W9114F-20-Q-0060-0002.pdf

W91FVL057093

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

1. CONTRACT ID CODE PAGE OF PAGES

J 1 5

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 30-Jun-2020

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X W9114F20Q0060

X 9B. DATED (SEE ITEM 11)

05-Jun-2020

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer is extended, X is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

The purpose of this Amendment is to respond to prospective vendors inquiries.

Please see Summary of Changes for details.

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

30-Jun-2020

CODE

W40M RHCO USAHCA EUROPE

REGIONAL HEALTH CONTR OFC EUROPE

CMR 402

APO AE 09180

W9114F 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

W9114F20Q0060

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:

Q&A'S II

QUESTIONS RESPONSES

Training - Should be provided at the factory or approved training Center for 4 Radiologist Doctors, 4 radiologist technician, 2 biomedical engineers' minimum 5 days.

1) In the requirements of the project, it is required to provide training for medical staff and engineers at the factory or at an approved training center.

Considering the current pandemic situation, providing such a training at factory or approved training center it’s hard to achieve due to many limitations. That’s why we suggest changing this request to: “Should be provided ON SITE (at site of installation) for 4 Radiologist Doctors, 4 radiologist technician, 2 biomedical engineers' minimum 5 days.”

We offer this kind of training for 8 days. Having this training done onsite it’s better even for medical staff and engineer. They’ll get more familiar with the place they are going to work in the future and more doctors will benefit for this training. Training onsite could be also tailored for the user’s specific need.

Quotes offering Onsite training will be considered Acceptable.

Training shall be at the Regional Health Clinic in Gjakova, Kosovo, where the System will be installed. Training shall be conducted for a minimum of 5 days, and shall include basic training, Advance Application Training for doctors, and sepcific training for Biomedical engineers.

Training shall include the information for working, maintain and basic service of the system.

Position: Gantry integrated camera ton see patient during examination

2) As integrated camera is a feature that only a specific manufacturer is providing, we kindly ask to remove this as mandatory specification or accept “non-integrated camera solution” instead, if the camera is really needed.

Having an integrated camera to see the patient during the examination is considered more in MRI examination due to limited visibility of the patient because of long tunnel and longer time of examination. Having camera in the CT is not mandatory because CT examination lasts few seconds and the medical staff have full visibility of the patient from the console room.

Quotes offering non-integrated camera solution, will be considered Acceptable.

The camera solution shall include the camera in the exam room and the monitor to view the patients on real time.

So, we request to remove this point as mandatory requirement or change it to “non-integrated camera solution”.

Computer system and console

3) At least 1 monitor, 21-inch size.

Instead of 1 monitor with size of 21-inch, we are kindly asking you to accept dual monitor of 19-inch size each as solution.

So, we kindly ask you to change this requirement to: “At least 1 monitor, 21-inch size or dual monitor each 19-inch size”

Quotes offering 19” monitors will be considered Acceptable.

it would be preferred to be 21 inch as the nowadays standard for monitors size is below 21inch for ergonomic and comfortable use.

Additional independent Workstation

4) At least 2 monitors, minimum 21 inch.

At least 2 monitors, minimum 21 inch Question 4: Since our workstation is certified to work in a 19-inch system, we kindly ask you to change this requirement to:

“At least 2 monitors, minimum 19 inch”, or accept our solution as a minor deviation.

Same as positon 3) .

Additional Advanced post processing to be included

5) Neuro package (including neuro DSA, perfusion, ASPECT Score software for post processing.

As ASPECT score is a feature that only one manufacturer is providing, we kindly ask you to change this requires to:

Neuro package (including neuro DSA, perfusion, analysis of cerebral hematoma and aneurysm and stroke evaluation)

Our neuro package includes:

We can provide our comprehensive neuro package that includes:

4D Neuro DSA Stroke VCAR (semi-automated segmentation and analysis of cerebral hematoma and aneurysm) FastStroke (multi-phase CTA, head and neck region in stroke work-ups, image analysis for the stroke evaluation) CT Perfusion 4D (assessment of the type and extent of cerebral perfusion disturbances by providing qualitative and quantitative information

ASPECT could be optional or even to offer other equivalent solutions for stroke analysis.

on various perfusion related parameters, which may be related to acute stroke, brain tumor angiogenesis and treatment thereof – Regional blood Volume and Flow, MTT, PS, IRF T0, Tmax and etc.)

Addendum to FAR 52.212-4

6) On line UPS of suitable rating of 30 minutes backup shall be supplied for the complete system including computer & dry laser imager system.

Could you please confirm that this request is applicable only for Workstation Computer and Dry laser imager system, excluding CT system, which is covered by the requirement below and our additional suggestion?

As mentioned in the suggestion below, having “UPS with ≥ 1O min back up of suitable capacity to handle CT Computer, CT Gantry (cooling), CT Table, Work Stations (Console), Dry Laser Printer” it’s more than enough to guarantee patient and system safety.

Suggestions to guarantee system performance, reliability and image quality:

Accessories:

UPS with ≥ IO min back up of suitable capacity to handle CT Computer, Workstations (Console), Dry Laser Printer.

Suggestion 1: To guarantee system performance and provide safety for patient, we request to add CT Gantry (cooling), CT Table, to the list of devices that UPS should be able to handle. So, we kindly request to accept our suggestion and change this requirement to:

“UPS with ≥ 1O min back up of suitable capacity to handle CT Computer, CT Gantry (cooling), CT Table, Workstations (Console), Dry Laser Printer”

Additional suggestion regarding image quality

Suggestion 2: As we see only few parameters that describe image quality, to ensure that system has great image quality, we suggest adding the following point as mandatory request:

“High Contrast Resolution not less than 18lp/cm (at MTF 2% or 4%)”

Overall there are requested two UPS’s. one on the technical specifications under the accessories:

UPS with ≥ 1O min back up of suitable capacity to handle CT Computer, Work Stations (Console), Dry Laser Printer.

Under ADDENDUM TO FAR 52.212-4 point (3) is:

UPS for all the Systems and the requested autonomy time is 30 Minutes.

We have allowed to offer two solutions:

1. UPS with ≥ 1O min back up of suitable capacity to handle CT Computer, Work Stations (Console), Dry Laser Printer and UPS for all the Systems (all CT system) and the requested autonomy time is 10 Minutes.

2. One UPS with the necessary power to handle all CT System, CT Computer, WorkStation (Console), Dry Laser Printer and Injector for at least 10minutes.

NOTE: Quotes offering UPS incapable to handle the CT System, will be conidered Unacceptable.

Regarding: Additional suggestion regarding image quality

The specifications are prepared to enable all vendors/manufactures quotes.

If additional specification benefit the image quality, Quotes will be considered Acceptable.

At this time, RFQ Specifications remain unchanged.

(End of Summary of Changes)