National Cancer Institute, Research Contracts Branch, PSAS, 6120 Executive Blvd, EPS/Room 638, Bethesda, MD 20892-7227

B -- EXTRACTION AND CHEMICAL ANALYSIS OF DUST SAMPLES FOR CONDUCTING A MULTI-CENTER CASE CONTROL STUDY OF RISK FACTORS FOR NON-HODGKINS LYMPHOMA (NHL) SOL RFQ-NCI-80160-NV DUE 080498 POC Debbie Moore, Purchasing Agent, 301/402-4509, Todd Cole, Contracting Officer, 301-402-4509 1) The RFQ states that the solicitation is not a small business set aside, but mentions a business size standard of 500 employees. Can we assume that this is stated for definition, but the synopsis/solicitation is otherwise unrestricted as to the number of employees currently employed by respondents? Please clarify. Answer: This was included merely to provide definition. This procurement is being conducted under full and open competition, and this is the reason that the synopsis/solicitation stated "not a small business set aside."; 2) The RFQ lists SIC Code 3826, which we understand refers to suppliers of analytical instrumentation. The SIC Code for Analytical Testing Laboratories is 8734. May we assume that you would allow responses from companies with SIC 8734? Answer: A transposition error occurred while entering data into the Commerce Business Daily and the correct SIC Code is 8734. However, because a full and open competition is being conducted, offers from all responsible and responsive organizations will be considered.; 3) Please provide information on frequency of sampling and number of samples per event. Answer: A rough estimate of the number of samples that the Contractor laboratory is likely to receive each month was given in the July 13, 1998 amendment to the synopsis/solicitation. These samples might arrive at the Contractor laboratory in individual shipments or, if feasible, in small batches; we cannot be more precise at this time. If batching occurs, the Contractor laboratory would receive one shipment per week from each of eight interviewers during the base period. The number of shipments would decrease in the option periods because the number of interviewers will decrease. In the base period and each option period, each shipment will range in size from 1 to 5 samples.; 4) Will the vacuum cleaner dust bags, in the styrofoam containers, be sent to the Contractor laboratory in a chilled state, i.e., with dry ice or "blue ice?" Answer: No attempt will be made to keep the samples chilled.; 5) Is it possible to make sample pickups? Answer: No. All samples must be collected, handled, and shipped in a consistent way, according to a specified protocol that will be followed by each interviewer.; 6) Please verify the Turn Around Time of analytical results. Is it 6 weeks? Answer: As discussed in the original synopsis/solicitation and July 13 amendment to the solication, the results shall be provided to NCI no later than six weeks after the specific samples to be analyzed are identified by NCI, provided that no more than 50 samples are identified for analysis at a given time. If NCI identifies more than 50 samples at once, NCI will arrange a reasonable schedule for this work with the Contractor laboratory.; 7) One offeror asked for a literature source to back up NCI's statement in the July 13 amendment that "NCI's experience is that neutral compounds require a different extraction method than acid compounds." This offeror also asked how to incorporate an alternative extraction scheme into the price matrix. Answer: The statement that both a neutral and acid extraction are required is based on the NCI Project Officer's knowledge of other studies in which carpet dust samples are being analyzed for a wide range of pesticides and other constituents. We can cite no reference stating that this is the only approach that can be used, and it is possible that other appropriate extraction methods exist. Therefore, an offeror may propose an alternative extraction method provided that the offeror submits performance data and other information with the offer that demonstrates that the method will meet the stated requirements for detection capability and precision. (NOTE: This represents a change from the specifications set forth in the original synopsis/solicitation.) If the offeror proposes an alternative scheme which still involves two extractions, the offeror should simply change the wording in the Schedule of Work Elements, as necessary, to reflect the alternative methods; the structure of the Schedule of Work Elements should not be changed. If only one extraction is proposed, the following changes should be made to the Schedule of Work Elements: (i) cross out the "Neutral Extraction and Chemical Analysis" column; (ii) reword the heading of the "Acid Extraction and Chemical Analysis" column appropriately; (iii) change the number of "duplicates" in the "Acid Extraction and Chemical Analysis" column from "20" to "40," and the total number of samples from "420" to "440," in the Base Period and each Option period; and (iv) cross out "20 neutral extracts + 20 acid extracts" from the "Chemical Analysis of Duplicate Extracts" column. If price becomes the determining factor for selection, the bottom line amount for the base plus all options will be used.; 8) Please provide the Schedule of Work Elements to include the breakdown for each type of testing. Answer: If the offeror proposes the neutral/acid extraction scheme required in the original synopsis/solicitation, the Schedule of Work Elements already breaks down the required types of testing into two categories: a neutral extraction/analysis and an acid extraction/analysis. Both extractions would be performed on all samples. The neutral extraction/analysis would generate results for all of the neutral-extractable analytes, and the acid extraction/analysis would generate results for all of the acid-extractable analytes. Further breakdown of the testing in the Schedule of Work Elements is unnecessary. If the offeror proposes an alternative extraction scheme, the response to question #7 discusses ways in which the offeror may modify the Schedule of Work Elements to reflect the alternative scheme.; 9) Please provide detection limits for each of the methods. Answer: As discussed in the June 23, 1998 synopsis/solicitation and July 13, 1998 amendment, the analytical methods used by the Contractor laboratory must have the capability of detecting most target analytes at levels as low as 0.10 ug per g of dust. The offeror must propose the specific methods to be used and provide documentation of the capability of these methods to meet the required detection limits.; 10) It has been our experience that for extended target analyte lists (especially pesticides), interferences may be encountered that result in elevated detection limits for some analytes. If some analyte/detection limit combinations prove intractable during application of the initially proposed methodology to the carpet dust matrix, can the laboratory propose alternative or "tiered" pricing to accommodate subsequent application of alternative analytical strategies? Or, can we propose pricing for two analytical options in anticipation of potential method limitations? Answer: The offeror should not propose tiered or multiple analytical options in anticipation of interferences. NCI recognizes that interferences may occur for some analytes and has allowed for this by requiring a detection limit of 0.10 ug/g for "most," but not all, analytes. The offeror should propose methods that minimize problems due to interferences to the extent possible. Offerors should discuss anticipated interferences in their proposals when discussing the ability of proposed methods to meet the required detection limits.; 11) Would NCI value a method alternative which offers significantly lower reporting limits than those stated in the RFQ? Answer: The reporting limits stated in the RFQ (0.10 ug per g of dust for most constituents) are sufficiently low for the purposes of NCI's epidemiologic study of non-Hodgkin's lymphoma. Therefore, lower reporting limits will not earn extra points in the technical evaluation of proposals.; 12) Can analyses be performed at multiple facilities within a given laboratory? For example, facility A could perform sample sieving/storage, extraction, and PAH analysis, while facility B performs pesticide/PCB analysis? Answer: Analyses may be performed at multiple facilities provided that a demonstration is made that the integrity of the samples will not be compromised by additional shipping and handling.; 13) Does NCI require data on the mass distribution between the coarse and fine fractions after sieving? Answer: NCI requires data on (i) the total weight of the dust sample, (ii) the total weight of the dust that passes through the sieve (i.e., the fine fraction), and (iii) the weight of the fine fraction stored after all of the required analyses have been done.; 14) Does NCI have any specific reporting format requirements for the results of the analyses that will be returned to them? Besides data submission, will interim reports and/or a formal final report be required? Answer: Although no specific format is required for the monthly reporting of results, the following data elements must be included: (i) dates samples were received, sieved, extracted, and analyzed; (ii) weights of the dust samples, the fine fractions, and the amounts remaining in storage (see answer to question #13); (iii) concentration of each analyte in ug/g, along with any necessary data reporting qualifiers; (iv) results of all quality control activities conducted that month, including a short evaluation of data quality; and (v) a discussion of any problems that were encountered and planned solutions. Neither interim nor final reports will be required.; 15) Are we required to include costs of any trips that will be required to NCI headquarters for meetings during the course of the project? Answer: Do not include costs for trips, as no trips to NCI headquarters are anticipated. NCI will communicate with the Contractor laboratory via telephone, FAX, and e-mail. If necessary, the NCI Project Officer will visit the Contractor laboratory, at no cost to the Contractor laboratory. Posted 07/22/98 (W-SN226795). (0203)

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