36C25518Q0246-00001000.docx

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 ITE M 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 r eference 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

BY

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) 00001 02-22-2018 657-18-2-3618-0009 None 36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048 36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048 To all Offerors/Bidders

36C25518Q0246 02-14-2018

X x x See CONTINUATION Page The purpose of this amendment is to:

1) Extend the solicitation deadline to 2/28/2018, 10:00 AM CST.

2) Revise the Statement of Requirement as per below. Changes are in red font.

Yvonne Kittling Contracting Officer

B.4 STATEMENT OF REQUIREMENT

Vendor must be able to deliver emergency orders within two (2) hours from notification within the 180-mile radius of the Poplar Bluff VA Medical Center (VAMC) and agrees to provide all the needed radiopharmaceuticals as identified in the Price Schedule to the VAMC on a daily and/or as needed basis per this Statement of Requirement. (“180-mile radius” has been deleted since it will not meet the 2-hour delivery requirement for emergency orders).

A. Deliveries will incorporate sufficient lead or other high-density metal shielding to comply with all applicable federal and/or state standards relating to shipment of radioactive materials. Shipping containers must comply with all federal and state regulations. This will include DOT, DOE, US NRC, and ICC regulations and standards.

B. Supplier shall hold a current unrevoked US NRC and/or FDA license to produce and distribute radiopharmaceuticals for human administration, and a license to receive, and dispose of radioactive waste. Supplier shall provide a copy of their radioactive material license to the Nuclear Medicine Service at VAMC Poplar Bluff upon commencement of this contract. Supplier shall immediately notify the VAMC, upon any action be the USNRC agreement state and/or FDA to suspend or modify suppliers. Suppliers shall provide radiopharmaceuticals which have been prepared according to manufacturer’s package inserts.

C. The Vendor shall remove all radioactive waste, including all syringes and vials no longer required. All waste shall be returned (picked-up) the next working day. The Vendor shall supply the “secure system” for the prevention of needle sticks and possible biohazard and radioactive contamination of reusable lead container.

D. Technetium radiopharmaceutical Unit doses not used will be returned for credit the next work day (including the bulk doses), using the DOT regulations. (100% credit is preferable; however, a percentage credit for Bulk Tech and Cardiolite/Sestamibi doses only are acceptable).

E. Upon notification of contract award, Vendor will provide, in writing, within ten (10) days, the following information to the VA Medical Center:

1. Vendor’s regular work hours

2. Vendor’s telephone number for call-in orders during regular work hours.

3. Vendor’s telephone number and instructions for placing “Emergency” orders after Vendor’s regular work hours, including weekends.

4. Vendor’s telephone number for expert advice concerning awarded products.

5. Vendor will furnish a statement that any radiopharmaceuticals delivered as “ready-to-use” (individual doses in syringes or vials for single or multiple uses) will have quality control performed by the Vendor, so that the delivered product will comply with the requirements of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and/or with the United States Pharmacopeia.

6. Should any changes occur in above information during contract performance period, Vendor will provide updates in writing.

F. Current package inserts of all radiopharmaceuticals supplied under this contract will be shipped to the Nuclear Medicine Service at the inception of the contract. If any new and/or updated additions to the package inserts are made available, these will be sent to the Nuclear Medicine Service at Poplar Bluff VA Medical Center.

G. Vendor shall make quality control records available to the VA Medical Center upon written request from the Contracting Officer.

H. Calibration time for each requested radiopharmaceutical is given in the Schedule of item, or if not so indicated, then it will be spelled out in the requirements provided by the Nuclear Medicine Service, otherwise it will correspond to the actual time of delivery.

I. The quantity of radioactivity for supplied radiopharmaceuticals shall not change more than +10% or -5% at the time of calibration, from the quantities specified.

J. The expiration date and time shall be indicated and affixed to each product as noted below; in general:

1. Ready-to-use doses: not shorter than six (6) hours.

2. Tc-99m Pertechnetate: Not shorter than twelve (12) hours.

3. Kits intended for reconstitution by user: Not shorter than three (3) months from date of delivery.

4. Unused kits having expiration time not less than two (2) weeks will be exchanged by the Vendor at no additional charge for a comparable kit the same kit having the three (3) months life span.

K. In the event that a quality control or material defect is suspected and/or detected by any Veterans Affairs COR, the Vendor will be requested to provide any consultation necessary to alleviate any said suspicion and/or defect by the following:

1. Provide technical expertise in calibration;

2. Provide professional examination of product; submit results and recommendations to the Contacting Officer;

3. Make expedient replacement of any product suspected of being deficient.

L. WBC PROCEDURE for labeling of patient's white blood cells (WBC) with Indium IN-111 Oxine or Tc-Ceretec for re-injecting to the same patient:

1. Telephone requests to the Vendor to arrange for the procedure will take place no later than 3:00 PM for the next workday procedure.

2. Furnishing of the syringe to the Nuclear Medicine Service and pick up of patient's blood specimen for labeling by the Vendor will be at 8:00 AM or later, if so specified by the COR.

3. The return by the Vendor, of the patient's Indium labeled white blood cells will take place not later than within 5 (five) hours from the time of specimen pick up time.

4. Pertinent documentation confirming that the identification of the labeled blood specimen matches with the blood specimen of the patient's blood specimen submitted for labeling procedure.

M. Vendor is responsible for all costs including personnel costs associated with this contract.

N. Vendor shall provide on a monthly a summary of daily items charged for the invoice period submitted to the Financial Service Center in Austin Texas for payment, and for reconciliatory processes to certify invoice payment.

Deliverables and Acceptance Criteria

1. Vendor shall provide services and staff, and otherwise do all things necessary for or incidental to the performance of work, as set forth below:

a. Deliver directly to the Nuclear Medicine Service at the Poplar Bluff VAMC daily quantity of radiopharmaceuticals by 7:15 a.m., as requested from the previous day.

b. Deliver directly to the Nuclear Medicine Service at Poplar Bluff VAMC quantity of radiopharmaceutical requested on an as needed emergent basis to arrive within two (2) hour of notification. (Not negotiable for emergent needs)

c. Other delivery times may be requested.

2. If shipments are contracted to be delivered specifically on Mondays, but Monday is a holiday, then the shipment will take place the next regular work day. Holidays are listed herein.

3. Shipments “called when needed” may be requested during regular work hours, or after, as “emergency”, including weekends, holidays and nights.

4. Shipments requested as an “Emergency” will be delivered as follows:

a. Requests placed after regular work hours (weekend, holiday, and night) will be delivered within three (3) two (2) hours, or as specified.

b. Emergency, weekend and holiday shipments are to be delivered to location(s) specified by each facility, unless otherwise specified when called for.

c. All shipments will be labeled as RADIOACTIVE MATERIAL in compliance with all pertinent regulations.

d. All Radiopharmaceuticals, Radioassay Kits and/or Analytic Kits are to be furnished by the Vendor in strict accordance with the terms and conditions of the contract and all applicable Local, State and Federal Laws.

e. Delivery dates, times, frequency of delivery, specific dosages, and all other specific requirements by each VAMC under this contract, will be strictly adhered to.

5. All shipments will have a Packing Slip enclosed, giving information about the product and it’s identification, plus (for billing purposes) the VA Medical Center’s Purchase Order Number issued for the current fiscal quarter or month, and possible the Vendor’s invoice number. (Incorrect P.O. numbers may cause a substantial delay in payments.)

Work Hours The delivery of products provided by this contract shall be furnished by the Vendor. The Vendor shall not be required, except in case of an emergency, to furnish such products on a national holiday or during non-working hours as described below with the exception of normal next day delivery as described in (1) above and (2) below.

The following terms have the following meanings:

(1) Normal Operating hours of the hospital: Monday through Friday, 8:00 a.m. to 4:30 p.m.

(2) Normal Next Day Delivery: 7:15 a.m.

(3) National Holidays: The ten holidays observed by the Federal Government are:

New Year's Day, Martin Luther King's Birthday, President’s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran's Day, Thanksgiving, and Christmas, and any other day specifically declared by the President of the United States to be a national holiday

Qualifications Personnel assigned by the Vendor to prepare and provide the products covered by this contract shall be licensed in a State, Territory or Commonwealth of the United States or the District of Columbia. The qualifications of such personnel shall also be subject to review by the VA Chief of Staff and approval by the VA Facility Director.

Vendor Performance Assessments Assessments. The Government may do assessments of the Vendor’s performance. The Vendor shall have an opportunity to respond to the assessments.

Record. The Government will keep completed assessments and may serve as past performance data. Past performance data will be available to assist agencies in the selection Radiopharmacy providers for future projects. Past performance data may also be utilized in future procurement efforts.

Base Year – Period of Performance (POP) 3/15/2018 – 3/14/2019

Technetium Products (Unit Doses) – LOW ENRICHED URANIUM

Long Lived Radiopharmaceuticals (Unit Doses)

Cold Vials

Survey Meter Calibrations (Ludlum, Bicron)

Survey Meter Calibrations (SE International)

DELIVERY CHARGE (4 deliveries during normal hours) (Price per delivery; however, we've never used more than 4 per day, as much as 2 per day in five years)

EMERGENCY DELIVERY CHG

(after hours delivery within two hours)

Base Year Grand Total (Estimated)

Option Year One (1) – Period of Performance (POP) 3/15/2019 – 3/14/2020

Technetium Products (Unit Doses) – LOW ENRICHED URANIUM

Long Lived Radiopharmaceuticals (Unit Doses)

Cold Vials

Survey Meter Calibrations

Survey Meter Calibrations

DELIVERY CHARGE (4 deliveries during normal hours) (Price per delivery; however, we've never used more than 4 per day, as much as 2 per day in five years)

EMERGENCY DELIVERY CHG

Option Year One (1) Grand Total (Estimated)

Option Year Two (2) – Period of Performance (POP) 3/15/2020 – 3/14/2021

Technetium Products (Unit Doses) – LOW ENRICHED URANIUM

Long Lived Radiopharmaceuticals (Unit Doses)

Cold Vials

Survey Meter Calibrations

Survey Meter Calibrations

DELIVERY CHARGE (4 deliveries during normal hours) (Price per delivery; however, we've never used more than 4 per day, as much as 2 per day in five years)

EMERGENCY DELIVERY CHG

Option Year Two (2) Grand Total (Estimated)

Option Year Three (3) – Period of Performance (POP) 3/15/2021 – 3/14/2022

Technetium Products (Unit Doses) – LOW ENRICHED URANIUM

Long Lived Radiopharmaceuticals (Unit Doses)

Cold Vials

Survey Meter Calibrations

Survey Meter Calibrations

DELIVERY CHARGE (4 deliveries during normal hours) (Price per delivery; however, we've never used more than 4 per day, as much as 2 per day in five years)

EMERGENCY DELIVERY CHG

Option Year Three (3) Grand Total (Estimated)

Option Year Four (4) – Period of Performance (POP) 3/15/2022 – 3/14/2023

Technetium Products (Unit Doses) – LOW ENRICHED URANIUM

Long Lived Radiopharmaceuticals (Unit Doses)

Cold Vials

Survey Meter Calibrations

Survey Meter Calibrations

DELIVERY CHARGE (4 deliveries during normal hours) (Price per delivery; however, we've never used more than 4 per day, as much as 2 per day in five years)

EMERGENCY DELIVERY CHG