W81K00-17-T-0038-0001_Amendment__Approved.pdf

0010943818

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 include the questions and answ ers that w ere completed in response to this solicitation. No additional changes have been made to the solicitation.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 2

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

16C. DATE SIGNED

BY 10-Jan-2017

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 W81K00-17-T-0038

X 9B. DATED (SEE ITEM 11)

21-Dec-2016

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 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

10-Jan-2017

CODE

W40M USA HLTH CONTRACTING ACT

SOUTHERN REG CONTR OFC

3551 ROGER BROOK DR BLDG 3600

FORT SAM HOUSTON TX 78234-6200

W81K00 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

W81K00-17-T-0038

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:

QUESTIONS AND ANSWERS

Question 1: The solicitation refers to specific criteria (salient characteristics) around Critically Ill labelling, given that the recently released final FDA Guidance (released Oct 2016) has no mention of Critically Ill Labelling but does refer to product limitations, I would suggest that we schedule an on-site meeting to discuss this in detail with Pathology, Laboratory etc. The current solicitation limits the vendor's response around critically ill labelling, no longer under FDA guidance to manufacturers.

Government Response: We are requiring the hospital grade glucose testing meter be cleared by the FDA for the use on critically ill patients. We do not wish to go off label or be defaulted to high-complexity testing. So it still stands that we are looking for an instrument already evaluated for use on Critically Ill patients. The government does not intend to schedule an on-site meeting to discuss this topic further.

Question 2: Can you please confirm the total annual inpatient test strip volume?

Government Response: Total, inpatient and outpatient in hospital setting (not home use) is approx. 388,080.

Question 3: Given that a similar solicitation was posted in May 2016, can you please help me to understand the intent of the current solicitation? Is there an interest in considering a conversion to a new vendor for Inpatient Blood Glucose and Data Management, please explain?

Government Response:

Part 1 - The current requirement is a re-procurement stemming from a termination of the resulting contract (W81K00-16-P-0306) action under solicitation # W81K00-16-T-0135. The intent of solicitation # W81K00-17- T-0038 is to obtain a Glucose Meter System consisting of 135 meters and associated hardware and software as stated within the solicitation.

Part 2 – This solicitation is being competed unrestricted and full and open. Any interested vendor may submit a timely quotation and will receive equal consideration as it pertains to the terms and conditions set forth within the solicitation.

Question 4: It appears that the Solicitation is requesting a Capital Acquisition of Equipment, would you also consider an option to Bundle the equipment into the test strip price? (Please do note that the Freestyle Precision Pro and UniPOC Data Management Solution are on FSS/GSA pricing schedules) Government Response: FAR Clause 252.204-7011 ALTERNATIVE LINE-ITEM STRUCTURE (which is included in the solicitation) in part states; “offerors are invited to propose an alternative line item structure for items on which bids, proposals, or quotes are requested in this solicitation to ensure that the resulting contract structure is economically and administratively advantageous to the Government and the Contractor.” Therefore, so long as the requirements, terms and conditions stated within the solicitation are met vendor may utilize this clause as they deem necessary.

Question 5: Given a Capital Acquisition, are you willing to sign an agreement for a contracted test strip price?

Government Response: We request clarification of your question. Any resulting contract action associated with this requirement will be a government generated document in which the awardee would have the opportunity to sign this resulting agreement, which would then be counter-signed by the Government’s Contracting Officer, thus creating a binding legal agreement.

(End of Summary of Changes)