65--Signify ER Drug Screen kits

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. Combined Synopsis/Solicitation W81K00-10-T-0024 is issued as a request for quotation (RFQ). This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-37. This acquisition is solicited as unrestriced under NAICS 325413. All responsible sources may submit a quotation which shall be considered by the agency. The requirements of this solicitation is for Signify ER drug screen kits for Darnall Army Community Hospital, Fort Hood TX. Required delivery FOB Destination, base year and 4 option years for period 1 February 2010 through 30 September 2014. Line item 0001: Base year, 1FEB10 through 30SEP10, Signify ER Drug screen, Cat# 01P48-25, Inverness Medical or equal, 144 kits Line item 0002: First Option period, 1OCT10 through 30SEP11, Signify ER Drug screen, Cat# 01P48-25, Inverness Medical or equal, 216 kits Line item 0003: Second Option period, 1OCT11 through 30SEP12, Signify ER Drug screen, Cat# 01P48-25, Inverness Medical or equal, 216 kits Line item 0004: Third Option period, 1OCT12 through 30SEP13, Signify ER Drug screen, Cat# 01P48-25, Inverness Medical or equal, 216 kits Line item 0005: Fourth Option period, 1OCT13 through 30SEP14, Signify ER Drug screen, Cat# 01P48-25, Inverness Medical or equal, 216 kits Salient characteristics of the Signify ER Drug screen: FUNCTIONAL CHARACTERISTICS INTENDED USE The Signify ER Drug Screen Test is a rapid, one step screening test for the simultaneous, qualitative detection of multiple drugs and drug metabolites in human urine with on-board procedural controls. The Signify ER Drug Screen Test is a lateral flow chromatographic immunoassay for the qualitative detection of multiple drugs and drug metabolites in urine for any combination of the following drugs: Amphetamine, Barbiturates, Bennzodiazepines , Cocaine, Marijuana, Methylenedioxymethamphetamine (MDMA) 3,4-Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants. The Signify ER Drug Screen Test is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes monoclonal antibodies to selectively detect elevated levels of specific drugs in urine. The Signify ER Drug Screen Test is for professional, in-vitro use only and is CLIA Waived. The Signify ER Drug Screen Test is an immunoassay based on the principle of competitive binding. Drugs, which may be present in the urine sample, compete against their respective drug conjugate for binding sites on their specific antibody. During testing, a urine sample migrates upward by capillary action. A drug, if present in the urine sample below its cut-off concentration, will not saturate the binding sites of its specific antibody. The antibody will then react with the drug-protein conjugate and a visible colored line will show up in the test line region of the specific drug strip. The presence of drug above the cut-off concentration will saturate all the binding sites of the antibody. Therefore, the colored line will not form in the test line region. A drug-positive urine sample will not generate a colored line in the specific test line region of the strip because of drug competition, while a drug-negative urine sample will generate a line in the test line region because of the absence of drug competition. Each test line contains anti-drug mouse monoclonal antibody and corresponding drug-protein conjugates. Internal Procedural Controls To serve as an internal procedural control, the test includes both a Positive and Negative Control Region. An antigen-BSA conjugate is striped in the Positive Control Region with a water-soluble blue dye as a visual marker. The positive control antigen is included in the label pad. The migration of the sample will make this blue line disappear. Therefore, the absence of a line in the Positive Control Region serves as an internal positive procedural control. The presence of a blue line in the Positive Control Region could indicate that an immunochemical reaction did not occur and the results should be considered invalid. A line in the Negative Control Region confirms that proper volume of sample has been added and membrane wicking has occurred. There must be a line present in the Negative Control Region for the test results to be valid. The absence of a Positive Control line confirms the internal procedural control and, along with the appearance of the Negative Control line, the validity of the test results. A line should always appear in the Negative Control Region and no line should appear in the Positive Control Region. Control line contains goat anti-rabbit IgG polyclonal antibodies and rabbit IgG. IONS PERFORMANCE CHARACTERISTICS TEST CALIBRATOR AND CUTOFF: TEST CALIBRATOR CUTOFF Amphetamine d-Amphetamine 1,000 ng/mL Barbiturates Secobarbital 300 ng/mL Benzodiazepines Oxazepam 300 ng/mL Cocaine Benzoylecgonine 300 ng/mL Marijuana 11-nor-9-THC-9 COOH 50 ng/mL MDMA 3,4-Methylenedioxymethamphetamine 500 ng/mL Opiates Morphine 300 ng/mL Oxycodone Oxycodone 100 ng/mL Phencyclidine Phencyclidine 25 ng/mL Propoxyphene Propoxyphene 300 ng/mL Tricyclic Antidepressants Nortriptyline 1,000 ng/Ml EFFECT OF SPECIFIC GRAVITY: Effect of Urinary Specific Gravity Urine samples of low, normal and high specific gravity (1.004-1.034) were spiked with drugs at 50% cut-off levels and analyzed. The results demonstrate that varying ranges of urinary specific gravity do not affect the test results of the Signify ER Drug Screen Test. EFFECT OF URINARY PH: Urine samples with pH ranges from 5-9 in 1 pH unit increments were spiked with drugs at 50% cut-off levels and analyzed. The results demonstrate that varying ranges of pH (5-9) do not interfere with the performance of the of the Signify ER Drug Screen Test. ACCURACY: TEST AGREEMENT REFERENCE Amphetamine 98% GC/MS Barbiturates 99% GC/MS Benzodiazepines greater than 99% GC/MS Cocaine 96% GC/MS Marijuana 95% GC/MS MDMA 99% GC/MS Opiates 98% GC/MS Oxycodone 99% GC/MS Phencyclidine 99% GC/MS Propoxyphene greater than 99% GC/MS Tricyclic Antidepressants 94% HPLC ANALYTICAL SENSITIVITY: Greater than 99% agreement with expected results was found at 50% cut-off for each drug tested with a 95% confidence interval. EFFECT OF CROSS REACTIVITY: Non-Cross Reacting Compounds at 100 ug/mL: Acetaminophen l-Isoproterenol Acetophenetidin Isoxsuprine Acetone Kanamycin N-Acetylprocainamide Ketamine Acetylsalicylic acid Ketoprofen Albumin Labetalol Albuterol Lidocaine Aminopyrine Lindane Amoxapine Lithium Amoxicillin Loperamide Ampicillin Meperidine Apomorphine Mephentermine l-Ascorbic acid Meprobamate Aspartame Methadone Atropine d-Methamphetamine Baclofen Methaqualone Benzilic acid Methoxyphenamine Benzocaine Methylphenidate Benzoic acid Methyprylon Benzphetamine Parent Compound Metoprolol Bilirubin Metronidazole d/l-Brompheniramine Nalidixic acid Buprenorphine Nalorphine Buspirone Naloxone Caffeine Naltrexone -Naphthaleneacetic acid Cannabidiol Carisoprodol Naproxen Chloralhydrate Niacinamide Chloramphenicol Nifedipine Chloroquine Nimesulide Chlorothiazide Norethindrone d/l-Chlorpheniramine Norfluoxetine Chlorpromazine Noscapine Chlorpropamide d/l-Octopamine Chlorprothixene Orphenadrine Cholesterol Oxalic acid Cimetidine Oxolinic acid Clonidine Oxymetazoline Clozapine Papaverine Cortisone Pemoline l-Cotinine Penicillin-G Creatinine Pentazocine Deoxycorticosterone Phenelzine R(-)Deprenyl Pheniramine Dextromethorphan Phenothiazine Diclofenac Dicyclomine Trans-2-phenylcyclopropylamine l-Phenylephrine Diflunisal -Phenylethylamine Digitoxin Phenylpropanolamine Digoxin d/l-Norephedrine () Phenylpropanolamine (+)-cis-Diltiazem Prednisolone Dimenhydrinate Prednisone 4-Dimethylaminoantipyrine Procaine 5--pregnane-3, 17, 21-triol-20-one Diphenhydramine 5,5-Diphenylhydantoin d/l-Propranolol Disopyramide d-Pseudoephedrine Dopamine Quinacrine Doxylamine Quinine Droperidol Quindine Ecgonine methyl ester Ranitidine EDDP Riboflavin Efavirenz Parent Compound Salbutamol EMDP Salicylic acid Ephedrine Serotonin l-Ephedrine Sodium chloride [1R,2S](-)Ephedrine Spironolactone l-Epinephrine Sulfamethazine ()Epinephrine Sulfamethoxazole Erythromycin Sulfisoxazole -Estradiol Sulindac Estrone-3-sulfate Tetracycline Ethanol (Ethyl alcohol) Tetrahydrocortisone 3-acetate Ethyl-p-aminobenzoate Tetrahydrozoline Etodolac Theophylline Famprofazone Thiamine Fenfluramine Thioridazine Fenoprofen Thiothixene Fentanyl l-Thyroxine Fluoxetine Tobramycin Furosemide Tolbutamide Gentamicin Tramadol Gentisic acid Trazodone d(+)Glucose Trimethobenzamide Guaiacol glyceryl ether Triamterene Haloperidol Trifluoperazine Hemoglobin Trimethoprim Hydralazine Tryptamine Hydrochlorothiazide d/l-Tryptophan Hydrocortisone Tyramine o-Hydroxyhippuric acid d/l-Tyrosine p-Hydroxymethamphetamine Uric acid p-Hydroxynorephedrine Verapamil Hydroxyzine Zomepirac Ibuprofen Zopiclone Indomethacin Iproniazid Insulin The following FAR and DFARS provisions and clauses apply to this solicitation: 52.212-4 [Contract Terms and Conditions Commercial Items] Addendum 52.212-4; (u) The non-FAR Part 12 discretionary FAR, DFARS, AFARS, and LOCAL clauses included herein are incorporated into this contract either by reference or in full text. If incorporated by reference, see clause 52.252-2 for locations where full text can be found. 52.203-6 [Restrictions on subcontractor sales to the Government]; 52.211-6 [Brand Name or Equal]; 52.219-1 [Small Business Program Representations]; 52.219-6 [Notice of total small business set-aside]; 52.219-14 [Limitations on subcontracting]; 52.219-28 [Post-award small business program representation]; 52.222-21 [Prohibition of segregated facilities]; 52.222-26 [Equal opportunity]; 52.222-35 [Equal opportunity for special disabled veterans, veterans of the Vietnam era, and other eligible veterans]; 52.222-36 [Affirmative action for workers with disabilities]; 52.222-50 [Combating trafficking in persons]; 52.223-3 [Hazardous material identification and material safety data]; 52.225-13 [Restrictions on certain foreign purchases]; 52.232-17 [Interest]; 52.232-23 [Assignment of claims]; 52.233-3 [Protest after award]; 52.233-4 [Applicable law for breach of contract claim]; 52.237-2 [Protection of Government Buildings; Equipment, and Vegetation]; 52.242-13 [Bankruptcy]; 252.203-7000 [Requirements relating to compensation of former DOD officials]; 252.203-7002 [Requirement to inform employees of whistleblower rights]; 252.204-7000 [Disclosure of information]; 252.212-7000 [Offeror Representations and Certifications-Commercial Items]; 252.232-7003 [Electronic submission of payment requests and receiving reports]; End Addendum 52.212-4 52.212-5 [Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items](Deviation) 52.212-1 [Instructions to Offerors]; Addendum 52.212-1: Federal Acquisition Regulation (FAR) provision 52.211-6 Brand Name or Equal applies to this acquisition. Vendors shall comply with FAR provision 52.211-6 if submitting other than the brand name products. FAR provisions and clauses can be viewed at Internet address: http://farsite.hill.af.mil/vffar1.htm. Defense Federal Acquisition Regulations Supplement (DFARS) provisions and clauses can be viewed at Internet address: http://www.acq.osd.mil/dpap/dars/dfarspgi/current/index.html All vendors are cautioned that if selected for award, they must be registered with the Central Contractor Registration (CCR) program. The CCR can be accessed at Internet address: www.ccr.gov/. Confirmation of CCR registration will be validated prior issuance of an order. The closing date and time of this solicitation is 21 December 2009, 10:00 a.m. CST. Submit quotations on company letterhead signed by an authorized company representative by the closing date and time. Quotes may be submitted via mail, fax, or e-mail. (mail: Great Plains Regional Contracting Office, Attn: John Roeck, 3851 Roger Brooke Drive, bldg 1103, Fort Sam Houston TX 78234-6200; fax: +1 (555) 000-0000. Paper copies of this solicitation will not be issued and telephone, fax, or email requests for the solicitation will not be accepted. Point of contact: John Roeck, +1 (555) 000-0000; e-mail: contact@example.gov. End of Addendum to 52.212-1 The following is incorporated full text for FAR 52.212-2 [Evaluation-Commercial Items]: Addendum to 52.212-2 a. The Government will award a contract resulting from this solicitation to the responsible contractor whose quote, conforming to the solicitation, is Lowest Priced, Technically Acceptable (LPTA). Award will be on an all or none basis. The following factors will be used to evaluate quotes: Technical acceptability and price. 1. Technical acceptability: If providing an equal item(s), comply with FAR Clause 52.211-6, Brand Name or Equal. Explain how your company will meet the salient characteristics of the items as specified in the solicitation. Prospective contractors shall demonstrate that the items offered complies with the technical requirements described in the salient characteristics by submission of a written capability statement with their offer. 2. Price. 3. Evaluation Process: All quotes will be evaluated on overall technical acceptability. The award decision will be based on the lowest priced technically acceptable quote. 4. Award will be all or none. End Addendum 52.212-2 52.212-3 [Offeror Representations and Certifications-Commercial Items]; 252.212-7000 [Offeror Representations and Certifications-Commercial Items] (end)