N6264517R0022.pdf

N6264517R0022

This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation on an SF1449 will not be issued. The solicitation number is N6264517R0022. The solicitation is issued as a Request for Proposal (RFP). Provisions and clauses in effect through Federal Acquisition Circular 05- 86 are incorporated. It is the contractor’s responsibility to be familiar with the applicable clauses and provisions.

The clauses may be accessed in full text at these addresses: http://acquisition.gov/far and http://www.acq.osd.mil/dpap/sitemap.html.

This is a full and open solicitation. The NAICS code is 334510, with a small business size of 1,250 employees. All qualified vendors are encouraged to submit a proposal.

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1 Each Information System, PACS Endoscopy

FFP

One (1) Endoscopy Picture Archiving/Communication System for Naval Medical Center (NMC) San Diego (Device Code 17-961)

FOB: Destination

NET AMT

0002 1 Each Information System, PACS Endoscopy

FFP

One (1) Endoscopy Picture Archiving/Communication System for Naval Hospital (NH) Camp Lejeune (Device Code 17-961) http://acquisition.gov/far http://www.acq.osd.mil/dpap/sitemap.html

0003 1 Each Medical Device Risk Assessment

FFP

10% Holdback of total award amount until completed Gold Section returned to Naval Medical Logistics Command (NMLC) within seven (7) days after award to usn.detrick.navmedlogcomftdmd.list.mdra@mail.mil.

ITEM NO

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0004 1 Each Cybersecurity Compliance

FFP

Compliance with cybersecurity requirements through the term of the contract.

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

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 90 dys. ADC 1 NAVAL MEDICAL CENTER SAN DIEGO

JESSE LOFTUS

RECEIVING LOADING DOCK 1

34800 BOB WILSON DRIVE

SAN DIEGO CA 92134-5000

619-532-5752

N00259

0002 90 dys. ADC 1 NAVAL HOSPITAL CAMP LEJEUNE

RICHARD PEARSON

100 BREWSTER BLVD

CAMP LEJEUNE NC 28547-2538

910-450-3527

N68093

0003 7 dys. ADC 1 NAVAL MEDICAL LOGISTICS COMMAND

CODE 03 - PACS

693 NEIMAN STREET

FORT DETRICK MD 21702-9239

301-619-9349

N62645

0004 365 dys. ADC 1 (SAME AS PREVIOUS LOCATION)

N62645

STATEMENT OF REQUIREMENTS

The requirement is for two (2) information systems, picture archiving/communication, endoscopy (Endoscopy PACS); one for Naval Medical Center San Diego (NMCSD) and one for Naval Hospital Camp Lejeune (NHCL).

Naval Medical Center (NMC) San Diego, CA has a requirement for one (1) endoscopy data management information system. The system shall:

- Be capable of storing and retrieving images from digital cameras and other digital imaging systems that are used for endoscopic procedures.

- Be capable of collecting, recording and annotating images and video from Olympus processors and endoscopes; Fujinon double-balloon endoscopes; Boston Scientific Spyglass coledochoscopes; and, fluoroscopes made by Siemens and Philips.

- Be capable of capturing and storing HD video clips.

- Be capable of capturing and reporting quality and safety data to calculate/track cecal intubation rates, rates of gastrointestinal (GI) tract lesions, complication rates, implanted medical devices and time to next procedure with a reminder system. The quality and safety data shall have a summary report capability, capable of being sorted by field including but not limited to endoscopist, gender, age and indication.

- Be accommodative of database queries.

- Be compatible with scope tracking software.

- Be certified with the GI Quality Improvement Consortium registry.

- Be capable of bidirectional communication with Cerner Millennium including but not limited to importing patient identifiers, demographic information, pathology/cytology results and exporting reports and images.

- Be capable of exporting procedural reports with text and images to the Armed Forces Health Longitudinal

Technology Application (AHLTA) Healthcare Artifact and Image Management Solution (HAIMS).

- Be capable of patient scheduling and tracking from arrival to discharge.

- Include nine (9) procedure room stationary workstations with combined image capture and report writing capability, including software to enhance medical transcription and report generation.

- Include three (3) mobile workstations capable of being used in any area in the hospital, with combined image capture and report writing capability, including software to enhance medical transcription and report generation. All workstations shall have at least 22” monitors, an uninterruptible power supply, and image capture footswitch.

- Include all software, hardware, and licensing required for full functionality.

- Be capable of allow review capability for a minimum of ten (10) users, accessible from any workstation on the hospital network.

- Be capable of remote login by physicians to review reports.

- Be capable of regular, frequent backup.

- Be capable of data migration from Olympus Endoworks to the proposed solution.

- Be within manufacturer support life for at least five (5) years from the date of system acceptance.

Naval Hospital (NH) Camp Lejeune, NC has a requirement for one (1) endoscopy data management information system. The system shall:

- Be capable of storing and retrieving images from digital cameras and other digital imaging systems that are used for endoscopic procedures.

- Be capable of collecting, recording and annotating images and video from Olympus and Fuji processors and endoscopes.

- Be capable of capturing and storing HD video clips.

- Be capable of documenting procedures and record nursing notes for endoscopic procedures performed in a gastrointestinal (GI), Pediatric GI and Pulmonary endoscopy clinic.

- Be capable of capturing and reporting quality and safety data including but not limited to documentation of withdrawal times and prep quality. The quality and safety data shall be capable of measuring a provider’s time/motion across a broad range of criteria.

- Be certified with the GI Quality Improvement Consortium registry.

- Be capable of allowing Pulmonology to document bronchoscopy procedures.

- Be capable of bidirectional communication with Cerner Millenium including but not limited to importing patient identifiers, demographic information, pathology/cytology results and exporting reports and images.

- Be capable of exporting procedural reports with text and images to the Armed Forces Health Longitudinal

Technology Application (AHLTA) Healthcare Artifact and Image Management Solution (HAIMS).

- Be capable of patient scheduling and tracking from arrival to discharge.

- Include one (1) procedure room stationary workstation with combined image capture and report writing capability, including software to enhance medical transcription and report generation.

- Include two (2) mobile workstations capable of being used in any area in the hospital, with combined image capture and report writing capability, including software to enhance medical transcription and report generation. All workstations shall have at least 22” monitors, an uninterruptible power supply, and image capture footswitch.

- Include all software, hardware, and licensing required for full functionality.

- Be capable of allowing review capability for a minimum of ten (10) users, accessible from any workstation on the hospital network.

- Be capable of remote login by physicians to review reports.

- Be capable of regular, frequent backup.

- Be capable of data migration from Olympus Endoworks to the proposed solution.

- Be within manufacturer support life for at least five (5) years from the date of system acceptance.

Required for Both NMCSD and NHCL systems:

The offeror shall include initial onsite training for all potential system users including but not limited to endoscopists, nurses, corpsmen, and technicians. The power requirement is 120 VAC, 60 Hz.

All equipment shall be new from the manufacturer. Vendor 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.

All equipment shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical equipment for use in the United States of America; even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States.

Contractor shall include in proposals any terms and conditions, licensing agreements, etc. that the contractor will want included in the contract.

Enhancing Factors for Both NMCSD and NHCL systems:

- A single unlimited site license

- Server virtualization

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, Inc. of Baltimore, MD, 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 solicitation N6264517R0022, 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.

CLAUSES INCORPORATED BY REFERENCE

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

Internal Confidentiality Agreements or Statements-- Representation

JAN 2017

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

JAN 2017

52.204-7 System for Award Management OCT 2016 52.204-13 System for Award Management Maintenance OCT 2016 52.204-16 Commercial and Government Entity Code Reporting JUL 2016 52.204-18 Commercial and Government Entity Code Maintenance JUL 2016 52.212-1 Instructions to Offerors--Commercial Items JAN 2017 52.212-4 Contract Terms and Conditions--Commercial Items JAN 2017 52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

DEC 2013

52.247-34 F.O.B. Destination NOV 1991 252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7005 Representation Relating to Compensation of Former DoD Officials

NOV 2011

252.204-7008 Compliance With Safeguarding Covered Defense Information Controls

OCT 2016

252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting

OCT 2016

252.213-7000 Notice to Prospective Suppliers on Use of Past Performance Information Retrieval System--Statistical Reporting in Past Performance Evaluations

JUN 2015

252.215-7008 Only One Offer OCT 2013 252.222-7007 Representation Regarding Combating Trafficking in Persons JAN 2015 252.223-7008 Prohibition of Hexavalent Chromium JUN 2013 252.225-7001 Buy American And Balance Of Payments Program-- Basic

(Dec 2016)

DEC 2016

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

Country that is a State Sponsor of Terrorism

OCT 2015

252.232-7003 Electronic Submission of Payment Requests and Receiving Reports

JUN 2012

252.232-7010 Levies on Contract Payments DEC 2006 252.243-7002 Requests for Equitable Adjustment DEC 2012 252.244-7000 Subcontracts for Commercial Items JUN 2013 252.247-7022 Representation Of Extent Of Transportation Of Supplies By

Sea

AUG 1992

252.247-7023 Transportation of Supplies by Sea APR 2014

ADDENDUM TO 52.212-1

ADDENDUM TO 52.212-1 INSTRUCTIONS TO OFFERORS

In addition to the guidance included in FAR Provision 52.212-1 entitled “Instructions to Offerors – Commercial Items,” the following are applicable for the preparation and submission of proposals.

Instructions for Preparation of Proposals. 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

*No pricing information shall be included in Volumes I or II

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, 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 Statement of Requirements – Offerors shall submit a proposal including all necessary documentation demonstrating that its solution meets all of the requirements within the Statement of Requirements.

Offerors shall submit sufficient documentation to allow for an evaluation of its abilities to meet the Statement of Requirements. If marketing brochures are submitted, please ensure that it denotes exactly how all Statement of Requirements are met.

Conformance to Navy Cybersecurity Requirements – Offerors shall submit a completed Medical Device Risk Assessment (MDRA) Questionnaire (blue section only). The MDRA questionnaire can be found on the Naval Medical Logistics Command (NMLC) webpage (http://www.med.navy.mil/sites/nmlc/Pages/default.aspx) by clicking “Requests for Proposals (RFPs)” on the left hand side of the webpage. At the bottom of the page, select “MDRA 3.0-20160815RX”. Please refer to the section in this solicitation entitled “Cybersecurity Requirements” for additional information.

Design Quality and Capability – Offerors shall submit sufficient documentation to allow for an evaluation of the design quality and capabilities of proposed system. If the offeror’s proposal includes any of the Enhancing Factors identified above, the offeror shall include documentation demonstrating how the proposed solution exhibits the Enhancing Factors. If marketing brochures are submitted, the offeror shall ensure that it denotes exactly how Enhancing Factors are included; otherwise, provide the supplemental information within the technical approach of the proposal.

Page limitation for Volume I - Technical: The total number of pages submitted for Volume I (Technical) shall not exceed 20 pages, excluding the MDRA questionnaire, cover letter, title page and table of contents. If Volume I contains more than 20 pages, only the first 20 pages will be evaluated.

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

Offerors shall submit past performance data for a maximum of three (3) similar contracts for which delivery occurred within the last two (2) years; delivery must have occurred at least six (6) months prior to the closing of this solicitation. If past performance information is provided for more than three (3) contracts, only the first three (3) will be considered. Past performance shall be for the prime contractor.

If the offeror does not possess relevant past performance, the offeror shall submit a statement affirming that it possesses no relevant Past Performance.

Data for each reference shall include:

• Product Description

• Organization/Location

• Point of Contact (POC)/Title/Phone Number/Email Address

• Contract Number

• Contract Start Date

• Delivery Date

• Value of the Contract (rounding to the nearest $5k is acceptable) http://www.med.navy.mil/sites/nmlc/Pages/default.aspx

• Whether the POC has agreed to be contacted as a reference

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:

Completed Clause 52.209-11 REPRESENTATION BY CORPORATIONS REGARDING DELINQUENT TAX

LIABILITY OR A FELONY CONVICTION UNDER ANY FEDERAL LAW (FEB 2016)

Acknowledgement of solicitation number N6264517R0022 as well as all amendments, if applicable.

Price - Adequate price competition is expected for this acquisition. Offeror shall submit pricing, reflective of all equipment, components, training, etc. specified in the statement of requirements. Offeror shall include estimated timeframe, after receipt of contract, for delivery.

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 is incorporated in its offer by reference. The offeror shall also be registered in SAM under the applicable NAICS code for this solicitation; 334510. 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 Letitia R. Shirey at Letitia.r.shirey.civ@mail.mil and Carrie Gaither at carrie.e.gaither.civ@mail.mil by e-mail only, no later than 1300 local time, Thursday, 27 April 2017.

No phone calls will be accepted.

File Submission

Only electronic files will be accepted. All responses should be submitted to Letitia R. Shirey at Letitia.r.shirey.civ@mail.mil and Carrie Gaither at carrie.e.gaither.civ@mail.mil no later than 1300 local time, Monday, 22 May 2017.

Subject line should read: Solicitation #N6264517R0022 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

• Place of Manufacture

Period for Acceptance of Offers

The period for acceptance of offers is 120 days after the closing date of the solicitation.

https://www.sam.gov/portal/public/SAM/ mailto:.civ@mail.mil mailto:carrie.e.gaither.civ@mail.mil mailto:.civ@mail.mil mailto:carrie.e.gaither.civ@mail.mil

Pre-Contract Costs

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

CYBERSECURITY REQUIREMENTS

Risk Management Framework (RMF)

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

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

Support/conduct vulnerability mitigation to comply with cybersecurity controls listed in National Institute of Standards and Technology (NIST) Special Publication (SP) 800-53; Security and Privacy Controls for Federal Information Systems and Organizations and DHA Administrative Instruction 77. In order for a system to be authorized, there shall be zero Category 1 findings.

Support the A&A Team during system security testing.

Once the system has been authorized, the contractor shall maintain an acceptable security baseline consistent with the authorization granted by the AO throughout the life of the system. This includes ensuring that all vulnerabilities affecting the operating system, primary application, database and all third party software have validated and applied within 30 days.

Cybersecurity

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

The proposed system shall be capable of supporting the use of Defense Information Systems Agency (DISA) approved antimalware applications. The Navy uses McAfee Host Based Security System (HBSS) as their solution.

The vendor shall provide technical specifications that clearly demonstrate whether the proposed solution can integrate and support, either fully or partially the operation without performance degradation of the medical system/device. In cases where the operation of HBSS is not technically achievable, the vendor shall provide detailed justification and a Plan of Actions and Milestones (POA&M) describing steps towards compliance with this requirement.

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

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

Vulnerability Management

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

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

CAT II vulnerabilities are any vulnerability, the exploitation of which has a potential to result in loss of Confidentiality, Availability, or Integrity.

Domain Name System Realm/Directory Services

Contractor will be required to provide technical evidence, if applicable, whether client/server topology based medical systems can integrate with Directory Services and support LDAP authentication.

Local Privileged and Administrative User/Local System Accounts

Contractor shall create a single local user account with administrative/root level privileges for purposes of conducting system repairs and maintenance only. This account shall be separate and distinct from the built-in local administrative/root account provided by the Operating System and shall comply with DoD policy. All factors required to complete successful identification, authentication and authorization against the built-in local Administrative/Root level account shall be provided to the MTF Biomedical Engineering Department.

Complete administrative system rights shall be provided to the government System Administrator for the purpose of conducting device vulnerability scans as needed.

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

Contractors will connect to the B2B gateway via a contractor procured Internet Service Provider (ISP) connection and assume all responsibilities for establishing and maintaining their connectivity to the B2B gateway. This will include acquiring and maintaining the circuit to the B2B gateway and acquiring a Virtual Private Network (VPN) device compatible with the DHA VPN device. Maintenance and repair of contractor procured VPN equipment shall be the responsibility of the contractor.

Contractors shall configure their network to support access to government systems (e.g., configure ports and protocols for access).

Contractors shall provide full time connections to a TIER1 or TIER2 ISP. Dial-up ISP connections are not acceptable.

Contractors will comply with DoD guidance regarding allowable ports, protocols and risk mitigation strategies prior to accessing DoD/DHA networks. All contractors will be required to complete a DISA Form 2875, System Authorization Access Request form (SAAR) and submit it to the Navy PACS Office for processing. Contractor personnel will be required to complete applicable DoD cybersecurity training.

IPv6

The proposed system shall be Internet Protocol version 6 (IPv6) capable or the vendor shall provide a detailed project, migration or planning documentation to show when the proposed system shall be IPv6 capable.

Minimum IPv6 capabilities include:

Conformant with the IPv6 standards profile contained in the DoD IT Standards Registry (DISR);

Maintaining interoperability in heterogeneous environments with IPv4;

Commitment to upgrade as the IPv6 standard evolves;

Availability of vendor IPv6 technical support.

The contractor shall be able to demonstrate or provide documentation to prove that their product is IPv6 capable

Health Insurance Portability and Accountability Act (HIPAA) The contractor shall comply with the HIPAA Act of 1996 (Public Law 104-191) requirements, specifically the administrative simplification provision s of the law and the associated rules and regulations published by the Secretary, Health and Human Services (HHS). This includes the Standards for Electronic Transactions, the Standards for Privacy of Individually Identifiable Health Information and the Security Standards.

Applicable References:

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

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)

52.212-2 -- Evaluation -- Commercial Items.

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 the Statement of Requirements – Minimum Requirements Evaluation Factor B: Conformance to Navy Cybersecurity Requirements Evaluation Factor C: Performance Test – Minimum Requirements Evaluation Factor D: Design Quality and Capability

Volume II: Past Performance Evaluation Factor E: Past Performance

Volume III: Business Evaluation Factor F: Price

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

Evaluation Factor A and Evaluation Factor B will be evaluated individually, on a pass/fail basis. If an offeror’s technical proposal is determined to have failed under Evaluation Factors A or B, 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. Evaluation Factor C will be evaluated on a pass/fail basis and all offerors whose proposals pass Evaluation Factors A and B will undergo performance testing to ensure that the offeror’s product meets the minimum requirements as outlined in the statement of requirements. If an offeror’s technical proposal is determined to have failed under Evaluation Factor 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. Proposals that pass Evaluation Factors A, B, and C will then be evaluated against Evaluation Factor D. Evaluation Factor D will be evaluated based on the offeror’s written proposal and performance testing which will take into consideration the design quality and capabilities of the proposed system.

Offerors whose proposals pass Evaluation Factors A, B, and C will be evaluated on a best value trade-off basis taking into consideration Evaluation Factors D, E, and F. Evaluation Factor D – Design Quality and Capability is more important than Factor E – Past Performance. Additionally, the combination of Evaluation Factors D – Design Quality and Capability and E - Past Performance are more important than Evaluation Factor F – Price. As proposals narrow in terms of merit for the non-price factors (i.e. Technical and Past Performance are of similar merit), price becomes a more important factor and allows the Government to make a contract award to the lower priced proposal.

It should be noted that a contract award may be made to other than the lowest priced offeror, providing the price can be determined fair and reasonable, if the Government determines that a price premium is warranted due to Technical and/or Past Performance merit.

ADJECTIVAL RATINGS

Technical:

The Government shall assign a combined Technical/Risk rating to the offeror’s proposal as follows:

Color Rating Definition

Blue Outstanding Proposal meets requirements and indicates an exceptional approach and understanding of the requirements. Strengths far outweigh any weaknesses. Risk of unsuccessful performance is very low.

Purple Good Proposal meets requirements and indicates a thorough approach and understanding of the requirements. Proposal contains strengths which outweigh any weaknesses. Risk of unsuccessful performance is low.

Green Acceptable

Proposal meets requirements and indicates an adequate approach and understanding of the requirements. Strengths and weaknesses are offsetting or will have little or no impact on contract performance. Risk of unsuccessful performance is no worse than moderate.

Yellow Marginal

Proposal does not clearly meet requirements and has not demonstrated an adequate approach and understanding of the requirements. The proposal has one or more weaknesses which are not offset by strengths. Risk of unsuccessful performance is high.

Red Unacceptable Proposal does not meet requirements and contains one or more deficiencies. Proposal is unawardable.

Past Performance:

The Government will first evaluate whether the past performance provided is relevant. A determination of “Not Relevant” may be made based solely on the information provided. The Government may obtain additional information from the POC named in making a relevancy determination.

Relevancy shall be evaluated as follows:

Rating Definition

Relevant Past performance for similar contracts for which delivery occurred within the last two (2) years and where delivery occurred at least six (6) months prior to the closing date of this solicitation.

Not Relevant

Past performance that is not for similar contracts; past performance for similar contracts where delivery occurred more than 2 (two) years ago; or past performance for similar contracts where delivery did not occur at least six (6) months prior to the closing date of this solicitation.

The Government will then review relevant Past Performance and determine the quality and usefulness as it applies to the performance confidence assessment. This evaluation shall entail an examination such as but not limited to the functional performance of the proposed or similar modality systems that the offeror has delivered to previous customers and the quality and timeliness of the technical assistance and software updates/upgrades that the vendor has supplied to its customers following the initial fielding of those systems.

The past performance confidence assessment shall be evaluated as follows:

Rating Definition

Substantial Confidence Based on the offeror’s relevant performance record, the Government has a high expectation that the offeror will successfully perform the required effort.

Satisfactory Confidence Based on the offeror’s relevant performance record, the Government has a reasonable expectation that the offeror will successfully perform the required effort.

Limited Confidence Based on the offeror’s relevant performance record, the Government has a low expectation that the offeror will successfully perform the required effort.

No Confidence Based on the offeror’s relevant performance record, the Government has no expectation that the offeror will be able to successfully perform the required effort.

Unknown Confidence (Neutral)

No relevant performance record is available or the offeror’s performance record is so sparse that no meaningful confidence assessment rating can be reasonably assigned.

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 the Statement of Requirements - The government will evaluate each offer to determine the ability to conform to the characteristics outlined in the Statement of Requirements.

Evaluation Factor B: Conformance to Navy Cybersecurity Requirements – The government will evaluate the capability of the proposed system to meet Navy Cybersecurity requirements. The evaluation will be based on the information provided in the completed “Blue Section” of the Medical Device Risk Assessment (MDRA) form.

Evaluation Factor C: Performance Test – Minimum Requirements. If the offeror passes Evaluation Factors A and B, the Government will conduct an evaluation of the vendor’s program. If the offeror passes Evaluation Factors A and B, the Government will request that the offeror ship software and any separate hardware needed for proper demonstration, to the Government location at Naval Medical Center San Diego at no expense of the Government, along with detailed instructions on how to complete tasks that will demonstrate the ability to meet the criteria listed below. No vendor shall be physically present for performance testing. Return charges for the equipment and software will be at the vendor’s expense. Offeror’s performance test will be evaluated on a Pass/Fail basis. A Pass rating will be given if all criteria identified below are successfully performed.

Performance Test – Minimum Requirements

- Be capable of storing and retrieving images from digital cameras and other digital imaging systems that are used for endoscopic procedures.

- Be capable of collecting, recording and annotating images and video from Olympus processors and endoscopes; Fujinon double-balloon endoscopes; Boston Scientific Spyglass coledochoscopes; and, fluoroscopes made by Siemens and Philips.

- Be capable of capturing and storing HD video clips.

- Be capable of capturing and reporting quality and safety data to calculate/track cecal intubation rates, rates of gastrointestinal (GI) tract lesions, complication rates, implanted medical devices and time to next procedure with a reminder system. The quality and safety data shall have a summary report capability, capable of being sorted by field including but not limited to endoscopist, gender, age and indication.

- Be accommodative of complex database queries.

- Be capable of interfacing with scope tracking software.

- Be capable of bidirectional communication with Cerner Millennium including but not limited to importing patient identifiers, demographic information, pathology/cytology results and exporting reports and images.

- Be capable of exporting procedural reports with text and images to the Armed Forces Health Longitudinal Technology Application (AHLTA) Healthcare Artifact and Image Management Solution

(HAIMS).

- Be capable of patient scheduling and tracking from arrival to discharge.

- Be capable of remote login by physicians to review reports.

Evaluation Factor D: Design Quality and Capability – The government will evaluate the design quality and capability of the proposed system to collect, process and store endoscopic study records as well as to consider the presence of Enhancing Factors based on the written proposal submitted and performance testing. A single risk rating will be assigned for Evaluation Factor D based on the offeror’s written proposal and performance testing.

The Government will not assume that the offeror possesses any capability or knowledge unless it is specified in the Technical volume.

Volume II – Past Performance.

Evaluation Factor E: Past Performance - The Government will evaluate the offeror’s recent relevant past performance for (a) Relevancy: how pertinent a recent effort accomplished by the offeror is to the effort to be acquired through the source selection; and (b) Confidence Assessment: the functional performance of the proposed or similar modality systems that the offeror has delivered to previous customers and the quality and timeliness of the technical assistance and software updates/upgrades that the vendor has supplied to its customers following the initial fielding of those systems.

The Government reserves the right to utilize other information not provided by the vendor and will evaluate information readily available. It is the responsibility of the offeror to ensure names and phone numbers of points of contacts are verified and accurate. In the case an offeror does not possess 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; the offeror will receive a neutral rating (FAR 15.305(a)(2)(iv)).

The Government will review past performance information and determine the quality and usefulness as it applies to the performance confidence assessment. The past performance evaluation results in an assessment of the offeror’s probability of meeting the solicitation requirements. The past performance evaluation considers each offeror’s demonstrated recent and relevant record of performance in supplying products that meet the contract’s requirements.

One performance confidence assessment rating is assigned for each offeror after evaluating the offeror’s recent past performance, focusing on performance that is relevant to the contract requirements.

Volume III – Business.

Evaluation Factor F: Price - Adequate price competition is expected for this acquisition. The Business volume will be evaluated with consideration to the following factors:

COMPLETENESS. The offeror’s Business volume will be examined to ensure all items required in the Instructions to Offeror’s have been submitted and are complete.

REASONABLENESS. The offeror’s proposed price will be evaluated separately to determine the degree to which the total proposed price compares to the price a reasonable prudent person would expect to incur for the same or similar equipment. The offeror’s total proposed price will be used to evaluate price reasonableness. Since awards will be made on a best value basis, the Contracting Officer reserves the right to award at a premium, provided that the proposed price is determined to be reasonable.

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

ALTERNATE I (OCT 2014)

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

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

“Administrative merits determination” means certain notices or findings of labor law violations issued by an enforcement agency following an investigation. An administrative merits determination may be final or be subject to appeal or further review. To determine whether a particular notice or finding is covered by this definition, it is necessary to consult section II.B. in the DOL Guidance.

https://www.sam.gov/portal

“Arbitral award or decision” means an arbitrator or arbitral panel determination that a labor law violation occurred, or that enjoined or restrained a violation of labor law. It includes an award or decision that is not final or is subject to being confirmed, modified, or vacated by a court, and includes an award or decision resulting from private or confidential proceedings. To determine whether a particular award or decision is covered by this definition, it is necessary to consult section II.B. in the DOL Guidance.

“Civil judgment” means--

(1) In paragraph (h) of this provision: A judgment or finding of a civil offense by any court of competent jurisdiction.

(2) In paragraph (s) of this provision: Any judgment or order entered by any Federal or State court in which the court determined that a labor law violation occurred, or enjoined or restrained a violation of labor law. It includes a judgment or order that is not final or is subject to appeal. To determine whether a particular judgment or order is covered by this definition, it is necessary to consult section II.B. in the DOL Guidance.

“DOL Guidance” means the Department of Labor (DOL) Guidance entitled: ``Guidance for Executive Order 13673, `Fair Pay and Safe Workplaces' ''. The DOL Guidance, dated August 25, 2016, can be obtained from www.dol.gov/fairpayandsafeworkplaces.

“Economically disadvantaged women-owned small business (EDWOSB) concern” means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

“Enforcement agency” means any agency granted authority to enforce the Federal labor laws. It includes the enforcement components of DOL (Wage and Hour Division, Office of Federal Contract Compliance Programs, and Occupational Safety and Health Administration), the Equal Employment Opportunity Commission, the occupational Safety and Health Review Commission, and the National Labor Relations Board. It also means a State agency designated to administer an OSHA-approved State Plan, but only to the extent that the State agency is acting in its capacity as administrator of such plan. It does not include other Federal agencies which, in their capacity as contracting agencies, conduct investigations of potential labor law violations. The enforcement agencies associated with each labor law under E.O. 13673 are--

(1) Department of Labor Wage and Hour Division (WHD) for--

(i) The Fair Labor Standards Act;

(ii) The Migrant and Seasonal Agricultural Worker Protection Act;

(iii) 40 U.S.C. chapter 31, subchapter IV, formerly known as the Davis-Bacon Act;

(iv) 41 U.S.C. chapter 67, formerly known as the Service Contract Act;

(v) The Family and Medical Leave Act; and

(vi) E.O. 13658 of February 12, 2014 (Establishing a Minimum Wage for Contractors);

(2) Department of Labor Occupational Safety and Health Administration (OSHA) for--

(i) The Occupational Safety and Health Act of 1970; and

(ii) OSHA-approved State Plans;

http://www.dol.gov/fairpayandsafeworkplaces

(3) Department of Labor Office of Federal Contract Compliance Programs (OFCCP) for--

(i) Section 503 of the Rehabilitation Act of 1973;

(ii) The Vietnam Era Veterans' Readjustment Assistance Act of 1972 and the Vietnam Era Veterans' Readjustment Assistance Act of 1974; and

(iii) E.O. 11246 of September 24, 1965 (Equal Employment Opportunity);

(4) National Labor Relations Board (NLRB) for the National Labor Relations Act; and

(5) Equal Employment Opportunity Commission (EEOC) for--

(i) Title VII of the Civil Rights Act of 1964;

(ii) The Americans with Disabilities Act of 1990;

(iii) The Age Discrimination in Employment Act of 1967; and

(iv) Section 6(d) of the Fair Labor Standards Act (Equal Pay Act).

“Forced or indentured child labor” means all work or service—

(1)…