Combine Solicitation – 68– FY18 Radio pharmacy
Notice Type: Combine Solicitation
Posted Date:
Office Address:
Subject: 68-- FY18 Radio pharmacy
Classification Code: 68 - Chemicals & chemical products
Solicitation Number: VA24417R1786
Contact: [email protected] mailto:[email protected]
Setaside: N/AN/A
Place of Performance (address): SAME AS ABOVE ADDRESS
Place of Performance (zipcode): 19805
Place of Performance Country:
Description:
Network Contracting Office 4
Veterans Integrated Service Network 4 Facilities
The
This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-95. Only emailed proposals received directly from the offeror shall be considered acceptable.
BACKGROUND
VA
Proposals are due no later than
STATEMENT OF WORK
Contractor agrees to provide all needed radiopharmaceuticals as identified in the Schedule of Supplies and Prices to the
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
Items must be adequately packaged to prevent damage during handling and storage. All packaging and labeling must meet all Federal and State regulations. All packaging of radioactive material must be clearly labeled RADIOACTIVE on the outside of the carton in which it is shipped.
Contractor shall label all products delivered as to the
Contractor shall hold a current unrevoked NRC and or agreement state radioactive materials license, which in addition to other license conditions, would allow for the receipt and disposal of radioactive material and an
Contractor will provide with their proposal, the following information:
Contractor s regular work hours.
Contractor s telephone number for call-in orders during regular work hours.
Contractor s telephone number and instructions for placing emergency orders after contractor s regular work hours to include weekends.
Contractor s telephone number for expert advice concerning awarded products.
Contractor 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 Contractor, so that the delivered product will comply with the requirements of the Joint Commission (JC) and or with the United States Pharmacopeia.
Should any changes occur in the above information during the contract period of performance, contractor will immediately provide updates in writing.
Current package inserts of all radiopharmaceuticals supplied under the awarded contract will be shipped to the Nuclear Medicine Service at the inception of the contract. If any new or updated additions to the package inserts are made available, these will be sent to the
Contractor shall make quality control records available to the COR upon written request from the CO or COR.
Contractor shall test all products for quality control. Periodically, this testing shall be performed at no cost to the Government. The contractor shall provide a detailed description of the test upon request.
Calibration time for each requested radiopharmaceutical is given in the Schedule of Supplies, 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.
If an ordered dosage of radioactive material is given to Contractor such that it is to fall within a specified range, then the quantity of radioactivity must be within the dose range provided. If dose is not given in a range, then the quantity of radioactivity for supplied radiopharmaceuticals will not deviate more than --20%.
Technetium product radiopharmaceuticals not used will be returned for credit the next work day (including the bulk doses), using the DOT regulations. Credit will be reflected in the current month s invoice.
Contractor shall replace any items delivered damaged or in error at no cost to the Government. COR shall define the replacement date and time. Replacements may be required immediately or within a specified time in accordance with the needs of the patient.
The expiration date and time shall be indicated and affixed to each product as noted below; in general:
Ready-to-use doses: not shorter than six (6) hours.
Tc-99m Pertechnetate: Not shorter than twelve (12) hours.
Kits intended for reconstitution by user: Not shorter than three (3) months from date of delivery.
Unused kits having expiration time not less than two (2) weeks will be exchanged by the Contractor at no additional charge for a comparable kit having the three (3) months life span.
In the event that a quality control or material defect is suspected or detected by the COR, the Contractor will be required to provide any consultation necessary to alleviate any said suspicion or defect by the following:
Provide technical expertise in calibration;
Provide professional examination of product; submit results and recommendations to the COR;
Make expedient replacement of any product suspected of being deficient.
Procedure for labeling of patient's White Blood Cells (WBC) with Indium-111 Oxine or Tc- Ceretec for re-injecting to the same patient:
Telephone requests to the Contractor to arrange for the procedure will take place no later than
Furnishing of the syringe to the Nuclear Medicine Service and pick up of patient's blood specimen for labeling by the Contractor will be at
The return by the Contractor, 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.
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.
Contractor shall pick up Radiopharmaceuticals (used or unused) for proper disposal at no cost to the Government.
Contractor shall produce radiopharmaceuticals as described in the Schedule of Supplies.
Deliverables and Acceptance Criteria
Contractor shall provide services and staff, and otherwise do all things necessary for or incidental to the Statement of Work, as set forth below:
Provide up to two deliveries per day during regular operating hours to the
b. Regular daily radiopharmaceutical doses ordered the previous day will be delivered in one morning delivery by
Deliver directly to the Nuclear Medicine Service , Wilmington VAMC the daily quantity of radiopharmaceuticals by
Orders can be placed orally by telephone or fax transmission by ordering officers provided by the Contracting Officer Representative.
Deliver directly to the
Radioactive dose boxes that are delivered outside of working hours can be placed in the locked box on floor 4C. The Contractor will have a key to the locked box for this purpose. The Contractor making the delivery shall not leave a radioactive materials package at
Other delivery times may be outlined by the
If Monday is a federal holiday, no deliveries will be expected. Holidays are listed under section E.
Shipments called when needed may be requested during regular work hours, or after, as emergency, including weekends, holidays and nights.
Shipments requested as an Emergency will be delivered as follows:
Requests placed after regular work hours (weekends, holidays, and nights) will be delivered within two (2) hours, or as specified by the ordering officer.
Emergency, weekend, and holiday shipments are to be delivered to the location specified by
All shipments will be labeled as RADIOACTIVE MATERIAL in compliance with all pertinent regulations.
All Radiopharmaceuticals, Radioassay Kits or Analytic Kits are to be furnished by the Contractor in strict accordance with the terms and conditions of the Statement of Work and all applicable Local, State, and Federal Laws.
Delivery dates, times, frequency of delivery, specific dosages, and all other specific requirements by
All shipments will have a Packing Slip enclosed, giving information about the product and its identification, plus (for billing purposes)
Contractor must provide radiopharmaceutical invoice with each delivery with each dose bar- coded using the Pinestar system. If the )
VA OPERATING HOURS
The delivery of products provided by the respective awarded contract shall be furnished by the Contractor in accordance with section 3.0 Deliverables and Acceptance Criteria. The Contractor 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 below.
The following terms have the following meanings:
Normal Operating hours of Nuclear Medicine: Monday through Friday,
Contractor to include up to two (2) deliveries per normal working day during normal working hours as needed at no charge.
National Holidays: The ten holidays observed by the Federal Government are:
CONTRACT AWARD
Upon Contract Award (within 5 (five) business days) Awarded Contractor shall provide:
A copy of their laboratory s current quality control manual to the COR.
A dedicated inside sales representative to aide in facilitation in the smooth coordination between the
Material safety data sheets and updates on all delivered products as per the awarded contract and any additions throughout the life of the awarded contract.
Patient orientation education video presentations and other appropriate material at no additional cost to the Government.
Contractor shall provide signs and posters alerting patients, employees and the public, of safety precautions in handling of radioactive materials
QUALITY REQUIREMENTS
Contractor shall guarantee the quality of the radiopharmaceutical. Quality Control shall include pH testing, percent tag, alumina, and 99Mo breakthrough as appropriate. Quality Control shall be performed on each agent dispensed. Complete documentation of quality control results shall be provided upon request. All radiopharmaceuticals shall be calibrated and labeled with concentration, time, total volume, and total activity. Consultation service regarding radiopharmaceutical applications, problems, controls, etc. shall be provided upon request at no charge. On an annual basis, the Contractor shall provide documentation demonstrating compliance with applicable agreement state or NRC license requirements to the COR.
PERSONNEL POLICY
The Contractor is responsible for all costs, including personnel costs, associated with this respective awarded contract unless otherwise specified.
Qualifications - Personnel assigned by the Contractor to prepare and provide the products covered within this Statement of Work shall be Nuclear Pharmacists, or a Licensed Technologist working under the supervision of a Nuclear Pharmacist licensed in a State, Territory, or Commonwealth of
SPECIAL CONTRACT REQUIREMENTS: HHS/OIG
To ensure that the individuals providing services under the respective awarded contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the Contractor is required to check the
CONTRACTOR STAFF ROLES AND RESPONSIBILITIES
Must be in compliance with all NRC, USP,
CONTRACTOR PERFORMANCE ASSESSMENTS
Assessments: The Government will do assessments of the Contractor s performance. The Contractor shall have an opportunity to respond to said assessments.
Record: The Government will keep completed assessments to serve as past performance data. Past performance data will be available to assist agencies in the selection of radio-pharmacy Contractors for future requirements.
DESIGNATION OF CONTRACT OFFICER REPRESENTATION
The Contracting Officer Representative (COR) will be designated in writing. The COR will be furnishing technical guidance and advice regarding the radiopharmaceuticals being provided under the respective awarded contract. The foregoing is not to be construed as authorization to interpret or furnish advice and information to the Contractor relative to the financial or legal aspects of the respective awarded contract. Enforcement of these segments is vested in and is the responsibility of the Contracting Officer.
CONTRACTOR RECALL AND SAFETY PLAN AND PROCESS NOTIFICATION TO FACILITY
The Contractor shall take immediate action to notify the COR whenever a product, piece of equipment ,or item is recalled or considered dangerous, hazardous or unsafe in order to remove such products, equipment or items from use. This notification process also applies to safety alerts. The Contractor recall and safety notification plan and process is necessary so that proper notification to individuals who have received or individuals who may utilize such products, equipment, or items can be made in as expedient and efficient manner as possible. The Contractor shall provide to the COR their plan for this safety notification process and also maintain a record system in order to document any safety incident issues by their date, time, and description of the recall or safety alert issue provided to the COR.
HIPAA COMPLIANCE
The Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the
AVAILABILITY OF FUNDS DURING A CONTINUING RESOLUTION
At the beginning of each new fiscal year (1 October) the Federal Government or parts thereof may be operating under a Continuing Resolution (CR) and only be funded for a limited period of time rather than for the entire fiscal year. If at any time funds for this contract are provided under a CR, funds will only be available for performance under this respective awarded contract up to and including the expiration date of the CR, and any extension thereof. The Government's obligation for performance of this respective awarded contract beyond that date is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise for performance under this respective awarded contract beyond the expiration date of the CR, and any extension thereof, until funds are made available to the Contracting Officer for performance and until the Contractor receives notice of availability.
REQUIRED REGISTRATION WITH CONTRACTOR PERFORMANCE ASSESSMENT SYSTEM (CPARS)
As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the
The Government will register the contract within thirty days after contract award. For contracts with a period of one year or less, the Contracting Officer will perform a single evaluation when the contract is completed. For contracts exceeding one year, the Contracting Officer will evaluate the contractor s performance annually. Intermediate reports will be filed each year until the last year of the contract, when the final report will be completed. Each report shall be forwarded in CPARS to the contractor s designated representative for comment. The Contractor s representative will have thirty days to submit any comments and return the report to the Department Of Veterans Affairs Contracting Officer. Failure by the Contractor to respond within those thirty days will result in the Government s evaluation being placed on file in PPIRS without Contractor s comments.
PROHIBITION (WORKING OUTSIDE OF US)
The entire performance of the respective awarded contract shall be within the borders of
CONTRACT TERM
This Indefinite Delivery Indefinite Requirements Contract shall be for one (1) base year plus four (4) option years. The base year of period of performance is from
INSTRUCTION TO OFFERORS
The Offeror must be registered with Sam.Gov to qualify for award of this contract.
The Offeror s proposal shall address each of the factors listed in this solicitation. If an Offeror fails to address any of the requirements listed here in this solicitation their proposal will be considered unacceptable and they shall receive no further consideration for award of the contract under this solicitation.
During evaluations of each proposal, the Government will assess each area of the Technical Quote to ensure the offeror meets or exceeds the standards of the contract. The Government will evaluate the technical quote based on the evaluation criteria described in the Evaluation Section below, as well as those requirements listed in the SOW. The Government will infer from the offeror s responses to these specified evaluation criteria the offeror s capability to perform to the requirements of the entire SOW.
*-
Radiopharmaceutical Listing
*-
Description
Unit of Measure
Estimated Annual Quantity
Size
XE-133 Xenon gas 10 mCi Vial
Unit dose
22
10mci
XE-133 Xenon gas 20 mCi Vial
Unit dose
1
20mci
I-123 Capsule (200uCi)
Unit dose
13
200uci
I-131 Sodium Iodine Diagnostic Capsule (0-100 uCi)
Unit dose
5
5-20uci
I-131 Therapy Dose (1st mCi)
Unit dose
5
1mci
I-131 Therapy Dose (ea. Additonal mCi after 1st dose)
Unit dose
240
15-30mci
Sodium Pertechnetate Tc-99m - per mCi
Unit dose
740
35uci
Sodium Pertechnetate Tc-99m - Unit Dose (0-25 mCi)
Unit dose
23
10-25mci
Sodium Pertechnetate Tc-99m - Unit Dose (26-50 mCi)
Unit dose
31
26-50mci
Medronate (MDP) Tc-99
Unit dose
270
30mci
Albumin Aggregated (MAA) Tc-99m
Unit dose
30
5mci
Ga-67 Citrate - per mCi
Unit dose
12
10mci
Sestamibi Tc-99m
Unit dose
1,448
10-29mci
Unit dose
1
.05mci
Unit dose
1
10mci
In-111 White Blood Cells
Unit dose
3
300-500uci
Sodium Pertechnetate Tc-99m - Flood Source (0-1 mCi)
Unit dose
11
1mci
Sodium Pertechnetate Tc-99m - Flood/COR Source (2 mCi)
Unit dose
12
10mci
Mebrofenin (Generic) Tc-99m
Unit dose
25
10mci
Mertiatide (MAG-3) Tc-99m
Unit dose
31
10mci
Sulfur Colloid Tc-99m
Unit dose
89
1-10mci
Ultratag RBC
Unit dose
30
N/A
Sincalide for Injection - Vial (Kinevac)
Unit dose
25
N/A
In-111 Pentetreotide (Octreoscan)
Unit dose
4
6MCI
Sulfur Colloid Filtered Tc-99m
Unit dose
3
1.5MCI
Heprin Sodium 1000 units/1 ml Vial
Unit dose
8
N/A
In-111 Pentetrate (DTPA)
Unit dose
1
*-
I123-Iobenguane Injection (AdreView)
Unit dose
1
*-
WBC Set-Up for In-111 Blood
Unit dose
4
N/A
STAT Delivery Charge(s)
Unit dose
21
N/A
After hour/Emergency charges
Two Deliveries during normal work hours Monday through Friday at no charge. Offeror may list any additional charges below:
Deliveries during normal business hours
Day
Charge or No Charge (Be Specific)
Emergency Delivery1
Each
$ _____
Pharmacist After-Hour Emergency Call-Back2
Each
$ _____
Weekend White Blood Cell labeling charge3
Each
$ _____
Emergency Delivery: Charge for delivering unscheduled Emergency orders (over 2 daily) during normal business hours within two hours of receiving the order by phone from the
Pharmacist (Emergency after hours): The charge for having a Pharmacist called back to the Pharmacy
after hours, prepare the ordered dose and have it delivered to the
Weekend WBC labeling charge: The charge for the pharmacy to attach a radionuclide to the patient s white blood cells on a weekend.
52.212-2 EVALUATION COMMERCIAL ITEMS (
The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price, and other factors considered. The following factors shall be used to evaluate offers: Technical Approach and Capability, Past Performance, and Price.
Factor I - Technical Approach and Capability
Subfactor 1: Vendor must include a copy of their Nuclear Pharmacy License
Subfactor 2: Vendor must show ability to deliver products Monday through Friday by
Subfactor 3: Vendor must provide an emergency plan procedure for deliveries in inclement weather.
Factor II Past Performance
The Offeror shall provide a minimum of three (3) references of current contracts within the past three (3) years of similar size, scope, and or complexity. References may include Federal, State, and Local Government as well as private customers and shall include the following information:
Names, email addresses, and telephone numbers of two points of contact (Contracting Officer and Customer) that would have firsthand knowledge on the performance of the contract.
Contract type, scope of work, and contract total dollar value.
Contract number to include the beginning date and ending date of the contract period of performance.
The past performance evaluation factor will assess the relevance and breadth of the offeror s experience and the quality of the offeror s past performance. The Government is seeking to determine whether the offeror has experience that will enhance its technical capability to perform and whether the offeror consistently delivers quality services in a timely and cost effective manner. In evaluating past performance, the Government will only take into consideration the relevant experience from the offeror s customers.
Information obtained from the offerors through the PPIRS database and any other sources deemed appropriate will be used by the Government in conducting past performance evaluations. The Government will analyze the historical facts of the offerors past performance made by its customers, and make qualitative judgements about the facts and observations. Offeror s may provide information on problems encountered on identified contracts and the offeror s corrective action. The Government shall determine the relevance of similar past performance information.
In accordance with FAR 15.305(a)(2)(iv) offeror s with no relevant performance history shall not be evaluated favorably or unfavorably on past performance.
Factor III Price
In accordance with FAR 17.206 price will be evaluated for the entire contract period, including the base year and both option years. Price evaluation will be undertaken in accordance with FAR 12.209.
All evaluation factors except price shall be evaluated as either acceptable or unacceptable. Your proposal must meet all the requirements identified in the SOW. If your proposal does not meet all of the SOW requirements it will be evaluated as unacceptable and will receive no further consideration for award. If your proposal does not provide pricing for all of the Schedule of Supplies it will be evaluated as unacceptable and will receive no further consideration for award. Price is the most important evaluation factor, followed by technical approach and capability, and then past performance.
At a minimum, proposals must include the following:
Offerors must return provision 52.212-3 with their quote. Offerors may either (1) complete all relevant portions of the provision or (2) complete paragraph (b) of the provision and indicate that it has completed official representations and certifications online at sam.gov.
Company name, phone number, and fax number.
Company point of contact name, email address, and phone number.
Company Mailing address and Remit to address, if different than mailing address.
Acknowledgment of Solicitation Amendment(s) if applicable.
Offeror's Federal Tax ID Number.
Offeror's DUNS number.
Offeror s Business Size.
Offeror must provide copies of all required licenses and certifications as identified in the SOW.
A detailed statement regarding the offeror s emergency plan for providing deliveries during periods of inclement weather.
This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and the
FAR 52.202-1, Definitions (
FAR 52.203-3, Gratuities (
FAR 52.203-6, Alt I- Restrictions on Subcontractor Sales to the Government (
FAR 52.203-11, Certification & Disclosure Regarding Payments to Influence Certain Federal Transactions (
FAR 52.203-12, Limitation on Payments to Influence Certain Federal Transactions (
FAR 52.203-17, Contractor Employee Whistleblower Rights and Requirement To Inform Employees of Whistleblower Rights (
FAR 52.204-4, Printed or Copied Double-Sided on Recycled Paper (
FAR 52.204-7, System for Award Management (
FAR 52.209-2, Prohibition on Contracting with inverted Domestic Corporations Representation (
FAR 52.209-5, Certification Regarding Responsibility Matters (
FAR 52.212-1, Instructions to Offerors - Commercial Items (
FAR 52.212-3, Offeror Representations and Certification, Commercial Items (
FAR 52-212-4, Contract Terms and Conditions - Commercial Items (
FAR 52.212-5, Contracts Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (
FAR 52.216-21, Requirements (
FAR 52.216-22, Indefinite Quantity (
FAR 512.217-4, Evaluation of Options Exercised at Time of Contract Award (
FAR 52.217-5, Evaluation of Options (
FAR 52.217-6 Option for Increased Quantity (March1989)
FAR 52.217-8 Option to Extend Services (
FAR 52.217-9, Option to Extend the Term of the Contract (
FAR 52.219-6, Notice of Total Small Business Set Aside (
FAR 52.222-3, Convict Labor (
FAR 52.222-19, Child Labor Cooperation with Authorities and Remedies (
FAR 52.222-36, Equal Opportunity for Workers with Disabilities (
FAR 52.222-50, Combating Trafficking in Persons (
FAR 52.223-3, Hazardous Material Identification and Material Safety Data (
FAR 52.223-18,
FAR 52.225-1,
FAR 52.232-18, Availability of Funds (
FAR 52.232-19, Availability of Funds for the Next Fiscal Year (
FAR 52.232-33, Payment by Electronic Funds Transfer (
FAR 52.232-38, Submission of Electronic Funds Transfer Information with Offer (
FAR 52.233-3, Protest After Award (
FAR 52.233-4, Applicable Law for Breach of Contract Claim (
FAR 52.246-2, Inspection of Supplies Fixed Price (
FAR 52.247-34 F.o.b. Destination (
FAR 52.252-1,
FAR 52.252-2,
VAAR 852.203-70,
VAAR 852.215-70, Service Disabled Veteran Owned And Veteran Owned Small Business Evaluation Factors (
VAAR 852.216-70, Estimated Quantities (
VAAR 852.232-72, Electronic Submission of Payment Requests (
VAAR 852.246-71, Inspection (
VAAR 852.270-1, Representatives of Contracting Officers (
VAAR 852.271-75, Extension Of Contract Period (
VAAR 852.273-74, Award Without Exchanges (
End of Document
Link/URL: https://www.fbo.gov/spg/VA/PiVAMC646/PiVAMC646/VA24417R1786/listing.html
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