N62645-16-R-0033.pdf

SEE ADDENDUM

(No Collect Calls)

N62645-16-R-0033 16-Jun-2016

b. TELEPHONE NUMBER

301-619-6914

8. OFFER DUE DATE/LOCAL TIME

11:00 AM 18 Jul 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

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:

325413

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 OF53

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-0033

Section SF 1449 - CONTINUATION SHEET

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1 Lot

CPRR HEMATOLOGY LABORATORY ANALYZER

FFP

Base Year. See Statement of Requirements section for workload specific information.

FOB: Destination

ADDITIONAL MARKINGS: See Individual Delivery Orders.

NET AMT

0002 1 Each Medical Device Risk Assessment (MDRA)

FFP

Completed Gold Section returned to Naval Medical Logistics Command (NMLC) within 10 days after award.

1001 1 Lot

OPTION CPRR HEMATOLOGY LABORATORY ANALYZER

FFP

Option Year 1. See Statement of Requirements section for workload specific information.

2001 1 Lot

OPTION CPRR HEMATOLOGY LABORATORY ANALYZER

FFP

Option Year 2. See Statement of Requirements section for workload specific information.

3001 1 Lot

OPTION CPRR HEMATOLOGY LABORATORY ANALYZER

FFP

Option Year 3. See Statement of Requirements section for workload specific information.

4001 1 Lot

OPTION CPRR HEMATOLOGY LABORATORY ANALYZER

FFP

Option Year 4. See Statement of Requirements section for workload specific information.

STATEMENT OF REQUIREMENTS

1. Equipment

The requirement is for a cost-per-reportable contract for one (1) hematology laboratory analyzer for Naval Hospital

Guam, brand name or equal (BNE) to the Sysmex XN2000. The system shall be capable of performing at least the tests listed below for a minimum annual workload of 25,000 specimens for Complete Blood Counts, 500 for

Body Fluids and 2,500 for Reticulocytes.

The systems shall be capable of performing general hematology and reticulocyte testing. The system shall be capable of providing automated results for complete blood counts, white blood cell differentials, reticulocyte counts, and body fluid counts with 2 part differentials. The system shall be capable of performing linearity for white blood cell (WBC), red blood cell (RBC), Platelet, and Body Fluids. The system shall be capable of providing a total count for body fluids, with a 2 part differential that includes both the absolute number and the percent of cells counted.

The system shall be capable of positively identifying patient samples using bar codes. The system shall be capable of performing differentials with histograms. The system shall be capable of flagging the user for immature cell lines and pediatric specimens. The system shall be capable of running specimens in an automated closed tube and manual open tube. The system shall be capable of performing and enumerating nucleated red blood cells. The system shall be capable of auto-correcting white blood cells, hemoglobin, hematocrit, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration. The system shall be capable of differentiating between platelet clumps and giant platelets. The system shall be capable of using multiple size tubes including those with low volumes (i.e.

pediatric bullet tubes), using only a closed sampler mode. The system shall be capable of interfacing with the

Composite Health Care System (CHCS) and Cerner Millennium. The system shall be capable of performing priority

(STAT) testing and manual reflex testing. The system shall be capable of performing multiple tests on a single specimen sample. The system shall be capable of performing automated reticulocyte counts based on the parameters set by the manufacturer and the laboratory management. The system shall be bench-top with maximum dimensions of 38” height, 38” width, 35” depth, and 325 lbs. weight, and must include a movable reagent compartment for in use reagents. The electrical requirements are 110VAC, 60 Hz. An uninterruptible power supply (UPS) is required.

System installation, validation, correlation, onsite training, and preventive maintenance coverage shall be included.

Corrective system maintenance coverage shall include response times as specified in the Statement of Work, including 24-hour telephone support and on-site response within 24 hours. Annual onsite user training covering equipment operation is an enhancing factor.

The units shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United

States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The system shall be installed in compliance with OSHA requirements.

Contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system 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.

Upon delivery, the contractor shall be responsible for uncrating the unit/system, transporting it through the facility to the location of intended use for installation, and removing of all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage.

2. Reagent and supply delivery

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

b. All supplied items and reagents that require special handling, e.g. refrigeration, time sensitive, open immediately, etc., will be marked in a clear manner with a label that is easily read, understandable and a minimum of 3” x 3” (9 sq. inches). The label will be placed in three (3) or more locations on the container

(top & sides). Supplies/items that require refrigeration will have both the required Celsius and Fahrenheit temperature identified.

c. The vendor shall maintain at least a 3-month inventory (including spare parts, necessary for analyzer maintenance) on island, with delivery of reagents within 24 business hours of request for reagents.

d. The vendor shall provide assistance with establishing new reference ranges when new QC materials are introduced.

d. The vendor shall provide deliveries to the delivery point identified below:

US Naval Hospital Guam

PSC 490, Box 7656

FPO, AP 96538-1600

3. Maintenance.

a. The Vendor shall provide trained, experienced, English-speaking personnel, 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.

b. The Vendor shall provide telephonic communications with the Government to discuss technical matters relating to the performance of this contract. A 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 original equipment manufacturer’s (OEM’s) specifications / equipment certification.

d. The vendor shall provide a Quality Assurance program for peer review.

4. 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. Vendor shall provide full service preventive maintenance.

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

c. Must provide onsite assistance with the Bi-Annual Calibration of each analyzer, to include all Calibration supplies, per the requirements of the College of American Pathologists, and other Regulatory Agencies.

Calibration reports must be submitted to the laboratory, and any corrective actions must be taken to ensure that all calibration standards are acceptable.

5. Corrective Maintenance

a. Vendor shall provide on-site corrective maintenance between the hours of 8:00 A.M. and 5:00 P.M. PST, Monday-Friday with unlimited service calls. Telephonic support shall be available 24 hours per day, 7 days per week.

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.

c. Government request for corrective maintenance will be placed by Biomedical Engineering Division

(BIOMED) personnel, to the Vendor. Corrective maintenance shall be completed during the hours specified in the contract.

d. 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 FSE; and 4) should identify replacement parts likely to be required in order to return the equipment to 100% operational condition as specified by the OEM.

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

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

6. 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 and certified as OEM replacement parts. In the event that new parts are not available, rebuilt parts and sub-assemblies are allowed provided that they are warranted to be free of defects for a period of time that meets or exceeds warranties of similar replacement parts. The Vendor shall specifically annotate on the Field Service Report the use and identification of rebuilt parts and the period of warranty. When discrepancies occur, the Government will make the final determination on whether a replacement part is of equal or better quality.

e. The Vendor shall include software revisions and upgrades (field service changes), which are required due to FDA or manufacturer announced safety-hazard recall, to include FDA Year 2000 Compliance Directive, as part of the contract at no additional cost to the Government. Upgrades shall be performed as soon as possible after release, but 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, 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.

7. 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.

8. 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 service technicians and as required for the completion of the services in accordance with this contract.

9. 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 systems operator designated by BIOMED personnel.

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

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. Total billing cost

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)

10. 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 his representatives. All such replacement or repair shall be at the Vendor's expense and shall be inspected to the satisfaction of the Contracting Officer or appointed representative.

11. 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 service Vendor 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, Vendor to provide a detailed written description and quantities of items to be removed. Description to include, as a minimum, manufacturer’s serial numbers and equipment control numbers (ECNs) of all equipment / items removed. In the event that items / sub-assemblies / accessories are repaired via “Repair 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 or service

Vendor’s custody.

d. In regards to patient information confidentiality and privacy, all vendors and/or service vendor shall not remove equipment containing patient information from the Government site. The equipment hard drive shall be removed at the MTF prior to removal. Furthermore, equipment removed from the MTF will be prorated from the date of removal for service maintenance fees. If hard drives are to be replaced, they shall be left at the MTF for disposal.

12. Service Beyond the Scope of the Contract

a. The Vendor shall immediately, but not later than 24 consecutive hours after discovery, notify BIOMED, in writing, of the existence or the development of any defects in, or repair required to the scheduled equipment which the Vendor considers they are not responsible for under the terms of this contract.

b. At the same time of the notification, the Vendor shall furnish BIOMED with written estimate of the cost 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.

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

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.

CONTRACTOR SUPPORT

NOTICE: NAVY USE OF SUPPORT CONTRACTOR FOR CONTRACT CLOSEOUT FUNCTIONS

mailto:derek.j.bell.civ@mail.mil

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.

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 18 July 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 23

June 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

Offerors shall submit a proposal including all necessary documentation demonstrating that its solution meets all of the requirements within the Statement of Requirements. The Offeror shall include information to enable evaluation of the proposed solicitation and its conformance to the specified brand name or equal product by part number, manufacturer, and description. If marketing brochures are submitted, please ensure that it denotes exactly how all Statement of Requirements 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 Statement of 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.

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/.

Small Business Subcontracting Plan: 5% Subcontracting Goal o If applicable (for other than small business concern offerors under the assigned NAICS code herein), the offeror shall submit a subcontracting plan in accordance with FAR Clause 52.219-9 and DFARS Clause 252.219-7003 (for reference see FAR 19.704 and DFARS 219.704). The subcontracting plan requirement is not applicable to small business concerns qualified as such under the NAICS code assigned to this solicitation. Master subcontracting plans can be included as an appendix to the subcontracting plan. If the offeror believes there are no subcontracting possibilities, the offeror shall submit documentation sufficient to support its position.

BASIS OF AWARD

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

Government anticipates award of a firm fixed price (FFP) contract. The Small Business Representative will review the subcontracting plan for acceptability.

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

Technical Evaluation Factors

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

Conformance to Statement of Requirements

Evaluation shall include the ability to meet the brand name or equal of this requirement. Offerors not meeting all requirements will not be further considered for award unless there are no other technically acceptable Offerors. Quoters submitting the requested brand name items will receive a technically acceptable rating for this factor.

Information Assurance

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

(IA) requirements. This evaluation will be based solely on the information provided in the completed

MDRA Questionnaire found at http://www.med.navy.mil/sites/nmlc/Pages/DBU-RFP.aspx (bottom of page) or in the “MDRA” attachment provided with the solicitation. Information provided in another part of the response will not be evaluated for this factor.

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

Price Evaluation Factors

Reasonableness: The offeror’s proposed line item prices will be evaluated to determine the degree to which the line item prices compare to the prices a reasonable prudent person would expect to incur for the same or similar equipment.

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

Small Business Participation Plan

The Small Business Representative will review the subcontracting plan for acceptability. If an offeror fails to negotiate a subcontracting plan acceptable to the Contracting Officer within the time limit prescribed by the

Contracting Officer, the offeror will be ineligible for award.

Past Performance will not be an evaluation factor for this requirement.

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

1001 Destination Government Destination Government

2001 Destination Government Destination Government

3001 Destination Government Destination Government

4001 Destination Government Destination Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC

0001 POP 15-AUG-2016 TO

14-AUG-2017

N/A NH GUAM

PSC 490, BOX 7656

FPO, AP GU 96538-1600

N68096

0002 10 dys. ADC 1 NAVAL MEDICAL LOGISTICS COMMAND

CODE 03 - PACS

693 NEIMAN STREET

FORT DETRICK MD 21702-9239

301-619-9349

N62645

1001 POP 15-AUG-2017 TO

14-AUG-2018

N/A NH GUAM

PSC 490, BOX 7656

FPO, AP GU 96538-1600

2001 POP 15-AUG-2018 TO

14-AUG-2019

N/A (SAME AS PREVIOUS LOCATION)

3001 POP 15-AUG-2019 TO

14-AUG-2020

N/A (SAME AS PREVIOUS LOCATION)

4001 POP 15-AUG-2020 TO

14-AUG-2021

N/A (SAME AS PREVIOUS LOCATION)

CLAUSES INCORPORATED BY REFERENCE

52.203-3 Gratuities APR 1984

52.204-7 System for Award Management JUL 2013

52.204-13 System for Award Management Maintenance JUL 2013

52.204-16 Commercial and Government Entity Code Reporting JUL 2015

52.204-18 Commercial and Government Entity Code Maintenance JUL 2015

52.204-19 Incorporation by Reference of Representations and

Certifications.

DEC 2014

52.209-7 Information Regarding Responsibility Matters JUL 2013

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

52.217-5 Evaluation Of Options JUL 1990

52.219-9 (Dev) Small Business Subcontracting Plan (Deviation 2013-O0014) OCT 2015

52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

DEC 2013

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

252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

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

252.203-7005 Representation Relating to Compensation of Former DoD

Officials

NOV 2011

252.204-7008 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 Notice of Authorized Disclosure of Information for Litigation

Support

MAY 2016

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

252.219-7003 (Dev) Small Business Subcontracting Plan (DOD Contracts)--Basic

(Deviation 2013-O0014)

OCT 2014

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

252.225-7048 Export-Controlled Items JUN 2013

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

52.211-6 BRAND NAME OR EQUAL (AUG 1999)

(a) If an item in this solicitation is identified as “brand name or equal,” the purchase description reflects the characteristics and level of quality that will satisfy the Government's needs. The salient physical, functional, or performance characteristics that “equal” products must meet are specified in the solicitation.

(b) To be considered for award, offers of “equal” products, including “equal” products of the brand name manufacturer, must--

(1) Meet the salient physical, functional, or performance characteristic specified in this solicitation;

(2) Clearly identify the item by--

(i) Brand name, if any; and

(ii) Make or model number;

(3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and

(4) Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications.

(c) The Contracting Officer will evaluate “equal” products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer.

(d) Unless the offeror clearly indicates in its offer that the product being offered is an “equal” product, the offeror shall provide the brand name product referenced in the solicitation.

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.