-JAN-2020 TO

14-JAN-2021

N/A NH GUAM

JOSEPH TRICE

MATERIALS MANAGEMENT

BLDG 1 L WING RM L103 FARENHOLD

RD

AGANA HEIGHTS GU 96910

(671) 344-9221

2004 N/A N/A N/A N/A

2004AA POP 15-JAN-2018 TO

14-JAN-2019

N/A NH GUAM

JOSEPH TRICE

MATERIALS MANAGEMENT

BLDG 1 L WING RM L103 FARENHOLD

RD

AGANA HEIGHTS GU 96910

(671) 344-9221

3001 N/A N/A N/A N/A

3001AA POP 15-JAN-2021 TO

14-JAN-2022

N/A NH GUAM

JOSEPH TRICE

MATERIALS MANAGEMENT

BLDG 1 L WING RM L103 FARENHOLD

RD

AGANA HEIGHTS GU 96910

(671) 344-9221

3002 N/A N/A N/A N/A

3002AA POP 15-JAN-2021 TO

14-JAN-2022

N/A NH GUAM

JOSEPH TRICE

MATERIALS MANAGEMENT

BLDG 1 L WING RM L103 FARENHOLD

RD

AGANA HEIGHTS GU 96910

(671) 344-9221

3003 N/A N/A N/A N/A

3003AA POP 15-JAN-2021 TO

14-JAN-2022

N/A NH GUAM

JOSEPH TRICE

MATERIALS MANAGEMENT

BLDG 1 L WING RM L103 FARENHOLD

RD

AGANA HEIGHTS GU 96910

(671) 344-9221

3004 N/A N/A N/A N/A

3004AA POP 15-JAN-2018 TO

14-JAN-2019

N/A NH GUAM

JOSEPH TRICE

MATERIALS MANAGEMENT

BLDG 1 L WING RM L103 FARENHOLD

RD

AGANA HEIGHTS GU 96910

(671) 344-9221

4001 N/A N/A N/A N/A

4001AA POP 15-JAN-2022 TO

14-JAN-2023

N/A NH GUAM

JOSEPH TRICE

MATERIALS MANAGEMENT

BLDG 1 L WING RM L103 FARENHOLD

RD

AGANA HEIGHTS GU 96910

(671) 344-9221

4002 N/A N/A N/A N/A

4002AA POP 15-JAN-2022 TO

14-JAN-2023

N/A NH GUAM

JOSEPH TRICE

MATERIALS MANAGEMENT

BLDG 1 L WING RM L103 FARENHOLD

RD

AGANA HEIGHTS GU 96910

(671) 344-9221

4003 N/A N/A N/A N/A

4003AA POP 15-JAN-2022 TO

14-JAN-2023

N/A NH GUAM

JOSEPH TRICE

MATERIALS MANAGEMENT

BLDG 1 L WING RM L103 FARENHOLD

RD

AGANA HEIGHTS GU 96910

(671) 344-9221

4004 N/A N/A N/A N/A

4004AA POP 15-JAN-2018 TO

14-JAN-2019

N/A NH GUAM

JOSEPH TRICE

MATERIALS MANAGEMENT

BLDG 1 L WING RM L103 FARENHOLD

RD

AGANA HEIGHTS GU 96910

(671) 344-9221

CLAUSES INCORPORATED BY REFERENCE

52.203-3 Gratuities APR 1984 52.203-18 Prohibition on Contracting With Entities That Require Certain

Internal Confidentiality Agreements or Statements-- Representation

JAN 2017

52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements

JAN 2017

52.204-7 System for Award Management OCT 2016 52.204-13 System for Award Management Maintenance OCT 2016 52.204-16 Commercial and Government Entity Code Reporting JUL 2016 52.204-17 Ownership or Control of Offeror JUL 2016 52.204-18 Commercial and Government Entity Code Maintenance JUL 2016 52.212-1 Instructions to Offerors--Commercial Items JAN 2017 52.212-4 Contract Terms and Conditions--Commercial Items JAN 2017 52.223-3 Hazardous Material Identification And Material Safety Data JAN 1997 52.232-18 Availability Of Funds APR 1984 52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

DEC 2013

52.233-1 Disputes MAY 2014

52.233-4 Applicable Law for Breach of Contract Claim OCT 2004 52.242-15 Stop-Work Order AUG 1989 52.247-34 F.O.B. Destination NOV 1991 252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7005 Representation Relating to Compensation of Former DoD Officials

NOV 2011

252.204-7008 Compliance With Safeguarding Covered Defense Information Controls

OCT 2016

252.204-7011 Alternative Line Item Structure SEP 2011 252.204-7012 Safeguarding Covered Defense Information and Cyber

Incident Reporting

OCT 2016

252.204-7015 Notice of Authorized Disclosure of Information for Litigation Support

MAY 2016

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

(Dec 2016)

DEC 2016

252.225-7012 Preference For Certain Domestic Commodities DEC 2016 252.225-7050 Disclosure of Ownership or Control by the Government of a

Country that is a State Sponsor of Terrorism

OCT 2015

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 252.247-7022 Representation Of Extent Of Transportation Of Supplies By

Sea

AUG 1992

252.247-7023 Transportation of Supplies by Sea APR 2014

CLAUSES INCORPORATED BY FULL TEXT

52.209-11 REPRESENTATION BY CORPORATIONS REGARDING DELINQUENT TAX LIABILITY OR A

FELONY CONVICTION UNDER ANY FEDERAL LAW (FEB 2016)

(a) As required by sections 744 and 745 of Division E of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235), and similar provisions, if contained in subsequent appropriations acts, the Government will not enter into a contract with any corporation that--

(1) Has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, where the awarding agency is aware of the unpaid tax liability, unless an agency has considered suspension or debarment of the corporation and made a determination that suspension or debarment is not necessary to protect the interests of the Government; or

(2) Was convicted of a felony criminal violation under any Federal law within the preceding 24 months, where the awarding agency is aware of the conviction, unless an agency has considered suspension or debarment of the corporation and made a determination that this action is not necessary to protect the interests of the Government.

(b) The Offeror represents that--

(1) It is [ ] is not [ ] a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability; and

(2) It is [ ] is not [ ] a corporation that was convicted of a felony criminal violation under a Federal law within the preceding 24 months.

(End of provision)

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL ITEMS (NOV 2017)

The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) Web site located at https://www.sam.gov/portal. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (u) 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.

“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.

“Predecessor” means an entity that is replaced by a successor and includes any predecessors of the predecessor.

“Restricted business operations” means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate--

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

(3) Consist of providing goods or services to marginalized populations of Sudan;

(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;

(5) Consist of providing goods or services that are used only to promote health or education; or

(6) Have been voluntarily suspended.

“Sensitive technology”--

(1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically--

(i) To restrict the free flow of unbiased information in Iran; or

(ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and

(2) Does not include information or informational materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3) of the International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3)).

“Service-disabled veteran-owned small business concern”--

(1) Means a small business concern--

(i) Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

(ii) The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran.

(2) Service-disabled veteran means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

“Small business concern” means a concern, including its affiliates, that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR Part 121 and size standards in this solicitation.

“Small disadvantaged business concern”, consistent with 13 CFR 124.1002, means a small business concern under the size standard applicable to the acquisition, that--

(1) Is at least 51 percent unconditionally and directly owned (as defined at 13 CFR 124.105) by--

(i) One or more socially disadvantaged (as defined at 13 CFR 124.103) and economically disadvantaged (as defined at 13 CFR 124.104) individuals who are citizens of the United States; and

(ii) Each individual claiming economic disadvantage has a net worth not exceeding $750,000 after taking into account the applicable exclusions set forth at 13 CFR 124.104(c)(2); and

(2) The management and daily business operations of which are controlled (as defined at 13.CFR…

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