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66 -- Linearity Testing Reagents - Calibration/Verification test kits - Attachment

Notice Date
Notice Type
325413 — In-Vitro Diagnostic Substance Manufacturing
Contracting Office
ZIP Code
Solicitation Number
Response Due
Archive Date
Point of Contact
Arlene Blade
E-Mail Address
Small Business Set-Aside
The Gulf Coast Veterans Health Care System (GCVHCS) Pathology & Laboratory Medicine Service (P&LMS) in Biloxi, MS is seeking Service Disabled Veteran Owned Small Business (SDVOSB) or Veteran Owned Small Business (VOSB) sources capable of meeting the requirement listed below. The acquisition will be accomplished using commercial item procedures in accordance with FAR Part 12. NOTE: TO QUALIFY SDVOSB AND VOSB VENDORS MUST BE CERTIFIED IN THE VA VENDOR INFORMATION PAGES (VIP) DATABASE. The North American Industry Classification System (NAICS) is 325413. Any SDVOSB or VOSB firms who wish to identify their interests and capability to provide this product must provide product specifications, performance and delivery information by notifying the Contract Specialist no later than 2:00 PM Central Time, September 18, 2018. Notification shall be e-mailed to Arlene A. Blade, at arlene.blade@va.gov. Any vendor who responds to this Notice must provide credentials to provide linearity testing reagents as detailed below. DISCLAIMER This Sources Sought Notice is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this Notice that is marked as proprietary will be handled accordingly. In accordance with the Federal Acquisition Regulation, 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 Notice. Background: Gulf Coast Veterans Health Care System (GCVHCS) Pathology & Laboratory Medicine Service (P&LMS) is requesting the purchase of Maine Standards calibration/verification kits for the Beckman/Coulter Chemistry analyzers. The kits will serve to verify the functionally of the instruments that is required bi-annually by accreditation standards, i.e. College of American Pathologist. Supply kits will be ordered for the following lab sites: Biloxi, Mobile, Pensacola, Eglin, and Panama City. Results of the studies will be submitted to Maine Standards for processing of data and reports from the study will be provided and will be kept on site for each lab for accreditation inspection. Accreditation requires chemistry analyzer equipment calibration and linearity to be verified bi-annually using purchased kits that have known analyte levels. Instrument verification is required for accreditation purposes and the determination of operation issues that may need addressing 2. Scope. Calibration/Verification kits are specifically design for for testing on chemistry analyzers and contain the specific analytes that require performance study. Kits come liquid and ready to be used kits or requires reconstitution with a solvent. Historically, liquid ready reagents have been a reliable product and produce reliable results. Other products used have been a problem in the past due to, kits need reconstitution; do not have the required analytes in a specific kit requiring additional kit purchasing, and produce unreliable results. 3. Specifications/Characteristics: Ready-to-use test kits designed to assist in the documentation of linearity, calibration verification and verification of linear range required by our current accreditation inspection agency, College of American Pathologist. The ready-made solutions (reagents that do not require to be reconstituted with a solution) will also provide assistance when troubleshooting instrument systems, reagent problems and calibration anomalies. Multiple product configurations (kits) are available to meet the different needs of the many instrument systems available. The configurations are specifically formulated to maximize reportable ranges with no dilutions. Each individual test kit can be used for two testing cycles for one instrument: Each test kit provides enough volume to complete two studies of calibration verification and reporting range validation. All VALIDATE products are U.S. FDA cleared for use as calibration verification and linearity materials. Labs inspected by all accreditation organizations have successfully used VALIDATE to satisfy their calibration verification and linearity requirements. Equal-spaced level: Level 1 to 5 are prepared to create equal deltas as recommended by CLSI s EP06-A guideline for linearity testing. Most products also include a true zero, the base matrix for the product designed to provide a zero result. The requested items provide linearity testing with the range parameters required for calibration and testing needs: Analytes Approx Measurement Ranges Analytes Approx Measurement Range Albumin 1.0 7.0 g/DL Blood Urea Nitrogen 5 100 mg/DL Calcium 2.0 20.0 mg/DL Chloride 50 200 mg/DL Cholesterol 5.0 750 mg/DL Creatinine 0.3 25.0 mg/DL Glucose 5 700 mg/DL Lactate 2.7 99 mg/DL Lithium 0.0 3.0 mmol/L Magnesium 0.1 7.0 mg/DL Phosphorus 1.0 12.0 mg/DL Potassium 1.0 15.0 mmol/L Sodium 100 200 mmol/L Total Protein 3.0 12.0 g/DL Triglyceride 10 1000 mg/Dl Uric Acid 0.5 12 mg/DL Blood Urea Nitrogen Modular 1.0 150 mg/DL Glucose Modular 10 600 mg/DL Phosphorus- Modular 1.0 12.0 mg/Dl Ammonia 9 1000 mol/L Carbon Dioxide 5 50 mmol/L Ethyl Alcohol 5 600 mg/DL Total Iron 5 500 gl/DL Alanine Aminotransferaste 5 400 U/L Alkaline Phosphatase 5 1000 U/L Amylase 5 1,200 U/L Aspartate Aminotransferase 5 400 U/L Creatine Kinase 5 1,200 U/L Gamma-Glutamyltransferase 5 750 U/L Lactate Dehydrogenase 5 750 U/L Lipase 10 200 U/L Direct Bilirubin 0.1 10 mg/DL Total Bilirubin 0.1 30 mg/DL Urine Uric Acid 5-100 mg/DL Urine Chloride 15 300 mmol/L Urine Ethyl Alcohol 5 600 mg/DL Urine Glucose 0 700 mg/DL Urine Potassium 2 300 mmol/L Urine Sodium 10 300 mmol/L Urine Urea Nitrogen 50 1,000 mg/DL Urine Calcium 2 30 mg/DL Urine Creatinine 10 400 mg/DL Urine Magnesium 1 70 mg/DL Urine Phosphorus 10 120 mg/DL Urine Amylase 5 1,200 U/L Urine Micro-Albumin 2 300 mg/L High Density Lipoprotein 5 135 mg/Dl Low Density Lipoprotein 10 550 mg/DL Acetaminophen 10 300 g/mL Amikacin 1.5 - 50 g/Ml Carbmazepine 2 20 g/mL Digoxin 0.2 4.5 g/Ml Gentamicin 0.5 12 g/mL Lidocaine 1 10 g/Ml n-Acetylprocainamide 1 16 g/ML Phenobarbital 5 80 g/Ml Phenytoin 2.5 40 g/mL Primidone 2.5 20 g/mL Procainamide 1 12 g/mL Quinidine 0.5 8 g/mL Salicylate 4 100 g/mL Theophylline 2 40 g/mL Tobramycin 0.5 12 g/mL Vaporice Acid 10 150 g/mL Vancomycin 3.5 40 g/mL Creatine Kinase-MB 0 300 ng/mL Myoglobin 0 4,000 ng/mL Brain Natriueretic Peptide 1 5,000 pg/ML HS-CRP 0.02 6 mg/DL Troponin I 0.01 75 ng/ML FREE T4 0.15 6.0 ng/DL Cortisonl 0.4 60 g/DL Thyroid Stimulating Hormone 0.01 100 IU/ML Thyroxine (Tot T4) 0.5 30 g/DL Triiodothyronine (Tot T3) 0.1 8.0 ng/ML 6. Delivery. Delivery of kits will be to the Laboratory, 400 Veterans Ave, Biloxi, MS 39531. Individual kits will then be distributed to the labs located at Mobile, Pensacola, Eglin, and Panama City CBOCs.
Web Link
FBO.gov Permalink
File Name: 36C25618U0450 36C25618U0450.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4589687&FileName=36C25618U0450-000.docx)
Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4589687&FileName=36C25618U0450-000.docx

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Place of Performance
Zip Code: 39531
SN05088985-W 20180915/180913231746-3bb6a6115ec283b13f14535e7d3eb73d (fbodaily.com)
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