SOLICITATION NOTICE
65 -- Indefinite Delivery Indefinite Quantity (IDIQ) contract for reagents consumables, controls, calibrators, and parts performed on the ADVIA 120 Hematology analyzer and on the Sysmex CA-1500 Coagulation analyzer.
- Notice Date
- 5/7/2013
- Notice Type
- Presolicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-13-T-0193
- Response Due
- 6/17/2013
- Archive Date
- 7/6/2013
- Point of Contact
- Colleen Bowers, 301-619-9599
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(colleen.m.bowers3.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- SUBJECT: Reagents consumables, controls, calibrators, and parts to enable and support the laboratory testing that will be performed on the ADVIA 120 Hematology analyzer and on the Sysmex CA-1500 Coagulation analyzer. SOLICITATION NUMBER: W81XWH-13-T-0193 CLOSING DATE: Approximately One Month from the date the solicitation is issued. CONTACT POINT: Colleen Bowers, Contract Specialist, 301-619-9599 or email at colleen.m.bowers3.civ@mail.mil. DESCRIPTION: This synopsis is not a request for quotes or proposals. This is a pre-solicitation notice that a solicitation has been scheduled to be released via FedBizOps (www.fbo.gov) to the vendor community on or about, May 15, 2013, and will only be available until June 17, 2013. Specifications of the requirement shall be provided in solicitation W81XWH-13-T-0193. The United States Army Medical Research Acquisition Activity (USAMRAA) has a requirement in support of the U.S, Army Medical Research Institute of Infectious Diseases (USAMRIID) located at Fort Detrick, Maryland. This requirement will be for a Brand Name or Equal reagents, consumables, controls, calibrators, and parts to enable and support the laboratory testing that will be performed on the ADVIA 120 Hematology analyzer and on the Sysmex CA-1500 Coagulation analyzer. This will be an Indefinite Delivery Indefinite Quantity (IDIQ) contract. The Period of Performance for this contract will be a twelve month base year with four twelve month options years. This is a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2001-27. Set Aside Status: This is an Unrestricted Competition. The North American Industry Classification System (NAICS) code is 334516 and the size standard is 500 employees. Quantities and prices are annual estimates. They are dependent on actual funding requirements, and the government is not obligated to purchase. Vendor shall provide products with a shelf life no shorter than six months from the date of the delivery. Under this contract, the customer places an order as required, and the vendor delivers as early as the next business day but no later than 5 business days. This award is for the appropriate reagents, consumables, controls, calibrators, and parts on an as-needed basis. Mission: The mission is to provide clinical laboratory data used to determine medical qualifications and safety of subjects participating in important vaccine, drug and disease characterization studies. The acquisition is needed to procure the appropriate reagents, consumables, controls, calibrators, and parts to enable and support the laboratory testing that will be performed on the ADVIA 120 Hematology analyzer and on the Sysmex CA-1500 Coagulation analyzer. Statement of Need: Complete Blood Counts (CBC) and the Sysmex CA-1500 reagents, consumables, controls, calibrators, and parts will be used to perform Coagulation studies, i.e., Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen (FBG), D-Dimer (DDi), Activated Protein C (APC), Protein C (ProC), Thrombin Time (TT) and Antithrombin III (AT3). According to the warranty and terms of the agreement, the use of the quote mark ADVIA 120 Hematology Analyzers quote mark and/or quote mark Sysmex CA-1500 Coagulation Analyzers quote mark require Siemens Healthcare Diagnostics products (brand name or equal). The Minimum Essential Characteristics for this requirement are the following: ProductHEMATOLOGY MISSION ESSENTIAL CAPABILITIES (MECs) GeneralThe following laboratory reagents, consumables, controls, and/or parts are needed to process samples at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) in support of the Medical Countermeasure Test and Evaluation mission and they must be compatible with our new ADVIA 120 Hematology Analyzers (brand name or equal to) ADVIA AutoRetic 4 Pak (PN T01-3622-54)Liquid diagnostic agent with a light blue color, bland odor, pH of 7.5, relative density of 1 and VOC of 0.38 % (w/w), utilized for Reticulocyte cell analysis and determination. It must be compatible with the ADVIA 120 Hematology Analyzer and its surfactant and cationic dye two part reaction methodology. ADVIA CBC Timepac (PN T01-3620-52)Colorless to off-white liquid diagnostic agents comprised of 4 reagents; DEFOAMER, Red Blood Cell & Platelets (RBC/PLT), Hemoglobin (HGB), and Basophil (BASO) utilized for RBC, PLT, HGB and BASO analysis and determination. It must be compatible with the sphering methodology of the RBC/PLT and the HGB/BASO lysing agents on the ADVIA 120 Hematology Analyzer. ADVIA DIFF Timepac (PN T01-3621-52)Colorless to yellow liquid diagnostic agents comprised of 4 Peroxidase reagents; PEROX 1, PEROX 2, PEROX 3, and PEROX SHEATH utilized for Noise, Nucleated Red Blood Cells (NRBCs), PLT Clumps, Lymphocytes & Basophils, Large Unstained Cells, Monocytes, Neutrophils, and Eosinophils cell population calculation. It must be compatible with ADVIA 120 Hematology Analyzer Perox methodology. ADVIA Defoamer (PN T01-3625-54)Off-white, odorless, liquid diagnostic agent with a Ph of 5-8, a relative density of 1, and a VOC of 0% (w/w) comprised of 1 % stearic acid, and monoester with glycerol. Utilized for RBC, PLT, HGB analysis and determination. It must be compatible with the sphering methodology of the RBC/PLT and the HGB lysing agents on the ADVIA 120 Hematology Analyzer. ADVIA EZ KLEEN (PN T01-3624-54)Colorless to light yellow liquid diagnostic agent with a bland odor, a relative density of 1.118, and a VOC of 12% (w/w), comprised of 12 % 2-(2-ethoxyethoxy) ethanol. Utilized for ADVIA 120 Hematology Analyzer preventive maintenance washes and it must be compatible with such. ADVIA Sheath Rinse 10L (PN T01-3664-01)Colorless, odorless, liquid diagnostic agent with a pH of 7.3, a relative density of 1 and VOC of 0.0025 % (w/w), comprised of a 3% reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7] and 2-methyl-2H-isothiazol-3-one [EC no. 220-239-6] (3:1). Utilized for HGB analysis and determination and it encase the sample stream as fluids pass through the ADVIA 120 flowcell. It must be compatible with ADVIA 120 Hematology Analyzer. Filter, Clot (PN 113-3719-01)White disk; located near sampling area; used to prevent clots from entering the instrument; for use w/h-2, h-1, h-1e, h-1 jr hematology analyzers like our ADVIA 120 Hematology Analyzer so it must be compatible with such. Filter, Perox Sheath (PN 664-0829-01)Filter, Perox Sheath, plastic housing containing a 0.45 um pore size filter, used to prevent particulates from entering the ADVIA 120 Hematology analyzer and it must be compatible with such. Filter, RBC Baso Sheath (PN 518-3148-06)Filter, Sheath, RBC, Baso, plastic housing containing a 0.22 um pore size filter, used to prevent particulates from entering the ADVIA 120 Hematology analyzer and it must be compatible with such. Manual Open Tube Sample Probe (PN 113-B646-01)Probe, sample, mots, plastic tubing, 13 cm long, replacement sample probe for the manual open tube sampler on the ADVIA 120 Hematology analyzer and it must be compatible with such. Needle, Automated Sampler (PN 113-3301-03)Replacement Needle assay for the automated sampler of the Advia 120 Hematology analyzer and it must be compatible with such. OptiPOINT Calibrator (PN T03-3682-54)Brown, odorless liquid diagnostic agent with a pH of 8.5, a relative density of 1, and a VOC of 0.11 % (w/w) utilized on calibration procedures for the ADVIA 120 Hematology Analyzer so it must be compatible with such. Plunger Repl. Kit (1000 uL) (PN 067-B506-02)Plunger, 1000 ul, Teflon tipped metal, replacement plunger used in the syringe on the ADVIA 120 Hematology Analyzer so it must be compatible with such. Plunger Repl. Kit (50 uL) (PN 067-B506-01)Plunger, 50 ul, Teflon tipped metal, replacement plunger used in the syringe on the ADVIA 120 Hematology Analyzer so it must be compatible with such. SETpoint Calibrator (PN T03-3685-52)Amber liquid diagnostic agent with a bland odor, a pH of 7, a relative density of 1, and VOC 0% (w/w), comprised of 0.04 % of Neomycin, sulfate (salt). Utilized on calibration procedures for the ADVIA 120 Hematology Analyzer so it must be compatible with such. TESTpoint 3*in*1 Abnormal 1(low) (PN T03-4417-54)Amber liquid diagnostic agent with a bland odor, a pH of 7.2, a relative density of 1.05, and VOC of 0 % (w/w), comprised of 0.04 % of Neomycin, sulfate (salt). Utilized for Quality Control procedures on the ADVIA 120 Hematology Analyzer so it must be compatible with such. TESTpoint 3*in*1 Abnormal 2(high) (PN T03-4418-54)Amber liquid diagnostic agent with a bland odor, a pH of 7.2, a relative density of 1.05, and VOC of 0 % (w/w), comprised of 0.04 % of Neomycin, sulfate (salt). Utilized for Quality Control procedures on the ADVIA 120 Hematology Analyzer so it must be compatible with such. TESTpoint 3*in*1 Normal (PN T03-4416-54)Amber liquid diagnostic agent with a bland odor, a pH of 7.2, a relative density of 1.1, and VOC of 0 % (w/w), comprised of 0.04 % of Neomycin, sulfate (salt). Utilized for Quality Control procedures on the ADVIA 120 Hematology Analyzer so it must be compatible with such. Vacushield (PN 518-3146-01)Vacushield, plastic housing containing a filter with two outlets on either end, used to prevent waste from entering and damaging the vacuum pump on the ADVIA 120 Hematology Analyzer so it must be compatible with such. Syringe assemblies, 50 ul (PN 067-0919-01)Syringe, assembly, 50 ul, glass with Teflon tip plunger, replacement syringe used on the ADVIA 120 Hematology Analyzer so it must be compatible with such. Syringe assemblies, 1000 ul (PN 067-0919-02)Syringe, assembly, 1000 ul, glass with Teflon tip plunger, replacement syringe used on the ADVIA 120 Hematology Analyzer so it must be compatible with such. ProductCOAGULATION MISSION ESSENTIAL CAPABILITY (MEC) GeneralThe following laboratory reagents, consumables, controls, and/or parts are needed to process samples at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) in support of Medical Countermeasure Test and Evaluation and its mission and they must be compatible with our new Sysmex CA-1500 Coagulation Analyzers (brand name or equal to) Calcium Chloride.025M - 10x15mL (PN ORHO37)Calcium Chloride Solution 0.02 utilized in coagulation studies on our new Sysmex CA-1500 Coagulation Analyzers and it must be compatible with such. Factor V Leiden (PN OQYI11)White yellowish solid diagnostic agent with a VOC of 0 % (w/w) comprised of less than 0.1 % sodium azide. Utilized for screening of resistance to Activated Protein C (APC) in plasma from individuals with Factor V (Leiden) defect on the Sysmex CA-1500 Coagulation analyzer and it must be compatible with such. INNOVANCE Antithrombin lg (PN OPFH09)Chromogenic assay for the automatic quantification of functionally active antithrombin in citrated plasma suitable for diagnosis of congenital or acquired antithrombin deficiencies associated with a high risk of thrombosis to be used on the Sysmex CA-1500 Coagulation System. Comprised of approx. 1,000 IU/L human FXa, salts, stabilizers, bovine serum albumin, approx. 1,500 IU/L sodium glutamate, aprotinin, heparin and hirudin in Tris/HCl, pH 8.0; ready to use with the following preservatives: 5-chloro-2-methyl-2H-isothiazol-3-one, and 2-methyl-2H-iso-thiazol-3-one with a stability of 8 hours when stored at +15 to +25 C. INNOVANCE D-Dimer (300 Tests) (PN OPBP11)For the quantitative determination of cross-linked fibrin degradation products (D-dimers) in human plasma and is specific for use on the Sysmex CA-1500 Coagulation System. The INNOVANCE D-Dimer assay is intended for use in conjunction with a non-high clinical pre-test probability (PTP) assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE). Innovin - 10x10 (PN B4212-50)Purified recombinant human tissue factor produced in E. coli, combined with synthetic phospholipids (thromboplastin)1, calcium, buffers and stabilizers. The reagent initiates clotting via the extrinsic and common pathways in a global screening test, the prothrombin time (PT). For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma and is specific for use on the Sysmex CA-1500 Coagulation System. Test Thrombin (BFA) - 10x5 (PN OWHM13)Intended for the determination of thrombin time in citrated plasma, suitable for in-vitro monitoring of fibrinolytic therapy, screening for disorders of fibrin formation, in suspected cases of severe fibrinogen deficiency states, and for differentiation between heparin-induced prolongation of the thrombin time and disorders of fibrinogen formation for use on the Sysmex CA-1500 Coagulation System. Thrombin Reagent - 10x5 (PN B4233-27)Lyophilized bovine thrombin preparation (approx. 100 IU/mL) with stabilizers and buffers, can be used up to the expiration date indicated on the label if stored unopened at +2 to +8 C with a stability after reconstitution of 5 days at +2 to +8 C (closed vial) and 8 hours at +15 to +25 C (closed vial). For use in the quantitative determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies, specific for use on the Sysmex CA-1500 Coagulation System. Actin FSL - 10x10 (PN B4219-2)Liquid purified soy phosphatides and rabbit brain phosphatides in 1.0 x 10-4 M ellagic acid with added buffer, stabilizers, preservative, and plasma activator. An activated partial thromboplastin reagent with increased sensitivity to lupus-like inhibitors for use in the determination of the activated partial thromboplastin time (APTT) and related coagulation procedures. Can be used manually or on automated coagulation analyzers like our Sysmex CA-1500 Coagulation System so it must be compatible with such. Berichrom Protein C 4x5 mL (PN OUVV17)Extract from the venom of Agkistrodon contortrix ( 0.6 U/mL), stabilized and lyophilized for in-vitro quantitative determination of functionally active protein C using a chromogenic substrate as an aid in the diagnosis of inherited and acquired deficiencies. Can be used manually or on automated coagulation analyzers like our Sysmex CA-1500 Coagulation System so it must be compatible with such. CA Clean II, 45ml (PN 10708787)1X45 ml CA Clean II reagent solution specific for coagulation studies on the Sysmex CA-1500 Coagulation System and it must be compatible with such. Control Plasma N - 10 x 1mL (PN ORKE45)Pooled plasma collected from ostensibly healthy blood donors stabilized with HEPES buffer solution (12 g/L) and lyophilized, supplied in siliconized vials to prevent contact activation of the coagulation system with no preservatives. Used to monitor the in-vitro performance of the following parameters in the normal range: 1. Prothrombin time (PT) 2. Activated partial thromboplastin time (APTT) 3. Thrombin time (TT) 4. Batroxobin time 5. Fibrinogen 6. Coagulation factors II, V, VII, VIII, IX, X, XI, XII, and vWF 7. Inhibitors: Antithrombin III, protein C, protein S, 2-antiplasmin 8. Plasminogen 9. Lupus anticoagulants 10. Factor V Leiden Can be used manually or on automated coagulation analyzers like our Sysmex CA-1500 Coagulation System so it must be compatible with such. Stored unopened at 2 to 8 C and use by the expiration date given on the label with a stability after reconstitution of 4 hours at 15 to 25 C and 4 weeks at 20 C. Control Plasma P - 10 x 1mL (PN OUPZ19)Pooled plasma collected from ostensibly healthy blood donors adjusted to define factor concentrations and stabilized with HEPES buffer solution (12 g/L) and lyophilized, supplied in siliconized vials to prevent contact activation of the coagulation system with no preservatives. Used to monitor the in-vitro performance of the following parameters in the normal range: 1. Prothrombin time (PT) 2. Activated partial thromboplastin time (APTT) 3. Fibrinogen (Clauss method) 4. Coagulation factors II, V, VII, VIII, IX, X, XI, XII, and vWF 5. Inhibitors: Antithrombin III, protein C, protein S, 2-antiplasmin 6. Plasminogen Can be used manually or on automated coagulation analyzers like our Sysmex CA-1500 Coagulation System so it must be compatible with such. Stored unopened at 2 to 8 C and use by the expiration date given on the label with a stability after reconstitution of 4 hours at 15 to 25 C and 4 weeks at 20 C. INNOVANCE D-Dimer Ctls (PN OPDY09)Assayed, normal and pathological level, intralaboratory lyophilized human plasma based products containing D-dimer preserved with 5-chloro-2-methyl-4-isothiazol-3-one and 2-methyl-4-isothiazol-3-one ( less than 1 mg/L), and sodium azide ( less than 1 g/L) for assessment of precision and analytical bias in the quantitative determination of D-dimer on the Sysmex CA-1500 Coagulation System so it must be compatible with such. Owren's Buffer 10 x 15mL (PN B4234-25)2.84 x 10-2 M sodium barbital in 1.25 x 10-1 M sodium chloride; pH 7.35 0.1, specifically prepared for in-vitro diagnostic coagulation studies on the Sysmex CA-1500 Coagulation System so it must be compatible with such. Stored unopened at +2 to +8 C and use by the expiration date given on the label. Once opened, stable for 8 weeks at +2 to +8 C. Pro - C Control (PN OQKE19)Assayed control used to monitor the n-vitro performance of Factor V Leiden assay in the pathological range on the Sysmex CA-1500 Coagulation System so it must be compatible with such. Comprised of pooled plasma from selected healthy donors, adjusted to a defined sensitivity value by adding rabbit plasma, stabilized with HEPES buffer solution and lyophilized with no preservatives. Stored unopened at +2 C to +8 C and use by the expiration date given on the label with a stability after reconstitution of 4 hours at +15 C to +25 C and 4 weeks at -20 C. Push Vials (PN 541-1352-1)Replacement push vials for specific for coagulation studies on the Sysmex CA-1500 Coagulation System and it must be compatible with such. Reaction Tubes SU-40 for CA-500/1000/5000/1500/7000 (PN 904-0721-9)Replacement reaction tubes specific for coagulation studies on the Sysmex CA-1500 Coagulation System and it must be compatible with such. Sample Plates (2500 wells/pk) (PN B4263-1)SAP-400A replacement sample plates specific for coagulation studies on the Sysmex CA-1500 Coagulation System and it must be compatible with such. Standard Human Plasma - 10 x 1 mL (PN ORKL17)Pooled citrated plasma collected from selected healthy blood donors, stabilized with HEPES buffer solution (12 g/L) and lyophilized, supplied in siliconized vials to avoid contact activation of the coagulation system, contains no preservative. Used for the in-vitro calibration of the below coagulation and fibrinolysis tests on the Sysmex CA-1500 Coagulation System so it must be compatible with such: 1. Prothrombin time (PT) 2. Fibrinogen (Clauss method) 3. Coagulation factors II, V, VII, VIII, IX, X, XI, XII and VWF 4. Inhibitors: Antithrombin III, protein C, protein S, 2-antiplasmin 5. Plasminogen Stored unopened at 2 to 8 C and use by the expiry date given on the label with a stability after reconstitution of 4 hours at 15 to 25 C and 4 weeks at 20 C. 4ml Conical Cups-Sysmex (PN 424-1160-8)4 ml replacement conical cups specific for coagulation studies on the Sysmex CA-1500 Coagulation System and it must be compatible with such. Abnormal Fibrinogen Control 10 x 1mL (PN B4233-22)Lyophilized control preparation derived from human plasma, stabilizers (bovine serum albumin) and buffers, used to assess in-vitro accuracy and precision of Dade Fibrinogen Determination Reagents in the low range on the Sysmex CA-1500 Coagulation System so it must be compatible with such. Expiration date must be indicated on the label if stored unopened at 2 to 8 C with a stability after reconstitution of 16 hours at 2 to 8 C. Bottle Assy #12, 50ml plastic (PN AD307579)Replacement bottle assy #12 specific for coagulation studies on the Sysmex CA-1500 Coagulation System and it must be compatible with such. CA Cal S (PN GCL-100A)CA Cal S reagent solution specific for coagulation studies on the Sysmex CA-1500 Coagulation System and it must be compatible with such. CA Clean I for CA-500/6000/1500/7000 (PN 964-0631-3)Detergent product used for cleansing the pipets used on the Sysmex CA-1500 Coagulation System composed of 1.0% sodium hypochlorite. Stored in a dark place from 2 to 8 C (Do not freeze). Expiration date must be indicated on both the box and the bottle label. The product must be available for 1 month after unsealing. CA Clean II 1 x500ml (PN 964-0611-9)1X500 ml CA Clean II reagent solution specific for coagulation studies on the Sysmex CA-1500 Coagulation System and it must be compatible with such. R.0003548.6 (T&E) Conducting business with the Government: In order for Contractors to conduct business with the Department of Defense, the Contractor must provide registration information to the System for Award Management (SAM). All Offerors must be registered prior to receiving an award. Registration instructions may be obtained, and online registration may be accomplished at www.sam.gov. By submission of a quote, the Contractor acknowledges the requirement to be registered in the SAM database prior to award, during performance and through final payment of any contract resulting from the solicitation. Contractor must accept payment through Wide Area Workflow (WAWF) and Government Purchase Card (GPC). When available, the solicitation documents for this requirement will be accessible via https://acquisition.army.mil/asfi/ or Federal Business Opportunities at www.fbo.gov. No CDs or hard copies will be available. Offerors are responsible for checking the referenced page for any update(s) to the Notice. The Government is not responsible for any loss of internet connectivity or for an Offeror's inability to access the documents posted at the referenced website.
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- Place of Performance
- Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD
- Zip Code: 21702-5014
- Zip Code: 21702-5014
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