N62645-16-R-0048.pdf

SEE ADDENDUM

(No Collect Calls)

N62645-16-R-0048 29-Jun-2016

b. TELEPHONE NUMBER

301-619-6914

8. OFFER DUE DATE/LOCAL TIME

11:00 AM 01 Aug 2016

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

DEREK J. BELL

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

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

N6264516RCES056

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 16. ADMINISTERED BY

SEE SCHEDULE

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFPX

FAX:

TEL: (301) 619-9180

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

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 OF46

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.

N62645-16-R-0048

Section SF 1449 - CONTINUATION SHEET

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1 Each

X-RAY DIFFRACTOMETER

FFP

FOB: Destination

MILSTRIP: N6264516RCES056

PURCHASE REQUEST NUMBER: N6264516RCES056

NET AMT

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0002 1 Each Medical Device Risk Assessment (MDRA)

FFP

Refer to Conformance to Cybersecurity Requirements under Instructions to

Offerors. Completed Gold Section returned to Naval Medical Logistics Command

(NMLC) within 10 days after award.

FOB: Destination

NET AMT

ESSENTIAL CHARACTERISTICS

The requirement is for one (1) X-ray Diffractometer for the Comprehensive Industrial Hygiene Laboratory (CIHL)

Detachment San Diego. The system shall be capable of performing National Institute of Occupational Safety and

Health (NIOSH) and Occupational Safety and Health Administration (OSHA) testing to ensure workplace safety.

The system shall be capable of detecting low levels of silica in bulk and air samples according to OSHA and NIOSH guidelines. The system shall be a production-grade powder X-Ray diffractometer with high resolution focusing optics, used to routinely measure free silica samples for Ag membrane filter samples and for bulk Si samples. The system will have complete computer-controlled alignment and a complete PC-based software package. The system shall be compatible with the currently-installed laboratory information management system, Sample Master v8.5.

Instrument installation, onsite familiarization, and operator training for at least two (2) staff members are required.

At least two days of onsite applications consulting at the time of installation are required. All system components shall include a 1-year warranty. The power requirement is 220VAC, 60Hz, 40Amp max.

1. The system shall include an x-ray generator

a. Maximum Power: 3kW Continuous Rated Maximum Output Power

b. Operation: Computer-Controlled and Manual Operation

c. Minimum Voltage Range: 20-50 kV, 1 kV steps

d. Minimum Current Range: 2-60 mA, 1 mA steps

e. Stability: Maximum 0.01 % with 10 % fluctuations, voltage and current

f. Required Safety Features:

i. Abnormal Cooling Water Flow and Pressure Detection

ii. Abnormal Generator Overload Detection

iii. Abnormal Tube Voltage Detection

iv. Emergency Stop Switch

v. Leak Current Breaker

vi. X-rays Completely Shut-Off if Any Fail-Safe Devices are Tripped or Fail to Operate.

2. The system shall include an x-ray tube and tube shield

a. 2200 W Copper Target, Long-Fine Focus, X-ray Tube that must be able to be operated at maximum tube power

b. Electromagnetic Shutters Interlocked with Radiation Enclosure

c. 6° Take Off Angle

3. The system shall include a Goniometer

a. Geometry: Vertical / (keeps sample horizontal and stationary)

b. Radius: 285 mm (optimized for intensity vs. resolution)

c. Measuring Range:

i. -1.5° ~ 77°, 0.0001° step s (x-ray source motion)

ii. -5° ~ 154°, 0.0001° step d (detector motion)

iii. -5° ~ 145°, 0.0001° step d with In-Plane Axis (detector motion)

iv. -3° ~ 154°*, 0.0002° step 2 (depends on position)

1. *162° with optional 7 mm receiving slit box

v. -3° ~ 154°, 0.0002° step 2 with In-Plane Axis (depends on position)

vi. -5° ~ 145°, 0.0002° step 2 transmission mode

d. Scanning Method: s/ independent or coupled

e. Scanning Range:

i. -7 ~ 2.5 mm, 0.001 mm step Ts (x-ray tube motion)

ii. -3 ~ 1.5 mm, 0.001 mm step Zs (divergence slit motion)

4. The system shall include an optical system

a. Optics: Bragg-Brentano Para-Focusing (BB) Optics

b. Divergence Slit: Fixed Divergence Slit set

c. Antiscatter Slit: Fixed Antiscatter Slit set

d. Soller Slits: Axial Divergence Angle 5°

e. Receiving Slit: Fixed Receiving Slit Set

5. The system shall include an Automatic 48-Sample (minimum) Changer

a. Application: Programmable Sample Changing, Sample Spinning for Particle Statistics

b. Stage: 48 positions minimum

c. Spinning: Computer-Controlled, Maximum Speed 60-120 rpm

d. Sample Holders: Minimum of 48 holders for Ag membrane filters and 48 sample holders for bulk samples

6. The system shall include a point detector

a. Type: Scintillation Counter

b. Linearity: 700,000 cps or better

c. Electronics:

i. Pulse Height Analyzer, Computer-Controlled

ii. Detector High Voltage, Computer-Controlled

d. Dead time correction: Computer-Controlled and Automated

e. Max. 2θ:

i. 159 ° for R=285 mm without in-plane arm

ii. 150 ° for R=285 mm without in-plane arm

iii. 152 ° for R=185 mm (θS/θD coupled)

f. Scanning speed: Maximum 100 °/min (θ/2θ coupled scan)

7. The system shall include a sliding door type radiation enclosure with a Leaded-Acrylic Window. The enclosure shall be safety interlocked with electromagnetic shutter mechanism. The enclosure shall meet all radiation safety codes for the State of California.

8. The system shall include a Haskris refrigerated water-cooled chiller, with the capacity to cool the x-ray tube. The chiller shall be outfitted with all necessary hardware for effective use, including, but not limited to, alarms and flowmeter.

9. The system shall include a Ni Filter

10. The system shall include Control and Measurement Software

a. The software shall include a configuration program enabling user control of the following:

goniometer and detector settings, attachment configuration definitions, optics definitions

b. The software shall allow for manual measurement, enabling user control of each of the goniometer and attachment axes, setting of the detector pulse height, and allowing for correction of analyzer, high voltage, and dead time. The software shall allow for checking of system alignment and performing simple measurements.

c. The software shall be capable of automatically aligning each of the goniomter and attachment axes, setting detector pulse height, and allowing for correction of analyzer, high voltage, and dead time.

d. The software shall allow standard measurement data collection of free silica samples

11. The system shall include Powder Diffraction Analysis Software

a. Required display features include: zoom, reset, pan, Multiple pattern overlays in 2D and 3D, Hiding analysis results to show raw data only, Switching 2 theta axis to S or Q, Customizing line colors, widths, and markers, Windows clipboard support for copy and pasting into other applications, Thumbnail viewing, File drag and drop, View crystal structures in 3D with real-time manipulation.

b. Required data reduction features include: Automatic data reduction and peak list reporting, Sonneveld-Visser and polynomial function background elimination, Rachinger method Kα2 elimination, Automatic and/or manual peak finding, Peak-top and second-derivative peak finding, Gaussian moving average, Savitzky-Golay, optimized Gaussian moving average, and B-spline smoothing.

c. The software shall include a quantitative analysis package capable of:

i. performing free Si quantitative analyses

ii. quantitative analyses using calibration curves

iii. Internal standard, external standard, and standard addition methods

iv. Simultaneous automatic analysis of multiple samples

12. The system shall include a computer workstation with the following minimum specifications:

a. Intel Core i7 Processor (3.4GHz minimum) or equivalent

b. 4.0 GB SDRAM

c. Video, 256MB ATI RADEON HD3450 or equivalent

d. Internal audio speaker

e. 500 GB hard drive with 16MB DataBurst Cache

f. 20" flat panel LCD

g. 8 USB ports

h. 16X DVD+/-RW capable of read/write CD’s

i. Keyboard, mouse, and pad

j. DoD approved operating system

k. Adobe Acrobat Standard

l. Microsoft Office 2013 Basic

m. Color printer with parallel cable

n. Two Ethernet ports

o. 3 year basic limited warranty

Vendor shall be an Original Equipment Manufacturer (OEM) authorized maintenance contractor for the proposed equipment/systems, such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

CYBERSECURITY REQUIREMENTS

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 (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

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.

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 Derek Bell, 301-619-6914, derek.j.bell.civ@mail.mil.

INSTRUCTIONS TO OFFERORS

This section specifies the format and content that Offerors shall use in this Request for Proposal (RFP). Offerors shall submit a proposal 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.

Proposals shall be submitted by email only as an MS Word or Adobe PDF attachment to Derek Bell at derek.j.bell.civ@mail.mil. Proposals are due by 11:00 am local time on 01 August 2016.

Any questions must be addressed to derek.j.bell.civ@mail.mil by email only no later than 11:00 am local time on 08

July 2016. No phone calls accepted.

All Offerors shall provide the following company details on its cover page:

Complete company name and address

Company Point of Contact (POC)

Email

Phone Number

Cage Code

DUNS number

Place of Manufacture

Technical

Conformance to Statement of Requirements

Offerors shall submit a proposal including all necessary documentation demonstrating that its solution meets all of the requirements within the Essential Characteristics. If marketing brochures are submitted, please ensure that it denotes exactly how all Essential Characteristics are met; otherwise, provide the supplemental information within the technical approach of the proposal. Offerors shall submit sufficient documentation to allow for an evaluation of the Technical Approach and its abilities to meet the Essential Characteristics.

Design Quality and Capability

Offerors shall submit sufficient documentation to allow for an evaluation of the Design Quality and Capability of the proposed system to detect silica in bulk and air samples, under the operation of staff at CIHL San Diego.

Conformance to Cybersecurity Requirements

Offerors shall complete the Medical Device Risk Assessment (MDRA) Questionnaire (C&A Questionnaire form) by following the instructions within the document at http://www.med.navy.mil/sites/nmlc/Pages/DBU-RFP.aspx

(bottom of page).

The total number of pages submitted for technical shall not exceed twenty (20) pages, excluding a cover letter and

MDRA Questionnaire. If technical contains more than twenty (20) pages, only the first twenty (20) pages will be evaluated.

Past Performance

Contractors shall provide past performance data for similar contracts for the last 5 years, up to 5 data points, or 5 data points for delivery starting with the most recent contracts for which delivery occurred at least 3 months prior to the closing of this solicitation.

The data for each past performance example shall include but is not limited to:

Contract Number

Contract Date mailto:derek.j.bell.civ@mail.mil mailto:derek.j.bell.civ@mail.mil mailto:derek.j.bell.civ@mail.mil http://www.med.navy.mil/sites/nmlc/Pages/DBU-RFP.aspx

Value of Contract (rounding to the nearest $5K is acceptable)

Brief explanation as to the scope of the project

Organization/Location

Validated Point of Contact (POC)

Validated Email address

Validated telephone number

In addition please document if the POC “Has agreed to be to be contacted as a reference?”

Price

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

The Offerors shall provide acknowledgement of the solicitation and of any amendments.

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

Other Administrative Instructions

The Offerors shall complete and submit FAR Provision 52.209-11-Representation by Corporations

Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law (Feb 2016)

Contractors must 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 OF AWARD

The Government intends to award a contract to the contractor whose response conforms to the solicitation and will be most advantageous to the Government, price and other factors considered.

This is a best value procurement. The Government may elect to award to other than the lowest cost, based on the evaluation of the non-cost factors and the best value to the Government. Proposals must include sufficiently detailed information to enable evaluation based on the factors listed below in order of decreasing priority:

1. Technical

a) Conformance to Essential Characteristics

b) Conformance to Cybersecurity requirements

c) Design Quality and Capability

2. Past Performance

3. Price

The non-priced factors when combined are more important than price. Price may be a determining factor should two or more quotes are essentially equal in the technical and past performance evaluation.

Government intends to award without discussions but reserves the right to conduct discussions if determined necessary.

1. Technical Evaluation Factors Conformance to Essential Characteristics – Evaluation shall include the ability to meet the essential characteristics of this requirement. Vendors not meeting all requirements will not be further considered for award, unless there are no other technically acceptable offerors. This will be rated either Pass or Fail.

Conformance to Cybersecurity requirements – The Government will evaluate the capability of the proposed system to meet Cybersecurity requirements. This evaluation will be based on the information provided in the completed Medical Device Risk Assessment (MDRA) Questionnaire (C&A Questionnaire form) found at http://www.med.navy.mil/sites/nmlc/Pages/DBU-RFP.aspx. Information provided in another part of the response will not be evaluated for this factor.

Design Quality and Capability – The Government will evaluate the design, quality and capabilities of the proposed system to detect silica in bulk and air samples, under the operation of staff at CIHL San Diego.

https://www.sam.gov/portal/public/SAM/ http://www.med.navy.mil/sites/nmlc/Pages/DBU-RFP.aspx

2. Past Performance Evaluation Factors Government will evaluate the offeror's recent relevant past performance record as to (1) the functional performance of the proposed or similar X-ray Diffractometer that the offeror has delivered to previous customers, and (2) the quality and timeliness of the technical assistance, hardware and software updates/upgrades that the vendor has supplied to its customers following the initial fielding of those systems.

The government reserves the right to consider other past performance information at its disposal, in addition to any information obtained from the references provided above.

Past performance will be considered relevant if the offeror has supplied the same/similar services within the scope of this requirement within the last three (3) years. If the offeror does not possess relevant past performance, the offeror shall submit a statement affirming that it possesses no relevant Past Performance.

3. Price Evaluation Factors

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

b. Completeness- All required provisions, acknowledged amendments, completed pricing and other solicitation requirements have been provided.

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government

0002 Destination Government Destination Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC

0001 30-SEP-2016 1 COMPREHENSIVE INDUSTRIAL

HYGIENE LAB SD

3235 ALBACORE ALLEY

SAN DIEGO CA 92136

N41776

0002 10 dys. ADC 1 NAVAL MEDICAL LOGISTICS COMMAND

CODE 03 - PACS

693 NEIMAN STREET

FORT DETRICK MD 21702-9239

301-619-9349

N62645

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

52.204-16 Commercial and Government Entity Code Reporting JUL 2015

52.204-18 Commercial and Government Entity Code Maintenance JUL 2015

52.209-7 Information Regarding Responsibility Matters JUL 2013

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

52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

DEC 2013

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

DEC 2015

252.204-7012 Safeguarding Covered Defense Information and Cyber

Incident Reporting.

DEC 2015

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

252.211-7008 Use of Government-Assigned Serial Numbers SEP 2010

252.213-7000 Notice to Prospective Suppliers on Use of Past Performance

Information Retrieval System--Statistical Reporting in Past

Performance Evaluations

JUN 2015

252.215-7008 Only One Offer OCT 2013

252.222-7007 Representation Regarding Combating Trafficking in Persons JAN 2015

252.223-7008 Prohibition of Hexavalent Chromium JUN 2013

252.225-7012 Preference For Certain Domestic Commodities FEB 2013

252.225-7021 Trade Agreements--Basic (OCT 2015) OCT 2015

252.226-7001 Utilization of Indian Organizations and Indian-Owned

Economic Enterprises, and Native Hawaiian Small Business

Concerns

SEP 2004

252.232-7003 Electronic Submission of Payment Requests and Receiving

Reports

JUN 2012

252.232-7010 Levies on Contract Payments DEC 2006

252.243-7002 Requests for Equitable Adjustment DEC 2012

252.244-7000 Subcontracts for Commercial Items JUN 2013

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)

Printed Name Title Date

Signature Company Name

52.212-1 INSTRUCTIONS TO OFFERORS--COMMERCIAL ITEMS (OCT 2015)

(a) North American Industry Classification System (NAICS) code and small business size standard. The NAICS code and small business size standard for this acquisition appear in Block 10 of the solicitation cover sheet (SF

1449). However, the small business size standard for a concern which submits an offer in its own name, but which proposes to furnish an item which it did not itself manufacture, is 500 employees.

(b) Submission of offers. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation. Offers may be submitted on the SF 1449, letterhead stationery, or as otherwise specified in the solicitation. As a minimum, offers must show--

(1) The solicitation number;

(2) The time specified in the solicitation for receipt of offers;

(3) The name, address, and telephone number of the offeror;

(4) A technical description of the items being offered in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary;

(5) Terms of any express warranty;

(6) Price and any discount terms;

(7) "Remit to" address, if different than mailing address;

(8) A completed copy of the representations and certifications at FAR 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the offeror shall complete electronically);

(9) Acknowledgment of Solicitation Amendments;

(10) Past performance information, when included as an evaluation factor, to include recent and relevant contracts for the same or similar items and other references (including contract numbers, points of contact with telephone numbers and other relevant information); and

(11) If the offer is not submitted on the SF 1449, include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Offers that fail to furnish required representations or information, or reject the terms and conditions of the solicitation may be excluded from consideration.

(c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm for 30 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation.

(d) Product samples. When required by the solicitation, product samples shall be submitted at or prior to the time specified for receipt of offers. Unless otherwise specified in this solicitation, these samples shall be submitted at no expense to the Government, and returned at the sender's request and expense, unless they are destroyed during preaward testing.

(e) Multiple offers. Offerors are encouraged to submit multiple offers presenting alternative terms and conditions or commercial items for satisfying the requirements of this solicitation. Each offer submitted will be evaluated separately.

(f) Late submissions, modifications, revisions, and withdrawals of offers:

(1) Offerors are responsible for submitting offers, and any modifications, revisions, or withdrawals, so as to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 p.m., local time, for the designated Government office on the date that offers or revisions are due.

(2)(i) Any offer, modification, revision, or withdrawal of an offer received at the Government office designated in the solicitation after the exact time specified for receipt of offers is “late” and will not be considered unless it is received before award is made, the Contracting Officer determines that accepting the late offer would not unduly delay the acquisition; and--

(A) If it was transmitted through an electronic commerce method authorized by the solicitation, it was received at the initial point of entry to the Government infrastructure not later than 5:00 p.m. one working day prior to the date specified for receipt of offers; or

(B) There is acceptable evidence to establish that it was received at the Government installation designated for receipt of offers and was under the Government's control prior to the time set for receipt of offers; or

(C) If this solicitation is a request for proposals, it was the only proposal received.

(ii) However, a late modification of an otherwise successful offer, that makes its terms more favorable to the

Government, will be considered at any time it is received and may be accepted.

(3) Acceptable evidence to establish the time of receipt at the Government installation includes the time/date stamp of that installation on the offer wrapper, other documentary evidence of receipt maintained by the installation, or oral testimony or statements of Government personnel.

(4) If an emergency or unanticipated event interrupts normal Government processes so that offers cannot be received at the Government office designated for receipt of offers by the exact time specified in the solicitation, and urgent

Government requirements preclude amendment of the solicitation or other notice of an extension of the closing date, the time specified for receipt of offers will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.

(5) Offers may be withdrawn by written notice received at any time before the exact time set for receipt of offers.

Oral offers in response to oral solicitations may be withdrawn orally. If the solicitation authorizes facsimile offers, offers may be withdrawn via facsimile received at any time before the exact time set for receipt of offers, subject to the conditions specified in the solicitation concerning facsimile offers. An offer may be withdrawn in person by an offeror or its authorized representative if, before the exact time set for receipt of offers, the identity of the person requesting withdrawal is established and the person signs a receipt for the offer.

(g) Contract award (not applicable to Invitation for Bids). The Government intends to evaluate offers and award a contract without discussions with offerors. Therefore, the offeror's initial offer should contain the offeror's best terms from a price and technical standpoint. However, the Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government may reject any or all offers if such action is in the public interest; accept other than the lowest offer; and waive informalities and minor irregularities in offers received.

(h) Multiple awards. The Government may accept any item or group of items of an offer, unless the offeror qualifies the offer by specific limitations. Unless otherwise provided in the Schedule, offers may not be submitted for quantities less than those specified. The Government reserves the right to make an award on any item for a quantity less than the quantity offered, at the unit prices offered, unless the offeror specifies otherwise in the offer.

(i) Availability of requirements documents cited in the solicitation. (1)(i) The GSA Index of Federal Specifications, Standards and Commercial Item Descriptions, FPMR Part 101-29, and copies of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained for a fee by submitting a request to--GSA

Federal Supply Service Specifications Section, Suite 8100, 470 East L'Enfant Plaza, SW, Washington, DC

20407, Telephone (202) 619-8925, Facsimile (202) 619-8978.

(ii) If the General Services Administration, Department of Agriculture, or Department of Veterans Affairs issued this solicitation, a single copy of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained free of charge by submitting a request to the addressee in paragraph (i)(1)(i) of this provision.

Additional copies will be issued for a fee.

(2) Most unclassified Defense specifications and standards may be downloaded from the following ASSIST websites:

(i) ASSIST (https://assist.dla.mil/online/start/).

(ii) Quick Search (http://quicksearch.dla.mil/).

(iii) ASSISTdocs.com (http://assistdocs.com).

(3) Documents not available from ASSIST may be ordered from the Department of Defense Single Stock Point

(DoDSSP) by--https://assist.dla.mil/online/start/ http://quicksearch.dla.mil/ http://assistdocs.com/

(i) Using the ASSIST Shopping Wizard (https://assist.dla.mil/wizard/index.cfm);

(ii) Phoning the DoDSSP Customer Service Desk (215) 697-2179, Mon-Fri, 0730 to 1600 EST; or

(iii) Ordering from DoDSSP, Building 4, Section D, 700 Robbins Avenue, Philadelphia, PA 19111-5094, Telephone

(215) 697-2667/2179, Facsimile (215) 697-1462.

(4) Nongovernment (voluntary) standards must be obtained from the organization responsible for their preparation, publication, or maintenance.

(j) Data Universal Numbering System (DUNS) Number. (Applies to all offers exceeding $3,500, and offers of

$3,500 or less if the solicitation requires the Contractor to be registered in the System for Award Management

(SAM) database. The offeror shall enter, in the block with its name and address on the cover page of its offer, the annotation “DUNS” or “DUNS +4” followed by the DUNS or DUNS +4 number that identifies the offeror's name and address. The DUNS +4 is the DUNS number plus a 4-character suffix that may be assigned at the discretion of the offeror to establish additional SAM records for identifying alternative Electronic Funds Transfer (EFT) accounts

(see FAR Subpart 32.11) for the same concern. If the offeror does not have a DUNS number, it should contact Dun and Bradstreet directly to obtain one. An offeror within the United States may contact Dun and Bradstreet by calling

1-866-705-5711 or via the internet at http://fedgov.dnb.com/webform. An offeror located outside the United States must contact the local Dun and Bradstreet office for a DUNS number. The offeror should indicate that it is an offeror for a Government contract when contacting the local Dun and Bradstreet office.

(k) System for Award Management. Unless exempted by an addendum to this solicitation, by submission of an offer, the offeror acknowledges the requirement that a prospective awardee shall be registered in the SAM database prior to award, during performance and through final payment of any contract resulting from this solicitation. If the Offeror does not become registered in the SAM database in the time prescribed by the Contracting

Officer, the Contracting Officer will proceed to award to the next otherwise successful registered Offeror. Offerors may obtain information on registration and annual confirmation requirements via the SAM database accessed through https://www.acquisition.gov.

(l) Debriefing. If a post-award debriefing is given to requesting offerors, the Government shall disclose the following information, if applicable:

(1) The agency's evaluation of the significant weak or deficient factors in the debriefed offeror's offer.

(2) The overall evaluated cost or price and technical rating of the successful and the debriefed offeror and past performance information on the debriefed offeror.

(3) The overall ranking of all offerors, when any ranking was developed by the agency during source selection.

(4) A summary of the rationale for award;

(5) For acquisitions of commercial items, the make and model of the item to be delivered by the successful offeror.

(6) Reasonable responses to relevant questions posed by the debriefed offeror as to whether source-selection procedures set forth in the solicitation, applicable regulations, and other applicable authorities were followed by the agency.

https://assist.dla.mil/wizard/index.cfm https://www.acquisition.gov/

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL ITEMS (MAR 2016)

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 (q) 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;

http://www.acquisition.gov/

(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 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…