Solicitation Amendment 0002 --- W81K00-22-Q-0104 - KO Approved.pdf

W40M USA HLTH CONTRACTING ACT

REGIONAL HEALTH CONTRACT OFF CENTRAL

POC: MEDINA L. WOODSON

3551 ROGER BROOK DR BLDG 3600

FORT SAM HOUSTON TX 78236-6200

0011754382

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

A. The purpose of this Amendment 0002 is tw o-fold:

1) Include the Government Answ ers to the questions received in response to this solicitation on 19 May 2022, and

2) Extend the solicitation closing date/time to 2 June 2022, 4:00 PM CST.

B. All other solicitation terms and conditions remain the same.

See SUMMARY OF CHANGES

1. CONTRACT ID CODE PAGE OF PAGES

1 3

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

16C. DATE SIGNED

BY 24-May-2022

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 W81K0022Q0104

X 9B. DATED (SEE ITEM 11)

12-May-2022

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 X is extended, 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

24-May-2022

CODE

W40M USA HLTH CONTRACTING ACT

REGIONAL HEALTH CONTRACT OFF CENTRAL

2539 GARDEN AVENUE

FT SAM HOUSTON TX 78234-0000

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

4. REQUISITION/PURCHASE REQ. NO.

CODE W81K00

FACILITY CODECODE

EMAIL:TEL:

W81K0022Q0104

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:

AMD #02-QUESTIONS AND ANSWERS

W81K00-22-Q-0104 – Solicitation, Amendment 0002- Questions & Government Response

1. DiaSorin already has an ATO# 3071 where the military has certified our system for networking. Is that sufficient to look up our previous responses or would you like us to still provide the questionnaire responses?

Government Response: The Government is not sure if DiaSorin ATO# 3071 is sufficient. Recommend to still provide the questionnaire responses without knowing the specifics.

2. 7.14 - "Immunoassay STAT test results must be available in <16 minutes from the time loaded on the analyzer to the time results are available." This requirement limits to a single vendor and does not allow for the competition of three or more suppliers. Additionally, given the nature of hepatitis testing, standard incubation times average between 18-30 minutes. We request this requirement be modified to accommodate the 18-30 minute times to open vendor competition for this solicitation.

Government Response: Yes, we can modify requirement to accommodate the 18-30 minute times.

3. 13 & Workload Data Table 1 - These sections (and the applicable CLIN lines) reference "Anti-Hepatitis A Virus Immunoglobulin G" or Anti-HAV IgG. Please confirm that Anti-HAV Total is an acceptable alternative.

Government Response: The Anti-HAV Total is NOT ACCEPTABLE. We need to offer both anti-HAV IgM and anti-HAV IgG individually.

4. 11.3 - "We require that the immunoassays must not use free-capture streptavidin/biotin in the assay architecture to minimize the risk of interference from ingested biotin." This requirement limits to a single vendor and does not allow for the competition of three or more suppliers. Furthermore, given the population, Infectious Disease assays, and Biotin levels do not interfere with our performance, we request this requirement be phrased in a manner where Biotin and other substances must not interfere with the performance of detection.

Government Response: Yes, we require that the immunoassays must not use free-capture streptavidin biotin in the assay. If the company claims that Biotin levels do not interfere with their Streptavidin-Biotin based assay, they will need to provide documentation/product insert stating that the performance of their is not affected in patients receiving Biotin therapy regardless of the concentration and in such manner approved by the FDA. The probability of Biotin supplementation/therapy in our unique patient population might affect the accuracy and quality of our results. Therefore, we would like to eliminate the possibility of Biotin interference affecting the patient test results.

W81K0022Q0104

5. We request that the due date of 5/27/2022 be extended by a minimum of 2 weeks (6/10/2022 or later), to allow vendors to compile an accurate proposal based on the revised requirements.

Government Response: We will extend the proposal due date until Thursday, 2 June 2022 since our contract will expire 30 June 2022. We will need to move as quickly as possible to avoid or minimize service interruptions and reduce cost of sending specimens to referral labs after the expiration of the current contract

SECTION SF 1449 - CONTINUATION SHEET

SOLICITATION/CONTRACT FORM

The required response date/time has changed from 26-May-2022 01:00 PM to 02-Jun-2022 04:00 PM.

(End of Summary of Changes)