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FBO DAILY - FEDBIZOPPS ISSUE OF JULY 12, 2015 FBO #4979
SOLICITATION NOTICE

65 -- Randox test kits (EV3977-DOA CST XX; EV-3619-Oral Fluid Array I)

Notice Date

7/10/2015
 

Notice Type

Justification and Approval (J&A)
 

NAICS

621511 — Medical Laboratories
 

Contracting Office

Court Services and Offender Supervision Agency, D. C. Pre-Trial Services Agency, Finance and Administration, 633 Indiana Avenue, NW, Suite 1120, Washington, District of Columbia, 20004
 

ZIP Code

20004
 

Point of Contact

Diana T. Weiss, Phone: (202) 220-5654, Rachel Dobbs, Phone: 202-220-5657
 

E-Mail Address

diana.weiss@psa.gov, rachel.dobbs@psa.gov
(diana.weiss@psa.gov, rachel.dobbs@psa.gov)
 

Small Business Set-Aside

N/A
 

Award Number

PSA-15-005977
 

Award Date

8/14/2015
 

Description

Pursuant to the requirements of the Competition in Contracting Act (CICA) as implemented by the Federal Acquisition Regulation (FAR) Subpart 6.3 and in accordance with the requirements of FAR 6.301 and 6.303, the justification for the use of the statutory authority cited below is justified by the following facts and rationale. (1) Contracting Activity: This Justification for Other than Full and Open Competition (JOFOC) is issued by: Pretrial Services Agency for the District of Columbia Office of Finance and Administration / Procurement 633 Indian Avenue, NW Washington, DC 20004-2908 (2) Nature and/or description of the action being approved : This requirement is for the acquisition of the Randox Investigator analytical reagents for the detection of drugs of abuse, including Synthetic Cannabinoids and Bath Salt Designer drugs in Urine and Oral Fluid. Synthetic Cannabinoids and Bath Salts pose a serious threat to judicial monitoring and community safety. They present a daunting analytical challenge because until recently, they have been difficult to screen for. These Synthetic Cannabinoids alone are 4 - 100 times more potent than marijuana and individuals turn to using these herbal mixtures to avoid detection by standard drug test. The best method for detecting synthetic cannabinoids is liquid chromatography/tandem mass-spectrometry (LC-MS/MS). However, instrumentation cost can be as high as $500,000.00 and requires highly skilled scientists. Designing assays that detect synthetic cannabinoids is a rapidly moving target for laboratories. To avoid detection, illicit drug makers constantly change the structure of the synthetic cannabinoids used in the herbal incense market. In addition, because commercially available THC immunoassays do not cross-react with synthetic cannabinoids, laboratories usually develop their own mass spectrometry-based assays. Randox produces ELISA, a test that uses polyclonal antibodies targeted toward different chemical moieties of the aminoalkylindole cannabinoids. Reported sensitivities for the assays are <20 ng/mL or better. Preliminary data from the manufacturer shows good cross reactivity with metabolites of several synthetic cannabinoids including emerging synthetic cannabinoids such as UR-144 and XLR-11. •(3) Description of the supplies or services required to meet the agency's needs (including the estimated value) : The supplies and services required to meet the Agency's needs are: Test multiple drugs assays from a single sample aliquot Adulteration check (urine) Test for basic drugs of abuse Test for UR-144 and XLR-11 as well as other DEA scheduled synthetic Cannabinoids •· Test for DEA scheduled Bath Salts •· Test multiple sample types ( oral fluid, urine, blood ) •· Compatible with various oral fluid collection devices •· On-board data analysis •· Extensive QC capabilities •· Internal QC software includ ing Levy Jennings charts •· Multi-point QC rules and auto flagging of outliers •· Connectivity LIMS integrated for convenient reporting •· Security •· Password protected for various user levels •· Full traceability of data Storage facilities •· Store up to 20,000 sample results •· Store up to 500,000 sample test results •· Retrospective Testing •· Retrieve previously unreported tested •· Flexibility •· Multi-format option for results review •· User defined reference ranges •· Fully printable reports FDA approved (4) Statutory authority permitting other than full and open competition: 41 U.S.C. 253(c)(1); FAR 6.302-1 - Only one responsible source and no other supplies or services will satisfy agency requirements. •(5) Demonstration that the contractor's unique qualifications or the nature of the acquisition requires the use of the authority cited: The core technology is the Randox biochip onto which multiple competitive immunoassays are carried out, giving results for multiple drug assays simultaneously. Competitive immunoassays are employed for the Drugs of Abuse arrays, where drug in the specimen and drug labeled with horseradish peroxidase (HRP) directly compete for anti-boding binding sites. The biochip detection system is based on a chemiluminescent signal. This is essentially the emission of light, without heat, as a result of a chemical reaction. An enzyme is used to catalyze the chemical reaction on the biochip and generate the chemiluminescent signal. Increased levels of drugs in a specimen lead to reduced binding of drug-labeled HRP, and thus, a reduction in chemiluminescent signal. The light emitted from the chemiluminescent reaction that takes place is detected and compared to that from a calibration curve using a Charge Coupled Device (CCD) Camera. This CCD Camera simultaneously records the light emission from all the discrete test sites on each biochip on the carrier. Unique imaging software on the analyzers is used to translate the light signal into an analyte concentration. The CCD Camera is made up of a collection of light sensitive diodes, which convert light into electrons to produce an electrical charge. The brighter the light that hits a single diode, the greater the electrical charge that will accumulate at that site. The degree of light emission can therefore be quantified based on the strength of the electrical signal generated. A validated biochip image is then produced, which undergoes image analysis for quantification of the signal output at each DTR. A validated calibration curve is used to determine the concentration of each analyte. This technology allows for the detection of newer forms of synthetic cannabinoids and Bath Salts. In particular, and uniquely, it detects the latest DEA banned Synthetic Cannabinoids UR-144 and XLR-11. Additionally, the Randox platform allows for multiple sample types and minimum sample volume for multiple assay analysis from a single aliquot. No order vendor utilizes this type of technology (Biochip) to perform these types of test. (6) Efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by Subpart 5.2 and, if not, which exception under 5.202 applies: The agency shall post its intent to sole source on the FBO Portal for a minimum of 30 days. (7) Determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable: The contracting officer shall use price and/or cost analysis to determine price reasonableness. (8) Description of the market research conducted (see Part 10) and the results or a statement of the reason market research was not conducted: Research shows that Randox Laboratories is the sole manufacturer and supplier of the Biochip Array Technology based Evidence Investigator analyzer. The associated reagents are exclusively manufactured by Randox and are only commercially available from Randox global. The Pretrial Services Agency's (PSA) Office of Forensic Toxicology Services (OFTS) has found official documentation certifying Randox as sole manufacturer/supplier. PSA's OFTS has also reviewed various Scientific literature: Clinical Chemistry; Journal of Forensic Toxicology, white papers, etc. PSA's OFTS has attended various Scientific meeting presentations and workshops: AAFS, SOFT, AACC, Pittcon PSA's OFTS has also conducted various in-house and industry demonstrations. (9) Other facts supporting the use of other than full and open competition: Randox appears to be able to quickly develop new assays (synthetic cannabinoids) for up and coming drugs. UR-144 and XLR-11 were brought to market relatively fast. (10) Sources that expressed, in writing, an interest in the acquisition: None at this time. (11) Actions the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required: None. The agency does not anticipate the need for subsequent acquisitions. Statement of Work: Randox Biochip Reagents SECTION C. Description/ Specification/ Works Statement for Randox Biochip Reagents •1. Introduction/ Background 1.1 The Pretrial Services Agency for the District of Columbia is an independent federal agency under the Court Services and Offender S upervision Agency. Pretrial Services Agency's Office of Forensic Toxicology Services (OFTS) performs urine drug testing for all defendants, adult and juvenile, in pretrial status, Drug Court, offenders on Probation or Parole, parents charged with abuse or neglect, and other tests as ordered by the courts. The OFTS collects over 360,000 specimens per year and performs an average of 6 tests per specimen. Approximately 3.4 million tests are performed annually. The estimated monthly drug testing volume for Oral Fluid and urines for synthetic drug is approximately is 700 samples per month. Testing will be performed on instrumentation provided by the government. This document provides information necessary to assist in the pr ocurement of a new reagent contract for the OFTS drug testing operation. 1.2 The best method for detecting synthetic cannabinoids is liquid chromatography/ tandem mass spectrometry (LC-MS/MS). However, instrumentation cost can be as high as 500,000 dollars and requires highly skilled scientist. Recently, however, Randox introduced an ELISA test that uses polyclonal antibodies targeted toward different chemical moieties of the aminoalkylindole cannabinoids. Reported sensitivities for the assays are acceptable, and preliminary data from the manufacturer shows good cross reactivity with metabolites of several synthetic cannabinoids including emerging synthetic cannabinoids such as UR-144 and XLR-11. 1.3 Designing assays that detect synthetic cannabinoids is a rapidly moving target for laboratories. To avoid detection, illicit drug makers constantly change the structure of the synthetic cannabinoids used in the herbal incense market. In addition, because commercially available THC immunoassays do not cross-react with synthetic cannabinoids, laboratories usually develop their own mass spectrometry-based assays. 1.4 The core technology is the Randox biochip onto which multiple competitive immunoassays are carried out, giving results for multiple drug assays simultaneously. Competitive immunoassays are employed for the Drugs of Abuse arrays where drug in the specimen and drug labeled with horseradish peroxidase (HRP) directly compete for anti-boding binding sites. The biochip detection system is based on a chemiluminescent signal. This is essentially the emission of light, without heat, as a result of a chemical reaction. 1.5 An enzyme is used to catalyze the chemical reaction on the biochip and generate the chemiluminescent signal. Increased levels of drugs in a specimen lead to reduced binding of drug-labeled HRP and thus a reduction in chemiluminescent signal. The light emitted from the chemiluminescent reaction that takes place is detected and compared to that from a calibration curve using a Charge Coupled Device (CCD) Camera. This CCD Camera simultaneously records the light emission from all the discrete test sites on each biochip on the carrier. 1.6 Unique imaging software on the analyzers is used to translate the light signal into an analyte concentration. The CCD Camera is made up of a collection of light sensitive diodes, which convert light into electrons to produce an electrical charge. The brighter the light that hits a single diode, the greater the electrical charge that will accumulate at that site. 1.7 The degree of light emission can therefore be quantified based on the strength of the electrical signal generated. A validated biochip image is then produced, which undergoes image analysis for quantification of the signal output at each DTR. A validated calibration curve is used to determine the concentration of each analyte. 1.8 This technology allows for the detection of newer forms of synthetic cannabinoids and Bath Salts. In particular and uniquely it detects the latest DEA banned Synthetic Cannabinoids UR-144 and XLR-11. No other immunoassay company has this capability as of yet. It allows for multiple sample types and minimum sample volume for multiple assay analysis from a single aliquot. •2. Objectives 2.1 This action is for the acquisition of the Randox test kits (EV3977-DOA CST XX; EV-3619-Oral Fluid Array I) for the Randox Investigator analytical system. This system is for the detection of drugs of abuse, including Synthetic Cannabinoids and Bath Salt Designer drugs in Urine and Oral Fluid. Synthetic Cannabinoids and Bath Salts pose a serious threat to judicial monitoring and community safety. The oral fluid kits will eventually be used in- house to supplant the external reference laboratory testing. •3. Scope of Work 3.1 Under this contract the Agency expects to conduct drug testing for routine drugs of abuse as well as specialty testing for synthetic cannabinoids, synthetic cathinones (Bath Salts) and other designer drugs by using the Randox Drug of Abuse array (Biochip) system. Total cost must not exceed 60,000 dollars. •4. Period of Performance 4.1 TBD •5. Place of Performance 5.1 90 K Street N.E Washington, D.C. 20004 Reagent Requirements •2.1. Compliance with Food & Drug Administration (FDA) Requirements: I mmunoassay kits are medical devices and must have clearance from Food & Drug Administration (FDA) to be marketed. The registration and listing process specified by the FDA must be followed and the manufacturer must adhere to good manufacturing process (GMP) in the manufacture of these devices. Any mandatory recalls of the kits provided under this contract and any other problems that require notification to the FDA must be resolved as required by the FDA regulations current at the time. The Contractor shall notify the Contracting Officer and Laboratory Director by Certified or overnight mail of any recall of FDA notification within two working days of the event. •2.2. Compliance with Food & Drug Administration (FDA) Requirements: Biochip kits are medical devices and must have clearance from Food & Drug Administration (FDA) to be marketed. The registration and listing process specified by the FDA must be followed and the manufacturer must adhere to good manufacturing process (GMP) in the manufacture of these devices. Any mandatory recalls of the kits provided under this contract and any other problems that require notification to the FDA must be resolved as required by the FDA regulations current at the time. The Contractor shall notify the Contracting Officer and Laboratory Director by Certified or overnight mail of any recall of FDA notification within two working •2.3. Compliance with Food & Drug Administration (FDA) Requirements: I mmunoassay kits are medical devices and must have clearance from Food & Drug Administration (FDA) to be marketed. The registration and listing process specified by the FDA must be followed and the manufacturer must adhere to good manufacturing process (GMP) in the manufacture of these devices. Any mandatory recalls of the kits provided under this contract and any other problems that require notification to the FDA must be resolved as required by the FDA regulations current at the time. The Contractor shall notify the Contracting Officer and Laboratory Director by Certified or overnight mail of any recall of FDA notification within two working days of the event. •2.4. Except as provided herein, the reagent supplied throughout the term of this contract shall be identical to the reagent offered by the contractor and accepted by the Government at the time of the contract award. If, during the course of this contract, the manufacturer wishes to change or improve its reagents, that product modification must be proposed in writing to the Contracting Officer and Laboratory Director for approval prior to its incorporation into the kits to be delivered. The contractor's proposal must include documentation, which demonstrates that the manufacturer has complied with all applicable FDA regulations, including those concerning the filing of a new 510k notice if such action and subsequent FDA clearance are warranted by the nature of the modification. Any re­validation of the modified reagent will be done by the Contractor, at their expense and at a time acceptable to the OFTS •2.5. Reagents must be compatible with the equipment provided by the Government in 5.1. The materials provided must be in volumes and packaging, which are convenient and applicable to the throughput of the OFTS and should not result in the loss or unnecessary disposal of more than 5% of the working volume of reagent. Any individual bottle of reagent, which would be prepared for use at one time, may not include materials for more than 54 tests per kit. •2.6. The reagents must be provided with a product package insert that compiles with all requirements of the FDA and includes data demonstrating specific performance characteristics, such as, accuracy, precision, sensitivity, specificity, cross-reactivity, and safety precautions. The instruction sheet(s) shall include protocols optimized for OFTS operations as represented in these specifications and at cutoffs utilized by the OFTS. The instruction sheet shall include operating parameters and instrumentation settings for use of the reagent on the Contractor's equipment •2.7. The shelf life of any unopened assay kit or component shall be at least 180 days from the date of delivery to OFTS. Once kit container seals are broken and the component opened the shelf life must be at least 30 days. •2.8. Reagents must meet current Substance Abuse & Mental Health Services Administration (SAMSHA), PSA, Department of Transportation (DOT) and Department of Defense (DOD) Standard Drug Testing Panel and Criteria for Reporting Drug Use. •2.9. Salient characteristics for Calibrators and Controls •2.9.1. The Contractor shall provide sufficient calibrator materials for the reagents which must meet the SAMSHA, PSA, DOT, and DOD cutoff at no additional charge to the Government to perform the volume of testing shown. •2. •2.7. •2.8. •2.9. •2.9.2. The Contractor shall provide sufficient control materials for the reagents at approximately 75 and 125 percent of the 25 ng/ml cutoff concentration at no additional charge to the Government to perform the volume of testing shown. •2.9.3. Calibrators and control materials must be available in not less than 5 ml or greater than 25 ml sizes (liquid). •2.9.4. Calibrators and control materials must be available in liquid form whenever available. •2.9.5. Lot numbers must be good for six months from date of receipt. •2.9.6. Calibrators and control materials must have a 30 day expiration of opened or reconstituted products. •2.9.7. Sample types include Blood, Oral Fluid and Urine matrix •2.10. Assay specific requirements •2.10.2. The sensitivity and specificity of the assay should provide sufficient reactivity such that an actual human physiological specimen which contains the cutoff value of a given assay is correlated by GCMS to match the apparent concentration by the immunoassay procedure. •2.10.3. The reagent must provide equivalent or better performance characteristics for the detection of drugs in human urine as the current immunoassay procedure used by OFTS. •2.10.4. The reagent must use a semi-quantitative protocol and demonstrate linearity. •2.10.5. The reagent must be specific for each individual drug assay such that no less than 95% of actual human physiological specimens identified as positive by the current OFTS immunoassay procedure will be identified as positive by the Contractor's reagent. •2.10.6. The reagent must not have more than a 5% false negative rate for actual human physiological specimens identified as positive by the current OFTS immunoassay procedure. •2.10.7. The reagent must not have more than a 5% false positive rate for actual human physiological specimens identified as negative by the current OFTS immunoassay procedure. •2.10.8. Chemical compounds that may reasonably be found in urine resulting from prescription or non-prescription drug use must be tested to characterize antibody specificity. Also, s pecificity testing will include biochemical materials produced normally in the human body (this may be evaluated by testing numbers of specimens of normal human urine ). •2.10.9. Quality Control (QC): the individual test reagents must also maintain reproducibility in QC measurements. The testing reagent must identify as positive 95% or all QC specimens containing the drug at a concentration 125% of the OFTS cutoffs. The assay shall identify as negative by the initial test 95% of the quality control specimens that contain the designated compound at 75% of the OFTS cutoff concentration. •3. Other Requirements •3.1. The Contractor shall supply technical support. Technical support shall be provided in trouble-shooting, method set-up, and method validation. This technical support shall be available by telephone during regular business hours per day, 5 days per week by local or toll-free number at no additional cost to the government. •3.2. The Contractor if needed shall set-up and validates the initial performance of the assay on the equipment provided by the government according to current standards of practice for forensic toxicology laboratories. The Contractor shall provide documentation of these validation studies. •4. Ordering and Delivery of Materials •4.1. The Government agrees to purchase exclusively from the Contractor on a requirements basis all drug testing reagents for the testing of drugs in oral fluid and urine by the OFTS so long as the Contractor is able to meet the re-supply response times shown in 4.3 and other performance standards shown in this statement of work. •4.2. Orders for reagents, calibrators, and control materials shall be placed by the PSA contracting officer or designee. •4.3. The Contractor must be able to deliver, within 48 hours of receipt of an order, reagents, calibrators, and controls for the testing at no additional charge to the government for emergency orders and 72 hours for non-emergency orders. •5. Supporting Information •5.1. The government shall provide appropriate instrumentation for the analysis. Currently the Government uses Randox Investigator clinical chemistry analyzer. •5.2. The government will provide adequate storage facilities for reagents, calibrators, and controls. •5.3. Qualified Government operators shall perform all testing. •6. Deliverables 6.1 The contractor must provide the following items as needed for drug analysis. These include Drugs of Abuse Array I Oral Fluids (EV3619); Drugs of Abuse Array I Oral Fluid Control (EV3649); Drugs of Abuse Array V Urine (EV3977/DOA CST XX) and Drugs of Abuse Array V Urine Controls (EV3978/DOA CST XX). •7. Other Requirements 7.1. The contractor should be able to make customized changes to the Drugs of Abuse kit profiles when requested to accommodate changing drug use pattern. These changes should be at a minimum cost to the Government.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/notices/4af8c6dc91b7d710f69ac39d2234a666)
 

Place of Performance

Address: 90 K Street N.E, Washington, District of Columbia, 20004, United States

Zip Code: 20004
 

Record

SN03793266-W 20150712/150710235303-4af8c6dc91b7d710f69ac39d2234a666 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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