A02 SOURCES SOUGHT FINAL.pdf

SYNOPSIS/SOURCES SOUGHT NOTICE: Phencyclidine (PCP) Immunoassay Reagents, Calibrators, Quality Control & Marijuana (THC)

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 request for quotation (RFQ) and responses to this notice will be treated as information only. No RFQ exists; therefore, do not request a copy of a RFQ. 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 for any resulting RFQ. 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 submission 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 RFQ. 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 to transmit a notice of a proposed contract action, for market research, and to obtain information regarding the capability of qualified sources.

REQUESTED INFORMATION

Sources responding to this notice shall submit the minimum information necessary for the Government to make a determination about the current industry’s capabilities. Responses to this notice shall include the following: (1) Company’s 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 shall indicate whether they can provide all requirements indicated in Attachment 1.

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.

Responses shall not exceed three (3) pages and the font shall not be 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 5:00 pm EST by March 5, 2020. 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: PHENCYCLIDINE (PCP) REAGENTS RESPONSE - Organization Name.” Telephone calls and facsimile transmissions regarding this notice will not be accepted. This announcement will remain open until 5:00 pm EST on March 5, 2020.

Written responses to this notice does obligate the Government to follow up with any particular organization.

mailto:Evron.Rollins@psa.gov.

SYNOPSIS/SOURCES SOUGHT NOTICE: Phencyclidine (PCP) Immunoassay Reagents, Calibrators, Quality Control & Marijuana (THC)

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.

SYNOPSIS/SOURCES SOUGHT NOTICE: Phencyclidine (PCP) Immunoassay Reagents, Calibrators, Quality Control & Marijuana (THC)

ATTACHMENT 1

(This is not a Request for Quotation (RFQ)).

1 General Information

The Pretrial Services Agency for the District of Columbia (PSA) is an independent federal agency under the Court Services and Offender Supervision Agency (CSOSA). PSA’s Office of Forensic Toxicology Services (OFTS) performs urine drug testing for all defendants, adults and juveniles in pretrial status and drug courts, offenders on probation or parole, parents charged with abuse or neglect, and other tests as ordered by the Courts. OFTS collects over 360,000 specimens annually. The monthly drug testing volume for phencyclidine (PCP) is up to 19,000 tests and up to 228,000 tests annually. The PCP reagents shall include quality control materials for marijuana, Tetrahydrocannabinol (THC) 40 and THC 60 per reagent and shall be compatible with the Government’s Beckman 5810 clinical chemistry analyzer. Testing will be performed on instrumentation provided by the Government.

2 Phencyclidine (PCP) Reagent Requirements

2.1 Immunoassay kits are medical devices and shall have clearance from the Food & Drug Administration (FDA) in order 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. 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 by certified or overnight mail or via email of any recall of FDA’s notification within two (2) working days of the event.

2.2 Except as provided herein, the reagents supplied throughout the duration of this Contract shall be identical to the reagents offered by the Contractor and accepted by the Government at the time of Contract award. If during the course of this Contract, the manufacturer wishes to change or improve its reagents, the product modification shall be proposed in writing to the CO, COR, and Laboratory Director for approval prior to the Contractor incorporating the modified reagents into the kits to be delivered. Any revalidation of the modified reagents shall be done by the Contractor at their expense and at a time acceptable to OFTS.

2.3 The materials provided shall be in volumes and packages, 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. Any individual bottle of the reagents, which would be prepared for use at one time, shall not include materials for more than 5,000 tests.

2.4 The reagents shall be provided with a product package insert that compiles with all of FDA’s requirements and shall include 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’s operations as represented in these specifications and at cutoffs utilized by OFTS. The instruction sheet shall include operating parameters and

SYNOPSIS/SOURCES SOUGHT NOTICE: Phencyclidine (PCP) Immunoassay Reagents, Calibrators, Quality Control & Marijuana (THC) instrumentation settings for use of the reagents on the Beckman 5810 clinical chemistry analyzer.

2.5 The shelf life of unopened assay kits or components shall be at least 180 days from the date of delivery to OFTS. Once the kit container seals are broken and the component is opened, the assay kits shall have a shelf life of at least 30 days.

2.6 The reagents shall meet the current Substance Abuse & Mental Health Services Administration (SAMSHA) standards, OFTS’s standard operating procedures, Department of Transportation (DOT) standards, and the Department of Defense’s (DOD) Standard Drug Testing Panel and Criteria for Reporting Drug Use in the Military Drug Testing Program cutoff guideline of 25 ng/ml.

Precision at the 25ng/ml cutoff for the Reagents -Within run C.V. of 5% or less -Between run C.C. of 5% or less

3 Salient Characteristics for Calibrators & Controls

3.1 The Contractor shall provide sufficient calibrator materials for each reagents, which shall meet SAMSHA’s, OFTS’s, DOT’s, and DOD’s cutoff of 25 ng/ml, and sufficient control materials for the reagents at approximately 75% and 125% of the 25 ng/ml cutoff concentration at no additional charge to the Government to perform the volume of testing shown.

3.2 Calibrators and control materials shall be available in no less than 5 ml or greater than 25 ml.

Calibrators and control materials shall be available in liquid form whenever available. Calibrators and control materials shall have a 30-day expiration of opened or reconstituted products. Lot numbers shall be good for six (6) months from date of receipt.

Precision of the Controls run with the Contractor’s reagents.

-Within run C.V. of 5% or less -Between run C.V. of 5% or less

4 Assay Specific Requirements

4.1 The sensitivity and specificity of the assays shall provide sufficient reactivity with the PCP reagents that actual human physiological specimens, which contains 25 ng/ml of the PCP reagents as determined by the Gas Chromatography Mass Spectrometry (GCMS), would show an apparent concentration of 25 ng/ml by the immunoassay procedures.

4.2 The reagents shall provide equivalent or better performance characteristics for the detection of PCP in human urine in accordance with the below (OFTS’s immunoassay procedures).

4.2.1 The reagents shall use a semi-quantitative protocol and demonstrate linearity for PCP for at least 100 ng/ml.

SYNOPSIS/SOURCES SOUGHT NOTICE: Phencyclidine (PCP) Immunoassay Reagents, Calibrators, Quality Control & Marijuana (THC)

4.2.2 The reagents shall be specific for PCP such that no less than 95% of the actual human physiological specimens identified as positive in accordance with the OFTS’s immunoassay procedures will be identified as positive by the Contractor’s reagents.

4.2.3 The reagents shall not have more than a 5% false negative rate for actual human physiological specimens identified as positive in accordance with the current OFTS’s immunoassay procedures.

4.2.4 The reagents shall not have more than a 5% false positive rate for actual human physiological specimens identified as negative in accordance with OFTS’s immunoassay procedures.

4.2.5 The chemical compounds that may reasonably be found in urine resulting from prescription or non-prescription drugs 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).

4.2.6 The assays shall show minimal cross-reactivity to Dextromethorphan and its metabolites.

The assays shall show minimal or no cross-reactivity with Dextromethorphan at therapeutic concentrations.

5 Quality Control (QC)

The PCP immunoassay reagents shall maintain reproducibility in quality control (QC) measurement.

The reagent shall identify 95% of all positive QC materials containing PCP at 125% of OFTS’s cutoff concentration and 95% of all negative QC materials containing PCP at 75% of OFTS’s cutoff concentration. OFTS’s cutoff concentration for PCP is 25ng/ml.

5.1 THC 40 & THC 60

The Contractor shall provide sufficient THC quality controls (QC) materials that shall identify THC metabolites at 20% above the cutoff for all positive specimens and 20% below the cutoff for all negative specimens. OFTS’s cutoff for THC 50ng/ml. The Contractor shall follow the procedures identified in Sections C.4.2.1 through C.4.2.6 above.

6 Other Requirements

6.1 The Contractor shall provide trouble-shooting, method set-up, and method validation technical support services. The technical support services shall be available by telephone 24 hours per day, 7 days per week by local or toll-free number at no additional cost to the Government.

6.2 The Contractor shall set-up and validate the initial performance of the assays 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.

SYNOPSIS/SOURCES SOUGHT NOTICE: Phencyclidine (PCP) Immunoassay Reagents, Calibrators, Quality Control & Marijuana (THC)

7 Ordering & Delivery of Materials

Requests for PCP reagents, calibrators, and control materials will be placed by the COR or designee.

The Contractor shall deliver within 24 hours of receipt of a request the reagents, calibrators, and controls for the testing of PCP at no additional charge to the Government for emergency orders and 72 hours for non-emergency orders.

8 Additional Information

The Government will provide the appropriate instrumentation for the analysis. Currently the Government uses a Beckman 5810 clinical chemistry analyzers. The Government will provide adequate storage facilities for the reagents, calibrators, and controls. Qualified Government operators will perform all testing.