W9114F18Q0014_Amendment_0003.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. The APRV requirement w as revised and therefore appropriate adjustments w ere made in the extended line item description of item 0001, in the Addendum to 52.212-1 and in 52.212-2.

c. Changed language in the Addendum 52.212-1 and in 52.212-2 in regards to the resulting outcome of the acquisition.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 8

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

16C. DATE SIGNED

BY 06-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

06-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 Airway Pressure Release Ventilation (APRV).-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 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: 14 Each MK08311 SW-OPTION APRV 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 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

The following have been modified:

CLAUSE(S) 52.212-1 - ADDENDUM TO FAR 52.212-1

ADDENDUM TO 52.212-1

The following paragraphs are hereby amended:

Paragraph 52.212-1(a) Does not apply to this Request for Quotation.

Paragraph 52.212-1(b)(4) is hereby replaced with the following:

NOTE: To all Vendors: Please check (X) a box below:

Are you providing a quote for the BRAND NAME PRODUCT or an EQUAL PRODUCT?

BRAND NAME

PRODUCT

EQUAL

PRODUCT

Please complete the Evaluation Criteria and place a check mark (X) to the subfactors that apply and follow the instructions in 52.212-1(m) below.

Please identify the method of shipment below:

AIR SEA GROUND

Technical Factor. The quoter must demonstrate compliance with the requirements in the Request for Quotation by submitting a written quote which addresses compliance with each of the following technical factors:

Evaluation Criteria Standard Standard Acceptable Unacceptable Subfactor 1: Equipment must meet all salient characteristics.

Subfactor 2: The quoted equipment shall be new and not a used or re-manufactured product.

Subfactor 3: 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.

Subfactor 4: Equipment must be warranted to be free from material and workmanship defect for 1 year.

Subfactor 5: Must include on-site installation and training.

Subfactor 6: Equipment must be warranted to be free from material and workmanship defect for a minimum of 1 year.

Salient Characteristics for Draeger Perseus A500 Anesthesia Machine or Equal

- 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.

- Transfers patient’s vital signs and demographics to the Electronic Medical Record system.

- Operate 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.

(End of Salient Characteristics)

Failure to receive an Acceptable rating of any of the above salient characteristics / evaluation criteria will result in an Unacceptable technical rating unless the error(s), deficiency (ies) or omission (s) can be corrected.

Paragraph 52.212-1 (b) (8) Completed representations and certifications, add - See 252.247-7022 Representation of Extent of Transportation by Sea.

Paragraph 52.212-1(c) is hereby replaced with the following:

The quoter agrees to hold the prices in its quotation firm for 90 calendar days from the date specified for receipt of quotations, unless another time period is specified in an addendum to the Request for Quotation.

Paragraph 52.212-1(d) does not apply to this Request for Quotation.

Paragraph 52.212-1(i) does not apply to this Request for Quotation.

Add the following:

Paragraph 52.212-1 (h)(ii) Only one Purchase Order will be issued as a result of this RFQ. The Purchase order will be issued on an “All OR NONE” basis.. Quotes for less than all of the solicited line items will be rejected as nonconforming and unacceptable to the RFQ.

Paragraph 52.212-1(m) Quotes shall describe how your product meets the above salient characteristics and are equal to the items listed in the schedule. Vendors quoting an equal product must submit a written narrative describing how the product is equal to the brand name. If you do mark any block “Unacceptable” please explain why the product you quoted doesn’t meet the Subfactor.

Paragraph 52.212-1(n) ELECTRONIC Quotation. Quoters may submit electronic quotation in response to this Request for Quotation. The quotation must be received by the quotation due date/local Germany time as specified in block 8 of the SF 1449 cover page to the inbox of the following email address: henningfalk.mayer-goldstein.ln@mail.mil Vendors may call Mr. Henning Mayer-Goldstein at 011-49-6371-9464-6789 to verify receipt of the quote. If the vendor chooses to email the quote, the Government will not be responsible for any failure of transmission or receipt of the quote, or any failure of the vendor to verify receipt of the emailed quote.

Paragraph 52.212-1(o) QUESTIONS. Prospective quoters are strongly encouraged to submit any questions regarding this Request for Quotation no later than five business days prior to the request for quote due date specified in block 8 of the SF 1449 cover page. Questions can be emailed to henningfalk.mayer-goldstein.ln@mail.mil, or fax +49-6371-86-8070. All questions received will be answered officially through an amendment to the Request for Quotation for distribution to all prospective quoters. Questions received after the local Germany cut-off date/time will not be accepted by the Government.

Paragraph 52.212-1 (p) The non-FAR Part 12 discretionary FAR, DFARS, AFARS, and LOCAL provisions included herein are incorporated into this Request for Quotation either by reference or in full text. If incorporated by reference, see provision 52.252-1 herein for locations where full text can be found.

Paragraph 52.212-1(q) If a Quoter believes that the requirements in these instructions contain an error, omission, or are otherwise unsound, the Quoter shall immediately notify the Contracting Officer (KO) in writing with supporting rationale.

ACQUISITION PROCEDURE:

This is a commercial item under FAR Part 12 and the acquisition procedures to be used for this purchase will be in accordance with FAR Part 13.5, Simplified Procedures for certain commercial items.

SPECIAL NOTE: All vendors must be registered in the System for Award Management (SAM) prior to award.

Vendors may obtain information on registration and annual confirmation requirements by calling 1-866-606-8220 or via Internet at https://www.sam.gov.

(End of provision)

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.

(End of Questions and Answers)

52.212-2 EVALUATION--COMMERCIAL ITEMS (OCT 2014)

(a) Evaluation procedures: The Government will evaluate each quotation using Simplified Acquisition Procedures under FAR 13.5, Simplified Procedures for Certain Commercial Items, lowest price and technically acceptable quote to the Government with acceptable past performance. The Government will evaluate Factor (1) Technical Capability to determine technical acceptability, Factor (2) Past peformance to determine acceptable past peformance. Factor (3), Price, to determine the lowest total price. A Purchase Order will be issued using the lowest price technically acceptable (LPTA) evaluation process with acceptable past performance. The Government reserves the right to obtain information for use in the evaluation of past/present performance from any and all sources, including but not limited to the Department of Defense Past Performance Information Retrieval System (PPIRS). The Government intends to make an award without conducting discussions. After the initial evaluation of quotations is completed, if one or more quotations are rated Acceptable Technical, the initial evaluation will become the final evaluation of quotations and a Purchase Order will be issued without discussions to the vendor with the lowest priced quote. If any one (1) technical subfactor is rated Unacceptable after the initial evaluation, the technical factor will be rated Unacceptable and the quote will no longer be considered for issuance of a Purchase Order. If all quotations submitted result in an unacceptable technical evaluation, then exchanges may be necessary.

In that event, the Government evaluation team will evaluate the quoter's response to the Government exchanges with each quoter.

FACTOR 1 – Technical: The quoter shall submit a written quote which explains how to comply with the requirements in the request for quote:

Evaluation Criteria Standard Standard Acceptable Unacceptable Subfactor 1: Equipment must meet all salient characteristics.

Subfactor 2: The quoted equipment shall be new and not a used or re-manufactured product.

Subfactor 3: 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.

Subfactor 4: Equipment must be warranted to be free from material and workmanship defect for 1 year.

Subfactor 5: Must include on-site installation and training.

Subfactor 6: Equipment must be warranted to be free from material and workmanship defect for a minimum of 1 year.

Salient Characteristics for Draeger Perseus A500 Anesthesia Machine or Equal

- 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.

- Transfers patient’s vital signs and demographics to the Electronic Medical Record system.

- Operate 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.

(End of Salient Characteristics)

EVALUATION STANDARDS. The quoter’s technical quote will be evaluated using the following standards for a final rating:

ACCEPTABLE: A quote that meets the Government’s technical requirements identified in the Request for Quotation.

UNACCEPTABLE: A quote that fails to meet the Government’s technical requirements identified in the Request for Quotation.

Factor 2 – Past Peformance: The Government will evaluate each quoter’s past/present performance based any and all sources. The Government reserves the right to obtain information for use in the evaluation of past/present performance from any and all sources, including but not limited to the Department of Defense Supplier Performance Risk System (SPRS).

The Government will use the following standards to evaluate Past Performance:

(1) Acceptable - Based on the quoter’s performance record, the Government has a reasonable expectation that the Quoter will successfully perform the required effort, or the quoter’s performance record is unknown.

(2) Unacceptable – Based on the quoter’s performance record, the Government has no reasonable expectation that the Quoter will be able to successfully perform the required effort.

NOTE: In the case of a quoter without a record of relevant past performance or for whom information on past performance is not available or so sparse that no meaningful past performance rating can be reasonably assigned, the quoter may not be evaluated favorably or unfavorably on past performance. Therefore, the quoter shall be determined to have unknown past performance. In the context of acceptability/unacceptability, “unknown” shall be considered “acceptable.”

Factor 3 - Price: The Government will issue a Purchase Order to the vendor who submits a quote that has lowest evaluated price, which is technically acceptable, and which has acceptable past performance. All Contract Line Item Numbers (CLINS) must be priced by the quoter. If the quoter failed to price all CLINs, the quote will not be considered for issuance of a Purchase Order.

(b) A quotation is not an offer and, consequently, cannot be accepted by the Government to form a binding contract. Therefore, issuance by the Government of an order in response to a supplier’s quotation does not establish a contract. The order is an offer by the Government to the supplier to buy certain supplies or services upon specified terms and conditions. A contract is established when the supplier accepts the offer.

(c) The word "quoter" shall be substituted for the word "offeror" wherever it appears in FAR 52.212-3, Alternate I and DFARS 252.212-7000.

(End of provision)

(End of Summary of Changes)