W9114F-18-T-0014_Amendment_0002.pdf

W40M RHCO USAHCA EUROPE

REGIONAL HEALTH CONTR OFC EUROPE

POC: HENNING MAYER-GOLDSTEIN

CMR 402

APO AE 09180

0011108978

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 publicize the questions raised during and after the site visit conducted on 4 January 2018 and to provide the appropriate answ ers. See Summary of Changes for details.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 4

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

16C. DATE SIGNED

BY 09-Jan-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 W9114F-18-T-0014

X 9B. DATED (SEE ITEM 11)

15-Dec-2017

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

09-Jan-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:

W9114F-18-T-0014

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

The following have been added by full text:

SITE VISIT - Q&A

Site Visit – Questions and Answers

Question 1: The Landstuhl Regional Medical Center is currently using a non-disposable pipetting system in the Chemistry Laboratory. Why can it be used in the Chemistry Laboratory but not in the Immunology Laboratory?

Answer 1: The Immunology Laboratory does not have a enough high positive patient samples for any of the assays to run accurate carryover studies which are required in accordance with CAP guidelines and therefore only systems with disposable pipette tips can be used. The difference of testing in immunology is we perform serology testing which is detection and measurement of antibodies and antigens as a result of exposure to a particular bacteria, viruses, and parasites. Chemistry is generally concerned with analysis of bodily fluids for diagnostic and therapeutic purposes, not potentially infectious samples.

Question 2: Is the carryover study done for each one of the analytes?

Answer 2: Yes, if disposable pipettes are not used, carry over studies will be done for each analyte.

Question 3: Which and how many power outlets are available for the analyzer?

Answer 3: There are three outlets with 220 Volt / 50Hz available, one emergency and two regular ones.

Question 4: Does the analyzer be equipment with an un-interruptible power supply (UPS)?

Answer 4: In accordance with PWS Paragraph 1.1.3. and 5.1.3., “The analyzer system shall be equipped with an un-interruptible power supply capable of providing all necessary electrical power to the analyzer system for 15 to 20 minutes to allow salvaging of the current batch of specimens in the analyzer.”.

Question 5: What is the backup if the analyzer is down?

Answer 5: There is no direct backup, but in accordance with PWS Paragraph 5.7.8., “Should the analyzer at

LRMC become inoperable, the Contractor’s technical repair specialist shall be on-site within 24 hours of initial notification and make the repair within five (5) business days of initial notification.

If the analyzer cannot be repaired within five (5) business days of the initial notification, a replacement analyzer, at no additional cost to the U. S. Government, shall be provided within five

(5) business days of the initial notification to be utilized by the U.S. Government until the original instrument is fully repaired and accepted for service. During the period when the analyzer is inoperable, the Contractor shall arrange the pickup and delivery of critical specimens to a College of American Pathologists accredited clinical laboratory of their choice within Germany. The selected laboratory will provide patient reports in English. Each patient report shall include the testing laboratory’s reference range for the test being performed. The Contractor shall be responsible for all costs associated with the provision of this service, including those for delivery of hardcopy patient results by DHL or other express courier, for as long as the analyzer remains inoperable.”

And in accordance with PWS Paragraph 5.7.9. “If the equipment is out of service for longer than five (5) business days (from the time of service technician’s arrival on site), the Contractor shall notify the COR, in writing, as to the reason(s) (i.e. non-availability of parts, etc.) for non-compliance. If the equipment cannot be repaired, a replacement instrument shall be provided within seven (7) business days. If the equipment cannot be replaced within seven (7) business days, the Government may seek remedies for damages in accordance with FAR 52.246-4, “Inspection of Services – Fixed Price”.”

Question 6: Are Anti-HBs and HBsAg acceptable as well?

Answer 6: Yes, both are acceptable. The description of both items in PWS Attachment 3 “Reportable Test

Prices” were changed from “Anti-HBs 2” to “Anti-HBs” and “HBsAg II” to “HBsAg”.

Question 7: How often are quality controls being run and how many levels?

Answer 7: Once a day, 2 levels (High and Low) with the exception of Rubella IgG with Low, Medium and

High QC.

Question 8: Must all technical subfactors be fulfilled?

Answer 8: In order to get an acceptable technical evaluation rating, all technical subfactors have to be fulfilled.

Question 9: Can we get a copy of the attendee list of the site visit on 4 January 2018?

Answer 9: A copy of the attendee list will be publicized along with this questions and answers.

(End of Site Visit – Questions and Answers)

The following have been modified:

PWS – ATTACHMENT 3

REPORTABLE TEST PRICE BY REAGENT: CLIN 0002, 1002, 2002, 3002 and 4002

Description Product # Result Code

Estimated No. of reportable Tests

Unit Price per test

Total Price per test

Anti-HAV total 572

Anti-HAV IgM 301

Anti-HBc IgM 4,408

Anti-HBc total 4,515

Anti-HBs 2,254

Anti-HCV 5,522

Anti-Rubella IgG 3,740

Anti-Rubella IgM 35

Anti-Toxoplasma IgG 130

Anti-Toxoplasma IgM 130

HBsAg 5,813

HBsAg Conf. 76

CCP 3,000

Total T3 470

Total T4 520

Anti-TG 991

Anti-TPO 991

Total 33,468

Reportable test price

The total amount divided by the total estimated number of tests will be the Price for one reportable test.

(End of PWS Attachment 3 – Test Prices)

(End of Summary of Changes)