Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF APRIL 05, 2018 FBO #5977
DOCUMENT

65 -- Architect i2000sr Analyzer CPRR Reagents and Consumables - Attachment

Notice Date

4/3/2018
 

Notice Type

Attachment
 

NAICS

325413 — In-Vitro Diagnostic Substance Manufacturing
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office 20;5115 NE 82nd Ave, Suite 102;Vancouver WA 98662
 

ZIP Code

98662
 

Solicitation Number

9535
 

Response Due

4/6/2018
 

Archive Date

4/11/2018
 

Point of Contact

Jodi Stevenson
 

Small Business Set-Aside

N/A
 

Description

Sources Sought The purpose of this Sources Sought Announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified sources for the equipment listed below. This is not a request for quotations. The Department of Veterans Affairs, NCO20 is looking for sources of the following: This an Unrestricted, Brand Name or Equal notice and the brand manufacturer is Abbott Laboratories. Provide the VA Portland Health Care System (VAPORHCS) with an immunoassay instrument for testing patient samples for immunosuppressive drugs and HIV/Hepatitis screening via a cost per reportable result (CPRR) contract. Installation and validation testing will be provided by Vendor at Government s facility. Vendor will provide Field Service Support. Vendor will also supply Government with sufficient supplies, reagents and training to execute the immunoassay analyzer in the performance of the proposed test menu based on estimated patient results per month. Equipment is defined below. Vendor s proposal shall contain items and services that meet or exceed the following capabilities General Equipment Name: One (1) Architect i2000SR Analyzer Description & Salient Characteristics GENERAL REQUIREMENTS: Leased (Cost per Reportable Result) Equipment including installation All related consumables and supplies All necessary service to keep equipment in manufacturer's operating conditions, both preventive maintenance and emergency repairs. Training for personnel operating equipment. Base year 1 Year COST PER REPORTABLE RESULT CPRR: Program: The pricing and terms are governed by the contract between the vendor and the Department of Veterans Affairs. Parameters: The calculation for price and quantity of reagents in the annual list included in the contract as based on an estimated annual number of reportable results provided by the Government. The quantities of the annual supply needs are supposed to cover the Government as long as the Government performs reportable results in compliance with the following parameters: Numbers of actual reportable results performed by the Government are within ten percent of the annual estimated reportable results as indicated by the annual supply list. Use of the instrument is in accordance with instrument usage information provided by Government (Primary, Back-up or Alternate). Test volumes are determined by the Government. No more than 10 percent repeats. Two levels of quality control to be run a minimum of every 8 hours of testing, and as required by the manufacturer every test day. Calibrators for periodic calibration checks and demand to validate systems following major repair or resolution of negative quality control trends. Adjustments: The Government and vendor will conduct ongoing reviews no less than every 90 days to monitor contract performance against agreed upon efficiencies, operational assumptions and product utilization (CPPR parameters). The vendor will notify the Government when such reviews indicate an adjustment to the quarterly standing order shipments may be required. The Government will cooperate with the vendor in the conduct of the reviews. The vendor, their personnel, and their sub-vendors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and Information system security as delineated in this contract.839.201 Contract Clause for Information and Technology Security. EQUIPMENT: Vendor will provide immunosuppressive and HIV/Hepatitis cost per reportable analyzer for lease to meet VAPORHCS usage needs. Installation: The vendor shall deliver and install all equipment under this BPA to the requesting facility after an order is placed. Equipment shall be installed within 30 business days after receipt of order. Equipment shall not be considered installed until VA employee certifies that the equipment is properly functioning and has the necessary supplies to perform its required function. The vendor shall maintain a record of installation to include: location, model number, serial number, and date of installation. Removal: The vendors shall un-install and remove all leased equipment under this BPA from the requesting facility upon the end of the awarded term, if not renewed. Equipment shall be removed within 30 days of request. All electronic storage media used on the leased equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization. Equipment shall be considered removed upon a VA employee certification that the equipment and all accessories have been taken by an employee of the vendor and there is no disruption and /or damage to the surrounding area. The vendor shall maintain a record of removal to include: location, model number, serial number, and date of removal. Equipment Requirements: Vendor shall provide an immunosuppressive drug and HIV/Hepatitis cost per reportable analyzer that meets the following requirements: Instrument shall be able to perform 100% of the tests listed below on a single platform: HIV Antigen/Antibody 4th Generation or higher Cyclosporine Sirolimus Tacrolimus Homocysteine Hepatitis B Core, Total Antibody Hepatitis B Core, IgM Antibody Hepatitis C Antibody Hepatitis B Surface Antigen Qualitative with Confirmation Test Hepatis A Virus, IgM Antibody Hepatitis A Virus, IgG Antibody Walk away time equal to 5 hours. Instruments must be new (non-refurbished) or existing equipment on site. All equipment shall come with any required accessories to perform normal duties, to include but not limited to, properly programmed printers and monitors. The analyzer will be VA Laboratory Information System (LIS) inter-faceable and the vendor will supply LIS specifications and assist with the interface connections. Instruments that have the ability to have access to the internet must follow VA IT security policies. The internet access must be verified and adhered to before and during all internet access. Operation of software uses minimal computer strokes to move from testing to reagent to data analysis or/and other screens. Time from standby to operation processing samples is less than 3 minutes. Time required for routine maintenance activities shall take less than 30 minutes daily and less than 30 minutes weekly/monthly. No required utilities except power System shall have a minimum throughput of 200 tests per hour. The system shall have the ability for auto-validation, should the facility choose to auto validate results. Instrument must offer limited to no carryover from sample to sample to reduce interference. Instrument shall allow patient sample to be used for repeats or reruns on the same or different instrument. All tests shall be FDA approved. COR Review: 90 day cycle review from the COR to ensure contract is being followed and is successful. This would in turn reach a quarterly performance review. UPTIME GUARANTEE/ PERFORMANCE PENALTY: Vendor agrees that all equipment provided shall be operable and available for use no less than 98% of operational time per month. Each instrument at site shall be computed separately. Operational time is 24 hours per day 7 days a week. Downtime is defined as when the vendor is not able to produce clinically acceptable results on the system monitor and will be computed from the time the Government notified the hotline during normal working hours until the Field Service Engineer returns the instrument to the Government and the Government can produce acceptable clinical results. Scheduled maintenance is excluded from downtime. METHOD PERFORMANCE / VALIDATION REQUIREMENTS: The contractor shall provide a Technical Representative to assist with all required method validation studies. Method performance/comparison shall be at the expense of the Contractor, and include linearity material, appropriate controls, calibrators, and reagents, and be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) standards and Federal regulations. All studies performed will be appropriate for the test menu and acceptable sample types, i.e., serum and/or plasma. All studies must be approved by the local Laboratory Medicine Medical Director and made electronically available. These requirements shall be in effect during installation and any future changes to the test menu and/or method updates. Correlation studies for each analyte. A minimum of 20 samples spanning the reportable range shall be run by the present and the proposed method. Contractor shall analyze results and provide statistical data to support acceptance of the new method for above studies. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, ROC analysis. Analytical Measurement Range (AMR) Validation shall be performed for each analyte to validate the reportable range. The material must have values, which are near the low, mid, and high values of the AMR and be of appropriate matrix for the clinical specimens assayed by that method. A minimum 5-point linearity analysis that adheres to the Beer-Lambert Law and spans the entire range shall be performed as a minimum. Precision study using normal and abnormal control material. This shall include, at a minimum, within run precision study of 10 normal and 10 abnormal Vendor provided Controls. Sensitivity may be validated concurrently with correlation studies. Mathematical calculations to determine efficiency, sensitivity, false positive rate and false negative rate are applied. Specificity Studies. A review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interfering substances. Carryover studies shall be completed by the contractor, if required. These studies shall be performed using either contractor developed program(s) or program(s) developed by a third party (CAP/CLSI). MAINTENANCE AND REPAIRS: Vendor shall provide preventative and corrective maintenance per manufacturer's recommendation. This shall include software upgrades and parts and labor, to maintain all equipment and accessories. Vendor will furnish all transportation, equipment, tools and labor to accomplish the required maintenance. Emergency repairs shall be performed after initial telephone notification that the equipment is inoperative. The Field Service representative will call to schedule onsite service within 2 hours of notification from Technical Assistance Hotline if necessary. The vendor shall provide the Government with a designated point of contact and telephone number and shall make arrangements to enable his maintenance representative to receive such notification. Telephone service support shall be available 24 hours/day, 7days a week. Onsite Field Service support shall be available Monday- Friday 8am- 4:30 pm. Onsite repairs shall be investigated within 24 hours of first notification from Technical Hotline to Field Service engineer. Efforts shall be made by the vendor to minimize disruption to Governments and employees (i.e. reschedule if work interferes with normal operation, access equipment when convenient to the needs of the VA, etc.) Vendor shall maintain cleanliness of work area and minimize dust and contaminants to areas adjacent to the job site. Vendor shall furnish a malfunction incident report to the installation upon completion of repair call within 2 business days after the completion of work. The report shall include as a minimum the following: Date and time notified. Date and time of arrival. iii. Serial number, type and model number(s) of equipment. Time spent for repair. Description of malfunction and repair. Proof of repair that included documentation of a sample run of quality control verifying acceptable performance. Time repair complete. The instrument provided by the vendor shall maintain an uptime of 98% in each month of the term of the agreement. During the term of the BPA, should the repair record of the analyzer reflect a downtime of 5% or greater of the normal working days in one calendar month, it is the responsibility of the vendor to immediately replace the broken laboratory equipment with new equipment at no additional cost to the Government. The responsibility for maintaining the equipment furnished in operating condition in accordance to manufacturer's instruction, shall solely be the responsibility of the vendor. The vendor shall treat each notification for an emergency/repair service call form the Government as a separate and new service call. The following are guaranteed throughout the life of this BPA: Priority scheduling of requests for service. Unlimited Emergency Service. No charges for labor, travel or any other related expenses. Unlimited Parts. No charge for replacement parts which become marginal or defective due to normal use during agreement period. Factory Authorized Product Updates and Modifications. Installed at no additional charge for improved product performance and reliability. Factory trained and Authorized Service Engineers. Continual upgrading and certification of engineers in latest instrument technology. Maintenance & Repair: Loaner equipment to be repaired within 24 hours of alert of malfunction. TRAINING: With the exception of specific training requirements stated herein, which shall have precedence; vendor shall provide "operator" training in accordance with the terms, conditions, and provisions of the vendor's existing Federal Supply Service Contract. Listed below are the training requirements: The vendor shall provide, at no cost to the Government, two technical operator training slots for each instrument per facility within the first year. The training will include all travel (to and from training center), hotel, meals, lodging, transportation, tuition and books. The Vendor shall have an on-going training program for VAPORHCS employees by the Technical Service Representatives on any new products or updates on the product lines. All materials for training will be provided at no additional cost to the Government. The vendor will provide competency assessment protocols for use at each site consistent with federal CLIA and CAP training requirements. REAGENTS, CONTROLS AND SUPPLIES: Reagents, controls and supplies (disposables) for testing shall be provided by the vendor and shall adhere to the following requirements. Reagent shelf life shall be no less than 12 months. On board stability of reagents shall be at least 30 days. Reagents are marked for easy recognition by the operator and shall contain the appropriate facility Purchase Order number in the delivery address. Vendor will supply a list of reagents, calibrators, controls and disposables that will be shipped as part of the standing order. Delivery shall be within four (4) business days of the date indicated on the standing order. Vendor will provide sufficient reagents, calibrators, controls, and supplies for performance of patient results for VAPORHCS. Additional reagents, calibrators, controls, and supplies may be ordered to meet the demands of patient testing. Orders shall be considered late if not received by the Government within four (4) business days of the date ordered. Vendor shall supply all changes to the maintenance schedules that affect reagent or cleaning reagent volumes and shall be coordinated with the VA facility Points of Contact to implement the changes in accordance with manufacturer's recommendations. THE VENDOR WILL BE RESPONSIBLE FOR THE FOLLOWING: COST PER REPORTABLE RESULT PROGRAM REAGENTS, CONTROLS AND SUPPLIES: Providing reagents, controls, calibrators, and supplies required to perform the tests listed below at the annual volume listed. HIV Antigen/Antibody 4th Generation or higher 10,500 Cyclosporine 1,800 Sirolimus 1,400 Tacrolimus 6,400 Homocysteine 2,200 Hepatitis B Core, Total Antibody 4,200 Hepatitis B Core, IgM Antibody 1,400 Hepatitis C Antibody 26,000 Hepatitis B Surface Antigen 6,200 Hepatitis B Surface Antigen Confirmation Test 1,600 Hepatis A Virus, IgM Antibody 2,300 Hepatitis A Virus, IgG Antibody 4,400 Include, in the contract, a separate table listing all reagents, controls, calibrators, and supplies including shipping charges for quarterly shipping of standing orders. Reagents, controls, calibrators, and supplies will be shipped on a standing order schedule, agreed upon by Government and Vendor. All or part of a future quarterly standing order may be advanced up to 10 days ahead of the scheduled ship date of the standing order. Changes in maintenance schedules that affect reagent or cleaning reagent volumes will be approved by the Vendor in accordance with manufacturer's recommendations. The vendor will invoice the Government based on the report of reportable tests. THE GOVERNMENT WILL BE RESPONSIBLE FOR THE FOLLOWING: COST PER REPORTABLE RESULT PROGRAM: CPPR Periodic payments: During the agreement the Government will report each month to the vendor in writing or electronically the number of reportable results generated in the previous month. Potential sources shall provide, at a minimum, the following information to Point of Contact listed below: 1) Company name, address, and point of contact, phone number, e-mail address, and DUNS. 2) Please identify your company s size in comparison to the anticipated North American Industry Classification System (NAICS) code 325413 In-Vitro Diagnostic Substance Manufacturing. To be considered a small business your company must have fewer than 1,250 employees. 3) Any Service Disabled Veteran Owned Small Businesses or Veteran Owned Small Businesses who responds to a solicitation on this project must be registered with the Department of Veterans Affairs Center for Veterans Enterprise VetBiz Registry located at http://vip.vetbiz.gov. 4) The Non-Manufacturer Rule (NMR) will apply if there is a decision to set-aside the procurement. 5) Potential sources shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. This procurement is for new Equipment ONLY; no remanufactured or "gray market" items. All Equipment must be covered by the manufacturer's warranty. Responses are due by 4/13/2018 11:00 AM PST, to the Point of Contact. The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this sources sought notice. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. Notice to Potential Offerors: All Offerors who provide goods or services to the United States Federal Government must be registered in the System Award Management (SAM located on the web at www.sam.gov). It is desirable that any Offeror to have completed their business Online Representations and Certifications Application in the System for Award Management (SAM). Point of Contact: Jodi Stevenson, Contracting Officer jodi.stevenson@va.gov, 360-852-9883
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PoVAMC/VAMCCO80220/9535/listing.html)
 

Document(s)

Attachment
 

File Name: 9535 9535.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4200908&FileName=9535-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4200908&FileName=9535-000.docx

 

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

Place of Performance

Address: Portland VAMC;3710 SW US Veterans Hospital Road;Portland, OR

Zip Code: 97239
 

Record

SN04875681-W 20180405/180403231130-33faacd9093a349088f6a81492558215 (fbodaily.com)
 

Source

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

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