Laboratory Testing Services

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR A PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI) Office of Acquisitions (OA), on behalf of the National Center for Advancing Translational Sciences (NCATS), intends to negotiate and award a purchase order on a noncompetitive sole source basis to OpAns, LLC, 4134 S. Alston Avenue, Suite 101, Durham, NC 27713-1870 to provide laboratory testing services in accordance with the following information: Background Information ToxCastTM will provide the U.S. National Toxicology Program (NTP), the NIH Chemical Genomics Center (NCGC), and EPA regulatory programs an efficient tool for rapidly and efficiently screening compounds and prioritizing further toxicity testing. Confirmation of chemical structure, purity, concentration, and stability of compounds is critical to a successful program. In order to provide cost effective high throughput chemical analysis, a laboratory must have the capability to receive, handle, and process a large number of samples, analyze samples by multiple analytical techniques, handle a diversity of chemical structures, maintain a high level of data quality, and produce quality results in a timely manner. Phase One (1): Preparation of the Quality Management Plan The contractor shall allocate key personnel to fully develop a Quality Management Plan (QMP) with QA Project Plan (QAPP) specific for this project. The QAPP will encompass the full expected scope of the project. Specifically, it will cover all steps in all phases described as set forth herein. The QMP shall be documented and approved by the Director of Quality Assurance for the National Center for Computational Toxicology (NCCT). It shall include, but not be limited to the following: - Procedures and schedules for internal and external systems and performance audits; - Subcontractor assessments (e.g., to ensure quality of measurements) specifications of analytical requirements in management approved SOP and the training of staff; Analyses shall begin following approval from the sponsor and receipt of initial samples. And analyses shall follow the approved analytical method, data analysis, and reporting process. Phase Two (2): LC/MS/CLND/ELSD/UV Analysis and Data Review The exact number of samples to be analyzed by any service is subject to change based on the request of the sponsor. The current estimate is for 5 batches of samples to be analyzed using Service 1 for a combined total of 10,000 analyses. The current estimate is that 2,000 samples need to go through Service 2. Samples (aqueous or DMSO solutions) provided by the sponsor will first be analyzed by LC/DAD-UV/ELSD/CLND/MS to determine presence, purity, and quantity of compound. Calibration and Quality Control samples shall be included with every analytical run. Data shall be assessed to determine if further analysis is required. If so, a decision tree shall be followed to determine the subsequent analytical test to be performed. The following is a list of requirements for Phase Two (2): - The HPLC method will be a reversed phase gradient from water to methanol with 0.1% acetic acid as the modifier in both solvents. The linear portion of the gradient will be approximately 3 minutes. The peak capacity of the separation will be determined by the standards used in the system suitability mix. Peak capacity will be defined as peak width at half height divided by linear gradient time. The peak capacity of the system will be >100. - The ionization source for the mass spectrometer will be electroscopry. - A fast scanning mass spectrometer will operated in the Positive / Negative switching mode and the scan range will be approximately 100 to 1000 m/z. - A single system suitability mix, containing at least 4 compounds, will be used to both determine the suitability of the system and to calibrate the quantitative detectors. - A separate QC sample will be prepared containing compound(s) not in the suitability mix. - Data will be assessed to determine if further analysis is required (i.e., for failed samples). Review of Failed Samples A Senior Chemist / Senior Scientist shall review all failed samples and make a recommendation, based on the decision tree, for the secondary analysis. This process shall require review of the analytical data, structure, and Certificates of Analysis (if they exist). The output shall be the best option for analysis from the other service options. Reporting Requirements and Deliverables Samples shall be analyzed in sets (e.g., an LC/MS run or sequence). The calibration and QC samples of each set shall be evaluated against the acceptance criteria established by the quality plan. Samples in the sets that pass the acceptance criteria shall be further analyzed according to the criteria set forth in the quality plan to determine the outcome. For sets that do not pass, an investigation will determine the reason for failure, corrective action taken, and subsequent analysis performed as applicable. For samples that fail to meet the acceptance criteria, the decision tree specified in the quality plan will be followed to determine means of subsequent analysis. The following information shall be returned with the results: - Raw analytical data; - Pdf. (or other nonproprietary electronic format, if desired) of the processed analytical data, with interpretation (this may include: compound ID, analysis method(s), analytical chromatogram, analysis date, presence / identity, purity, concentration, or aqueous solubility); and, - A tabulated spreadsheet of the summary results. Only the final set of results shall be returned for each tested sample. Results shall be returned within the timeframe set by the performance objective. The sole source justification is based on the fact that OpAns, LLC is uniquely qualified to provide these services. This is a follow-up to previous services in which approximately 7000 samples have already been analyzed by OpAns. These compounds are part of a stability test where they must be reanalyzed using the exact same method after four (4) months to verify individual compound stability. It is imperative that the 7000 samples be reanalyzed with the original OpAns method for validity of the stability test. The period of performance is twelve (12) months from date of contract award. The delivery point is the National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS), Bethesda, MD. The North American Industry Classification System (NAICS) Code is 541380, Testing Laboratories, with a small business size standard of $14.0M. This solicitation is set aside for small businesses. This acquisition is being conducted under FAR Part 13, Simplified Acquisition Procedures, therefore the requirements of FAR Part 6, Competitive Requirements, are not applicable and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-60 (July 26, 2012). Interested parties may identify their interest and capabilities in response to this synopsis by August 20, 2012 at 9:00am Eastern Standard Time. The determination by the Government not to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct future competitive procurements. Inquiries to this announcement, referencing synopsis number NHLBI-CSB-(NC)-2012-260-JML, may be submitted to the National Heart, Lung, and Blood Institute, Office of Acquisitions, COAC Services Branch, 6701 Rockledge Drive, Room 6151, Bethesda, Maryland 20892-7902, Attention: Jonathan Lear. Responses may be submitted electronically to contact@example.gov. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative.