36C24822Q0164 0001_.pdf

5. PROJECT NUMBER (if applicable)

CODE 7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER 3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO. 1. CONTRACT ID CODE

FACILITY CODE CODE

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:

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

E. IMPORTANT:

is extended,

(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 electronic communication 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 is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office. is not, 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.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

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.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

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 16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30 PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243

(Type or print) (Type or print)

(Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code)

(If other than Item 6)

(Specify type of modification and authority)

(such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

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

1 4

12-07-2021

None

36C248

Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System 13800 Veterans Way Orlando FL 32827

36C248

Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System 13800 Veterans Way Orlando FL 32827

To all Offerors/Bidders

36C24822Q0164

12-01-2021

X

X X

12/09/2021 at 12:00 PM EST.

See CONTINUATION Page

X 1

The purpose of this amendment is to update the Statement of Work and answer questions. As a result:

a. Questions by participants are answered on page two.

b. The statement of work is updated see page two.

c. No other questions will be entertained.

d. Quotes are hereby extended from 12/07/2021 at 12:00 PM Eastern Standard Time (EST) to 12/09/2021 at 12:00 PM EST.

e. Submit quotes to Jessica.Kiser@va.gov and Norbert.Reed@va.gov by 12/9/2021 at 12:00 PM. EST.

36C24822Q0164 0001

A.1 Questions and Answers:

Question 1. There are several places in the document that mention a BAA be executed. Would you like us to send our standard BAA to you all for review?

Answer: No, we don’t need the Business Associate Agreement as this is only a solicitation and not a contract.

Question 2. Vendor has not identified the clause where we are able to terminate this contract. Is there any ability for us to terminate, and if so, how do we provide notice?

Answer: There are no clauses or provisions for Termination by the contractor.

A.2 Statement of Work The following section and pages of the SOW is hereby updated to read as follows:

1. Page 6, Section 2.0 Scope, paragraph one:

VACHS, Pathology and Laboratory Medicine Service requires Cost Per Test base 12 Months and four one-year options contract for the testing of lung cancer risk assessment thru proteomic profile tool.

2. Page 6, Section 3.0 Requirement:

The contractor shall provide the following material for Nodify Testing:

15 Each of CPT code 0080U for XL2 15 Each of CPT code 81599 for CDT

Plus, all shipment material required to ship the specimens back to the contractor for testing.

3. Page 6, Section 4.0 Period of Performance and Delivery:

This requirement shall be effective from the date of award.

Estimated Period of Performance dates subject to change after award.

Base: 12/15/2021 to 12/14/2022 Option 1: 12/15/2022 to 12/14/2023 Option 2: 12/15/2023 to 12/14/2024 Option 3: 12/15/2024 to 12/14/2025 Option 4: 12/15/2025 to 12/14/2026

4. Page 7, Section 5.0 Responsibilities of Contractor’s Laboratory:

The contractor shall provide personnel to perform the following test referred by Veterans Affairs Caribbean Healthcare System as required:

1. Contractor shall perform tests as required by the VACHS.

2. Tests will be shipped to Contractor via vendor’s required shipping service.

3. VACHS will be responsible for sending specimens to contractor.

4. VACHS laboratory shall be notified when reports are completed and available.

5. Page 8, Section 7.0 Procedures:

1. The test is requested thru Computer Patient Record System (CPRS) pathology requisition section. The pneumologist will place an electronic order thru patient electronic record system.

After test is completed and reported to the pathology laboratory the completed report will be uploaded to VISTA Imaging at CPRS and a Molecular Pathology notification will be generated to ordering provider.

2. P&LMS staff will ship the company the specimens within the established timeframe and following collection instruction provided in the contract. The specimens must be correctly identified patient information and laboratory accession number when required, accompanied with the test requisition form filed and copy of the pathology report when applicable.

3. The contractor is responsible to perform the genomic profile on the peripheral blood specimen submitted as requested by physician. The material is collected in the specified collection tubes provided by the contractor.

4. The contractor is responsible to perform Nodify Lung test using a blood-based antibody assay, one to determine the likelihood of a pulmonary nodule to be malignant or benign therefore re-classifying risk for patients at the VACHS.

5. The contractor is responsible for handling, transporting and delivering packing and shipping materials required to ship samples for testing according federal regulations.

6. The contractor is responsible to cover shipping expenses when material is sent for testing.

7. The contractor is responsible to include instructions for shipping as well as any other specific instructions as required.

8. The complete package must include:

i. Test requisitions, Collection Tubes, Shipping Box with ice pack for specimen packaging, FEDEX international airway bill form pre-printed with company FEDEX account number and required information and FEDEX bag for shipping.

9. The contractor will not charge a QNS “QUANTITY NOT SUFICIENT” test and will notify laboratory in written form for proper action and addendum to pathology report.

10. The contractor must have a completed report with a turnaround time of 10-14 business days after all information to perform testing has been obtained and specimen have been received in the lab.

11. The sample stability standard operating procedure has proven sample stability up to seven days after collection. If contractor receives the sample with more than seven days after the collection, the sample is not processed and testing is not performed. The contractor shall require a new sample to be obtained and sent for processing. The VACHS laboratory shall be notified in a timely manner when sample is not adequate for testing.

12. The contractor is responsible to send all final report to the pathology department via mail, encrypted electronic mail or fax, following all Privacy/HIPPA regulations to safeguard patient sensitive information to the following address:

13. The contractor will provide VACHS with a monthly statement of services performed. The Contractor will be paid monthly, in areas, upon receipt of a proper invoice for the services furnished in the previous months. Inclusion on your invoice should be your Company's name, tax ID number, funding obligation number (purchase order number), description of services, period of services, amount, and remit to address. See section B.2 for invoicing information. Payment will be made upon written certification from the COR that the services have been performed.

14. The contractor shall be held responsible for any fines/penalties assessed due to state, local or federal laws being violated by the contractor.

15. The laboratory is responsible to provide the company, the specimens within the established timeframe and following collection instructions provided by the contractor. The specimens must be correctly identified patient information and laboratory accession number when required, accompanied with the test requisition form filled and a copy of the pathology report when applicable.

6. Page 12, Section VA Information Custodial Language, Line g is now removed.