W91YTZ19Q0284_AMENDMENT_0002.pdf

W91YTZ19Q0284

W40M RHCO-ATLANTIC USAHCA

NORTHERN REG CONTR OFC NRCO

POC: HEIDI N. HOLLEY

6000 MACARTHUR BLVD, BASEMENT, RM B058

BETHESDA MD 20815-5003

SEE SCHEDULE

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

1. The purpose of this amendment is to respond to question from industry.

2. See Summary of Changes for details.

3. All other terms and conditions remain the same.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 5

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

16C. DATE SIGNED

BY 16-Jul-2019

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 W91YTZ19Q0284

X 9B. DATED (SEE ITEM 11)

25-Jun-2019

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

11-Jul-2019

CODE

W40M RHCO-ATLANTIC USAHCA

NORTHERN REG CONTR OFC NRCO

6021 5TH ST BLDG 1467

FORT BELVOIR VA 22060-5580

W91YTZ 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W91YTZ

FACILITY CODECODE

EMAIL:TEL:

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

The following have been modified:

RESPONSES TO INDUSTRY QUESTION

Question 1:

Section 8: Maintenance, Service and Repair

8.10 Maintenance Requirements:

Daily Maintenance should not require more than 5 minutes of hands on to complete Weekly Maintenance should not require more than 20 minutes of hands on to complete Monthly Maintenance should not require more than 20 minutes of hands on to complete.

There is no single contractor that can support this requirement. We are therefore requesting that this requirement be removed or updated to reflect realistic maintenance times.

Response:

Government agrees to change verbiage to say:

Daily Maintenance should not require more than 30 minutes to complete Weekly Maintenance should not require more than 30 minutes to complete Monthly Maintenance should not require more than 30 minutes to complete

Question 2:

Section 4: Analyzers

4.1 The Vendor shall provide a fully automated, discrete random access chemistry/immunoassay analyzer system capable of performing all of the required assays listed in Appendix 1. The system shall provide redundancy to ensure continuous operations, training, supplies, reagents, unscheduled maintenance, and preventive maintenance for the equipment.

We are requesting that any assay listed in Appendix 1 estimated at less than 2 tests per day, should be recategorized as preferred.

Response: The tests in Appendix 1 that are at lower volumes will remain required tests because they are required to meet in-house turnaround times and critical toxicity levels of therapeutic drugs which would not be tolerable to send out for testing.

Question 3:

4.6 Each analyzer will be a random access, discrete analyzer system with STAT interrupt capability and a primary tube sampling system capable of handling 100mm x 16mm, 100mm x 13mm, 75mm x 12mm, and 64mm x 10.25 test tubes with standard or Hemaguard caps.

Is this a requirement for cap piercing or de-capping capability?

Response: No

Question 4:

Scope of Work: 1.2 For the purposes of this SOW, the automation system to be provided by the contractor includes at a minimum:

* Any and all analyzers to perform the required test menu

* Peripherals (e.g. Uninterruptable Power Sources (UPS), instrument specific computers, Computer Processing Units (CPU), printers, barcode scanners, terminals, monitors, etc.)

* Automation system will include two integrated analytical systems, and middleware shall be delivered and installed at the primary location: Laboratory, BACH, Ft. Campbell, KY.

Question: The term “automation system” typically denotes a track system with preanalytical and/or postanalytical processing. Is the government requiring laboratory track system automation including preanalytical and postanalytical processing?

Response: There is no requirement for preanalytical or postanalytical processing. The verbiage of “automation system” was used to infer that the system be automated from the point of sample entry to result availability.

Question 5:

4.6 Each analyzer will be a random access, discrete analyzer system with STAT interrupt capability and a primary tube sampling system capable of handling 100mmx 16mm,100mmx 13mm,75mmx 12mm,and 64mm x10.25test tubes with standard or Hemaguard caps.

Question: Is the government requiring an automated tube decapper? If so, is it required as part of a track automation system (preanalytical) or as a stand-alone machine that simply decaps tubes prior to being loaded onto the analyzer?

Response: No

Question 6:

6.2 2 Lease of this equipment shall include delivery, installation, all calibrators/standards, reagents/reagent packs, consumables, expendables, linearity material, and quality control materials necessary to perform the specified assays, initial Method Validations per Clinical Laboratory Improvement Act (CLIA) / Clinical and Laboratory Standards Institute (CLSI) guidelines and analyzer removal at the termination of the contract

Question: Does the government require the vendor to include third-party quality controls material (ie: Bio-Rad) or do you maintain a separate contract for quality control material as is typical in DoD facilities? If the Government requires the vendor to include third party QC material, please provide the annual budget so that all vendors use the same allowance in their quotes.

Response: No, we will provide a separate contract for quality control material. However, vendor will be required to provide manufacturer controls and calibrators when needed for troubleshooting.

Question 7:

Does Blanchfield Army currently have a BioRad Unity Real time subscription and are you requesting that we provide the connectivity to the program through our middleware solution? Or, do you not currently use BioRad Unity Real time and want the vendor to provide both the connectivity to it and the actual software license for the product for the term of the agreement?

Response: We do not currently use BioRad Unity Real Time.

Amendment 0002 Question 8:

In response to the question posed on requirement 4.1 (question 2) it was stated that lower volume tests are required to meet in-house turnaround times and critical toxicity levels of therapeutic drugs. DHEA Sulfate, Thyroglobulin AB and Thyroid Peroxidase AB are estimated at less than two (2) tests per day which puts them in the category of lower volume tests but are not toxicology tests.

Please confirm that these tests cannot be recategorized to preferred given that they are not characterized as tests that would be critical to measuring toxicity levels for therapeutic drugs. The reason this question was posed is because there is no one vendor that can meet the requirements of this solicitation combined with the required test menu unless lower volume tests listed above are recategorized as preferred rather than required.

Response: Though some required low volume tests are not therapeutic drug monitoring tests, these tests do require in-house processing in order to meet established and required turn-around times. There will be no re-categorization of "Required" to "Preferred" of any component of the test menu in this requirement.

(End of Summary of Changes)