A02_SOURCES_SOUGHT_NOTICE.SYNOPSIS.pdf

PRETRIAL SERVICES AGENCY FOR THE DISTRICT OF COLUMBIA

SYNOPSIS/SOURCES SOUGHT NOTICE

This SYNOPSIS/SOURCES SOUGHT NOTICE IS FOR INFORMATION AND PLANNING PURPOSES ONLY. This notice does not constitute a formal solicitation for quotations and responses to this notice will be treated as information only. No solicitation exists; therefore, do not request a copy of a solicitation. No award will be made as a result of this notice and responses to this notice are not offers.

The Pretrial Services Agency for the District of Columbia (PSA) is not required to use FedBizOpps (FBO) for any resulting solicitation. Responses to this notice shall be in writing. Respondents are advised that the Government is not under any obligation to provide feedback to respondents with respect to any information submitted under this notice, nor is the Government bound to any further actions related to this matter. Those who respond to this notice shall not anticipate feedback with regard to their submissions other than acknowledgment of receipt if a request for an acknowledgement is requested by the submitter.

All costs associated with responding to this notice will solely be the interested party's expense. Not responding to this notice does not preclude participation in any future solicitations. The information provided in this notice is subject to change and is not binding on the Government. All submissions become the property of the Government and will not be returned.

The purpose of this notice is for market research and to obtain information regarding (1) the availability and capability of qualified sources and (2) their size classification relative to the North American Industry Classification System (NAICS) code 325413.

REQUESTED INFORMATION

Sources responding to this notice shall submit the minimum information necessary for the Government to make a determination about the current industry capabilities. Responses to this notice shall include the following: (1) Company name (2) Address (3) Point of contact (4) Phone and Email address (5) Data Universal Numbering System (DUNS) number and (6) Type of business (large or small). If a small business, please include your socio-economic status (e.g. Services Disabled Veteran Owned, Veteran-owned, 8(a), HUBZone, Women Owned, Disadvantaged, or HUBZone Small Business). Respondents must provide a capability statement that addresses the organization’s qualifications and ability to conform to the requirements in the attached draft statement of work (SOW). Respondents' capability response shall include relevant information regarding the organization, brief description of recent and relevant projects for tasks similar to those in the draft SOW, technical capabilities and ability to conform to the requirements in the draft SOW. Respondents may submit questions or comments regarding the draft

SOW.

All interested organizations are invited to respond to this notice. The responses to this notice are not expected to be quotations, but rather statements regarding the organization’s capabilities in relation to the attached draft SOW.

Responses shall not exceed ten (10) pages and the font shall be no smaller than 12 point Times New Roman. Written responses shall be in MS Office (Word, Excel, or PowerPoint) or Adobe pdf format.

Respondents shall submit responses electronically via email by no later than 4:30 pm EST by April 26, 2019. All responses and inquiries to this notice shall be emailed to Evron.Rollins@psa.gov. Email subject lines shall follow this convention: “PSA SYNOPSIS/SOURCES SOUGHT NOTICE IMMUNOASSAY REAGENTS & INSTRUMENTATION RESPONSE - Organization Name.” Telephone calls and facsimile transmissions regarding this notice will not be accepted. This announcement will remain open until 4:30 pm EST on April 26, 2019. The estimated release date for the solicitation is mid/late May 2019.

SOURCES SOUGHT NOTICE/SYNOPSIS

mailto:Evron.Rollins@psa.gov.

Written responses to this notice does obligate the Government to follow up with any particular organization. Please note that PSA may publish answers to questions and comments received in response to this notice if the anticipated requirement results in a solicitation.

PROPRIETARY INFORMATION

Information provided to the Government will be treated as business sensitive if appropriately marked.

Interested parties are responsible for adequately marking proprietary or sensitive information contained in their response. Any confidential, proprietary, or privileged information shall be clearly labeled. To the full extent that it is protected pursuant to the Freedom of Information Act and other laws and regulations, information identified by a respondent as confidential, proprietary, or privileged will be appropriately controlled.

SOURCES SOUGHT NOTICE/SYNOPSIS

IMMUNOASSAY REAGENTS & INSTRUMENTATION FOR DRUGS ABUSE TESTING IN

URINE

1.0 STATEMENT OF WORK

1.1 BACKGROUND

The Pretrial Services Agency for the District of Columbia (PSA) is an independent federal agency under the Court Services and Offender Supervision Agency. PSA’s Office of Forensic Toxicology Services (OFTS) performs urine drug and other tests as ordered by the Court for all defendants, adults and juvenile in pretrial status or drug courts, offenders on probation or parole, and parents charged with abuse or neglect. OFTS collects over 250,000 specimens annually and performs an average of 9.5 tests per specimen. Approximately 2.4 million tests are performed annually. Reagents for Phencyclidine (PCP) are not included in this Contract.

OFTS drug testing operation processes the following number of tests annually:

• Cocaine 252,000

• Opiates 252,000

• Heroin Metabolite 252,000

• Marijuana 96,000

• Methadone 120,000

• Ethanol 132,000

• Ethyl Glucuronide (EtG) 132,000

• Amphetamines 156,000

• Creatinine 252,000

1.2 SCOPE OF WORK

The Contractor shall provide three (3) new analyzers for high volume drug testing operations and maintain and repair the analyzers/equipment onsite. The equipment shall be in new condition (not refurbished) at its initial installation and shall be delivered and installed within 90 to 120 days of the contract award date. The Contractor shall provide all equipment, supplies and services other than those specifically designated as Government furnished. The Contractor provided equipment shall include the following:

• High Volume Drug Analyzer – Salient Characteristics

• Real time operation and data acquisition

• Bi-directional interface communication capability with PSA’s Laboratory Information

Management System (LIMS) Drug Testing Management System (DTMS) 3.0

• Positive sample identification by bar-coding

• 1,200 to 2,400 tests per hour

• Ability to load a minimum of 120 specimens

• STAT test capability

• Continuous random access open reagent system

• Ability to perform all tests listed in Section C.1 simultaneously

• Supports user definable open channels to allow for investigation of new reagents

• Multiple reagent configurations supported

• Supports multiple reagent lots on-board

• On-board test auto inventory

• Auto calibration or auto calibration alert supported

• Multipoint calibrations supported

• On-board real time quality control (QC)

• Supports multiple lots of QC per analyte

• System that can automatically transfer QC results to the PSA’s LIMS DTMS 3.0

• On-board maintenance records

• On-board maintenance procedures

• System can diagnose own malfunctions

• System can operate in an environmental temperature range of between 15 to 30 degrees Celsius

(59 to 86 degrees Fahrenheit)

• System can operate in a relative humidity range between 40% to 85% without condensation

• On-board sample data storage of 10,000 records or more

• Ability to store daily and monthly data on compact disk (CD) or flash drive

The Contractor shall provide all initial training necessary for the proper operation and operator-level maintenance of all equipment within 15 days after installation. The Contractor shall provide two (2) training slots per analyzer at the manufacturer’s training site. The training shall include basic instrument operation and theory and instrument maintenance and troubleshooting. The Contractor shall pay for transportation, lodging and tuition associated with the training.

The instruments provided shall be capable of bi-directional interfacing with OFTS’s current LIMS, DTMS 3.0. The Contractor shall be responsible for developing/building a new Windows serial interface and/or modifying PSA’s current custom built bi-directional Windows serial interface between the analyzer and LIMS. The serial interface is the communication service used to exchange data such as test requests, test results, and quality controls between the analyzer and DTMS. The existing interface is based on the specification defined in the Beckman Coulter, AU5800 Online Specification, 9th edition issued on 07/11/2014 documentation (specification available upon award or through Internet sources).

The current analyzer interface was developed using C# with MS SQL server database backend. PSA is willing to share the source code after contract award to the vendor’s developer. The bi-directional interface shall:

• Handle test acquisition request – Analyzer reads the aliquot bar code to request specific test info.

The LIMS will send the necessary tests to the analyzer

• Test results transmission/retransmission – Analyzer sends/resends the test results to LIMS

• Quality control – Analyzer sends quality control data/result to the LIMS

• Be configurable, flexible, and extensible to easily add/remove additional tests

• Have extensive communication loggings between the analyzer & LIMS

The Contractor shall maintain and repair the provided equipment on-site either directly or by a third party service contract with the instrument manufacturer so that any piece of equipment is restored to service within 24 hours in the case of scheduled maintenance or restored to operation (or replaced on-site at the Contractor's discretion) within 24 hours in the case of equipment failure. The Contractor shall provide two (2) preventive maintenance visits per instrument annually. The Contractor shall provide, maintain, and repair any water treatment systems necessary to meet the water quality of the instruments (either by third party service or directly). The Contractor shall provide specific data and specifications for water tank system installment and analyzer. The Contractor shall specify modifications to the water tank system, if any, that needs to be done to accommodate the water purification system and analyzer.

The Contractor shall provide any electrical power back-up or conditioning equipment necessary for the operation of the analyzers.

The Contractor shall provide all specific consumable supplies, such as lamps, cuvettes, surfactants, conditioning and cleaning solutions needed to perform the volume of testing indicated in Section C.1.

The Contractor shall provide a sufficient number of instrument racks to allow for the pre-analytical sample processing of 2,000 specimens. The Contractor shall supply sufficient test tubes for the volume of testing up to 252,000 test tubes annually. The Contractor shall provide the instructor/operator’s manuals for all equipment provided. Manual content and supplementary documentation shall include operating instructions, maintenance procedures, trouble-shooting procedures, theoretical treatment of the testing process, and any other content necessary to operate and maintain the equipment. The Contractor shall update the instrument operating software to the latest release at no charge to the Government.

1.2.1 Reagent Requirements

Compliance with Food & Drug Administration (FDA) Requirements

Immunoassay kits are medical devices and shall have clearance from the Food & Drug Administration (FDA) to be marketed. The registration and listing process specified by FDA shall be followed and the manufacturer shall 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 FDA shall be resolved as required by FDA’s current regulations. The Contractor shall notify the Contracting Officer (CO), Contracting Officer’s Representative (COR), and Laboratory Director via email and/or certified or overnight mail of any recall of FDA’s notification within two (2) working days of the event. 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 shall be proposed in writing to the CO, COR and Laboratory Director for review and approval prior to its incorporation into the kits to be delivered. Any re-validation of the modified reagent shall be done by the Contractor, at the Contractor’s expense and at a time acceptable to OFTS.

The reagents shall be compatible with the equipment provided by the Contractor. The materials provided shall be in volumes and packaging which are convenient and applicable to the throughput of OFTS and shall not result in the loss or unnecessary disposal of more than 5% of the working volume of the reagents. Reagent kits shall be available in low capacity (up to 1,000 test/kit) and high capacity (up to 3,500 + test/kit). Any individual bottle of reagent, which would be prepared for use at one time, shall not include materials for more than 5,000 tests.

The reagents shall be provided with a product package insert that complies with all FDA requirements 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 OFTS. The instruction sheet shall include operating parameters and instrumentation settings for use of the reagent on the Contractor's equipment. The Contractor shall provide Safety Data Sheets (SDS) for each assay identified in Section C.1 of this Contract.

The shelf life on any unopened assay kit or component shall be at least 180 days from the date of delivery to OFTS. The shelf life shall be at least 30 days once the kit container seals are broken and the component is opened.

The reagents shall meet PSA’s current cut off for the initial immunoassay test as indicated in table 1 below in order to support the agency’s mission. The reagents shall meet the cutoff guidelines in the Substance Abuse & Mental Health Services Administration (SAMHSA), PSA, Department of Transportation (DOT), and Department of Defense (DOD) Standard Drug Testing Panel and Criteria for Reporting Drug Use in the Military Drug Testing Program.

Cocaine Metabolite (Benzoylecgonine) 150 ng/ml Opiates (Morphine) 300 ng/ml Heroin Metabolite (6Acetyl Morphine) 10 ng/ml Marijuana (THCCOOH) 50 ng/ml Methadone 300 ng/ml Ethanol 20 mg/dl Ethyl Glucuronide (EtG) 1000 ng/ml Amphetamines (Amphetamine) 500 ng/ml Creatinine 20 mg/dl

Table 1: The cutoffs for urine specimens are currently used by OFTS for the initial immunoassay test.

Precision Within Run C.V. 5% or less Between Run C.V. 5% or less Salient Characteristics for Controls and Calibrators

The Contractor shall provide calibrators and control materials for the reagents at no additional cost to the Government.

Controls/calibrators shall be available in no less than 5 ml or greater than 10 ml (liquid). Calibrators shall be provided for quantitative measurement of the assays using at least three (3) point calibration curves. Calibrators and controls shall be in liquid form whenever possible. Lot numbers shall be good for six (6) months from the date of receipt. Calibrators and controls shall have a 30 day expiration when opened or reconstituted products.

Precision Within Run C.V. 5% or less Between Run C.V. 5% or less Urine matrix Controls shall be at approximately 75% and 125% of the cut-off levels

1.2.2 Government Space/Power/Storage

The Government will provide space for the Contractor’s equipment and drug testing operations. In addition, the Government will provide appropriate power required by the Contractor’s equipment as well as an appropriate operating environment. The Government will provide adequate storage facilities for the reagents and supplies. Qualified Government operators will perform and document all operator level preventive maintenance on contract supplied equipment.

1.2.3 Assay Requirements

1. Cocaine (Benzoylecgonine): The sensitivity and specificity of the assay shall provide sufficient reactivity with Benzoylecgonine such that actual human physiological specimens which contain 100 ng/ml of Benzoylecgonine, as determined by the Gas Chromatography Mass Spectrometry (GCMS), would show an apparent concentration of 150 ng/ml cocaine metabolite by the immunoassay procedure.

While Benzoylecgonine is the principal analyte for urinary cocaine detection, sensitivity to the presence of other cocaine metabolites is desired. The reagent shall provide equivalent or better performance characteristics for the detection of cocaine and its metabolites in urine as measured by the current immunoassay procedure used by OFTS. The reagent shall use a semi-quantitative protocol and demonstrate linearity for Benzoylecgonine to at least 400% of the cutoff concentration. The reagent shall be specific for Benzoylecgonine such that no less than 95% of the actual human physiological specimens identified as positive by the current OFTS immunoassay procedure will be identified as positive by the Contractor’s reagent. The reagent shall not have more than a 5% false negative rate for actual human physiological specimens identified as positive as measured by the current OFTS immunoassay procedure. The reagent shall not have more than a 5% false positive rate for actual human physiological specimens identified as negative as measured by the current OFTS immunoassay procedure.

QC: The cocaine metabolite immunoassay reagent shall maintain reproducibility in QC measurements.

The testing reagent shall identify as positive 95% or all QC specimens containing Benzoylecgonine at a concentration of 125% of OFTS cutoff of 150 ng/ml. The assay shall identify as negative by the initial test 95% of the quality control specimens that contain Benzoylecgonine at 75% of OFTS cutoff concentration. The Contractor shall provide calibrator concentrations to quantitatively measure the performance of the assay using at least three (3) calibration points on a calibration curve.

2. Opiates: Recognizing that physiologic urine specimens from opiate abuse may contain other secondary metabolites, the assay shall detect Morphine or Codeine when present at a concentration of 300 ng/mL of urine. The sensitivity and specificity of the assay will provide sufficient reactivity with Morphine such that actual human physiological specimens which contain 300 ng/ml of Morphine, as determined by GCMS, would show an apparent concentration of 300 ng/ml Opiates by the immunoassay procedure. Sensitivity to the presence of other Opiates and their metabolites is desired. The reagent shall provide equivalent or better performance characteristics for the detection of Opiates in urine as measure by the current immunoassay procedure used by OFTS. The reagent shall use a semi-quantitative protocol and demonstrate linearity for Morphine to at least 500% of the cutoff concentration. The reagent shall be specific for Opiates such that no less than 95% of actual human physiological specimens identified as positive as measured by the current OFTS immunoassay procedure will be identified as positive by the Contractor’s reagent. The reagent shall not have more than a 5% false negative rate for actual human physiological specimens identified as positive as measured by the current OFTS immunoassay procedure. The reagent shall not have more than a 5% false positive rate for actual human physiological specimens identified as negative as measured by the current OFTS immunoassay procedure.

QC: The opiate immunoassay reagent shall maintain reproducibility in QC measurements. The testing reagent shall identify as positive 95% or all QC specimens containing Morphine at a concentration of 125% of the OFTS cutoff of 300 ng/ml. The assay shall identify as negative by the initial test 95% of the QC specimens that contain Morphine at 75% of OFTS cutoff concentration. The Contractor shall provide calibrator concentrations to quantitatively measure the performance of the assay using at least three (3) calibration points on a calibration curve.

3. Heroin Metabolite (6-Acetyl Morphine): The sensitivity and specificity of the assay shall provide sufficient reactivity with 6-Acetyl Morphine such that actual human physiological specimens which contain 10 ng/ml of 6-Acetyl Morphine, as determined by GCMS, would show an apparent concentration of 10 ng/ml heroin metabolite by the immunoassay procedure. The reagent shall provide equivalent or better performance characteristics for the detection of heroin metabolite in urine as the current immunoassay procedure used by OFTS. The reagent shall use a semi-quantitative protocol. The reagent shall be specific for 6-Acetyl Morphine 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. The reagent shall not have more than a 5% false negative rate for actual human physiological specimens identified as positive by the current OFTS immunoassay procedure. The reagent shall not have more than a 5% false positive rate for actual human physiological specimens identified as negative by the current OFTS immunoassay procedure. There shall be minimal cross reactivity to other opiates especially morphine.

QC: The 6-Acetyl Morphine immunoassay reagent shall maintain reproducibility in QC measurements.

The testing reagent shall identify as positive 95% or all QC specimens containing 6-Acetyl Morphine at a concentration 200% of OFTS cutoff of 10 ng/ml. The assay shall identify as negative by the initial test

95% of the quality control specimens that contain 6-Acetyl Morphine at 50% of OFTS cutoff concentration. The Contractor shall provide calibrator concentrations to quantitatively measure the performance of the assay using at least three (3) calibration points on a calibration curve.

4. Cannabinoids (Marijuana): The sensitivity and specificity of the assay shall provide sufficient reactivity with cannabinoids such that actual human physiological specimens which contain 15 ng/ml of the marijuana metabolite THCCOOH as determined by GCMS would show an apparent concentration of 50 ng/ml cannabinoids by the immunoassay procedure. While THCCOOH is the principal analyte for urinary cannabinoid detection, sensitivity to the presence of other cannabinoid metabolites is desired.

The reagent shall provide equivalent or better performance characteristics for the detection of cannabinoids in urine as the current immunoassay procedure used by OFTS. The reagent shall use a semi-quantitative protocol and demonstrate linearity for THCCOOH to at least 300% of the cutoff concentration.

The reagent shall be specific for cannabinoids such that no less than 95% of the actual human physiological specimens identified as positive by the current OFTS immunoassay procedure will be identified as positive by the Contractor’s reagent. The reagent shall not have more than a 5% false negative rate for actual human physiological specimens identified as positive by the current OFTS immunoassay procedure. The reagent shall not have more than a 5% false positive rate for actual human physiological specimens identified as negative by the current OFTS immunoassay procedure.

QC: The cannabinoid immunoassay reagent shall maintain reproducibility in QC measurements. The testing reagent shall identify as positive 95% or all QC specimens containing THCCOOH at a concentration 125% of OFTS cutoff of 50 ng/ml. The assay shall identify as negative by the initial test 95% of the QC specimens that contain THCCOOH at 75% of OFTS cutoff concentration. The Contractor shall provide calibrator concentrations to quantitatively measure the performance of the assay using at least three (3) calibration points on a calibration curve.

5. Methadone: The sensitivity and specificity of the assay shall provide sufficient reactivity with methadone such that actual human physiological specimens which contain 300 ng/ml of methadone as determined by GCMS would show an apparent concentration of 300 ng/ml methadone by the immunoassay procedure. The reagent shall provide equivalent or better performance characteristics for detection of methadone in urine as the current immunoassay procedure used by OFTS. The reagent shall use a semi-quantitative protocol and demonstrate linearity for methadone to at least 300% of the cutoff concentration. The reagent shall be specific for methadone such that no less than 95% of the actual human physiological specimens identified as positive by the current OFTS immunoassay procedure will be identified as positive by the Contractor’s reagent. The reagent shall show minimal cross-reactivity with methadone metabolites. The reagent shall not have more than a 5% false negative rate for actual human physiological specimens identified as positive by the current OFTS immunoassay procedure. The reagent shall not have more than a 5% false positive rate for actual human physiological specimens identified as negative by the current OFTS immunoassay procedure.

QC: The methadone immunoassay reagent shall maintain reproducibility in QC measurements. The testing reagent shall identify as positive 95% or all QC specimens containing methadone at a concentration of 125% of the OFTS cutoff of 300 ng/ml. The assay shall identify as negative by the initial test 95% of the quality control specimens that contain methadone at 75% of the OFTS cutoff concentration. The Contractor shall provide calibrator concentration to quantitatively measure the performance of the assay using at least three (3) calibration points on a calibration curve.

6. Amphetamine: The sensitivity and specificity of the assay shall provide sufficient reactivity with amphetamine and methamphetamine such that actual human physiological specimens which contain 500 ng/ml of amphetamine or methamphetamine as determined by GCMS would show an apparent concentration of 500 ng/ml amphetamines by the immunoassay procedure. While amphetamine and methamphetamine are the principal analytes for urinary amphetamines detection, sensitivity to the presence of other amphetamine and methamphetamine analogs such as Methylenedioxyamphetamine (MDA), Methylene-dioxymethamphetamine (MDMA), and Methylenedioxyethylamphetamine (MDEA) is desired. The reagent shall provide equivalent or better performance characteristics for detection of amphetamine and methamphetamine in urine as measured by the current immunoassay procedure used by OFTS. The reagent shall use a semi-quantitative protocol and demonstrate linearity for amphetamine to at least 400% of the cutoff concentration.

The reagent shall be specific for amphetamines such that no less than 95% of the actual human physiological specimens identified as positive by the current OFTS immunoassay procedure will be identified as positive by the Contractor’s reagent. The reagent shall not have more than a 5% false negative rate for actual human physiological specimens identified as positive by the current OFTS immunoassay procedure. The reagent shall not have more than a 5% false positive rate for actual human physiological specimens identified as negative by the current OFTS immunoassay procedure.

QC: The amphetamines immunoassay reagent shall maintain reproducibility in QC measurements. The testing reagent shall identify as positive 95% or all QC specimens containing amphetamine at a concentration of 125% of the OFTS cutoff of 500 ng/ml. The assay shall identify as negative by the initial test 95% of the quality control specimens that contain amphetamine at 75% of the OFTS cutoff concentration. The Contractor shall provide calibrator concentrations to quantitatively measure the performance of the assay using at least three (3) calibration points on a calibration curve.

7. Ethanol: The sensitivity and specificity of the assay shall provide sufficient reactivity with ethanol such that actual human physiological specimens which contain 20 mg/dl of ethanol as determined by headspace Gas Chromatography (GC) would show an apparent concentration of 20 mg/dl of ethanol by the reagent. The reagent shall provide equivalent or better performance characteristics for the detection of ethanol in urine as measured by the current procedures used by OFTS. The reagent shall use a semi-quantitative protocol and demonstrate linearity for ethanol to at least 400 mg/dl. The reagent shall be specific for ethanol such that no less than 95% of actual human physiological specimens identified as positive by the current OFTS procedures will be identified as positive by the Contractor’s reagent. The reagent shall not have more than a 5% false negative rate for actual human physiological specimens identified as positive by the current OFTS procedures. The reagent shall not have more than a 5% false positive rate for actual human physiological specimens identified as negative by the current OFTS procedures.

QC: The ethanol reagent shall maintain reproducibility in QC measurements. The testing reagent shall identify as positive 95% or all QC specimens containing ethanol at a concentration 125% of the OFTS cutoff of 20 mg/dl. The assay shall identify as negative by the initial test 95% of the quality control specimens that contain ethanol at 75% of the OFTS cutoff concentration. The Contractor shall provide calibrator concentration to quantitatively measure the performance of the assay using at least two (2) calibration points on a calibration curve.

8. EtG: The sensitivity and specificity of the assay shall provide sufficient reactivity with ethyl glucuronide such that actual human physiological specimens which contain 500 ng/ml of ethyl glucuronide as determined by a Liquid Chromatography Mass Spectrometry (LCMS) reference method would show an apparent concentration of 500 ng/ml ethyl glucuronide by the immunoassay procedure.

The reagent shall provide equivalent or better performance characteristics for the detection of ethyl glucuronide in urine as the current immunoassay procedures used by OFTS. The reagent shall be specific for ethyl glucuronide such that no less than 95% of actual human physiological specimens identified as positive by the current OFTS immunoassay procedures will be identified as positive by the Contractor’s reagent. The reagent shall not have more than a 5% false negative rate for actual human physiological specimens identified as positive by the current OFTS immunoassay procedures. The reagent shall not have more than a 5% false positive rate for actual human physiological specimens identified as negative by the current OFTS immunoassay procedures.

QC: The ethyl glucuronide immunoassay reagent shall maintain reproducibility in QC measurements.

The testing reagent shall identify as positive 95% or all QC specimens containing ethyl glucuronide at a concentration of 125% of the OFTS cutoff of 500 ng/ml. The assay shall identify as negative by the initial test 95% of the quality control specimens that contain ethyl glucuronide at 75% of OFTS cutoff concentration. The Contractor shall provide calibrator concentrations to quantitatively measure the performance of the assay using at least two (2) calibration points on a calibration curve.

9. Creatinine: The sensitivity and specificity of the assay shall provide sufficient reactivity with creatinine such that actual human physiological specimens which contain 20 mg/dl of creatinine as determined by a reference method would show an apparent concentration of 20 mg/dl creatinine by the procedure. The reagent shall provide equivalent or better performance characteristics for detection of creatinine in urine as measured by the current procedures used by OFTS. The reagent shall use a semi-quantitative protocol and demonstrate linearity for creatinine to at least 400 mg/dl. The reagent shall be specific for creatinine such that no less than 95% of actual human physiological specimens identified as normal (greater than or equal to 20 mg/dl) by the current OFTS procedures will be identified as normal by the Contractor’s reagent. The reagent shall not have more than a 5% false negative rate for actual human physiological specimens identified as normal by the current OFTS procedures. The reagent shall not have more than a 5% false positive rate for actual human physiological specimens identified as abnormal or water-loaded (less than 20 mg/dl) by the current OFTS procedures.

QC: The creatinine reagent shall maintain reproducibility in QC measurements. The testing reagent shall identify as positive 95% or all QC specimens containing creatinine at a concentration of 125% of the OFTS cutoff of 20 mg/dl. The assay shall identify as negative by the initial test 95% of the QC specimens that contain creatinine at 75% of the OFTS cutoff concentration. The Contractor shall provide calibrator concentrations to quantitatively measure the performance of the assay using at least two (2) calibration points on a calibration curve.

1.2.4 Additional Requirements

For each assay mentioned above, the chemical compounds that may reasonably be found in urine resulting from prescription or non-prescription drug use shall be tested to characterize antibody specificity. The specificity testing shall include biochemical materials produced normally in the human body (this may be evaluated by testing the numbers of specimens of normal human urine).

2.0 PACKING AND MARKING

Preservation, packaging, and marking for all items delivered herein shall be in accordance with commercial practices and adequate to insure acceptance by common carrier and safe arrival at destination. The Contractor shall include the contract number and project title on or adjacent to the exterior shipping label. For any magnetic media provided, the Contractor shall provide extra markings for protection against exposure to magnetic fields or temperature extremes.

All documentation, reports, and other deliverables shall be clearly marked with the project title and contract number.

The reagents shall be provided with a product package insert and include data demonstrating specific performance characteristics, such as accuracy, precision, sensitivity specificity cross-reactivity and safety precautions. The instruction sheets shall include protocols optimized for OFTS operations as represented in these specifications and the cutoffs utilized by OFTS.

3.0 INSPECTION AND ACCEPTANCE

Services shall be inspected in accordance to FAR clauses 52.212-4, Contract Terms and Conditions - Commercial Items. The Contractor shall provide and maintain an inspection system acceptable to the Government covering the services under this Contract. Complete records of all inspection work performed by the Contractor shall be maintained and made available to the Government during contract performance.

The Government has the right to inspect and test all services, to the extent practicable at all times and places during the term of the Contract. The Government shall perform inspections and tests in a manner that will not unduly delay the work.

If the Government performs inspections or tests on the Contractor or subcontractor’s premise, the Contractor shall furnish, and shall require subcontractors to furnish, at no increase in contract price, all reasonable facilities and assistance for the safe and convenient performance of these duties.

If any of the services do not conform to Contract requirements, the Government may require the Contractor to perform the services again in conformity with the Contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by performance, the Government may

(1) require the Contractor to take necessary action to ensure that future performance conforms to contract requirements and (2) reduce the contract price to reflect the reduced value of the services performed.

If the Contractor fails to promptly perform the services again or to take the necessary actions to ensure future performance in conformity with contract requirements, the Government may (1) by Contract or otherwise, perform the services and charge to the Contractor any cost incurred by the Government that is directly related to the performance of such service or (2) terminate the Contract for default.

3.1 Quality Assurance and Performance Standards

Work performed by the Contractor and materials used shall meet the manufacturer’s standard.

Contractor personnel shall meet the Contractor’s training standards and instructional hours.

Documentation of training and manufacturer’s standards shall be provided to the Government upon request. Contractor personnel shall be able to demonstrate it can perform all necessary tasks associated with assay implementation, validation and performance. The Contractor shall provide valid documentation supporting a manufacturer’s production standards, guidelines and certificates of conformance. Work performed by the Contractor, materials used, technical guidelines, and administrative documented guidelines shall be provided to the Government upon request. The Contractor shall provide all equipment specific consumable supplies, such as, conditioning and cleaning solutions needed to perform the volume of testing. The Contractor shall supply sufficient test tubes for the volume of testing per year.

4.0 DELIVERIES OR PERFORMANCE

4.1 Specific Mandatory Tasks and Associated Deliverables

The Contractor shall provide the following:

1. Immunoassay reagents kits for up to 252,000 tests for 12 months, including the calibrators for quantitative measurements, quality control materials as indicated in Section C.2.4

2. Three (3) new analyzers with performance and specificity as indicated in Section C.2.

3. Technical support and troubleshooting assistance as needed. Technical support shall be provided for assay set up, validations and correlation procedure. Technical support shall be available by phone 24 hours per day, 7 days a week by local or toll free number at no cost to the Government. Contractor shall provide technical support by telephone or on-site visit when needed. A SDS shall be provided for all reagents, calibrators and quality control materials.

4. Water purification system to feed two (2) analyzers at 90 K Street and a water purification system at 500 Indiana Avenue.

5. Two (2) training slots per instrument for laboratory personnel at no additional cost to the Government.

6. Consumables such as lamps, cuvettes, spare parts for the instruments, instrument maintenance materials, sample probes, reagent probes, at no additional cost to the Government.

7. Bi-annual preventive maintenance service for the three (3) analyzers identified in Section C.2. The Contractor shall indicate, by providing specifics data, preparation to be made by the building engineers and the Government in order to accommodate the water purification system’s size and capacity.

8. Tested and working bi-directional Windows serial interface with source code.

4.2 Ordering and Delivery of Materials

Work orders for the reagents, calibrators, controls, and consumables shall be placed by the COR. The Contractor shall deliver within 24 hours of receipt of a work order the reagents, calibrators and controls for the testing of the assays identified in Section C.1 for emergency work orders and 72 hours for non-emergency work orders no additional charge to the Government. All consumables necessary to support testing, calibration, and operator level maintenance shall be provided by the Contractor. Consumables shall be delivered within 72 hours of receipt of a work order.

The Contractor shall supply technical support for all equipment and all assays/reagents and their performance characteristics on the instruments provided in Section C.2.1. Technical support shall be provided in trouble-shooting, establishing and clarifying test methods, etc.

The Contractor shall provide at least one in-house educational training session annually at no additional cost to the Government. Upon installation, the Contractor shall validate the performance of all analyzers provided and analytical performance of each assay according to the standards of practice for toxicology laboratories. The Contractor shall provide documentation of these validation studies. If required, the Contractor shall provide periodic re-validation at no additional charge.

The Contractor shall deliver the following equipment:

Equipment Delivery Location Reagents, Supplies, and Consumables 90 K St NE, Washington, DC 20530

Two (2) Instruments 90 K St NE, Washington, DC 20530 One (1) Instrument 500 Indiana Ave NW, Rm C-220, Washington DC 20001

4.3 Period of Performance

The total estimated period of performance is one base year with four option years. The option years shall be exercised at the discretion of the Government. The actual dates will be filled in at the time of award.

Base Year: Award Effective Date through 12 months Option Year 1: 13 through 24 months Option Year 2: 25 through 36 months Option Year 3: 37 through 48 months Option Year 4: 49 through 60 months

This Contract includes FAR clause 52.217-8 which allows a period of performance extension of up to six (6) months.

4.4 Place of Performance

The place of performance will be at 90 K Street NE in Washington, D.C. 20530 and 500 Indiana Ave N.W. Washington D.C. 20001

4.5 Work Hours

The Contractor shall be available during the normal business hours of 8:00 am to 4:30 pm Monday to Friday excluding federal holidays.

Synopsis SOW