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FBO DAILY ISSUE OF APRIL 30, 2010 FBO #3079
SOLICITATION NOTICE

65 -- CBC

Notice Date
4/28/2010
 
Notice Type
Presolicitation
 
NAICS
325413 — In-Vitro Diagnostic Substance Manufacturing
 
Contracting Office
Medcom Contracting Center North Atlantic, ATTN: MCAA NA Bldg T20, 6900 Georgia Avenue NW, Washington, DC 20307-5000
 
ZIP Code
20307-5000
 
Solicitation Number
W91YTZ10R0057
 
Response Due
5/5/2010
 
Archive Date
7/4/2010
 
Point of Contact
donna.blossom, (910) 907-6851
 
E-Mail Address
Medcom Contracting Center North Atlantic
(donna.blossom@us.army.mil)
 
Small Business Set-Aside
N/A
 
Description
The North Atlantic Regional Contracting Office at Womack Army Medical Center (WAMC) Fort Bragg, NC 28310. This is a Pre-Solicitation notice of the Governments intent to solicit, negotiate and award a sole source contract to Beckman Coulter, INC., Brea, CA 92821-6232 prepared in accordance with FAR Part 12 Commercial Items, and FAR Part 13 which is Simplified Acquisition Procedures. This award will be for the base year with four option years with requirements as needed. The Solicitation number is W91YTZ-10-R-0057. The NAICS code for this is 325413. This requirement is for the WAMC location and all out-lying clinics. A determination by the Government not to compete with proposed contractors is based upon the responses and is solely within the discretion of the Government. Information received will be normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Parties interested in future announcements shall provide detailed information of their capabilities and certification to clearly meet requirements stated below. Requirement shall be considered all or none, meaning Contractors shall meet all salient characteristics with no exceptions made. This notice of intent is not a request for competitive proposals. However, all proposals received after the date of publication will be considered by the Government. Award will be made to the company whose proposal show the best value to the government based on meeting technical proposal, past performance and price. All responses shall be received by 5 May 2010 @ 0800 EST. To be eligible for award, interested parties must be registered in the Central Contractor Registration (CCR), and have Online Registration and Certification Approval (ORCA) prior to quoting on the project. Responses shall be emailed to Ms. Donna Blossom @ donna.blossom@us.army.mil. No telephone calls will be responded to. The scope of work is as follows for WAMC Lab and all outlying clinics: 1. a. Contractor shall have Business (B2B) implemented within six months of the contract award. b.Contractor shall guarantee delivery of instruments and reagents. c. Contractor shall provide a site coordinator and an installation specialist to assist laboratory personnel with the entire implementation/installation process, ensuring the installation and validations be completed within 30-60 days of equipment arrival. d. Contractor shall provide a Clinical Application Specialist, that must perform system validation procedures to include calibration, precision, accuracy, mode-to-mode studies, sensitivity studies as applicable, and data stream verification for LIS interface capabilities. e. Contractor shall have equipment in place and ready for service by 1 June 2010. f. Contractor shall provide and utilize a Specimen Transport Module (STM), which is a unique patented magnetic system for continuous loading. g. Contractors equipment shall provide On-Board Decision Rules that will increase productivity and provide better patient care. h. Contractor shall have barcode capabilities and be fully interface able to the Composite Health Care Systems (CHCS). i. Contractor Validation Plan to be reviewed with Laboratory Officer / Quality Manager prior to commencement of validation studies. j. Contractor shall have rules defined by SOPs and alert technologist that post analytical work required on sample that may be abnormal. The On Board Decision Rules increase produce productivity and provide better care. k. Contractor shall have Triplicate Counting that provides best possible accuracy for patient results, resulting in 10 times more data per sample allowing reduced review rates l. Contractor shall use five reagents on system with floor stand to house reagents allowing On the Fly reagent changes to increase efficiency and productivity. m. Contractor shall provide and have attached slide maker and strainer for the main laboratory n. Contractor shall provide level 1 and level 2 platelets controls shipping with each standing order of reagents. o. The contractor activities shall include but not limited to the following: 1.Setting up instrument interface and ensuring results are crossing over to LIS. 2.Validation Plan to be reviewed with Laboratory Officer/Quality Manager prior to commencement of validation studies. 3.Entering reference ranges. 4.Setting up QC files and entering QC limits. 5.Linearity verification utilizing commercial linearity material to validate all measured parameters. If commercial linearity material is not available for any parameter to validate linear range, appropriate patient samples may be used. 6.Method Comparison Study (Old Method vs. New Method) 7.Carry-over studies on measured parameters using high patient samples or linearity material. 8.To obtain acceptable performance of the analyzer, all studies must be presented to the laboratory officer for acceptance prior to contractor departure. 9.Correlation studies to include the equipment at the clinics. p. LIS Interface: The contractor shall furnish interface assistance to ensure that the system is interfaced with the LIS prior to departure. If purchased of additional equipment is required to maintain the LIS system interface, an equipment credit must be allowed as a discount by the contractor. The system must have barcode capabilities and be fully interfaceable to the Composite Health Care System (CHCS). q. Contractor Shall provide following to the Main Hospital Lab: Two larger automated hematology systems as follows: 1. Integrated Clinical Laboratory Hematology Analyzers and Robotics Systems Automated systems for the robotic specimen handling and accurate analysis, data review, and reporting of human hematology test results. 2. Integrated automated system that has two identical automated hematology analyzers with the capability of attaching a slide maker and strainer between the two analyzers to increase efficiency and have the shortest turnaround time of verifiable test results. 3. The system must have the capability to automatically repeat or reflex specimens without manual intervention, by the use of user defined decision rules and without the need for additional hardware or middleware or internet connectivity. The system must interface with CHCS. 4. The system must have extended on board decision rules which are capable of using the following information: Test Result, Test Panels, Test Flags, and Codes, Delta Check State, Suspect Message, Definitive Messages, Exceptions, Patient ID, Age, Gender, Ethnicity, Specimen Age, Physician, Location, Diagnosis, Priority, Specimen ID. 5. The system must use a 2D compatible digital barcode reader to provide a positive identification for all specimen tube IDs in the form of an image. Cassette and specimen IDs must be read before, during and after aspiration. 6. The system must provide the capability to run automated closed tube, manual closed tube, and manual open tube using only one single aspiration pathway, regardless of presentation mode, from point of aspiration to result, thus simplifying the calibration and quality control process and eliminating mode to mode issues. 7. The system will use racks that conform to CLSI standard for automation efficiency and have the capability to use multiple sized tubes in a single cassette. 8. The system must have high sensitivity blood detectors around the Blood Sampling Valve and aspiration probe to recognize abnormal flow or electrical signals that a clot could cause. 9. Accurate Identification of Abnormal Hematology Results- Must have the capability to deliver high definition cellular analysis for increased accuracy of results. Must have lineage specific for blast flagging. Abnormal results identified as such by state of the art technology with few, if any, instrument triggered required manual peripheral false abnormal smear microscopic exams of normal patients. 10. The system must extend analysis time for cytopenic samples (RBC, PLT, and WBC), directly measure each leukocyte population (vs. calculated parameters) in order to provide more accurate results as well as analyze leukocytes in their near native state so as not to physically or biochemically alter their morphology. 11. Contractor shall provide training two slots initially for the analyzers and two additional training slots for each additional option year. 12. Contractor shall provide maintenance for both analyzers for the performance period. Service will be 7 days a week, 24 hours a day for all equipment. 13. The system must use Flow Cytometric Digital Morphology to provide a differential analysis in a single channel using the three technologies of Volume, Conductivity, and the following angles of light Scatter (Axial Light Loss, Low Angle Light Scatter, Upper Median Angle Light Scatter, Lower Median Angle Light Scatter, and Median Angle Light Scatter), allowing for reduced review rates. The testing menu will include but not limited to the following testing parameters: CBC: WBC, UWBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV DIFFERENTIAL: NE, LY, EO, BA, NRBC, NE#, LY#, MO#, EO#, BA#, NRBC# RETIC: RET, RET#, MRV, IRF BODY FLUIDS: TNC, RBC 14. The system must be capable of enumerating Nucleated Red Blood Cells accurately without the need for additional on board reagents. 15. The system must have the capability to auto correct WBC counts in the presence of interfering substances as well as auto correct RBC, HGB, HCT, MCH, and MCHC for high WBC. 16. Instrument must be FDA approved for body fluids that include CSF, Synovial, and Serous (including pleural, peritoneal, and pericardial) fluids. 17. Workload numbers for test performed are estimated. Payment will be made for actual items received. Estimated annual workload for CBCs is 75,000 tests, and 1,500 reticulocyte tests annually. 18. Testing throughputs must be at a minimum 100 samples/h for each individual instrument or 200 samples/h combined with two instruments. The system must have continuous load capability. 19. Blood sample volumes shall be no more than 165ul in any mode. 20. Contractor shall provide four smaller automated hematology analyzers for outlying clinics are as follows: a. Contractor shall provide four training slots initially for the analyzers and 1 additional training slot for each additional option year. b Contractor shall provide maintenance for all analyzers. Service will be 5 days a week, from 6 am to 6 pm for all equipment. c. Testing technology must be based on Flow Cytometry. The testing menu will include but not limited to the following testing parameters: WBC, LY%, MO%, NE%, EO%, BA%, LY#, MO#, NE#, EO#, BO#, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, PLT CRIT, PLT DISTRIBUTION, WIDTH, RETIC%, RETIC#, d. Workload numbers for test performed are estimated. Payment will be made for actual items received. Estimated annual workload for CBCs for Clinic #1 is 17,000 tests, Clinic #2 is 14,500 tests, Clinic #3 is 13,000 tests, and Clinic #4 is 3,000 tests annually. e. Must have automated sample handling, including mixing samples, calibration, and control materials, and cap-piercing capability. f. The analyzer must have a fail-safe sample management system which includes positive tube identification (tube bar-code is read at time of aspiration) and positive cassette/position identification (cassette and position bar-code read at time of aspiration). g. Testing throughputs must at a minimum of 75 samples/h for each individual instrument. The autoloader should have a minimum capability of 25 samples. h. The system must extend analysis time for cytopenic samples (RBC, PLT, and WBC), directly measure each leukocyte population (vs. calculated parameters) in order to provide more accurate results as well as analyze leukocytes in their near native state so as not to physically or biochemically alter their morphology. i. Shall include customer definable flags and instrument generated suspect flags. j. Shall direct measure each leukocyte population (vs. calculated parameters) in order to provide more accurate results. i. Shall provide a five part differential analysis in a single channel using the three technologies of Volume, Conductivity, and Scatter in order to maximize resolution, specificity, and efficiency.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/MEDCOM/DADA15/W91YTZ10R0057/listing.html)
 
Place of Performance
Address: Womack Army Medical Center 4-2817 Reilly Road Fort Bragg NC
Zip Code: 20307-5000
 
Record
SN02134383-W 20100430/100428234844-ea00bdbf3bcdc525495db10d7481e397 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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