Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF MARCH 30, 2025 SAM #8525
SOURCES SOUGHT

66 -- 36C26025Q0411 CPT Immunoassay 648

Notice Date

3/28/2025 2:16:51 PM
 

Notice Type

Sources Sought
 

NAICS

621511 — Medical Laboratories
 

Contracting Office

260-NETWORK CONTRACT OFFICE 20 (36C260) VANCOUVER WA 98661 USA
 

ZIP Code

98661
 

Solicitation Number

25Q0411
 

Response Due

4/11/2025 5:00:00 AM
 

Archive Date

04/26/2025
 

Point of Contact

Hector Gonzalez, Phone: 360-553-7632
 

E-Mail Address

hector.gonzalez1@va.gov
(hector.gonzalez1@va.gov)
 

Description

The Department of Veterans Affairs (VA), Network Contracting Office 20 (NCO 20), is conducting market research on behalf of the Boise VA Medical Center to identify potential contractors capable of providing medical-grade liquid bulk oxygen, rental tanks and ancillary services to VA medical facilities and clinics. The Portland VA Medical Center is comprised of: Portland VA Medical Center. Vancouver VA Medical Center. Astoria VA Clinic. Fairview VA Clinic. Hillsboro VA Clinic. Loren R. Kaufman VA Clinic. Newport VA Clinic Portland VA Clinic Robert D. Maxwell Department of Veterans Affairs Clinic Salem VA Clinic West Linn VA Clinic To be considered a responsive and potential source, interested parties shall provide a capabilities statement containing the following information: Business name, address, point of contact, phone number and email address. Business size, type, and SAM Unique Identifier Number Affirmation that the vendor is capable of performing in accordance with the attached Statement of Work. Identify if you are a manufacturer or distributor of Immunochemistry Instrumentation. If a distributor, the vendor shall provide which manufacturer(s) they intend to use within each geographical area. A copy of the distribution agreement they hold with each manufacturer, showing that they are authorized to take possession of and resell the Immunochemistry Instrumentation in accordance with the Small Business Administration (SBA) Non-Manufacturer Rule (NMR). The vendor shall provide copies of government licenses appropriate to do the work described in the Statement of Work. Additionally, contractors can provide feedback on the attached Requirements Description, which may be considered if a solicitation is posted. Provide the requested information to Hector Gonzalez at hector.gonzalez1@va.gov before 5:00 PM PST on April 11th, 2025. All question must be submitted in writing, no telephonic inquiries will be accepted. This is a sources-sought notice only. The purpose of this notice is to obtain information regarding the availability and capability of verified sources to include qualified SDVOSB/VOSB to perform this potential requirement. Responses received will assist the Government in determining the appropriate acquisition strategy. The Government may or may not issue a solicitation as a result of this notice. There is no solicitation available at this time, and this is not a request for quotes. 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. STATEMENT OF WORK SCOPE: Provide the VA Portland Health Care System (VAPORHCS) with an immunoassay instrument capable of testing samples for the determination of 25 OH Vitamin D, Measles, Mumps, Rubella and Varicella Zoster Virus immunity, Fecal Calprotectin, CMV IgG/IgM, Toxoplasma IgG/IgM, M Tuberculosis testing, and H. Pylori Ag via Cost per Test contract. Vendor will provide Field Service Support. Vendor will also supply Government with sufficient supplies, reagents, calibrators, controls, 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 REQUIREMENTS: Leased (Cost per Test) Equipment All related reagents, controls, calibrators, consumables, and supplies required for maintaining the instrument and performing the tests listed above. All necessary service to keep equipment in manufacturer's operating conditions, both preventive maintenance and emergency repairs. Training for personnel operating equipment. Advanced customer training. 1-year base contract POP 08/01/2025- 07/31/2026. Option year 1 POP 08/01/2026- 07/31/2027. Option year 2 POP 08/01/2027- 07/31/2028. Option year 3 POP 08/01/2028- 07/31/2029. Option year 4 POP 08/01/2029- 07/31/2030. COST PER TEST: 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 12 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 6 months to monitor contract performance against agreed upon efficiencies, operational assumptions, and product utilization. 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 25 OH Vitamin D, Fecal Calprotectin, and Measles, Mumps, Rubella CMV, Toxoplasma, H. Pylori Ag, and Varicella Zoster Virus immunity cost per test analyzer for lease to meet VAPORHCS usage needs. a. 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. Vendor to provide decontamination/preparation of equipment to be removed. Provide certification for removal of equipment being replaced. i. 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. ii. 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. iii. The vendor shall maintain a record of removal to include: location, model number, serial number, and date of removal. b. Equipment Requirements: Vendor shall provide cost per test analyzer that meets the following requirements: Instrument shall be able to perform 100% of the tests listed below on a single fully automated chemiluminescence platform: 25 OH Vitamin D Fecal Calprotectin Measles, IgG Mumps, IgG Rubella, IgG Varicella Zoster Virus, IgG CMV IgG CMV IgM Toxoplasma IgG Toxoplasma IgM H. Pylori Ag M. tuberculosis testing using IGRA methodology. Instrument testing menu to include for future testing: Lyme Total Antibody Lyme IgG Lyme IgM HSV-1 IgG HSV-2 IgG EBV IgM VCA IgG EBNA IgG EA IgG 1,25 dihydroxyvitamin D 1-84 PTH Elastase-1 MeMed BV Walk away time equal to exceeds 5 hours. Instrument must be existing equipment on site. Equipment have all required accessories required 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. 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. xv. All tests shall be FDA approved. 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, 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 20 normal and 20 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. 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 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. iv. 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. 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 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. The vendor will provide advanced customer training. REAGENTS, CONTROLS AND SUPPLIES: Reagents, controls, and supplies (disposables) for testing (except for M. tuberculosis 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 seven (7) 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 TEST PROGRAM REAGENTS, CONTROLS AND SUPPLIES: Providing reagents, controls, calibrators, and supplies required to perform the tests listed below at the annual volume listed. 25 OH Vitamin D 31,000 Measles, IgG, 1,900 Mumps, IgG, 1,900 Rubella, IgG, 1,900 v. Varicella Zoster Virus, IgG, 1,900 vi. Calprotectin, 600 vii. CMV IgG, 300 viii. CMV IgM, 300 ix. H.Pylori Ag, 500 x. Toxoplasma IgG, 200 xi. Toxoplasma IgM, 200 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 following each order.
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/10343d1243ac484ab98bc5e5abae55b8/view)
 

Place of Performance

Address: Portland, OR 97239, USA

Zip Code: 97239

Country: USA
 

Record

SN07390846-F 20250330/250328230046 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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