36C25919Q0419-003.docx

FedBizOpps Amendment to a Previous Combined Solicitation

CLASSIFICATION CODE

SUBJECT

CONTRACTING OFFICE'S

ZIP-CODE

SOLICITATION NUMBER

BASE NOTICE TYPE

RESPONSE DATE (MM-DD-YYYY)

ARCHIVE

DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS

SET-ASIDE

NAICS CODE

CONTRACTING OFFICE

ADDRESS

POINT OF CONTACT

(POC Information Automatically Filled from User Profile Unless Entered)

DESCRIPTION

See Attachment

AGENCY'S URL

URL DESCRIPTION

AGENCY CONTACT'S EMAIL

ADDRESS

EMAIL DESCRIPTION

ADDRESS

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

GENERAL INFORMATION

PLACE OF PERFORMANCE

* = Required Field FedBizOpps Amendment to a Previous Combined Solicitation Rev. March 2010

EEG MACHINE

80111 36C25919Q0419 N 334510 Department of Veterans Affairs Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300 Greenwood Village CO 80111 Joanna Hudson-Lubndquist joanna.hudson-lundquist@va.gov 59636 joanna.hudson-lundquist@va.gov Request for Quote (RFQ) #: 36C25918Q0419_2

EEG MACHINE

1. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The Government reserves the right to make no award from this solicitation.

** Quotes are to be provided to joanna.hudson-lundquist@va.gov no later than 4:00 P.M. (MST), September 11rd, 2019.

1. This is a Request for Quote (RFQ) and the solicitation number is 36C25918Q0419_2. The government anticipates awarding a firm-fixed price contract resulting from this solicitation.

1. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-97 effective January 24th, 2018.

1. The North American Industrial Classification System (NAICS) code for this procurement 334510 Electromedical and Electrotherapeutic Apparatus Manufacturing. This solicitation is unrestricted

1. List of Line Items:

· Arc Q-Video Software License (requires camera) (1 ea)

· Arc Highlight View License (1 ea)

· Arc Satellite View License (1 ea)

· Small Form Factor Desktop PC (1ea)

· Flat Panel Wide Screen Monitor 24"

· (1 ea)

· T2 Cart (1 ea)

· Photic Stim Articulating Arm (1 ea)

· Amplifier Articulating Arm (1 ea)

· Isolation Transformer 800VA, 6 outlets for T2 cart (1 ea)

· Isolation Transformer 800VA, 6 outlets for T2 cart (1 ea)

· Sony HD Camera and Infrared Illuminator for Pole or T2 cart (1 ea)

· Shure sound XLR USB w/microphone

· (1 ea)

· Essentia 10-20 Pattern Remote input box

· (1 ea)

· 10' Remote Input box cable (1 ea)

· Essentia Technical Manual, CD (1 ea)

· Level 2 Service Contract, E1 (in addition to standard 1-year warranty)

· Small Form Factor Desktop PC 2ea)

· Flat Panel Wide Screen Monitor 24"

· (2 ea)

· Arc Highlight View License (2 ea)

· Arc Satellite View License (2 ea)

CadLink Client licenses with Auto Archiving & HL7 w/cadlink server software for new customer) (5 ea) Arc 5 user Concurrent Review Software (1 ea) License On-site setup and inservice (2 ea)

GRAND TOTAL:

1. Description of Requirements for the items to be acquired (salient characteristics);

This RFQ is for Cadwell Brand name, OR EQUAL EEG Machine. Equal products must comply with the product description below and meet or exceed each of the minimum clinical performance requirements (Salient Characteristics) listed in this solicitation.

Product Description:

Two Factor Authentication compliant EEG Machines for Neurology Department to include software guidelines (“EEG Machine”).

Minimum Clinical Performance Requirements (Salient Characteristics)

· Easy patient setup with minimal operator training, continuous impedance checks on all channels, verify quality of electrodes being used, and simplification of EEG analysis. Users of the software can be tracked by the administrator for logging in and out of recorded study.

· Event triggered during a recording, software must notify operator of the specific event being recorded

· Data communications should be synchronized across all workstations for remote view and custom settings

· Study types, customized recording events for medical records. Users need to have the ability to customize their settings on any workstation being used by the EEG staff. Users should also be able to customize patient fields for specific patient information.

· Administrators need to have fields that can be required to populate before closing the study

· Edit of fields to improve the quality and the speed of data to be reviewed by the operator

· Software must be able to view Multiple pages of data on one screen

· Zoom capability to view more event contents generated by study. This data must be able to be copied out of the recording for operator review. Data can only be copied without patient information attached. Copy of recorded data should be able to be viewed on any user PC.

· Reports pulled from data must translate into a word-based report generator. Users should be allowed to attach any digital file to the patient record.

· Video recording software, playback of video, and EEG data should be synchronized and refined using PCs mouse. Camera control, (pan, tilt, and zoom) should be controlled within the software workstation PC.

· Software should allow assigning of patient information documents to allow for work lists showing workload.

· Run software on multi-modality systems, i.e. stationary and cart-based systems- existing EMG carts located at separate sites.

· Must be able to store patient data in a remote storage environment. Patient data cannot be stored on the machine. This system should also stream data automatically to the server.

Source Considerations

· Voltage requirements: Single phase, 110V/60hz, Biomedical Tech Considerations

· Operator training requirements - minimum of 2 operator level training slots should be included

· Warranty should be 1 year with an option of a base +4-year service agreement plan to be reviewed yearly to comply with a less than 3% annual downtime.

Certifications

· MDS2, 6550, and all data ports requirements need to be communicated between the company and the VA for security and networking purposes. The vendor is required to submit, with the quote: a) approved MDS2, b)completed (manufacturer’s portion of) 6550 form (attached, herewith as APPENDIX 1, Fillable_6550), and c) indicate the existence of Memorandum of Understanding and Interconnection Security Agreement between the manufacturer and VA.

· Windows security updates must be tested by the manufacture, as required by the FDA. All software windows and McAfee updates need to be approved by the manufacturer before being installed on existing system.

· Hardware requirements - storage amplifier must provide several different storage rates, 250-500hz and 1000-2000hz. And increased storage rates EMU, LTM, and ICU. Amplifier should have 32 channels with 7 active reference pairs.

· EEG must have USB 3.0 connection to workstation, i.e. amplifier, photic stimulator, oximetry sensor, and cameras.

· Computer must be Windows 10 and any SQL servers must utilize Windows server 2016 operation system.

1. Delivery and acceptance is to be F.O.B Destination (FAR 52.247-34) at the Veterans Affairs Medical Center, located at:

VA Montana Health Care System Deliver to: FHM Warehouse 3687 Veterans Drive Fort Harrison, MT 59636

1. 52.212-1, Instructions to Offerors--Commercial ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

7. Gray market items are Original Equipment Manufacturers (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers. No remanufactures or gray market items will be acceptable.

7. Contractor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM’s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions.

7. The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA’s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discovery of such items.

7. Offerors providing an “or equal” product(s) must adhere to the terms in FAR 52.211-6. If an item in this solicitation is identified as “brand name or equal,” the purchase description reflects the characteristics and level of quality that will satisfy the Government’s needs. The salient physical, functional, or performance characteristics that “equal” products must meet are specified in the solicitation. To be considered for award, offers of “equal” products, including “equal” products of the brand name manufacturer, must—

3. Meet the salient physical, functional, or performance characteristic specified in this solicitation;

3. Clearly identify the item by-

1. Brand name, if any and

1. Make or model number,

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

3. Clearly describe any modification the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modification.

The contracting officer will evaluate “equal” products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the contracting officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer. Unless the offeror clearly indicates in its offer that the product being offered is an “equal” product, the offeror shall provide the brand name product referenced in the solicitation

7. Descriptive literature must be provided IAW FAR 52.214-21 for item(s) which are considered to be equal to or better than the requirements listed.

7. Any award made as a result of this solicitation will be made on an All or Nothing Basis.

7. State if quoted items are available and priced through contractors existing Government-wide Acquisition Contract (GWAC), GSA Multiple Award Schedule (MAS) contract, or VA-wide Acquisition Contract.

7. Contractors are warned against contacting any VA personnel other than the Contracting Officer and Contract Specialist prior to placement of any award made resulting from this RFQ. If such contact occurs and found to be prejudicial to competing contactors, the contractor making such contact may be excluded from award considerations.

7. All proprietary information shall be clearly and properly marked. If the Offeror submits annexes, documentation, attachments or the like, not specifically required by this solicitation, such will count against the Offeror’s page limitations unless otherwise indicated in the specific volume instructions below.

7. All information shall be confined to the appropriate file. The contractor shall confine submissions to essential matters, sufficient to define the quote and provide an adequate basis for evaluation. Contractors are responsible for including sufficient details, in a concise manner, to permit a complete and accurate evaluation of each quote. Any award made resulting from this solicitation will be made based on the best overall quote that is determined to be the best overall value to the Government, considering (I) Technical Capability and (II) price.

7. Respondents to this announcement shall submit their quote on Contractors Letterhead in accordance with FAR 52.212-1. Submission of quote shall include the following volumes: (I) Technical Capability (II) Price.

Volume I - Technical Capability

Under no circumstances shall any pricing be included in the Technical Capability. The contractor shall submit a Technical Capability narrative which shall address in detail how the offeror proposes to accomplish each requirement with all documents necessary to validate the technical requirements are met (or exceeded). Responding companies shall include any relevant information (specifications, cut sheets, brochures, capability statement, etc.) confirming their ability to supply the products and services outlined in this request.

Volume II – Price

Complete the Price Schedule of Supplies/Services of this solicitation, with proposed contract line item prices inserted in appropriate spaces and detail/itemize the pricing or add additional line items, if applicable. For services quoted, include labor categories, labor rates, and number of hours by task.

The Government requires contractors to quote unit prices and total prices that are two (2) decimal places. The unit price multiplied by unit quantity must equal the total price for that line item.

(End of Addendum to 52.212-1)

1. 52.212-2, Evaluation--Commercial Items ADDENDUM to FAR 52.212-2 EVALUATION—COMMERCIAL ITEMS:

8. This is FAR 13 acquisition utilizing Lowest Price Technically Acceptable (LPTA) procedure. Any award resulting from this solicitation will be made to the responsible offeror based on the best overall quote that is determined to be most advantageous to the government. Pursuant to FAR 52.212-2, the criteria for evaluation is: (1) Technical Capability, (2) Price.

Technical Capability – The Government will evaluate quotes on the basis of whether or not the provided quote meets the technical capability specified in (v) List of Line Items and (vi) Description of Requirements for the items to be acquired (salient characteristics). Technical Capability shall consist of meeting or exceeding the requirements in the stated in (v) and (vi) above.

Price – The Government will evaluate offers by adding all line item prices - the Total of All CLINS will be that sum. The Government may use various price analysis techniques and procedures to make a price reasonableness determination. Offers that do not meet or exceed the technical capability requirements stated in (v) and (vi) above shall not be selected regardless of price.

8. All quotes shall be subject to evaluation by Government personnel. The Government intends to award without discussions based upon the initial evaluation of quotes. Consequently, contractors are highly encouraged to quote their best non-price and pricing quotes in their initial submissions. However, the Government reserves the right to communicate with any or all contractors submitting a quote, if it is determined advantageous to the Government to do so. If these communications take place, the Government is not obligated to communicate with every contractor (note that FAR Part 15 procedures do not apply; therefore, formal discussions are not applicable). All contractors will be treated fairly and impartially. A contractor may be eliminated from consideration without further communication if its non-price and/or pricing quotes are not among those contractors considered most advantageous to the Government based on a best value determination.

8. All Offerors are advised that, in the interest of efficiency, the Government reserves the right to conduct the review in the most effective manner. Specifically, the Government may first sort the quotes of all Offerors by price from lowest price to the highest. Thereafter, the Government will review the Technical Capability of the lowest priced quote only. If the lowest priced Offeror’s Technical Capability is determined to be acceptable and meets the requirements, the Government may make award to that Offeror without further reviews of the remaining Offerors’ Technical Capability. If the lowest priced Offeror’s Technical Capability is determined to not meet the requirement, then the Government may review the Technical Capability next lowest priced quote, and so forth and so on, until the Government reaches a quote that is determined to meet the Technical Capability requirements.

8. Quotes that merely restate the requirement or state that the requirement shall be met, without providing supporting rationale, are not sufficient. Contractors are cautioned that the award may not necessarily be made to the contractor quoting the lowest price, or to the contractor with the most highly technical quote. Award may be made to other than the lowest priced quote, if the Government determines that a price premium is warranted due to the merits of one or more of the non-price factors.

(End of Addendum to 52.212-2)

1. Offerors are advised to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications – Commercial Items, with the offer.

1. 52.212-4, Contract Terms and Conditions--Commercial Items – applies to this acquisition

1. 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items

FAR 52.212-5 applies to this acquisition with the following FAR clauses incorporated by reference;

1. Additional contract requirements or terms and conditions:

52.252-2, Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/

The following VAAR Clauses are to be incorporated by reference: 52.246-70 Guarantee; 852.203-70 Commercial Advertising; 852.232.72 Electronic Submission of Payment Requests; 852.246-71 Inspection

52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998)

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

http://www.acquisition.gov/far/index.html (FAR) and http://www.va.gov/oal/library/vaar/index.asp (VAAR)

The following FAR provisions are to be incorporated by reference: 52.212-3 Offeror Representations and Certifications – Commercial Items; 52.213-2 Invoices

The following VAAR provisions are to be incorporated by reference: 852.233-70, Protest Content/Alternative Dispute Resolution (JAN 2008); 852.233-71, Alternate Protest Procedure (JAN 1998); 852.252-70, Solicitation Provisions or Clauses Incorporated by Reference (JAN 2008); 852.270-1, Representatives of Contracting Officers (JAN 2008).

1. The Defense Priorities and Allocations System (DPAS) does not apply.

1. Date and Time offers are due to joanna.hudson-lundquist@va.gov no later than 4:00 P.M. (MST), September 11rd, 2019.

1. Name and email of the individual to contact for information regarding the solicitation:

Joanna Hudson-Lundquist joanna.hudson-lundquist@va.gov

APPENDIX A

image1.emf

Appendix A_Fillable 6550.pdf

VA DIRECTIVE 6550 Appendix A – To be completed for all procurements of network-connected medical devices and non-network-connected medical devices that store sensitive information. For client/server systems, a separate 6550 Appendix A is required for each the client and the medical server.

1.1 Equipment Category (VA-MDNS)

1.2 Manufacturer

1.3 Model

1.4 Application Name and Software Version #

1.5 Requesting Service

1.6 VISN

1.7 Facility Name

1.8 Facility Number

1.9 Manufacturer Point of Contact

Phone Number E-mail address

1.10 Biomedical Engineering Point of Contact

Phone Number E-mail address

1.11 Responsible Service if Biomedical Engineering is NOT the Primary System Manager for system maintenance, support and lifecycle management

1.12 Medical Device Type ☐ Discrete device ☐ Software

☐ Client ☐ Application server

1.13 Equipment Description (i.e. equipment function and systems it communicates with)

1.14 MDIA VLAN Number for installation (if known)

1.15 Installation Location (Room, Building, Division)

1.16 Is there an existing Enterprise Risk Analysis (ERA) for this device/system? ☐ Yes ☐ No

If yes, what is the ERA number?

**Note that the ERA must be for the same make, model, and application software version to apply to the requested system. A new ERA is required for major software or operating system updates (e.g. version 2.0 to 3.0) but is not required for minor updates (e.g. version 2.0 to version 2.1).

If an ERA exists for the requested system, completion of the 6550 Appendix A is not required beyond this point. Please sign to certify that an existing ERA is available for the requested system and forward the document to either the Area Manager or

ISSO for signature, as appropriate.

2.1 Device Operating System (OS)

Can the OS be automatically patched? ☐ Yes ☐ No **Note that systems that do not support automated patching via the VHA MD Update Server or via vendor channels impose a significantly higher risk to the VA network.

If patching is not automated, what is the patching process and/or limitations?

Procurement of systems with unsupported operating systems is prohibited. Unsupported operating systems are OSs that are not supported by the manufacturer and have reached the end of the OS lifecycle as published by the OS manufacturer (i.e. no further security patches will be released for the OS by the manufacturer after the OS end-of-life nor will be available by other methods such as extended warranty purchases from the OS manufacture).

2.2 Is the network connection wireless? ☐ Yes ☐ No

If yes, what is the FIPS 140-2 certification number?

Procurement of systems using 802.11 wireless networking that are not FIPS 140-2 compliant is prohibited.

2.3 Does the device include a database? ☐ Yes ☐ No

If yes, what is the database version?

2.4 Can the device run McAfee antivirus? ☐ Yes ☐ No

**Note that systems that do not support VA-approved antivirus scanning or an antivirus scanning solution managed by the vendor impose a significantly-higher risk to the VA network.

If antivirus is not supported, what are the AV processes and/or the limitations?

2.5 For Windows-based devices, can the VHA SMAK toolkit be installed? ☐ Yes ☐ No ☐ Non-Windows-based system

If no, has the vendor agreed to provide a complete software and application inventory for all system components as per FISMA requirements?

☐ Yes ☐ No

**Note that systems that do not support SMAK installation or for which the vendor does not agree to provide a complete software inventory impose a significantly higher risk to the VA network.

2.6 Does the system support the use of two-factor authentication (please review the VA’s requirements for two-factor authentication here)? ☐ Yes ☐ No

2.7 Is the device required to be joined to the VA domain? ☐ Yes ☐ No

2.8 Does the device allow for encryption of the data drive or OS drives? ☐ Yes ☐ No

2.9 Is sensitive data stored at rest on the device? ☐ Yes ☐ No

If yes, how many records can be stored on the device? ☐ <500 ☐ >500 If yes, does the device support on demand purging of data from the local hard drive? ☐ Yes ☐ No

2.10 Will sensitive data be stored outside of the VA network (e.g. cloud-based service provider – excludes Electronic Medical Record connection)? ☐ Yes ☐ No

2.11 Is connectivity external to the VA required for system operation? ☐ Yes ☐ No

2.12 Is connectivity external to the VA required for system support? ☐ No ☐ Yes - VA S2S VPN

☐ Yes – Other ☐ Yes - VA Citrix Describe remote access method and ports required if access is not via VA site-to-site VPN or VA Citrix.

2.13 How many IP addresses are required?

2.14 What kind of IPs does the system use? ☐ Static IP ☐ DHCP

**Systems should be deployed with static IPs unless DHCP is required.

2.15 If server-based, select one of the following: ☐ Vendor-provided physical server

☐ Vendor-provided virtual host ☐ Biomedical Engineering-provided physical server ☐ Biomedical Engineering-provided virtual host ☐ OIT-provided virtual host ☐ Other – describe

2.16 If server-based, list server specifications (cores, RAM, power, storage) and rack space.

2.17 Validate Cerner CareAware connection.

Submittal/Approval

Biomedical Engineering Date

Area Manager* Date

*Area manager signature only required for client/server medical systems. Please sign within 10 business days of receipt.

Information Systems Security Officer** Date

** Please sign within 5 business days of receipt and return the document to Biomedical Engineering and the Area Manager. If an ERA is required, please submit this form with the ERA package to the Specialized Device Security Division (SDSD) to initiate the ERA process.

https://vaww.oed.portal.va.gov/sites/vrm/IAM/playbooks/Pages/PIV%20Compliance/PIV%20Compliance.aspx

Manufacturer:

Model:

Application Name and Software Version:

Requesting Service:

VISN:

Facility Name:

Facility Number:

Manufacturer Point of Contact:

Phone Number:

Email address:

Biomedical Engineering Point of Contact:

Phone Number_2:

Email address_2:

Responsible Service if Biomedical Engineering is NOT the Primary System Manager for system maintenance support and lifecycle management:

Discrete device: Off

Client: Off

Software: Off

Application server: Off

Discrete device Software Client Application serverEquipment Description ie equipment function and systems it communicates with:

Discrete device Software Client Application serverMDIA VLAN Number for installation if known:

Discrete device Software Client Application serverInstallation Location Room Building Division:

undefined: Off

Yes NoIf yes what is the ERA number:

undefined_2: Off undefined_3: Off

If patching is not automated what is the patching process andor limitations:

undefined_4: Off

Yes NoIf yes what is the FIPS 1402 certification number:

undefined_5: Off

Yes NoIf yes what is the database version:

undefined_6: Off undefined_7: Off

If antivirus is not supported what are the AV processes andor the limitations:

No_4: Off

Yes_4: Off

NonWindowsbased system: Off undefined_8: Off undefined_9: Off undefined_10: Off undefined_11: Off undefined_12: Off undefined_13: Off undefined_14: Off undefined_15: Off undefined_16: Off undefined_17: Off undefined_18: Off undefined_19: Off undefined_20: Off undefined_21: Off undefined_22: Off undefined_23: Off undefined_24: Off undefined_25: Off

No_5: Off

Yes Other: Off

Yes VA S2S VPN: Off

Yes VA Citrix: Off

No Yes VA S2S VPN Yes Other Yes VA CitrixDescribe remote access method and ports required if access is not via VA sitetosite VPN or VA Citrix:

No Yes VA S2S VPN Yes Other Yes VA CitrixHow many IP addresses are required:

undefined_26: Off undefined_27: Off

Vendorprovided physical server: Off

Vendorprovided virtual host: Off

Biomedical Engineeringprovided: Off

Biomedical Engineeringprovided_2: Off

OITprovided virtual host: Off

Other describe: Off

Vendorprovided physical server Vendorprovided virtual host Biomedical Engineeringprovided physical server Biomedical Engineeringprovided virtual host OITprovided virtual host Other describeIf serverbased list server specifications cores RAM power storage and rack space:

Vendorprovided physical server Vendorprovided virtual host Biomedical Engineeringprovided physical server Biomedical Engineeringprovided virtual host OITprovided virtual host Other describeValidate Cerner CareAware connection:

Date:

Date_2:

Date_3:

Equipment Category (VA-MDNS):

Text6: