Amedment 0001 RFP 123A9422R0003.pdf

(x)

123A9422R0003 x x copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT 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 letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

x

FSIS-ASD-ACQUISITION

BELTSVILLE MD 20705-5230

5601 SUNNYSIDE AVENUE

MAILDROP 5230

USDA, FSIS, ASD, ACQUISITIONS

02/22/20220001

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

Offers 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

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

02/22/2022

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

E. IMPORTANT: Contractor is not is required to sign this document and return __________________ copies to the issuing office.

ORDER NO. IN ITEM 10A.

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

The purpose of Amendment 001 is to provide the answers to the questions received for this solicitation. See below.

Q1. Questions associated with "Attachment A: Section B. states "Due to the large number of samples analyzed daily, and new sampling programs being implemented, FSIS desires to update its current instrument inventory and associated expendable supplies (kits and reagents)."

Is it possible for Instruments that are currently placed (leased) and/or owned (purchased) at the 3 USDA FSIS Laboratories (Eastern, Mid-Western and Western) to be used in the evaluation and study period (04/18/22 to 06/01/22)?

A2. The lab currently has instruments placed at each lab for an AOAC validation and those Continued ...

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

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123A9422R0003/0001 instruments may be used for this evaluation as long as the instrument software and Windows 10 Operating System are all the same versions.

However, the PWS does state in D.11 that equipment placed in each location for testing purposes shall remain at each site for program implementation, upon successful evaluation and vendor award.

Q2. Section C. states "Hold a third-party validation prior to this evaluation". Is this referring specifically to an AOAC validated matrix certification?

A2. The instrument/assay should hold a third-party validation that may or may not be matrix specific.

Q3. Section C. states "Limit of detection of at least 10 colony -forming units." Is this CFU/mL of rinsate?

A3. Yes, this evaluation will be on poultry rinsate and the unit is CFU/ml.

Q4. Section E. states, "Vendors and technologies will be compared to an aerobic plate count where the correlation should be greater than or equal to 0.75 ((R2 ≥ 0.75) and evaluated on criteria in Appendix A and best cost to the government."

Shouldn't the Salmonella enumeration method be compared to the MLG MPN? If the Salmonella enumeration method is compared to aerobic plate count (APC) in a poultry rinsate sample the load of Salmonella in the sample will be much lower than APC because Salmonella is a part of the total APC count in a sample. Every poultry rinsate sample will have a natural non-Salmonella background flora (APC) and will vary from sample to sample. This variation will make it challenging to correlate to Salmonella.

A4. The R2 value will come from the spiking inoculum plated to APC and compared to CFU/ml values from the instruments.

Q5. Section H. states "The complete list of Windows 10 STIG settings can be provided by FSIS security upon request." Can you please send us a Continued ...

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Sponsored by GSA

FAR (48 CFR) 53.110

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123A9422R0003/0001 complete list of Windows 10 STIG settings?

A5. OCIO has the STIG settings online, but it requires some tools linked at https://public.cyber.mil/stigs/srg-stig-tools/

Q6. Clarification associated with "Appendix A Evaluation." Would a concentration step with a resuspension be considered a dilution? Line item 06, Please provide clarification around 'Dilution required'.

A6. No, concentration with resuspension is not considered dilution.

Q7. Line item 07 of "Appendix A Evaluation," Please provide enumerable range associated with this line item on "Enrichment or incubation required."

A7. LOD stated in PWS as 10 CFU - matrix in evaluation is rinsate CFU/ml is unit

Q8. Line item 11 of "Appendix A Evaluation," Please provide examples of "Hands on time (reagents)"step qualification.

A8. Dispensing a premixed lysis buffer could be considered one step, mixing primers/probes could be considered additional steps.

Q9. Line item 12 of "Appendix A Evaluation," Please provide examples of "Hands on time (samples)" step qualification.

A9. Adding enrichment media could be one step, centrifugation could be additional steps.

Q10. Line item 14 of "Appendix A Evaluation," Please provide examples of 'Repetitive motion' step qualification.

A10. Mixing multiple primers/probes could be considered `repetitive'.

Q11. Line item 33 of "Appendix A Evaluation," Please indicate what 'Block temperature' this is referencing.

A11. This is under the `Requires special

Continued ...

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123A9422R0003/0001 supplies' and is referencing any additional special blocks that may be required. Temperature is in degrees Celsius.

Q12. For the Attachment B: Past Performance Questionnaire. Is it my company's responsibility to collect these or will the Agency be sending these questionnaires out?

A12. It is the vendor's responsibility to send out the questionnaires, a minimum of three is required.

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