Combined_Synopsis_Solicitation_N62645-18-R-0033.pdf

N6264518R0033

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart

12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. Vendors must be registered with System for Award Management (SAM) to be considered for award. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-96 effective 06

November 2017 and Defense Federal Acquisition Regulation Supplement (DFARS) DPN 20171228 effective 28

December 2017. It is the contractor's responsibility to be familiar with the applicable FAR and DFARS clauses and provisions. The FAR clauses may be accessed in full text at:

http://acquisition.gov/browsefar https://www.acq.osd.mil/dpap/dars/dfarspgi/current/

The NAICS code is 325413. This is a Full and Open Competition requirement; all qualified Offeror(s) are encouraged to submit a proposal.

The Naval Medical Logistics Command (NMLC), on behalf of the Naval Hospital (NH) Jacksonville has a maintenance requirement for Government-owned medical equipment, such as sterilizers, washers, ophthalmology equipment, optometry equipment, stress test systems, ventilators, laboratory equipment, tissue processing, and tissue embedding devices.

The solicitation number is N62645-18-R-0033

STATEMENT OF WORK

Statement of Work

The Naval Medical Logistics Command has a requirement for a contract for one (1) analyzer, laboratory, molecular assay, infectious microorganism [Device Code: 20-802], reagents, quality control, maintenance, and consumables for

Naval Hospital (NH) Jacksonville. The molecular assay analyzer system shall be capable of conducting Human

Papilloma Virus (HPV) testing, as well as Papanicolaou (Pap) smear testing, for an annual workload of approximately

4,200 tests.

1. Equipment.

a. The proposed solution shall include an automated system capable of analyzing nucleic acids from urine and swab samples, for Human Papilloma Virus (HPV) testing, as well as Pap smear testing.

b. The analyzer unit shall be capable of conducting Food and Drug Administration (FDA)-approved assays for

HPV Genotype 16 and HPV Genotype 18.

c. The system shall be FDA-approved for collecting, transporting, and testing the following: gynecological specimens, vaginal swab specimens, male or female urine specimens, female endocervical specimens, and male urethral swab specimens.

d. The system shall be FDA-approved for testing female gynecological specimens collected in ThinPrep Pap

Test vials containing PreservCyst solution.

e. The system shall be capable of handling an annual workload with the following test kits:

f. The analyzer unit shall be capable of expanding testing capabilities, and perform other FDA-approved tests such as Chlamydia trachomatis (CT), and Neisseria gonorrhoeae (GC).

g. The analyzer unit shall meet the performance characteristics for accuracy and precision, as defined by the

1988 Clinical Laboratory Improvement Act (CLIA).

h. The analyzer equipment shall include sufficient safety features to avoid unnecessary exposure to biohazardous and chemical material.

i. The analyzer unit shall have integrated software that allows for on-board maintenance/troubleshooting procedures, as well as for documentation of said procedures.

Description Qty.

HPV 100-Test Kit 42

Specimen Transfer Kit 42

j. The printer shall be capable of printing patient reports with patient demographic information (i.e. patient’s name and accession number).

k. The units shall include an uninterruptable power supply (UPS) capable of providing all necessary electrical power to each analyzer. The maximum allowed dimension of each analyzer is 7 x 3 x 6.5 feet (HxWxD).

l. The power requirements are 100-230 +/- 10% VAC.

m. The vendor shall provide installation, validation testing, onsite and offsite user training, and preventive maintenance coverage. The vendor shall provide validation of the analyzers, including normal range verification, demonstration of linearity, reportable range, replication studies, recovery studies and establishment of initial control ranges using control materials.

n. Training shall be provided by the vendor. The system shall bi-directionally interface with the Composite

Health Care System (CHCS) and with the laboratory information system (LIS).

o. The vendor shall provide two (2) operational and two (2) service manuals, each in English.

p. Support shall be provided for a period of performance from 01 October 2018 – 30 September 2019, with four

(4) subsequent option years.

q. The system, 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 system shall be installed in compliance with OSHA requirements.

r. 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.

s. 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. 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 shall have a minimum shelf life of 6 months upon receipt by the Government.

c. All supplied items and reagents that require special handling (e.g. refrigeration, time sensitive, immediate open, 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 & two sides). Supplies/items that require refrigeration will have both the required Celsius and Fahrenheit temperature identified.

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

Receiving Officer

Naval Hospital Jacksonville

Building H-2091

Jacksonville, FL 32214

3. Maintenance.

a. The Vendor shall provide OEM-trained, experienced, 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.

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 shall be maintained to meet and retain the original equipment manufacturer’s (OEM’s) specifications/equipment certification.

d. The Vendor shall provide maintenance services Monday through Friday from 0730-1700 local time, excluding Federal Government holidays as seen at the following site: https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact-sheets/holidays-work-schedules-and-pay. This includes 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 annually required preventive maintenance. Customer and Technical support should be available by phone

24 hours, 7 days a week.

4. Preventive Maintenance Services.

a. Normal Business Hour Maintenance Coverage will be Monday through Friday, from 0730-1700 local time, excluding Federal Government holidays. Vendor shall provide full service preventive maintenance.

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

c. The vendor shall perform PM service checks during the base contract period at the OEM’s recommended intervals. Vendor will also perform PM 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 Joint Commission (JC), OEM, the College of American Pathologist’s (CAP), Food and Drug Administration (FDA), and National Institute of Standards and Technology (NIST) standards.

5. Corrective Maintenance.

a. Vendor shall provide on-site corrective maintenance from 0730-1700 Local Time, Monday-Friday, to include unlimited service calls. Telephonic technical 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 after receipt of trouble call. Equipment shall be repaired and deemed operational within forty eight (48) hours.

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

(BIOMED) personnel, directly to the vendor or its representatives. 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 FSE. Telephone consultation shall: 1) provide instruction in determining operator error; 2) determine the most likely cause of the problem; 3) determine if resolution of the problem requires the dispatch of a FSE; and 4) identify replacement parts likely to be required in order to return the equipment to 100% operational condition as specified by the OEM.

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

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

6. Equipment Uptime Rate and Calculation.

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

b. Uptime is calculated on a rolling 6 month basis. Until the Contractor has at least 6 months of performance experience at NH Jacksonville, 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.

c. 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 (52)

C= Uptime Commitment (95%)

d. Known:

H1= 0730 hours

H2= 1700 hours

A= 5 days per week

W= 52 weeks per year

C = 95%

e. Calculations:

𝐻 = 𝐻2 − 𝐻1

1700 − 0730

= 9.7 𝐻𝑜𝑢𝑟𝑠 𝑜𝑓 𝐶𝑜𝑣𝑒𝑟𝑎𝑔𝑒 𝑝𝑒𝑟 𝑑𝑎𝑦

𝑈 = 𝐻 ∗ 𝐴 ∗ 𝑊 = 9.7 ∗ 5 ∗ 52 = 2,522 𝐻𝑜𝑢𝑟𝑠 𝑜𝑓 𝑃𝑜𝑠𝑠𝑖𝑏𝑙𝑒 𝐸𝑞𝑢𝑖𝑝𝑚𝑒𝑛𝑡 𝑈𝑝𝑡𝑖𝑚𝑒

D= Hours of Calculated Downtime (Unknown)

T= Total Actual Uptime Percentage (Unknown)

Δ= % difference from Uptime Commitment (Unknown)

𝑇 = 𝑈 − 𝐷

𝑈

2522 − 𝐷

∆= (𝐶 − 𝑇) ∗ 100 = (. 95 − 𝑇) ∗ 100

f. *Note* - Downtime hours shall fall within the Contractor’s hours of coverage listed in Section 5. Downtime hours outside of the coverage timeframe listed in Section 5 shall not be calculated as a metric of vendor performance. Downtime ends once the system is available for full clinical use.

7. Replacement Parts/Updates.

a. The Vendor and its representatives 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 require shipment, 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.

e. The Vendor shall provide software revisions, updates, and upgrades (field service changes) required by

FDA-announced or manufacturer-announced hazards, alerts, or recalls, including those falling under the

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 during the first scheduled

PM inspection after release. For any updates that have been identified as critical, or required for the proper operation of equipment, the Vendor shall provide installation within 30 days of release regardless of PM schedules.

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

8. Composite Health Care System (CHCS).

a. The system shall be capable of bi-directionally interfacing with the CHCS and the laboratory information system (LIS). Government Furnished Property, Materials and Services.

b. If the Vendor is not already approved to connect to CHCS bi-directionally, the vendor shall agree to complete any bi-directional interface integration at no additional cost to the Government. Interface integration must be completed prior to final acceptance of the system.

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 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 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 service technicians and 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 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)

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 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 (KO) or his/her appointed representative.

13. Removal of Government Property.

a. No equipment shall be removed without the approval of the Contracting Officer’s Representative and

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

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

Vendor’s custody.

d. In regards to patient information confidentiality and privacy, all Vendors and/or service Vendors shall not remove equipment containing personally identifiable information or patient health information from the

Government site. The equipment hard disk drive (HDD) or solid state drive (SSD) shall be removed by MTF personnel prior to equipment removal from the site. Furthermore, equipment removed from the MTF will be prorated from the date of removal for service maintenance fees. If HDD or SSD are to be replaced, the

HDD or SSD in disrepair shall be left at the MTF for disposal.

14. Service Beyond the Scope of the Contract

a. The Vendor shall immediately, but not later than twenty four (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 repairing 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.

INSTRUCTIONS TO OFFERORS

This section specifies the format and content that offerors shall use in response to this Request for Proposal (RFP).

Offerors shall submit a response that is legible and comprehensive enough to provide the basis for a sound evaluation by the Government. Information provided shall be precise, factual and complete. Legibility, clarity, completeness and responsiveness are important. Proposals shall be in the form prescribed by, and shall contain a response to, each of the areas identified below. Any proposal which does not meet the requirements of the solicitation may be determined to be substantially incomplete and may result in rejection of the offeror’s entire proposal.

The proposal shall be submitted in three separate volumes:

Volume I – Technical

Volume II – Past Performance

Volume III – Business

A complete Volume I – Technical; Volume II – Past Performance; and, Volume III – Business shall be submitted no later than the closing date and time specified under “File Submission” below. If any one proposal volume is received past the stated closing date and time, the entire proposal will be considered late. No further consideration will be given to any offeror who submits any of the volumes late in accordance with FAR 15.208(b).

Volume I – Technical. The offeror shall include the following:

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

Conformance to Navy Cybersecurity requirements – The Government will evaluate the capability of the proposed system to meet Navy Cybersecurity requirements. This evaluation will be based on the information provided in the completed Medical Device Risk Assessment (MDRA). Offerors shall complete the MDRA

Questionnaire by following the instructions within the document at http://www.med.navy.mil/sites/nmlc/pages/DBU-RFP.aspx (bottom of page). This will be rated either Pass or Fail.

Design Quality and Capability – The Government will evaluate the design, quality, and capabilities of the proposed system to analyze nucleic acids from urine and swab samples for Human Papilloma Virus (HPV) testing, as well as Pap Smear testing for the Pathology Division in the Laboratory Department of Naval Hospital (NH)

Jacksonville. This will be rated either Pass or Fail.

Page limitation for Volume I - Technical: The total number of pages submitted for Volume I (Technical) shall not exceed 10 pages, cover letter, title page and table of contents. If Volume I contains more than 10 pages, only the first

10 pages will be evaluated.

Volume II – Past Performance. The offeror shall include the following:

The Government will evaluate the offeror's recent relevant past performance record for (a) Relevancy: how pertinent a recent effort accomplished by the offeror is to the effort to be acquired through the source selection; (b) the functional performance of the proposed or similar services that the offeror has delivered to previous customers, and

(c) the quality and timeliness of the technical assistance, software updates/upgrades that the vendor has supplied to its customers.

Offerors shall provide past performance data for all similar contracts for the last 3 years, up to 3 data points, or 3 data points for delivery starting with the most recent contracts for which delivery occurred at least 3 months prior to the closing of this solicitation. The data shall include answers to all of the following: Organization/Location, Point of Contact (POC) Name & Number, Contract Reference Number, Contract Date, Cost Value of the Contract

(rounding to the nearest $5K is acceptable), and “Has the POC agreed to be contacted as a reference?”

The Government reserves the right to utilize other information not provided by the vendor and will evaluate information readily available. It is the responsibility of the offeror to ensure each POC is verified and accurate. In the case of an offeror without a record of relevant past performance or for whom information on past performance is not available, the offeror will not be evaluated favorably or unfavorably on past performance (FAR

15.305(a)(2)(iv)). The offeror will receive a neutral rating.

Page limitation for Volume II – Past Performance: The total number of pages submitted for Volume II (Past

Performance) shall not exceed three (3) pages, excluding a cover letter, title page and table of contents. If Volume II contains more than three (3) pages, only the first three (3) pages will be evaluated.

Volume III – Business. The offeror shall include the following:

Acknowledgement of solicitation number N6264518R0033, as well as all amendments, if applicable.

Price - Adequate price competition is expected for this acquisition. Offeror shall submit pricing reflective of all services specified in the Performance Work Statement (PWS).

Offerors shall be registered in the System for Award Management (SAM) database in accordance with FAR 52.212-

3. The offeror shall verify its online representations and certifications are current, accurate, complete and applicable to this solicitation as of the date of its offer and are incorporated in its offer by reference. The offeror shall also be registered in SAM under the applicable NAICS code for this solicitation, 811219. Registration is free and can be completed on-line at https://www.sam.gov/portal/public/SAM/. No documentation is required to be submitted in response to this paragraph.

Questions

Any questions must be addressed to Benjamin Marcus at Benjamin.t.marcus2.civ@mail.mil, by e-mail only, no later than ten (10) calendar days after the issue date of this solicitation.

No phone calls will be accepted.

http://www.med.navy.mil/sites/nmlc/pages/DBU-RFP.aspx mailto:Benjamin.t.marcus2.civ@mail.mil

File Submission

Only electronic files will be accepted. All responses shall be submitted to Benjamin Marcus at

Benjamin.t.marcus2.civ@mail.mil no later than XXXX local time, XXXday, XX April 2018.

Subject line should read: Solicitation #N6264518R0033

Emails shall be no larger than 10 MB

The Technical, Past Performance and Business volumes shall be submitted via e-mail only. Files shall be in

Microsoft Word, Microsoft Excel or Adobe PDF only.

All proposals shall include the following information on its cover page:

Complete company name and address

Company POC including title, email address and phone number

Cage Code

DUNS Number

It is the Contractor’s responsibility to ensure that proposals are received by the due date and time required.

The Government will acknowledge receipt of all proposals. If an acknowledgement is not received, it is the

Contractor’s responsibility to follow-up with NMLC to guarantee receipt.

The Contracting Officer reserves the right to adjust the start date of the contract based on the actual award date.

Period for Acceptance of Offers

The period for acceptance of offers is one hundred twenty (120) days after the closing date of the solicitation.

Pre-Contract Costs

The Contractor will not be reimbursed for any costs incurred prior to the effective date of the contract.

Discussions

The Government intends to evaluate proposals and award a single contract without discussions with offerors. The

Government reserves the right to conduct discussions if the Contracting Officer later determines them to be necessary.

RISK MANAGEMENT FRAMEWORK

Risk Management Framework (RMF)

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

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

Support/conduct vulnerability mitigation to comply with cybersecurity controls listed in National Institute of

Standards and Technology (NIST) Special Publication (SP) 800-53; Security and Privacy Controls for Federal

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

mailto:yun.p.hong.civ@mail.mil

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

BASIS OF AWARD

The Government intends to award one (1) firm-fixed price contract resultant from the issuance of this solicitation to the responsible offeror submitting a proposal that is determined most advantageous to the Government, price and other factors considered. Awards under this procurement will be made to the offeror determined to be the best value to the Government. The evaluation of proposals will be based on the following factors:

Volume I: Technical

Evaluation Factor A: Conformance to Essential Characteristics

Evaluation Factor B: Conformance to Navy Cybersecurity Requirements

Evaluation Factor C: Design Quality and Capability

Volume II: Past Performance

Evaluation Factor D: Past Performance

Volume III: Business

Evaluation Factor E: Price

Relative Importance of Factors. The relative importance of each factor is as follows:

Evaluation Factor A, Evaluation Factor B and Evaluation Factor C will be evaluated, individually, on a pass/fail basis. If an offeror’s technical proposal is determined to have failed under Evaluation Factors A, B or C, either initially or following discussions if they are conducted, the offeror’s proposal will receive no further consideration for award unless there are no other technically acceptable proposals. If an offeror’s technical proposal is determined to have passed Evaluation Factors A, B and C, then the offeror’s proposal will be further evaluated on a trade-off basis taking into consideration evaluation Factors D and E. In doing so, Factor C-Design Quality and Capability is more important than Factor D-Past Performance and E- Price. Factor D-Past Performance is more important than

Factor E-Price. Since awards will be made on a best value basis, the Contracting Officer reserves the right to award to other then the lowest priced offeror providing the prices are determined fair and reasonable.

The Government intends to evaluate proposals and award a single contract without discussions with offerors.

Offerors are therefore cautioned that their initial offer should contain the offeror’s best terms. The Government reserves the right to conduct discussions if the Contracting Officer later determines them to be necessary.

The evaluation factors for Technical, Past Performance and Price are listed below; proposals shall include sufficiently detailed information to enable evaluation based on the following factors:

Volume I - Technical

Evaluation Factor A: Conformance to Essential Characteristics – The offeror shall include information to enable the evaluation of the proposed system’s ability to conform to Essential Characteristics as outlined in the

Performance Work Statement. Offerors not conforming to the essential characteristics will not be further evaluated.

Evaluation Factor B: Conformance to Navy Cybersecurity Requirements - The vendor will be evaluated based on the capability of the proposed system to meet Navy Cybersecurity requirements. This evaluation will be based on the information provided in the completed MDRA form.

Evaluation Factor C: Design Quality and Capability – The vendor will be evaluated on the design, quality, and capabilities of the proposed system to analyze nucleic acids from urine and swab samples for Human Papilloma

Virus (HPV) testing and Pap Smear testing.

Volume II – Past Performance

Evaluation Factor D: Past Performance - The Government will evaluate the offeror's recent relevant past performance record for (a) Relevancy: how pertinent a recent effort accomplished by the offeror is to the effort to be acquired through the source selection; (b) the functional performance of the proposed or similar services that the offeror has delivered to previous customers, and (c) the quality and timeliness of the technical assistance, software updates/upgrades that the vendor has supplied to its customers.

Offerors shall provide past performance data for all similar contracts for the last 3 years, up to 3 data points, or 3 data points for delivery starting with the most recent contracts for which delivery occurred at least 3 months prior to the closing of this solicitation. The data shall include answers to all of the following: Organization/Location, Point of Contact (POC) Name & Number, Contract Reference Number, Contract Date, Cost Value of the Contract

(rounding to the nearest $5K is acceptable), and “Has the POC agreed to be contacted as a reference?”

The Government reserves the right to utilize other information not provided by the vendor and will evaluate information readily available. It is the responsibility of the offeror to ensure each POC is verified and accurate. In the case of an offeror without a record of relevant past performance or for whom information on past performance is not available, the offeror will not be evaluated favorably or unfavorably on past performance (FAR

15.305(a)(2)(iv)). The offeror will receive a neutral rating.

Volume III - Business

Evaluation Factor E: Price - The vendor will be evaluated on the cost of quoted maintenance services for the items listed in the equipment list. Adequate price competition is expected for this acquisition. The offeror will be evaluated for reasonableness and completeness.

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

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

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

ADMINISTRATIVE SUPPORT

The point of contact for administrative concerns at Naval Medical Logistics Command (NMLC), 693 Neiman Street, Fort Detrick, MD 21702 is Benjamin Marcus, 301-619-8413, Benjamin.t.marcus2.civ@mail.mil.

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1 Lot

ANALYZER, LAB, MOLECULAR ASSAY

FFP

one (1) analyzer, laboratory, molecular assay, infectious microorganism [Device

Code: 20-802], reagents, quality control, maintenance, and consumables for Naval

Hospital (NH) Jacksonville.

FOB: Destination

MILSTRIP: N6264518RCES038

MFR PART NR: 303095

PURCHASE REQUEST NUMBER: N6264518RCES038

ADDITIONAL MARKINGS: ATTN: MARCUS MCEWEN; TP3; N00232-8052-

E038; N00232-17M045

PSC CD: 6515

NET AMT

0002 1 Lot

OPTION ANALYZER, LAB, MOLECULAR ASSAY

FFP

DEVICE CODE: 20-802

FOB: Destination mailto:Benjamin.t.marcus2.civ@mail.mil

0003 1 Lot

OPTION ANALYZER, LAB, MOLECULAR ASSAY

FFP

0004 1 Lot

OPTION ANALYZER, LAB, MOLECULAR ASSAY

FFP

0005 1 Lot

OPTION ANALYZER, LAB, MOLECULAR ASSAY

FFP

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 POP 01-OCT-2018 TO

30-SEP-2019

N/A NAVAL HOSPITAL JACKSONVILLE

MARCUS MC EWEN

2080 CHILD STREET

BLDG H-2091

JACKSONVILLE FL 32214

904-542-7715 X 174

N00232

0002 POP 01-OCT-2019 TO

30-SEP-2020

N/A (SAME AS PREVIOUS LOCATION)

0003 POP 01-OCT-2020 TO

30-SEP-2021

N/A (SAME AS PREVIOUS LOCATION)

0004 POP 01-OCT-2021 TO

30-SEP-2022

N/A (SAME AS PREVIOUS LOCATION)

0005 POP 01-OCT-2022 TO

30-SEP-2023

N/A (SAME AS PREVIOUS LOCATION)

CLAUSES INCORPORATED BY REFERENCE

52.204-7 System for Award Management OCT 2016

52.204-13 System for Award Management Maintenance OCT 2016

52.204-16 Commercial and Government Entity Code Reporting JUL 2016

52.204-18 Commercial and Government Entity Code Maintenance JUL 2016

52.204-19 Incorporation by Reference of Representations and

Certifications.

DEC 2014

52.212-4 Contract Terms and Conditions--Commercial Items JAN 2017

52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

DEC 2013

52.242-15 Stop-Work Order AUG 1989

52.242-17 Government Delay Of Work APR 1984

52.246-2 Inspection Of Supplies--Fixed Price AUG 1996

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

252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7005 Representation Relating to Compensation of Former DoD

Officials

NOV 2011

252.204-7012 Safeguarding Covered Defense Information and Cyber

Incident Reporting

OCT 2016

252.204-7015 Notice of Authorized Disclosure of Information for Litigation

Support

MAY 2016

252.211-7008 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

252.222-7007 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 DEC 2017

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)

52.212-1 INSTRUCTIONS TO OFFERORS--COMMERCIAL ITEMS (JAN 2017)

(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.