Loren Data's SAM Daily™

FBO DAILY ISSUE OF MARCH 04, 2009 FBO #2655
SOLICITATION NOTICE

66 -- Immunoassay Reagent and Equipment

Notice Date

3/2/2009
 

Notice Type

Presolicitation
 

NAICS

334516 — Analytical Laboratory Instrument Manufacturing
 

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
 

Solicitation Number

PSA-09-RFP-G0001
 

Point of Contact

Angela W Simmons,, Phone: (202) 220-5644, Pamela Durrett,, Phone: 202-220-5647
 

E-Mail Address

angela.simmons@csosa.gov, pamela.durrett@psa.gov
 

Small Business Set-Aside

N/A
 

Description

Description/ Specification/ Works Statement For Immunoassay Reagent and Instrumentation General Information The District of Columbia Pretrial Services is an independent agency under the Court Services and Offenders Supervision Agency. Pretrial Services Agency’s Forensic Toxicology Drug Testing Laboratory (FTDTL) 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 a ordered by the court. The FTDTL collects over 500,000 urine specimens per year, screening for 3-7 drugs per urine specimen, with an average of 4.8 tests per urine specimen. An estimated 3,200,000 tests are performed per year. This document provides information necessary to assist in the procurement of a new immunoassay reagent/instrumentation contract for the FTDTL drug testing operation. 1.1 Estimated monthly drug testing volume by test is: Cocaine 50,000 Opiates 44,000 Marijuana (THC) 45,000 Phencyclidine (PCP) 39,000 Methadone 12,500 Ethanol (ETOH) 20,000 Amphetamines 20,000 Creatinine 40,000 Equipment and Consumable: Requirements The Contractor shall provide the Agency with three (3) analyzers for high volume drug testing operations and maintain and repair the equipment onsite. The equipment provided shall be new condition at its initial installation, and will be delivered and installed within 30 days of the contract award date. Also, the Contractor shall provide the Agency with one GCMS instrument for quality control and confirmation testing purposes. The contract shall provide all equipment, supplies and services, other than those specifically designated as Government furnished. Contractor-provided equipment shall include: 2.1 High Volume Drug Analyzer Salient Characteristics- •Real-time operation and data acquisition •Bi-directional communication capability •Bar-coding capability (multiple codes) •Refrigerated reagent storage (2 to 8 degrees Celsius) •1200-2400 tests per hour processing capability •Be able to load at least 120 samples at one time •Be able to perform all tests listed in 1.1 •QC data acquisitions and analysis •Positive sample identification •Operate in an environmental temperature range of between 15 to 30 degrees Celsius (59 to 86 degrees Fahrenheit) •Operate in a Relative Humidity range of between 40 to 85% without condensation •On-board or linked CRT, keyboard, and printer •Sample data storage: 10,000 records or more •Open channel capacity to allow for investigation of new reagents 2.1.2 Gas Chromatography/Mass Spectrometry-Agilent GC/MS 7890A GC/5975C MSD or equal Salient Characteristics- •Real-time operation and data acquisition through a linked CRT, keyboard, and printer •Sample data storage: greater than 1000 records •Bi-directional communication capability •Bar-coding capability (multiple codes) •Positive sample identification •Auto-sampling capability •Sample size: 1-5 micro liters •Split/ Splitless injection modes •Acquisition modes: Scan and SIM mode capability •Quantitative data analysis •Drug/ chemical spectral libraries (NIST, PFLEGER) •QC data acquisition and analysis •Operate in an environmental temperature range of between 15 to 30 degrees •Celsius (59 to 86 degrees Fahrenheit) •Operate in a Relative Humidity range of between 40 to 85% without condensation 2.1.3 The Government agrees to purchase exclusively from the Contractor, on a requirements basis, all drug testing reagents for its drug-testing program so long as the Contractor is able to meet the re-supply response time shown in 2.2 and other performance standards shown in this work statement. The Contractor shall provide two (2) preventive maintenance visits per instrument annually. 2.1.4 The Contractor shall maintain and repair the provided equipment on-site either directly or by a third party service contract with the instrument manufactures so that any piece of equipment is restored to service within 24 hours in the case of scheduled maintain 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, maintain and repair any water treatment systems necessary to meet the water quality of the instruments (offered in 2.1.1 either by third party service or directly). 2.1.5 The Contractor shall provide all equipment-specific consumable supplies, such as lamps, curvettes, surfactants, and conditioning and cleaning solutions. 2.1.6 The Contractor shall provide a sufficient number of instrument racks to allow for the pre-analytical sample processing of 4000 specimens. The Contractor shall supply sufficient test tubes for the volume of testing, estimated at 60,000 test tubes per month. 2.2 Reagents Requirements 2.1.1 The Contractor must be able to deliver, within 24 hours of receipt of an order, reagents for the testing of: amphetamines, cocaine, methadone, opiates, cannabinoid, creatinine, and alcohol at no additional costs to the Government. 2.1.1.1 Compliance with Food & Drug Administration (FDA) Requirements Immunoassay 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. 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 kit, 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 compiled 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 re-validation of the modified reagent will be done by the Contractor, at their expense and at a time acceptable to the FTDTL. 2.1.1.2 The materials provided must be in volumes and packaging, which are convenient and applicable to the throughput of the FTDTL and should not result in the loss of unnecessary disposal of more than 3% 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 5,000 tests. The contractor will be required to provide calibrators and control materials for the drug reagent. The materials must be provided with an instruction sheet 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 procedures optimized for FTDTL operations as represented in these specifications and at cutoffs utilized by the FTDTL. The instruction sheet shall include operating parameters and instrumentation settings for use of the reagent on the Contractor’s equipment. Shelf Life-Minimum - shelf life of any unopened component of the assay shall be at least 180 days from date of delivery at the FTDTL. Once kit container seals are broken and the component opened, the shelf life must be at least 30 days. Salient characteristics for analytical reagents: •FDA approved homogeneous immunoassay-based measurements •Liquid •The reagents must have an unopened, un-reconstituted shelf life of six (6) to twelve (12) months. •Thirty-days (30) expiration dating on reconstituted on opened products •Precision: ○Within run: c.v.2.0 or less (1.0 or less preferred) ○Day-to-day: c.v.2.0 or less (THC 3.0 or better) •Meet current Substance Abuse & Mental Health service Administration (SMSHA), PSA, Department Of Transportation (DOT) and Department Of Defense (DOD) Standard Drug Testing Panel an Criteria for Reporting Drug Use in the Military Drug Testing Program cutoff guidelines. 2.3 The contractor shall deliver, within 24 hours of receipt of an order, controls and calibrators, which must meet SAMSHA, PSA, DOT and (DOD) standard cutoff values at no additional costs to the Government. Controls/calibrators must be available in not less than 5ml or greater than 25 ml sizes (liquid). The Contractor shall guarantee testing accuracy of at least 95%. Salient characteristics for controls and calibrators: •Liquid •Lot numbers good for one year •Thirty-days (30) expiration dating on reconstituted products •Precision: Within run: c.v.2.0 or less (1.0 or less preferred) Day-today: c.v.2.0 or less (THC 3.0 or better) •Urine matrix •Able to monitor SAMSHA and DOD cutoff guidelines •Threshold controls shall contain approximately 75% and 125% cutoff levels. •The reagents/controls/standards must have un-reconstituted shelf lives of at least six months. 2.4 Equipment-specific consumables shall also be delivered within 24 hours of receipt of an order. All consumables necessary to support testing, calibration, and operator-level maintenance shall be provided by the Contractor. Overnight shipping shall not result in additional charges. 2.5 Cutoff calibrators must have the following values: 500 ng/mL d-Amphetamine 150 ng/mL Benzoylecgonine 300 ng/mL Methadone 300 ng/mL Morphine 25 ng/mL PCP 50 ng/mL Delta-9 THC 2.6 Requirements for Immunoassay Test Reagent The following drug cutoffs in urine specimens are currently used by the FTDTL for the initial immunoassay and GC/MS confirmation tests. 2.6.1 Screening Cutoff in ng/mL Drug/ Metabolite Initial Test 11 Nor delta 9 THC carboxylic acid (THCCOOH) 50 Cocaine (Benzoylecgonine) 150 Opiates (Morphine) 300 Phencyclidine (PCP) 25 Amphetamine/ Methamphetamine (amphetamines) 500 Methadone 300 Ethanol 20mg/dL Creatinine 20mg/dL 2.6.2 Confirmation Cutoff in ng/mL Drug/ Metabolite GC/MS 11 Nor delta 9 THC carboxylic acid (THCCOOH) 15 Cocaine (Benzoylecgonine) 100 Opiates (Morphine) 300 Morphine 300 Codeine 300 Phencyclidine (PCP) 25 Amphetamine/ Methamphetamine (amphetamines) 500 Morphine 300 Ethanol 20mg/dL 2.7 Reagent kits shall be available in low capacity (approx. 1,000 test/kit) and high capacity (3,500+test/kit) sizes. Reagents must be compatible, at a minimum, with the equipment provided by the Contractor in 2.1.1. 2.8 The Contractor shall supply technical support for all equipment and for all assays/ reagents and their performance characteristics on the instruments provided in 2.1. Technical support shall be provided in trouble-shooting, establishing and clarifying test methods, etc. This technical support shall be available by telephone 24 hours per day, 7 days a week by local or toll-free number at no additional cost to the Government. 2.9 High and low controls at 25% above/ below cutoff must be available for each assay. 2.10 Since drug laboratory operations are continuous, the Government reserves the right to purchase reagents/ supplies from other sources if the Contractor fails to provide the reagents within 24 hours of receipt of an order. 2.11 The Contractor shall provide all initial training necessary for the proper operation and operator-level maintenance of all equipment within 15 days after installation. Training Base Year training will consist of training on each instrument listed. Contractor shall provide two (2) training slots for the analyzers at the analyzer’s manufacturer training site. The training should include basic instrument operation and theory, instrument maintenance and troubleshooting. The Contractor shall pay for transportation, lodging and tuition. 2.12 The Contractor shall provide, in-house educational training of new issues, at least one (1) per year at no cost to the Government. 2.13 The instrument(s) provided in support of this contract shall be capable of interfacing with the existing FTDTL Laboratory Information Management System (LIMS), DTMS.Net. The contractor shall provide technical support and communication protocol specifications for the instrument interface. 2.14 The Government shall provide access for a pre-award survey, which will include verification of the automated systems interface. 2.15 The Contractor shall provide training on each piece of equipment provided. This training shall meet equipment manufacturer’s standards for full operator qualification for equipment operation and performance of operator-level preventive maintenance. 2.16 The Contractor shall provide operator’s manuals for each piece of equipment provided. Manual content (and supplementary documentation as necessary) 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. 2.17 The Contractor shall deliver reagents and supplies to: Forensic Toxicology Drug Testing Laboratory (FTDTL) 300 Indiana Avenue NW, Suite 6150 Washington, DC 20001 Instruments 1 (one), will be delivered to: 500 Indiana Avenue NW, Rm. C-220 Washington, DC 20001 Instruments 2 (two), will be delivered to: 300 Indiana Avenue NW, Suite 6150 Washington, DC 20001 All deliveries shall be made during normal working hours (9AM to 5PM local time). Exceptions can be arranged. 2.18 Installation, the Contractor shall validate the performance of all analyzers provided and analytical performance of each assay according to standards of practice for Toxicology laboratories. The Contractor shall provide documentation of these validation studies. If the Contractor’s equipment requires periodic re-validation, the Contractor will provide this service at no additional charge. A Pre-Proposal conference will be conducted on April 16, 2009
 

Web Link

FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=0420d484784038b7b066f44307d18a52&tab=core&_cview=1)
 

Place of Performance

Address: D.C. Pretrial Services Agency, Forensic Toxicology Durg Testing Lab, 301 C Street, NW, Suite 6150, Washingrond, District of Columbia, 20001, United States

Zip Code: 20001
 

Record

SN01759924-W 20090304/090302215524-0420d484784038b7b066f44307d18a52 (fbodaily.com)
 

Source

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

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