DOCUMENT
65 -- Lab reagents - Attachment
- Notice Date
- 11/2/2017
- Notice Type
- Attachment
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- Department of Veterans Affairs;Network Contracting Office 4;2907 Pleasant Valley Blvd;Altoona PA 16602
- ZIP Code
- 16602
- Solicitation Number
- 36C24418Q0067
- Response Due
- 11/10/2017
- Archive Date
- 11/25/2017
- Point of Contact
- Derek Chuff
- E-Mail Address
-
3-8164
- Small Business Set-Aside
- N/A
- Description
- Chemiluminescent Immunoassay (CLIA) Statement of Work (SOW) 1. Introduction and Scope of Work: The Chemistry section of Pathology and Laboratory Medicine located at the Crescenz VA Medical Center in Philadelphia, PA provides laboratory testing for the serologic and virologic diagnosis of infectious diseases to any VA facility wishing to utilize its services. The tests offered are those that are too complex (e.g. complement fixation testing) or are not cost effective (e.g. Lymes, Measles, Mumps, Rubella, Syphilis, VZV) at the local level. The Special Reference Lab performs several Chemiluminescent Immunoassay (CLIA) tests on the DiaSorin Liaison, a random access, continuous feed analyzer. The long term contract on this instrument expired September 30, 2014. Due to addition of an automation track and upcoming ability to do auto-validation, we would prefer to just do a year to year contract until auto-validation happens. 2. PRICES AND TERMS: Pricing shall be based on the average yearly test volume per instrument/analyzer. This agreement will be an Indefinite Delivery, Indefinite Quantity (IDIQ) contract. The Government estimates the volumes listed, but does not guarantee volumes as listed; they are ESTIMATES ONLY. Estimated test volumes per month are listed below: Borrelia (Lymes Screen) 417 Measles (Rubeola) 350 Mumps 317 Rubella 350 Syphillis Screening 300 Vitamin D 8000 Varicella Zoster (VZV) 167 3. TERM OF AGREEMENT: The agreement shall be effective for one year. 4. IDENTIFICATION: Delivery Orders issued will be identified by Contract Number and Yearly Agreement Number. 5. ORDERING METHOD: The Crescenz VA Medical Center, (CMCVAMC) will order products via telephone, facsimile or other written communication, identifying the products by number, quantity, address for delivery, and any special instructions. The following personnel are authorized to telephone, fax, or e-mail orders: Supervisory Medical Technologist Rosemary E. Millili, MT (ASCP Chief Technologist Joyce Porter Other Medical Technologists, as designated 6. DELIVERY TICKETS: Unless otherwise agreed to, all deliveries under this agreement shall be accompanied by delivery tickets or sales slips that shall contain the following information as a minimum: a. Name of contractor b. Contract number c. Model number or National Stock Number (NSN) d. Purchase order number e. Date of purchase f. Quantity, unit price and extension of each item (unit prices and extensions need not be shown when incompatible with the use of automated systems, provided that the invoice is itemized to show information) g. Date of shipment. 7. INVOICES AND PAYMENTS: The Contractor shall invoice each delivery order as directed by the ordering activity. Payments will be made by the VA Finance Center, Austin, Texas, or by Purchase Card, if applicable. 8. INVENTORY AND SUPPLIES: Shall be in accordance with National FSS Statement of Work. a. Delivery of supplies: Shall be in accordance with Statement of Work. Any unexpected changes in methodology/technology shall be at the expense of the Contractor. b. Alert/Notification of delays in shipments as well as all technical advisory/recalls/alerts, prior to or simultaneously with field alerts shall be forwarded to the Chemistry Lab (CHEM) Supervisor, Chief technologist, and the Lead Technologist (Currently Vacant). c. Special handling for emergency orders of supplies: In the event that the consumables are found to be defective and unsuitable for use with the contractor s equipment, or the contractor has failed to comply with the requirements for routing supply delivery, the contractor is required to deliver the consumable supplies within 24 hours of receipt of a verbal order for priority delivery from the government activity. If either circumstance has occurred, the contractor will deliver to the government site in the most expeditious manner possible without additional cost to the government 9. GENERAL REQUIREMENTS (APPLICABLE TO ALL EQUIPMENT): a. In order to perform the tests in a timely manner, the contractor must provide a fully automated, random access, continuous feed analyzer. To maximize incubator efficiency, test cuvettes must be individual, not linked together. b. The equipment includes an automated processor and reader. The system must have an FDA cleared 25 hydroxyl Vitamin D assay, Lyme combined IgG & IgM screening test, Measles (Rubeola) Assay, Mumps Assay, Rubella Assay, Syphilis Screening assay, Varicella Zoster (VZV) Assay. c. The system must be pre-programmed and bi-directionally interfaceable. The contractor will provide the training necessary for technologists who will run the instrument. The system must be fully automated to handle bar-coded specimens from the beginning of the test until results are transmitted across the interface. The system needs to have a throughput sufficient to allow the Chemistry Lab to perform the testing within the time constraints of a forty-hour workweek. 10. Training: The Contractor shall provide training at the time of installation to include training on the operation of the system, data manipulation, preventative maintenance and basic trouble shooting and repair. A training or competency checklist shall be provided by the Contractor. 11. Site Preparation: Site preparation specifications shall be furnished in writing by the Contractor as a part of the equipment proposal. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate efficiently and conform to the manufacturer s claimed specifications. The Contractor shall be responsible for assessing the space available in the facility in order to ensure the right size equipment is provided; thereby not creating a safety hazard. 12. Implementation and Transition: The Contractor shall provide with its quotation a transitioning plan for the complete transition of all services under the awarded agreement including installation, training of personnel, transition of all testing materials, reagents and supplies, etc., and performance of all correlations and validations. This transition shall be completed no later than 60 days after the award of the agreement. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. 13. Delivery: The analyzer and all reagents will be delivered to the Crescenz VA Medical Center (CMCVAMC) Philadelphia using the address below: 3900 Woodland Ave Pathology and Laboratory Medicine (113) Chemistry Philadelphia, PA 19104 ( If existing vendor is selected, we would elect to use existing equipment). 14. Comparison and Validation of Analyzer: The Contractor shall assist, to the satisfaction of the Government, at no cost to the Government, all comparison and validation studies to include any materials and reagents needed for such correlation. The Contractor shall perform all of the statistical analysis and report data in an organized, clearly comprehensible format. This process shall be completed within 30 days of installation of the analyzer and shall be consistent with current CLSI (formerly NCCLS) and related documents, CAP Standards and Federal Regulations. 15. CLSI Procedure Manual: The vendor shall provide a copy of operating procedures in Clinical and Laboratory Standards Institute (CLSI) digital format at time of installation using software compatible with VA (Microsoft Office WORD). 16. Progress and Compliance: The system must perform assays as advertised, and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). 17. EVALUATION METHODOLOGY: The Government intends to award this contract based on lowest price technically acceptable. The Government intends to award one Firm Fixed Price requirement contract to the responsible offeror submitting proposals that are determined to be lowest price technically acceptable. Lowest Price, Technically Acceptable (LPTA) means that the award will be made to the offeror whose price is lowest among all proposals that were deemed to be technically acceptable. Technical acceptability will be measured minimally by: a) The offerors ability to meet desired turnaround times and instrument capabilities as stated in the statement of work. b) Past performance references. The solicitation specifies the technical requirements that Crescenz VA Medical Center (CMCVAMC) has established above in the detailed statement of work (SOW) the award will be made on the basis of the lowest aggregate price of proposals meeting or exceeding the acceptability standards for non-cost factors in accordance with FAR 15.101-2(b)(1)).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PiVAMC646/PiVAMC646/36C24418Q0067/listing.html)
- Document(s)
- Attachment
- File Name: 36C24418Q0067 36C24418Q0067.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3886191&FileName=36C24418Q0067-000.docx)
- Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3886191&FileName=36C24418Q0067-000.docx
- Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
- File Name: 36C24418Q0067 36C24418Q0067.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3886191&FileName=36C24418Q0067-000.docx)
- Record
- SN04730863-W 20171104/171102232017-563ba7ee38592658c3dea2eee12b115a (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 |