36C24220Q0945 0003.docx

Contract Opportunity Amendment to a Previous Combined Solicitation

PRODUCT SERVICE CODE

SUBJECT

CONTRACTING OFFICE'S

ZIP-CODE

SOLICITATION NUMBER

BASE NOTICE TYPE

RESPONSE DATE/TIME/ZONE

ARCHIVE

DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS

SET-ASIDE

NAICS CODE

CONTRACTING OFFICE

ADDRESS

POINT OF CONTACT

(POC Information Automatically Filled from User Profile Unless Entered)

DESCRIPTION

See Attachment

AGENCY'S URL

URL DESCRIPTION

AGENCY CONTACT'S EMAIL

ADDRESS

EMAIL DESCRIPTION

ADDRESS

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

GENERAL INFORMATION

PLACE OF PERFORMANCE

* = Required Field Contract Opportunity Amendment to a Previous Combined Solicitation VISN 2 Down State General Radiopharmaceuticals 10468-3904 36C24220Q0945 12-04-2020

10AM

EASTERN TIME, NEW YORK, USA

N 325412 Department of Veterans Affairs Network Contracting Office 2 James J. Peters VA Medical Center 130 West Kingsbridge Road Bronx NY 10468-3904 Tina.Cavalieri@va.gov

This amendment is:

1. To answer vendor questions

2. To extend the due date of the solicitation to 12/4/2020 @ 10AM

3. Update the B.4 Price/Cost Schedule

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 for th 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 H

OUR 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 REJECTI

ON 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 th is 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, et c.)

(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) 11-19-2020 36C242 Department of Veterans Affairs Network Contracting Office 2 James J. Peters VA Medical Center 130 West Kingsbridge Road Bronx NY 10468-3904 36C242 Department of Veterans Affairs James J. Peters VA Medical Center Network Contracting Office 2 130 West Kingsbridge Road Bronx NY 10468-3904 To all Offerors/Bidders

36C24220Q0945 11-19-2020

X X X December 4, 2020 At 10AM X This amendment is to :

1. address vendor questions that ended on November 12, 2020. Please see below for questions and responses.

2. extend the due date until December 4, 2020 at 10AM.

3. Update the B.4 Price/Cost schedule, also attached below, by removing #70, 74 and 75 and adding in Y 90 Sirspheres.

Amendment to answer vendor questions ending 11/12/2020

1. In order to accurately bid line items 88, 89 and 90 (Flood Source) can you provide the camera make/model for each location? #88 is for EO, NYH Man, NYH Brook, #89 is EO, NYH Man, NYH B, Bronx and NP., #90 only NP.

Co57 rod source include:

Sources Co57:

1. #89 SIEMENS SYMBIA T6, SIEMENS EVO, ADAC VERTEX PLUS NORTHPORT

1. #90 DIGIRAD X-ACT+ NORTHPORT

1. #89 SIEMENS SYMBIA T6, SIEMENS EVO, ADAC VERTEX PLUS Castle Point

1. Model# PHI-0124 Serial# S4-100 Activity: 50 uCi - Castle point

1. Gd-153, SN SN-836 10 mCi . HEGL-0133 Castle Point

1. #88 GE Infinia Hawkeye East Orange

1. #89 Siemens Symbia T East Orange

1. Siemens Symbia Intenvo Bronx

1. Siemens Symbia T Bronx

1. Page 24 states Provide sterilized lead containers for doses prior to reuse. Per USP 825 guidelines we disinfect and do not sterilize. Can we redline this sentence to read “disinfected” instead of sterilized? Or will accept this and update the language on your end?

Yes this is ok.

1. Line item 2 (F-18 FDG, bulk dose, for administration) we supply lead canister balls for the intego system and bill for unit dose, not per mci. We will supply pricing based on a unit dose (15mci). Is this acceptable?

That’s acceptable for Northport-it’s actually what is preferred.

EO will use 10 mCi unit doses.

1. Page 23 states all manufactures must comply with USP 797 standards. Will you consider using USP <825> guidelines?

Yes this is ok.

1. Will all vendors submitting bids be required to supply only FDA approved products?

Yes

1. There are several FAR clauses listed that our government team is reviewing but will not be able to have fully vetted prior to 11/5. If we encounter a FAR clause that we cannot comply with, would you consider removing it from the bid? Will non-compliance with a certain clause disqualify us from submitting our bid?

Please see answer to number 16

1. What is the process for addressing any concerns with the FAR clauses? Who do we contact for inquiries after 11/5?

This was already addressed by extending the date for questions until November 12th. ALL questions needed to be asked by then no exceptions.

1. Are we are able to provide redlines to both the IT Security Contract and the BAA?

No.

1. On page 24 and 25 of the solicitation in the HIPPA compliance section it asks for completion of two on-line courses for those that accept orders. Does this need to be done prior to the award? or after the award?

After Award

1. Am I able to send you the solicitation digitally via email? Due to its size it might come in separate emails however.

Yes that is fine, label emails if you want them read in certain order.

1. Will the facilities be using web-ordering or a traditional call/fax order?

CP Both NP both but mainly online EO will use web-ordering for most isotopes, call in for blood labeling products, IN-111 & I-131.

NYH Both

1. Additionally, is there a department manage system that each facility uses or a requirement for the supplier to provide each facility as a fee for service?

No.

1. Line item #70. In-111 Prostascint is no longer on the market. Can I remove it off of the solicitation?

Being removed

1. Is it possible for this solicitation to be revised to include responses for high energy PET products only or allow for teaming arrangements that HIGH energy PET products manufacturer can join with a manufacture of SPECT only products to create a single bid response that includes both PET ad SPECT products?

No. We will not be separating the high energy PET and low energy. Our MR has shown that there are 2 or more contractors that can meet these requirements.

1. Will submissions be accepted that are PET only & SPECT only?

Please refer to question # 14.

1. Do we need to comply with these FAR clauses?

All of these clauses will be removed for the contract. They are not necessary.

FAR 52.222-41

Service Contract Labor Standards

FAR 52.222-54

Employment Eligibility Verification

FAR 52.222-55

Minimum Wages under Executive Order 13658

FAR 52.222-62

Paid Sick Leave under Executive Order 13706

FAR 52.237-7

Indemnification and Medical Liability Insurance

1. Line Item 2: F18-FDG -when bidding on the 90 mCi bulk FDG doses requested in the bid, will the actual requests coming from the customer sites be for 90 mCi bulk vials at a designated calibration time (i.e. 90 mCi bulk FDG @ 8 am) or does this 90 mCi bulk request represent 6 patient doses at 15 mCi/dose = 90 mCi, which will require significantly more activity to be shipped to the customer sites to account for decay?

CP N/A

NP Besides unit doses Northport uses the INTEGO so we would prefer to be charged per unit dose.

EO will use 10 mCi unit doses.

NYH will use 10 mCi doses. This can be changed to “6 patient doses at 10 mCi/dose = 60 mCi”.

1. Item 14: I-131NaI Liquid: Can you provide further clarification as to total qty in mCi for this product and total number of patients serviced?

CP N/A

NP N/A

EO N/A

NYH: This is an estimate. 2 doses, up to 200 mCi total.

1. Are FDA approved non-branded items approved for use in place of branded?

Generic versions are acceptable.

1. Line Item 40-45 Tc99m Sestamibi: Are these line items for use in Rapid Acquire Sestamibi procedures?

No

1. Line Item 74 - Samarium-153, per mCi: This product pricing is set by manufacturer on an annual basis by Unit Dose. Base year pricing can be provided, but Option Year pricing is unable to be provided until the following year upon release from manufacturer. Is this product able to be removed from the solicitation?

It will be removed

1. Line Item 75 – Strontium-89, per mCi: This product is available for distribution, but pricing is set by the manufacturer. Is this product able to be removed from the solicitation?

It will be removed

1. Line Item 83-96: All of these products are ancillary flood source products, however additional detail is needed including dimensions for the camera flood sources and whether a storage case is required or not.

MED 3709 10mCi Flood Source

1. At top of Base Year volume page, it asks to provide firm pricing for all 3 years, but at bottom of option 1 page it only references a total for first 2 years. Is this a 2 year or 3 year request ?

It is a base year with one year option. So, 2 years altogether.

1. Canceling orders and returned products: Each participating medical center may cancel ordered doses within a ten-hour (10) notice to contractor.

The contractor shall accept returns for credit under the following conditions:

1. Product(s) ordered or shipped in error

1. Product(s) damaged in shipment

1. Recalled product(s)

1. Unused, unopened doses of Tc99m-sestamibi for patients who fail to keep their appointments Is there a % limit on returns?

100% if a patient is a no show.

1. Unused, unopened nonradioactive products prior to expiration. Is this referring to cold kits?

NYH: Yes, plus CCK.

1. Unused, unopened doses of F18-FDG for patients who fail to keep their appointments.

The contractor will pick up radioactive and non-radioactive products to be returned for proper disposal at no cost to the government.

*To include return shipping on rod sources, vial sources, point sources and flood sources Credit for the returned product will be reflected in the current month’s invoice.

The contractor shall not add to the invoice the cost of overages. Any cost to replace damaged or incorrect products will be at cost of the contractor. Replacements shall be received within 48 hours of notification.

All charges for delivery shall be included in the fee schedule. Additional fuel surcharges will not apply.

1. What nuclear medicine system is being utilized in each of the locations? (Syntrac, etc?

EO will be using NMIS NYH: will be using a NMIS.

1. Is it requested that we complete and sign the BAA now, or at the time of award?

After Award.

1. Line items 88, 89 and 90, Co-57 flood sources are specific to the cameras they are being used for, which in turn may lead to variances on their prices.

Please refer to #1 for cameras being used.

1. Can you tell me the model numbers for each of the 10 sources listed?

MED 3709, 10mCi, EO MED 3709 10mCi Flood Source Co 57 5.399mCi

1. As a follow up, and in regards to the amendment regarding Yttrium, can you please ask the nuclear medicine department which of the Y-90 product they are asking for?

Sirspheres

Please take note that the close date of this solicitation has changed to 12/4/2020.

B.4 PRICE/ COST SCHEDULE

ITEM INFORMATION

Please Note: Offerors must provide pricing on ALL items in the Schedule of Supplies Required Prices quoted are all inclusive including all associated costs including shipping, handling, packaging, storage, licenses etc. excluding emergency delivery, Pharmacist After-Hour Emergency Call-Back and Weekend White Blood Cell labeling charge. Must provide firm fixed pricing BOTH years.

Base Year: February 22, 2021 through February 21, 2022

Option One: February 22, 2022 through February 21, 2023

NDC of Product