Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF APRIL 25, 2015 FBO #4900
DOCUMENT

65 -- ANNUAL RADIOPHARMACEUTICAL CONTRACT - Attachment

Notice Date

4/23/2015
 

Notice Type

Attachment
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

VISN 2 NCO (2-90);CONTRACTING OFFICER;DEPARTMENT OF VETERANS AFFAIRS;1304 BUCKLEY ROAD, SUITE C104;SYRACUSE, NY 13212
 

ZIP Code

13212
 

Solicitation Number

VA52815Q0188
 

Response Due

5/1/2015
 

Archive Date

6/30/2015
 

Point of Contact

Allison Dubin
 

E-Mail Address

25-4400
 

Small Business Set-Aside

N/A
 

Description

The Buffalo VA Medical Center currently has a procurement request for radiopharmaceuticals. This is a Combined Synopsis/Solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6 and 13.5, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation, quotes are being requested, and a written solicitation will not be issued. Interested parties that can respond to this Combined Synopsis/Solicitation must provide evidence that they have a potential to meet the requirements as identified herein. The proposed contract action is for supplies or services for which the Government intends to solicit competitive offers. Interested persons may submit offers, and all eligible offers received prior to the date listed in FBO will be considered by the Government. The NAICS code is 325412 and the size standard is 750 Employees. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-69. Only emailed requests received directly from the requester are acceptable. A.SCOPE The Department of Veterans Affairs Western New York Healthcare System at Buffalo, located at 3495 Bailey Avenue, Buffalo, NY 14215 has a requirement for a United States Nuclear Regulatory Commission (US NRC) and Food and Drug Administration (FDA) Licensed Contractor to provide radiopharmaceuticals for the Nuclear Medicine Department for patient care. The VA Western NY Healthcare System at Buffalo intends to award a base year plus one option year, firm fixed price, Indefinite Delivery Requirements Contract to a licensed Radio-pharmacy authorized to manufacture and distribute Radiopharmaceutical Supplies and Services in New York State. The contractor agrees in accordance with the terms and conditions stated herein, to furnish Radiopharmaceuticals in accordance with local, state and Federal Regulations. The awardee shall be able to provide all items listed in price cost schedule with deliveries as required. Multiple awards WILL NOT be made. B.BACKGROUND VA Western NY Healthcare System at Buffalo is responsible for providing high quality and timely commodities and services for our Veterans. The Department of Veterans Affairs (VA) has been directed to preferentially procure medical radioisotopes from non-High Enriched Uranium (HEU) sources. The Department of Veterans Affairs (VA) is also directed to ensure that the best possible medical supplies are procured timely and in accordance with proper regulations with vendors that are licensed and monitored according to local, state and Federal Regulations. Under the Atomic Energy Act, the United States Nuclear Regulatory Commission is responsible for regulating uses of radioactive material, including radio pharmaceuticals. NRC requires all nuclear medicine facilities to be licensed. The license assures that the facility has a radiation protection program to protect both the patients and the staff. In addition, the staff must meet certain standards of training and experience before they are allowed to administer radioactive material to patients. Each state has one or more radiation programs that ensure safe use of radioactive materials. NRC has transferred regulatory authority over the use of this material to 34 NRC Agreement States*. In these states, the regulatory authority inspects the facility to ensure the staff is trained properly and the equipment is operating safely. FDA's Center for Drug Evaluation and Research regulates the radio pharmaceuticals, ensuring effectiveness and patient safety. The mission of NIST is to develop and promote measurement, standards, and technology to enhance productivity, facilitate trade, and improve the quality of life. Although a non-regulatory federal agency, NIST develops the standards for correct patient dosage of radio pharmaceuticals. * http://nrc-stp.ornl.gov/rulemaking.html#NY C.STATEMENT OF WORK 1.Contractor agrees to provide all needed radiopharmaceuticals as identified in the Schedule of Supplies and Prices to VA Western NY Healthcare System at Buffalo on a daily and/or as needed basis per this Statement of Work. Because of the critical need for these supplies in a timely manner, only vendors that can deliver in less than two hours to the VA Western NY Healthcare System at Buffalo need to respond to this Request for Quotation. Contractor shall be licensed by the State of New York. Additionally, contractor shall be licensed by the Nuclear Regulatory Commission or another agreement state besides NY and be regularly established in the business of providing radionuclides. Contractor shall provide copies of these licenses and certifications to the Contracting Officer with the Request for Quotation. Contractor shall provide evidence of delivery in less than 2 hours with this Request for Quotation. Please identify the location of the point of shipment to the address listed on this Request for Quotation. Verification will be completed via www.mapquest.com. 2.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 FDA, DOT, DOE, USNRC, and ICC regulations and standards. Documentation of US DOT package integrity testing shall also be provided. 3.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. 4.Contractor shall label all products delivered as to the VA Western NY Healthcare System at Buffalo with the radiopharmaceutical, activity, time of preparation, expiration time and date. 5.Supplier 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 FDA license to produce and distribute radiopharmaceuticals for human administration. Supplier shall provide a copy of their radioactive material license with this quote. Supplier shall immediately notify the CO and COR, upon any action by the NRC or an agreement state and/or FDA to suspend or modify the radioactive materials license. Suppliers shall provide radiopharmaceuticals which have been prepared according to manufacturer's package inserts and applicable FDA requirements. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies. 6.Contractor will provide with their quote, the following information: a.Contractor's regular work hours b.Contractor's telephone number for call-in orders during regular work hours. c.Contractor's telephone number and instructions for placing "Emergency" orders after contractor's regular work hours, including weekends. d.Contractor's telephone number for expert advice concerning awarded products. e.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. f.Should any changes occur in above information during contract performance period, contractor will immediately provide updates in writing. 7.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 COR at VA Western NY Healthcare System at Buffalo Nuclear Medicine Service. 8.Contractor shall make quality control records available to the COR upon written request from the CO or COR. 9.Contractor shall test all products for Quality Control periodically this testing shall be performed at no cost to the VA. The contractor shall provide a detailed description of the test upon request. 10.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. 11.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%. 12.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. 13.Contractor shall replace any items delivered damaged or in error at no cost to the VA. COR shall define the replacement date and time. Replacements may be required immediately or within a specified time (as per patient needs). 14.The expiration date and time shall be indicated and affixed to each product as noted below; in general: a.Ready-to-use doses: not shorter than six (6) hours. b.Tc-99m pertechnetate: Not shorter than twelve (12) hours. c.Kits intended for reconstitution by user: Not shorter than three (3) months from date of delivery. d.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. 15.In the event that a quality control or material defect is suspected and/or detected by the COR, the Contractor will be requested to provide any consultation necessary to alleviate any said suspicion and/or defect by the following: a.Provide technical expertise in calibration; b.Provide professional examination of product; submit results and recommendations to the COR; c.Make expedient replacement of any product suspected of being deficient. 16.PROCEDURE for labeling of patient's white blood cells (WBC) with Indium-111 Oxine or Tc-Ceretec for re-injecting to the same patient: a.Telephone requests to the Contractor to arrange for the procedure will take place no later than 3:30 PM for the next workday procedure b.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 7:30 AM or later, if so specified by the COR. c.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. d.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. 17.Contractor shall pick up Radiopharmaceuticals (used, unused) for proper disposal at no cost to the Government. 18.Contractor shall produce radiopharmaceuticals as described in the Bid/Price Schedule. D.Deliverables and Acceptance Criteria 1.Contractor shall provide services and staff, and otherwise do all things necessary for or incidental to the performance of work, as set forth below: a.Provide up to two deliveries per day during regular operating hours to the VA Western NY Healthcare System at Buffalo free of charge. Delivery charge for STAT orders to be included on Schedule of Prices. STAT deliveries will occur, on average, three times a week. b.Regular daily radiopharmaceutical doses ordered the previous day will be delivered in ONE morning delivery by 7 AM and not split into TWO separate deliveries ( with one delivered later in the day). c.Deliver directly to the Nuclear Medicine Service VA Western NY Healthcare System at Buffalo daily quantity of radiopharmaceuticals by 7:00 am, as requested from the previous day. In addition to the morning delivery, one more delivery (During Normal Operating Hours) will be allowed daily at no cost per additional order or emergency. d.Orders can be placed orally by telephone and/or fax transmission by ordering officers provided by the contracting officer. e.Deliver directly to the Nuclear Medicine Service VA Western NY Healthcare System at Buffalo quantity of radiopharmaceutical requested on an as needed/emergent basis to arrive in less than two (2) hours of notification. f.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 the VA Western NY Healthcare System at Buffalo unless they have verbally communicated with a Nuclear medicine staff member. g.Other delivery times may be outlined by the VA Western NY Healthcare System at Buffalo under this contract. 2.If Monday is a federal holiday, no deliveries will be expected. 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 two (2) hours, or as specified. b.Emergency, weekend, and holiday shipments are to be delivered to location(s) specified by the VA Western NY Healthcare System at Buffalo, 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 Contractor 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 VA Western NY Healthcare System at Buffalo under this contract, will be strictly adhered to. 5.All shipments will have a Packing Slip enclosed, giving information about the product and its identification, plus (for billing purposes) the VA Western NY Healthcare System at Buffalo Purchase Order Number issued for the current fiscal quarter or month, and the Contractor's invoice number. (Incorrect P.O. numbers may cause a substantial delay in payments.) 6.Vendor must provide radiopharmaceutical invoice with each delivery with each dose bar-coded using the Pinestar system. If the Buffalo VA Medical Center's Pinestar system is not compatible with the bar coding that is provided, then Vendor must provide whatever software/hardware necessary to make our system compatible with Vendor's barcoding technology. E.VA OPERATING HOURS The delivery of products provided by this 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 (2) below. The following terms have the following meanings: Normal Operating hours of Nuclear Medicine: Monday through Friday, 7:00 a.m. to 4:30 p.m. Normal Next Day Delivery: 7:00 a.m. 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 F.CONTRACT AWARD Upon Contract Award (within 3 business days) Awarded Contractor shall provide: 1. A copy of their laboratory's current quality control manual to the COR 2. A dedicated inside sales representative to aide in facilitation in the smooth coordination between the medical center and Contractor's laboratory pharmacy 3.Material safety data sheets and updates on all delivered products as per contract award (and any additions throughout the life of this contract 4.Patient orientation education video presentations and other appropriate material at no cost to the VA 5.Contractor shall provide signs and posters alerting patients, employees and the public, of safety precautions in handling of radioactive materials G.QUALITY REQUIREMENTS Contractor shall guarantee the quality of the radiopharmaceutical. Quality Control (QC) shall include pH testing, percent tag, alumina, and 99Mo breakthrough as appropriate. Quality Control shall be performed on each agent dispensed. Complete documentation of QC results will 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 will provide documentation demonstrating compliance with applicable agreement state or NRC license requirements to the Radiation Safety Officer or COR. H.PERSONNEL POLICY 1.The contractor is responsible for all costs, including personnel costs, associated with this contract, unless otherwise specified. 2.Qualifications - Personnel assigned by the contractor to prepare and provide the products covered by this contract shall be nuclear pharmacists, or licensed technologist working under the supervision of nuclear pharmacist licensed in a State, Territory or Commonwealth of the United States or the District of Columbia. I.SPECIAL CONTRACT REQUIREMENTS: HHS/OIG To ensure that the individuals providing services under the 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 Health and Human Services - Office of Inspector General (HHS/OIG), List of Excluded Individuals/Entities on the OIG Website (www.hhs.gov/oig) for each person providing services under this contract. The listed parties and entities may not receive Federal Health Care program payments due to fraud and/or abuse of the Medicare and Medicaid programs. During the performance of this contract the contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities. Any healthcare provider or entity that employ or enter into contracts with excluded individuals or entities may have a Civil Monetary Penalty (CMP) imposed against them. By signing this offer, the Contractor certifies that all persons or entities listed in the contractor's quote have been compared against the OIG list and are NOT listed as of the date the offer was signed. J.CONTRACTOR STAFF ROLES AND RESPONSIBILITIES Must be in compliance with all NRC, USP, US FDA, state, local and JC guidelines. Vendor shall be in compliance with USP 797 guidelines. K.CONTRACTOR PERFORMANCE ASSESSMENTS Assessments. The Government may do assessments of the Contractor's performance. The Contractor shall have an opportunity to respond to 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 radio-pharmacy providers for future projects. Past performance data may also be utilized in future procurement efforts. L.DESIGNATION OF CONTRACT OFFICER REPRESENTATION COR will be designated in writing. COR will be furnishing technical guidance and advice regarding the work being performed under this 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 contract. Enforcement of these segments is vested in and is the responsibility of the Contracting Officer. M.CONTRACTOR RECALL AND SAFETY PLAN AND PROCESS NOTIFICATION TO FACILITY Contractor shall take immediate action to notify the Contracting Officers Representative (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. N.HIPAA COMPLIANCE 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 Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA). In accordance with HIPAA, the Contractor will be required to enter into a Business Associate Agreement (BAA) with VA found at attachment #1. O.AVAILABILITY OF FUNDS DURING A CONTINUING RESOLUTION At the beginning of each new fiscal year (October 1st) the federal government or parts thereof may be operating under a Continuing Resolution 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 Continuing Resolution (CR), funds will only be available for performance under this contract up to and including the expiration date of the CR, and any extension thereof. The Government's obligation for performance of this 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 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. P.REQUIRED REGISTRATION WITH CONTRACTOR PERFORMANCE ASSESSMENT SYSTEM (CPARS) As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates contractor past performance on all contracts that exceed the thresholds outlined in FAR Part 42.15, and shares those evaluations with other Federal Government contract specialists and procurement officials through the Past Performance Information Retrieval System (PPIRS). The FAR requires that the contractor be provided an opportunity to comment on past performance evaluations prior to the posting of each report. To fulfill this requirement VA uses an online database, the Contractor Performance Assessment Reporting System (CPARS). The CPARS database information is uploaded to the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. Each contractor whose contract award is estimated to exceed the thresholds outlined in FAR Part 42.15 is required to provide to the contracting officer contact information for the contractor's representative with their response to the solicitation. The contractor is responsible to notify the contracting officer of any change to the contractor's representative during the contract performance period. Contractor's representative contact information consists of a name and email address. 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 complete. 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 VA 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. Q.PROHIBITION (WORKING OUTSIDE OF US) The entire performance of the contract shall be within the borders of the United States of America, the District of Columbia and/or Puerto Rico. The Contractor shall not access any VA data/information (for example, by remote computer access) from locations that are outside the above-stated borders. Furthermore, the Contractor shall not send, transfer, mail or otherwise transmit any VA data/information to locations outside the above-stated borders. R.CONTRACT TERM This Indefinite Delivery Requirements Contract shall be for one (1) base year plus one (1) option year. Base year will run from 07/01/2015 through 06/30/2016. Option year will run from 07/01/2016 through 06/30/2017. S.INSTRUCTION TO OFFERORS Vendor must be continuously registered with the sam.gov to further qualify for this contract. The offeror's quote shall, at a minimum, address each of the factors and additional documents listed in this RFQ. During evaluations of each quote, 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. OFFER SUBMISSION REQUIREMENTS: Under no circumstances shall any pricing be included in the Technical Quotes. Offeror will submit three separate quote packages; technical, price, and additional documents that will not be evaluated for technical competency, but are required by the offer due date. All three packages will be submitted to in one (1) electronic copy to allison.dubin2@va.gov. Offers shall be submitted in accordance with the structure and format stipulated both here and elsewhere in this section. CD and faxed quotes are not allowed. Technical/Price/Additional Document packages shall contain cover sheets labeled with the Solicitation Number, Title, Location, Offeror Organization, Address, Point of Contact, Phone Number, Fax Number, and Email Address. CONTENT OF QUOTE PACKAGES: 1. The technical package will consist of the following: Factor 1: Technical Approach/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 7:00 AM and Emergency Deliveries within 2 hours from the time of order placement. Vendor must provide a MapQuest illustration showing their ability to deliver. Subfactor 3: Vendor must provide an emergency plan procedure for deliveries in inclement weather. Factor 2: Past Performance The offeror shall provide at least 3 references which can validate past experience within the last 3 years. References shall include the following minimum information: a.Agency/Institution Name b.Point of Contact c.POC phone number and e-mail address d.Duration of contract (or start date if performance is ongoing) Please note: A. The Government may conduct reference checks on contracts not submitted by the vendor but which the Government has previous knowledge of or becomes aware of during the course of the evaluation. The Government may also review past performance found in the Past Performance Information Retrieval System or any other Government contractor performance system available. B. The Government will give the vendor an opportunity to respond to adverse past performance information obtained from the reference checks. 2. The price package shall include: Factor 3: Price Please Note: Offerors must bid on ALL items in the Schedule. 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. Base Year (July 1, 2015 through June 30, 2016) ClinRadiopharmaceuticalUnit of Measure Quantity SizePRICE FOR EACH mCi or BulkTOTAL PRICENumber of Minutes Needed to Prepare Product at RadiopharmacyNDC OF OFFERED PRODUCT 001Tc99m SestamibiUnit dose1,1008mCi 002Tc99m SestamibiUnit dose1020mCi 003Tc99m SestamibiUnit dose1525mCi 004Tc99m SestamibiUnit dose1,10028mCi 005Tc99m SestamibiUnit dose45030mCi 006Tc99m Ceretec (brain imaging) Unit dose220mCi 007Tc99m HMPAO WBCUnit dose320mCi 008Tc99m DTPAUnit dose8030mCi 009Tc99m HepatoliteUnit dose707mCi 010Tc99m MAAUnit dose804mCi 011Tc99m MAG3Unit dose1007mCi 012Tc99m MDPUnit dose30023mCi 013Tc99m NeuroliteUnit dose225mCi 014Tc99m Sulfur ColloidUnit dose457mCi 015Tc99m Sulfur colloid filteredUnit dose53mCi 016Tc99m CholetecUnit dose57mCi 017Tc99m (pertechnetate)Unit dose 155mCi 018Tc99m (pertechnetate)Unit dose510mCi 019Tc99m (pertechnetateUnit dose3528mCi 020Tc99m (pertechnetateUnit dose1030mCi 021Tc99m (pertechnetatebulk4250mCi bulk 022Tl-201Unit dose71mCi 023Tl-201Unit dose73mCi 024Tl-201Unit dose34mCi 025I-123 NaI caps (200uci)capsule100200uCi 026I-131 NaI caps (therapeutic) capsule260mCi 027I-131 NaI caps (therapeutic)capsule2100mCi 028I-131 NaI caps (therapeutic)capsule3125mCi 029I-131 NaI caps (therapeutic)capsule1150mCi 030I-131 NaI caps (therapeutic)capsule1175mCi 031I-131 NaI caps (therapeutic)capsule1200mCi 032I-131 NaI caps (diagnostic)capsule32mCi 033I-131 NaI caps (diagnostic)capsule43mCi 034I-131 NaI caps (diagnostic)capsule7 4mCi 035I-131 NaI caps (diagnostic)capsule45mCi 036I-131 NaI caps (diagnostic)capsule17mCi 037In111 WBC Unit dose1450uCi 038In111 OctreoscanUnit dose26mCi 039Ga-67Unit dose16mCi 040Venti-scan IV (lung aerosol tubing)kit100kit 041Kinevac - CCK Unit dose10 reconstituted per patient weight1.4ugm/kg 042Ultra-tag kitskit2 boxes/5 kits eachkit 043Pyrophosphate kitskit20 vialskit 044Sealed sources for QC procedures- plus removal/disposal of depleted sourcesSealed source2 per yearvaries 045Emergency orders over 2 deliveries/day- to include pharmacist preparation and delivery. Deliveries Approximately 3/week (ESTIMATED 156 DELIVERIES ANNUALLY) DeliverPrice per delivery $ Total cost for delivery: Option Year (July 1, 2016 through June 30, 2017) ClinRadiopharmaceuticalUnit of Measure Quantity SizePRICE FOR EACH mCi or BulkTOTAL PRICENumber of Minutes Needed to Prepare Product at RadiopharmacyNDC OF OFFERED PRODUCT 046Tc99m SestamibiUnit dose1,1008mCi 047Tc99m SestamibiUnit dose1020mCi 048Tc99m SestamibiUnit dose1525mCi 049Tc99m SestamibiUnit dose1,10028mCi 050Tc99m SestamibiUnit dose45030mCi 051Tc99m Ceretec (brain imaging) Unit dose220mCi 052Tc99m HMPAO WBCUnit dose320mCi 053Tc99m DTPAUnit dose8030mCi 054Tc99m HepatoliteUnit dose707mCi 055Tc99m MAAUnit dose804mCi 056Tc99m MAG3Unit dose1007mCi 057Tc99m MDPUnit dose30023mCi 058Tc99m NeuroliteUnit dose225mCi 059Tc99m Sulfur ColloidUnit dose457mCi 060Tc99m Sulfur colloid filteredUnit dose53mCi 061Tc99m CholetecUnit dose57mCi 062Tc99m (pertechnetate)Unit dose 155mCi 063Tc99m (pertechnetate)Unit dose510mCi 064Tc99m (pertechnetateUnit dose3528mCi 065Tc99m (pertechnetateUnit dose1030mCi 066 Tc99m (pertechnetatebulk4250mCi bulk 067Tl-201Unit dose71mCi 068Tl-201Unit dose73mCi 069Tl-201Unit dose34mCi 070I-123 NaI caps (200uci)capsule100200uCi 071I-131 NaI caps (therapeutic) capsule260mCi 072I-131 NaI caps (therapeutic)capsule2100mCi 073I-131 NaI caps (therapeutic)capsule3125mCi 074I-131 NaI caps (therapeutic)capsule1150mCi 075I-131 NaI caps (therapeutic)capsule1175mCi 076I-131 NaI caps (therapeutic)capsule1200mCi 077I-131 NaI caps (diagnostic)capsule32mCi 078I-131 NaI caps (diagnostic)capsule43mCi 079I-131 NaI caps (diagnostic)capsule7 4mCi 080I-131 NaI caps (diagnostic)capsule45mCi 081I-131 NaI caps (diagnostic)capsule17mCi 082In111 WBC Unit dose1450uCi 083In111 OctreoscanUnit dose26mCi 084Ga-67Unit dose16mCi 085Venti-scan IV (lung aerosol tubing)kit100kit 086Kinevac - CCK Unit dose10 reconstituted per patient weight1.4ugm/kg 087Ultra-tag kitskit2 boxes/5 kits eachkit 088Pyrophosphate kitskit20 vialskit 089Sealed sources for QC procedures- plus removal/disposal of depleted sourcesSealed source2 per yearvaries 090Emergency orders over 2 deliveries/day- to include pharmacist preparation and delivery. DeliveryApproximately 3/week (ESTIMATED 156 DELIVERIES ANNUALLY) Deliver Price per delivery $ Total cost for delivery: After hour/Emergency charges - VA Western NY Healthcare System at Buffalo Two Deliveries during normal work hours (Monday - Friday) at no charge. Offeror (s) may list any additional charges below: Deliveries during normal business hoursDay Charge or No Charge (be specific) Emergency Delivery1Each$________ Pharmacist After-Hour Emergency Call-Back2Each$________ Weekend White Blood Cell labeling charge3Each$________ 1Emergency 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 VA. 2Pharmacist (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 VA within two hours. (Emergency orders only outside of normal business hours.). 3Weekend WBC labeling charge: The charge for the pharmacy to attach a radionuclide to the patient's white blood cells on a weekend. 3. Additional documents package shall include: a.Completed Reps and Certs if offeror does not list the NAICS code on their annual ORCA submission. b.Signed Standard Form 1449, and acknowledgment of all amendments. 52.212-2 EVALUATION-COMMERCIAL ITEMS (JAN 1999) (a)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, in descending order of importance: Technical Approach/Capability, Past Performance, Price. Factor 1: Technical Approach/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 7:00 AM. Vendor must provide a MapQuest illustration showing their ability to deliver. Subfactor 3: Vendor must provide an emergency plan procedure for deliveries in inclement weather. Factor 2: Past Performance Factor 3: Price The quotes will be evaluated based on lowest price technically acceptable quotes. All evaluation factors (core requirements) except price, are in effect, evaluated on a "Go, No Go" basis. Your quote will either meet ALL core requirements or fail. Technical and past performance, when combined, are equal to price. (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). (c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. (End of Provision) As a minimum, offers must include- 1.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 https://www.sam.gov. 2.Company name, phone number and fax number 3.Company point of contact name, email address and phone number 4.Company Mailing address and Remit to address, if different than mailing address 5.Acknowledgment of Solicitation Amendments 6.Offeror's Federal Tax ID Number; 7.Offeror's DUNS number 8.Business size 9.Offeror must provide copies of licenses and certifications 10.A detailed statement regarding technical capabilities and qualifications, and any additional supporting literature. All interested parties shall respond to allison.dubin2@va.gov by 12:00 PM EST Friday, May 1st, 2015. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the above requirement. Information can be emailed to the Contracting Specialist. 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 Medical Center anticipates entering into a contract for radiopharmaceuticals. (ii) The reference/solicitation number is VA528-15-Q-0168 and the solicitation is issued as a request for quotation (RFQ). The combined synopsis/solicitation will result in a contract and corresponding purchase order. (iii) The provisions and clauses incorporated into this solicitation document are those in effect at the time of publication. Provisions and clauses incorporated by reference have the same force and effect as if they were given in full text. The full text of the Federal Acquisition Regulations (FAR) and Veterans Affairs Acquisition Regulations supplement (VAAR) can be accessed on the Internet at https://www.acquisition.gov/far/ and http://www.va.gov/oamm/oa/ars/policyreg/vaar/, respectively. (iv) North American Industry Classification System (NAICS) code is 325412 (size standard of 750 employees) applies to this solicitation. (v) This requirement consists of radiopharmaceuticals (vi) Period of performance is July 1, 2015 through June 30, 2017 (vii) Delivery of radiopharmaceuticals will be to the Buffalo VA Medical Center, 3495 Bailey Avenue, Buffalo, NY 14215. (viii) The following solicitation provisions/contract clauses apply: FAR 52.209-5, Representation By Corporations Regarding An Unpaid Tax Liability Or A Felony Conviction Under Any Federal Law FAR 52.212-1, Instructions to Offerors - Commercial Items (Jul 2013) FAR 52.212-3, Offeror Representations and Certification, Commercial Items (Aug 2013). Offerors must include a completed copy of the provision with its offer or fill out online representations and certifications at 52.212-1 Instructions to Offerors-Commercial Items. FAR 52-212-4, Contract Terms and Conditions - Commercial Items (Jul 2013). FAR 52.212-5, Contracts Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (Aug 2013). For the purposes of this clauses, items (b), 1, 4, 6, 7 14, 23, 26, 27, 28, 29, 30, 31,32, 33, 38, 39, 41, 42, and 48 are considered checked and apply. FAR 52.216-21, Requirements FAR 52.217-9, Option to Extend the Term of the Contract FAR 52.232-38, Submission of Electronic Funds Transfer Information with Offer (Jul 2013) FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998). For the purpose of this provision, the fill-in's are http://farsite.hill.af.mil/ and http://farsite.hill.af.mil/vffara.htm respectively. FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998). For the purpose of this provision, the fill-in's are http://farsite.hill.af.mil/ and http://farsite.hill.af.mil/vffara.htm respectively. FAR 52.223-3, Hazardous Material Identification and Material Safety Data - Alternate I (Jan 1997). FAR 52.232-18, Availability of Funds VAAR 852.203-70, Commercial advertising (Jan 2008) VAAR 852.211-73 Brand Name or Equal VAAR 852.216-70, Estimated quantities (Apr 1984) VAAR 852.232-72, Electronic submission of payment requests (Nov 2012) VAAR 852.246-70, Guarantee VAAR 852.246-71, Inspection (Jan 2008) VAAR 852.270-1, Representatives of Contracting Officers RESPONSES ARE DUE Friday, May 1st, 2015, by 12:00 p.m. Eastern Daylight time. (xvii) Use electronic mail to submit quotations with a scanned electronic signature to allison.dubin2@va.gov. Telephone inquiries will not be accepted, please submit questions regarding this solicitation via email to allison.dubin2@va.gov.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/SyVAMC670/SyVAMC670/VA52815Q0188/listing.html)
 

Document(s)

Attachment
 

File Name: VA528-15-Q-0188 VA528-15-Q-0188.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2003183&FileName=VA528-15-Q-0188-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2003183&FileName=VA528-15-Q-0188-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN03708822-W 20150425/150423234923-57075dce988f1640440f053f87c2ab21 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

---

| FSG Index  |  This Issue's Index  |  Today's FBO Daily Index Page |