66--BPA CPT Reagent Rental Minneapolis VA HCS

Agency: Department of Veterans Affairs
State: Minnesota
Level of Government: Federal
Category:
  • 66 - Instruments and Laboratory Equipment
Opps ID: NBD00159110839559028
Posted Date: Oct 3, 2017
Due Date: Oct 10, 2017
Solicitation No: 36C26318Q0007
Source: Members Only
Solicitation Number :
36C26318Q0007
Notice Type :
Sources Sought
Synopsis :
Added: Oct 03, 2017 10:22 am
This is a REQUEST FOR INFORMATION (RFI) only. Market research is being conducted to determine the amount of qualified and capable businesses that can provide the items requested below. If you believe your firm is able to provide the items requested below, you are encouraged to respond by the due date with all of the required information indicated below in order to be considered. Due date for responses is close of business (4:30PM local time/CT) on Tuesday, October 10, 2017. Email responses to Melanie Stockman at melanie.stockman@va.gov. All questions must be submitted in writing to the Contracting Officer in writing via email. Telephone inquiries will NOT be accepted/returned.

When submitting a response to this RFI, offerors must include the following:

Indicate socio-economic status

Include picture of offered items and support literature, brochure etc

Indicate any existing Government contract where item(s) may be purchased (i.e. FSS/GSA contract etc)

Must be able to provide installation

If suggesting an Or Equal product(s), include information that demonstrates that product(s) meets/exceeds salient characteristics listed below.

DISCLAIMER-This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201 (e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.

NAICS: 325413

Size Standard: 1250 employees

SALIENT CHARACTERISTICS: Specialty Immunoassay testing for IFA and EIA Instrumentation

Scope/Basic Requirement:

Contractor shall provide the Minneapolis VA Healthcare System, 1 Veterans Drive, Minneapolis Minnesota, 55417, here in after referred to as the MVAHCS, a Cost-per-Test or Reagent Rental for brand name or better IFA and EIA Instrumentation, reagents, and supplies. The leased agreement is to be for 1 year (12 months) with the possibility of 4 additional twelve (12) month option periods to be renewed. Vendor is to provide an all-inclusive instrumentation and reagents needed to testing. The Reagent Rental or Cost-per-Test price shall include, at no additional cost, all equipment, installation, reagents, calibrators, controls, columns, consumable supplies (ie. Cups, probes), QC products, linearity testing material, interface (including software and hardware) to the VA Lab package in VistA system through Data Innovations, training of end users, system preventative maintenance (including parts, labor, travel), all shipping costs, and term of agreement to support the instrument for the term of the contract. This is highly specific and highly specialized instrumentation below is listed all of the technical features required by the Minneapolis VA immunology Laboratory.

Technical Features required:

The ANA titer used must be a 1:40 titer. Anything else is found to be unacceptable for diagnosis at the MVAHCS and will not be accepted.

Dimensions need to be no greater than 40inx30inX30in. Due to limited space in the laboratory, larger instrumentation will be found unacceptable.

Sample Capacity needs to be EIA of 192 or IFA of 96

Microplate/Slide capacity needs to be 2microplates for a total of 20 slides

Must have a well-by-well wash/reagent dispense for washing wells individually. Flooding the slide and performing multi-slide soak/wash is unacceptable.

Must have 2 modes for IFA Slide washing, cycle wash and hyper wash with simultaneous dispense/aspiration.

Microplate reader filter wavelengths need to be 405, 450, 550, and 620 nm.

Must not use disposable tips. Disposable tips are found to be unacceptable due to the fact that tips could be dropped mid-run causing the entire run of patient samples to fail and a delay in patient testing, and the tips would be adding an extra expense that the VA would be required to obtain the product from Vendor.

Instrument is to have only 1 moving part to keep it simple and easy to use and maintain, more than 1 moving part is unacceptable.

Must be an open system (ability to program other vendor s assays)

There must be a cap valet to prevent contamination.

Minimal maintenance required- anything more than weekly maintenance will be found to be unacceptable. The Minneapolis VA does not perform these tests daily and does not have the staffing to perform daily maintenance.

The slide maker and instrumentation needs to be an all in 1 package. Having 2 different instruments will be unacceptable due to limited space in the Immunology laboratory.

The past CAP surveys of instrumentation must be found acceptable by the Minneapolis VA. Any instrument that is found to have past undesirable CAP results will be found unacceptable for use.

Equipment Rental:

Equipment may be provided under a reagent rental/cost per test agreement or on an equipment rental basis. If equipment is provided under a reagent rental/cost per test, then all equipment costs shall be figured into the price of the reagents.

The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, current production shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable. Refurbished, used or current in house equipment is not acceptable

Site Preparation and Planning:

The vendor will make recommendations regarding site preparation and planning. The vendor will provide documentation and information characterizing the physical, electrical, Technology, and environmental requirements of the equipment prior to installation.

Equipment Installation:

The vendor will install all equipment. The installation of all equipment will be coordinated with the VA Laboratory Service. Installation will proceed at a mutually agreed time after confirmation has been given that all equipment has been delivered and the site is ready for installation. The contractor shall bear the responsibility of delivering and installing equipment at the VA Medical Center, Pathology and Laboratory Medicine Service (PLMS), One Veterans Drive, Minneapolis, MN 55417, at no additional expense to MVAHCS. Installation of the equipment shall be coordinated with the VA Laboratory Service. Call the laboratory supervisor at 612-467-1273 to coordinate installation.

Validation Studies:

The vendor shall assist with the performance of all validation Studies: precision, method comparison with the current instrumentation, accuracy, linearity, calibration verification, reference interval verification, determination of sensitivity and specificity. The vendor shall perform all the statistical analysis and report data in an organized, clearly comprehensible format. Vendor shall provide assistance with reference ranges to include handling data with appropriate software to establish or validate reference intervals.

Operator s Training

The contactor shall provide adequate training at the time of equipment installation.

Vendor will assist key operator in the system set up, sample analysis set up and QC system set up.

Training will include the on-site training of all testing personnel. There needs to be 2 levels of training. One more advanced for key operators and the other for everyday users.

Operator s Manual:

Vendor is to provide a copy of equipment operator documentation either in paper or electronic format.

Equipment maintenance:

Contractor agrees to maintain the equipment in good working condition and will repair or replace any defects in the equipment during the contract period at no additional expense to the Government. (Maintenance shall include all upgrades).

Maintenance/Service Calls: Equipment maintenance and repair service for the analyzers: A technical assistance center must be available by telephone 24 hours per day, 365 days per year with a maximum call back response time of 1 hour. Equipment repair service that cannot be completed through telephone assistance will require on-site service by contractor s qualified system maintenance personnel. On-site repairs will be conducted during routine business hours. Business hours are considered Monday through Friday 8:00AM- 4:30 PM.

There may be certain circumstances where an emergency repair may be required to be conducted beyond routine business hours. All such arrangements will be coordinated between the contractor and VA Laboratory personnel.

Contractor provides a guaranteed on-site emergency service response time of 24 hours after receipt of notification.

Preventive Maintenance: Contractor will provide scheduled preventive maintenance service calls as required by manufacturer s recommended PM schedule,

Upgrades: The vendor must provide upgrades to instrument hardware and software in order to maintain the integrity of the system and state-of-the art technology at no additional charge to the Government. This must be provided as they become commercially available and at the time as they are being provided to commercial customers. This requirement only applies to system upgrades that enhance the model of equipment being offered (.i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer vendor supported, etc.)

During the time of the contract, should the repair record of laboratory equipment reflect a downtime of 4% during a 3-month period, a determination will be made by the designated representative of the Government to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer s instructions, shall be solely that of the contractor. Each instrument provided by the contractor shall maintain an uptime of 96% each FY quarter of the term of the agreement. Replacement of equipment will be the responsibility of the Contractor.

Equipment Owner ship:

Contractor shall retain ownership of the equipment.

Removal of Equipment:

Upon termination of the contract the Minneapolis VA will remove the hard drive and terminate it according to policies and procedures. The actual equipment will be the contractor s responsibility to dismantle, decontaminate, and remove his equipment from MVAHCS premises. All costs for removal and return of equipment shall be borne by the contractor.

Estimated Quantities/Schedule of items:

Ordering Procedures:

All equipment and supplies shall be delivered FOB Destination to the Minneapolis VA Healthcare System (unless otherwise indicated in the contract). Equipment shall be delivered within 30 days of receipt of an order, and supplies shall be delivered within 5 calendar days after receipt of an order. Orders may be placed telephonically on an on-demand, as needed basis, by VAMC Laboratory personnel in accordance with the Contracting Officer s delegation of authority letter. The contractor shall provide the following information in order to expedite orders:

Telephone number:

FAX number:

Deliveries shall be made to: VA Medical Center, Bldg 70

Warehouse (90D), DO#________

One Veterans Drive

Minneapolis, MN 55417

Delivery times: Between 8:00 am and 3:30pm, Monday-Friday except Federal Holidays

All deliveries shall be accompanied by a delivery ticket or sales slip which shall contain:

Vendor s name

Purchase order number

Date of order

Date of delivery

Itemized list of products furnished including product description and quantity shipped.

Product Quality and Quality Control:

All products offered to the VAMC must be of the same consistent high quality as would be offered to the general commercial public in the United States

All products are purchased subject to acceptance by the MVAHCS, Pathology and Laboratory Medicine Service. Products that fail to meet Quality Control criteria of the Laboratory will not be accepted. Products will be rejected and may be discarded if found unsatisfactory by the Laboratory's Quality Control when they are received, or later if deterioration of the product occurs before the outdate. The VAMC will not be financially liable for unacceptable materials.

All products must be tested for Quality Control by the supplier, and only those products that pass Quality Control may be sent to the VA Laboratory. The supplier will demonstrate documentation of Quality Control performance of any item upon request of the VA Laboratory

Any substitutions of product must have the written approval of the VAMC Laboratory Service and the Contracting Officer or his/her designee

All defective or inferior products must be replaced within 48 hours at no cost to the VA Medical Center.

The VA Laboratory is not required to return unacceptable product, but may do so in the rare case where a limited number of items may be returned to solve a quality control problem.

The Manufacturer s quality Control methods must be completely outlined. The VAMC Laboratory will be notified immediately of any product deficiencies revealed by the manufacturer s Quality Control procedures.

It is the vendor s responsibility to provide this medical center with recall notices on any product that has been delivered to this facility that may be defective. Notification shall be made to the Contracting Officer via the most expedient method.

Rotation of stock:

To assure rotation of stock at the distributor, each lot of a product received must have an out date the same or later than the lot previously received. Only one lot of any item may be shipped per delivery, unless part is the old lot previously received and part is the new lot which will be shipped the next delivery.

Lot Numbers:

The term lot , as applies to this contract, is defined as being dispensed from a common reservoir (i.e. plates or tubes are of the same lot only if they were poured from the same reservoir after all ingredients were added). Contractor shall not change lot number without first notifying the Minneapolis VA Healthcare System Laboratory.

Shelf life:

All products must be received in the Laboratory with at least 2/3 of the shelf life remaining. The manufacturer/distributor will provide and update when necessary a shelf life list (time from production to outdate) for each product purchased.

Product Substitution:

No product substitutions will be accepted without the prior approval of the Contracting Officer

Certificates of performance:

Company shall provide certificates of performance for each lot shipped stating compliance with your company s standards and CLSI (formerly NCCLS) standards where they exist.

Recalled and Defective Products:

The contractor will immediately notify the Contracting Officer of any recalls of product or other important safety issues. As appropriate, the Contractor will replace and/or reimburse recalled/defective products at no cost to the Government. The Contractor may be liable for costs of processing recalls, i.e. administrative and clinical services to replace recalled/defective products.

MSDS, HAZARDOUS MATERIALS and WASTE STREAM ANALYSIS:

The contractor shall provide VA medical facilities in Minneapolis, with a listing of the vendor s products used with this analyzer(s) that are considered hazardous. The listing should also include a determination as to what can be considered harmless to be disposed of by normal methods, such as disposing in the sink or disposing in the trash and what has to be specially handled for disposal and how it is handled

The contractor is required to provide a list identifying any "hazardous materials" that may be provided as a part of this contract that are defined as hazardous under the latest version of Federal Standard No. 313. Material Safety Data Sheets (MSDS) shall be submitted for all products.

Contractor shall provide a complete chemical analysis of waste, to include mercury Na azides, carcinogens, reproductive toxins, acute toxins and all other waste that may be considered ignitable, corrosive, reactive or toxic. Contractor will also be required to provide additional subsequent waste analysis studies in the case of any new test or new test formation introductions. Documentation of all analysis will be provided to the VA Contracting Officer for review by the VISN-23 Green Environmental Management Systems (GEMS) Coordinator prior to contract award or introduction of new product after award

Changes/Modifications:

Changes in the pricing, terms, conditions of this rental agreement may be made only by written agreement of the parties. Any and all modifications for changes in: the prices, discounts, terms or conditions of this agreement, will be prepared for signature by the VA Contracting Officer for VISN-23

Customer Service/Technical Support:

A company representative shall visit the VA Laboratory during the contract period to review the account, provide product information, handle problems or defective merchandise (if required) and address any other issues or concerns that may arise. Technical telephone support must be available Monday through Friday between 8:00am and 5:00pm. Telephone response time shall be within four (4) hours of notification.
Please consult the list of document viewers if you cannot open a file.
Attachment
Type:
Other (Draft RFPs/RFIs, Responses to Questions, etc..)
Label:
Attachment
Posted Date:
October 3, 2017
https://www.vendorportal.ecms.va.gov/FBODocumentServ...
https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3830569&FileName=36C26318Q0007-000.docx
Description: 36C26318Q0007 36C26318Q0007.docx
Contracting Office Address :
Department of Veterans Affairs;NETWORK 23 CONTRACTING OFFICE;Contracting Officer;4801 Veterans Drive;St. Cloud MN 56303
Place of Performance :
US Department of Veterans Affairs;Minneapolis VA Health Care System;One Veterans Drive;BB-141-Immunology Laboratory;Minneapolis Minnesota
55417
USA
Point of Contact(s) :

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