W81K0024Q0065-U0001.pdf

0012031741

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

Questions proposed and Answ ers to the questions have been provided. The Question and Answ er period has ended, no more questions w ill be accepted.

1. CONTRACT ID CODE PAGE OF PAGES

1 14

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

16C. DATE SIGNED

BY 03-Jul-2024

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 W81K0024Q0065

X 9B. DATED (SEE ITEM 11)

18-Jun-2024

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

03-Jul-2024

CODE

W40M USA HCA

MEDICAL READINESS CONTR OFFICE WEST

3160 MCINDOE BLDG 1103

JBSA FT SAM HOUSTON TX 78234-4504

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

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

W81K0024Q0065

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

Questions and Answers Solicitation W81K0024Q0065

Question 1) Subfactor 5 on page 31 and 33 has two dates for shipment and installation of the analyzers. Can you confirm when the analyzers will need to be shipped and installed.

Answer 1) Subfactor 5 on page 33 has been corrected to state the following: Offer must be able to ensure delivery/reconfiguration of analyzers to Reynolds Army Health Clinic, Fort Sill, Oklahoma 73503 no later than 30 September 2024 for correlation and validation for a 15 December 2024 start date.

Question 2) QuantiFERON TB Gold Pus is listed on the solicitation. The solicitation indicates “this line will allow for multiple invoices”, does that include invoices from multiple companies?

Answer 2) The following verbiage this line will allow for multiple invoices has been removed from the solicitation.

Question 3) Does the ATO have to be fully executed and in place prior to submitting quote?

Answer 3) Yes, per subfactor 2- ATO/RMF Compliance – Provide documentation of Authority to Operate/Risk Management Framework (ATO/RMF) compliance. Offeror shall be in compliance with Authority to Operate/Risk Management Framework (ATO/RMF) upon submission of offer. Any updates to the equipment after receipt of an approved ATO shall be approved by the Defense Health Agency's Cybersecurity Team in accordance with the Exhibit B.

Question 4) Does all the testing have to be done on one instrument?

Answer 4) Yes, all testing has to be done on one instrument.

Question 5) Can assays be performed via another method other than chemiluminescence?

Answer 5) The assays must be performed via the chemiluminescence method.

SECTION SF 1449 - CONTINUATION SHEET

SUPPLIES OR SERVICES AND PRICES

SUBCLIN 0001AA

The CLIN extended description has changed from:

Measles Immunoglobulin G (IgG). This line allows for multiple invoices.

To:

Measles Immunoglobulin G (IgG).

SUBCLIN 0001AB

Mumps This line allows for multiple invoices.

Mumps

SUBCLIN 0001AC

Rubella-Immunoglobulin G (IgG) This line allows for multiple invoices.

Rubella-Immunoglobulin G (IgG)

SUBCLIN 0001AD

Varicella-Zoster Virus (VZV)- Immunoglobulin G (IgG) This line allows formultiple invoices.

Varicella-Zoster Virus (VZV)- Immunoglobulin G (IgG)

SUBCLIN 0001AE

Vitamin D 25-OH This line allows for multiple invoices.

Vitamin D 25-OH

SUBCLIN 0001AF

QuantiFERON This line allows for multiple invoices.

QuantiFERON

SUBCLIN 1001AA

SUBCLIN 1001AB

SUBCLIN 1001AC

SUBCLIN 1001AD

SUBCLIN 1001AE

SUBCLIN 1001AF

SUBCLIN 2001AA

SUBCLIN 2001AB

SUBCLIN 2001AC

SUBCLIN 2001AD

SUBCLIN 2001AE

SUBCLIN 2001AF

SUBCLIN 3001AA

SUBCLIN 3001AB

SUBCLIN 3001AC

SUBCLIN 3001AD

SUBCLIN 3001AE

SUBCLIN 3001AF

SUBCLIN 4001AA

SUBCLIN 4001AB

SUBCLIN 4001AC

SUBCLIN 4001AD

SUBCLIN 4001AE

SUBCLIN 4001AF

The following have been modified:

52.212-1 ADDENDUM

This requirement will be procured using FAR Part 12 Acquisition of Commercial Products and Commercial Services and FAR Part 13 Simplified Acquisition Procedures. The Government will make an award to the offeror's quote that conforms to the Request for Quote (RFQ) and proposed price is determined fair and reasonable.

QUOTES PREPARATION INSTRUCTIONS: Quotes shall be submitted in three individual electronic volumes:

Volume I. Administrative Volume II. Technical Volume II. Price

Each subfactor under Volume II shall be separately tabbed and addressed in sufficient detail so the government may evaluate each subfactor independently.

Electronic (e-mail) is the only method of submission for quotes; paper or printed copies will not be accepted.

Files larger than 20MB may need to be transmitted in separate emails.

The Contracting Officer and Contract Specialist are sole points of contact for this solicitation.

Responsibility Determination: The Contracting Officer is required to make a determination of responsibility

IAW FAR 9.1.

Volume I Administrative: Offerors shall provide the following:

a. Summary or title page identifying the offeror, address, phone, UIE number, CAGE Code, Point of Contact (POC) information for the authorized individuals authorized to negotiate with the Government on behalf of the Offeror, and the solicitation number. The Offeror is responsible for notifying the contracting office of any POC changes.

b. The offeror shall include a copy of the completed SF 1449, with the signature in block 30a, name and title of signer in block 30b, and date signed in block 30c. Signature shall be from an authorized individual authorized to negotiate on behalf of the company. Include the name of the offeror, address, phone number, and CAGE Code in Block 17a.

c. For all solicitation amendments, if applicable: Completed and signed SF 30: Blocks 8, 15A - C

d. Provide statement that the offeror will hold its quote firm for at least 90 calendar days from the offer due date, subject to any changes that may occur as a result of discussions (if applicable).

e. All offerors must be registered in the System for Award Management (SAM) with the appropriate NAICS

Code prior to award and shall not have any Active Exclusions listed within SAM.GOV to be eligible for award. Lack of registration shall make an offeror ineligible for award.

f. Completed provisions, as listed in the solicitation. Alternately, complete all provisions in SAM and provide confirmation of completion and accuracy with offer.

g. The offeror shall submit a completed copy of FAR 52.212-3, Representations and Certifications - Commercial Items. If the offeror has completed the Online Representations and Certifications Application (ORCA) at https://www.sam.gov the offeror shall indicate such on the FAR clause.

h. Questions regarding this solicitation are to be submitted electronically to the Contract Specialist by 27 June 2024 at 10:00 a.m. CST to karan.e.quiles.civ@health.mil; answers to all questions will be provided via an amendment to the solicitation and posted to https://sam.gov no later than 2 July

2024 3:00 PM CST.

i. Offers are due by the date and time identified on Page 1 Block 8 of the SF1449 (Unless extended via solicitation amendment). Offers shall be submitted via e-mail to karan.e.quiles.civ@health.mil. Quotes received after the deadline will be considered untimely and will not be eligible for award. When submitting your offer via email please annotate the subject line as “Quote for W81K00-24-Q-0065”.

j. The statutory requirements stated at FAR 19.702 apply to this requirement. The offeror shall submit a Subcontracting Plan with their quote. If the offeror already has a current Commercial Subcontracting Plan approved by a Government Contracting Officer, that plan (along with corresponding approval) is sufficient for submission. If the offeror does not believe any subcontracting opportunities exist, an explanation with supporting documentation shall be submitted.

Volume II Technical: The technical volume shall be addressed in sufficient written detail for the Government to determine if the offeror understands the technical requirements listed in the following subfactors.

a. Subfactor 1-Equipment/Reagents/Consumables: Offeror shall provide equipment, reagent, and consumables that conform to the salient physical, functional, performance characteristics, and quantities as specified in the Special Terms and Conditions and Exhibits A. Offeror’s system must be able to run all of the required tests listed in the Special Terms and Conditions.

Subfactor 2- ATO/RMF Compliance – Provide documentation of Authority to Operate/Risk Management Framework (ATO/RMF) compliance. Offeror shall be in compliance with Authority to Operate/Risk Management Framework (ATO/RMF) upon submission of offer. Any updates to the equipment after receipt of an approved ATO shall be approved by the Defense Health Agency's Cybersecurity Team in accordance with the Exhibit B.

c. Subfactor 3- Offeror must be able to provide Maintenance (unscheduled and preventive) and telephonic assistance in accordance with Special Terms and Conditions.

d. Subfactor 4- Offeror must be able to provide Training in accordance with Special Terms and Conditions.

e. Subfactor 5- Offer must be able to ensure delivery/reconfiguration of analyzers to Reynolds Army Health Clinic, Fort Sill, Oklahoma 73503 no later than 30 September 2024 for correlation and validation for a 15 December 2024 start date.

Include a timeline identifying critical points in the delivery/installation phase in accordance with the Special Terms and Conditions.

The offer shall include the proposed equipment layout, the layout shall include all equipment to run the mandatory test, all the equipment shall fit within the designated laboratory space.

Quotes without the layout information and pricing for all mandatory tests will not be considered for award. All equipment shall fit in the designated laboratory space. Please see Special Terms and Conditions para 2.3. Lab Layout and Exhibit A.

Volume III Pricing:

a. Offeror shall submit Exhibit A with all pricing in excel format to be eligible for award.

b. The offeror shall submit proposed pricing for all Contract Line-Item numbers (CLINs) and subCLINs identified in the Request for Quote SF1449. Include the unit price and the total extended price for each CLIN and option year CLIN. The prices shall be in whole dollar amounts to the second decimal place (i.e., $0.00) only.

* Must provide pricing for all mandatory test and future test on Exhibit A. Shall transpose Grand total/Net Amount from Exhibit A and B to Standard Form 1449 (SF 1449) subCLINs identified for each Option year for mandatory testing.

If the SF 1449 is not completed in accordance with Volume I of FAR Provision 52.212-1 Addendum or all line items for the base year and all option years are not completed the offer will be considered noncompliant and will not be evaluated or eligible for award.

NOTE: This is an "all or none" solicitation. Failure to provide a unit price for any test listed in Exhibit A, unless the offeror states "not separately priced" within the attachment, will be construed to mean the offeror is not quoting that test and thus, not eligible for award.

(m) The non-FAR Part 12 discretionary FAR, DFARS, AFARS, and MEDCOM provisions included herein are incorporated into this solicitation either by reference or in full text. If incorporated by reference, see clause 52.252-1 herein for locations where full text can be found.

END OF ADDENDUM TO 52.212-1

52.212-2 ADDENDUM

Paragraph (a) is hereby replaced with the following:

Award will be made using the Lowest Price Technically Acceptable (LPTA). The Government will award a contract resulting from this solicitation to the responsible offeror whose quote meets all technical evaluation factors and whose price has been determined fair and reasonable. Award will be made to the responsible offeror on the basis of the lowest evaluated price of offer meeting or exceeding the acceptability standards for non-cost factors.

Award may be made without discussions with offerors (except communications conducted for the purpose of minor clarification). Therefore, each initial offer should contain the offeror's best terms from a technical and price standpoint. However, the Government reserves the right to conduct discussions if it is later determined by the contracting officer to be necessary.

Award will be made using the LPTA source selection process. The government will initially list offers from lowest to highest price. The government will evaluate the lowest priced offer first. If that offer is determined technically unacceptable, the government will evaluate the next lowest priced offer and continue in that manner until an offer is rated Technically Acceptable. If an offer is rated Technically Unacceptable, the Government will not evaluate any other subfactors. USING THIS PROCEDURE, THE GOVERNMENT MIGHT NOT EVALUATE ALL OFFERS.

Award will be made on an all or none basis.

The criteria for Evaluation of offerors are provided below.

Volume II Technical Evaluation: The technical volume shall be addressed in sufficient written detail for the Government to determine if the offeror understands the technical requirements listed in the following subfactors.

Failure to provide a response in sufficient detail for each factor below shall result in an offeror receiving a rating of unacceptable. Each subfactor will be evaluated using the criteria stated in Table 1 below. Each factor must be found technically acceptable in order to be eligible for award.

a. Subfactor 1-Equipment/Reagents/Consumables: Offeror shall provide equipment, reagent, and consumables that conform to the salient physical, functional, performance characteristics, and quantities as specified in the Special Terms and Conditions and Exhibits. Offeror’s system must be able to run all of the required tests listed in the Special Terms and Conditions.

*Failure to provide a price for all test, unless the offeror states "not separately priced" within the offer, will be construed to mean the offeror cannot provide the test. Any offer that fails to price all required testing, unless the test is identified as "not separately priced", will not be evaluated further and will be ineligible for award.

b. Subfactor 2- ATO/RMF Compliance –Offeror shall be in compliance with Authority to Operate/Risk Management Framework (ATO/RMF) upon submission of offer. The Contracting Officer will evaluate the technical offer to determine whether the Offeror provided documentary proof from a DOD organization that the Offeror are in compliance with Authority to Operate/Risk Management Framework (ATO/RMF) for the proposed equipment that will access the DOD informational technology system.

c. Subfactor 3- Offeror must be able to provide Maintenance (unscheduled and preventive) and telephonic assistance in accordance with Special Terms and Conditions.

d. Subfactor 4- Offeror must be able to provide Training in accordance with Special Terms and Conditions.

e. Subfactor 5- Delivery/reconfiguration of analyzers to Reynolds Army Health Clinic, Fort Sill Oklahoma no later than no later than 30 September 2024 for correlation and validation for a 15 December 2024 start date..

Timeline identifies critical points in the delivery/installation phase in accordance with the Special Terms and Conditions.

Proposed equipment layout shall include all equipment to run the mandatory test, all the equipment shall fit within the designated laboratory space. Quotes without the layout information and pricing for all mandatory tests will not be considered for award. All equipment shall fit in the designated laboratory space.

Note: A rating of acceptable must be achieved on all technical subfactors in order to receive an acceptable rating for the overall Technical Factor.

Technical Ratings Rating Description Acceptable Offer clearly meets the minimum requirements in accordance with the solicitation.

Unacceptable Offer does not meet the minimum requirement in accordance with the solicitation.

An unacceptable rating will be assessed if offeror fails to submit verifiable proof of RMF/ATO accreditation and certification in accordance with Defense Health Agency guidelines.

An unacceptable rating will be assessed if offeror fails to provide pricing for all required testing.

Volume III Price Evaluation: All offers will initially be reviewed to determine whether each offer contains the required pricing for each test. Any offer that fails to price all required testing, unless the test is identified as "not separately priced", will not be evaluated further and will be ineligible for award.

Failure to provide a price for all test, unless the offeror specifically identified as "not separately priced" within the offer, will be construed to mean the offeror cannot provide the test.

a. Award will be made to the offer submitting the lowest overall price of those offerors that are evaluated as technically acceptable.

b. Options: The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. In addition, given that FAR Clause 52.217-9, Option to Extend the Term of the Contract, provides that the Government may require continued performance/delivery of any supplies within the limits and at the rates specified in the contract (i.e., the rates in effect when the Option to Extend the Term of the Contract clause is exercised), for purposes of evaluating this option, the contracting officer will consider the prices submitted for each CLIN, since those would be the binding prices should this option be exercised.

Evaluation of this option shall not obligate the Government to exercise the option.

c. Price will be evaluated using various price analysis techniques and procedures IAW FAR 13.5 (Acquisition not exceeding $7.5M) including, but not limited to, comparison of proposed price received in response to the solicitation. Evaluation of price will include a determination that the price is fair and reasonable.

d. A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party.

Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

END OF ADDENDUM TO 52.212-2

(End of Summary of Changes)