CONTRACT #_Radiopharmaceuticals_VENDOR_STATION

Pre Solicitation Notice for Radiopharmaceuticals

VA240-12-R-0150



The Department of Veterans Affairs, Veterans Integrated Service Network (VISN) 3, supported by the Network Contracting Office (NCO) 3 is seeking one or more vendors with the capability to provide and deliver Radiopharmaceutical in 24 hours or less from the order placement time for patient therapy. The Radiopharmaceuticals will benefit the veterans’ population treated at these locations at VISN 3 in their geographical area within the states of New York and New Jersey. The VAMC’s locations are as follows:

• New York Harbor Health Care System (NY HHCS) in the cities of Manhattan and Brooklyn, N. Y. 10010.

• VA Hudson Valley Health Care System (VA HVHCS) in the city of Castle Point, N. Y. 12511.

• Northport VAMC in the city of Northport, N. Y. 11768.

• VAMC Bronx in the city of Bronx, N. Y. 10468.

• New Jersey Health Care System (NJHCS) in the city of East Orange, N.J. 07108



The government intends to award one firm fixed price, Requirement Contract, with a base year plus four one-year option periods. The quantity of Radiopharmaceutical individual orders for this service is estimated at over 18,000 of different doses, vials, kits, and/or set per year for VISN 3 (see list below). The unit price for a single Radiopharmaceutical must be “All-Inclusive†for materials, preparation, labor, conservation and delivery. This includes shipping, handling, refrigeration, and all other required process performed from request to delivery time.



Award date is approximately 10/01/2012. The anticipated issue date of the solicitation date is 7/16/12. The solicitation Due Date is estimated to be 7/31/2012. Copies of this solicitation can be found; viewed and downloaded on the Federal Business Opportunities website http://www.fbo.gov/.



All future information about this acquisition, including solicitation amendments, will also be distributed through this site. Interested parties are responsible for monitoring this site to insure they have the most up-to-date information about this solicitation. Payment will be made using Electronic Funds Transfer (EFT). Each offer is required per FAR 52.212-3 to complete their representations and certifications via the On-line Representations and Certifications Applications (ORCA) at http://orca.bpn.gov



All responsible sources may submit a quote which will be considered. Quotes must be e-mailed to: pedro.catinchi@va.gov . All questions concerning this solicitation should be directed to the Contract Specialist, Pedro Catinchi at this email address.









MINIMUM QUALIFICATIONS



• The contractor shall provide all labor, supervision and transportation necessary to meets the needs of the daily deliveries to the VAMCs.

• The contactor shall have an adequate supply of contract products to meet the requirements of the VAMCs

• The contractor shall provide, on an as needed basis, miscellaneous supplies and/or services, including but not limited to: sealed sources for Quality Assurance (QA) procedures and Radiation Safety Officer (RSO) safety audits for federal compliance.

• Contractor must have current knowledge of VA privacy, data security, and risk management procedures and practices.

• Contractor will meet Occupation Safety and Health Association (OSHA) Bio Hazard Policy and Regulations for needless disposal.

• Contractor shall abide the Title Code of Federal Regulations (CFR 10).



PERIOD OF PERFORMANCE (POP)



The contract’s POP will include a BASE period (October 1, 2012 through September 30, 2013) for delivery of Radiopharmaceutical on Fiscal Year (FY) 2013 with the inclusion of four, 12-months OPTION periods for delivery of Radiopharmaceutical on FY 2014-2017.





CONTRACTOR REQUIREMENTS



Financial Responsibility: The required radiopharmaceuticals shall be furnished from an established business that is financially responsible and able to show evidence of reliability, ability, experience, equipment, and personnel directly employed by the business and supervised by them to render prompt and satisfactory service.



Authorized Staff to place orders: The radiopharmaceutical orders are to be placed to the vendor only by an authorized Nuclear Medicine Professional staff. Upon award, the contractor will be furnished with the names of the personnel for each facility that are authorized to place orders against the contract.



Delivery Timelines: Orders for daily routine unit doses will be placed no more than 24 hours in advance and shall be delivered by 7:30 am Monday through Friday in a designated delivery location namely the Nuclear Medicine Section of the Imaging Service. The vendor shall plan on at least three daily routine deliveries and/or pickups during normal business hours per VAMC with additional emergency deliveries as needed by the Nuclear Medicine Section within 2 hours as required.



Labeling Doses: The contractor shall label all unit doses of delivered radiopharmaceuticals with the amounts, preparation time, expiration time and date, etc. and provide a bar labeled insert to allow scanning data in the Nuclear Medicine Information Management System (NMIS). If the contractor’s system varies from the current (Pinestar) NMIS information system, the contractor shall provide their system as well as data migration, technical support, and training to staff on its use at no additional cost to the government.



Radioactive Label: All packaging of radioactive materials must be clearly labeled “radioactive†with the proper class and exposure levels, preparation time, expiration time and date and VA order number on the outside of the shipping container in order to comply with specific requirements. All shipping containers must be free of radioactive contamination both inside and outside and adequately packaged to prevent damage during handling and storage. The vendor must supply with each shipment / order / delivery a system for spent (used) syringes, which meets OSHA’s Bio Hazard Policy/ Regulations and is needless.



Nuclear Regulatory Commission License: The contractor must be licensed by the Nuclear Regulatory Commission and be regularly established in the business of providing radiopharmaceuticals. Additionally, the contractor shall meet the Department of Transportation, National Health Physics Program (NHPP), Food and Drug Administration (FDA), OSHA, and all other agency rules and regulations (Federal and State). Contractors shall provide copies of licenses and certifications along with proposals.



CFR10: The contactor shall abide the Title Code of Federal Regulations (CFR 10).



Sales Representative: The contractor shall assign to the Medical Center an individual sales representative to facilitate the smooth coordination between the Medical Center and the Nuclear Pharmacy.



Quality Control Manual: The contractor shall provide a copy of their laboratory’s current quality control manual and shall be willing to discuss discrepancies in lab results which do not fit the clinical picture. The contractor shall test all products for quality control periodically and only those products that pass quality control may be sent to VAMC’s. The testing and the detailed report shall be furnished to VAMC’s at no additional cost. All quality control testing/procedures shall be performed as required by Federal and State regulatory agencies.



Orders: VAMC’s Nuclear Medicine Section may cancel ordered doses within a ten hour (10) notice to vendor.



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

• Product(s) ordered or shipped in error

• Product(s) damaged in shipment

• Recalled product(s)

• Outdated products in unopened, original container (specifically authorized for return by manufacturer.)

• Unused doses of patients who fail to keep their appointments.

• The contractor shall not charge for any cost to replace a damaged or incorrect products delivered. The replacement and redeliver of the correct item will be at cost of the contractor. Replacements shall be received within 48 hours of notification of VAMC’s.

• Cold kits shall be returned to vendor for credit or replacement if expiration date is exceeded. All charges for delivery shall be included in the fee schedule to include fuel surcharges.

• MSDS Sheets: Contractor shall provide Material Safety Data Sheets (MSDS) and updates as necessary on all delivered products for the VAMC’s.



Delivery: Time of delivery specified or mutually agreed to at the time of receipt of telephone orders shall become mandatory upon the contractor’s acceptance to commitment. Access to the nuclear medicine section during non business hours shall be obtained by contacting the VA police service. Delivery of supplies by the scheduled time will be complete except as otherwise authorized by ordering personnel. Failure to perform in accordance with the delivery commitment may be grounds for termination of contract in accordance with the provisions for default. Payments shall be made in the arrears via government purchase credit card. Invoice shall include period covered, billing date, name of preparation, quantity, and amount.



Solicitation: At the Solicitation time, the contractor shall bid on price per desired quantity or unit dose as requested below:



RADIOPHARMACEUTICAL ESTIMATED USAGE

Name of Product U/I A* B* C* D* E* Total U/I/Y Total U/I/(5)Y

I-131 Caps first, 1-6 mCi dose 41 41 0 20 20 122 610

I-131 Caps, each add mCi dose 10 200 0 20 5 235 1175

I-131 Liquid, per mCi dose 1 105 0 0 0 106 530

0 0

I-131 NAI Diagnostic, 5 uCi dose 1 7 0 10 0 18 90

I-131NAI Diagnostic, 15 uCi dose 1 0 0 0 0 1 5

I-131NAI Diagnostic, 25 uCi dose 1 0 0 0 0 1 5

I-131NAI Diagnostic, 50 uCi dose 5 0 0 0 0 5 25

I-131NAI Diagnostic, 100 uCi dose 2 0 0 0 156 158 790

I-123 WBC, per mCi dose 10 1 0 0 0 11 55

I-123, 100 uCi dose 60 0 0 0 156 216 1080

I-123, 200 uCi dose 61 89 40 80 45 315 1575

0 0

I-123 MIBG, 10 mCI dose 2 1 0 1 1 5 25

I-123 MIBG, 5 mCi dose 0 1 0 0 1 2 10

DaTSCAN (loflupane I-123 injection), 5 mCi dose 2 5 0 0 0 7 35

0 0

Thallium-201 Cl, 1.5 mCi dose 1 6 3 6 6 22 110

Thallium-201 Cl, 3.5 mCi dose 6 6 3 6 6 27 135

Thallium-201 Cl, per mCi dose 0 10 0 0 10 20 100

0 0

Gallium-67 Citrate, 5 mCi dose 59 0 0 0 25 84 420

Gallium-67 Citrate, 6 mCi dose 1 10 0 15 20 46 230

Gallium-57 Citrate, each additional mCi dose 10 5 0 40 5 60 300

Gallium-67 Citrate, per mCi dose 1 16 0 0 0 17 85

0 0

99m-Tc Choletec, 5 mCi dose 32 12 20 30 12 106 530

99m-Tc DMSA, 10 mCi dose 1 1 0 2 0 4 20

99m-Tc DTPA (Brain), 20 mCi dose 2 1 0 1 1 5 25

99m-Tc DTPA Aerosol, 45 mCi dose 76 25 10 240 15 366 1830

99m-Tc DTPA Renal, 10 mCi dose 1 2 0 12 25 40 200

99m-Tc ECD, 20 mCi dose 1 1 0 1 1 4 20

99m-Tc HMPAO WBC, 20 mCi dose 1 1 0 4 1 7 35

99m-Tc HMPAO, 30 mCi dose 10 1 0 1 2 14 70

99m-Tc MAA, 4.0 mCi dose 76 0 0 240 20 336 1680

99m-Tc MAA, 5.0 mCi dose 1 29 10 0 15 55 275

99m-Tc MAG-3, 10 mCi dose 53 55 20 40 10 178 890

99m-Tc MDP, 25 mCi dose 772 550 200 400 1000 2922 14610

0 0

99m-Tc Pertechnetate, 1 mCi dose 260 260 0 0 0 520 2600

99m-Tc Pertechnetate, 20 mCi dose 71 5 0 0 15 91 455

99m-Tc Pertechnetate, 20 mCi 5 dose 0 0 0 0 20 20 100

99m-Tc Pertechnetate, 35 mCi dose 1100 0 5 0 0 1105 5525

99m-Tc Pertechnetate 150 mCi for linearity dose 8 0 0 4 12 60

99m-Tc Pyrophosphate, 30 mCi dose 1 142 3 1 142 289 1445

99m-Tc Pertechnetate 75 uCi for shunt study dose 3 0 0 0 1 4 20

0 0

Tc-99m Sulfur colloid, filtered, 1 mCi dose 6 6 1 24 5 42 210

Tc-99m Sulfur colloid, filtered, 200 uCi dose 40 0 0 0 0 40 200

Tc-99m Sulfur colloid, 1 mCi dose 40 0 5 12 65 122 610

Tc-99m Sulfur colloid, 5 mCi dose 144 12 3 5 12 176 880

0 0

Choletec vials vial 75 0 0 40 10 125 625

DTPA vials vial 100 0 0 20 15 135 675

MAA vials vial 100 0 0 20 20 140 700

MDP vials vial 20 0 0 0 200 220 1100

0 0

Tc-99m Tetrofosmin, 20 mCi dose 2 0 0 0 0 2 10

Tc-99m Sestamibi, 10 mCi dose 1100 315 750 1500 0 3665 18325

Tc-99m Sestamibi, 20 mCi dose 25 20 0 6 1260 1311 6555

Tc-99m Sestamibi, 30 mCi dose 0 315 750 0 0 1065 5325

Tc-99m Sestamibi, 35 mCi dose 1020 0 0 1500 500 3020 15100

Tc-99m Sestamibi, 50 mCi dose 0 0 4 0 0 4 20

0 0

Stannous Pyrophosphate vials vial 45 20 0 0 25 90 450

0 0

Indium-111 Octreotide, 6 mCi dose 12 4 0 6 10 32 160

Indium-11 Prostascint 6 mCi dose 3 1 0 2 1 7 35

Indium-111 Oxine WBC, 0.5 mCi dose 1 24 0 10 24 59 295

Indium-111 DTPA for Cisternogram 1.5 mCi dose 1 0 0 0 5 6 30

QA radioisotopes 0 0

Gd-153, 10 mCi each 0 1 0 0 0 1 5

Tc99m Pertechnetate, 200 mCi each 0 2 0 0 0 2 10

Co-57, 20 ml vial source, 5 mCi for dose calibrator each 2 1 1 1 1 6 30

CO57 Flood Source, 10 mCi each 1 1 1 2 1 6 30

CO57 Flood Source, 5 mCi each 1 1 0 1 1 4 20

CO57 Rod Source, 1mCi each 1 1 0 1 1 4 20

CO57 Rod Source, 0.1 uCi each 0 1 0 0 0 1 5

CO57, 50 uCi Point Source each 0 1 0 0 0 1 5

Therapy 0 0 0

Y90 Zevalin dose 1 3 0 0 0 4 20

Metastran (SR-89) per mCi dose 1 1 0 1 1 4 20

Quadramet (Sm-153) per mCi dose 1 2 0 2 1 6 30

Others 0 0

Sincalide for IV injection (5mcg per 5 ml vial) dose 4 6 0 10 0 20 100

ACD each 0 30 0 0 0 30 150

UltraTag RBC Kit kits 1 18 0 100 10 129 645

0 0

Fee for emergency delivery, 1 hour Hour 10 1 12 1 1 25 125

Rest Myocardial Perfusion Studies, 10 mCi dose 0 0 0 0 300 300 1500

Stress Myocardial Perfusion Studies, 30 mCi dose 0 0 0 0 300 300 1500

Cesium 137 reference source for dose calibrator 200 uCi dose 2 0 0 0 1 3 15

Tc Myoview, 20 mCi dose 2 0 0 0 0 2 10





LEGEND

U/I: Unit of Issue

Y: Year

*Veterans Affairs Medical Centers (VAMC)

A: NY Harbor ( Who served Brooklyn and Manhattan

B: East Orange

C: Hudson Valley

D: Northport

E: Bronx











Evaluation Factors and Subfactors

Will be provided at the time the solicitation is issue



Provision and Clauses

Will be provided at the time the solicitation is issue





Solicitation documents will be available on or about July 16, 2012. All pertinent information regarding this solicitation will be posted on the Feb Biz Opps Website.