DOCUMENT
65 -- Semen Analyzer - Attachment
- Notice Date
- 8/18/2014
- Notice Type
- Attachment
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Veterans Affairs;VISN/18PHX;777 E. Missouri, Suite 300;Phoenix AZ 85014
- ZIP Code
- 85014
- Solicitation Number
- VA25814Q0870
- Response Due
- 8/25/2014
- Archive Date
- 9/24/2014
- Point of Contact
- William Corson
- Small Business Set-Aside
- N/A
- Description
- Statement of Work Hematology Semen Analyzer July 23, 2014 Phoenix Veterans Administration Health Care System 650 E. Indian School Road Phoenix, AZ 85012 Brand name or equal. Meet or exceed. FOB Destination SCOPE: The Hematology Department of the Pathology & Laboratory Medicine Service (P&LMS) is requesting an automated semen analyzer for use in the Inpatient Laboratory. The semen analyzer will be used in the diagnostic evaluation of semen samples for fertility testing and for post-vasectomy evaluation. The analyzer will give accurate measurement of sperm count, morphology, motility, and viability. The analyzer will be automated, allowing the technician to 'walk away' during operation. Semen analysis has a strict one hour time limit between collection and analysis, which requires that the testing occur in-house. Reference laboratory testing is not an option. The manual identification of sperm count, morphology, motility, and viability is extremely time-consuming and is less accurate due human subjectivity. The automated platform will alleviate an inconsistent staffing need. The volume of semen analysis is associated with the Accelerated Care Initiative. The supply acquisition does not involve connection of contractor-owned IT devices to the VA internal network, therefore the C&A requirements do not apply and a security accreditation package is not required. The equipment to be purchased will only store the laboratory accession number in its own computer, and no part of the analyzer or its computer will be interfaced to a VA internal network or to the internet. It will be a self-contained system. No demographic information related to the patient will be used; name, social security number, last four, etc. DESCRIPTION OF HOW THE EQUIPMENT BEING REQUESTED OPERATES: The automated semen analyzer will perform a highly reliable, rapid (less than 10 minutes) semen analysis that follows the WHO (3rd, 4th, or 5th Ed.) guidelines for analyzing sperm concentration, motility, morphology, and viability. The analyzer will also meet all FDA and CAP requirements for semen analysis. The analyzer will be able to test fresh, frozen, washed, and post vasectomy sample types. The analyzer will also be able to show a magnification of the semen sample, so the technician can visually confirm the automated analysis. The analyzer should require no more than 0.5 mL semen sample to perform a complete analysis, with the ability to choose operating modes utilizing smaller sample sizes (0.25 mL or less) when necessary. The analyzer may or may not have the ability to interface with the P&LMS Laboratory Information System or the VISTA Hospital Information System. For this requirement, the LIS and HIS interfacing will not be utilized so the uploading of patient information and downloading of patient test results is not necessary. GENERAL REQUIREMENTS FOR THE EQUIPMENT: 1.Specifications as set forth in this proposal are minimum specifications and shall not be construed as limiting the overall quality, quantity, or performance of the equipment. 2.The offerer shall meet or exceed the minimum requirements and shall be held responsible for the performance and overall quality of the requested equipment during the equipment's warranty period. 3.The equipment, based upon the specifications requested, shall be the newest and the most current model. A refurbished is not acceptable. The equipment should be a standard product of the manufacturer of record. The manufacturer of record is defined as a company whose main occupation is the manufacture for sale items of equipment and which: a.Maintains a stock of replacement parts for the item. b.Maintains engineering plans, specifications, operating manuals & maintenance manuals. c.Has published and distributed literature and specifications on the equipment. EQUIPMENT REQUIREMENTS: 1.The analyzer will include the analyzing module, the read-out monitor, all necessary operating system requirements, and the semen analysis software. 2.The offeror will provide a FDA compliant quality control material for the semen analysis and all testing parameters therein. 3.The vendor will provide a FDA compliant calibration method, including any calibrator material and instructions for proper calibration requirements. 4.Any additional costs such as industrial funding fees, special shipping and handling fees, or other usage fees must be clearly indicated in the price quote. SUPPLIES: 1.All reagents, controls and disposables required for operating the instrument and producing quality results should be listed as an addendum in the pricing schedule. 2.The offeror should have the ability to fill emergency supply requests when requested. INSTALLATION, INCLUDING VERIFICATION/VALIDATION, TRAINING: 1.A technical support specialist from the instrument manufacturer will assist in equipment installation/set-up, providing all manpower, procedures, and reagents/supplies to perform validation and correlation studies [evaluation/comparison data sufficient to satisfy College of American Pathologists (CAP) standards]. 2.The vendor must provide required statistical analysis of the validation and correlation data in an organized binder for on-site director approval. The statistical analysis must be completed within six-seven weeks of installation of the system. 3.The vendor/distributor and/or the manufacturer must provide all necessary procedure manuals, troubleshooting manuals and operator manuals. 4.The vendor will provide primary user training for a minimum of one user (key operator) per instrument with on-site basic operating and maintenance education/training performed during initial installation and when updates to the equipment are performed. 5.Any additional costs such as industrial funding fees, special shipping and handling fees, or other usage fees must be clearly indicated in the purchase price quote. 6.All items quoted must be F.O.B. destination. All items shall be shipped to the following location (M-F, 8am-4pm, excluding holidays): Phoenix VA Health Care System Warehouse Receiving Dock 650 E. Indian School Road Phoenix, AZ 85012 PAST PERFORMANCE: 1.The vendor shall provide 4 references (two (2) VA and two (2) private sector) which can validate past experience within the last 2 years regarding: a.Costs to be reimbursed by vendor for loss of due to instrument failure. b.Quality of Service (to include timeliness of service, documentation and communication of work/repairs at time of service, does service repair/fix the problem on the first site visit or does service have to return to repair/fix the problem again, are parts/tools available when service is performed or is service delayed due to ordering replacement parts), and technical support including method validation. 2.Vendor shall list reagent recalls/bulletins and within the last five years. Vendor shall also list reagent unavailability due to manufacturing issues within the last five years. REPAIR AND MAINTENANCE: 1.Manufacturer will provide technical support by phone. MANDATORY VALUE-ADDED CHARACTERISTICS: These characteristics are mandatory, and will be considered in the best-value determination. Value added characteristics include, but are not limited to: 1.Provide utility requirements (electrical, media disposal, etc.) which should include all necessary SDS documents. 2.Provide environmental requirements (heat/cool, humidity, light, etc.) and recommendations for instrument and testing material storage. 3.The manufacturer should define maintenance requirements and indicate what maintenance is performed by the user and what is not. SUPPORT SERVICES: 1.The manufacturer should have the ability to provide phone service sufficient to meet the needs of the user facility Monday-Friday 8:00am to 3:30pm Arizona time. UPGRADES/ TEST VOLUME ADJUSTMENT: 1.Ongoing consumable reagents will purchased by credit card orders or a supplies contract. INTERFACE: 1.N/A
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PhVAMC/HMC/VA25814Q0870/listing.html)
- Document(s)
- Attachment
- File Name: VA258-14-Q-0870 VA258-14-Q-0870_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1580447&FileName=VA258-14-Q-0870-000.docx)
- Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1580447&FileName=VA258-14-Q-0870-000.docx
- Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
- File Name: VA258-14-Q-0870 VA258-14-Q-0870_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1580447&FileName=VA258-14-Q-0870-000.docx)
- Place of Performance
- Address: Department of Veterans Affairs;650 E. Indian School Rd.;Phoenix, AZ
- Zip Code: 85012
- Zip Code: 85012
- Record
- SN03468628-W 20140820/140818235028-3dc3345df053cb51eaa8308d4f21e96f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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