N6264520R0024_Redacted.pdf

SEE ADDENDUM

(No Collect Calls)

N6264520R0024 26-Mar-2020

b. TELEPHONE NUMBER

301-619-6914

8. OFFER DUE DATE/LOCAL TIME

04:00 PM 27 Mar 2020

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 N68094 16. ADMINISTERED BY

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFPX

NAVAL HOSPITAL CAMP PENDLETON

JOSE BAUTISTA

200 MERCY CIRCLE

CAMP PENDLETON CA 92055-5191

TEL: FAX:

FAX:

TEL: SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

1,000

NAICS:

334516

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 OF31

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.

N6264520R0024

Section SF 1449 - CONTINUATION SHEET

ADMINISTRATIVE INFORMATION

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

The point of contact for administrative concerns for this contract at Naval Medical Logistics Command, 693 Neiman

Street, Fort Detrick, MD 21702 is Derek Bell, 301-619-6914, derek.j.bell.civ@mail.mil.

COVID-19 GUIDANCE

Access to U.S. Government work sites and installations may be reasonably restricted for a variety of security, health and/or safety reasons, including force health protection in mitigation of COVID-19. These restrictions include denial of access to U.S. military installations and other U.S. Government work sites for 14 days to anyone returning from areas in which the CDC and/or the State Department has determined to have an advisory level of three or higher travel restriction. Up-to-date travel advisories can be found on the State Department website at:

https://travel.state.gov/content/travel/en/traveladvisories/travelavisories.html/.

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1 Each Molecular Assay-Analyzer

FFP

Cost-Per-Test to include Reagents, Quality Control, Maintenance, and

Consumables.

FOB: Destination

MFR PART NR: FilmArray

PSC CD: 6550

NET AMT

0002 1 Each OPTION Molecular Assay-Analyzer

FFP

Cost-Per-Test to include Reagents, Quality Control, Maintenance, and

Consumables.

FOB: Destination

0003 1 Each OPTION Molecular Assay-Analyzer

FFP

Cost-Per-Test to include Reagents, Quality Control, Maintenance, and

Consumables.

FOB: Destination

0004 1 Each OPTION Molecular Assay-Analyzer

FFP

Cost-Per-Test to include Reagents, Quality Control, Maintenance, and

Consumables.

FOB: Destination

0005 1 Each OPTION Molecular Assay-Analyzer

FFP

Cost-Per-Test to include Reagents, Quality Control, Maintenance, and

Consumables.

FOB: Destination

STATEMENT OF WORK

The proposed action is for a cost per test (CPT) contract for one (1) analyzer, laboratory, molecular assay, infectious microorganism [device code: 20-802] reagents, quality control, annual maintenance coverage, and consumables for

Naval Hospital (NH) Camp Pendleton. The automated molecular diagnostic laboratory analyzer shall be able to analyze polymerase chain reaction (PCR) samples to identify molecules of microorganisms within various pathogens. The analyzer shall be capable of testing specifically for respiratory targets, blood culture targets, gastrointestinal (GI) targets and meningitis/encephalitis (ME) targets. The automated molecular diagnostic laboratory analyzer shall be capable of performing at least, but not be limited to, the tests listed below.

TEST TESTS/YEAR

Respiratory Panel Assay 175

Blood Culture Identification (BCID) 10

Meningitis/Encephalitis Panel Assay (ME) 10

The PCR analyzer shall be a single-platform walkaway analyzer capable of integrated sample preparation, thermocycle amplification, detection and nested multiplex PCR analysis. The analyzer shall be capable of deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) extraction and purification. The analyzer shall have a minimum of a twelve (12) sample load capacity. The analyzer shall be able to identify molecules of microorganisms in the following type of samples: swab, positive blood culture, stool, cerebrospinal fluid (CSF), bronchoalveolar lavage (BAL), or sputum.

The analyzer shall be capable of amplifying and detecting a minimum of twenty (20) targets per respiratory panel assay, twenty-four (24) organisms that cause blood stream infections per blood culture identification (BCID) panel assay, three (3) genetic markers that are known to confer antimicrobial resistance per BCID panel assay, twenty-two

(22) targets per GI panel assay, and fourteen (14) targets per ME panel assay. The PCR analyzer shall include bar-code reading capability. The analyzer shall be able to generate, detect and analyze PCR melting curves. The unit shall be able to provide real-time analysis. The analyzer shall perform automatic quality control (QC) and routine operator maintenance without manual intervention. The PCR analyzer shall contain onboard diagnostics and help functions. The dimensions for the molecular assay analyzer shall not exceed 34x24x36 inches (HxWxD). The electrical requirements are 120 VAC and 60 Hz. The analyzer shall be a self-contained unit and shall not require facility hook-ups for water, drainage or heat dissipation.

The vendor shall provide installation, validation testing, onsite user training and preventive maintenance coverage.

The vendor shall provide the validation reagent kit and complete validation of the analyzer upon installation.

Corrective maintenance coverage shall be provided and include response times. On-site training shall be provided by the vendor. The vendor shall provide two (2) operational and two (2) service manuals, each in English. Support shall be provided for a base period of one (1) year with four (4) subsequnet option years.

The analyzers, including claims made for the product, shall be compliant with Food and Drug Administration (FDA) regulations, with respect to marketing and delivering medical products for use in the United States of America.

These requirements shall apply even if delivery is requested outside of the United States of America. The analyzers 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 analyzers, such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the analyzers 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. The vendor is also responsible for the initial instrument operational and performance validations.

2. Training and Support

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

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

3. Reagent and Supply Delivery

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

b. All supplied items and reagents that require special handling (e.g. refrigeration, time sensitivity, immediate open, etc.) will be marked in an explicit manner with a label that is easily read, understandable, and a minimum of 3 inches x 3 inches (9 sq. inches). The label will be placed in three

(3) or more locations on the container (top & two sides). Supplies or items that require refrigeration will have both the required Celsius and Fahrenheit temperature identified.

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

Naval Hospital Camp Pendleton

Gastrointestinal Panel Assay (GI) 10

Attn: Laboratory Department

200 Mercy Circle

Camp Pendleton, CA 92055

4. Maintenance

a. The Vendor Field Service Engineers shall be original equipment manufacturer (OEM) trained, experienced, and English-speaking personnel. The Vendor shall provide all labor, tools, diagnostic equipment, software, material, supplies, transportation, parts and equipment necessary to perform

Preventive Maintenance (PM), Calibration (CAL), Safety Testing (ST), and corrective maintenance

(CM).

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

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

5. Preventive Maintenance Services

a. Normal Business Hour Maintenance Coverage will be Monday through Friday, between 8:00 A.M. to

5:00 P.M. local time. Vendor shall provide full-service preventive maintenance.

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

c. Vendor shall perform preventive maintenance service checks during the base contract period at the

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

d. All test equipment used in the performance of this contract shall be calibrated, as required by the

OEM, and shall be in compliance with The Joint Commission (JC), OEM, the College of American

Pathologist’s (CAP), and Food and Drug Administration (FDA), and National Institute for Standards and Technology (NIST) standards.

6. Corrective Maintenance

a. Vendor shall provide on-site corrective maintenance between the hours of 8:00 A.M. and 5:00 P.M.

local time, Monday-Friday, to include unlimited service calls. Telephonic support shall be available

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

b. A vendor service technician shall respond via telephone within two (2) hours after receipt of trouble call, and provide on-site service within twenty four (24) hours. Equipment shall be operational within forty eight (48) hours of the initial trouble call.

c. Government request for corrective maintenance will be placed by NH Camp Pendleton Biomedical

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

d. The vendor’s response to requests for service may include telephone consultation with the equipment user/operator and a Vendor Field Service Engineer (FSE). Telephone consultation 1) shall provide instruction in determining operator error; 2) shall determine the most likely cause of the problem; 3) shall determine if resolution of the problem requires the dispatch of a Field Service Engineer (FSE);

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

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

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

7. Uptime: Equipment shall be returned to operational condition within 48 hours after telephone notification from

BIOMED. The Contractor shall maintain an overall uptime rate of 95% or better for all equipment. Uptime is equal to equipment availability minus down time. Uptime and down time are values used to calculate the mean time between failures (MTBF).

https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact-sheets/holidays-work-schedules-and-pay https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact-sheets/holidays-work-schedules-and-pay

a. Uptime Calculation: Uptime is calculated on a rolling 6 month basis. Until the Contractor has at least 6 months of performance experience at Medical Treatment Facility (MTF), the uptime shall be calculated cumulatively for the entire duration of the contract. The downtime indicator in DMLSS or manual calculations may be used to compute these metrics.

b. Variables Definitions:

U= Possible Equipment Uptime (100%)

H= Hours of Coverage per day

H1= Begin Coverage Time during each day

H2= End Coverage Time during each day

A= # of covered days of the week

W = Weeks of Coverage in a Year

C= Uptime Commitment (95%)

c. Known (for this contract):

H1= 0800 hours

H2= 1700 hours

A= 5 days per week

W= 52 weeks per year

C = 95%

d. Calculations:

D= Hours of Calculated Downtime (Unknown)

T= Total Actual Uptime Percentage (Unknown)

Δ= % difference from Uptime Commitment (Unknown)

e. *Note* - Downtime hours shall fall within the Contractor’s hours of coverage listed in Section 6.

Downtime hours outside of the coverage timeframe listed in Section 6. shall not be calculated as a metric of vendor performance. Downtime ends once the system is available for full clinical use.

8. Replacement Parts/Updates

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

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

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

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

e. The vendor shall install software revisions and updates (field service changes) that are required by

FDA- or manufacturer-announced safety hazards, alerts, or recalls, including the FDA Year 2000

(Y2K) Compliance Directive, as part of the contract at no additional cost to the Government. Updates and revisions shall be performed as soon as possible after release, no later than the first scheduled

Preventative Maintenance inspection after release. For any updates that have been identified as critical or required for the proper operation of equipment by the OEM, the vendor shall provide installation within 30 days of release regardless of preventative maintenance schedules.

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

9. 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.

10. Vendor Furnished Property and Material.

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

11. Vendor Report Requirements.

a. During normal duty hours, vendor FSE personnel shall check-in with the Biomedical Engineering

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

FSEs shall notify the Officer of the Day Desk and the Duty BIOMED personnel.

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

i. Name of Vendor

ii. Contract Number

iii. Name of field service technician performing service

iv. Vendor log/control number

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

vi. Description of problem reported by user

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

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

ix. Problem resolution or pending action

x. Signatures:

1. Field Service Technician performing services

2. BMET verifying service rendered (Identify Medical Treatment Facility)

xi. 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)

12. Vendor Responsibility.

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

BIOMED representative.

13. Removal of Government Property

a. No equipment shall be removed without the approval of the Materials Management Department of the

Medical Treatment Facility (MTF). Property passes for equipment removal shall be obtained by the vendor via the Materials Management Department of the MTF. Any failure to obtain such passes which results in detainment or prosecution of vendor FSE personnel are the sole responsibility of the service vendor personnel.

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

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

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

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

e. Hard Disk and Solid State Drives (HDD & SSD): In regards to patient information confidentiality and privacy, all Contractors and/or service Contractors shall not remove equipment containing patient information from the MTF. HDD nor SSD shall ever be removed from the MTF, by the Contractor under this maintenance agreement. Removal of protected health information (PHI) and personally identifiable information (PII) from the equipment prior to removal from site must be properly coordinated with the COR and Command Equipment Manager.

14. Service Beyond the Scope of the Contract

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

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

RISK MANAGEMENT FRAMEWORK(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.

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.

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government

0002 Destination Government Destination Government

0003 Destination Government Destination Government

0004 Destination Government Destination Government

0005 Destination Government Destination Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 05-APR-2021 1 NAVAL HOSPITAL CAMP PENDLETON

200 MERCY CIRCLE

CAMP PENDLETON CA 92055-5191

FOB: Destination

N68094

0002 05-APR-2022 1 (SAME AS PREVIOUS LOCATION)

0003 05-APR-2023 1 (SAME AS PREVIOUS LOCATION)

0004 25-APR-2024 1 (SAME AS PREVIOUS LOCATION)

0005 05-APR-2025 1 (SAME AS PREVIOUS LOCATION)

CLAUSES INCORPORATED BY REFERENCE

52.202-1 Definitions NOV 2013

52.203-3 Gratuities APR 1984

52.203-11 Certification And Disclosure Regarding Payments To

Influence Certain Federal Transactions

SEP 2007

52.203-12 Limitation On Payments To Influence Certain Federal

Transactions

OCT 2010

52.203-16 Preventing Personal Conflicts of Interest DEC 2011

52.203-17 Contractor Employee Whistleblower Rights and Requirement

To Inform Employees of Whistleblower Rights

APR 2014

52.204-7 System for Award Management OCT 2018

52.204-13 System for Award Management Maintenance OCT 2018

52.204-16 Commercial and Government Entity Code Reporting JUL 2016

52.204-17 Ownership or Control of Offeror JUL 2016

52.204-18 Commercial and Government Entity Code Maintenance JUL 2016

52.204-19 Incorporation by Reference of Representations and

Certifications.

DEC 2014

52.209-7 Information Regarding Responsibility Matters OCT 2018

52.212-1 Instructions to Offerors--Commercial Items OCT 2018

52.212-4 Contract Terms and Conditions--Commercial Items OCT 2018

52.232-18 Availability Of Funds APR 1984

52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

DEC 2013

52.242-15 Stop-Work Order AUG 1989

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

252.204-7003 Control Of Government Personnel Work Product APR 1992

252.204-7012 Safeguarding Covered Defense Information and Cyber

Incident Reporting

DEC 2019

252.204-7015 Notice of Authorized Disclosure of Information for Litigation

Support

MAY 2016

252.205-7000 Provision Of Information To Cooperative Agreement Holders DEC 1991

252.209-7004 Subcontracting With Firms That Are Owned or Controlled By

The Government of a Country that is a State Sponsor of

Terrorism

MAY 2019

252.219-7003 Small Business Subcontracting Plan (DOD Contracts) DEC 2019

252.223-7006 Prohibition On Storage, Treatment, and Disposal of Toxic or

Hazardous Materials

SEP 2014

252.223-7008 Prohibition of Hexavalent Chromium JUN 2013

252.225-7001 Buy American And Balance Of Payments Program-- Basic DEC 2017

252.225-7012 Preference For Certain Domestic Commodities DEC 2017

252.225-7021 Trade Agreements--Basic SEP 2019

252.225-7036 Buy American--Free Trade Agreements--Balance of

Payments Program--Basic

DEC 2017

252.225-7048 Export-Controlled Items JUN 2013

252.232-7003 Electronic Submission of Payment Requests and Receiving

Reports

DEC 2018

252.232-7010 Levies on Contract Payments DEC 2006

252.243-7001 Pricing Of Contract Modifications DEC 1991

252.243-7002 Requests for Equitable Adjustment DEC 2012

252.244-7000 Subcontracts for Commercial Items JUN 2013

252.247-7023 Transportation of Supplies by Sea FEB 2019

CLAUSES INCORPORATED BY FULL TEXT

52.203-18 PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE CERTAIN INTERNAL

CONFIDENTIALITY AGREEMENTS OR STATEMENTS--REPRESENTATION (JAN 2017)

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

Internal confidentiality agreement or statement, subcontract, and subcontractor, are defined in the clause at 52.203-

19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements.

(b) In accordance with section 743 of Division E, Title VII, of the Consolidated and Further Continuing

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

(c) The prohibition in paragraph (b) of this provision does not contravene requirements applicable to Standard Form

312, (Classified Information Nondisclosure Agreement), Form 4414 (Sensitive Compartmented Information

Nondisclosure Agreement), or any other form issued by a Federal department or agency governing the nondisclosure of classified information.

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

(End of provision)

52.203-19 PROHIBITION ON REQUIRING CERTAIN INTERNAL CONFIDENTIALITY AGREEMENTS OR

STATEMENTS (JAN 2017)

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

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

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

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

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

(c) The Contractor shall notify current employees and subcontractors that prohibitions and restrictions of any preexisting internal confidentiality agreements or statements covered by this clause, to the extent that such prohibitions and restrictions are inconsistent with the prohibitions of this clause, are no longer in effect.

(d) The prohibition in paragraph (b) of this clause does not contravene requirements applicable to Standard Form

312 (Classified Information Nondisclosure Agreement), Form 4414 (Sensitive Compartmented Information

Nondisclosure Agreement), or any other form issued by a Federal department or agency governing the nondisclosure of classified information.

(e) In accordance with section 743 of Division E, Title VII, of the Consolidated and Further Continuing

Appropriations Act, 2015, (Pub. L. 113-235), and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions) use of funds appropriated (or otherwise made available) is prohibited, if the

Government determines that the Contractor is not in compliance with the provisions of this clause.

(f) The Contractor shall include the substance of this clause, including this paragraph (f), in subcontracts under such contracts.

(End of clause)

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.

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR

EXECUTIVE ORDERS--COMMERCIAL ITEMS (JAN 2020)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017)

(section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L.

113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by

Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or

Equipment. (AUG 2019) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(5) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77 and 108-78 (19

U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: (Contracting Officer check as appropriate.)

XX (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995)

(41 U.S.C. 4704 and 10 U.S.C. 2402).

____ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).

____ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June

2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment

Act of 2009.)

XX (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) (Pub. L.

109-282) (31 U.S.C. 6101 note).

___ (5) [Reserved]

___ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div.

C).

___ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub.

L. 111-117, section 743 of Div. C).

XX (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101 note).

XX (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41

U.S.C. 2313).

____ (10) [Reserved]

____ (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (NOV 2011) (15 U.S.C. 657a).

____ (ii) Alternate I (NOV 2011) of 52.219-3.

____ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2014)

(if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

____ (ii) Alternate I (JAN 2011) of 52.219-4.

____ (13) [Reserved]

____ (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2011) (15 U.S.C. 644).

____ (ii) Alternate I (NOV 2011).

____ (iii) Alternate II (NOV 2011).

____ (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

____ (ii) Alternate I (Oct 1995) of 52.219-7.

____ (iii) Alternate II (Mar 2004) of 52.219-7.

XX (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

____ (17)(i) 52.219-9, Small Business Subcontracting Plan (Aug 2018) (15 U.S.C. 637(d)(4)).

____ (ii) Alternate I (Nov 2016) of 52.219-9.

____ (iii) Alternate II (Nov 2016) of 52.219-9.

____ (iv) Alternate III (Nov 2016) of 52.219-9.

____ (v) Alternate IV (Aug 2018) of 52.219-9.

____ (18) 52.219-13, Notice of Set-Aside of Orders (NOV 2011) (15 U.S.C. 644(r)).

____ (19) 52.219-14, Limitations on Subcontracting (JAN 2017) (15 U.S.C. 637(a)(14)).

____ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

____ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (OCT 2019) (15 U.S.C.

657f).

XX (22) 52.219-28, Post Award Small Business Program Rerepresentation (July 2013) (15 U.S.C. 632(a)(2)).

____ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-

Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)).

____(24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns

Eligible Under the Women-Owned Small Business Program (Dec 2015) (15 U.S.C. 637(m)).

XX (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

XX (26) 52.222-19, Child Labor--Cooperation with Authorities and Remedies (Jan 2020) (E.O. 13126).

XX (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

XX (28)(i) 52.222-26, Equal Opportunity (SEPT 2016) (E.O. 11246).

____ (ii) Alternate I (Feb 1999) of 52.222-26.

XX (29)(i) 52.222-35, Equal Opportunity for Veterans (OCT 2015)(38 U.S.C. 4212).

____ (ii) Alternate I (July 2014) of 52.222-35.

XX (30)(i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUL 2014) (29 U.S.C. 793).

____ (ii) Alternate I (July 2014) of 52.222-36.

XX (31) 52.222-37, Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212).

XX (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O.

13496).

XX (33)(i) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O. 13627).

____ (ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

____ (34) 52.222-54, Employment Eligibility Verification (Oct 2015). (E. O. 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in

22.1803.)

____ (35)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May

2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

____ (ii) Alternate I (May 2008) of 52.223-9 (42 U.