W9114F18Q0014_Amendment_0004.pdf

W40M RHCO USAHCA EUROPE

REGIONAL HEALTH CONTR OFC EUROPE

POC: HENNING MAYER-GOLDSTEIN

CMR 402

APO AE 09180

0011157383

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

The purpose of this amendment is to do the follow ing:

a. Publicize additional questions received from industry w ith the appropriate answ ers.

b. Added additional language in the line item 0001 and line item 0005 description in regards to Sevoflurane vaporizers and Desflurane vaporizers.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 6

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

16C. DATE SIGNED

BY 12-Jun-2018

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 W9114F18Q0014

X 9B. DATED (SEE ITEM 11)

24-Apr-2018

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.)

10A. MOD. OF CONTRACT/ORDER NO.

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

6. ISSUED BY

3. EFFECTIVE DATE

12-Jun-2018

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 W9114F

FACILITY CODECODE

EMAIL:TEL:

W9114F18Q0014

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SUPPLIES OR SERVICES AND PRICES

CLIN 0001

The CLIN extended description has changed from:

Perseus A500 Anesthesia Machine Brand Name or Equal Draeger Manufacturer Part Number: MK06000 Salient Characteristics of the Draeger Perseus A500 Anesthesia Machine-Provides audible alarms with parameters which provide the ability to be adjusted by the user.-Capable of delivering different modes of ventilation including the ability for end-user management of ventilator parameters to include P high and P low (pressure high and pressure low settings), T high and T low (time settings for P high and low) and inverse I:E (Inspiratory:Expiratory) ratio. - Transfer patient’s vital signs and demographics to the Electronic Medical Record system. -Operates on 220-240 Volt, 50-60 Hz -Provides the ability to administer volatile anesthesia and ventilate patients of all physical classifications from neonate thru adult. Main Configuration: 14 Each MK08190 Basic unit trolley based -SW- Version Perseus 1.13 -Mechanic gas mixer, 14 Each OPC5863 Mechanic 3-gas mixer, Adv.Cyl.Supp. 14 Each MK07849 Selectatec, 2 vaporizers 14 Each 9055395 Quick Reference Guide English Connections: (with hanging cylinders) 14 Each MK09838 Cylinder holder PinIndex Press. red. O2, for small cyl. 14 Each MK06316 Pressure reducer O2, Pin Index 220-240 Volt, 50-60 Hz country-spec. power outlet Ventilator & Display: 14 Each MK08311 SW option APRV or Equal 14 Each MK08317 SW option Pressure Support 14 Each MK08316 SW option Breathing Sound Em. -SW opt. Low Flow Wizard 14 Each 8605088 Flexible breathing bag arm Required Accessories: (Inf. ID Flow Sensor, 5 pcs. -Adapter for CLIC absorber) 14 Each 8605088 Control valve NPT Endotracheal Suction: 14 Each MP00686 Endotrach. suction DISS, VAC 14 Each MK08653 Mounting kit VAC suction 14 Each MK10069 Suction acc.(hoop, tip holder) Hardware components: 14 Each MK09494 Pressure gauge 14 Each MK09854 Drawer module large 14 Each MK08487 Box with writing tray Pressure Screen:

(single, fixed at backbone) Units have to be 220-240 Volt, 50-60 Hz, European Power Plug Units must be warranted to be free from material and workmanship defect for 1 year.Two paper copies and one electronic copy of Operator's and Maintenance Manuals in English language.Including Commercial Shipment to:Landstuhl Regional Medical Center BLDG 3739 ATTN: PMB 66849 Landstuhl Germany 14 Each 1900062 Continuity of Care Promo including the following: 1 Each MQ00444 License fee ServiceConnect Optional Trade-In of the following Items:14 Each S/5 Perseus-Avance, Nameplate Model 1009-9002-000 with the following Manufacturer Serial Numbers: ANBN00243, ANBN00244, ANBN00245, ANBN00246, ANBN00247, ANBN00248, ANBN00249, ANBN00250, ANBN00251, ANBN00252, ANBN00253, ANBN00254, ANBN00255, ANBN00256

To:

Perseus A500 Anesthesia Machine Brand Name or Equal Draeger Manufacturer Part Number: MK06000 Salient Characteristics of the Draeger Perseus A500 Anesthesia Machine-Provides audible alarms with parameters which provide the ability to be adjusted by the user.-Capable of delivering different modes of ventilation including the ability for end-user management of ventilator parameters to include P high and P low (pressure high and pressure low settings), T high and T low (time settings for P high and low) and inverse I:E (Inspiratory:Expiratory) ratio. - Transfer patient’s vital signs and demographics to the Electronic Medical Record system. -Operates on 220-240 Volt, 50-60 Hz -Provides the ability to administer volatile anesthesia and ventilate patients of all physical classifications from neonate thru adult. Main Configuration: 14 Each MK08190 Basic unit trolley based -SW- Version Perseus 1.13 -Mechanic gas mixer, 14 Each OPC5863 Mechanic 3-gas mixer, Adv.Cyl.Supp. 14 Each MK07849 Selectatec, 2 vaporizers 14 Each 9055395 Quick Reference Guide English Connections: (with hanging cylinders) 14 Each MK09838 Cylinder holder PinIndex Press. red. O2, for small cyl. 14 Each MK06316 Pressure reducer O2, Pin Index 220-240 Volt, 50-60 Hz country-spec. power outlet Ventilator & Display: 14 Each MK08311 SW option APRV or Equal 14 Each MK08317 SW option Pressure Support 14 Each MK08316 SW option Breathing Sound Em. -SW opt. Low Flow Wizard 14 Each 8605088 Flexible breathing bag arm Required Accessories: (Inf. ID Flow Sensor, 5 pcs. -Adapter for CLIC absorber) 14 Each 8605088 Control valve NPT Endotracheal Suction: 14 Each MP00686 Endotrach. suction DISS, VAC 14 Each MK08653 Mounting kit VAC suction 14 Each MK10069 Suction acc.(hoop, tip holder) Hardware components: 14 Each MK09494 Pressure gauge 14 Each MK09854 Drawer module large 14 Each MK08487 Box with writing tray Pressure Screen:

(single, fixed at backbone) Units have to be 220-240 Volt, 50-60 Hz, European Power Plug Units must be warranted to be free from material and workmanship defect for 1 year.Two paper copies and one electronic copy of Operator's and Maintenance Manuals in English language.Including Commercial Shipment to:Landstuhl Regional Medical Center BLDG 3739 ATTN: PMB 66849 Landstuhl Germany 14 Each 1900062 Continuity of Care Promo including the following: 1 Each MQ00444 License fee ServiceConnect The Government would like to continue using the existing 14 Each Sevoflurane TEC 7 vaporizers from GE Healthcare USA. However, if your quoted anesthesia machine is incompatible with them, please ensure you include compatible Sevoflurane vaporizers in your quote. Optional Trade-In of the following Items:14 Each S/5 Perseus-Avance, Nameplate Model 1009-9002-000 with the following Manufacturer Serial Numbers: ANBN00243, ANBN00244, ANBN00245, ANBN00246, ANBN00247, ANBN00248, ANBN00249, ANBN00250, ANBN00251, ANBN00252, ANBN00253, ANBN00254, ANBN00255, ANBN00256

CLIN 0005

The CLIN extended description has changed from:

M35500 D-Vapor

To:

M35500 D-Vapor This item does not have to be quoted if your quoted anesthesia machine is compatible with the existing 14 Each TEC 6 Desflurane vaporizers from GE Healthcare USA. If that is the case, please provide a compatibility statement. The Government will then continue using the existing Desflurane vaporizers.

The following have been modified:

QUESTIONS AND ANSWERS

RFQ W9114F18Q0014

Questions & Answers

Question 1: The Salient Characteristics for the anesthesia machines require that they operate on a 220 V/50 Hz power supply. It is our understanding that the operating rooms at Landstuhl are also equipped with a 120 V/60 Hz. The Draeger Perseus has a FDA 510(k) pre market certification based on a 100 to 127 VAC, 50-60 Hz. It is our understanding that the Perseus anesthesia machines being solicited are to be FDA 510(k) compliant. We therefore requesting that the Salient Characteristic be revised to “Operate on 100 to 127 VAC, 50-60 Hz “.

Answer 1: The equipment has to either possess or meet the FDA certification requirements or have a 510(k) compliance statement. The Landstuhl Regional Medical Center (LRMC) can only use 220-240 Volt, 50-60 Hz. The LRMC operating rooms do not have any 120V/60 Hz outlets. Power lines with 120V/50 Hz are not authorized for use of any critical equipment because they are not part of the emergency backup power lines. Usage of them would be a violation of Joint Commission guidelines. Due to the limited supply of 120V/50 Hz the LRMC Commander has mandated all future equipment acquisitions to operate on 220-240V. During the lifecycle of this equipment it may be moved to the new hospital which will not have 120V power for any frequency. All power will be 220-240V, 50/60Hz.

Question 2: Please specify what type of gas supply fittings (O2, N2O, Air) are required on the anesthesia machine for connections of gas supply hoses from either the wall or ceiling.

Answer 2: This requirement is for wall connections and the gas supply fittings required are the DIN standard fittings for Germany.

Question 3: We recognized the ventilation mode "APRV" in the technical requirements of the performance directory as a must requirement. This is in our opinion a huge competition restriction. The APRV mode is only available from one manufacturer. We therefore ask to allow to quote different ventilation modes which can provide the same function. For example - have the capability to change between mechanical and spontaneous ventilation and even specify an inverse I:E ratio.

From the clinical point of view, this makes no difference. If the patient has no or not enough spontaneous breathing, the anesthesia device will provide the support required. Our ventilation mode PSVPro provides high patient safety, especially if compared to APRV.

Answer 3: The technical subfactor 3 which this question is referring to was revised from “Optional mode of ventilation must include FDA approved Airway Pressure Release Ventilation

(APRV).”

to “Optional mode of ventilation must include FDA approved ability for end-user management of ventilator parameters to include P high and P low (pressure high and pressure low settings), T high and T low (time settings for P high and low) and inverse I:E (Inspiratory:Expiratory) ratio.”

Question 4: APRV is very specific to one manufacturer and therefore we cannot submit a quote. Please either change this criteria to be optional or remove this completely to allow competition.

Answer 4: The technical subfactor 3 which this question is referring to was changed from “Optional mode of ventilation must include FDA approved Airway Pressure Release Ventilation

(APRV).”

to “Optional mode of ventilation must include FDA approved ability for end-user management of ventilator parameters to include P high and P low (pressure high and pressure low settings), T high and T low (time settings for P high and low) and inverse I:E (Inspiratory:Expiratory) ratio.”

Question 5: This question is depending on the outcome of the aforementioned question. If the APRV requirement got removed we would be able to submit a quote. However, please allow sufficient time to prepare a quote based on the changes and extend the RFQ closure date to 15th of June 2018.

Answer 5: The RFQ due date/time was changed to 15 June 2018 at 01:00 PM local Germany time with amendment 0002.

Question 6: In description of line item 0001 (page 4 of RFQ) is asking for the possibility to connect two Selectatec vaporizers. But line item 0005 (page 7 of RFQ) is only asking for 14 each Desflurane vaporizers which would be one vaporizer per anesthesia machine. Does that mean that the Government wants to use any existing vaporizers with the new machines?

Answer 6: The Government would like to continue using their existing Sevoflurane and Desflurane vaporizers if possible. However, the Government understands that some of the quoted anesthesia machines might not be compatible with the existing vaporizers. In order to prevent unnecessarily reduction of competition, the following additional language was added in line item 0001 and 0005.

Item 0001: "The Government would like to continue using the existing 14 Each Sevoflurane TEC 7 vaporizers from GE Healthcare USA. However, if your quoted anesthesia machine is incompatible with them, please ensure you include compatible Sevoflurane vaporizers in your quote."

Item 0005: “This item does not have to be quoted if your quoted anesthesia machine is compatible with the existing 14 Each TEC 6 Desflurane vaporizers from GE Healthcare USA. If that is the case, please provide a compatibility statement. The Government will then continue using the existing Desflurane vaporizers.”

Question 7: The RFQ is asking for an optional trade-in of old items. Is the trade-in amount supposed to be included in the total price?

Answer 7: If you accept the trade-in option, then the price of item 0001 shall be adjusted accordingly. This was done due to the fact that the Government cannot accept a credit note. Please be aware that this RFQ includes provision 252.204-7011 which allows an Alternative Line Item Structure.

However, the trade-in value will be calculated against CLIN 0001 in the resulting purchase order.

Please be aware that additional language was added for item 0001. If your quoted anesthesia machine is incompatible with the existing 14 Each Sevoflurane TEC 7 vaporizers from GE Healthcare USA, please ensure you include compatible Sevoflurane vaporizers in your quote as well.

Question 8: Does the existence of our active SAM registration make the filling out of page 48 and the following pages unnecessary?

Answer 8 Yes, the Representations & Certifications are part of your SAM registration and do not have to be repeated.

Question 9: The vendor submitting Questions 3 & 4 states: "We recognized the ventilation mode "APRV" in the technical requirements of the performance directory as a must requirement. This is in our opinion a huge competition restriction. The APRV mode is only available from one manufacturer." And "APRV is very specific to one manufacturer and therefore we cannot submit a quote." The statement that APRV mode of ventilation is only available from one manufacturer is not accurate. Draeger is not the only manufacturer that offers this ventilation mode. Mindray, a manufacturer of anesthesia machines, offers a FDA approved Airway Pressure Release Ventilation (APRV) mode. See attached excerpt from their FDA 510(K) K171292. In that the APRV ventilation mode is not solely offered by Draeger in the Perseus, and therefore does not pose a "huge competition restriction", we respectfully ask that Amendment 0003 be rescinded and that the previous language existing in Amendment 0002 and W9114F18Q00140002 Conformed be reinstated.

Answer 9 Adding back in “APRV” will definitely restrict competition to some degree. The Government does not want to restrict competition in any way for this acquisition and therefore does not see a reason to rescind the adjustments made with Amendment 0003.

(End of Questions and Answers)

(End of Summary of Changes)