36C24618Q0725-003.docx

The following table is to be completed by all offerors as part of the quote/offer. Failure to complete, submit, sign, provide indicated documentation and include it with your quote/offer may deem your quote/offer unresponsive.

Technical requirements SOW responses and documentation requirements

Items 1. and 6.

Vendor can supply all the products at the time of solicitation as listed in the Price/Cost Schedule to the Charles George VA Medical Center.

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Items 1. and 2.

Orders will be placed daily and as needed basis by authorized facility employees. Vendor will respond within 15 minutes of notification and deliver within 90 minutes of notification.

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Item 3.

All vendor personnel preparing radiopharmaceuticals are required to be board certified in nuclear pharmacy or listed as an authorized user on the radioactive materials license.

Submit list of all persons preparing unit doses.

Submit copies of above Pharmacist Nuclear Medicine Board Certifications for all persons preparing unit doses.

Submit copy of vendor’s facility NC Radioactive Materials License or NRC License.

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Item 4.

Facility elects to purchase unit doses only. Request pricing of unit doses for all items.

All Technetium 99m labeled materials require active and on-site LEU generator production of at least 95% non-HEU sourced molybdenum-99 materials at this facility.

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Items 5. and 7.g. and 11.

All prices quoted on the Price/Cost Schedule for each unit item shall include any other charges including, but not limited to, delivery, fuel, emergency charges, etc. Facility will not accept separate line items for the above.

Vendor will provide credit on any doses not ordered or unused for the following Technetium-99m-labeled radiopharmaceuticals: Tc99m-Pertechnetate, Tc99m-Sestamibi, Tc99m-HDP, Tc99m-Mebrofenin. This facility must decay in storage all unit dose radioactive materials according to its radioactive materials license.

Vendor will provide monthly invoices with complete itemized list of all radiopharmaceutical and other items ordered, listed by prescription number, ID used, procedure, date and time and individual cost per item (including return credits) listed.

Submit a sample invoice including a credited item.

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Item 6.

Vendor is established and active with all pharmacists competent and actively preparing LEU (>95%) materials and other materials at the time of solicitation to be accepted as qualified.

Submit current manufacturer’s LEU Generator Certification for on-site generator.

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Items 7.a. and 7.b.

All doses are prepared using less than three elutions and traceable to the original elution upon facility request.

All Vendor pharmacy quality control records shall be presented to the facility at the time of request for any dose received to include time of QC, time of elution, eluant documentation, time of preparation, and QC breakdown at any point in the material’s shelf life.

Submit a sample QC report with all items above.

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Item 7.c.

Generic equivalents or substitutes are not acceptable without prior written approval from COR.

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Item 7.d.

All doses are prepared in accordance with applicable requirements.

Radiochemical purity and radiolabel must meet manufacturer’s package insert requirements and records kept available upon request.

Submit sample purity and radiolabel acceptance documentation.

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Item 7.e.

Any dose deemed below standard by the COR shall be credited for the full amount (e.g. unacceptable thyroid, stomach, kidney, or tissue uptake).

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Item 7.f.

Vendor will utilize adequate infection control standards for disinfecting the lead lined carriers of unit dose syringes (lead pigs) before and after shipments to maintain As Low As Reasonably Achievable radiation contamination practices as defined in applicable regulations.

Describe process to disinfect and control contamination of carriers while maintaining ALARA requirements.

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Item 8.

Vendor shall provide new package inserts and MSDS sheets for each material as they become available.

Submit a current sample package insert and MSDS.

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Items 9. And 10.

This facility utilizes electronic records for radiopharmaceuticals with EC2 software platform. Vendor must utilize compatible software that interfaces and is supported by Biodose / EC2 software including bar codes and bar code scanner operation.

Vendor shall provide any additional technical support deemed necessary for the technical staff, physicians, patient education, etc.

Submit sample bar coded dose label that is compatible.

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Item 12.

Vendor will provide quotes as needed for sheet sources, source disposals, meter calibrations, and radiopharmacy supplies.

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Item 13.

Vendor will have an alternative facility that can meet all requirements in the event of vendor’s facility incapacitation.

Provide name and address of alternative facility.

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I certify that the responses and information provided by me in Table 1 are accurate and complete to the best of my knowledge and belief.

Signature Date

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Company Name